阅读说明：本技术 外科手术引导系统和装置 (Surgical guidance system and device ) 是由 阿施施·杰恩 苏博德·莫雷 蒂莫西·P·哈拉 查鲁达塔·C·阿拉德耶 拉吉夫·库马尔·辛格 于 2018-06-20 设计创作，主要内容包括：引导装置可以包括基部构件,基部构件包括延伸穿过其中的孔。引导装置可以包括联接至基部构件的手柄。此外,驱动器可以定位在基部构件内并且联接至在基部构件和手柄之间延伸的轴。(The guide device may include a base member including an aperture extending therethrough. The guide device may include a handle coupled to the base member. Further, the driver may be positioned within the base member and coupled to a shaft extending between the base member and the handle.)

1, A guide device, comprising:

a base member including a bore extending therethrough;

a handle coupled to the base member; and

a driver positioned within the base member and coupled to a shaft extending between the base member and the handle.

2. The guide device of claim 1, wherein the base member includes a radiopaque member extending around a periphery of the base member aperture.

3. The guide device of claim 2, wherein the radiopaque member is a radiopaque ring.

4. The guide device of any , wherein the handle is coupled to an actuator that is rotatable relative to the handle.

5. The guide device of any of the preceding claims, wherein the actuator extends proximally of the handle, is coupled to the shaft, and is rotatable about a longitudinal axis of the shaft.

6. The guide device of any of claims 1-3, wherein the shaft is coupled to a motor disposed within the handle.

7. The guide device of claim 6, further comprising a speed selector operably coupled to the motor.

8. The guide device of , wherein the step includes a mode selector configured to move between a forward marker, a neutral marker, and a reverse marker relative to the handle.

9. The guide device of claim 8, wherein actuation of the motor causes the shaft to rotate in an th direction when the mode selector is aligned with the forward facing marker.

10. The guide device of any one of claims 8 or 9, , wherein actuation of the motor causes the shaft to rotate in a second direction when the mode selector is aligned with the reverse index.

11. The guide device of any of , further step comprising a battery operably coupled to the motor.

12. The guide device of any of the preceding claims, wherein the distal end of the shaft includes a shaft gear.

13. The guide device of claim 12, wherein the driver includes a th shaft having an th gear, the th gear including teeth configured to mesh with teeth of the shaft gear.

14. The guiding device of at least of the preceding claims, wherein the drive comprises pairs of rollers, each roller including a channel therein.

15. The guide device of any of the preceding claims, wherein the shaft includes a portion and a second portion, wherein, in a configuration, the portion is coupled with the second portion, and wherein, in a second configuration, the portion is separate from the second portion.

Technical Field

In particular, aspects relate to surgical guidance systems, devices, and methods.

Background

For example, percutaneous nephrolithotomy (or "PCNL") is such procedures in which an object (such as a needle) is inserted through the skin and into the kidney to remove the kidney stone.

Further, once the proper angle of entry is determined, the medical professional typically grasps the proximal end of the needle (e.g., the end opposite the puncture tip) and applies a pushing or advancing force to pierce the skin and advance the needle through the patient tissue and into a target location within the kidney (e.g., a target renal calyx). however, applying a pushing or advancing force on the proximal end of the needle may cause the needle to bend outward from (e.g., away from) the needle axis, thereby potentially interfering with proper orientation or insertion angle of the needle.

The systems, devices, and methods of the present disclosure may correct or mitigate the challenges described above, and/or address other aspects of the prior art.

Disclosure of Invention

Each of the various aspects disclosed herein can include or more features described in connection with any other disclosed aspect.

In examples, the guide device can include a base member including a bore extending therethrough.

The method may include providing a motor, a mode selector, a motor, a pair of rollers 355631, a pair of rollers , a pair of rollers, a.

In the further example, the method can include positioning a base member of the guide apparatus at a location on the skin of the patient the method can further include rotating a shaft extending between a handle of the guide apparatus and the base member of the guide apparatus, further the method can include rotating the pair of rollers to move the insertion apparatus toward the skin of the patient and through the aperture of the base member.

The method may include identifying a position of the base member via a radiopaque member positioned on the base member.

In an example of the step , the guide device can include a base member including a hole extending therethrough.

An example of the guide device may include or more of the following features the shaft may include a th portion and a second portion, and in a configuration, a th portion may be coupled with the second portion, and in a second configuration, a th portion may be separate from the second portion.

As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises an series of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

Drawings

The accompanying drawings incorporated in and forming a part of the specification illustrate exemplary aspects that, together with the written description , serve to explain the principles of the disclosure.

Fig. 1 illustrates an exemplary guide system including a base and an insertion device according to an aspect of the present disclosure;

FIG. 2 illustrates a drive of the guidance system of FIG. 1 in accordance with a further aspect of the present disclosure, and

fig. 3 illustrates an additional exemplary guidance system including a base and an insertion device according to still another aspect of the present disclosure.

Detailed Description

The surgical guide system may include a base and at least insertion devices associated with the base for insertion into an organ (e.g., a kidney) of a patient via a puncture in the patient's skin.

Reference will now be made in detail to the above-described examples of the present disclosure and examples illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

The terms "proximal" and "distal" are used herein to refer to the relative position and directional position of components of an exemplary base or insertion device. As used herein, "proximal" refers to a location that is closer to the exterior of the patient's body or closer to the operator and/or medical professional using a base or insertion device. Conversely, "distal" refers to a location farther away from the operator and/or medical professional, or closer to the interior of the patient's body, using a base or insertion device.

Accordingly, the example surgical guidance systems, devices, and methods described herein may be used with or in conjunction with any other suitable procedure, insertion device, treatment area, or imaging technique, medical or other aspect .

As shown in fig. 1, the surgical guide system includes a base 10 extending along a longitudinal axis L the base 10 includes a base member 12 and a handle 14 coupled to the base member 12 (or formed integrally with the base member 12 ) as shown in fig. 1, the base member 12 can be generally rectangular shaped and have a dimension (e.g., a width extending in a direction perpendicular to the longitudinal axis) that is greater than a dimension (e.g., a width or diameter) of the handle 14. however, in other arrangements, the base member 12 can have any suitable shape (e.g., a square, a circle, an ellipse, a triangle, a polygon, an irregular shape, and/or combinations thereof). further, in other arrangements, the base member 12 can have a dimension (e.g., a width) that is less than or equal to a dimension (e.g., a width or diameter) of the handle 14. further, the base 10 can be a clamshell arrangement in which two halves (e.g., a top or half 10A and a bottom or second half 10B) of the base 10 are coupled to one another to form the base 10.

As also shown in FIG. 1, base member 12 includes a through hole 16. through hole 16 extends between a opening 18 on a -th surface 20 (on -th half 10A) of base member 12 and a second opening (not shown in the orientation of FIG. 1) on a second surface 22 (on second half 10B) of base member 12 opposite -th surface 20. -opening 18 may be tapered, conical, or otherwise funnel-shaped to facilitate passage of insertion device 40 therethrough. silicone, rubber, semi-rigid, or elastomeric material may line or be included in the wall of through hole 16 to frictionally engage insertion device 40. alternatively, through hole 16 may have a diameter sufficiently similar in size to the diameter of a portion of insertion device 40 extending therethrough to frictionally grip insertion device 40. in any arrangement, insertion device 40 may be securely positioned within through hole 16, and may be advanced steps as described below.

The base member 12 includes a radiopaque member 24 on or in a groove in the surface 20 of the , for example, the radiopaque member 24 may include a ring or wire of radiopaque material that extends circumferentially around the opening 18 of the second (e.g., surrounding the opening ) in arrangements , however, in arrangements , the radiopaque member 24 may extend less than about the entire circumference of the opening 18 of the second , further, in arrangements , the radiopaque member 24 may be discontinuous around all or of the circumference of the opening 18 of the second , in arrangements , the radiopaque member 24 may be a radiopaque member, and the base 10 may include a second radiopaque member (not shown) on the second surface 22, such a second radiopaque member may include a ring or wire of radiopaque material that extends circumferentially around a second opening (not shown) (e.g., surrounding the second opening).

As shown in FIG. 1, handle 14 may be of different sizes, including th portion 14A and second portion 14B, second portion 14B may be enlarged relative to th portion 14A to facilitate grasping by a medical professional.in arrangements , second portion 14B may include or more ribs, channels, or other such geometric features 14C to ensure that second portion 14B is securely grasped by the medical professional.base member 12 may be positioned at end of handle 14 while actuator 26 may be positioned at a second end of handle 14 opposite end.actuator 26 may be rotated about longitudinal axis L (e.g., in either or both of clockwise and counterclockwise directions) to rotate shaft 28 (FIG. 2) to actuate driver 30 (FIG. 2) as will be described in more detail below.accordingly, actuator 26 may be of any shape or arrangement to facilitate medical professional in use, e.g., as shown in FIG. 1, actuator may have a curved shape to enable a medical professional to position actuator 26 around the longitudinal axis L (e.g., as shown in FIG. 1) to position actuator 26 around the second finger section 26B of the medical professional such that the second portion 26 may be positioned around the longitudinal axis L of the second finger 26, such as to enable the medical professional's hand to be rotated, such as to position the medical professional's hand 26, such as to position the medical professional's hand around the medical professional's longitudinal axis L (e.g., the medical professional's longitudinal axis 26) around the second hand's longitudinal axis L, such as may be positioned around the medical professional's longitudinal axis of the medical professional 26, such as may be positioned around the medical professional's longitudinal axis of the medical professional's longitudinal axis L, such as may be positioned around the medical professional's longitudinal axis of the medical professional's finger 26, such as may be positioned around the medical professional's longitudinal axis of the medical professional 26, such as may be positioned around the medical professional's finger 26.

An exemplary insertion device 40 is shown in fig. 1 as having an elongated body or shaft 42 extending along an axis N. the insertion device 40 may be any type of elongated object, such as a needle, cannula, catheter having or more working channels, rigid or flexible tubing, or similar elements hi arrangements, the insertion device 40 may be an 18-gauge or 21-gauge insertion needle having a lumen extending therethrough. the distal end of the insertion device may have a sharp or angled tip configured or arranged to facilitate penetration of bodily tissue (e.g., into and/or through the skin of a patient). at least portion of the insertion device 40 includes a radiopaque material to enhance visibility of the insertion device 40 via fluoroscopy.

FIG. 2 is a view of the base member 12 with the th portion 10A removed to provide a view of the driver 30, as shown, the driver 30 includes a gear system to convert rotational motion of the shaft 28 into linear motion to advance or retract the insertion device 40. for example, the distal end of the shaft 28 terminates in a th gear or drive gear 32. the drive gear 32 includes a plurality of teeth to mesh with, engage, interlock, or otherwise mate with the teeth of the shaft gear 34. the shaft gear 34 is coupled to the th shaft 36 such that rotation of the shaft gear 34 results in the same rotation of the th shaft 36. furthermore, the th roller 38 is coupled to or mounted on the th shaft 36. the roller 38 includes an insertion device groove or channel 50 sized to receive the shaft 42 of the insertion device 40. as shown, the second roller 52 is coupled to or mounted on the second shaft 54 of the driver 30. like the roller 38, the second roller 52 includes an insertion device groove or channel 56 sized to receive the shaft 42 of the insertion device 40. each of the channels 50 and 56 may include a compressible rubber, a semi-elastomeric material to secure the insertion device 40 on the friction device and secure the friction device.

As shown, shaft 28 has a central longitudinal axis that is collinear with longitudinal axis L, while the central longitudinal axis of each of shaft and shaft 54 is not collinear with longitudinal axis L. conversely, the central longitudinal axis A of shaft and the central longitudinal axis B of shaft 54 are parallel to each other and parallel to longitudinal axis L. in other words, shaft and shaft 54 are disposed on opposite sides of longitudinal axis L. further, each of shaft 28, shaft 1 and shaft 54 are received within at least supports 60 to maintain axial alignment of the respective shafts.for example, the distal end portion of shaft 28 is received within support 60. although not shown, the proximal end portion of shaft 28 may likewise be received within support 60. further, each of shaft and shaft 54 may be received within pairs of supports 60 disposed on opposite sides of respective rollers 38 and 52. as shown in FIG. 2. as such, each of shaft 28, shaft 36 and shaft 54 may be received within a respective pair of supports 38 and 52, or may be positioned between a respective longitudinal axis L, a longitudinal axis B of shaft 54 and a respective support channel 62, or channel 62 may be included in a channel 62, or channel 62, which may be positioned between a respective channel 62 or channel 62, which may be positioned between a channel 62, including a channel 62 for lubricating the longitudinal axis L of shaft 28, a channel 62, or channel 62, which may be positioned in which may be included in the longitudinal support channel 62, a channel 62, or channel 62, which is positioned between a channel 62, laid down as shown, laid down in the longitudinal axis L of each channel 62, laid down.

The surgical guide system arranged in accordance with re is shown in fig. 3 the system of fig. 3 is similar to the system of fig. 1, but the mechanical actuator 26 is replaced by a motor 126 coupled to a shaft 128 as shown, the system includes a base 110 extending along a longitudinal axis L the base 110 includes a base member 112 and a handle 114 coupled to the base member 112 may be similarly shaped and configured as the base member 112 described above in addition, the base member 112 includes a through hole 116, the through hole 116 extending between a opening 118 on a th surface 120 (on a half 112A of the base member 112) and a second opening (not shown in the orientation of fig. 3) on a second surface 122 opposite the th surface 120 (on a second half 112B of the base member 112) the through hole 116 may be tapered, conical or otherwise funnel-shaped to facilitate passage of the insertion device 40 therethrough, silicone, rubber, semi-rigid or elastomeric material may line or otherwise line the through hole 116 or be included in the through hole 116 to frictionally engage the device 40, alternatively the insertion device may be inserted through the through hole 116, the friction device 40 may be securely positioned as described with the through hole , the friction device 116, and the through hole 116.

Base member 112 includes a radiopaque member 124 on surface , for example, radiopaque member 124 may include a ring or wire of radiopaque material that extends circumferentially around opening (e.g., surrounding opening ). in addition, in some arrangements , radiopaque member 124 may be discontinuous around the periphery of opening . in some arrangements , radiopaque member 124 may be a radiopaque member, and base 110 may include a second radiopaque member (not shown) on second surface 122. such a second radiopaque member may include a ring or wire of radiopaque material that extends circumferentially around (e.g., surrounding) a second opening (not shown). in some arrangements , the second radiopaque member may extend less than about the entire periphery of the second opening and/or be discontinuous around the periphery of the second opening.

As shown in FIG. 3, handle 114 may have -th section 114A and second section 114B, second section 114B being enlarged relative to -th section 114A for grasping by a medical professional -th section 114A may be selectively uncoupled from second section 114B along axis C. for example, after a procedure is completed, the medical professional may disconnect, decouple or otherwise disengage -th section 114A from second section 114B so that second section 114B may be sterilized and reused for another procedures. in this arrangement, rotation of -th section 114A and second section 114B relative to -th section 114A about longitudinal axis L in the -direction (e.g., clockwise) may cause -th section 114A and second section 114B to be securely coupled, and further rotation of second section 114B about longitudinal axis L (e.g., counter-clockwise) may cause section 114A to be rotatably coupled with respect to -th section 114A, 114B about longitudinal axis L.

Additionally, the shaft 128 includes th and second portions 128A, 128B. th and second portions 128A, 128B may be magnetically coupled to one another such that th and second portions 128A, 128B of the shaft 128 may contact one another when the th portion 114A of the handle 114 is coupled to the second portion 114B. due to the magnetic attraction between the th and second portions 128A, 128B, rotation of the second portion 128B via the motor 126 will result in the same rotation of the th portion 128A, thereby resulting in rotation of the gears and shafts of the driver 30 housed within the base member 112 (described in connection with FIG. 2) to advance or retract the shaft 42 of the insertion device 40. alternatively, the connection of the th and second portions 128A, 128B of the shaft 128 may be made in any other suitable manner (such as a threaded (e.g., screw) coupling, dovetail connection, bonding, interference fit, or the like) without departing from the scope of the present disclosure.

The proximal end of the shaft 128 (e.g., the second portion 128B) may be coupled with the motor 126 for rotation therewith the motor 126 is additionally connected to the power source 130 may be an internal battery (e.g., rechargeable or -time battery) and/or a power adapter to provide an electrical connection to a wall outlet (not shown). in any arrangement, the power source 130 may provide sufficient power to drive the motor 126 to rotate the shaft 128 and drive the driver 30 (fig. 2). alternatively, the motor 126 may be replaced with any other suitable drive mechanism, such as, for example, a pneumatic actuator, a hydraulic actuator, or the like.

As shown in FIG. 3, handle 114 further includes a direction selector 132 having an indicator 134 and a speed selector 136 having an indicator 138, each of direction selector 132 and speed selector 136 is in communication with motor 126. direction selector 132 may be movable between three markers (i.e., an insertion device travel (e.g., forward) marker F, a neutral or stop marker F, and an insertion device retraction (e.g., reverse) marker R.) in use, a medical professional may apply a force to push or retract direction selector 132 relative to handle 114 to align indicator 134 with of forward marker F, neutral marker N, or reverse marker R. when indicator 134 travels toward marker F, direction selector 132 transmits a signal to motor 126 to drive shaft 128 in a first direction (e.g., clockwise) to actuate drive driver 30 to travel distally or insert insertion device 40 through the skin and toward a target renal calyx of the patient's kidney (e.g., in a direction X disposed toward the dashed line in FIG. 3. when indicator 40 is retracted through the skin and toward target renal calyx of the patient's kidney (e.g., in a second direction), direction, e.g., a direction, as shown by withdrawing indicator 134 in a second direction , a third direction, e.g., a signal may be transmitted to stop the signal from being transmitted to motor 132 in the second direction, e.g., a third direction, indicated by motor 132, indicated by arrow 128, indicated by arrow 3, e.g., a third direction, indicated by arrow, e.g., indicated by arrow 3, a third direction, e.g., a third direction, indicated by arrow, indicated.

The speed selector 136 may be moved between a plurality of markings 140 that indicate the rotational speed of the motor 126, for example, each progressively distal marking 140 of the plurality of markings indicates a higher rotational speed of the motor 126. for example, the most proximal marking 140 may indicate the slowest speed of the motor 126, while the most distal marking 140 may indicate the fastest speed of the motor 126. the markings 140 between the most proximal and most distal markings 140 may indicate progressively increasing speeds between the slowest and fastest speeds of the motor 126. for example, each of the markings 140 between the most proximal and most distal markings 140 may be equally spaced to indicate equal increases in speed of the motor 126. however, in other aspects, the markings 140 may be unequally spaced to indicate unequal increases in speed between adjacent markings 140. correspondingly, to increase or decrease the speed of the motor 126, the medical professional may advance or retract the speed selector 136 to bring the indicator 138 into alignment with the desired markings of the markings 140, thereby sending a signal from the speed selector 136 to adjust the rotational speed of the motor 126 to maintain the desired rotational speed of 355 mm, such as 0 mm, 84 mm, 136 mm, or the like.

As schematically illustrated in FIG. 3, each of the selectors 132 and 136 includes a slider arrangement, however, the present disclosure is not so limited, rather, any or both of the selectors 132 and 136 may alternatively or additionally include a knob, wheel, or depressible member/button (not shown). for example, in arrangements, the speed selector 136 may be a depressible member such that an increase in the depressing force applied to the speed selector 136 may signal an increase in the speed of the motor 126.

In use, a medical professional can use any of the bases 10 or 110 to align the insertion device 40 with a desired treatment location (e.g., a target calyx of a kidney). optionally, prior to or during surgery (e.g., a PCNL surgery), the patient can be directed to ingest a radiopaque contrast agent.alternatively, or more portions or structures of the patient (e.g., a target calyx in a kidney) can be injected with a radiopaque contrast agent.

Next, the medical professional can move the base 10 and/or the base 110 relative to the patient's skin (e.g., on the patient's torso and/or sides). for example, the medical professional can translate, slide, or otherwise move the second surface 22 or 122 of the base member 12 or 112 along the patient's skin to position the base 10 or 110 (and thus the insertion device 40) into the target calyx at a preferred angle.

Upon confirming the appropriate insertion angle of insertion device 40, the medical professional may rotate the C-arm of the fluoroscopy device to an angle that is perpendicular to the angle at which the fluoroscopy device is positioned when identifying the insertion angle of insertion device 40. in this orientation, the fluoroscopy device allows for clear observation of the insertion depth of insertion device 40. after confirming the insertion angle and the angle of rotation of the C-arm of the fluoroscopy device, the insertion device 40 may be advanced (e.g., moved distally along axis N) through holes 16 and/or 116 to penetrate the skin of the patient and advance the tip of insertion device 40 to a target location (e.g., a target kidney) within the patient. to that end, the medical professional may grasp actuator 26 and rotate actuator 26 relative to handle 14 in a second direction (e.g., clockwise) (FIG. 1), or align indicator 134 of direction selector 132 with forward marker F and align indicator 138 of speed selector 136 with of plurality of markers 140, so as to select the desired speed (e.g., 3. 3) of insertion device 40, and rotate indicator 34 relative to the second axis 140, thereby cause the second roller 34 to be retracted into the insertion device 40, if the insertion device 40, or rotated in a desired direction, or counter-direction, then the second axis 28, and the second roller 34 is rotated relative to retract the insertion device 34, 35, and the second roller 34, 35 is rotated relative to the insertion device 34, or 16, 35, and the second roller 34, or 16, 35, and the second roller 32, 35, and the second roller 32, or 16, 35, and the second roller 32, if the second roller 32 is rotated, or 16, 32, or 16, 32, or 16, respectively, 32, and the second roller, and the second.

The proper insertion depth of the insertion device 40 may be confirmed in any suitable manner, such as, for example, via visualization of or more radiopaque portions (e.g., the band 44) of the insertion device 40, visual confirmation of urine reaching through the needle, aspiration of urine through a syringe connected to the needle, or some combination of the above.

As noted above, speed selector 136 may be adjusted to change (e.g., increase or decrease) the rotational speed of shaft 128, and thus the insertion speed or retraction speed of insertion device 40. in some arrangements , for example, the total insertion depth of the insertion device may be about 10cm before 12 cm. may be traversed at a faster or increased speed, and then 2cm may be traversed at a lower or decreased speed.that is, the medical professional may first align indicator 138 of speed selector 136 with indicia 140 and advance insertion device 40 a distance of 10 cm.

While the principles of the disclosure are described herein with reference to illustrative aspects for particular applications, it should be understood that the disclosure is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, aspects, and substitutions of equivalents which fall within the scope of the aspects described herein. Accordingly, the disclosure is not to be considered as limited by the foregoing description.