# Patent

## Title
Ligation clip loading device

## Abstract

A ligation clip loading device includes a cannula including a cannula body and an instrument lumen extending through a longitudinal axis of the cannula body, and a stack of ligation clips axially arranged about the instrument lumen. The ligation clips are accessible through a series of slots allowing for loading of an endoscopic clip applier with the ligation clips within a body cavity, such as an intra-abdominal cavity.

## Background
CROSS-REFERENCE TO RELATED APPLICATION
The present application claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 62/956,462, filed on Jan. 2, 2020, the entire content of which is incorporated herein by reference.


FIELD
This disclosure is generally related to ligation clips and, more particularly, to a ligation clip loading device for intra-cavity loading of ligation clips to a ligation clip applicator device.
BACKGROUND
Polymeric ligation clips typically include first and second beams that are coupled together at one end by a pivotable connection, e.g., living hinge, such that the first and second beams can be moved in relation to each other between open and clamped positions. The ligation clips can be applied to tissue endoscopically through a small diameter incision or through a small diameter cannula positioned through the incision to minimize trauma to a patient during a surgical procedure.
Typically, when polymeric clips are applied to tissue through a cannula and/or stored within an endoscopic clip applier, the clips are supported in a compressed or partially compressed state to minimize an overall dimension of the clips and facilitate delivery of the clips through the cannula or incision. Storing polymeric clips in a compressed or partially compressed state may impact the condition of the clips which may impact the performance of the clips.
In minimally-invasive surgical procedures, operations are carried out within an internal body cavity through small entrance openings in the body. The entrance openings may be natural passageways of the body or may be surgically created, for example, by making a small incision into which a cannula is inserted.
Minimally-invasive surgical techniques may be used for placement of ligation clips within an internal body cavity, such as an intra-abdominal space, by a ligation clip application device (e.g., endoscopic clip applier). Ligation clips are loaded into an end effector of an endoscopic clip applier and the endoscopic clip applier clamps the ligation clip at a desired site.
SUMMARY
In one aspect of the disclosure, an intra-cavity clip loading device includes a cannula including a cannula body defining an instrument lumen extending along a longitudinal axis of the cannula body. A clip stack is defined in the cannula body. The clip stack includes ligation clips axially arranged about the instrument lumen. Clip retention features are formed in the cannula body. Each clip retention feature holds a ligation clip.
In some aspects of the disclosure, each ligation clip includes a first arm and a second arm defining a central region between the first and second arms. The instrument lumen extends through the central region. The cannula includes an inner wall and an outer wall. The inner wall defines the instrument lumen. The first and second arms of each of the ligation clips are positioned between the inner wall and the outer wall of the cannula. The inner wall of the cannula separates the plurality of ligation clips from the instrument lumen to maintain a fluid integrity of the instrument lumen.
In some aspects of the disclosure, the cannula body includes slots formed in the cannula body. Each slot is associated with a clip retention feature. Each ligation clip is accessible by a clip applier through a respective slot.
In some aspects of the disclosure, the first arm of each ligation clip includes a first boss and the second arm of each ligation clip includes a second boss. The first boss and the second boss are each coupled to a clip retention feature.
In some aspects of the disclosure, the slots are covered by a sheath positioned about the cannula body. The slots may be located proximate a distal end portion of the cannula body.
In some aspects of the disclosure, the cannula includes a mate cap and an instrument seal formed in the mate cap to maintain a predetermined pressure in the instrument lumen.
In some aspects of the disclosure, a distal seal provides a barrier between an internal body cavity and the instrument lumen.
In one aspect of the disclosure, a method of robotic intra-abdominal clip loading includes robotically introducing the intra-cavity clip loading device into an intra-abdominal space. A robotic ligation clip application device is loaded into the intra-abdominal space. The end effector of the ligation clip application device is robotically inserted into a portion of the clip stack. The end effector of the ligation clip application device grasps the ligation clip of the plurality of ligation clips. The end effector of the ligation clip application device is withdrawn to remove the ligation clip from the clip stack defined in the distal end portion of the cannula body.
In some aspects of the disclosure, the end effector of the ligation clip application device is robotically inserted into a slot of the clip stack to grasp the ligation clip. The end effector may be robotically inserted into the slot at a location proximate the distal end portion of the cannula body. The first arm and the second arm of the end effector may be inserted into the portion of the clip stack to grasp the ligation clip. The first arm and the second arm of the ligation clip application device separates the ligation clip from the clip retention feature.
Other features of the disclosure will be appreciated from the following description.



BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate aspects and features of the disclosure and, together with the detailed description below, serve to further explain the disclosure, in which:
FIG. 1A is a side view of an intra-cavity clip storing and/or loading device in accordance with the disclosure;
FIG. 1B is a cross-sectional view along line 1B-1B of FIG. 1A;
FIG. 2A illustrates the intra-cavity clip loading device of FIG. 1A positioned in a body cavity adjacent to a ligation clip application device;
FIG. 2B illustrates loading of a ligation clip from the intra-cavity clip loading device of FIG. 1A to the ligation clip application device;
FIG. 3 is a side view of an intra-cavity clip loading device in accordance with another embodiment of the disclosure;
FIG. 4 is an internal cross-sectional view of the intra-cavity clip loading device of FIG. 3;
FIG. 5 is a cross-sectional view along line 5-5 of FIG. 3;
FIG. 6 illustrates loading of a ligation clip from the intra-cavity clip loading device of FIG. 3 to a ligation clip application device;
FIG. 7 is a flow chart of a method of robotic intra-abdominal clip loading in accordance with the disclosure; and
FIG. 8 is a schematic illustration of a robotic surgical system configured for use in accordance with the disclosure.



DETAILED DESCRIPTION
As used herein, the term “distal” refers to the portion that is being described which is further from a user, while the term “proximal” refers to the portion that is being described which is closer to a user. Further, to the extent consistent, any of the aspects and features detailed herein may be used in conjunction with any or all of the other aspects and features detailed herein.
As used herein, the terms parallel and perpendicular are understood to include relative configurations that are substantially parallel and substantially perpendicular up to about + or −10 degrees from true parallel and true perpendicular.
Exemplary axes or directions such as an X-axis direction, a Y-axis direction and a Z-axis direction may be illustrated in the accompanying drawings and/or described herein. As an example, the X-axis direction may perpendicular to the Y-axis direction, and the Z-axis direction may be orthogonal to the X-axis direction and the Y-axis direction.
“About” or “approximately” or “substantially” as used herein may be inclusive of the stated value and means within an acceptable range of variation for the particular value as determined by one of ordinary skill in the art, considering the measurement in question and the error associated with measurement of the particular quantity (e.g., the limitations of the measurement system). For example, “about” may mean within one or more standard variations, or within ±30%, 20%, 10%, 5% of the stated value.
Descriptions of technical features or aspects of an exemplary embodiment of the disclosure should typically be considered as available and applicable to other similar features or aspects in another exemplary embodiment of the disclosure. Accordingly, technical features described herein according to one exemplary embodiment of the disclosure may be applicable to other exemplary embodiments of the disclosure, and thus duplicative descriptions may be omitted herein.
Exemplary embodiments of the disclosure will be described more fully below (e.g., with reference to the accompanying drawings). Like reference numerals may refer to like elements throughout the specification and drawings.
The intra-cavity clip loading devices described herein allow intra-cavity loading of ligation clips while still optionally providing an instrument lumen (e.g., for use by 5 mm instruments). Thus, a single endoscopic port can be employed for intra-cavity ligation clip storing and loading of a ligation clip application device and for providing access to a surgical instrument through the instrument lumen extending between the ligation clips.
FIGS. 1A, 1B, 2A and 2B illustrate an embodiment of an intra-cavity clip loading device 100. The intra-cavity clip loading device 100 includes cannula 101 including distal cannula portion 102 defining an instrument lumen 103 extending along a longitudinal axis “X-X” defined by the cannula 101.
A clip stack 104 is defined in the cannula 101. The clip stack 104 includes ligation clips 105 axially arranged about the instrument lumen 103. The clip stack 104 includes a stack of ligation clips 105 spaced apart from each other such that each ligation clip 105 can be individually removed by a ligation clip application device 201 (see, e.g., FIGS. 2A and 2B). The ligation clip application device 201 may be a robotically controlled device (see, e.g., FIG. 8).
The ligation clips 105 each include a first arm 110 and a second arm 120 positioned at opposite sides of the instrument lumen 103. The instrument lumen 103 allows passage of a surgical instrument through the instrument lumen 103 between the first arm 110 and the second arm 120 of each of the ligation clips 105.
In some aspects of the disclosure, the instrument lumen 103 of cannula 101 may be omitted, and the intra-cavity clip loading device 100 may provide intra-cavity ligation clip loading without providing an access port for an additional surgical instrument. Thus, the clip stack 104 may be defined in the body of an obturator without the presence of the instrument lumen 103.
In use, with specific reference to FIGS. 2A and 2B, the intra-cavity clip loading device 100 may be inserted and secured to an endoscopic port 150 (e.g., by mate cap 130) at a proximal end portion 112 of the cannula 101. The cannula 101 extends through a body cavity wall 200 (e.g., an intra-abdominal wall). A distal end portion 114 of the intra-cavity clip loading device 100 is positioned in an intra-cavity space 250 (e.g., intra-abdominal) such that the ligation clips 105 can be removed by the ligation clip application device 201 without removing the intra-cavity clip loading device 100 from the intra-cavity space. The ligation clip application device 201 may extend through a separate endoscopic port 152. The ligation clip application device 201 may include an end effector 202 (e.g., jaws) configured to grasp and apply ligation clips 105. The end effector 202 is configured for insertion into slots 106 of the clip stack 104 to individually remove ligation clips 105 stored within the intra-cavity space 250.
FIGS. 3-6 illustrate an exemplary intra-cavity clip loading device 300. The intra cavity clip loading device 300 includes a cannula 301 including a cannula body 302 defining an instrument lumen 303 extending along a longitudinal axis “X-X” defined by the cannula body 302. A clip stack 304 is defined in the cannula body 302 (e.g., at a location proximate a distal end thereof). The clip stack 304 includes ligation clips 305 axially arranged about the instrument lumen 303. Clip retention features 501 are formed in the cannula body 302. Each clip retention feature 501 holds a ligation clip 305.
The intra-cavity clip loading device 300 may include a mate cap 330 for securing the intra-cavity clip loading device 300 to an endoscopic port. The mate cap 330 may include an instrument seal 401 and/or a zero seal 402 for allowing access to a surgical instrument through the instrument lumen 303. The instrument seal 401 or the zero seal 402 can maintain a fluid integrity of the instrument lumen 303. A distal seal 403 may be formed at a distal end portion 314 of the cannula body 302. The distal seal 403 may include a first flap 410 and a second flap 420 for allowing passage of a surgical instrument therethrough, while also maintaining a fluid integrity of the instrument lumen 303. The distal seal 403 provides a barrier between an internal body cavity and the instrument lumen 303. It is envisioned that instrument seal 401 and zero seal 402 may be incorporated directly into clip loading device 300.
As an example, the cannula body 302 may have a diameter of from about 12 mm to about 15 mm, and the instrument lumen 303 may have a diameter of from about 3 mm to about 5 mm.
Each ligation clip 305 includes a first arm 310 and a second arm 320 defining a central region between the first and second arms 310 and 320. The first and second arms 310 and 320 may reversibly pivot or flex with respect to each other through compression or flexure of a hinge 331. The instrument lumen 303 extends through the central region between the first and second arms 310 and 320 of each ligation clip 305.
With reference to FIGS. 5 and 6, the cannula 301 and cannula body 302 include an inner wall 352 and an outer wall 353. The inner wall 352 defines the instrument lumen 303. The first and second arms 310 and 320 of each of the ligation clips 305 are positioned between the inner wall 352 and the outer wall 353 of the cannula 301. The inner wall 352 of the cannula 301 separates the plurality of ligation clips 305 from the instrument lumen 303 to maintain a fluid integrity of the instrument lumen 303.
The cannula body 302 includes slots 306 formed in an outer surface thereof (e.g., outer wall 353). Each slot 306 is associated with a clip retention feature 501. Each ligation clip 305 is accessible by a clip applier (e.g., a ligation clip application device) through a respective slot 306. The use of separate slots 306 each employing a separate clip retention feature 501 allows each ligation clip 305 to be individually securely removed by the clip applier.
The first arm 310 of each ligation clip 305 includes a first boss 332 and the second arm 320 of each ligation clip 305 includes a second boss 333. The first boss 332 and the second boss 333 are each coupled to a clip retention feature 501. Thus, the first and second bosses 332 and 333 may be employed for securing the ligation clips 305 to corresponding clip retention features 501 in corresponding slots 306.
The slots 306 may be covered by a sheath 307 positioned about the cannula body 302. As an example, the sheath 307 may include or may be formed of plastic. The sheath 307 may assist in guiding an end effector 202 of a ligation clip application device 201 into a desired slot 306, and may assist in maintaining ligation clips 305 within slots 306.
The slots 306 may each be located proximate a distal end portion 314 of the cannula body 302. As an example, the clip stack 304 may include a stack of six ligation clips 305 and a six corresponding slots 306.
The cannula 101 and cannula body 102, or the cannula 301 and cannula body 302 may be configured for bladeless insertion by employing a distal tip having bladeless insertion geometry (see, e.g., FIG. 3), in the manner of an obturator or the like.
FIG. 6 illustrates removal of a single ligation clip 305 through a single slot 306 by a ligation clip application device 201. The ligation clip application device 201 may include an end effector 202 having a first arm 210 and a second arm 220. The first arm 210 may grasp a first arm 310 of the ligation clip 305 and the second arm 220 may grasp a second arm 320 of the ligation clip 305. The bosses 332 and/or 333 may be employed by the end effector 202 for grasping the ligation clip 305. The hinge 331 of the ligation clip 305 allows flexing of the first and second arms 310 and 320 toward or away from each other to detach the ligation clip 305 from the clip retention feature 501. Thus, the ligation clip 305 may be freed from the clip retention feature 501 and retracted out of slot 306 while being securely grasped by end effector 202 of ligation clip application device 201.
FIG. 7 is a flowchart illustrating a method of robotic intra-abdominal clip loading. The method includes robotically introducing the intra-cavity clip loading device 100 having the clip stack 104 into an intra-abdominal space (step 701; see, e.g., FIGS. 2A and 2B—intra-cavity space 250). The method includes introducing a robotic ligation clip application device 201 into the intra-abdominal space (step 702). The end effector 202 of the ligation clip application device 201 is robotically inserted into a portion (e.g., a slot 106) of the clip stack 104 (step 703). The end effector 202 of the ligation clip application device 201 grasps the ligation clip 105 (step 704). The end effector 202 of the ligation clip application device 2012 is withdrawn to remove the ligation clip 105 from the clip stack 104 (step 705; see, e.g., FIG. 6).
The end effector 202 of the ligation clip application device 201 is robotically inserted into the slot 106 of the clip stack 104 to grasp the ligation clip 105. The end effector 202 may be robotically inserted into the slot 106 (e.g., at a location proximate the distal end portion 114 of the cannula body 302). The first arm 210 and the second arm 220 of the end effector 202 may be inserted into the portion (e.g., the slot 106) of the clip stack 104 to grasp the ligation clip 105. The first arm 210 and the second arm 220 of the ligation clip application device 201 separates the ligation clip 105 from the clip retention feature 501.
The various embodiments disclosed herein may also be configured to work with robotic surgical systems and what is commonly referred to as “Telesurgery.” Such systems employ various robotic elements to assist the surgeon and allow remote operation (or partial remote operation) of surgical instrumentation. Various robotic arms, gears, cams, pulleys, electric and mechanical motors, etc. may be employed for this purpose and may be designed with a robotic surgical system to assist the surgeon during the course of an operation or treatment. Such robotic systems may include remotely steerable systems, automatically flexible surgical systems, remotely flexible surgical systems, remotely articulating surgical systems, wireless surgical systems, modular or selectively configurable remotely operated surgical systems, etc.
The robotic surgical systems may be employed with one or more consoles that are next to the operating theater or located in a remote location. In this instance, one team of surgeons or nurses may prep the patient for surgery and configure the robotic surgical system with one or more of the instruments disclosed herein while another surgeon (or group of surgeons) remotely controls the instruments via the robotic surgical system. As can be appreciated, a highly skilled surgeon may perform multiple operations in multiple locations without leaving his/her remote console which can be both economically advantageous and a benefit to the patient or a series of patients.
The robotic arms of the surgical system are typically coupled to a pair of master handles by a controller. The handles can be moved by the surgeon to produce a corresponding movement of the working ends of any type of surgical instrument (e.g., end effectors, graspers, knifes, scissors, etc.) which may complement the use of one or more of the embodiments described herein. The movement of the master handles may be scaled so that the working ends have a corresponding movement that is different, smaller or larger, than the movement performed by the operating hands of the surgeon. The scale factor or gearing ratio may be adjustable so that the operator can control the resolution of the working ends of the surgical instrument(s).
The master handles may include various sensors to provide feedback to the surgeon relating to various tissue parameters or conditions, e.g., tissue resistance due to manipulation, cutting or otherwise treating, pressure by the instrument onto the tissue, tissue temperature, tissue impedance, etc. As can be appreciated, such sensors provide the surgeon with enhanced tactile feedback simulating actual operating conditions. The master handles may also include a variety of different actuators for delicate tissue manipulation or treatment further enhancing the surgeon's ability to mimic actual operating conditions.
FIG. 8 illustrates a medical work station shown generally as work station 1000 and generally may include a plurality of robot arms 1002, 1003; a control device 1004; and an operating console 1005 coupled with control device 1004. Operating console 1005 may include a display device 1006, which may be set up in particular to display three-dimensional images; and manual input devices 1007, 1008, by means of which a person (not shown), for example a surgeon, may be able to telemanipulate robot arms 1002, 1003 in a first operating mode.
Each of the robot arms 1002, 1003 may include a plurality of members, which are connected through joints, and an attaching device 1009, 1011, to which may be attached, for example, a surgical tool “ST” supporting an end effector 1100, in accordance with any one of several embodiments disclosed herein, as will be described in greater detail below.
Robot arms 1002, 1003 may be driven by electric drives (not shown) that are connected to control device 1004. Control device 1004 (e.g., a computer) may be set up to activate the drives, in particular by means of a computer program, in such a way that robot arms 1002, 1003, their attaching devices 1009, 1011 and thus the surgical tool (including end effector 1100) execute a desired movement according to a movement defined by means of manual input devices 1007, 1008. Control device 1004 may also be set up in such a way that it regulates the movement of robot arms 1002, 1003 and/or of the drives.
Medical work station 1000 may be configured for use on a patient 1013 lying on a patient table 1012 to be treated in a minimally invasive manner by means of end effector 1100. Medical work station 1000 may also include more than two robot arms 1002, 1003, the additional robot arms likewise being connected to control device 1004 and being telemanipulatable by means of operating console 1005. A medical instrument or surgical tool (including an end effector 1100) may also be attached to the additional robot arm. Medical work station 1000 may include a database 1014, in particular coupled to with control device 1004, in which are stored, for example, pre-operative data from patient/living being 1013 and/or anatomical atlases.
From the foregoing and with reference to the various figure drawings, those skilled in the art will appreciate that certain modifications can also be made to the disclosure without departing from the scope of the same. While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

## Claims

1. An intra-cavity clip loading device, comprising:
a cannula including a cannula body defining an instrument lumen extending along a longitudinal axis of the cannula body, wherein the cannula includes an inner wall and an outer wall, the inner wall defining the instrument lumen; and
a clip stack defined in the cannula body, the clip stack including:
a plurality of ligation clips axially arranged about the instrument lumen, wherein each ligation clip of the plurality of ligation clips includes a first arm and a second arm defining a central region between the first arm and the second arm, and wherein the instrument lumen extends through the central region defined by the first arm and the second arm of each ligation clip of the plurality of ligation clips, wherein the first arm and the second arm of each of the plurality of ligation clips are positioned between the inner wall and the outer wall of the cannula; and
a plurality of clip retention features formed in the cannula body, each clip retention feature of the plurality of clip retention features holding a ligation clip of the plurality of ligation clips,

wherein the inner wall of the cannula separates the plurality of ligation clips from the instrument lumen to maintain a fluid integrity of the instrument lumen.

2. The device of claim 1, wherein the first arm of each ligation clip of the plurality of ligation clips includes a first boss, wherein the second arm of each ligation clip of the plurality of ligation clips includes a second boss, and wherein the first boss and the second boss are each coupled to a clip retention feature of the plurality of clip retention features.

3. An intra-cavity clip loading device, comprising:
a cannula including a cannula body defining an instrument lumen extending along a longitudinal axis of the cannula body; and
a clip stack defined in the cannula body, the clip stack including:
a plurality of ligation clips axially arranged about the instrument lumen; and
a plurality of clip retention features formed in the cannula body, each clip retention feature of the plurality of clip retention features holding a ligation clip of the plurality of ligation clips, wherein:

the cannula body includes a plurality of slots,
each slot of the plurality of slots is associated with a clip retention feature of the plurality of clip retention features, and
each ligation clip of the plurality of ligation clips is accessible by a clip applier through a respective slot of the plurality of slots formed in the cannula body.

4. The device of claim 3, wherein the slots of the plurality of slots are covered by a sheath positioned about the cannula body.

5. The device of claim 3, wherein the plurality of slots are located proximate a distal end portion of the cannula body.

6. An intra-cavity clip loading device, comprising:
a cannula including a cannula body defining an instrument lumen extending along a longitudinal axis of the cannula body, wherein the cannula includes a mate cap and an instrument seal formed in the mate cap to maintain a predetermined pressure in the instrument lumen; and
a clip stack defined in the cannula body, the clip stack including:
a plurality of ligation clips axially arranged about the instrument lumen; and
a plurality of clip retention features formed in the cannula body, each clip retention feature of the plurality of clip retention features holding a ligation clip of the plurality of ligation clips.

7. The device of claim 6, further including a distal seal configured to provide a barrier between an internal body cavity and the instrument lumen.

8. An intra-cavity clip loading device, comprising:
a cannula including a cannula body and an instrument lumen extending through a longitudinal axis of the cannula body;
a clip stack positioned at a distal end portion of the cannula body, the clip stack including a plurality of ligation clips loaded in the distal portion of the cannula body; and
a sheath positioned about the distal end portion of the cannula body, the sheath defining a plurality of slots, each of the plurality of slots configured to provide access to a ligation clip of the plurality of ligation clips,
wherein the plurality of ligation clips are axially arranged about the instrument lumen.

9. The device of claim 8, wherein each ligation clip of the plurality of ligation clips includes a first arm and a second arm defining a central region between the first arm and the second arm, and wherein the instrument lumen extends through the central region defined by the first arm and the second arm of each ligation clip of the plurality of ligation clips.

10. The device of claim 9, wherein the cannula includes an inner wall and an outer wall, the inner wall defining the instrument lumen, and wherein the first and second arms of each of the plurality of ligation clips are positioned between the inner wall and the outer wall of the cannula.

11. The device of claim 10, wherein the inner wall of the cannula separates the plurality of ligation clips from the instrument lumen to maintain a fluid integrity of the instrument lumen.