Electrically weldable suture material and apparatus and methods for forming welded suture loops and other welded structures

文档序号：366661 发布日期：2021-12-07 浏览：12次中文

阅读说明：本技术 可电焊接缝合线材料以及用于形成焊接缝合线环和其它焊接结构的设备和方法 (Electrically weldable suture material and apparatus and methods for forming welded suture loops and other welded structures ) 是由 T·D·伊根于 2020-02-07 设计创作，主要内容包括：一种用于在动物的身体内定位的装置,所述装置包括可以被定位成彼此接触的第一部分和第二部分,所述第一部分和所述第二部分均包括生物相容的导电热塑性材料,使得当所述装置被定位在动物的所述身体内且电流从所述第一部分流到所述第二部分时,通过在所述第一部分和所述第二部分之间的接触点处的电阻产生热,以便熔化所述第一部分和所述第二部分的区域,并且当之后终止所述电流时,所述第一部分和所述第二部分的熔化区域再次凝固使得在所述第一部分和所述第二部分之间形成焊接部。(A device for location within the body of an animal, the device comprising first and second parts which can be positioned in contact with one another, the first and second parts each comprising a biocompatible, electrically conductive thermoplastic material, such that when the device is positioned within the body of an animal and an electrical current flows from the first part to the second part, heat is generated by the electrical resistance at the point of contact between the first and second parts so as to melt an area of the first and second parts, and when the electrical current is thereafter terminated, the melted area of the first and second parts resolidifies so as to form a weld between the first and second parts.)

1. An apparatus for applying a suture to tissue, wherein the suture comprises a biocompatible, electrically conductive thermoplastic material having a diameter, the apparatus comprising:

a shaft;

a jaw assembly comprising a first jaw member comprising a first tip and a first channel for slidably receiving the suture, and a second jaw member comprising a second tip and a second channel for slidably receiving the suture, wherein at least one of the first jaw member and the second jaw member is pivotably mounted movable between: (i) at least one open position in which the first and second tips of the first and second jaw members are separated from one another by a gap; and (ii) a closed position in which the first and second channels form a continuous path;

a gripping assembly comprising a first holder comprising a first gripping surface and a second holder comprising a second gripping surface, wherein at least one of the first holder and the second holder is movably mounted to a shaft so as to be movable between: (i) a release position in which the first and second gripping surfaces of the first and second holders are separated from each other by a gap greater than a diameter of a suture used to form a suture loop, and (ii) a gripping position in which the first and second gripping surfaces of the first and second holders are separated from each other by a distance less than a diameter of a suture used to form the suture loop;

an electrode assembly comprising electrodes for selectively applying an electrical potential to sutures clamped between the first and second gripping surfaces of the first and second holders, wherein the electrodes are movably mounted to the shaft so as to be movable between: (i) a non-welding position in which the electrode is spaced from a suture thread clamped between the first and second gripping surfaces of the first and second holders, and (ii) a welding position in which the electrode engages a suture thread clamped between the first and second gripping surfaces of the first and second holders; and

an operating mechanism for selectively operating the grip assembly and the electrode assembly in response to at least one of the first and second jaw members of the jaw assembly, wherein the step-wise movement of the at least one of the first and second jaw members of the jaw assembly toward at least one open position thereof sequentially results in:

(a) at least one of the first and second holders moves from its release position to its gripping position;

(b) the electrode is moved from its non-welding position to its welding position; and

(c) at least one of the first holder and the second holder is moved from its gripping position to its releasing position.

2. The apparatus of claim 1, wherein the operating mechanism comprises a cam on the at least one of the first and second jaw members of the jaw assembly and a cam follower on the at least one of the first and second holders of the gripping assembly and on the electrode of the electrode assembly.

3. The apparatus of claim 1, further comprising a cutting assembly including a cutter blade movably mounted to the shaft so as to be movable between: (i) a non-cutting position in which the cutting blade is spaced from suture thread clamped between the first and second gripping surfaces of the first and second holders, and (ii) a cutting position in which the cutting blade engages suture thread clamped between the first and second gripping surfaces of the first and second holders;

and further wherein the operating mechanism is configured to move the cutting assembly from its non-cutting position to its cutting position after step (b) and before step (c).

4. The apparatus of claim 1, wherein an electrical potential is applied across a suture gripped between the first and second gripping surfaces of the first and second holders using (i) the electrode and (ii) at least one of the first and second holders.

5. The apparatus of claim 1, wherein the first channel in the first jaw member is a groove, and further wherein the second channel in the second jaw member is a groove.

6. A medical device for applying a suture to tissue, comprising:

a jaw assembly, a grip assembly, an electrode assembly, and an operating mechanism operably coupled to the jaw assembly, the grip assembly, and the electrode assembly;

the jaw assembly includes a first jaw member and a second jaw member,

the first jaw member includes a first tip and a first channel for the suture,

the second jaw member comprising a second tip and a second channel for the suture,

at least one of the first and second jaw members is movable between an open position and a closed position,

the open position is a position in which the first and second tips of the first and second jaw members are separated from each other by a gap, and

the closed position is a position in which the first and second channels of the first and second jaw members form a continuous channel for the suture;

the gripping assembly includes a first holder and a second holder,

the first holder includes a first gripping surface,

the second holder includes a second gripping surface,

at least one of the first holder and the second holder is movable between a release position and a gripping position,

the release position is a position in which the first and second gripping surfaces of the first and second holders are spaced apart from each other by a gap larger than a diameter of the suture, and

the gripping location is a location where the first and second gripping surfaces of the first and second holders are spaced apart from each other by a distance that is less than the diameter of the suture;

the electrode assembly includes an electrode configured to apply an electric potential to the suture thread clamped between the first and second gripping surfaces of the first and second holders,

the electrode is movable between a welding position and a non-welding position,

the welding position is a position where the electrode engages the suture between the first and second gripping surfaces of the first and second holders, and

the non-welding position is a position in which the electrode is spaced from the suture between the first and second gripping surfaces of the first and second holders; and is

The operating mechanism operates the grip assembly and the electrode assembly such that with the electrode assembly in the non-welding position, the grip assembly in the release position, the jaw assembly in the closed position, and the suture positioned between the first and second gripping surfaces of the grip assembly, the progressive movement of at least one of the first and second jaw members toward the open position sequentially results in:

at least one of the first holder and the second holder is moved from the release position to the holding position, and thereafter

The electrode is moved from the non-welding position to the welding position and thereafter

At least one of the first holder and the second holder is moved from the gripping position to the release position.

7. A method for applying a suture to tissue, wherein the suture comprises a biocompatible, electrically conductive thermoplastic material having a diameter, the method comprising:

providing an apparatus, the apparatus comprising:

a shaft;

a jaw assembly comprising a first jaw member including a first tip and a first channel for slidably receiving the suture, and a second jaw member including a second tip and a second channel for slidably receiving the suture, wherein at least one of the first jaw member and the second jaw member is pivotably mounted to be movable between: (i) at least one open position in which the first and second tips of the first and second jaw members are separated from each other by a gap, and (ii) a closed position in which the first and second channels form a continuous path;

an operating mechanism for selectively operating the grip assembly and the electrode assembly in response to at least one of the first jaw member and the second jaw member of the jaw assembly, wherein, when the electrode assembly is in its non-welding position and the grip assembly is in its release position and the jaw assembly is in its closed position, and when a suture is positioned between the first gripping surface and the second gripping surface of the grip assembly, the progressive movement of the at least one of the first jaw member and the second jaw member of the jaw assembly toward at least one open position thereof sequentially results in:

(a) at least one of the first and second holders moves from its release position to its gripping position;

(b) the electrode is moved from its non-welding position to its welding position; and

positioning the apparatus adjacent the tissue while (i) the jaw assembly is in its at least one open position, (ii) the grip assembly is in its release position and (iii) the electrode assembly is in its non-welding position;

moving at least one of the first and second jaw members such that the jaw assembly is in its closed position;

advancing the suture through the continuous path such that the suture forms a suture loop; and

progressively moving the at least one of the first and second jaw members of the jaw assembly toward its at least one open position sequentially results in:

(a) at least one of the first and second holders moves from its release position to its gripping position;

(b) the electrode is moved from its non-welding position to its welding position; and

(c) at least one of the first holder and the second holder is moved from its gripping position to its releasing position.

8. The method of claim 7, wherein the operating mechanism comprises a cam on the at least one of the first and second jaw members of the jaw assembly and a cam follower on the at least one of the first and second holders of the gripping assembly and on the electrode of the electrode assembly.

9. The method of claim 7, further comprising a cutting assembly including a cutter blade movably mounted to the shaft so as to be movable between: (i) a non-cutting position in which the cutting blade is spaced from suture thread clamped between the first and second gripping surfaces of the first and second holders, and (ii) a cutting position in which the cutting blade engages suture thread clamped between the first and second gripping surfaces of the first and second holders;

and further wherein the operating mechanism is configured to move the cutting assembly from its non-cutting position to its cutting position after step (b) and before step (c).

10. The method of claim 7, wherein an electrical potential is applied across a suture clamped between the first and second gripping surfaces of the first and second holders using (i) the electrode and (ii) at least one of the first and second holders.

11. The method of claim 7, wherein the first channel in the first jaw member is a groove, and further wherein the second channel in the second jaw member is a groove.

12. A suture advancing/retracting mechanism for advancing/retracting a suture, the suture advancing/retracting mechanism comprising:

a first tubular element comprising a sidewall having a distal end, a proximal end, and a lumen extending therebetween, a shoulder formed on an exterior of the sidewall, and a flange extending radially outward from the sidewall, the flange being spaced from the shoulder, and a portion of the sidewall adjacent the shoulder being compressible;

a second tubular element comprising a sidewall having a distal end, a proximal end and a lumen extending therebetween, a shoulder formed on an interior of the sidewall, and a flange extending radially outward from the sidewall, the second tubular element being concentrically mounted on the first tubular element such that the shoulder formed on the interior of the sidewall of the second tubular element is engageable with the shoulder formed on the exterior of the sidewall of the first tubular element;

a spring concentrically mounted on the sidewall of the first tubular member so as to engage the flange of the first tubular member and the flange of the second tubular member, thereby biasing the first tubular member proximally and the second tubular member distally, thereby biasing the shoulder of the first tubular member and the shoulder of the second tubular member into engagement with one another; and

a stopper engageable to the first tubular member to selectively stop proximal movement of the first tubular member such that:

(i) a suture may be advanced through the lumen of the first tubular member when the first tubular member engages the stop and pushes the flange of the second tubular member toward the flange of the first tubular member to compress the spring;

(ii) when the flange of the second tubular member is thereafter pushed away from the flange of the first tubular member, the shoulder of the second tubular member engages the shoulder of the first tubular member so as to compress the sidewall of the first tubular member and grip the suture advanced through the lumen of the first tubular member, thereby driving the suture distally;

(iii) when the flange of the second tubular element is thereafter moved toward the flange of the first tubular element, the shoulder of the second tubular element remains engaged with the shoulder of the first tubular element to continue to compress the sidewall of the first tubular element and grip the suture advanced through the lumen of the first tubular element, thereby driving the suture proximally; and

(iv) when the first tubular element is thereafter moved into engagement with the stop and the flange of the second tubular element is moved toward the flange of the first tubular element, the shoulder of the second tubular element disengages from the shoulder of the first tubular element to stop compressing the sidewall of the first tubular element and release the suture extending through the lumen of the first tubular element.

13. The suture advancement/retraction mechanism according to claim 12, wherein the shoulder of the first tubular element is frustoconical and the shoulder of the second tubular element is frustoconical.

14. The suture advancement/retraction mechanism according to claim 12, wherein the compressible portion of the sidewall of the first tubular element comprises a slit.

15. The suture advancement/retraction mechanism according to claim 12, further comprising a motor assembly for moving the second tubular member proximally and distally.

16. The suture advancement/retraction mechanism according to claim 15, wherein the second tubular element further comprises a second flange extending radially outwardly from the sidewall of the second tubular element, the second flange being disposed distally of the flange, and further wherein the motor assembly comprises a motor and an actuator nut movable proximally and distally by the motor, the actuator nut engaging the second tubular element between the flange and the second flange.

17. The suture advancement/retraction mechanism according to claim 12, further comprising a barrel for housing the first tubular element, the second tubular element, the spring and the stop.

18. A medical device for advancing and retracting a suture, the medical device comprising:

a first tubular member, a second tubular member, a spring, and a stop;

the first tubular element including a first sidewall, a first shoulder formed on an exterior of the first sidewall, and a first flange spaced from the first shoulder and extending radially outward from the first sidewall,

the first sidewall includes a distal end, a proximal end, a lumen extending between the proximal and distal ends of the first sidewall, and a compressible portion adjacent the first shoulder;

the second tubular element including a second sidewall, a second shoulder formed on an interior of the second sidewall, and a second flange extending radially outward from the second sidewall,

the second tubular element is concentrically mounted on the first tubular element such that the second shoulder of the second tubular member is engageable with the first shoulder of the first tubular element, and

the second sidewall includes a distal end, a lumen having a proximal end extending between the proximal end and the distal end of the second sidewall;

said spring being concentrically mounted on said side wall of said first tubular member so as to engage said flange of said first tubular member and said flange of said second tubular member,

the spring is positioned to bias the first tubular member proximally and the second tubular member distally, and

the spring positioned to bias the first and second shoulders into engagement with each other; and is

The stopper is selectively engageable to the first tubular member to stop proximal movement of the first tubular member such that:

(i) with the first tubular element engaged to the stop and the second flange urged toward the flange, the suture is advanced through the lumen of the first tubular element without restriction; and thereafter

(ii) To drive the suture distally with the second flange of the second tubular element pushed away from the first flange, the second shoulder engages the first shoulder and compresses the compressible portion of the first sidewall to grip the suture advanced through the lumen of the first tubular element; and thereafter,

(iii) to drive the suture proximally with the second flange moving toward the first flange, the second shoulder remains engaged with the first shoulder to continue compressing the compressible portion of the first sidewall to grip the suture advanced through the lumen of the first tubular element; and thereafter,

(iv) to release the suture extending through the lumen of the first tubular element with the first tubular element moved into engagement with the stop and the second flange moved toward the first flange, the second shoulder disengages from the first shoulder to stop compressing the compressible portion of the first sidewall.

19. A method for advancing/retracting a suture, the method comprising:

providing a suture advancing/retracting mechanism for advancing/retracting a suture, the suture advancing/retracting mechanism comprising:

a stopper engageable to the first tubular member to selectively stop proximal movement of the first tubular member such that:

(i) a suture can be advanced through the lumen of the first tubular member when the first tubular member is engaged to the stop and the flange of the second tubular member is urged toward the flange of the first tubular member to compress the spring;

moving the first tubular element into engagement with the stop and urging the second flange towards the flange so as to compress the spring;

advancing the suture through the lumen of the first tubular element;

pushing the flange of the second tubular member away from the flange of the first tubular member to cause the shoulder of the second tubular member to engage the shoulder of the first tubular member to compress the sidewall of the first tubular member and grip the suture advanced through the lumen of the first tubular member, thereby driving the suture distally;

moving the flange of the second tubular member toward the flange of the first tubular member while the shoulder of the second tubular member remains engaged with the shoulder of the first tubular member to continue compressing the sidewall of the first tubular member and gripping the suture advanced through the lumen of the first tubular member, thereby driving the suture proximally; and

moving the first tubular element into engagement with the stop and moving the flange of the second tubular element toward the flange of the first tubular element such that the shoulder of the second tubular element disengages from the shoulder of the first tubular element to stop compressing the sidewall of the first tubular element and release the suture extending through the lumen of the first tubular element.

20. The method of claim 19, wherein the shoulder of the first tubular element is frustoconical and the shoulder of the second tubular element is frustoconical.

21. The method of claim 19, wherein the compressible portion of the sidewall of the first tubular element comprises a slit.

22. The method of claim 19, further comprising a motor assembly for moving the second tubular member proximally and distally.

23. The method of claim 22, wherein the second tubular element further comprises a second flange extending radially outward from the sidewall of the second tubular element, the second flange being disposed distal of the flange, and further wherein the motor assembly comprises a motor and an actuator nut movable proximally and distally by the motor, the actuator nut engaging the second tubular element between the flange and the second flange.

24. The method of claim 19, further comprising a barrel for housing the first tubular member, the second tubular member, the spring, and the stop.

25. An apparatus for applying a suture to tissue, wherein the suture comprises a biocompatible, electrically conductive thermoplastic material and has a diameter, the apparatus comprising:

a shaft having a distal end and a proximal end;

a jaw assembly comprising a first jaw member including a first tip, a first channel for slidably receiving a suture, and a first slot, and a second jaw member including a second tip, a second channel for slidably receiving a suture, and a second slot, wherein at least one of the first jaw member and the second jaw member is pivotally mounted to the shaft so as to be movable between: (i) at least one open position in which the first and second tips of the first and second jaw members are separated from each other by a gap, and (ii) a closed position in which the first and second tips of the first and second jaw members engage each other such that the first and second channels form a continuous path;

a gripping assembly comprising a first holder having a first gripping surface, a second holder having a second gripping surface, and a holder clip for engaging the first holder and the second holder to move at least one of the first holder and the second holder between: (i) a release position in which the first and second gripping surfaces of the first and second holders are separated from each other by a gap greater than a diameter of a suture used to form a suture loop, and (ii) a gripping position in which the first and second gripping surfaces of the first and second holders are separated from each other by a distance less than the diameter of a suture used to form the suture loop;

an electrode assembly comprising electrodes for selectively applying an electrical potential to sutures clamped between the first and second gripping surfaces of the first and second holders, wherein the electrodes are movable between: (i) a non-welding position in which the electrode is spaced from a suture thread clamped between the first and second gripping surfaces of the first and second holders, and (ii) a welding position in which the electrode engages a suture thread clamped between the first and second gripping surfaces of the first and second holders;

an actuator rod assembly for selectively operating the jaw assembly, the grip assembly, and the electrode assembly in response to movement of the actuator rod assembly in a distal direction, the actuator rod assembly including an actuator rod movably mounted to the shaft, drive pins mounted to the actuator rod and extending through the first slot of the first jaw member and the second slot of the second jaw member, the holder clip of the grip assembly being mounted to the actuator rod, and the electrode of the electrode assembly being spring biased away from the actuator rod and engaging the first holder and the second holder of the holder assembly when the holder assembly is in its grip position, wherein when the electrode assembly is in its non-welding position, the grip assembly is in its release position, and the jaw assembly is in its open position and the suture is positioned at the suture The step-wise movement of the actuator rod in the distal direction while gripping the assembly between the first holder and the second holder sequentially results in:

(a) at least one of the first and second jaws of the jaw assembly is moved from its open position to its closed position;

(b) at least one of the first and second holders moves from its release position to its gripping position; and is

and subsequent stepwise movement of the actuator rod in the proximal direction sequentially results in:

(d) the electrode is moved from its welding position to its non-welding position;

(e) at least one of the first and second holders moves from its gripping position to its releasing position; and

(f) at least one of the first and second jaws of the jaw assembly moves from its closed position to its open position.

26. The apparatus of claim 25, wherein the first slot of the first jaw member comprises a curved portion and a straight portion, and further wherein the second slot of the second jaw member comprises a curved portion and a straight portion.

27. The apparatus of claim 25, wherein the first holder comprises at least one proximal first cut, at least one distal first cut, and at least one intermediate first cut disposed between the at least one proximal first cut and the at least one distal first cut, wherein the second holder comprises at least one proximal second cut, at least one distal second cut, and at least one intermediate second cut disposed between the at least one proximal second cut and the at least one distal second cut, and further wherein the first holder and the second holder rest on their respective cuts as they move between their release positions and their gripping positions.

28. The apparatus of claim 25, further comprising a cutter blade mounted to the holder clip so as to be movable between: (i) a non-cutting position in which the cutting blade is spaced from suture thread clamped between the first and second gripping surfaces of the first and second holders, and (ii) a cutting position in which the cutting blade engages suture thread clamped between the first and second gripping surfaces of the first and second holders;

and further wherein the actuator rod is configured to move the cutter blade from its non-cutting position to its cutting position after step (c) and before step (d).

29. The apparatus of claim 25, wherein an electrical potential is applied across a suture clamped between the first and second gripping surfaces of the first and second holders using at least one of (i) the electrode and (ii) the first and second holders.

30. The apparatus according to claim 25, wherein the first channel in the first jaw member is a groove, and further wherein the second channel in the second jaw member is a groove.

31. A medical device, comprising:

a jaw assembly, a grip assembly, an electrode assembly, and an actuator rod assembly operably coupled to the jaw assembly, the grip assembly, and the electrode assembly;

the jaw assembly includes a first jaw member and a second jaw member,

the first jaw member including a first tip, a first slot, and a first channel for receiving a suture,

the second jaw member including a second tip, a second slot, and a second channel for receiving a suture,

at least one of the first and second jaw members is movable between an open position and a closed position,

the open position is a position in which the first and second tips of the first and second jaw members are separated from each other by a gap, and

the closed position is a position in which the first and second channels form a continuous channel for the suture;

the actuator rod assembly includes a movable actuator rod and a drive pin mounted to the actuator rod,

the drive pin extends through the first slot of the first jaw member and the second slot of the second jaw member;

the gripping assembly includes a first holder, a second holder, and a holder clip,

the first holder includes a first gripping surface,

the second holder includes a second gripping surface,

the holder clip is mounted to the actuator stem and engages the first holder and the second holder to move at least one of the first holder and the second holder between a release position and a gripping position,

the release position is a position in which the first and second gripping surfaces of the first and second holders are spaced apart from each other by a gap larger than a diameter of the suture, and

The electrode assembly includes an electrode configured to apply an electric potential to the suture thread clamped between the first and second gripping surfaces of the first and second holders,

the electrode is movable between a non-welding position and a welding position,

the non-welding position is a position in which the electrode is spaced from the suture between the first and second gripping surfaces of the first and second holders, and

the welding location is a location where the electrode engages the suture thread between the first and second gripping surfaces of the first and second holders;

wherein with the holder assembly in the gripping position, the electrodes of the electrode assembly are spring biased away from the actuator stem and engage the first and second holders of the holder assembly; and is

Wherein with the electrode assembly in the non-welding position, the grip assembly in the release position, the jaw assembly in the open position, and the suture positioned between the first and second holders of the grip assembly, then a first stepwise movement of the actuator stem in a distal direction sequentially results in:

(a) at least one of the first and second jaws of the jaw assembly moves from the open position to the closed position;

(b) at least one of the first holder and the second holder moving from the release position to the gripping position; and is

and a subsequent second step-wise movement of the actuator rod in the proximal direction sequentially results in:

(d) the electrode is moved from the welding position to the non-welding position;

(e) at least one of the first holder and the second holder moving from the gripping position to the release position; and

(f) at least one of the first and second jaws of the jaw assembly moves from the closed position to the open position.

32. A method for applying a suture to tissue, the method comprising:

providing an apparatus for applying a suture to tissue, wherein the suture comprises a biocompatible, electrically conductive thermoplastic material and has a diameter, the apparatus comprising:

a shaft having a distal end and a proximal end;

a gripping assembly comprising a first holder comprising a first gripping surface, a second holder comprising a second gripping surface, and a holder clip for engaging the first holder and the second holder to move at least one of the first holder and the second holder between: (i) a release position in which the first and second gripping surfaces of the first and second holders are separated from each other by a gap greater than a diameter of a suture used to form a suture loop, and (ii) a gripping position in which the first and second gripping surfaces of the first and second holders are separated from each other by a distance less than the diameter of a suture used to form the suture loop;

an electrode assembly comprising electrodes for selectively applying an electrical potential to sutures clamped between the first and second gripping surfaces of the first and second holders, wherein the electrodes are movable between: (i) a non-welding position in which the electrode is spaced from a suture thread clamped between the first and second gripping surfaces of the first and second holders, and (ii) a welding position in which the electrode engages a suture thread clamped between the first and second gripping surfaces of the first and second holders;

(a) at least one of the first and second jaws of the jaw assembly is moved from its open position to its closed position;

(b) at least one of the first and second holders moves from its release position to its gripping position; and is

and subsequent stepwise movement of the actuator rod in the proximal direction sequentially results in:

(d) the electrode is moved from its welding position to its non-welding position;

(e) at least one of the first and second holders moves from its gripping position to its releasing position; and

(f) at least one of the first and second jaws of the jaw assembly is moved from its closed position to its open position;

positioning the device adjacent the tissue while the jaw assembly is in its at least one open position, the grip assembly is in its release position, and the electrode assembly is in its non-welding position;

moving the actuator rod stepwise in a distal direction to sequentially cause:

(a) at least one of the first and second jaws of the jaw assembly is moved from its open position to its closed position;

(b) at least one of the first and second holders moves from its release position to its gripping position; and is

subsequently moving the actuator rod stepwise in a proximal direction so as to cause, in turn:

(d) the electrode is moved from its welding position to its non-welding position;

(e) at least one of the first and second holders moves from its gripping position to its releasing position; and

(f) at least one of the first jaw and the second jaw of the jaw assembly moves from its closed position to its open position.

33. The method of claim 32, wherein the first slot of the first jaw member includes a curved portion and a straight portion, and further wherein the second slot of the second jaw member includes a curved portion and a straight portion.

34. The method of claim 32, wherein the first holder comprises at least one proximal first cut, at least one distal first cut, and at least one intermediate first cut disposed between the at least one proximal first cut and the at least one distal first cut, wherein the second holder comprises at least one proximal second cut, at least one distal second cut, and at least one intermediate second cut disposed between the at least one proximal second cut and the at least one distal second cut, further wherein the first holder and the second holder rest on their respective cuts as they move between their release positions and their gripping positions.

35. The method of claim 32, further comprising a cutter blade mounted to the holder clip so as to be movable between: (i) a non-cutting position in which the cutting blade is spaced from suture thread clamped between the first and second gripping surfaces of the first and second holders, and (ii) a cutting position in which the cutting blade engages suture thread clamped between the first and second gripping surfaces of the first and second holders;

and further wherein the actuator rod is configured to move the cutter blade from its non-cutting position to its cutting position after step (c) and before step (d).

36. The method of claim 32, wherein an electrical potential is applied across a suture clamped between the first and second gripping surfaces of the first and second holders using (i) the electrode and (ii) at least one of the first and second holders.

37. The method according to claim 32, wherein the first channel in the first jaw member is a groove, and further wherein the second channel in the second jaw member is a groove.

Technical Field

The present invention relates to the use of electrical energy to fuse polymeric materials into useful shapes, and more particularly to the use of electrical energy to fuse polymeric materials into useful shapes within the body of animals (which term is intended to include humans and other mammals), and even more particularly to fuse polymeric sutures and other structures for surgical bonding of tissues within the body (such as for surgical suturing and closure of blood vessels or organs) and/or for surgical ligation of tissues within the body (such as surgical ligation of blood vessels or organs) using electrical energy.

Background

During surgery, sutures are often used to secure edges of tissue together in order to maintain the tissue edges in proximity to each other until substantially complete healing. The suture is typically guided through the portions of the tissue to be joined and formed into a single loop or stitch, after which it is tied or otherwise secured (e.g., using a crimp fastener) to maintain the edges of the tissue in proper relation to one another for healing to occur.

In some cases, a series of individual separate stitches with substantially uniform tension are created in the tissue. Since the stitches are separate and apart from each other, removing one stitch does not require removing all stitches or causing the remaining stitches to loosen. However, each individual stitch requires a separate knot (or some other stitch closure device, such as a crimp fastener) to secure the stitch in place around the wound.

It is sometimes necessary or desirable to close a wound with sutures without having to form knots in the sutures or utilize a loop closure device (e.g., a crimped fastener), such as, for example, in surgical repair of organs or tissues with limited access to the repair site. In these cases, a fused loop of suture can be used to maintain the wound margins close enough for a sufficient period of time to allow healing to occur.

The polymeric suture is particularly suitable for use in various fusion or bonding processes, such as, for example, by welding, wherein sections of the suture are capable of fusing together upon application of sufficient heat to the sections of the suture to cause partial melting and fusion of the sections of the suture.

To date, efforts have been made to fuse sections of polymeric sutures together using (i) direct application of heat, or (ii) application of ultrasonic energy.

Unfortunately, achieving welding via direct application of heat has two significant drawbacks. First, applying heat directly to the suture in situ can produce undesirable heating of the surrounding tissue. Second, in the case of direct application of heat to the suture, it is difficult to selectively melt only the interface between the suture segments to be welded without melting the entire cross-section of the suture, which can seriously weaken the suture.

For these reasons, it is generally preferred to apply non-thermal energy to the suture material in situ in order to cause localized heating of the suture material in the region or section to be fused. In particular, ultrasonic energy may be effectively applied to sections of suture material to induce frictional heating of the sections so as to fuse or weld the sections of suture together. While such ultrasonic welding of the suture can be a significant improvement over direct thermal welding of the suture (i.e., ultrasonic welding melts only the portions of the suture that are in contact with each other and does not melt the entire cross-section of the suture, thereby maintaining the strength of the suture), ultrasonic welding itself has two significant drawbacks. First, ultrasonic welding requires bulky and expensive equipment. Such devices may not be compatible with certain surgical types and in any case add cost. Second, due to the nature of the ultrasonic transducer and waveguide, ultrasonic welding requires a straight path between the energy source and the weld site, making it incompatible with curved or flexible instruments.

In addition to the foregoing, in some cases it is necessary or desirable to ligate tissue such as blood vessels or organs. Such ligation is typically accomplished by the use of sutures that are passed around the tissue and then secured using a knot or closure device (e.g., a crimped fastener). Also, in some instances (e.g., where access to the ligation site is restricted), it may be desirable to use a fused suture loop to effect ligation. And also, in some cases, it may be difficult to achieve welding by direct application using heat or application of ultrasonic energy.

It is therefore an object of the present invention to provide a new and improved method for forming a joint (which is also referred to as a bond or weld) in the body, which does not have the problems associated with the prior art.

Disclosure of Invention

The present invention comprises providing and using a new and improved method for forming a joint (which is also referred to as a bond or weld) within the body that does not have the problems associated with the prior art.

The present invention includes, among other things, providing and using new and improved methods and apparatus for creating suture welds of sufficient strength and reliability to replace suture knots or other loop closure devices.

An important aspect of the present invention includes providing and using a novel polymeric biomaterial that is strong, biocompatible, and weldable with electrical energy (i.e., "electrically weldable polymer").

Another important aspect of the present invention is to provide and use a method for bonding polymeric devices in the body to create medically useful structures.

And another important aspect of the present invention is to provide and use a device for delivering and incorporating medically useful structures within the body.

It is yet another important aspect of the present invention to provide and use novel medically useful structures, including but not limited to: (i) a fusogenic ring of an electrically weldable polymer; (ii) a welded hemostatic clip of an electrically weldable polymer; and (iii) a continuously conveyable spike chain of electrically weldable polymer fasteners.

In one form of the invention, there is provided a device for location within the body of an animal, the device comprising first and second parts which can be positioned in contact with one another, the first and second parts each comprising a biocompatible, electrically conductive thermoplastic material, such that when the device is positioned within the body of an animal and an electric current flows from the first part to the second part, heat is generated by the electrical resistance at the point of contact between the first and second parts so as to melt the region of the first and second parts, and when the current is thereafter terminated, the melted region of the first and second parts resolidifies so as to form a weld between the first and second parts.

In one form of the invention, there is provided apparatus for forming a weld between a first portion of a biocompatible, electrically conductive thermoplastic material and a second portion of a biocompatible, electrically conductive thermoplastic material, the apparatus comprising:

a first electrode;

a second electrode;

a structure for holding the first and second electrodes opposite each other with a space therebetween for receiving the first and second portions in contact with each other, wherein the structure is electrically non-conductive; and

a circuit comprising a power source and a switch, the switch being arranged such that closure of the switch applies a voltage potential across the first and second electrodes such that when the first and second portions are positioned within the body of an animal and placed between the first and second electrodes in contact with each other and the switch is thereafter closed, heat is generated by electrical resistance at the point of contact so as to melt an area of the first and second portions, and when the switch is thereafter opened, the melted portions of the first and second portions re-solidify so that a weld is formed at the point of contact.

In one form of the invention, there is provided a method for forming a weld between two parts of a biocompatible, electrically conductive thermoplastic material within the body of an animal, wherein the method comprises:

positioning a first portion and a second portion of a biocompatible, electrically conductive thermoplastic material within the body of the animal between the first electrode and the second electrode such that the first portion contacts the first electrode, the second portion contacts the second electrode, and the first portion and the second portion of the biocompatible, electrically conductive thermoplastic material contact each other;

applying a selected amount of current across the first and second electrodes to generate a selected amount of heat through electrical resistance at a contact point between the first and second portions, resulting in a particular desired amount of melting of the first and second portions;

and terminating the current across the first and second electrodes such that the melted regions of the first and second portions re-solidify such that a weld is formed at the point of contact.

In one form of the present invention, novel methods and apparatus for suturing tissue are provided.

In one form of the present invention, there is provided an end effector for a suturing device, the end effector comprising:

a first arm having a tissue engaging surface;

a second arm having a tissue engaging surface;

at least one of the first arm and the second arm is configured for movement as follows: (i) toward the other of the first and second arms to clamp tissue between the tissue engaging surface of the first arm and the tissue engaging surface of the second arm, and (ii) away from the other of the first and second arms to release tissue clamped between the tissue engaging surface of the first arm and the tissue engaging surface of the second arm;

the second arm has an opening therein; and

a needle having a penetrating tip, the needle configured for movement of: (i) toward the tissue engaging surface of the first arm so as to position the penetrating tip of the needle adjacent the tissue engaging surface of the first arm, thereby penetrating tissue clamped between the tissue engaging surface of the first arm and the tissue engaging surface of the second arm, and (ii) away from the tissue engaging surface of the first arm so as to withdraw from tissue clamped between the tissue engaging surface of the first arm and the tissue engaging surface of the second arm;

the needle is configured to pass through the opening in the second arm as the needle moves toward the tissue engaging surface of the first arm and to pass through the opening in the second arm as the needle moves away from the tissue engaging surface of the first arm.

In one form of the present invention, a novel method and apparatus for ligating tissue is provided.

In one form of the invention, there is provided an apparatus for applying a suture to tissue, wherein the suture comprises a biocompatible, electrically conductive thermoplastic material having a diameter, the apparatus comprising:

a shaft;

a jaw assembly comprising a first jaw member including a first tip and a first channel for slidably receiving a suture, and a second jaw member including a second tip and a second channel for slidably receiving a suture, wherein at least one of the first jaw member and the second jaw member is pivotably mounted to be movable between: (i) at least one open position in which the first and second tips of the first and second jaw members are separated from each other by a gap; and (ii) a closed position in which the first and second channels form a continuous path;

a gripping assembly comprising a first holder comprising a first gripping surface and a second holder comprising a second gripping surface, wherein at least one of the first holder and the second holder is movably mounted to a shaft so as to be movable between: (i) a release position in which the first and second gripping surfaces of the first and second holders are separated from each other by a gap larger than a diameter of a suture used to form the suture loop; and (ii) a gripping position in which the first and second gripping surfaces of the first and second holders are spaced from each other by a distance that is less than the diameter of the suture being used to form the suture loop;

an electrode assembly comprising electrodes for selectively applying an electrical potential to a suture thread clamped between first and second gripping surfaces of the first and second holders, wherein the electrodes are movably mounted to the shaft so as to be movable between: (i) a non-welding position in which the electrodes are spaced from a suture line clamped between the first and second gripping surfaces of the first and second holders; and (ii) a welding position in which the electrode engages a suture thread clamped between the first and second gripping surfaces of the first and second holders; and

an operating mechanism for selectively operating the grip assembly and the electrode assembly in response to at least one of the first jaw member and the second jaw member of the jaw assembly, wherein when the electrode assembly is in its non-welding position and the grip assembly is in its release position and the jaw assembly is in its closed position and when a suture is positioned between the first gripping surface and the second gripping surface of the grip assembly, the progressive movement of the at least one of the first jaw member and the second jaw member of the jaw assembly toward its at least one open position sequentially results in:

(a) at least one of the first and second holders moves from its release position to its gripping position;

(b) the electrode is moved from its non-welding position to its welding position; and

(c) at least one of the first holder and the second holder is moved from its gripping position to its releasing position.

In one form of the present invention, there is provided a medical device for applying a suture to tissue, comprising:

a jaw assembly, a grip assembly, an electrode assembly, and an operating mechanism operably coupled to the jaw assembly, the grip assembly, and the electrode assembly;

the jaw assembly includes a first jaw member and a second jaw member,

the first jaw member includes a first tip and a first channel for a suture,

the second jaw member includes a second tip and a second channel for suture,

at least one of the first and second jaw members is movable between an open position and a closed position,

the open position is a position in which the first and second tips of the first and second jaw members are separated by a gap, and

the closed position is a position in which the first and second channels of the first and second jaw members form a continuous channel for the suture;

the gripping assembly includes a first holder and a second holder,

the first holder includes a first gripping surface,

the second holder includes a second gripping surface,

at least one of the first holder and the second holder is movable between a release position and a holding position,

the release position is a position in which the first and second gripping surfaces of the first and second holders are spaced apart from each other by a gap larger than the diameter of the suture, and

the gripping position is a position where the first and second gripping surfaces of the first and second holders are spaced apart from each other by a distance that is less than the diameter of the suture;

the electrode assembly includes an electrode configured to apply an electrical potential to a suture thread clamped between first and second gripping surfaces of the first and second holders,

the electrode is movable between a welding position and a non-welding position,

the welding position is a position of a suture line where the electrodes are engaged between the first and second gripping surfaces of the first and second holders, and

the non-welding position is a position where the electrodes are spaced from the suture between the first and second gripping surfaces of the first and second holders; and is

The operating mechanism operates the grip assembly and the electrode assembly such that, with the electrode assembly in a non-welding position, the grip assembly in a release position, the jaw assembly in a closed position, and the suture positioned between the first and second gripping surfaces of the grip assembly, the progressive movement of at least one of the first and second jaw members toward the open position sequentially results in:

at least one of the first holder and the second holder is moved from the release position to the holding position, after which

The electrode is moved from a non-welding position to a welding position and thereafter

At least one of the first holder and the second holder is moved from a gripping position to a releasing position.

In one form of the invention, there is provided a method for applying a suture to tissue, wherein the suture comprises a biocompatible, electrically conductive thermoplastic material having a diameter, the method comprising:

providing an apparatus, the apparatus comprising:

a shaft;

a gripping assembly comprising a first holder comprising a first gripping surface and a second holder comprising a second gripping surface, wherein at least one of the first holder and the second holder is movably mounted to a shaft so as to be movable between: (i) a release position in which the first and second gripping surfaces of the first and second holders are separated from each other by a gap larger than a diameter of a suture used to form the suture loop; and (ii) a gripping position in which the first and second gripping surfaces of the first and second holders are spaced from each other by a distance that is less than the diameter of the suture being used to form the suture loop;

an operating mechanism for selectively operating the grip assembly and the electrode assembly in response to at least one of the first jaw member and the second jaw member of the jaw assembly, wherein when the electrode assembly is in its non-welding position and the grip assembly is in its release position and the jaw assembly is in its closed position and when a suture is positioned between the first gripping surface and the second gripping surface of the grip assembly, the progressive movement of the at least one of the first jaw member and the second jaw member of the jaw assembly toward its at least one open position sequentially results in:

(a) at least one of the first and second holders moves from its release position to its gripping position;

(b) the electrode is moved from its non-welding position to its welding position; and

positioning the device adjacent to the tissue while (i) the jaw assembly is in its at least one open position, (ii) the grip assembly is in its release position and (iii) the electrode assembly is in its non-welding position;

moving at least one of the first and second jaw members such that the jaw assembly is in its closed position;

advancing the suture through the continuous path such that the suture forms a suture loop; and

such that the step-wise movement of the at least one of the first and second jaw members of the jaw assembly toward its at least one open position sequentially results in:

(a) at least one of the first and second holders moves from its release position to its gripping position;

(b) the electrode is moved from its non-welding position to its welding position; and

(c) at least one of the first holder and the second holder is moved from its gripping position to its releasing position.

In one form of the present invention, there is provided a suture advancing/retracting mechanism for advancing/retracting a suture, the suture advancing/retracting mechanism comprising:

a first tubular element including a sidewall having a distal end, a proximal end, and a lumen extending therebetween, a shoulder formed on an exterior of the sidewall, and a flange extending radially outward from the sidewall, the flange being spaced from the shoulder, and a portion of the sidewall adjacent the shoulder being compressible;

a second tubular member including a sidewall having a distal end, a proximal end, and a lumen extending therebetween, a shoulder formed on an interior of the sidewall, and a flange extending radially outward from the sidewall, the second tubular member being concentrically mounted on the first tubular member such that the shoulder formed on the interior of the sidewall of the second tubular member is engageable with the shoulder formed on the exterior of the sidewall of the first tubular member;

a stopper engageable to the first tubular member to selectively stop proximal movement of the first tubular member such that:

(i) the suture may be advanced through the lumen of the first tubular member when the first tubular member is engaged with the stop and the flange of the second tubular member is urged toward the flange of the first tubular member to compress the spring;

(ii) when the flange of the second tubular member is thereafter pushed away from the flange of the first tubular member, the shoulder of the second tubular member engages the shoulder of the first tubular member to compress the sidewall of the first tubular member and grip the suture advanced through the lumen of the first tubular member, thereby driving the suture distally;

(iii) when the flange of the second tubular member is thereafter moved toward the flange of the first tubular member, the shoulder of the second tubular member remains engaged with the shoulder of the first tubular member to continue to compress the sidewall of the first tubular member and grip the suture advanced through the lumen of the first tubular member, thereby driving the suture proximally; and

(iv) when the first tubular member is thereafter moved into engagement with the stop and the flange of the second tubular member is moved toward the flange of the first tubular member, the shoulder of the second tubular member disengages from the shoulder of the first tubular member to stop compressing the sidewall of the first tubular member and release the suture extending through the lumen of the first tubular member.

In one form of the invention, there is provided a medical device for advancing and retracting a suture, the medical device comprising:

a first tubular member, a second tubular member, a spring, and a stop;

the first tubular element includes a first sidewall, a first shoulder formed on an exterior of the first sidewall, and a first flange spaced from the first shoulder and extending radially outward from the first sidewall,

the first sidewall includes a distal end, a proximal end, a lumen extending between the proximal and distal ends of the first sidewall, and a compressible portion adjacent the first shoulder;

the second tubular element includes a second sidewall, a second shoulder formed on an interior of the second sidewall, and a second flange extending radially outward from the second sidewall,

the second sidewall includes a distal end, a proximal end, a lumen extending between the proximal end and the distal end of the second sidewall;

the spring is concentrically mounted on the sidewall of the first tubular member to engage the flange of the first tubular member and the flange of the second tubular member,

a spring is positioned to bias the first tubular member proximally and the second tubular member distally, and

a spring positioned to bias the first and second shoulders into engagement with each other; and is

A stopper is selectively engageable to the first tubular member to stop proximal movement of the first tubular member such that:

(i) with the first tubular element engaging the stop and the second flange urged toward the flange, the suture is advanced through the lumen of the first tubular element without restriction; and thereafter

(ii) To drive the suture distally with the second flange of the second tubular member pushed away from the first flange, the second shoulder engages the first shoulder and compresses the compressible portion of the first sidewall to grip the suture advanced through the lumen of the first tubular member; and thereafter,

(iv) to release the suture extending through the lumen of the first tubular element if the first tubular element is moved to engage the stop and the second flange is moved toward the first flange, the second shoulder disengages from the first shoulder to stop compressing the compressible portion of the first sidewall.

In one form of the invention, there is provided a method for advancing/retracting a suture, the method comprising:

providing a suture advancing/retracting mechanism for advancing/retracting a suture, the suture advancing/retracting mechanism comprising:

a stopper engageable to the first tubular member to selectively stop proximal movement of the first tubular member such that:

(ii) when the flange of the second tubular member is thereafter pushed away from the flange of the first tubular member, the shoulder of the second tubular member engages the shoulder of the first tubular member to compress the sidewall of the first tubular member and grip the suture advanced through the lumen of the first tubular member, thereby driving the suture distally;

(iv) when the first tubular element is thereafter moved into engagement with the stop and the flange of the second tubular element is moved toward the flange of the first tubular element, the shoulder of the second tubular element disengages from the shoulder of the first tubular element to stop compressing the sidewall of the first tubular element and releasing the suture extending through the lumen of the first tubular element;

moving the first tubular member into engagement with the stop and urging the second flange towards the flange so as to compress the spring;

advancing a suture through the lumen of the first tubular member;

pushing the flange of the second tubular member away from the flange of the first tubular member to cause the shoulder of the second tubular member to engage the shoulder of the first tubular member to compress the sidewall of the first tubular member and grip a suture advanced through the lumen of the first tubular member, thereby driving the suture distally:

moving the first tubular member into engagement with the stop and moving the flange of the second tubular member toward the flange of the first tubular member such that the shoulder of the second tubular member disengages from the shoulder of the first tubular member to stop compressing the sidewall of the first tubular member and release the suture extending through the lumen of the first tubular member.

a shaft having a distal end and a proximal end;

a jaw assembly comprising a first jaw member including a first tip, a first channel for slidably receiving a suture, and a first slot, and a second jaw member including a second tip, a second channel for slidably receiving a suture, and a second slot, wherein at least one of the first and second jaw members is pivotally mounted to a shaft so as to be movable between: (i) at least one open position in which the first and second tips of the first and second jaw members are separated from each other by a gap; and (ii) a closed position in which the first and second tips of the first and second jaw members engage one another such that the first and second channels form a continuous path;

a gripping assembly comprising a first holder comprising a first gripping surface, a second holder comprising a second gripping surface, and a holder clamp for engaging the first holder and the second holder to move at least one of the first holder and the second holder between: (i) a release position in which the first and second gripping surfaces of the first and second holders are separated from each other by a gap larger than a diameter of a suture used to form the suture loop; and (ii) a gripping position in which the first and second gripping surfaces of the first and second holders are spaced from each other by a distance that is less than the diameter of the suture being used to form the suture loop;

an electrode assembly comprising electrodes for selectively applying an electrical potential to a suture thread clamped between first and second gripping surfaces of the first and second holders, wherein the electrodes are movable between: (i) a non-welding position in which the electrodes are spaced from a suture line clamped between the first and second gripping surfaces of the first and second holders; and (ii) a welding position in which the electrode engages a suture thread clamped between the first and second gripping surfaces of the first and second holders;

an actuator rod assembly for selectively operating the jaw assembly, the grip assembly, and the electrode assembly in response to movement of the actuator rod assembly in a distal direction, the actuator rod assembly including an actuator rod movably mounted to the shaft, a drive pin mounted to the actuator rod and extending through the first slot of the first jaw member and the second slot of the second jaw member, a holder clip of the grip assembly mounted to the actuator rod, and the electrodes of the electrode assembly are spring biased away from the actuator stem and into engagement with the first and second holders of the holder assembly when the holder assembly is in its gripping position, wherein when the electrode assembly is in its non-welding position, the grip assembly is in its release position, and the jaw assembly is in its open position with a suture positioned between the first and second holders of the grip assembly, the stepwise movement of the actuator rod in the distal direction sequentially results in:

(a) at least one of the first jaw and the second jaw of the jaw assembly is moved from its open position to its closed position;

(b) at least one of the first and second holders moves from its release position to its gripping position; and

and subsequent stepwise movement of the actuator rod in the proximal direction results in turn in:

(d) the electrode is moved from its welding position to its non-welding position;

(e) at least one of the first and second holders moves from its gripping position to its releasing position; and

(f) at least one of the first jaw and the second jaw of the jaw assembly moves from its closed position to its open position.

In one form of the invention, there is provided a medical device comprising:

a jaw assembly, a grip assembly, an electrode assembly, and an actuator rod assembly operably coupled to the jaw assembly, the grip assembly, and the electrode assembly;

the jaw assembly includes a first jaw member and a second jaw member,

the first jaw member includes a first tip, a first slot, and a first channel for receiving a suture,

the second jaw member including a second tip, a second slot, and a second channel for receiving a suture,

at least one of the first and second jaw members is movable between an open position and a closed position,

the open position is a position in which the first and second tips of the first and second jaw members are separated from each other by a gap, and

the closed position is a position in which the first and second channels form a continuous channel for the suture;

the actuator rod assembly includes a movable actuator rod and a drive pin mounted to the actuator rod,

the drive pin extends through the first slot of the first jaw member and the second slot of the second jaw member;

the gripping assembly includes a first holder, a second holder, and a holder clip,

the first holder includes a first gripping surface,

the second holder includes a second gripping surface,

a holder clip is mounted to the actuator stem and engages the first holder and the second holder to move at least one of the first holder and the second holder between a release position and a gripping position,

The electrode assembly includes an electrode configured to apply an electrical potential to a suture thread between first and second gripping surfaces of the first and second holders,

the electrode is movable between a non-welding position and a welding position,

the non-welding position is a position where the electrodes are spaced from the suture between the first and second gripping surfaces of the first and second holders, and

the welding position is a position of the electrode engaging a suture between the first and second gripping surfaces of the first and second holders;

(a) moving at least one of the first jaw and the second jaw of the jaw assembly from an open position to a closed position;

(b) at least one of the first holder and the second holder is moved from a release position to a gripping position; and is

and a subsequent second step-wise movement of the actuator rod in the proximal direction sequentially results in:

(d) moving the electrode from the welding position to a non-welding position;

(e) at least one of the first holder and the second holder is moved from a gripping position to a releasing position; and

(f) at least one of the first jaw and the second jaw of the jaw assembly moves from a closed position to an open position.

In one form of the invention, there is provided a method for applying a suture to tissue, the method comprising:

providing an apparatus for applying a suture to tissue, wherein the suture comprises a biocompatible, electrically conductive thermoplastic material and has a diameter, the apparatus comprising:

a shaft having a distal end and a proximal end;

a jaw assembly comprising a first jaw member including a first tip, a first channel for slidably receiving a suture, and a first slot, and a second jaw member including a second tip, a second channel for slidably receiving a suture, and a second slot, wherein at least one of the first and second jaw members is pivotally mounted to a shaft so as to be movable between: (i) at least one open position in which the first and second tips of the first and second jaw members are separated from each other by a gap; and (ii) a closed position in which the first and second tips of the first and second jaw members engage one another such that the first and second channels form a continuous path;

an electrode assembly comprising electrodes for selectively applying an electrical potential to a suture thread clamped between first and second gripping surfaces of the first and second holders, wherein the electrodes are movable between: (i) a non-welding position in which the electrodes are spaced from a suture line clamped between the first and second gripping surfaces of the first and second holders; and (ii) a welding position in which the electrode engages a suture thread clamped between the first and second gripping surfaces of the first and second holders;

an actuator rod assembly for selectively operating the jaw assembly, the grip assembly, and the electrode assembly in response to movement of the actuator rod assembly in a distal direction, the actuator rod assembly including an actuator rod movably mounted to the shaft, a drive pin mounted to the actuator rod and extending through the first slot of the first jaw member and the second slot of the second jaw member, a holder clip of the grip assembly mounted to the actuator rod, and the electrodes of the electrode assembly are spring biased away from the actuator stem and into engagement with the first and second holders of the holder assembly when the holder assembly is in its gripping position, wherein when the electrode assembly is in its non-welding position, the grip assembly is in its release position, and the jaw assembly is in its open position with a suture positioned between the first and second holders of the grip assembly, the stepwise movement of the actuator rod in the distal direction sequentially results in:

(a) at least one of the first jaw and the second jaw of the jaw assembly is moved from its open position to its closed position;

(b) at least one of the first and second holders moves from its release position to its gripping position; and

and the subsequent stepwise movement of the actuator rod in the proximal direction in turn results in:

(d) the electrode is moved from its welding position to its non-welding position;

(e) at least one of the first and second holders moves from its gripping position to its releasing position; and

(f) at least one of the first jaw and the second jaw of the jaw assembly is moved from its closed position to its open position;

positioning the device adjacent the tissue with the jaw assembly in its at least one open position, the grip assembly in its release position, and the electrode assembly in its non-welding position;

moving the actuator rod stepwise in the distal direction so as to cause, in turn:

(a) at least one of the first jaw and the second jaw of the jaw assembly is moved from its open position to its closed position;

(b) at least one of the first and second holders moves from its release position to its gripping position; and is

subsequent stepwise movement of the actuator rod in the proximal direction so as to cause, in turn:

(d) the electrode is moved from its welding position to its non-welding position;

(e) at least one of the first and second holders moves from its gripping position to its releasing position; and

(f) at least one of the first jaw and the second jaw of the jaw assembly moves from its closed position to its open position.

Drawings

These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments of the invention, which is to be considered in conjunction with the accompanying drawings, wherein like reference numerals refer to like parts, and further wherein:

FIG. 1 is a schematic diagram showing a short length of filamentary material formed in accordance with the present invention (filamentary material is sometimes referred to herein as an "electrically conductive thermoplastic suture");

FIG. 2A is a schematic diagram showing a novel apparatus for welding electrically conductive thermoplastic sutures;

FIG. 2B is a schematic diagram showing the formation of a weld in an electrically conductive thermoplastic suture using the novel apparatus of FIG. 2A;

FIG. 3 is a schematic diagram illustrating a tissue fastening device or construct formed in accordance with the present invention;

FIGS. 4A and 4B are schematic diagrams illustrating the novel device made of molded electrically conductive thermoplastic material that is attempted to be electrically welded in situ;

FIGS. 5A and 5B are schematic diagrams illustrating another novel device made of a molded electrically conductive thermoplastic material that is intended to be electrically welded in situ;

FIG. 6 is a schematic view showing the novel stapling instrument used in surgery;

FIG. 7A is a schematic view showing a distal end effector portion of the novel stapling instrument of FIG. 6;

FIG. 7B is a schematic diagram illustrating actuation of the grasper portion of the distal end effector shown in FIG. 7A;

FIG. 7C is a schematic view showing a needle (with a channel) advanced through tissue (not shown) clamped between the grasping surfaces of the distal end effector;

FIG. 7D is a schematic showing the distal end effector of FIG. 7C with the suture advanced by pushing the suture into the groove of the needle and the groove of the grasper;

FIG. 7E is a schematic diagram illustrating actuation of the articulated gripping mechanism of the distal end effector of FIG. 7D;

FIG. 7F is a schematic showing the distal end effector of FIG. 7E with the needle retracted and the suture advancement mechanism reversed;

FIG. 7G is a schematic showing the distal end effector of FIG. 7F with the electrodes advanced to contact a portion of the suture;

FIG. 7H is a schematic view showing the distal end effector of FIG. 7G with the blade advanced to cut a suture;

FIG. 7I is a schematic view showing the distal end effector of FIG. 7H with the grasper in a reopened position;

FIGS. 8A and 8B are schematic views showing the novel end effector used in robotic surgery;

8C-8F are schematic views showing further details of the novel end effector shown in FIGS. 8A and 8B;

8G-8M are schematic partial cross-sectional views illustrating another form of the invention;

9A-9E are schematic diagrams illustrating the anatomical closure achieved using the novel end effector shown in FIGS. 8A and 8B;

FIG. 10A is a schematic view showing another novel end effector for use in robotic surgery;

FIGS. 10B-10E are schematic diagrams illustrating the anatomical closure achieved using the novel end effector shown in FIG. 10A;

FIG. 11 is intentionally omitted;

FIG. 12 is an isometric schematic view of an embodiment of a suture feed and tensioning instrument for an automatic stapling and/or ligating instrument;

FIGS. 13a and 13b are detailed isometric views of a subcomponent of the apparatus shown in FIG. 12;

FIGS. 14a-14d are isometric schematic views of steps in the operation of the apparatus shown in FIG. 12;

FIG. 14e is a schematic view showing the suture cartridge in combination with the device shown in FIG. 12;

FIGS. 15a and 15b are isometric views of the novel robotic instrument end effector particularly useful for vessel ligation;

FIGS. 16a-16c are detailed front views showing the relationship between actuator position and jaw movement of the end effector shown in FIGS. 15a and 15 b;

FIG. 17a is an isometric view of a novel internal mechanism for delivering a suture that is part of the end effector of FIG. 15 a;

FIG. 17b is an exploded schematic view of the novel internal mechanism for delivering a suture that is part of the end effector of FIG. 15 a;

18a-18f are a series of schematic side cross-sectional views illustrating a sequence of operation of the suture transfer mechanism of FIGS. 17a and 17 b; and

fig. 19a-19f are isometric views illustrating the operational steps of the ligation instrument of fig. 15a and 15b from the perspective of a user.

Detailed Description

The present invention comprises providing and using new and improved methods and apparatus for producing suture welds of sufficient strength and reliability to replace or enhance the strength of suture knots or other loop closure devices.

The present disclosure describes the inventive concept with reference to specific examples. The intention, however, is to cover all modifications, equivalents, and alternatives falling within the inventive concept consistent with the present disclosure.

For the purposes of this patent application, the term "suture" means a filament used in surgical procedures to join tissue and/or objects (e.g., using suture stitches) or to ligate a vessel, tissue or object (e.g., using ligation stitches).

For purposes of this application, the term "stitch" means a length of suture where portions of the length of suture are joined together to form a continuous loop that is passed through or around tissue and/or objects to provide surgical purposes, such as closing a wound (e.g., using suture stitches), occluding a blood vessel (e.g., using ligation stitches), and the like.

For the purposes of this patent application, the term "suture loop" means a length of suture that forms a continuous structure with overlapping portions before and/or after those overlapping portions are joined, for example by welding.

Summary of the invention

Forming surgical stitches in an anatomical region with difficult surgical access is a challenge in minimally invasive surgery. The present disclosure describes an invention for joining suture by welding (e.g., instead of tying or tying a knot). This saves time and can be done in extremely limited space. Unlike existing suture welding systems, the present invention enables the use of low cost welding equipment to deliver suture welds through tortuous paths, such as through a curved conduit. Aspects of the disclosed invention can be particularly beneficial to manufacturers of robotic surgical systems. For example, a fully automated suturing apparatus attachment can be utilized in a surgical robotic system.

Conventional "needle and thread" sutures require manual or instrument access and are time consuming, require space to maneuver, and leave large knots at the surgical site. Crimp-type bonding devices leave foreign matter (e.g., metal crimps) at the bond site, and the large crimping force required to actuate the crimp requires a substantial shaft diameter and a limited shaft length. Existing suture welding devices utilizing direct application of heat present the risk of undesirable heating of the surrounding tissue and/or weakening of the suture. Existing ultrasonic suture welding devices are bulky and expensive and require a straight line path to the surgical site. Existing surgical robotic manipulators are time consuming, require operating space, and have steep learning curves.

Traditionally, shaped sutures are passed through tissue using a needle and tied in a loop using a knot to close the wound and allow healing of the tissue. Minimally Invasive Surgery (MIS) and robotic surgery place demands on the surgeon's skills because of the need to tie suture knots in areas of the body that are inaccessible to the surgeon's hands. Many surgical instruments have been developed to assist surgeons in tying knots or providing a knot substitute. The present inventors and others have invented such an instrument. One known instrument includes a tool for forming a welded loop of suture, and another contemplates the welded loop of suture itself as a surgical fastener. While the method of joining sutures into stitches facilitates suturing in difficult to reach areas of the body, in practice it requires an ultrasonic generator, transducer and waveguide to accomplish the welding in a monofilament suture. Such devices are bulky and expensive and require a straight line path from the incision point to the surgical site.

The present invention seeks to improve upon these earlier inventions by using novel suture materials and novel welding devices that do not require bulky, expensive ultrasonic instruments and can be delivered through elongate and/or curved shafts.

Among other things, novel aspects of the disclosed invention include:

1. a suture material that can be directly welded using a small amount of simple low voltage electrical energy;

2. a tissue fastening device or construct comprising a continuous welded loop of filamentary material comprised of an electrically weldable polymer;

3. apparatus for welding an electrically weldable suture that provides precise control of welding parameters to ensure a consistent high strength weld;

4. apparatus for welding an electrically weldable wire, which can be safely handled inside the body without damaging adjacent tissue; and

5. apparatus for welding an electrically weldable wire which can be conveyed through a serpentine path to a remote area of the body.

These and other advantages are achieved by the novel materials, apparatus, methods and devices of the present invention.

The suture material aspect of the present invention is made of a filament of biocompatible material having a diameter, strength and flexibility consistent with surgical sutures and having an electrical conductivity with a predictable electrical resistance value.

The apparatus aspect of the invention comprises: a mechanism for retaining the overlapping portion of the suture loop; means for applying a contact pressure through the overlapping region; and means for applying and controlling a current through the overlapping region to locally heat the overlapping region by the current flowing through the overlapping region and thereby cause local melting of the overlapping region, which then solidifies again to form the weld.

Some forms of the apparatus further comprise: a mechanism for clamping the suture to maintain suture tension during the welding process; a mechanism for trimming the suture tail extending beyond the suture loop; a handle with controls to allow a user (e.g., a surgeon) to manipulate the device and begin the welding process; and an elongated straight, curved, articulated, flexible and/or steerable shaft connecting the distal welding device to the proximal handle, allowing a user to maneuver the welding device into hard to reach areas of the body (such as in MIS procedures).

Additional forms of the apparatus include instruments for controllably or automatically penetrating tissue, delivering suture, tensioning suture, trimming suture tail, and releasing a formed tissue-secured suture loop. Examples of these appliances are disclosed in the inventor's prior U.S. patent No. 5,417,700 (which is hereby incorporated by reference herein) and may be used alone or in combination with such new welding equipment.

The welding process aspect of the present invention shares many of the same features as resistance or spot welding of metals, but has several important novel differences, including but not limited to: the low voltages and special electrical isolation necessary for medical devices; the ability to work with non-metallic conductive materials; and means for controlling the localization and depth of material melting so as to maintain high strength of the highly linear molecular chains of the conductive polymer or composite being welded.

The suture loops formed by the materials, devices, and processes disclosed herein are tissue-fastening devices or constructs formed in situ in the form of a continuous loop. The loop comprises a wire of biocompatible, electrically conductive material disclosed herein, which approximates an arc in a circular configuration, with overlapping areas joined by a weld.

Other structures are also disclosed herein that are made from the disclosed materials and are welded in place but not necessarily in the form of a ring or comprise a filamentous material with a uniform cross-section.

In one form of the invention, a welded suture loop is used to secure two or more portions of tissue together.

In another form of the invention, a welded suture loop is used to ligate tissue.

Material used to form weldable suture and/or weldable structure

Figure 1 shows a short length of filamentous biocompatible material 5. In one form of the invention, the material 5 has the following characteristics: are substantially circular in cross-section and fall within the ranges specified by the united states pharmacopeia for suture diameter (USP 29-861) and tensile strength (USP 29-881) and equivalent international standards. The material 5 further has the following characteristics: has an electrical conductivity with a known resistance and can be melted at a melting temperature higher than 37 ℃ (so that the material 5 is in solid form in the human body). Thus, the material 5 comprises an electrically conductive thermoplastic material.

In a preferred form of the invention, the material 5 is a monofilament of a thermoplastic polymer compounded with a conductive additive. In some forms, a dispersant is used to ensure uniform mixing of the conductive additives within the polymer matrix. In some forms, the base thermoplastic polymer and the conductive additive (and dispersant, if desired)) Melt compounded (mixed), extruded and drawn to produce monofilaments having substantially linear molecular chains for excellent strength and flexibility. In other forms, the melt compounded (blended) material is injection molded into single or multi-component devices for medical applications. In some forms, the thermoplastic polymer is a bioabsorbable material (e.g., polylactic acid (PLA), Polyglycolide (PGA), Polydioxanone (PDS), thermoplastic linear polyesters such as those under the tradename TephaFLEX) that are currently approved for use as sutures or implants^TMThose sold, etc.). In other forms, the thermoplastic polymer is a non-absorbable material (e.g., nylon, polypropylene, polycarbonate, etc.). In some forms, the conductive additive is an inert and/or non-toxic material, such as carbon black, carbon fiber, iron oxide (Fe)₂O₃Etc.) or metal powders, nanoparticles (such as carbon nanotubes or fullerenes, also known as "Buckyball"), or metal-coated glass microspheres. In other forms, the conductive additive is any one of an Intrinsically Conductive Polymer (ICP) including, but not limited to, polyacetylene, polyaniline, polythiophene, and polyphenylacetylene. In some forms, these non-thermoplastic polymers are compounded with a thermoplastic base polymer. In other forms, the non-thermoplastic polymer is applied as a thin film coating to the base polymer filament or component. In some forms, the conductive coating is a continuous or patterned coating of conductive ink. In some forms, the conductive polymer or composite may be coextruded on the outside of another, not necessarily conductive, polymer at its core. In one form, the core material has a higher melting temperature than the outer layer being coextruded. In other forms, the filaments may be a multi-strand structure, such as a braided suture made from bundles of micro-filaments of a conductive thermoplastic polymer, or a composite of different filaments braided together. In one form, the conductive and non-conductive filaments are combined into a single braided suture. In another embodiment, microwires with varying melting temperatures and electrical conductivities are woven together such that localized solder melting does not melt the higher melting temperature filaments, thereby maintaining their highly linearized molecular orientation and high strengthThe features and the creation of strong weld areas.

In one form, the high strength, high melting temperature polymer filaments are provided in a low melting temperature metal matrix such that when an electrical current is applied through adjacent portions of the polymer filaments/metal matrix, the metal fuses but leaves the high strength filaments undamaged. In yet another form, metal sutures or wires are used, although pure metals are generally less desirable than electrically conductive thermoplastics because of the high melting temperature of metals and the high thermal conductivity in metals which present a risk of damaging surrounding tissue, and the diffusion of melt in metals is more difficult to control than in polymers. In one form of the material, the material filaments have lateral (side-to-side) conductivity but no axial (end-to-end) conductivity, which has the advantage of protecting the body from stray currents in the event of suture breakage before or during welding. Transverse rather than axial conductivity characteristics can result from drawing or stretching a composite material with a low conductive additive fill ratio because the chains of additives can be broken axially during stretching, but compacted laterally due to the reduction in diameter.

In one form of the invention, the material 5 is a conductive thermoplastic polymer.

Apparatus for welding electrically conductive thermoplastic suture

Fig. 2A shows an apparatus 10 for welding a length of electrically conductive thermoplastic suture 15. The length of electrically conductive thermoplastic suture 15 includes a first end 20 and a second end 25. The first end 20 and the second end 25 overlap at a contact point 30 to form a loop of suture 15. The loop of suture 15 is held in its loop configuration by a clamping mechanism 35 applied at the point of contact 30. The clamping mechanism 35 includes a first electrode 40 conforming to a surface of the first end 20 of the suture 15 and a second electrode 45 conforming to a surface of the second end 25 of the suture 15. The spring 50 exerts a predetermined force between the electrodes 40, 45 to maintain pressure on the contact point 30. In one form, first electrode 40 and second electrode 45 are disposed substantially parallel to one another, resulting in a line contact (not shown) between first suture end 20 and second suture end 25. In another form (i.e., the form shown in FIG. 2A), there is a relative bend between first electrode 40 and second electrode 45, resulting in a point contact between first suture end 20 and second suture end 25. The structural frame 55 holds the components of the clamping mechanism (i.e., the first electrode 40, the second electrode 45, and the spring 50) in place. Importantly, the structural frame 55 is not electrically conductive between the first electrode 40 and the second electrode 45. Circuit 60, including at least power source 65 and switch 70, is connected to first electrode 40 and second electrode 45, as shown in FIG. 2A, such that closing switch 70 applies a voltage across first electrode 40 and second electrode 45 and allows current to flow through first suture end 20 and second suture end 25 at contact point 30. Preferably, the power supply 60 comprises a DC battery, although in other forms the power supply 60 may comprise an external AC power source with an isolation transformer and rectifier or a low or high frequency AC power source.

In other forms of the invention, additional features may be added to the device 10 to facilitate its use as a surgical instrument, such as a tissue penetrating and suture passing instrument; a tensioning device; a clamping fixture for securing suture ends 20, 25 to facilitate welding with the suture under tension; a suture tail trimming implement; a welding zone dry gas introduction means; an elongated and/or serpentine delivery shaft; and/or a handle for a manual user interface or an electromechanical interface for connection to a surgical robot. These additional instruments and features are well known in the art and are described in detail in prior patents (e.g., U.S. patent No. 5,417,700) by the present inventors and other inventors.

An illustrative method and process for forming a weld in the conductive thermoplastic stitch line 15 is shown in fig. 2B. Closing switch 70 causes current to flow from first electrode 40, through first suture end 20, across contact point 30, through second suture end 25, and then to second electrode 45. The maximum resistance in the circuit is at contact point 30, resulting in heat accumulation in this region and diffusion into first and second suture ends 20 and 25. The heat build-up results in a localized melted region 75, which localized melted region 75 diffuses into first suture end 20 and second suture end 25 as heat increases. In one form, the switch 70 is opened and the current is stopped before the melt spreads across the entire cross-section of the suture material. This is different from conventional resistance welding of metals, where the entire metal thickness is expected to be contained in the weld and is due to the non-isotropic nature of drawn, extruded monofilament sutures.

To repeatedly and reliably achieve an optimal depth of melt penetration into the suture ends 20, 25, a variety of process control methods may be used. Among many of these process control methods, we will mention circuits and components not shown in the simplified schematic diagrams shown in fig. 2A and 2B, such as microprocessors and various sensors, although they can be considered to be deployed in a conventional manner familiar to those skilled in the art. In one such form, a simple timer is used to control the amount of time the welding circuit is on. In another form, the first and second electrodes 40, 45 are configured such that as the melt diffuses, the electrodes 40, 45 move toward each other as the molten material is displaced, and the electrodes 40, 45 contact each other when the optimum amount of material has melted. The contact electrodes are shorted together, shunting current around the suture and stopping heating. The current sensor may then be used to signal the microprocessor to interrupt the welding circuit. In another form, the displacement sensor may replace the self-contacting electrode to signal the microprocessor to shut down the circuit when the desired weld displacement has occurred. Other forms use a temperature sensor to control the welding circuit through a microprocessor to shut down the welding circuit when a preset peak temperature or thermal profile has been sensed. In still other forms, a combination of time, displacement and temperature sensors are used and the optimal welding parameters are determined by a microprocessor-based algorithm. It is noted that the apparatus and method shown in fig. 2A and 2B are applicable to both tissue stapling and tissue ligation processes.

Tissue fastening device or construct formed by welding a suture

Fig. 3 shows a tissue fastening device or construct 100 having a length of electrically conductive thermoplastic material formed in situ as a continuous loop and bonded by a partial depth penetration weld. In this figure we see a region of original monofilaments 105 surrounding a welded region 110, the original monofilaments 105 having a high tensile strength due to highly straightened molecular chains, which is theoretically represented by lines substantially parallel to the axis of the suture, the welded region 110 having an amorphous molecular orientation, which is theoretically represented by randomly disordered lines. The tensile strength of the original monofilament is significantly greater than the tensile strength of the remelted regions. When tension is applied to the ring, the top and bottom portions of the overlapping ring ends load the weld area in shear, and because the area of the weld area is larger than the cross-section of the suture, the stress in this area is reduced as long as there is raw high strength suture material on both sides of the weld area to distribute the load.

Molded thermoplastic tissue fixation device

Fig. 4A and 4B illustrate a clip 150 made of a molded conductive thermoplastic material that can be electrically welded in place, for example, to occlude blood vessels (such as veins and arteries) for surgical hemostasis, or to clamp tissues together, or the like. Fig. 4A shows the clip 150 prior to deployment. The clip 150 includes a first end 155 having a recess 160 and a second opposing end 165 having a protruding feature 170. The protruding feature 170 on the second end 165 mates with the recess 160 on the first end 155 to create a high resistance contact point to initiate weld melting. Fig. 4B shows clip 150 welded in place around blood vessel 175. Electrodes (not shown) applied to facing surfaces of the first and second ends 155, 165 on the clip 150 open the weld melted region 180 and cause the first and second ends 155, 165 to join to each other such that the clip 150 occludes the blood vessel 175.

Fig. 5A and 5B show an illustrative device 200 made of a molded electrically conductive thermoplastic material that is electrically welded in situ to occlude a section of a hollow organ 205, such as the stomach, in order to allow the organ to be surgically segmented. The apparatus 200 comprises: (i) a first strip 210 having a row of electrically conductive thermoplastic needles 215 terminating in needle tips 220, and (ii) a second strip 225 having corresponding recesses (not shown) for receiving the needle tips 220. In this form of the invention, a device (not shown) delivers a first strip 210 of electrically conductive thermoplastic needles 215 through two layers of the organ (i.e., through both side walls of the hollow organ), and a second strip 225 is welded to the needle tips 220 of the first strip 210 after the needle tips 220 have penetrated the organ and emerge therefrom. By controlling the depth of melting of the needle 215, the distance between the top portion (i.e., the second strip 225) and the bottom portion (i.e., the first strip 210) of the device 200 can be controlled, thereby controlling the degree of "extrusion" applied to the organ and accommodating organs having variable thicknesses. In this manner, the welded surgical fasteners are functionally similar to a row of stitches, or the surgical staples can be delivered in a continuous linear process.

Suturing and ligating instrument

Fig. 6 shows a stapling instrument 300 for surgical use, which includes a distal end 305 and a proximal end 310 connected by a shaft 315. The distal end 305 is an end effector and includes mechanical and electrical instruments for manipulating tissue and suture material to form surgical stitches. The proximal end 310 contains actuating means for driving and operating stitch forming means at the distal end 305 by a wire and linkage mechanism (not shown in fig. 6) passing through a shaft 315. The shaft 315 has sufficient length to reach anatomical structures within the interior of the body, with the proximal end 310 of the instrument remaining outside the body, the distal end 305 reaching the target tissue at the surgical site, and the shaft 315 passing through intervening tissue and space, e.g., by passing through a small incision in the body wall, such as the abdominal wall. In one form (not shown), the proximal end 310 of the instrument 300 includes a handle adapted to be held by a human hand, and the actuation means on the proximal end 310 includes various buttons, triggers, levers, etc. for controlling stitch forming means at the distal end 305 and a battery for supplying power to weld the suture. In another form (also not shown), the handle contains a motor, linear actuator, pneumatic or hydraulic cylinder or other actuating means for driving the stitch forming tool, microprocessor controlled circuitry for sequencing stitch formation and welding, a trigger or button to initiate the stitch formation process, and a power source to power the actuator and circuitry. Still other versions have a handle and an external power implement such as a power cord or a pneumatic or hydraulic hose. In another form (shown), the proximal end 310 includes an electrical and/or mechanical interface 320 for connection to a surgical robot.

Fig. 7A illustrates one form of a distal end effector 305 for use with surgical stapling instrument 300 (or other surgical stapling instrument). The distal end effector 305 includes a slidable grasper 325 for grasping a piece of tissue and a tool for delivering and welding a suture loop around the grasped tissue, as will be discussed in further detail below.

The slidable grasper 325 includes a passageway 330 for passing a length of conductive thermoplastic polymer monofilament suture 335 (having a distal end 337) therethrough, a hook feature 340 having a groove 345 opening on an inner side of the hook feature 340, and a needle aperture 350 aligned with the groove 345 of the hook feature 340. Slidable gripper 325 also includes an aperture 352 for passing needle 355 therethrough.

In use and looking now at fig. 7B, the hook feature 340 of the slidable gripper 325 is moved proximally (i.e., in the direction of arrow 357) to clamp tissue (not shown) to be stapled between the first and second textured gripping surfaces 360, 365.

Looking now at fig. 7C, needle 355 includes a groove 370 such that after needle 355 has been advanced through tissue (not shown) clamped between gripping surfaces 360, 365 and needle 355 is disposed in needle aperture 350 of hook feature 340, groove 370 in needle 355 aligns with groove 345 in hook feature 340, thereby forming a continuous circular path (i.e., by way of groove 345 of hook feature 340 and groove 370 in needle 355).

Looking next to fig. 7D, the suture 335 can be advanced through the continuous circular path formed by the groove 370 of the needle 355 and the groove 345 of the hook feature 340 until the distal end 337 of the suture 335 passes back over a portion of the suture 335 proximal of the distal end 337, thereby forming a suture loop through the tissue captured in the distal end effector 305, wherein the distal end 337 of the suture 335 contacts the proximal portion of the suture 335 at the overlap region 375. The suture 335 is advanced by a motor-driven roller in the shaft 315 and/or proximal end 310 of the instrument 300 that engages and pushes the suture 335 through a circular path, or the suture 335 is advanced by other driving implements (not shown) in the shaft 315 and/or proximal end 310 of the instrument 300 known to those skilled in the art.

After the suture 335 has been advanced through the aforementioned circular path to form a suture loop, the hinged gripping mechanism 400 may be used to securely grasp the distal end 337 of the suture 335 adjacent the proximal portion of the suture 335 at the overlap region 375, leaving the proximal portion of the suture 335 free to slide axially for tensioning. To this end and looking now at fig. 7E, the hinged gripping mechanism 400 includes a first lever 405 and a second lever 410 that pivot about pins 415 and 420, respectively. As the suture 335 is being advanced through the groove 370 of the needle 355 and the groove 345 of the hook feature 340, the rods 405, 410 remain separated creating a gap in line with the groove 370 in the needle 355 and the circular groove 345 of the hook feature 340, thereby allowing the distal end 337 of the suture 335 to pass through the gap to form a suture loop. After the distal end 337 of the suture 335 is in place at the overlap region 375, the rods 405, 410 are closed over the distal end 337 of the suture 335, grasping the distal end 337 and holding it securely in place in the overlap region 375. The shafts 405, 410 are made of a non-conductive material, except for the first electrode 425, which is disposed where the shafts 405, 410 grip the distal end 337 of the suture 335. The electrode 425 is in electrical contact only with the distal end 337 of the suture 335.

After the distal end 337 of the suture 335 is clamped by the rods 405, 410 in the overlap region 375, the needle 355 is retracted and suture advancement means that the advancing suture through the circular path is reversed so as to retract the loop of suture 335 and tighten the loop of suture 335 around the tissue grasped by the slidable grasper 325 (fig. 7F).

Once the suture loop has been tightened around the tissue (not shown), the second electrode 430 is advanced to contact the portion of the suture that overlaps the distal end 337 of the suture 335 in the overlap region 375 (i.e., the portion 440 of fig. 7G). A voltage potential is applied across the first electrode 425 and the second electrode 430 and a current flows through the overlapping seam region 375, thereby causing heating, melting, and forming a weld according to the methods described above with respect to fig. 2A.

After welding the distal end 337 of the suture 335 to the proximal portion of the suture at the overlapping suture region 375, the blade 500 is advanced to cut the suture supply proximal of the weld in order to separate the welded ring from the instrument 300 (fig. 7H). The hook feature 340 of the slidable gripper 325 is then moved distally to reopen the slidable gripper 325, thereby releasing the gripped tissue. The first bar 405 and the second bar 410 are also separated to release the welded loop stitch 445 (fig. 7I) around the tissue. The actuator at the proximal end 310 of the instrument 300 then returns the distal end effector 305 to the position of fig. 7A and the instrument 300 is ready to form another stitch.

It should be understood that a wide range of additional devices and systems are capable of using the disclosed materials, apparatus and methods, and are included within the scope of the present disclosure.

It will be appreciated that the stapling instrument 300 can be used to ligate tissue as well as staple tissue, if desired. For example, and without limitation, in an exemplary ligation application, the stapling instrument 300 is slid around tissue (e.g., a blood vessel) to be ligated while in the position shown in fig. 7B. The needle 355 is then advanced distally (fig. 7C) to grasp the tissue to be ligated in the space between the slidable grasper 325, the shaft of the suturing instrument 300, and the needle 355. The suture is then advanced through the aforementioned circular path (fig. 7D) such that the looped suture surrounds the tissue to be ligated. Thereafter, the looped suture is gripped by the rods 405, 410 (FIG. 7E), the needle 355 is retracted, and the suture loop is tightened (FIG. 7F). The suture loop is then welded (fig. 7G) and excess suture is trimmed (fig. 7H). Finally, the suture loop (and ligated blood vessel) is released from the stapling instrument 300 (fig. 7I). Note that for tissue ligation applications, the needle 355 can have a blunt distal end as desired.

Suture end effector for use in robotic surgery

Fig. 8A illustrates a form of the invention incorporated into a highly articulated end effector 801 for robotic surgery. This embodiment includes a four degree of freedom (DoF) slave robotic end effector that is remotely controlled by a surgeon residing at a master robotic console. The main degrees of freedom include: the instrument shaft 802 rolls about axis R, the middle section "joint" 803 is pitch articulated about axis P, and first (804) and second (805) independently rotating tool elements disposed opposite each other each rotate about yaw axis Y. Other robotic end effectors use articulating segments or other means to effect movement of four or five dofs, and the invention is applicable to these devices as well. The end effectors thus far described in this paragraph are well known in the art and are commonly used in robotic surgery. We will now describe the unique novel aspects of the present invention.

Fig. 8B illustrates an embodiment of the present invention that forms suture stitches in the same manner as the invention described in fig. 7A-7I, but differs by the addition of a highly articulated end effector (e.g., the end effector of fig. 8A). In one embodiment, the first articulating counter tool element 804 is a semi-circular rigid body having an inwardly facing groove 810 terminating in a needle hole 811 at a distal end thereof. The second tool element 805 is a semicircular needle having an inwardly facing suture groove 812 and a sharp tissue penetration point 813 at its distal end. The distal portion of the needle 805 (i.e., the second tool element 805) has a radius 814 to align with the needle receiving aperture 811 in the tool element 804. When the first and second tool elements 804 and 805 are relatively closed (as shown in fig. 8A), the inwardly facing grooves 810 and 812 form a continuous groove through which the suture may be advanced.

FIG. 8C shows a partial cross-sectional view of an embodiment of the present invention schematically illustrating a tool for forming suture stitches using an end effector. When the tool elements 804 and 805 are relatively closed, the flexible suture transport tube 820 is aligned with the grooves 810 and 812 in the opposing tool elements 804 and 805. The distal end 821 of suture delivery tube 820 is fixed relative to first tool element 804 (in other embodiments the mechanism may be reversed and delivery tube 820 may be fixed to second tool element 805). The flexibility of the suture transport tube 820 allows the suture transport tube to maintain its alignment with the first tool element 804 throughout the entire range of motion of the articulating end effector. Flexible suture transport tube 820 serves the same purpose as suture passage 202 described in fig. 7A, except it is flexible and allows articulation of the end effector.

Fig. 8D, 8E, and 8F show detailed views of suture holders 825 and 826. Suture holders 825 and 826 provide a variety of functions during suture formation. In one embodiment, they are disposed on ramped guide surfaces (not shown in fig. 8D, 8E, and 8F, but of a type known to those skilled in the art of gripping mechanisms) provided on the end effector such that they separate when the grippers 825 and 826 are moved distally and come together as they are moved proximally. Their movement is controlled by a flexible holder actuation linkage 827, which linkage 827 is sufficiently flexible to actuate the holder throughout the end effector's entire range of motion. The holders 825 and 826 move into three different positions: a feed position (fig. 8D) where the gripper portions are separated to allow suture to pass therebetween; a clamping/welding position (FIG. 8E) where the steps 828 in the holder surface come together to clamp and hold the distal ends of the suture strands (i.e., the overlapping portions of the suture strands) for loop tensioning and welding; and a release/cut position (fig. 8F) where the gripper is wide enough apart to release the welded suture loop, and the sharpened cutter surface 829 slides distally to shear the welded suture loop from the suture supply exiting the feed tube 820.

Fig. 8C also shows a welding electrode 830 that is actuated distally and proximally by a flexible electrode linkage 831, which flexible electrode linkage 831 is sufficiently flexible to control the movement of the welding electrode throughout the entire range of motion of the end effector. In one embodiment, suture holders 825 and 826 are electrically insulated except for the distal surfaces of the holders' contacts that overlap the distal sides of the conductive suture segments that are held in a clamped position. Electrode 830 is electrically insulated except for a portion of the distal surface that can contact the proximal side of the overlapping conductive suture segments that are held in the clamped position. In one embodiment, either or both of the flexible actuation linkages 827 and 831 (of electrodes 830) of the holders 825 and 826 are insulated and electrically conductive and are arranged to deliver electrical energy to either the holders or the electrodes or both. In other embodiments, separate flexible insulated wires deliver electrical energy to either or both of the holders 825 and 826 and/or the electrode 830. In embodiments where only one element (i.e., the holders 825 and 826, or the electrode 830) has an insulated conductor, the other element (i.e., the electrode 830, or the holders 825 and 826) may be connected to ground through the instrument shaft and the connected component. An electrical potential is applied between the holder surface and the non-insulated portions of the electrodes causing current to flow through the overlapping conductive suture segments, thereby causing local melting at the interface between the suture segments, resulting in a welded connection between the suture segments. Where the overlapping conductive suture segments are either end of a continuous suture loop, welded stitches are formed.

It should be noted that the end effector 801 can be used for tissue ligation as well as tissue stapling, if desired. For example, and without limitation, where the end effector 801 is to be used to ligate tissue (e.g., a blood vessel), the arms 804, 805 are deployed around the tissue so as to wrap around the tissue without penetrating the tissue. In this manner, the suture loop is positioned around the tissue prior to suture tightening and welding.

Figures 8G-8M illustrate an embodiment of the invention that eliminates the need for a flexible holder actuation linkage 827 and a flexible electrode linkage 831 adjacent to the actuation holders 825 and 826 and the electrode 830 by moving the holders 825 and 826 using a cam (see below) associated with the relative motion of the tool element 804 and the needle 805. Advantages of this alternative arrangement include (i) design simplification, and (ii) a reduction in the total number of actuators (or dofs) required to complete a pin, i.e., a reduction of two in the total number of actuators required to complete a pin (i.e., a reduction of two in the actuators or dofs required to complete a pin with this alternative arrangement).

FIG. 8G illustrates the distal portion of the end effector, the relative angular relationship between the fantasy rubber of the tool element 804 and the needle 805, wherein the fantasy rubber of the needle 805 is divided into four regions or locations: (i) feeding, (ii) tensioning (or clamping), (iii) welding, and (iv) cutting/releasing.

Fig. 8H shows suture that has been fed into the inward facing channel 812 in the needle 805 in a similar manner to that shown in fig. 7D.

Fig. 8I shows a partial cross-sectional view of the interior workings of the hub defined by axis Y, which is the axis of rotation of the tool element 804 and the needle 805, and shows a cam 840, which is part of the needle 805 or carried by the needle 805 and thus rotates with the needle 805. In a similar manner to that shown in fig. 8D, we can see that in fig. 8I, the holders 825 and 826 are positioned to be slightly opened by the cam 840, which cam 840 presses against the follower surfaces 841 and 842 (which are part of the holders 825 and 826).

Fig. 8J shows the needle 805 and cam 840 (connected to the needle 805) rotated slightly past the "feed" region (see fig. 8G) and to the "tension (or grip)" region (see fig. 8G) such that the cam 840 pushes the grips 825 and 826 in a proximal direction where the sloped surfaces approximate the gap between the grips, causing the stepped surfaces 828 of the grips 825 and 826 to grip the distal end of the suture in a manner similar to that shown in fig. 7E, so that the suture can be tensioned.

Fig. 8K shows the suture having been tensioned in a manner similar to that shown in fig. 7F, and the needle 805 is further rotated to a position in the "tensioned (or clamped)" region (see fig. 8G) just prior to the "welded" region (see fig. 8G). Fig. 8K further shows welding electrode 830 sandwiched between holders 825 and 826 (from this cross-sectional view proximal holder 826 has been removed to allow viewing of electrode 830). Electrode 830 has cam follower surfaces 845 and 846 that advance rotationally from holder follower surfaces 841 and 842 such that as needle 805 and cam 840 rotate, electrode 830 moves before holders 825 and 826 move, allowing a single cam surface to perform multiple functions in a sequence (i.e., moving holders 825 and 826, and then moving electrode 830). In other embodiments, multiple cam lobes may be employed to achieve this same sequential operation.

Fig. 8L shows the needle 805 and cam 840 rotated to the "weld" region (see fig. 8G). In fig. 8L, we see that holders 825 and 826 (again, proximal holder 826 has been removed from this cross-sectional view to allow electrode 830 to be seen) still hold the distal end of the suture while electrode 830 has been advanced to compress the overlapping portions of the suture loop. In a manner similar to FIG. 7G, a current is then applied to the overlapping portion of the suture loop through (i) the conductive surfaces on the grippers 825 and 826 and (ii) the electrode 830, causing a weld to be formed in the overlapping portion of the suture loop.

Fig. 8M shows the needle 805 and cam 840 rotated to the "cut/release" region (see fig. 8G). In FIG. 8M, we see that the holders 825 and 826 (from which view the proximal holder 826 is no longer removed) are advanced distally by the cam 840, causing the gripping surfaces to separate, while the advancing sharpened cutter surface 829 spans the suture feed opening, severing the suture loop from the suture supply and releasing the stitches (i.e., the welded suture loop) from the suturing instrument.

It will be appreciated in view of this disclosure that the needle 805 may be moved through its aforementioned operative position in various ways well known to those skilled in the art, for example, the needle 805 may be rotated about a pivot axis by advancing and retracting an actuation rod.

Fig. 9A-9E illustrate an embodiment of the invention within the body, as may be seen by the surgeon at the robotic console.

Fig. 9A shows an opening 900 in tissue 901 that the surgeon wishes to close using stitches. The surgeon's hand and wrist motions at the master robot on the console are replicated in the body by the instrument end effector 801. The surgeon's thumb and index finger movements are replicated by tool element 804 and needle 805. The surgeon positions the tool element 804 and needle 805 to rest on the tissue opening to be sutured.

Fig. 9B shows the tool element 804 and needle 805 relatively closed in response to the surgeon bringing their thumb and forefinger together. The needle 805 has penetrated through both sides of the tissue opening, completing a continuous circular groove (i.e., circular grooves 812 and 810 joined together) from the needle 805 to the tool element 804. If they are satisfied with the stitch position defined by the needle placement, the surgeon initiates the suturing procedure by depressing a foot pedal or voice activated command or other means available for initiating action. In one embodiment, the stitching process is a fully automated sequence. In other embodiments, some steps are automatically initiated in sequence and others are initiated by the surgeon. The first step in this sequence is to activate a suture advancement mechanism coupled to flexible suture delivery tube 820 that advances a length of electrically conductive suture equal to the circumference of the continuous inward facing groove of tool element 804 and needle 805 (i.e., circular grooves 810 and 812 joined together) plus additional material to form the overlapping region of the suture loop. The next step in the sequence is to activate the actuation mechanism connected to the flexible holder actuation linkage 827 and the suture holders 825 and 826 to move the holders from the feed position (fig. 8D) to the clamping/welding position (fig. 8E), thereby gripping the distal ends of the advanced sutures in the overlap region.

Fig. 9C shows the tool element 804 and needle 805 open and released from the tissue, leaving a conductive suture 905 passing through both sides of the tissue opening. In one embodiment, this movement is controlled by the surgeon at the console by separating their thumb and forefinger. In another embodiment, separation of the tool element 804 and needle 805 is automatically initiated by a robot as part of an automated suturing process.

FIG. 9D shows the reverse tensioned suture loop through the suture advancement mechanism. In one embodiment, the tension is automatically opened and the suture is pulled to a predetermined or programmed tension value. In another embodiment, the surgeon controls the tensioning process by means of a control means such as a trigger, a slide mechanism, a foot switch or similar means. In one embodiment, the control instrument includes tactile feedback so that the surgeon has the feel of pulling on the suture to achieve the desired tension of the stitch. In embodiments where separation of the tool element 804 and needle 805 is performed robotically, the surgeon controls and feels tension through tactile feedback by separating their thumb and forefinger, which temporarily disengage from controlling the movement of the tool element 804 and needle 805. Once the desired or predetermined tension has been achieved, the welding process is turned on by turning on the actuator connected to the flexible electrode linkage 831. The electrode 830 is in contact with the proximal side of the overlapping region of the conductive suture loop with a predetermined contact force. Current is then passed through the overlap region (i.e., by passing current between electrode 830 and holders 825 and 826), causing the interface between the suture segments in the overlap region to locally melt and fuse into a weld.

FIG. 9E shows the final step in the suturing sequence, wherein the tensioned welded ring 906 has been severed from the suture supply exiting the suture transport tube 820 and released from the end effector by actuation and movement of the suture holders 825 and 826 from the clamping/welding position (FIG. 8E) to the cutting/release position (FIG. 8F).

Fig. 10A illustrates an embodiment with integrated tissue grasping and manipulation capabilities. This embodiment of the end effector has a first tool element 804, a needle 805, and a second relatively hollow tool element 1000. Hollow tool element 1000 includes an opening 1001 large enough for needle 805 to rotate through and a blunt or textured non-tissue penetrating end 1002 directly opposite and aligned with a matching blunt or textured non-tissue penetrating end 1003 on tool element 804.

Fig. 10B-10E illustrate an embodiment of an end effector (i.e., the end effector of fig. 10A) having tissue grasping and manipulation capabilities, as may be seen by a surgeon in vivo at a robotic console.

Fig. 10B shows the first and second opposing tool elements 804 and 1000 separated in preparation for grasping tissue. The needle 805 is outside the hollow tool element 1000 and the needle tip 813 (not shown in fig. 10B) is protected in the hollow opening 1001. The movement of the opposing tool elements is controlled by the movement of the surgeon's thumb and forefinger, and while the surgeon is grasping and manipulating tissue as with surgical forceps, needle 804 moves with hollow tool element 1000 and maintains its protected orientation relative to hollow tool element 1000.

Fig. 10C shows opposing tool elements 804 and 1000 grasping tissue at a location where a surgeon wishes to place a stitch. The non-tissue-penetrating ends of opposing tool elements 804 and 1000 grip tissue at the exact point that needle 805 will penetrate, thereby facilitating easy entry and penetration by needle 805. When satisfied with the position, the surgeon initiates the suturing procedure by depressing a foot switch, using voice commands, or other means of initiating an automatic sequence. The first step in the sequence is to activate an actuator that "fires" the needle 805 through the tissue.

Fig. 10D shows a needle tip 813 that penetrates tissue and is positioned in a needle hole 811 in the tool element 804 and (in conjunction with the tool element 804) establishes an uninterrupted suture channel (i.e., circular channels 810 and 812 joined together) through the tissue.

Fig. 10E shows hollow tool element 1000 automatically retracted from the tissue, either by action of the surgeon or as part of an automated suturing sequence, leaving needle 805 in place (i.e., passed through the tissue and positioned in needle hole 811 in tool element 804). The remainder of the stitching sequence is the same as that described in fig. 9B-9E.

Suture feed and tensioning mechanism and replaceable suture cartridge

Fig. 12 illustrates an embodiment of a suture feed and tensioning mechanism 1200 for (i) advancing a suture to form a loop configuration, and (ii) retracting the suture when it is in the loop configuration to tension the suture. In one form of the invention, suture feed and tensioning mechanism 1200 includes a supply of weldable suture filament 1201, a means for guiding the suture to the end effector 1202, and a reversible suture driving means 1203 for advancing/retracting the suture.

In the illustrated embodiment, a supply of weldable suture filament 1204 is wound on a freely rotating spool 1205. In other embodiments, the supply may be in the form of a free loop of suture, a length of straight suture, or any other form of control from which suture filament may be withdrawn.

In the illustrated embodiment, a tool 1202 is provided to guide a suture to an end effector. The instrument 1202 comprises a system of tubes (rigid, flexible, or a combination of both) with an internal diameter slightly larger than the diameter of the suture filament 1204. In other embodiments, the instrument for guiding the suture may be one or more passageways machined or molded into the inner member portion of the instrument. In embodiments having an articulated end effector, a flexible section of tubing may be used at the distal end to guide sutures through one or more articulation joints of the end effector. In some embodiments, as the articulation of the end effector changes the distance between (i) the feed and tension mechanism 1200 and (ii) the end effector, the suture guide instrument 1202 and/or the entire suture feed and tension mechanism 1200 moves axially within the instrument to maintain a constant length of suture wire. In other embodiments, the computer calculates a change in suture guide path length based on the articulation angle and compensates for the change in guide path length by repositioning the actuator.

In the illustrated embodiment, a reversible suture driving instrument 1203 is provided. Reversible suture driving instrument 1203 includes a reversible linear actuator (including motor 1206, screw 1207, and nut 1208 in this embodiment) and a translatable suture holding instrument 1209. In this embodiment, translatable suture grip 1209 comprises a collet-like device as shown in fig. 13a and 13b, wherein the collet-like device comprises a first tubular element 1301 having a slit 1302 and an outer conical surface 1303, and a second tubular element 1304 having an inner conical surface 1305. The first and second tubular members 1301, 1304 are concentric such that when the inner and outer conical surfaces 1303, 1305 of the first and second tubular members 1301, 1304 are pushed together by the spring 1306, the walls of the first tubular member 1301 near the slit 1302 are twisted inwardly to grip a suture wire placed within the first tubular member 1301.

In other embodiments, different suture-driven instruments are optionally used, including other types of linear actuators, such as pneumatic or hydraulic cylinders, motors, cable and pulley drives, piezoelectric "inchworm" type drives, and other actuators. In still other embodiments, non-linear drive implements, such as pinch rollers, may optionally be used. In other embodiments, different implements for holding the suture may optionally be used, such as the pinch rollers described above, mechanical graspers, magnetic graspers, and the like. In yet another embodiment, the optional piezoelectric inchworm actuator acts directly on the suture itself, rather than a tubular gripping mechanism. In this way, the inchworm actuator combines the functions of an actuator and a suture grasping tool. Yet another embodiment optionally uses a linear (or other) actuator to drive the translatable suture holding instrument assembly against a linear spring such that the feeding action is achieved by releasing the potential energy of the spring. This embodiment has the advantage of high speed suture advancement within the end effector, which takes advantage of the time-dependent stiffness of the polymeric suture material to effectively push foreign objects out of the suture path.

The functional operation of suture feed and tensioning mechanism 1200 is illustrated in fig. 14a-14 d. Fig. 14a shows an initial step in loading a suture into the mechanism 1200. The actuator nut 1208 of the actuator 1203 has been driven upward (as indicated by the upward arrow in this figure) to the mechanical stop 1401, compressing the spring 1306. Upward movement of the actuator nut 1208 causes relative movement of the first and second tubular gripping members 1301 and 1304, thereby causing the outer conical member 1303 and the inner conical member 1305 to separate and thereby release the gripping features and allow a suture 1204 to be inserted through the aperture 1402 in the mechanical stop 1401 which is aligned with the lumens of the tubular gripping members 1301 and 1304. The suture 1204 is then advanced by hand or by mechanical means (not shown) through the translatable suture-grasping means 1209 to the distal end 1403 of the axially fixed, non-translatable, flexible tube 1404, which is in communication with a suturing/ligating end effector (not shown in fig. 14a-14 d) as described elsewhere in this application. Once so loaded, the suture feed and tensioning mechanism 1200 is able to form multiple suture loops (e.g., fastening or ligation stitches) and will not need to be reloaded until the suture supply 1201 is depleted.

Fig. 14b shows suture feed and tensioning mechanism 1200 in its "ready to suture" configuration, in which the mechanism is ready to begin forming a suture loop. The suture 1204 has been advanced to the distal end 1403 of the non-translating flexible tube 1404. Actuator nut 1208 of actuator 1203 has been driven slightly downward to a position that allows spring 1306 to move tubular gripping elements 1301 and 1304 toward each other, thereby exerting a gripping force on the suture within translatable suture gripping device 1209.

Fig. 14c shows the "feed" configuration of suture feed and tensioning mechanism 1200. At an appropriate time in the suturing or ligation sequence (described elsewhere), the suture 1204 will be advanced into the end effector (not shown in fig. 14a-14 d) to form a suture loop 1405, which will be welded (by the suturing/ligation end effector, not shown in fig. 14a-14 d) to form a stitch (i.e., a suture stitch or a ligation stitch). In fig. 14c, the actuator nut 1208 of the actuator 1203 has moved the translatable suture grasping instrument 1209 distally (i.e., downward in the orientation of fig. 14 c) into the close-fitting lumen of the non-translatable flexible tube 1404, with the suture 1204 at the distal end 1403 entering the end effector (not shown in fig. 14a-14 d), where the suture 1204 forms a loop 1405.

Fig. 14d illustrates a "tensioned" configuration of suture feed and tensioning mechanism 1200 in which tension is applied to the suture to tighten the suture loop. The distal end 1406 of the suture 1204 has been held within the end effector (not shown in fig. 14a-14 d) and the suture can now be tensioned to form a smaller, tighter stitch 1407 (which may be a suture stitch or a ligation stitch). To achieve this tensioning action, the actuator 1203 is reversed, causing the actuator nut 1208 to translate in an upward (proximal) direction. Because the actuator nut 1208 is attached to the second (outer) tubular element 1304 and pulls on the second outer tubular element 1304, and because the suture 1204 is gripped by the end effector (not shown in fig. 14a-14 d) and the lumen of the first (inner) tubular element 1301 frictionally engages the suture, thereby holding the first inner tubular element 1301 stationary, the outer conical feature 1303 and the inner conical feature 1305 are separated from each other, thereby reducing the grip on the suture. There is a relationship between suture tension and gripping force such that at a predetermined tension, the spring will compress and the suture will slide, thereby adjusting the tension on the suture (which must be tight enough to effectively perform its surgical function and not so tight as to damage tissue or damage suture filaments). Once the suture begins to slide under the desired tension, the actuator 1203 will continue to move the sliding translatable suture gripper 1209 to the position shown in fig. 14b, where the system will be ready to form the next suture loop (e.g., suture stitch or ligation stitch) after the current suture loop is welded and cut from the end effector.

In the embodiment shown in fig. 12, 13a, 13b, and 14a-14d, the spring 1306 has a known force that will exert a known repeatable tension on the suture when it is tensioned to the point where slippage begins. In other embodiments, the spring force may be adjusted by changing the initial compression of the spring, either manually or by remote control and prior to use or during the surgical procedure. In yet another embodiment, suture tension is automatically adjusted in real time as part of a haptic feedback system that allows the surgeon to have a sense of the tension that the robotic instrument is applying on tissue through the robotic instrument control station. The suture tension slip limit is associated with the tactile tension felt by the surgeon so that as the suture begins to slip, the tactile tension remains constant.

In embodiments where the suture feeding and tensioning mechanism 1200 is located in the proximal end of a stapling/ligating instrument (which carries a stapling/ligating end effector), the distance between the suture supply and the end effector can be very long, and thus one of the advantages of the embodiments shown in fig. 12, 13a, 13b, and 14a-14d is that the first and second tubular elements 1301, 1304 can be made very long, allowing the suture supply 1201 and suture driving instrument 1203 to be located in the proximal end of the instrument, and the grasping instrument 1209 to be located distally, proximal to the end effector. In this way, frictional losses of pushing the suture filament through the elongated tube are minimized, as are inaccuracies in the feed length due to the compressive resilience of pushing the long length suture through the elongated tube.

In practice, robotic suturing and/or ligating instruments may be cleaned and re-sterilized after a surgical procedure, and thus can be reused on multiple patients. However, suture filaments undergo rigorous sterilization and transfer protocols and are difficult to re-sterilize once exposed to contaminants. In addition, the suture is consumable and the robotic suturing and/or ligating instrument may need to be reloaded with suture after extended use. Accordingly, in some instrument embodiments, it may be desirable for part or all of a suture feeding and tensioning system (e.g., suture feeding and tensioning system 1200 shown in fig. 12, 13a, 13b, and 14a-14 d) to be separable from the primary suturing/ligating instrument and replaceable in use. For this reason, it may be desirable to provide some or all of the suture feed and tensioning system in the form of a "suture cartridge". In one embodiment, a suture cartridge is provided that includes (i) an enclosure having an opening and an implement for securing the enclosure to a suturing/ligating instrument, (ii) a supply of weldable suture received within the enclosure, and (iii) an implement for advancing the suture out of the opening of the enclosure and to the suturing/ligating instrument and retracting the suture from the suturing/ligating instrument (e.g., for suture tensioning).

Fig. 14e shows an embodiment where the supply of suture 1201 is a removable and replaceable part of the suture feeding and tensioning mechanism 1200. Given that sutures are difficult to resterilize once exposed to contaminants, the ability to replace the supply of sutures is particularly important in the following situations: instruments including suture feed and tensioning mechanism 1200 may be reusable and must be resterilized between surgical procedures. In the embodiment shown in fig. 14e, a suture cartridge 1409 is provided. The suture cartridge 1409 includes a length of suture 1204 on a spool 1205. Spool 1205 is mounted to frame or housing 1401a (which may include mechanical stop 1401 discussed above) and further includes suture pre-feed mechanism 1410. In one embodiment, suture pre-feed mechanism 1410 includes first and second pinch rollers 1411, 1412 that engage suture 1204. The pinch rollers 1411, 1412 are driven by a rotational energy source 1413 such as a motor or knob turned by hand.

Frame or housing 1401a is configured such that it may be releasably attached to an instrument that includes suture feed and tensioning mechanism 1200. Frame or housing 1401a includes an alignment feature (not shown) that ensures that suture end 1414 exiting suture pre-feed mechanism 1410 is aligned with proximal opening 1415 in translatable suture grasping instrument 1209.

In practice, changing the suture cartridge 1409 in an instrument that includes the suture feeding and tensioning mechanism 1200 includes the steps of:

(1) driving suture feed and tensioning mechanism 1200 to a "loading position" (shown in fig. 14 a);

(2) releasing a mechanical latch (not shown) to release the old suture cartridge to be replaced;

(3) separating the old suture barrel (and any remaining old suture) from the instrument;

(4) positioning the new cartridge 1409 on the instrument and engaging the mechanical latching means (not shown) described above to attach the new suture cartridge 1409 to the instrument and align the exiting suture end 1414 with the proximal opening 1415 in the translatable suture holding means 1209;

(5) advancing the exiting suture end 1414 into the translatable suture grasper 1209 and then all the way to the distal end 1403 of the axially fixed, non-translatable, flexible tube 1404 in communication with a suturing/ligating end effector (not shown in fig. 14a-14 e) using a suture pre-feed mechanism 1410, noting that in some embodiments, this pre-feed step is automatically accomplished by a controller operating a motorized rotational energy source 1413 (e.g., a motor); and in other embodiments, the pre-feeding is done manually, wherein the rotational energy source 1413 comprises a hand-turned knob;

(6) suture feed and tensioning mechanism 1200 is moved to the "ready to suture" position shown in fig. 14 b.

The remainder of the stitching cycle is identical to that described previously and shown in figures 14c and 14 d.

It should be noted that other embodiments of the suture cartridge 1409 and suture feed and tensioning mechanism 1200 can vary in the location of components within the system. In other words, embodiments may have a suture cartridge 1409 that includes only a spool 1205 of suture, and the suture pre-feed mechanism 1410 may be housed in the instrument along with the remainder of the suture feed and tensioning mechanism 1200; or embodiments may include a suture barrel 1409 that includes not only a suture 1204, a spool 1205, a frame or housing 1401a, and a suture pre-feed mechanism 1410, but also a translatable suture-grasping instrument 1209, while a reversible suture-driving instrument 1203 is still part of the instrument; or the embodiments may include any other similar division of components while still maintaining the essence of the invention.

Ligation end effector for use in robotic surgery

Fig. 15a illustrates a novel end effector 1500 that is particularly suited for surgical ligation of blood vessels in the body. While some embodiments of the illustrated end effector may be directly coupled to the distal end of the shaft of the surgical instrument under robotic control, fig. 15a illustrates other embodiments in which the platform of this end effector 1500 includes rolling articulation joints for pitch (P) and yaw (Y) about orthogonal axes and roll (R) about a midline. Such platforms are commonly referred to as "wrists" and may include one, two, three, or more controllable mechanical degrees of freedom (DOF). There is also a fourth degree of freedom which includes first 1502 and second 1503 opposing jaw members which move symmetrically about plane 1501 and pivot about hinge axis 1504 in response to axial movement of a driver pin 1505 which engages slots (not shown in fig. 15 a) in proximal portions of the first and second jaws 1502, 1503.

Fig. 15b illustrates the arrangement and relative positions of some of the internal components added to the instrument platform described above to form the novel stapling and/or ligating end effector 1500. These components include a first grip 1506 and a second grip 1507, a grip actuation clip 1508, a flexible actuator rod 1509, a rigid suture guide tube 1510, a flexible suture guide tube 1511, and a jaw hinge pin 1512. The function of these components will become apparent from the ensuing description and drawings, which are presented herein in summary form to give the reader an understanding of their location within the instrument platform.

Fig. 16a-16c illustrate first and second opposed jaw members 1502, 1503 with selected end effector support structures removed. In response to axial (distal-proximal along the midline of the end effector) movement of the drive pin 1505 in the first and second jaw slots 1601, 1602 (located in the second jaw member 1503 behind the first jaw member 1502 in fig. 16a-16 c), the jaw members 1502, 1503 pivot about the hinge axis 1504. The jaw slots 1601, 1602 have two geometric regions: a first slot region 1603 (shown in fig. 16a on the first jaw slot 1601, but also present on the second jaw slot 1602), wherein axial (proximal/distal) movement of the drive pin 1505 results in reciprocating movement of the first jaw 1502 and the second jaw 1503; and a second slot region 1604 (shown on the first jaw slot 1601 in fig. 16a, but also present on the second jaw slot 1602), wherein axial movement of the drive pin 1505 does not result in movement of the jaws (the jaws are instead held in a closed orientation relative to each other, as can be seen in fig. 16b and 16 c). It can thus be seen that over the length of the axial travel of the drive pin 1505 in the slots 1601 and 1602, there are two regions: region 1 from the proximal-most position of the drive pin 1505 to approximately the midpoint of its range of motion, wherein movement of the drive pin 1505 moves the jaw members 1502, 1503 (see fig. 16a and 16 b); and a region 2 from approximately the midpoint of the drive pin travel range to the most distal drive pin position, where no jaw movement occurs (see fig. 16b and 16 c). In this way, it can be seen that a single degree of freedom (i.e., axial movement of the actuator stem 1509 in the slots 1601, 1602) can be used to achieve multiple functions by operating in different regions.

FIG. 17a shows an assembly of components for delivering, welding, trimming and releasing a welded suture loop to form surgical stitches for suturing and ligation. The first and second holders 1506, 1507 are constrained from axial movement by hinge pins 1512. The gripper actuation clip 1508 is connected to a flexible actuator rod 1509 that moves axially in response to user and/or computer control inputs. The pinch feature 1701 on the gripper actuation clip 1508 slides over the first and second grippers 1506 and 1507 and clamps the gripper pairs together at different positions along their length as the flexible actuator rod 1509 moves. In other words, the first and second holders 1506, 1507 can be moved toward or away from each other by axial movement of the flexible actuator rod 1509.

Fig. 17b shows an exploded view of the assembly in fig. 17 a. There are cut-outs (facets) 1702 on the inside opposite edges of the first and second holders 1506, 1507, three on each side (1702 a, 1702b, 1702 c), so that the holders angularly oscillate against each other depending on where the holders are gripped by the holder actuators 1508 along their length. Sandwiched between the holders 1506, 1507 is an electrode 1703 having an exposed conductive surface 1704 at its distal end. The electrodes 1703 are connected by flexible wires (not shown) to a switched current source (not shown). A first protruding headed pin 1705 extends proximally from the electrode 1703, and a light spring 1706 acts proximally of the hinge pin 1512 against the head 1706a (see fig. 18a-18 f) and counter-sunk hole 1706b (see fig. 18a-18 f) of the pin 1705 to maintain a small proximal (downward) force on the electrode 1703. Housed within central aperture 1707 in holder actuator clip 1508 is a second headed pin 1708 having a head 1708a supported using a heavy spring 1709, the heavy spring 1709 engaging an annular shoulder 1709a provided at the base of central aperture 1707. The holder actuator clip 1508 includes a sharp edge 1710 on one side.

Fig. 18a-18f are cross-sectional views of the assembly shown in fig. 17a and 17b, illustrating sequential functional aspects of this assembly.

Figure 18a shows the flexible actuator stem 1509 in its proximal-most position. The drive pin 1505 engages the first jaw slot 1601 and the second jaw slot 1602 (neither shown in this view) to position the first jaw 1502 and the second jaw 1503 (neither shown in this view) in their fully open positions (i.e., the positions shown in fig. 16 a). The gripper actuator clip pinch feature 1701 (shown in phantom in fig. 18a, behind the hinge pin 1512) pinches the first and second grippers 1506 and 1507 on their proximal-most edges such that the grippers swing on the proximal-most cut planes 1702a in their sets of opposing cut planes (not shown in fig. 18 a) to create a gap 1801 at the distal edges of the first and second grippers 1506 and 1507. In this component orientation, the holder gap 1801 is wider than the diameter of the suture filament.

Fig. 18b shows the flexible actuator rod 1509 moving distally so that the drive pin 1505 (connected to the actuator rod 1509) also moves distally to the distal end of region 1 (i.e., the jaw movement region shown in fig. 16 b). By sliding along the edges of the grippers 1506 and 1507, the pinch feature 1701 carried by the gripper actuator clip 1508 (which is also connected to the flexible actuator rod 1509) moves distally the same distance, however, the pinch feature 1701 is still in the region of the most proximal slice 1702a in the three sets of gripper slices (not shown in fig. 18 b) and thus the wider gripper gap 1801 remains unchanged. An important aspect of this embodiment is the ability to control multiple functions using one actuator (one degree of freedom). It can be seen that when the actuator lever 1509 moves the drive pin 1505 within region 1, the jaws 1502, 1503 move in accordance with the user input and the assembly shown in figures 17a and 17b remains unaffected. When the actuator lever 1509 moves the drive pin 1505 in the region 2, the assembly shown in figures 17a and 17b is activated while the jaws 1502, 1503 remain closed and stationary.

Figure 18c shows the flexible actuator lever 1509 and the connected drive pin 1505 and pinch feature 1701, driven distally so that the drive pin 1505 is in the proximal region of region 2 (i.e. the position shown in figure 16 b). The pinch feature 1701 has been slid distally along the edges of the holders 1506 and 1507 to approximately mid-way along their lengths, thereby swinging a middle one of the three holder facets 1702b (not shown in fig. 18 c) into contact. Thus, the distal surfaces of the holders 1506, 1507 have moved toward each other to reduce the width of the holder gap 1801 such that it is less than one suture diameter width (but still greater than zero). First and second stepped surfaces 1803 and 1804, respectively on the inner surfaces of grips 1506 and 1507, form a stepped gap 1805 (fig. 18 c) having a width greater than one suture diameter and less than 2 suture diameters. This gap arrangement 1805 allows suture to be passed between the first step surface 1803 and the second step surface 1804 without constraint, while not being able to escape through the now reduced gap 1801.

Fig. 18d shows the actuator stem 1509 moved further distally. The pinch feature 1701 on the gripper actuator clip 1508 now grips the first and second grippers 1506, 1507 along the distal third of their length, swinging the gripper to the distal-most cut 1702c (not shown in fig. 18 d) of the three sets of edge cuts, further narrowing the distal gripper gap 1801, and narrowing the step gap 1805 to a width less than one suture diameter, allowing the step surfaces 1803 and 1804 to grasp the suture loop passing between the grippers 1506, 1507. Once the distal end of the suture loop is grasped by the graspers 1506, 1507, the suture feed mechanism (e.g., the suture feed mechanisms shown in fig. 12, 13a, 13b, and 14a-14 d) may be reversed and the suture loop tensioned to the desired force.

Fig. 18e shows the actuator stem 1509 moved further distally. It can be seen that the second headed pin 1708 (held distally under the force of the heavy spring 1709) contacts the first headed pin 1705 (held proximally under the force of the light spring 1706), causing the first pin 1705 and connected electrode 1703 to move distally (i.e., in the use direction shown in fig. 18 e) and the distal conductive electrode surface 1704 to contact the overlapping suture segments (not shown in fig. 18 e) held near the step gap 1805. As the overlapping suture segments block further distal movement of the electrode 1703, continued distal movement of the actuator rod 1509 compresses the heavy spring 1709. The force of the electrode 1703 bearing on the overlapping suture segments (held between the holders 1506 and 1507) is now equal to the compression spring force of the heavy spring 1709 minus the compression spring force of the light spring 1706. In one embodiment, the holders 1506 and 1507 are made of a conductive material and are connected to one pole of a power source (e.g., electrical ground) and the conductive surface 1704 of the electrode 1703 is connected to the opposite pole of the switch of the same power source. In a preferred embodiment, the grippers 1506 and 1507 are made of a non-conductive material (e.g., ceramic) and the stepped surfaces 1803 and 1804 of the grippers 1506 and 1507 have conductive plating connected to one pole of a power source and the conductive surface 1704 of the electrode 1703 is connected to the opposite pole of a switch of the same power source such that a controlled current (triggered by an external instrument) can be caused to flow between the overlapping segments of the suture loop to weld the overlapping segments of the suture loop together. After welding, a dwell time of up to 1.2 seconds may be required to allow the molten polymer in the weld zone to solidify before proceeding to the next step in the sequence.

Fig. 18f shows actuator stem 1509 moved to its distal-most position. The sharp edge 1710 of the actuator clip 1508 (the distal side of the assembly, also shown in fig. 17 b) slides distally with the movement of the actuator stem 1509 so that the sharp edge 1710 extends across the opening of the rigid suture guide tube 1510 (shown in fig. 15 b), trimming the welded suture loop from the suture supply. In the final step of the sequence, the actuator rod 1509 is moved to its neutral (i.e., distal end of region 1 as shown in fig. 16 c) position, returning to the configuration shown in fig. 18b, thereby re-opening the distal gripper gap 1801 to a width greater than one suture diameter, and thereby releasing the tensioned welded trimmed suture loop from the end effector. The user is then free to manually open the first jaw 1502 and the second jaw 1503 (not shown in fig. 18 f) to return to the configuration of fig. 18a in order to reposition the end effector for the next stitch.

Fig. 19a-19e illustrate an embodiment of the ligation device 1500 in use, as viewed from the perspective of a user.

Fig. 19a shows a first jaw 1502 and a second jaw 1503 having a first inward facing groove 1901 and a second inward facing groove 1902, respectively. The first jaw 1502 and the second jaw 1503 pivot about a hinge pin 1512. The drive pin 1505 is in its fully proximal position such that the jaws are fully open (i.e., in the position shown in figure 16 a).

Figure 19b shows the drive pin 1505 in its mid-stroke position (i.e., at the beginning of the distal end of zone 1/zone 2) so the jaws are fully closed (i.e., in the position shown in figure 16 b). The jaws 1502, 1503 are free to open and close in response to input from a user at a surgical robotic console or other input device prior to beginning the loop formation sequence. All surgeon initiated jaw movement occurs with the driver pin 1505 operating in zone 1. To ligate (tie) a blood vessel or other tubular anatomical structure (not shown), the surgeon will first dissect the connective tissue attached to the blood vessel so as to approximate its entire circumference. The surgeon will then close the jaws 1502, 1503 under manual control around the vessel to be ligated and position the instruments where they want to place a stitch (e.g., ligation loop). When ready, the user will begin the loop formation process by generating a control command, such as by depressing a foot switch, depressing a button, issuing a voice command, or taking similar action to begin the loop formation sequence.

FIG. 19c shows a first step in an automatic or semi-automatic stitching process controlled by a computer or other type of sequence controller. The suture loop 1903 (shown in phantom inside the jaws 1502, 1503) is advanced (i) through the suture guide tubes 1511 and 1510, (ii) through the above-described gap 1805 (formed between the first and second holders 1506, 1507) wherein the gap 1805 has a width greater than one suture diameter but less than two suture diameters (see fig. 18 c), (iii) around the aligned inward facing grooves 1901 and 1902 formed in the jaws 1502 and 1503, respectively, and (iv) back into the gap 1805 formed between the holders 1506, 1507 such that the distal end of the suture loop ends between the stepped surfaces 1803 and 1804 of the holders 1506, 1507. The actuator rod 1509 will then advance to the position shown in FIG. 18d, causing the gripper actuator clip 1508 to move upward so that the grippers 1506, 1507 grasp the distal end of the suture loop. The suture feed mechanism is then reversed to tension the suture loop around the blood vessel to be ligated. In one embodiment, the tensioning is part of an automatic sequence and the tension value is predetermined. In another embodiment, the surgeon uses haptic feedback to select the tension value or tension stitch through a haptic action at the console.

FIG. 19d shows the tensioned suture loop 1904 in the instrument as it appears during the welding (see FIG. 18 e) and trimming (see FIG. 18 f) steps.

FIG. 19e illustrates the final step of the automated process in which the actuator rod is returned to the release position (see FIG. 18 b) such that the grippers 1506, 1507 reopen to release the suture loop 1905 from the end effector. In fig. 19e, the completed stitch 1905 has been released and control of the jaws 1502, 1503 has now been returned to the user. In practice, unless a manual suture tensioning step is included, the automatic loop forming process should take less than one second to complete the stitch.

Fig. 19f shows the jaws 1502, 1503 having been opened manually by the user, thereby releasing the ligated vessel and being ready for repositioning for the next suture loop.

Modifications of the preferred embodiment

It will be appreciated that numerous additional changes in the details, materials, steps and arrangement of parts, which have been herein described and illustrated in order to explain the nature of the invention, may be made by those skilled in the art while still remaining within the principle and scope of the invention.

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Electrically weldable suture material and apparatus and methods for forming welded suture loops and other welded structures

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