阅读说明：本技术 用于微创手术的人体工程学外科器械 (Ergonomic surgical instrument for minimally invasive surgery ) 是由 弗瑞德里克·E·C·莱森 彼得·索贝克 于 2019-10-02 设计创作，主要内容包括：本发明涉及一种外科器械(1),包括手柄(2),中空轴(3)和端部执行器(4),端部执行器(4)联接至中空轴(3)的远端(3b),并且端部执行器(4)通过在中空轴(3)内延伸的操作装置(5)操作性地连接至手柄(2)。多轴关节(6)将手柄(2)的远端(2a)联接至中空轴(3)的近端(3a),多轴关节(6)允许中空轴(3)相对于手柄(2)的多轴旋转。多轴旋转包括中空轴(3)围绕中空轴(3)的中心轴线(C)的旋转,以及在至少两个平面内相对于手柄(2)的远端(2a)的旋转。(The invention relates to a surgical instrument (1) comprising a handle (2), a hollow shaft (3) and an end effector (4), the end effector (4) being coupled to a distal end (3b) of the hollow shaft (3), and the end effector (4) being operatively connected to the handle (2) by an operating device (5) extending within the hollow shaft (3). A polyaxial joint (6) couples the distal end (2a) of the handle (2) to the proximal end (3a) of the hollow shaft (3), the polyaxial joint (6) allowing polyaxial rotation of the hollow shaft (3) relative to the handle (2). The multi-axis rotation includes rotation of the hollow shaft (3) about a central axis (C) of the hollow shaft (3), and rotation in at least two planes relative to the distal end (2a) of the handle (2).)

1. A surgical instrument (1) comprising

A handle (2) is arranged on the upper portion of the handle,

a hollow shaft (3) is arranged in the hollow shaft,

an end effector (4), said end effector (4) being coupled to the distal end (3b) of the hollow shaft (3) and said end effector (4) being operatively connected to the handle (2) by an operating device (5) extending within the hollow shaft (3),

a polyaxial joint (6), the polyaxial joint (6) coupling the distal end (2a) of the handle (2) to the proximal end (3a) of the hollow shaft (3), and the polyaxial joint (6) allowing polyaxial rotation of the hollow shaft (3) relative to the handle (2),

the multi-axis rotation includes rotation of the hollow shaft (3) about a central axis (C) of the hollow shaft (3), and rotation in at least two planes relative to a distal end (2a) of the handle (2).

2. Surgical instrument (1) according to claim 1, wherein the hollow shaft (3) is rotatable around the central axis (C) and simultaneously in three planes.

3. The surgical instrument (1) according to claim 1 or 2, wherein the multi-axis rotation does not affect the position of the end effector (4) relative to the handle (2).

4. A surgical instrument (1) as claimed in any one of the preceding claims, wherein the operation device (5) comprises at least one of a wire, a hose and a rod, the operation device (5) extending through the interior of the polyaxial joint (6) and through the distal end (2a) of the handle (2) into the interior of the handle (2).

5. A surgical instrument (1) according to claim 4, wherein said handle (2) comprises at least one grip component (2b, 2c) and one actuation component (2d), said actuation component (2d) being pivotally connected to said grip component (2b, 2c) and operatively connected to said end effector (4).

6. A surgical instrument (1) according to claim 5, wherein said operating device (5) comprises an axially extending rod (28) and a first pivoting link (39), said first pivoting link (39) being arranged inside said handle (2) and being operatively connected to said rod (28), said gripping members (2b, 2c) and said actuating member (2 d).

7. A surgical instrument (1) according to claim 6, wherein the proximal end (28a) of the lever (28) is connected to the proximal end (39a) of the first pivoting link (39), the proximal end (39a) of the first pivoting link (39) is also slidingly connected to the gripping means (2b, 2c) and the distal end (39b) of the first pivoting link (39) is pivotally connected to the actuation means (2 d).

8. A surgical instrument (1) according to any one of the preceding claims, wherein the polyaxial joint (6) is a spherical joint comprising a first shell (7) and a second shell (8) that are at least partially spherical, the open ends (7a, 8a) of the first shell (7) and the second shell (8) having mating surfaces (7b, 8b) such that when the open end (7a, 8a) of one of the first shell (7) and the second shell (8) is pressed into the open end (8a, 7a) of the other of the first shell (7) and the second shell (8), there is a common overlapping area (a) between the first shell (7) and the second shell (8) comprising the open ends (7a, 8 a).

9. A surgical instrument (1) according to claim 8, wherein one of the first housing (7) and the second housing (8) is formed integrally with or connected to at least one of the gripping members (2b, 2 c).

10. A surgical instrument (1) according to claim 8 or 9, wherein the size of said common overlapping area (a) changes as said first housing (7) and said second housing (8) rotate relative to each other in at least one said plane.

11. Surgical instrument (1) according to any one of claims 8-10, wherein at least one of the first housing (7) and the second housing (8) is provided with a hollow guide tube (9), the hollow guide tube (9) protruding from at least one of the outer and inner surfaces of the first housing (7) and the second housing (8) and accommodating at least one of the proximal end (3a) of the hollow shaft (3), the operating means (5) and the connection to the handle (2).

12. Surgical instrument (1) according to claim 11, further comprising a bearing (45) arranged between the hollow guide tube (9) and the hollow shaft (3), the bearing (45) allowing the hollow shaft (3) to rotate around the central axis (C).

13. A surgical instrument (1) according to any of claims 8-12, wherein at least one mating surface (7b, 8b) of the first and second housings (7, 8) is provided with at least one of a microstructure (43), a coating and a roughening thereon to increase friction within the common overlapping area (a).

14. A surgical instrument (1) according to claim 13, wherein the mating surface (7b) of the first housing (7) is provided with a first microstructure (43a) and the mating surface (8b) of the second housing (8) is provided with a second microstructure (43b), the first and second microstructures (43a, 43b) comprising one of a plurality of recesses and at least one protrusion adapted to engage and interlock with the recesses.

15. A surgical instrument (1) according to claim 14, wherein one of said first and second microstructures (43a, 43b) is provided on a radially displaceable tongue (44).

16. A surgical instrument (1) according to any of claims 8-15, wherein at least one of the first housing (7) and the second housing (8) is provided with at least one slit (10) extending from an open end (7a, 8a) of the first housing (7) and/or the second housing (8).

17. Surgical instrument (1) according to any one of claims 8 to 16, wherein the polyaxial joint (6) further comprises a third shell (11), the third shell (11) being arranged within the common overlapping region (A) around the periphery of the first and second mating shells (7, 8),

a lock lever (12), the lock lever (12) protruding from the third housing (11),

the third housing (11) is movable between an unlock position (P1) and a lock position (P2) by operating the lock lever (12).

18. Surgical instrument (1) according to claim 17, wherein, in the unlocked position (P1), the diameter of the first and second housings (7, 8) is not affected by the third housing (11), allowing the first and second housings (7, 8) to rotate relative to each other,

and wherein, in the locking position (P2), the diameter of at least one of the first housing (7) and the second housing (8) decreases at least within the common overlapping area (A) such that the first housing (7) and the second housing (8) cannot rotate relative to each other.

19. A surgical instrument (1) according to claim 17 or 18, wherein the inner surface of the third shell (11) or the outer surface of the radially outermost positioned one of the first shell (7) and the second shell (8) comprises a circumferentially extending radially oriented groove (13), the radial depth (D) of the groove (13) decreasing in a direction towards the open end (7a, 8a, 11a) of the first shell (7), the second shell (8) or the third shell (11) such that the groove (13) comprises a maximum bottom thickness section (T1) and a minimum bottom thickness section (T2),

when one of the radially outermost positioning shell (7, 8) and the third shell (11) is at least partially arranged within the minimum bottom thickness section (T2), the third shell (11) is in the unlocked position (P1), and

when one of the radially outermost positioned casing (7, 8) and the third casing (11) is at least partially arranged within the maximum bottom thickness section (T1), the third casing (11) is in the locked position (P2).

20. Surgical instrument (1) according to any one of claims 17-19, wherein the radially displaceable tongue (44) is formed within the radially outermost positioned one (7, 8) of the first and second housings (7, 8), wherein in the unlocked position (P1) the radial position of the radially displaceable tongue (44) is unaffected by the third housing (11) and the first and second housings (7, 8) are rotatable relative to each other, and wherein in the locked position (P2) the radially displaceable tongue (44) is moved towards the radially innermost positioned one of the first and second housings (7, 8), the first and second microstructures (43a, 43b) being engaged within at least the common overlapping region (A), such that the first housing (7) and the second housing (8) cannot rotate relative to each other.

21. Surgical instrument (1) according to any one of claims 17 to 20, wherein one of the first housing (7) and the second housing (8) is rotatably connected to the hollow shaft (3) and the other of the first housing (7) and the second housing (8) is rigidly connected to the handle (2), and wherein the handle (2) is locked to the polyaxial joint (6) when the third housing (11) is in the locked position (P2).

22. Surgical instrument (1) according to any one of claims 8 to 21, further comprising a joint housing (14), a proximal end (14a) of the joint housing (14) being connected to the handle (2) and a distal end (14b) of the joint housing (14) being connected to the first shell (7) or the second shell (8), the joint housing (14) covering the proximal end (3a) of the hollow shaft (3) and the polyaxial joint (6).

23. Surgical instrument (1) according to claim 22, wherein the joint housing (14) shares a central axis (C) with the hollow shaft (3) and the joint housing (14) is partially rotatable around the central axis (C).

24. A surgical instrument (1) according to claim 22 or 23, wherein the joint housing (14) comprises a flexible member (15), the flexible member (15) extending in the direction of the central axis (C) between at least a first rigid member (16) and a second rigid member (17), the first rigid member (16) being connected to the first shell (7) or the second shell (8), the second rigid member (17) being connected to the handle (2).

25. A surgical instrument (1) according to claim 24, wherein at least one of said first rigid component (16) and said second rigid component (17) comprises a plurality of grooves (18) extending in the direction of said central axis (C), each groove (18) comprising an end face (18a) extending at an angle to said central axis (C), said end faces (18a) being arranged at a proximal end (16a) of said first rigid component (16) and/or at a distal end (17b) of said second rigid component (17), said flexible component (15) filling said grooves (18) so as to form a flexible component surface (15a) in each groove (18) corresponding to said end face (18 a).

26. A surgical instrument (1) according to claim 25, wherein said end face (18a) comprises an opening (19), said flexible member (15) extending through said opening (19), said opening (19) extending substantially parallel to said central axis (C).

27. A surgical instrument (1) according to any of the claims 24-26, wherein the section (15b) of the flexible member (15) extends on a radially outer and/or a radially inner side of the first rigid member (16) and the section (15c) of the flexible member (15) extends on a radially inner and/or a radially outer side of the second rigid member (17).

28. A surgical instrument (1) according to any of the claims 24-27, wherein at least one of said first rigid part (16) and said second rigid part (17) has a truncated cone shape, the outer diameter and/or the inner diameter of said first rigid part (16) being smaller than the outer diameter and/or the inner diameter of said second rigid part (17).

29. A surgical instrument (1) according to any one of claims 24-28, wherein the proximal end (17a) of the second rigid member (17) comprises a locking means (20), said locking means (20) being adapted to interact with at least one corresponding recess (21) in the handle (2).

30. A surgical instrument (1) as claimed in claim 29, wherein the locking means (20) is one of a peripheral flange and a snap lock.

31. A surgical instrument (1) according to any one of the preceding claims, wherein the handle (2) and the operating means (5) are configured to actuate the end effector (4) between an Open Position (OP) and a Closed Position (CP),

a proximal end (4a) of the end effector (4) is coupled to a distal end (3b) of the hollow shaft (3), the end effector (4) including a first leg (22) and a second leg (23), the second leg (23) being pivotally connected to the first leg (22) at a distal end of the end effector (4b),

the second leg (23) extends at an acute angle (a) relative to the first leg (22) when the end effector (4) is in the Open Position (OP), and the second leg (23) extends substantially parallel to the first leg (22) when the end effector (4) is in the Closed Position (CP).

32. A surgical instrument (1) according to any one of the preceding claims, wherein the operating device (5) comprises an axially extending rod (28) and a second pivoting link (29),

a distal end (28b) of the rod (28) is coupled to a distal end (23b) of the second leg (23) by the second pivot link (29), a first end (29a) of the second pivot link (29) is pivotally connected to the axially extending rod (28), and a second end (29b) of the second pivot link (29) is pivotally connected to the second leg (23).

33. A surgical instrument (1) as claimed in claim 32, wherein the second leg (23) is pivotally suspended from the lever (28) at a first location on the second leg (23), and the second end (29b) of the pivot link (29) is pivotally connected to the second leg (23) at a second location spaced from the first location.

34. A surgical instrument (1) according to claim 32 or 33, wherein the second pivoting link (29) comprises a plate extending between the first end (29a) and the second end (29b), the first end (29a) being connected to the rod (28) by a first hinge pin (40), the second end (29b) being connected to the second leg (23) by a second hinge pin (41), and the second leg (23) being articulated to the hollow shaft (3) by a third hinge pin (42).

35. A surgical instrument (1) according to claim 33 or 34, wherein said second leg (23) has a free proximal end (23a) and an articulated distal end (23b), and wherein said first position is located at or near said articulated distal end (23 b).

36. A surgical instrument (1) according to claim 35, wherein said second position is closer to said articulated distal end (23b) than said free proximal end (23 a).

37. A surgical instrument (1) according to any one of claims 34-36, wherein the third hinge pin (42) is arranged in or near the central axis (C) of the hollow shaft (3).

38. A surgical instrument (1) according to any one of claims 34-37, wherein said second pivot link (29) is operatively connected to said rod (28) at or near a proximal end (28a) or a distal end (28b) of said rod (28).

39. A surgical instrument (1) according to any one of claims 34-38, wherein the second leg (23) is configured to rotate towards the hollow shaft (3) when the rod (28) is translated in a direction away from the third hinge pin (42), and the second leg (23) is configured to rotate away from the hollow shaft (3) when the rod (28) is translated in a direction towards the third hinge pin (42).

40. A surgical instrument (1) as claimed in any one of claims 30 to 39, wherein said rod (28) is partially enclosed by a first leg (22) of said end effector (4), said end effector (4) being actuated from said Open Position (OP) to said Closed Position (CP) when said rod (28) is moved in a direction away from a distal end (4b) of said end effector (4), and said end effector (4) being actuated from said Closed Position (CP) to said Open Position (OP) when said rod (28) is moved in a direction towards a distal end (4b) of said end effector (4).

41. A surgical instrument (1) as claimed in any one of claims 6-40, wherein said operation device (5) further comprises a piston (30) and a spring (31), said rod (28) being partially enclosed by said piston (30) and said spring (31), said spring (31) exerting a force on a proximal end (30a) of said piston (30) in a direction towards a distal end (4b) of said end effector (4), said rod (28) and said piston (30) being axially movable relative to each other and at least one of said end effector (4).

42. A surgical instrument (1) as claimed in claim 41, wherein said rod (28) and said piston (30) are releasably connected such that said rod (28) and said piston (30) are axially movable as a unit relative to said end effector (4).

43. A surgical instrument (1) according to claim 42, wherein the rod (28) and the piston (30) are releasably connected by means of a piston lock comprising a plurality of locking grooves (32) arranged in the rod (28), and corresponding locking protrusions (33) arranged at the distal end (30b) of the piston (30).

44. A surgical instrument (1) as claimed in any preceding claim, wherein the end effector (4) is adapted for at least one of photographing and manipulating tissue.

45. A surgical system comprising the surgical instrument (1) according to any one of claims 1-44, and at least one ligation clip (34), an end effector (4) of the surgical instrument (1) being configured to enclose the ligation clip (34) such that a distal end (34b) of the ligation clip (34) is disposed adjacent to the distal end (4b) of the end effector (4) and a proximal end (34a) of the ligation clip (34) is disposed adjacent to the proximal end (4a) of the end effector (4), the ligation clip (34) comprising a first ligation clip leg (35) and a second ligation clip leg (34d), the first ligation clip leg (35) and the second ligation leg (36) being pivotally connected at the distal end (34b) of the ligation clip (34), the first ligation leg (35) and the second ligation leg (36) comprising a locking means (37), for interlocking the first and second ligation clip legs (35, 36) at a proximal end (34a) of the ligation clip where the first and second ligation clip legs (35, 36) overlap one another, wherein the ligating clip (34) has an open configuration when the end effector (4) is in an initial Open Position (OP), wherein the second ligating clip leg (36) extends at an acute angle (γ) relative to the first ligating clip leg (35), the ligating clip (34) having a closed configuration when the end effector (4) has been actuated to a Closed Position (CP), wherein the first and second ligation clip leg portions (35, 36) overlap one another, the ligating clip (34) is held in the closed configuration by means of the locking device (37) when the end effector (4) is returned to an Open Position (OP).

46. The surgical system of claim 45, further comprising a plurality of ligating clips (34), the plurality of ligating clips (34) being in an open configuration and disposed serially between the distal end (4b) of the end effector (4) and the handle (2), all ligating clips (34) being enclosed by the first leg (22) of the end effector (4) and the rod (28) except for a first ligating clip (34-1) located near the distal end (4b) of the end effector (4).

47. The surgical system according to claim 45 or 46, wherein the ligating clips (34, 34-1) are arranged to abut each other such that axial displacement of any ligating clip (34) enclosed by the first leg (22) and the rod (28) causes a corresponding displacement of all ligating clips (34, 34-1) located between the ligating clip (34) and the distal end (4b) of the end effector (4).

Technical Field

The present disclosure relates to a surgical instrument for minimally invasive surgery comprising a handle, an end effector operatively connected to the handle, and a hollow shaft connecting the handle to the end effector.

Background

Minimally invasive procedures require surgical instruments to engage tissue through small incisions or natural orifices in the patient's body, and generally reduce the amount of recovery time and complications compared to traditional open procedures.

Minimally invasive surgery also requires some versatility embedded in the instrument so that the user has the best possible conditions for engaging tissue. These conditions include allowing the user to ergonomically grip the handle of the surgical instrument, for example allowing the user to keep their wrist straight.

EP1836986 discloses a surgical instrument comprising a ball and socket joint connecting the handle to the shaft, allowing the handle to pivot slightly in two planes of motion relative to the shaft. The end effector is connected to the handle by means of four wires running equidistantly along the outside of the shaft. As the handle pivots, a pair of opposing wires interact such that the end effector mimics and moves simultaneously with the handle. Thus, the end effector mimics the movement of the handle, which mimicks movement that includes corresponding movement by which the end effector moves in the same direction and in the same orientation as the handle and mirrored movement by which the end effector moves in the opposite direction and in the opposite orientation to the handle. Control of the end effector is improved, however, the user's ergonomics is not significantly improved. Accordingly, there is a need to provide an improved surgical instrument that allows a user to operate the instrument without bending or otherwise straining the wrist.

Disclosure of Invention

It is an object to provide an improved surgical instrument. The foregoing and other objects are achieved by the features of the independent claims. Other implementations are apparent from the dependent claims, the description and the drawings.

According to a first aspect, there is provided a surgical instrument comprising a handle, a hollow shaft, an end effector, the end effector being coupled to a distal end of the hollow shaft and being operatively connected to the handle by an operation device extending within the hollow shaft, a polyaxial joint coupling the distal end of the handle to a proximal end of the hollow shaft and allowing polyaxial rotation of the hollow shaft relative to the handle, the polyaxial rotation including rotation of the hollow shaft about a central axis of the hollow shaft and rotation relative to the distal end of the handle in at least two planes.

Such surgical instruments allow a user to ergonomically place and hold the handle of the surgical instrument, for example, allowing the user to keep their wrist straight with respect to the shaft and end effector, which is comfortable over extended periods of time. This solution also allows the user to adjust the position of the handle about multiple axes, allowing the user to place the handle in any comfortable position while maintaining the shaft and end effector in the correct working position. Furthermore, the instrument becomes more flexible, which in turn improves the reach of the instrument and thus the user.

In a possible realization of the first aspect, the handle is rotatable around a central axis and the handle is rotatable relative to the proximal end of the hollow shaft in two planes extending parallel or perpendicular to the central axis and perpendicular to each other, thereby allowing within certain limits to place the handle in at least any desired two-dimensional position relative to the shaft.

In another possible implementation form of the first aspect, the hollow shaft is capable of rotating around the central axis and simultaneously in three perpendicular planes, allowing, within certain limits, to place the handle in any desired three-dimensional position with respect to the shaft.

In another possible implementation form of the first aspect, the multi-axis rotation does not affect the position of the end effector relative to the handle, thereby allowing for maintaining a secure and stable placement of the end effector regardless of how the handle may move.

In another possible implementation form of the first aspect, the operation device comprises at least one of a wire, a hose and a rod, and the operation device extends through an interior of the polyaxial joint and through the distal end of the handle into the interior of the handle, thereby protecting the operation device from external influences at all.

In another possible implementation form of the first aspect, the handle includes at least one grasping feature and an actuating feature pivotally connected to the grasping feature and operatively connected to the end effector.

In another possible implementation form of the first aspect, the operating device includes an axially extending rod and a first pivot link disposed inside the handle and operatively connected to the rod, the gripping member, and the actuating member, thereby facilitating simultaneous operation of the end effector with operation of the handle.

In another possible implementation form of the first aspect, the proximal end of the lever is connected to the proximal end of the first pivot link, the proximal end of the first pivot link is also slidingly connected to the grasping member, and the distal end of the first pivot link is pivotally connected to the actuating member, thereby allowing the end effector to be operated without exerting too much stress on the handle.

In another possible implementation form of the first aspect, the polyaxial joint is a spherical joint including first and second housings that are at least partially spherical, the open ends of the first and second housings having mating surfaces such that when the open end of one of the first and second housings is pressed into the open end of the other of the first and second housings, there is a common overlapping region between the first and second housings including the open end, thereby allowing the handle to rotate relative to the shaft over a majority of the surface of one of the spherical housings.

In another possible implementation form of the first aspect, one of the first housing and the second housing is integrally formed with or connected to the at least one gripping member.

In another possible implementation form of the first aspect, the size of the common overlapping area changes as the first housing and the second housing rotate relative to each other in at least one plane, thereby allowing as large a rotation as possible between the two housings.

In another possible implementation form of the first aspect, at least one of the first and second housings is provided with a hollow guide tube protruding from at least one of an outer surface and an inner surface of the first and second housings and accommodating at least one of a proximal end of the hollow shaft, the operating device and the connection to the handle, the hollow guide tube providing additional support and protection for components accommodated within the hollow guide tube and facilitating, for example, the alignment of the connection of the operating device to the handle.

In another possible implementation form of the first aspect, the surgical instrument further comprises a bearing disposed between the hollow guide tube and the hollow shaft, thereby allowing the hollow shaft to rotate about the central axis without affecting the position of the handle.

In another possible implementation form of the first aspect, at least one mating surface of the first and second housings is provided with at least one of a microstructure, a coating, and a roughening thereon to increase friction in the common overlap region to further increase the level of interlocking between the first and second housings.

In another possible implementation form of the first aspect, the mating surface of the first housing is provided with a first microstructure and the mating surface of the second housing is provided with a second microstructure, the first and second microstructures comprising one of a plurality of recesses and at least one protrusion adapted to engage and interlock with the recesses, thereby facilitating a secure locking between the first and second housings preventing the housings from rotating relative to each other.

In another possible implementation form of the first aspect, one of the first and second microstructures is provided on a radially displaceable tongue, allowing a simple and releasable interlock between the housings.

In another possible implementation form of the first aspect, at least one of the first and second housings is provided with at least one slit extending from an open end of the first and/or second housing, allowing a tongue to be formed between the slits, which tongue can be bent radially outwards, allowing one housing to be pushed onto a surface of the other housing.

In another possible implementation form of the first aspect, the polyaxial joint further includes a third housing disposed around peripheries of the first and second mating housings in the common overlapping region, a locking lever protruding from the third housing, the third housing being movable between an unlocked position and a locked position by operation of the locking lever, thereby allowing the first housing and the second housing to be interlocked.

In another possible implementation form of the first aspect, in the unlocked position, the diameters of the first and second housings are not affected by the third housing, thereby allowing the first and second housings to rotate relative to each other, and wherein, in the locked position, the diameter of at least one of the first and second housings is reduced in at least a common overlapping region such that the first and second housings cannot rotate relative to each other. This allows the handle to be not only rotated relative to the shaft, but also locked in a rotational position relative to the shaft. Thus, this embodiment allows the user to lock the handle in a comfortable position.

In another possible implementation form of the first aspect, the inner surface of the third casing or the outer surface of the radially outermost positioned one of the first casing and the second casing comprises a circumferentially extending radially oriented groove, the radial depth of the groove decreasing in a direction towards the open end of the first casing, the second casing or the third casing such that the groove comprises a maximum bottom thickness section and a minimum bottom thickness section, the third casing being in the unlocked position when one of the radially outermost positioned casing and the third casing is at least partially arranged within the minimum bottom thickness section, and the third casing being in the locked position when one of the radially outermost positioned casing and the third casing is at least partially arranged within the maximum bottom thickness section. Thus, a locking function is provided comprising as few interacting parts as possible.

In another possible implementation form of the first aspect, the radially displaceable tongue is formed within a radially outermost positioned one of the first and second housings, wherein in the unlocked position the radial position of the radially displaceable tongue is unaffected by the third housing and the first and second housings are rotatable relative to each other, and wherein in the locked position the radially displaceable tongue is moved towards the radially innermost positioned one of the first and second housings, the first and second microstructures engaging in at least a common overlapping region such that the first and second housings cannot rotate relative to each other.

In another possible implementation form of the first aspect, one of the first and second housings is rotatably connected to the hollow shaft and the other of the first and second housings is rigidly connected to the handle, and wherein the handle is locked to the polyaxial joint when the third housing is in the locked position, thereby facilitating a firm and intentional polyaxial rotation.

In another possible implementation form of the first aspect, the surgical instrument further comprises a joint enclosure, a proximal end of the joint enclosure being connected to the handle, a distal end of the joint enclosure being connected to the first housing or the second housing, the joint enclosure covering the proximal ends of the polyaxial joint and the hollow shaft to provide additional support and protection for components housed within the joint enclosure.

In another possible implementation form of the first aspect, the joint housing shares a central axis with the hollow shaft, and the joint housing is partially rotatable about the central axis, thereby providing a degree of flexibility to the joint housing such that the handle may rotate substantially unrestricted.

In another possible implementation form of the first aspect, the joint enclosure comprises a flexible part extending between at least a first rigid part and a second rigid part in the direction of the central axis, the first rigid part being connected to the first shell or the second shell, the second rigid part being connected to the handle, thereby facilitating a secure connection between the parts while still allowing the handle to rotate.

In another possible implementation form of the first aspect, at least one of the first rigid part and the second rigid part comprises a plurality of grooves extending in the direction of the central axis, each groove comprising an end surface extending at an angle to the central axis, the end surfaces being arranged at a proximal end of the first rigid part and/or at a distal end of the second rigid part, the flexible part filling the grooves, thereby forming a flexible part surface in each groove corresponding to the end surface. This allows a tight and secure interface between the flexible component and the rigid component.

In another possible implementation form of the first aspect, the end face includes an opening through which the flexible member extends, the opening extending substantially parallel to the central axis, thereby providing a simple but rigid connection between the flexible member and the rigid member such that the flexible member does not easily separate from the rigid member.

In another possible implementation form of the first aspect, a section of the flexible member extends on a radially outer side and/or a radially inner side of the first rigid member and a further section of the flexible member extends on a radially inner side and/or a radially outer side of the second rigid member, thereby contributing to a more stable joint shell.

In another possible implementation form of the first aspect, at least one of the first and second rigid parts has a truncated cone shape, the outer diameter and/or the inner diameter of the first rigid part being smaller than the outer diameter and/or the inner diameter of the second rigid part, thereby facilitating the joint shell to have a shape that substantially corresponds to the shape of the polyaxial joint allowing for as small an outer dimension as possible.

In another possible implementation form of the first aspect, the proximal end of the second rigid part comprises locking means adapted to interact with at least one corresponding recess in the handle, thereby providing a secure and simple interconnection between the handle and the joint without restricting rotation.

In another possible implementation form of the first aspect, the locking device is one of a peripheral flange and a snap lock.

In another possible implementation form of the first aspect, the handle and the operation device are configured to actuate the end effector between an open position and a closed position, a proximal end of the end effector is coupled to the distal end of the hollow shaft, the end effector includes a first leg and a second leg, the second leg is pivotally connected to the first leg at the distal end of the end effector, the second leg extends at an acute angle relative to the first leg when the end effector is in the open position, and the second leg extends substantially parallel to the first leg when the end effector is in the closed position. This solution is advantageous for creating an end effector that is safely inserted into the body through an incision or opening because the legs of the end effector, when in the open configuration, automatically close into the closed configuration so that they are not inadvertently trapped within the tissue. Furthermore, the surgical instrument is actuated only by the handle, without the use of external instruments.

In another possible implementation form of the first aspect, the second leg includes a cutting device and the first leg includes a recess for receiving the cutting device when the end effector is in the closed position, thereby facilitating safe cutting applications and significantly reducing the risk of accidentally cutting tissue.

In another possible implementation form of the first aspect, the second leg includes a staple cartridge to facilitate further application of the surgical instrument.

In another possible implementation form of the first aspect, the distal end of the end effector includes a protective lip extending between the first leg and the second leg, the protective lip preventing tissue from becoming lodged in the connection between the first leg and the second leg.

In another possible implementation form of the first aspect, the surgical instrument further includes at least one support bar, a proximal end of the support bar pivotally connected to a proximal end of the end effector, the support bar extending at an acute angle relative to the first leg when the end effector is in the open position and the support bar extending parallel to the first leg when the end effector is in the closed position. The support bar ensures that tissue clamped between the legs of the end effector does not accidentally slip out from between the legs.

In another possible implementation form of the first aspect, the operating device includes an axially extending rod and a second pivot link, the distal end of the rod is coupled to the distal end of the second leg by the second pivot link, a first end of the second pivot link is pivotally connected to the axially extending rod, and a second end of the second pivot link is pivotally connected to the second leg. This facilitates a reliable way of operating the end effector without requiring any additional space.

In another possible implementation form of the first aspect, the second leg is pivotally suspended from the lever at a first location on the second leg, and the second end of the pivot link is pivotally connected to the second leg at a second location spaced from the first location, thereby allowing manipulation of the second leg.

In another possible implementation form of the first aspect, the second pivot link includes a plate extending between a first end and a second end, the first end is connected to the lever by a first hinge pin, the second end is connected to the second leg by a second hinge pin, and the second leg is hinged to the hollow shaft by a third hinge pin.

In another possible implementation form of the first aspect, the second leg has a free proximal end and a hinged distal end, and the first position is located at or near the hinged distal end. This solution facilitates the creation of an end effector that is safely inserted into the body through an incision or opening, while also allowing as much reach as possible for the user of the instrument.

In another possible implementation form of the first aspect, the second position is closer to the hinged distal end than the free proximal end.

In another possible implementation form of the first aspect, the third hinge pin is arranged in or near a central axis of the hollow shaft.

In another possible implementation form of the first aspect, the second pivot link is operatively connected to the rod at or near a proximal or distal end of the rod.

In another possible implementation form of the first aspect, the second leg is configured to rotate toward the hollow shaft when the lever translates in a direction away from the third hinge pin, and the second leg is configured to rotate away from the hollow shaft when the lever translates in a direction toward the third hinge pin, thereby allowing the second leg to close completely or nearly completely against the first leg.

In another possible implementation form of the first aspect, the rod is partially enclosed by the first leg of the end effector, and the end effector is actuated from the open position to the closed position when the rod is moved in a direction away from the distal end of the end effector, and the end effector is actuated from the closed position to the open position when the rod is moved in a direction toward the distal end of the end effector. This facilitates a reliable operation device that includes as few components as possible while still providing sufficient force to actuate the end effector between positions when tissue is disposed within the end effector.

In another possible implementation form of the first aspect, the operation device further comprises a piston and a spring, the rod being partially enclosed by the piston and the spring, the spring applying a force to a proximal end of the piston in a direction towards a distal end of the end effector, the rod and the piston being axially movable relative to each other and to at least one of the end effector, thereby facilitating enabling the operation device to not only actuate the end effector, but also move, for example, a ligating clip to a correct position.

In another possible implementation form of the first aspect, the rod and the piston are releasably connected such that the rod and the piston are axially movable as a unit relative to the end effector, thereby allowing the operation device to be multifunctional yet reliable.

In another possible realization of the first aspect, the rod and the piston are releasably connected by means of a piston lock comprising a plurality of locking grooves arranged in the rod, and corresponding locking protrusions arranged at the distal end of the piston, allowing to operate the surgical instrument, thereby allowing to interlock the components of the operating device by means of a simple and reliable solution which is easy to implement.

In another possible implementation form of the first aspect, the end effector is adapted to at least one of photograph and manipulate tissue, thereby facilitating a wide range of applications for the surgical instrument.

According to a second aspect, there is provided a surgical system comprising a surgical instrument as described above and at least one ligation clip, the end effector of the surgical instrument being configured to enclose the ligation clip such that a distal end of the ligation clip is disposed adjacent a distal end of the end effector and a proximal end of the ligation clip is disposed adjacent a proximal end of the end effector, the ligation clip comprising first and second ligation clip legs pivotally connected at the distal end of the ligation clip, the first and second ligation clip legs comprising a locking device for interlocking the first and second ligation clip legs at a position where they overlap one another at the proximal end of the ligation clip, wherein the ligation clip has an open configuration when the end effector is in an initial open position, wherein the second ligation clip leg extends at an acute angle relative to the first ligation clip leg, when the end effector has been actuated to the closed position, the ligation clip has a closed configuration in which the first and second ligation clip legs overlap one another, and when the end effector is returned to the open position, the ligation clip is retained in the closed configuration by means of the locking device.

Such a system facilitates safe insertion of a surgical instrument into the body through an incision or opening because the legs of the end effector, when in the open configuration, automatically close into the closed configuration so that they are not inadvertently trapped within the tissue. Furthermore, the system is actuated only by the handle, without the use of external instruments.

In a possible implementation form of the second aspect, a plurality of ligation clips are included in an open configuration and are disposed in series between the distal end of the end effector and the handle, all of the ligation clips being enclosed by the first leg and the rod of the end effector except for a first ligation clip located near the distal end of the end effector, thereby allowing the surgical instrument to be loaded with a plurality of ligation clips and, thus, allowing the surgical system to be used to ligate multiple locations in one stage without having to be reloaded between separate instances of ligation.

In another possible implementation form of the second aspect, the ligating clips are arranged to abut one another such that axial displacement of any ligating clip enclosed by the first leg and the rod causes a corresponding displacement of all ligating clips located between the ligating clip and the distal end of the end effector, thereby providing a simple way to move a series of ligating clips from a storage position to a use position.

According to a third aspect, a method of operating a surgical system is provided, wherein the operating device includes at least one axially extending rod, and wherein a first ligation clip is disposed within the end effector such that the first ligation clip is enveloped by the rod and a first leg of the end effector, the first ligation clip having an open configuration, the method comprising the steps of: the method further includes displacing the first ligation clip in a direction toward the distal end of the end effector by moving the rod in a direction toward the distal end of the end effector to a position where the first ligation clip is enclosed by the first and second legs of the end effector and the end effector is in an open position, actuating the end effector to a closed position by moving the rod in a direction away from the distal end of the end effector to thereby close the first ligation clip, and moving the rod in a direction toward the distal end of the end effector to return the end effector to the open position, thereby allowing the first ligation clip having the closed configuration to be released from the end effector.

In this way, an end effector is provided that is safely inserted into the body through an incision or opening because the legs of the end effector, when in the open configuration, automatically close into the closed configuration so that they are not accidentally trapped within the tissue. Further, the system is actuated solely by the handle, without the need for an external instrument to, for example, close the end effector or remove a closed ligation clip.

In a possible implementation form of the third aspect, the operating device further includes a piston and a spring, the piston lock including a rod lock slot and a piston lock protrusion that interlock the rod and the piston in a first locked position when the end effector is returned to the open position, the second ligation clip being disposed within the end effector such that the second ligation clip is enclosed by the first leg and the rod of the end effector, the second ligation clip having an open configuration, the method further including the step of moving the rod in a direction away from the distal end of the end effector, thereby releasing the piston lock from the first locked position and allowing the piston to move relative to the rod while actuating the end effector to the closed position, and applying a force to the proximal end of the piston by way of the spring, the piston moving toward the end effector until the piston lock engages the second locked position, the distal end of the piston being disposed such that when the piston lock is in the second locked position, moving the rod in a direction toward the distal end of the end effector closer to the distal end of the end effector than when the piston lock is in the first locked position, the piston moving in the same direction with the rod while actuating the end effector to the open position, moving the rod in a direction away from the distal end of the end effector thereby releasing the piston lock from the second locked position, the locking protrusion engaging a longitudinal slot disposed in the rod thereby allowing the piston to move relative to the rod while actuating the end effector to the closed position, the distal end of the piston engaging the second ligating clip, urging the second ligating clip in a direction toward the distal end of the end effector by way of a spring until the second ligating clip or a third ligating clip located between the second ligating clip and the distal end of the end effector is enclosed by the first and second legs of the end effector, moving the rod in a direction toward the distal end of the end effector, simultaneously actuating the end effector to the open position. Because as few components as possible are provided, the method allows for reliable operation of the surgical instrument while still providing sufficient force to actuate the end effector between positions when tissue is disposed within the end effector.

In another possible implementation form of the third aspect, the method further comprises the step of: the end effector is actuated to the closed position by moving the lever in a direction away from the distal end of the end effector, thereby closing the second or third ligation clips enclosed by the first and second legs of the end effector, and the lever is moved in a direction toward the distal end of the end effector such that the end effector returns to the open position, thereby allowing the second or third ligation clips in the closed configuration to be released from the end effector. This method allows actuation by means of the handle of the surgical instrument alone, without the need for an external instrument to, for example, close the end effector or remove a closed ligation clip.

These and other aspects will be apparent from and elucidated with reference to the embodiment(s) described hereinafter.

Drawings

In the following detailed part of the disclosure, aspects, embodiments and implementations will be explained in more detail with reference to example embodiments shown in the drawings, in which:

FIGS. 1a and 1b illustrate side and rear views of a surgical instrument according to one embodiment of the present invention;

FIGS. 2a and 2b illustrate a cross-sectional side view and an exploded perspective view of components of a surgical instrument according to one embodiment of the present invention;

FIG. 2c shows an exploded perspective view of a surgical instrument according to another embodiment of the present invention;

figure 3 illustrates an exploded perspective view of a polyaxial joint in accordance with one embodiment of the present invention;

figures 4a and 4b show a side view and an exploded perspective view of a polyaxial joint, joint shell, and handle in accordance with one embodiment of the present invention;

FIG. 5a shows a partial perspective view of a handle according to one embodiment of the present invention;

FIG. 5b shows a partial perspective view of a handle according to another embodiment of the present invention;

figures 6a and 6b show side and cross-sectional side views of an assembled polyaxial joint and joint shell with the polyaxial joint in an unlocked position in accordance with one embodiment of the present invention;

figures 7a and 7b are side and cross-sectional side views of the assembled polyaxial joint and joint shell shown in figures 5a and 5b with the polyaxial joint in a locked position;

FIG. 8a illustrates a cross-sectional side view of components of a surgical instrument according to one embodiment of the present invention;

figure 8b shows a cross-sectional side view of an assembled polyaxial joint and joint shell in accordance with one embodiment of the present invention;

FIGS. 9a to 9c show an exploded perspective view and a cross-sectional side view of a surgical instrument according to yet another embodiment of the present invention;

figures 10a and 10b illustrate perspective and cross-sectional side views of a polyaxial joint in accordance with one embodiment of the present invention;

figure 10c shows a side view of the polyaxial joint shown in figures 10a and 10 b;

figures 11a and 11b show perspective views of a polyaxial joint in accordance with one embodiment of the present invention;

fig. 12a and 12b show cross-sectional side views of the embodiment of fig. 11a and 11 b.

Figures 13a and 13b show perspective and cross-sectional side views of a joint shell according to one embodiment of the present invention;

figure 14a shows a side view of a component of the joint housing shown in figures 13a and 13 b.

Fig. 14b and 14c show perspective views of the components shown in fig. 14 a.

Figures 15a and 15b show a detailed view of the interlock between the flexible component and the component shown in figures 14a-14 c.

FIGS. 16a and 16b show side and cross-sectional side views of a shaft, an operating device, and an end effector with the end effector in an open position, according to one embodiment of the present invention;

FIGS. 16c and 16d show side and cross-sectional side views of the shaft, manipulator device and end effector shown in FIGS. 16a and 16b, with the end effector in a closed position;

FIGS. 17a and 17b illustrate perspective views of an end effector in accordance with one embodiment of the present invention, the end effector being in open and closed positions, respectively;

FIGS. 18a and 18b illustrate perspective views of an end effector in accordance with another embodiment of the present invention, the end effector being in open and closed positions, respectively;

fig. 19 illustrates a side view of a ligating clip according to one embodiment of the invention;

FIGS. 20a and 20b show perspective and cross-sectional side views of a shaft, an operating device, and an end effector according to another embodiment of the present invention;

FIG. 20c shows an exploded perspective view of the shaft, manipulator and end effector shown in FIGS. 20a and 20 b.

FIGS. 21a-21h illustrate partial side views of a surgical system and the functionality of the surgical system according to one embodiment of the present invention;

FIGS. 22a and 22b are side and cross-sectional side views of a shaft, an operating device and an end effector with the end effector in an open position according to yet another embodiment of the present invention.

FIGS. 22c and 22d illustrate side and partial side views of the end effector shown in FIGS. 22a and 22 b.

Detailed Description

Fig. 1a and 1b show a surgical instrument 1 comprising a handle 2, a hollow shaft 3 and an end effector 4. The hollow shaft 3 is an elongated body made of a suitable material, such as stainless steel or carbon fiber reinforced composite. The polyaxial joint 6, shown in more detail in fig. 3-12, couples the distal end 2a of the handle 2 to the proximal end 3a of the hollow shaft 3.

A "surgical instrument" is a device by which a patient's tissue is contacted by another individual, such as a surgeon. In this application, the term "surgical instrument" includes devices such as prostheses or implants.

"proximal" refers to the end of the component closest to the handle, and thus also closest to the individual holding the handle of the surgical instrument. Accordingly, "distal" refers to the end of the component furthest from the individual holding the handle and handle.

As shown in fig. 1a-1b and 16a-16d, the proximal end 4a of the end effector 4 is coupled to the distal end 3b of the hollow shaft 3. The end effector 4 is adapted to at least one of photograph and manipulate tissue. "manipulation" includes procedures such as severing, ligating, injecting, burning, cutting, grasping, tearing, and suturing. One or several programs may be executed simultaneously. "tissue" includes veins, arteries, intestines or umbilical cord (a non-exhaustive list).

The end effector 4 is operatively connected to the handle 2 by an operating device 5 which extends partially within the hollow shaft 3, from the end effector 4 towards and past the proximal end 3a of the hollow shaft 3, through the interior of the polyaxial joint 6 and through the distal end 2a of the handle 2, and into the interior of the handle 2. The operation device 5 includes at least one of a wire, a hose, and a rod. In one embodiment, the operating means 5 comprises a combination of wires and rods.

The handle 2 may be a squeeze handle or any other type of suitable handle, either manually operated or robotically operated. As shown in fig. 1a, 4b and 5a-5b, the handle 2 may include at least one grasping feature 2b, 2c and an actuating feature 2d, the actuating feature 2d being pivotally connected to the grasping features 2b, 2c and operatively connected to the end effector 4.

The operating means 5 may comprise an axially extending rod 28 and a first pivot link 39, as shown in fig. 8 a. The first pivoting link 39 is arranged inside the handle 2 and is operatively connected to the lever 28, the gripping members 2b, 2c and the actuating member 2 d.

The proximal end 28a of the lever 28 is connected to the proximal end 39a of the first pivot link 39. The proximal end 39a of the first pivot link 39 is also slidingly connected to the gripping members 2b, 2 c. The distal end 39b of the first pivot link 39 is pivotally connected to the actuating member 2 d.

When the actuating member 2d of the handle is pivoted towards the grip members 2b, 2c, the first pivot link 39 is also pivoted and the proximal end 39a of the first pivot link 39 is moved in a direction towards the proximal end of the handle 2, i.e. in a direction away from the hollow shaft 3 and the end effector 4. Because the proximal end 28a of the lever 28 is connected to the proximal end 39a of the first pivot link 39, the lever 28 moves in the same direction at the same time.

A polyaxial joint is a joint in which movement occurs about multiple axes and/or in multiple planes. The polyaxial joint 6 allows rotational movement of the hollow shaft 3 and the end effector 4 relative to the handle 2 about the central axis C of the hollow shaft 3, i.e. the entire hollow shaft 3 can rotate about its own central axis. The poly-axial joint 6 also allows rotation about the distal end 2a of the handle in at least two planes. In one embodiment, at least one plane is not parallel to the central axis C of the hollow shaft 3. The plane may extend to the central axis at any angle such that the plane is, for example, perpendicular to the central axis. The polyaxial joint 6 may also allow rotational movement in a plane parallel to the hollow shaft 3.

The polyaxial joint 6 allows polyaxial rotation of the hollow shaft 3 and end effector 4 relative to the handle 2, which is substantially the same as allowing polyaxial rotation of the handle 2 relative to the hollow shaft 3 and end effector 4. As previously described, multi-axis rotation includes rotation about the central axis C of the hollow shaft 3, with the end effector 4 rotating with the hollow shaft 3. Furthermore, the multi-axis rotation does not affect the position of the end effector 4 relative to the handle 2, such that the end effector 4 remains in the same position when the handle 2 is pivoted relative to the hollow shaft 3. In other words, the end effector 4 remains stationary and neither rotates nor pivots as the handle 2 moves. The movement produced by the handle 2 in relation to the end effector 4 is limited to actuating the end effector 4 between the open position OP and the closed position CP by the actuating member 2d, as will be described in more detail below.

The hollow shaft 3 is rotatable about its own central axis C. In one embodiment, the hollow shaft 3 is also capable of rotating simultaneously in three planes relative to the distal end 2a of the handle 2, allowing simultaneous free rotation in three planes while preventing translation in any direction. In one embodiment, each plane extends parallel or perpendicular to the central axis and perpendicular to each other. The hollow shaft 3 is capable of rotating around the central axis C and in three planes simultaneously.

In one embodiment, the polyaxial joint 6 is a spherical joint including a first shell 7 and a second shell 8 that are at least partially spherical, each spherical shell including a spherical portion. In one embodiment, the first housing 7 or the second housing 8 comprises a spherical segment formed by a pair of parallel planes cutting an imaginary sphere, the center of which is arranged between the parallel planes. In another embodiment, one of the parallel planes coincides with the center of the imaginary sphere. In a further embodiment, both parallel planes extend on the same side of the centre of the imaginary sphere, i.e. one parallel plane is arranged between the centre of the imaginary sphere and the other parallel plane. Each housing 7, 8 may comprise one integral part, as shown in fig. 5a, or may comprise several interconnected housing parts, as shown in fig. 5b, which shows about half of the second housing 8.

One of the first and second housings 7, 8 may be integrally formed with at least one of the grip members 2b, 2 c. One of the first and second housings 7, 8 may also be connected to at least one of the gripping members 2b, 2 c. Fig. 5a shows an embodiment where one of the second housings 8 is connected to one of the grip parts 2b, 2 c.

As shown in fig. 3, the first housing 7 includes an open end 7a, and the second housing 8 includes an open end 8 a. The first and second casings 7 and 8 are arranged such that the open end 7a of the first casing 7 overlaps the open end 8a of the second casing 8, or the open end 8a of the second casing 8 overlaps the open end 7a of the first casing 7. This overlap is shown in more detail in fig. 6a-7b, 8b, 10a-10c, 11a-11b and 12 b. The open end of one housing is pressed into the open end of the other housing to provide a so-called press fit between the two housings 7, 8 in a manner that allows one housing to rotate relative to the other, as shown in fig. 6a-7b and 10a-10c, or to provide a so-called press fit in a manner that interlocks the two housings 7, 8 such that one housing cannot rotate relative to the other, as shown in fig. 11a-11b and 12 b. In other words, the open ends 7a and 8a have mating surfaces 7b, 8b such that a common overlap area a exists between the first and second housings 7 and 8 when the first and second housings 7 and 8 are mated.

With respect only to the movement of the first and second housings 7, 8 relative to each other, in embodiments where the two housings 7, 8 are rotatable relative to each other, the polyaxial joint 6 may correspond to a ball and socket joint, wherein the ball moves within the socket to allow rotational movement in each direction within certain limits.

As the first housing 7 and the second housing 8 rotate relative to each other in at least one plane, the size of the common overlap area a may change. Further, the position of the overlap area a changes at least partially. Both the first and second housings 7, 8 may share a central axis C with the hollow shaft 3, i.e. as long as the handle 2 is not rotated in any of the three planes mentioned above with respect to the proximal end 3a of the hollow shaft 3, and in this case the common overlap area a extends around the entire circumference of both the first and second housings 7, 8. This position is shown in fig. 1a and fig. 4a-7 a. When the first and second housings 7, 8 are only rotated about the central axis C, i.e. the housings 7, 8 are held in the position shown in fig. 6b, the size and position of the overlapping area a is unchanged. However, when the first and second housings 7 and 8 are rotated relative to each other in any one of the three planes described above, as shown in fig. 10a and 10b, the common overlap area a extends only along a portion of the periphery of both the first and second housings 7 and 8.

One of the first and second housings 7, 8 is rotatably connected to the hollow shaft 3, and the other of the first and second housings 7, 8 is rigidly connected to the handle 2. For ease of reading, an embodiment will be described below in which the first housing 7 is rotatably connected to the hollow shaft 3 and the second housing 8 is rigidly connected to the handle 2. Further, of the two partially overlapped casings, the first casing 7 will be described as an inner casing, and the second casing 8 will be described as an outer casing. However, an embodiment comprising a first outer housing and a second inner housing as well as a first housing 7 rigidly connected to the handle 2 and a second housing 8 rotatably connected to the hollow shaft 3 is equally possible.

At least one of the first and second housings 7 and 8 may be provided with a hollow guide tube 9. A hollow guide tube 9 protrudes from one or both of the outer and inner surfaces of the first and/or second housings 7, 8. The hollow guide tube 9 houses at least one of the proximal end 3a of the hollow shaft 3, a part of the operating device 5 and a connection to the handle 2.

As shown in fig. 8b, a bearing 45 may be arranged between the hollow guide tube 9 and the hollow shaft 3, allowing the hollow shaft 3 to rotate around the central axis C.

At least one of the first and second housings 7, 8 may be provided with a through slit 10 extending from the open end 7a, 8a of the housing, allowing the housings 7, 8 to overlap. By providing slits on the second housing 8, the tongues formed between the slits can be bent radially outwards, allowing the second housing 8 to be pushed onto the surface of the first housing 7. Furthermore, in a direction away from the open end 7a of the first housing, the tongue may return to a radially more inward position as the second housing 8 is pushed further onto the first housing 7, since the cross-sectional outer diameter of the first housing 7 decreases in that direction. This allows the first housing 7 and the second housing 8 to interlock, at least to some extent, by a press fit.

At least one of the mating surfaces 7b, 8b of the first and second housings 7, 8, which together constitute the common overlap area a, may be provided with microstructures 43, coatings and/or roughening to increase friction within the common overlap area a to further increase the level of interlocking between the first and second housings 7, 8.

Microstructures 43 may include interconnecting protrusions and recesses as shown in fig. 11a-11b and 12 b. In one embodiment, the mating surface 7b of the first housing 7 is provided with a first microstructure 43a and the mating surface 8b of the second housing 8 is provided with a second microstructure (43 b). The first and second microstructures 43a, 43b include one of a plurality of recesses and at least one protrusion adapted to engage and interlock with the recesses. Fig. 11a-12b show an embodiment where the first housing 7 is provided with a first microstructure 43a comprising a plurality of recesses and the second housing 8 is provided with a second microstructure 43b comprising protrusions.

One of the first and second microstructures 43a, 43b may be provided on the radially displaceable tongue 44. Fig. 11b-12b show an embodiment in which the radially displaceable tongue 44 projects slightly radially outwards in a direction away from the innermost of the two shells 7, 8 in a state of equilibrium without external pressure. This allows the two housings to rotate relative to each other. As the tongue 44 moves radially inward toward the innermost shell, the first and second microstructures 43a, 43b eventually interconnect, thereby preventing such rotation.

In one embodiment, the polyaxial joint 6 further includes a third shell 11, the third shell 11 being disposed around the perimeter of the first and second mating shells 7, 8 within the common overlap region a. The third housing 11 is preferably substantially annular, but may have any other suitable configuration, such as a part-spherical or elliptical housing. The inner diameter of the third housing 11 may be slightly smaller than the largest outer diameter of the second housing 8, such that the third housing 11 is able to press the tongues on the second housing 8 inwards towards the first housing 7 and subsequently interlock the first and second housings 7, 8 by means of a press fit or mechanical locking means provided by the microstructures 43.

The lock lever 12 protrudes from the third casing 11 so as to allow the third casing 11 to move between the unlock position P1 and the lock position P2 when operated manually or by a robot. During this operation, the third casing is pivoted about the first casing 7 and the second casing 8, so that one peripheral portion of the third casing 11 is moved in a direction toward the open end 8a of the second casing 8, and the opposite peripheral portion is moved away from the open end 8a of the second casing 8. Depending on the actual position of the third housing 11, the first housing 7 and the second housing 8 may or may not be interlocked with respect to each other. By interlocking the first and second housings 7, 8, the position of the handle 2 is locked relative to the housing (preferably the second housing 8) attached to the proximal end 3a of the hollow shaft 3, thereby allowing the person operating the surgical instrument to lock the instrument at any suitable angle.

The diameters of the first inner housing 7 and the second outer housing 8 remain unaffected by the radial pressure from the third housing 11, so that the first housing 7 and the second housing 8 can rotate relative to each other when the third housing 11 is in the unlocked position P1.

The diameter of at least one of the first inner housing 7 and the second outer housing 8, preferably the second outer housing 8, is reduced at least in the common overlapping area a by the radial pressure exerted by the third housing 11, such that when the third housing 11 is in the locking position P2, the inner surface of the second outer housing 8 is pressed against the outer surface of the first inner housing 7, thereby preventing the first housing 7 and the second housing 8 from rotating relative to each other.

The inner surface of the third housing 11 or the outer surface of the radially outermost positioned one of the first and second housings 7, 8 (i.e. the second housing 8 for ease of reading) may comprise at least one radially oriented groove 13 extending circumferentially. As shown in fig. 10c, the radial depth D of the groove 13 decreases in a direction towards the open end of the housing (e.g. the open end 8a of the second housing 8) such that the groove 13 comprises a maximum bottom thickness section T1 and a minimum bottom thickness section T2, the bottom thickness section being defined by the vertical distance between the outer and inner surfaces of the housings 7, 8, 11 (i.e. the thickness of the housing walls).

When the third housing 11 is located at the unlocked position P1, the third housing 11 is at least partially disposed within the minimum bottom thickness section T2, as shown in fig. 6a and 6 b. When the third housing 11 is in the locking position P2, the third housing 11 is at least partially disposed within the maximum bottom thickness section T1, as shown in fig. 7a and 7b, and the handle 2 is locked to the multi-axis joint 6.

In embodiments comprising radially displaceable tongues 44, the tongues 44 are formed in the radially outermost positioned one of the first casing 7 and the second casing 8. In the unlocked position P1, the radial position of the radially displaceable tongue 44 is unaffected by the third housing 11, and the first and second housings 7, 8 are rotatable relative to each other. In the locking position P2, the radially displaceable tongue 44 has been moved towards the radially innermost one of the first and second housings 7, 8 such that the first and second microstructures 43a, 43b engage in at least the common overlapping area a. This engagement prevents the first and second housings 7, 8 from rotating relative to each other.

In one embodiment, the surgical instrument 1 further comprises a joint housing 14. The proximal end 14a of the joint housing 14 is connected to the handle 2 and the distal end 14b of the joint housing 14 is connected to the first shell 7 or the second shell 8, preferably the second shell 8. The joint housing 14 is arranged such that it covers the polyaxial joint 6 and the proximal end 3a of the hollow shaft 3, see fig. 4a and 4 b.

The joint housing 14 shares a central axis C with the hollow shaft 3, and the joint housing 14 is at least partly rotatable around the central axis C.

In one embodiment, as shown in fig. 13a-13b and 14a-14C, the joint shell 14 includes a flexible member 15, the flexible member 15 extending between at least a first rigid member 16 and a second rigid member 17 in the direction of the central axis C. The first rigid member 16 is connected to the first housing 7 or the second housing 8, and the second rigid member 17 is connected to the handle 2. When the hollow shaft 3 rotates about the central axis C, one of the rigid members 16, 17 and a portion of the flexible member 15 also rotate about the central axis C, causing the joint housing 14 to partially twist. The rigid part is preferably made of a hard plastic, such as ABS (acrylonitrile butadiene styrene) plastic. Thus, as used herein, "rigid" is not absolutely rigid, but rather indicates that the stiffness of the material is relatively high, i.e., significantly higher than the stiffness of the component denoted as "flexible". The term "flexible" includes properties such as elasticity and bendability.

The proximal end 17a of the second rigid part 17 may comprise locking means 20, the locking means 20 being adapted to interact with at least one corresponding recess 21 in the handle 2. As shown in fig. 4b and 14a, the locking means may be a peripheral flange 20 interacting with a recess 21. The locking means may also comprise a snap lock, as shown in fig. 9a and 9 b.

At least one of the first rigid member 16 and the second rigid member 17 may include a plurality of grooves 18 extending in the direction of the central axis C (i.e., the direction from the first rigid member 16 to the second rigid member 17). Each slot 18 includes an end surface 18a that extends at an angle to the central axis C, as shown in fig. 15a and 15 b. The end face 18a is arranged at the proximal end 16a of the first rigid part 16, while correspondingly the other end face 18a is arranged at the distal end 17b of the second rigid part 17. The flexible member 15 fills the grooves 18, thereby forming a flexible member surface 15a corresponding to the end surface 18a in each groove 18.

Each end face 18a comprises an opening 19 through which the flexible member 15 extends, the opening 19 extending substantially parallel to the central axis C.

The section 15b of the flexible member may extend on a radially outer and/or a radially inner side of the first rigid member 16, and correspondingly, the section 15c of the flexible member 15 may extend on a radially inner and/or a radially outer side of the second rigid member 17. In one embodiment, the sections of the flexible member 15 extend on a radially outer side as well as a radially inner side of the first rigid member 16, such that the two sections of the flexible member 15 extend in parallel, separated by a wall of the first rigid member 16.

In one embodiment, at least one of the first rigid part 16 and the second rigid part 17 has a truncated cone shape, the outer diameter and/or the inner diameter of the first rigid part 16 being smaller than the outer diameter and/or the inner diameter of the second rigid part 17.

The handle 2 and the operating device 5 are configured to actuate the end effector 4 between any possible open position OP and closed position CP, i.e., from the open position to the closed position, and from the closed position to the open position.

The end effector 4 includes a first leg 22 and a second leg 23, the second leg 23 being pivotally connected to the first leg 22 at the distal end 4b of the end effector 4. As shown in fig. 16a and 16b, the second leg 23 extends at an acute angle a relative to the first leg 22 when the end effector 4 is in the open position OP. As shown in fig. 16c, 16d and 17b, the second leg 23 extends generally parallel to the first leg 22 when the end effector 4 is in the closed position CP. In other words, the first leg 22 is fixed with respect to the hollow shaft 3, while the second leg 23 is pivotable with respect to the first leg 22 and the hollow shaft 3.

As shown in fig. 17a and 18a, the distal end 23b of the second leg 23 is pivotally connected to the distal end 22b of the first leg 22 such that the second leg 23 overlies the first leg 22 in the closed position CP. The pivotal connection is arranged at the end 4b of the end effector 4 that is furthest from the handle 2, and thus the individual operating the handle 2. When the end effector 4 is actuated from the open position OP to the closed position CP, the proximal end 23a of the second leg 23 is at least partially moved toward the handle 2.

In one embodiment, as shown in fig. 17a, the second leg 23 includes a cutting device 24 for cutting tissue and the first leg 22 includes a recess 25 for receiving the cutting device when the end effector 4 is in the closed position CP.

In another embodiment, the second leg 23 comprises a staple magazine.

As shown in fig. 17a and 18a, the distal end 4b of the end effector 4 may include a protective lip 26 extending between the first and second legs 22, 23, the protective lip 26 preventing tissue from becoming lodged in the pivotal connection connecting the first and second legs 22, 23.

At least one support rod 27 may be connected to the end effector 4 as shown in fig. 18a and 18 b. The proximal end 27a of the support bar 27 is pivotally connected to the proximal end 4a of the end effector 4 such that when the end effector 4 is in the open position OP, the support bar 27 extends at an acute angle β relative to the first leg 22, thereby allowing the first leg 22, the second leg 23, and the support bar 27 to enclose a triangular space that may contain tissue. When the end effector 4 is in the closed position CP, the support bar 27 extends parallel to the first leg 22.

In one embodiment the operating means 5 comprise an axially extending rod 28 extending parallel to the centre axis C of the hollow shaft 3, and a second pivot link 29. The rod 28 is partially enclosed by the first leg 22 of the end effector 4, preferably disposed in a radially extending recess in the first leg 22, as shown in FIGS. 20a-20 c.

The distal end 28b of the rod 28 is coupled to the distal end 23b of the second leg 23 by a second pivot link 29, the second pivot link 29 extending at an angle relative to the axial extension of the rod and at an angle relative to the second leg 23. The proximal end 28a of the rod 28 is operatively connected to the handle 2. When the lever 28 is moved in a direction away from the distal end 4b of the end effector 4, the end effector 4 is actuated from the open position OP to the closed position CP. Accordingly, when the lever 28 is moved in a direction toward the distal end 4b of the end effector 4, the end effector 4 is actuated from the closed position CP to the open position OP.

The operating device 5 may further comprise a piston 30 and a spring 31, the rod 28 being partly enclosed by the piston 30 and the spring 31. Preferably, a proximal section of the rod 28 is enclosed by the first leg 22 and a distal section of the rod 28 is enclosed by the piston 30 and the spring 31. A spring 31 is arranged between the piston 30 and the handle 2 and/or the poly-axial joint 6. The spring 31 applies a force to the proximal end 30a of the piston 30 in a direction toward the distal end 4b of the end effector 4.

The rod 28 and the piston 30 are axially movable relative to each other and at least one of the end effector 4. Further, the rod 28 and piston 30 are releasably connected such that the rod 28 and piston 30 are axially movable as a unit relative to the end effector 4. The rod 28 and the piston 30 may be releasably connected by means of a piston lock, as shown in fig. 20b, 21a and 21c, comprising a plurality of locking grooves 32 arranged in pairs in the rod 28, and corresponding locking protrusions 33 arranged at the distal end 30b of the piston 30.

The present disclosure also relates to a surgical system comprising the surgical instrument 1 as described above and at least one ligating clip 34. Ligating clips, also known as clips, are used, for example, to ligate a body fluid flow within tissue, see fig. 19.

The end effector 4 of the surgical instrument 1 is configured to enclose the ligation clip 34 such that a distal end 34b of the ligation clip 34 is disposed adjacent the distal end 4b of the end effector 4 and a proximal end 34a of the ligation clip 34 is disposed adjacent the proximal end 4a of the end effector 4, as shown in fig. 21 a.

The ligation clip 34 includes a first ligation clip leg 35 and a second ligation clip leg 36, the first and second ligation clip legs 35, 36 being pivotally connected at a distal end 34b of the ligation clip 34. The first and second ligation clip legs 35, 36 include a locking device 37 for interlocking the first and second ligation clip legs 35, 36 at the proximal end 34a of the ligation clip 34 where the first and second ligation clip legs 35, 36 overlie one another.

When the end effector 4 is in the initial open position OP and the ligation clip 34 is enclosed by the first and second legs 22, 23 of the end effector 4, the ligation clip 34 has an open configuration in which the second ligation clip leg 36 extends at an acute angle γ relative to the first ligation clip leg 35. When the end effector 4 is subsequently actuated to the closed position CP, the configuration of the ligation clip 34 changes to a closed configuration in which the first and second ligation clip legs 35, 36 overlap one another. As the end effector 4 returns to the open position OP, the ligating clip 34 is held in the closed configuration by means of the locking device 37.

The surgical system may include a plurality of individual ligating clips 34, all in an open configuration and disposed continuously along the rod 28 and/or the first leg 22 of the end effector 4 between the distal end 4b of the end effector 4 and the handle 2. All of the ligation clips 34-X are enclosed by the first leg 22 and the rod 28 of the end effector 4, except for the first ligation clip 34-1 which is located near the distal end 4b of the end effector 4 and enclosed by the first leg 22 and the second leg 23 of the end effector 4.

The ligation clips 34 are arranged to abut one another such that axial displacement of any one of the ligation clips 34-X enclosed by the first leg 22 and the rod 28 of the end effector 4 causes a corresponding displacement of all of the ligation clips 34 between the ligation clips 34-X and the distal end 4b of the end effector 4. In other words, all of the ligation clips 34 that are closer to the distal end 4b of the end effector 4 than the ligation clip 34-X are urged in a direction toward the distal end 4b by the ligation clip 34-X.

The present disclosure is also directed to a method of operating the surgical system described above, as shown in fig. 21b-21h, wherein the first ligating clip 34-1 is disposed within the end effector 4 such that the first ligating clip 34-1 is enclosed by the first leg 22 and the rod 28 of the end effector 4, and the first ligating clip 34-1 has an open configuration.

By moving the lever 28 in a direction toward the distal end 4b of the end effector 4, the first ligation clip 34-1 is displaced in a direction toward the distal end 4b of the end effector 4 to a position where the first ligation clip 34-1 is enclosed by the first and second legs 22, 23 of the end effector 4 and the end effector 4 is in the open position OP, as shown in FIG. 21 a.

By moving the lever 28 in a direction away from the distal end 4b of the end effector 4, the end effector 4 is actuated to the closed position CP, thereby closing the first ligation clip 34-1.

Subsequently, the rod 28 is moved in a direction toward the distal end 4b of the end effector 4 such that the end effector 4 returns to the open position OP, thereby allowing the first ligating clip 34-1, having a closed configuration, to be released from the end effector 4.

The surgical system may include a plurality of ligating clips 34. For ease of reading, the following description will be limited to first, second, and third ligating clips 34, however, additional ligating clips 34 are possible.

The second ligation clip 34-2 may be disposed within the end effector 4 such that the second ligation clip 34-2 is enclosed by the first leg 22 and the rod 28 of the end effector 4, the second ligation clip 34-2 having an open configuration. Further, when the end effector 4 returns to the open position OP, the piston locks 32, 33 interlock the rod 28 and piston 30 in the first locked position LP1, as described above and shown in fig. 21 a.

The rod 28 is moved in a direction away from the distal end 4b of the end effector 4, as shown in FIG. 21b, thereby releasing the piston locks 32, 33 from the first locked position LP1 and allowing the piston 30 to move relative to the rod 28. At the same time, the end effector 4 is actuated to the closed position CP and the piston 30 is moved toward the end effector 4 by applying a force to the proximal end 30a of the piston 30 via the spring 31 until the piston locks 32, 33 engage the second locked position LP2, as shown in fig. 21 c. The distal end 30b of the piston 30 is disposed closer to the distal end 4b of the end effector 4 when the piston lock 32, 33 is in the second locked position LP2 than when the piston lock 32, 33 is in the first locked position LP 1.

The rod 28 moves in a direction toward the distal end 4b of the end effector 4, and the piston 30 moves in the same direction with the rod 28. Simultaneously, the end effector 4 is actuated to the open position OP, as shown in fig. 21 d.

The rod 28 is moved in a direction away from the distal end 4b of the end effector 4, thereby releasing the piston locks 32, 33 from the second locked position LP2, as shown in fig. 16 e. The locking protrusion 33 engages a longitudinal slot 38 disposed in the rod 28, thereby allowing the piston 30 to move relative to the rod 28 while actuating the end effector 4 to the closed position CP, as shown in fig. 21 f.

The rod 28 and piston 30 may include only one piston lock 32, 33 and one longitudinal slot 38. However, the rod 28 preferably includes a plurality of longitudinal grooves 38 and a plurality of individual or pairs of locking grooves 32, each pair of locking grooves allowing the locking protrusion 33 of the piston 30 to assume the first locking position LP1 when engaging one of the pair of locking grooves and the second locking position LP2 when engaging the other of the pair of locking grooves. Each longitudinal slot 38 is associated with a single locking slot 32 or a pair of locking slots 32.

The distal end 30b of the piston 30 engages the second ligation clip 34-2, urging the second ligation clip 34-2 in a direction toward the distal end 4b of the end effector 4 by means of the spring 31 until the second ligation clip 34-2, or a third ligation clip 34-3 located between the second ligation clip 34-2 and the distal end 4b of the end effector 4, is enclosed by the first and second legs 22, 23 of the end effector 4, as shown in fig. 21 g. The ligating clip 34 slides over the longitudinal slot 38 such that the longitudinal slot 38 and the ligating clip 34 do not interact.

Moving the rod 28 in a direction toward the distal end 4b of the end effector 4 simultaneously actuates the end effector 4 to the open position OP, as shown in fig. 21 h.

By moving the lever 28 in a direction away from the distal end 4b of the end effector 4, the end effector 4 is actuated to the closed position CP, thereby closing the second or third ligation clips 34-2, 34-3 enclosed by the first and second legs 22, 23 of the end effector 4.

Moving the lever 28 in a direction toward the distal end 4b of the end effector 4 causes the end effector 4 to return to the open position OP, thereby allowing the second or third ligating clip 34-2, 34-3 in the closed configuration to be released from the end effector 4.

FIGS. 16a-d, 21a-d, and 22a-d illustrate an embodiment of a surgical instrument 1 for actuating an end effector 4 between an open position and a closed position. The hollow shaft 3 is configured to guide the rod 28 so as to move the rod 28 in translation. The second leg 23 is pivotally suspended from the hollow shaft 3 at a first position on the second leg 23. The second leg 23 has a free proximal end 23a and a hinged distal end 23b, and the first position is located at or near the hinged distal end 23 b.

A second pivot link 29 operatively connects the rod 28 with the second leg 23 by way of a first end 29a and a second end 29b of the second pivot link 29, the first end 29a of the second pivot link 29 being pivotally connected to the axially extending rod 28, and the second end 29b of the second pivot link 29 being pivotally connected to the second leg 23 at a second location spaced from the first location. In one embodiment, the second pivot link 29 includes a plate extending between a first end 29a and a second end 29 b.

The first end 29a is connected to the lever 28 by a first hinge pin 40. The second pivot link 29 may be operatively connected to the lever 28 at or near the end of the lever 28, such as at the proximal end 28a or distal end 28b of the lever 28. Accordingly, the second end 29b may be connected to the second leg 23 by a second hinge pin 41. The second position is closer to the hinged distal end 23b relative to the free proximal end 23 a.

In one embodiment, the second leg 23 is hinged to the hollow shaft 3 by a third hinge pin 42. The third hinge pin 42 is arranged in or near the centre axis C of the hollow shaft 3.

The second leg 23 is configured to rotate toward the hollow shaft 3 when the lever 28 translates in a direction away from the third hinge pin 42, and the second leg 23 is configured to rotate away from the hollow shaft 3 when the lever 28 translates in a direction toward the third hinge pin 42.

Various aspects and embodiments have been described in connection with various embodiments herein. However, other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed subject matter, from a study of the drawings, the disclosure, and the appended claims. In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.

Any reference signs used in the claims shall not be construed as limiting the scope thereof.