System for endoscopic submucosal dissection

Abstract

A surgical system for performing endoscopic submucosal dissection includes first and second surgical clips, each having first and second jaw members for grasping tissue therebetween. The first surgical clip includes a resilient member attached to one of the jaw members, the resilient member configured to flex outwardly to engage tissue. Each of the jaw members of the first surgical clip has a pointed tip, and each of the jaw members of the second surgical clip has a blunt distal tip.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 031,620, filed May 29, 2020, the entire disclosure of which is incorporated herein by reference.

[0002] FIELD OF THEINVENTION The present technology generally relates to surgical tissue clips used in endoscopic submucosal dissection. [Background technology]

[0003] Endoscopic removal has been accepted as the first choice for the treatment of early stage gastrointestinal (GI) cancer due to its minimal invasiveness and lower cost. Endoscopic submucosal dissection (ESD) allows for en bloc removal and accurate histopathological diagnosis regardless of the size, the presence of severe fibrosis in the submucosa, and the location of the lesion. One of the advantages of ESD is the lower recurrence rate compared to endoscopic mucosal resection (EMR). During some ESD procedures, the jaw members of a hemostatic clip are engaged with the tissue. After performing the removal, the jaw members are separated from the tissue. Summary of the Invention [Means for solving the problem]

[0004] In one aspect, the present disclosure provides a surgical system for performing endoscopic submucosal dissection. The surgical system includes first and second surgical clips, each having a first and second jaw member, each configured to move between an open configuration and a closed configuration to grasp tissue therebetween. The first and / or second jaw members of the first surgical clip have a pointed distal tip. The first surgical clip has a resilient member attached to one of the first or second jaw members. The resilient member is configured to transition between a stored state and a deployed state in which the resilient member bends outward. Each of the first and second jaw members of the second surgical clip has a blunt distal tip.

[0005] In some variations, the distal tip of each of the first and second jaw members of the second surgical clip can have a flat distal-most edge.

[0006] In some variations, the distal tip of each of the first and second jaw members of the second surgical clip can have an arcuate distal-most edge.

[0007] In some variations, each of the first and second jaw members of the second surgical clip can include a proximal end and a distal end having a distal tip.

[0008] In some variations, the distal tips of each of the first and second jaw members of the second surgical clip may be curved inwardly toward one another.

[0009] In some variations, the proximal end of each of the first and second jaw members of the second surgical clip may have a chamfered proximal end.

[0010] In some aspects, the second surgical clip can include a proximal body portion and the first and second jaw members of the second surgical clip can be coupled to the proximal body portion. A gap can be defined between a distal edge of the proximal body portion and a chamfered proximal end of each of the first and second jaw members of the second surgical clip.

[0011] In some aspects, the first jaw member of the first surgical clip can have a proximal end defining a pair of holes. The resilient member can be attached to the first jaw member of the first surgical clip via the pair of holes.

[0012] In some aspects, each of the pair of holes can have a diameter greater than a diameter of the elastic member.

[0013] In some aspects, the elastic member can be a monolithically formed wire having first and second ends crimped together.

[0014] In some aspects, the wire may be made from a shape memory material.

[0015] In some variations, the first and second surgical clips can each include a proximal body portion to which the respective first and second jaw members are movably coupled. The present invention provides, for example, the following: (Item 1) 1. A surgical system for performing endoscopic submucosal dissection, comprising: A first surgical clip, first and second jaw members configured to move between open and closed configurations to grasp tissue therebetween; a resilient member attached to one of the first jaw member or the second jaw member and configured to transition between a stored state and a deployed state, the resilient member bending outward in the deployed state; a first surgical clip, a second surgical clip including a first jaw member and a second jaw member configured to move between an open configuration and a closed configuration to grasp tissue therebetween; Equipped with A surgical system, wherein the first jaw member and the second jaw member of the second surgical clip each have a blunt distal tip. (Item 2) 2. The surgical system of claim 1, wherein the distal tip of each of the first jaw member and the second jaw member of the second surgical clip has a planar distal-most edge. (Item 3) 2. The surgical system of claim 1, wherein the distal tip of each of the first jaw member and the second jaw member of the second surgical clip has an arcuate distal most edge. (Item 4) each of the first jaw member and the second jaw member of the second surgical clip A proximal end portion; a distal end portion having the distal tip; 2. The surgical system of item 1, comprising: (Item 5) Item 5. The surgical system of item 4, wherein the distal tip of each of the first and second jaw members of the second surgical clip curve inwardly toward one another. (Item 6) 5. The surgical system of claim 4, wherein the proximal end of each of the first jaw member and the second jaw member of the second surgical clip has a beveled proximal end. (Item 7) 7. The surgical system of claim 6, wherein the second surgical clip comprises: a proximal body portion to which the first jaw member and the second jaw member of the second surgical clip are coupled; and a gap defined between a distal edge of the proximal body portion and the beveled proximal end of each of the first jaw member and the second jaw member of the second surgical clip. (Item 8) 2. The surgical system of claim 1, wherein the first jaw member of the first surgical clip has a proximal end defining a pair of holes, and the elastic member is attached to the first jaw member of the first surgical clip via the pair of holes. (Item 9) 9. The surgical system according to claim 8, wherein each of the pair of holes has a diameter greater than a diameter of the elastic member. (Item 10) 9. The surgical system of claim 8, wherein the elastic member is a monolithically formed wire having a first end and a second end crimped together. (Item 11) 11. The surgical system of claim 10, wherein the wire is fabricated from a shape memory material. (Item 12) 2. The surgical system of claim 1, wherein the first surgical clip includes a proximal body portion to which the first jaw member and the second jaw member of the first surgical clip are movably coupled, and the second surgical clip includes a proximal body portion to which the first jaw member and the second jaw member of the second surgical clip are movably coupled. (Item 13) 2. The surgical system of claim 1, wherein at least one of the first jaw member or the second jaw member of the first surgical clip has a pointed distal tip. [Brief description of the drawings]

[0016] Objects and features of the presently disclosed surgical system will become apparent to those skilled in the art upon reading the description of the various embodiments in conjunction with the accompanying drawings. [Figure 1] FIG. 1 is a side view illustrating a surgical system including a first handheld surgical instrument having a first surgical clip and a second handheld surgical instrument having a second surgical clip. [Figure 2A] 2 is a side perspective view of the first surgical clip of FIG. 1 with its resilient member in a deployed state; [Figure 2B] 2 is a side perspective view of the first surgical clip of FIG. 1 with the alternative type of elastic member in a deployed state; FIG. [Figure 3A] 2B is a top view of the first surgical clip of FIG. 2A shown without the elastic member. [Figure 3B] 3B is a side view of the first surgical clip of FIG. 3A showing the jaw members in an open position; [Figure 3C]3B is a side view of the first surgical clip of FIG. 3A showing the jaw members in a closed position; [Figure 4] 2 is a top view of the second surgical clip of FIG. 1. FIG. [Diagram 5] 5 is a front view of a pair of jaw members of the second surgical clip of FIG. 4; FIG. [Figure 6] 13 is a top perspective view of another embodiment of the jaw members of the second surgical clip; FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] The present disclosure generally relates to a surgical system including first and second separate surgical clips for use in performing an endoscopic submucosal dissection. The first surgical clip has an elongate body, a pair of jaw members received within and deployable therefrom, and an elastic wire coupled to one of the jaw members. The elastic wire is configured to assume a predefined curved shape when the first surgical clip is deployed at a surgical site. The second surgical clip, unlike the first surgical clip, does not have an elastic wire and has a blunt distal tip designed to non-traumatically grasp and hold tissue. In some aspects, each of the first and second surgical clips may have a blunt distal tip.

[0018] In use, the target tissue (e.g., lesion) is grasped between the jaw members of a first surgical clip, with the elastic wire (in a deployed state) facing upward (e.g., away from the target tissue) at the target location. The jaw members of a second surgical clip may be used to grasp the end of the elastic wire, and the second surgical clip is moved away from the first surgical clip to straighten the elastic wire. The jaw members are closed around the second target tissue (e.g., healthy tissue) while simultaneously grasping the elastic wire. With the elastic wire holding the lesion away from the stomach wall, the lesion may be severed. It is contemplated that the surgical system of the present disclosure may be used to perform procedures on any suitable type of tissue (e.g., esophageal tissue, colorectal tissue, etc.). These and other aspects of the present disclosure are described in more detail below.

[0019] 1 illustrates a surgical system 1 including a first handheld surgical instrument 10 and a second handheld surgical instrument 50. The first handheld surgical instrument 10 may be, for example, a primary tissue grasping catheter for deploying a first surgical clip 100 (FIG. 2A), and the second handheld surgical instrument 50 may be, for example, a secondary tissue grasping catheter for deploying a second surgical clip 200. The first surgical clip 100 is configured to grasp tissue, and the second surgical clip 200 is used to simultaneously grasp tissue and a resilient member 108 of the first surgical clip 100, as will be described below.

[0020] Each of the surgical instruments 10, 50 generally includes a handle assembly or actuator 11, 51 and a shaft 12, 52 extending distally from the handle assembly 11, 51. A first surgical clip 100 is removably coupled to a distal end 14 of the shaft 12 of the first surgical instrument 100, and a second surgical clip 200 is removably coupled to a distal end 54 of the shaft 52 of the second surgical instrument 50. In some aspects, instead of the clips 100, 200 being deployable from a handheld instrument, the clips 100, 200 may be deployed from a surgical robotic arm.

[0021] Each of the surgical instruments 10, 50 includes an actuation mechanism, such as, for example, a retractor (not shown) axially movable within the shaft 12, 52. The retractor may have a proximal end operably coupled to a trigger 15, 55 of the handle assembly 11, 51 such that actuation of the trigger 15, 55 causes the retractor to translate in a proximal direction. The retractor may have a distal end detachably coupled to the surgical clip 100, 200 such that proximal translation of the retractor causes the surgical clip 100, 200 to move from an open configuration to a closed configuration and ultimately disengage the surgical clip 100, 200 from the remainder of the surgical instrument 10, 50. It is envisioned that the surgical instruments 10, 50 may include any suitable actuation mechanism for deploying the surgical clip 100, 200, such as, for example, a drive rod or drive tube.

[0022] 2A, first surgical clip 100 has a proximal body portion 102 (e.g., a tubular body), a first jaw member 104 and a second jaw member 106 received in proximal body portion 102, and a resilient member 108 coupled to proximal body portion 102. Resilient member 108 of first surgical clip 100 may be fabricated from a shape memory material, such as, for example, copper-aluminum-nickel or nickel-titanium. In some aspects, resilient member 108 may be fabricated from any suitable material configured to maintain a predetermined shape. The resilient member 108 may be fabricated from a monolithic wire of shape memory material (e.g., nickel-titanium) having first and second free ends 116a, 116b that are passed through a pair of holes 118a, 118b, respectively, in the first jaw member 104 and pulled proximally until the resilient member 108 snaps into engagement with the first jaw member 104. The holes 118a, 118b in the first jaw member 104 have a diameter larger than that of the free ends 116a, 116b to accommodate the resilient member 108 therein without changing the shape of the resilient member 108. The free ends 116a, 116b of the resilient member 108 are crimped or otherwise joined together with a metal tube 120, which may have an adhesive filler added. Instead of fabricating the elastic member 108 from a folded wire, the elastic member 108 may be a thin elongated sheet of elastic material. Other means for connecting the elastic member 108 to the jaw member 104 (e.g., adhesive, tabs, etc.) are also contemplated.

[0023] It is contemplated that the diameter of the elastic member 108 is large enough to provide sufficient upward lift (e.g., about 0.005 inches to about 0.01 inches, in some embodiments, about 0.008 inches), but small enough so as not to pull the muscle layer too tightly into the cutting plane. The radius of curvature of the elastic member 108 is large enough (e.g., about 7 mm) so that the user can grasp the inside of the loop of the elastic member 108 with the second surgical clip 200 to fully deploy the first surgical clip 100, and small enough to provide adequate traction. In some embodiments, the elastic member 108 has a width large enough (e.g., about 9 mm and about 10 mm) so that the elastic member 108 lies flat against the tissue and does not need to be moved. Other configurations for the elastic member 108 are also contemplated.

[0024] Figure 2B illustrates another embodiment of elastic member 122, similar to elastic member 108 of Figure 2A. Elastic member 122, unlike elastic member 108, is longer than elastic member 108 (e.g., approximately 3.5 cm in length compared to approximately 2 cm in length for elastic member 108) and is therefore used to operate on larger lesions as compared to elastic member 108.

[0025] 3A-3C, a proximal body portion 102 of a first surgical clip 100 is configured to be removably coupled to a distal end 14 (FIGS. 2A and 2B) of a shaft 12. In some aspects, the shaft 12 can have a release latch (not shown) coupled to the proximal body portion 102 and an actuation mechanism (e.g., a pull rod, not shown) for actuating the release latch to deploy the surgical clip 100 from the shaft 12.

[0026] First and second jaw members 104, 106 are each coupled to the proximal body portion 102. First and second jaw members 104, 106 each have a proximal end 104a, 106a slidably received within the hollow interior of the proximal body portion 102 and a distal end 104b, 106b disposed distally of the proximal body portion 102. The proximal end 104a of the first jaw member 104 defines a pair of holes 118a, 118b therethrough that are dimensioned to receive a resilient member 108.

[0027] Each corresponding distal end 104b, 106b of the jaw members 104, 106 has a sharpened distal tip 104c, 106c to assist in grasping tissue between the jaw members 104, 106. The sharpened distal tip 104c, 106c may be configured to pierce tissue when the jaw members 104, 106 are in a closed position about the tissue. The jaw members 104, 106 may be resiliently biased toward an open configuration by a biasing member (not shown). Alternatively, the jaw members 104, 106 may not have a resilient bias. The jaw members 104, 106 are axially movable relative to the proximal body portion 102 from a proximal position in which the distal ends 104b, 106b of the jaw members 104, 106 are close to each other and a distal position in which the distal ends 104b, 106b of the jaw members 104, 106 are spaced apart from each other.

[0028] 4 and 5, the second surgical clip 200 of the surgical system 10 includes a proximal body portion 202 removably coupled to the flexible shaft 52 (FIG. 1) of the second surgical instrument 50 (FIG. 1) and a pair of jaw members 204, 206 coupled to the proximal body portion 202. The second surgical clip 200 differs from the first surgical clip 100 in that it does not include the elastic member 108 and is configured to atraumatically grasp tissue. Each of the first and second jaw members 204, 206 of the second surgical clip 200 may also be longer than the jaw members 104, 106 of the first surgical clip 200 and includes a proximal end 204a and a distal end 204b having distal tips 204c, 206c. Proximal end 204a of each of first and second jaw members 204, 206 of second surgical clip 200 has a chamfered proximal end 210. A gap 212 is defined between distal edge 207 of proximal body portion 202 and chamfered proximal end 210 of each of first and second jaw members 204, 206 of second surgical clip 200. Chamfered proximal end 210 is configured to prevent and / or resist trapping a puller wire within gap 212 during use. In some aspects, proximal end 210 may define a groove therein instead of being chamfered.

[0029] Corresponding distal tips 204c, 206c of first and second jaw members 204, 206 of second surgical clip 200 are curved inwardly toward one another. Corresponding distal tips 204c, 206c of first and second jaw members 204, 206 of second surgical clip 200 have flat distal-most edges 214, 216 disposed between curved lateral ends 217a, 217b. Lateral ends 217a, 217b have a relatively large radius of curvature (e.g., about 0.05 mm to about 0.4 mm), thereby exhibiting a generally planar curvature. Curved lateral ends 217a, 217b may be formed by stamping or a secondary process such as deburring or grinding. The distal most edges 214, 216 are configured to prevent penetrating or otherwise damaging tissue when it is grasped between the distal tips 204c, 206c. It is contemplated that the clamping force between the distal tips 204c, 206c will not exceed about 1.9 pounds with a gap of about 1 mm between the distal tips 204c, 206c.

[0030] Unexpectedly, it has been found that by making the most distal edges 214, 216 of the distal tips 204c, 206c blunt (e.g., flat and / or curved, without any sharp points or abrupt protrusions that may damage tissue), the jaw members 204, 206 have the added advantage of not causing any damage to the healthy tissue being grasped while still being able to effectively grasp tissue therebetween. Conventional hemostatic clips have pointed or sharp tips that pierce or otherwise damage tissue. Typical hemostatic clips are not removed after the procedure. Rather, they are left on the tissue.

[0031] 6, the most distal edge 214, 216 of the distal tip 204c, 206c may be arcuate rather than planar and / or may have a continuous curvature therealong. For example, the distal tip 204c, 206c may be curved over the entire length thereof and may have a radius of curvature between about half the width of the distal tip 204c and about 0.05 mm.

[0032] In use, the first surgical instrument 10 having the first surgical clip 100 attached thereto is inserted into and passed through a working channel of an endoscope (not explicitly shown). In some aspects, the first surgical clip 100 may be received in an introducer that passes through the working channel of the endoscope. After passing through the endoscope, the first surgical clip 100 is directed to the target gastrointestinal tissue by manipulation of the endoscope and the first surgical instrument 10.

[0033] With the first surgical clip 100 coupled to the shaft 12 and the jaw members 104, 106 in an open configuration, the first surgical clip 100 is positioned adjacent tissue (e.g., a lesion). The tissue is positioned between the jaw members 104, 106, after which a retractor of the surgical instrument 10 retracts the jaw members 104, 106 proximally through the proximal body portion 102. The inner walls of the proximal body portion 102 act on the jaw members 104, 106 to move them into a closed configuration about the tissue. With the tissue grasped between the jaw members 104, 106, further retraction of the retractor disengages the jaw members 104, 106, separating the proximal body portion 102 of the first surgical clip 100 from the shaft 12 and leaving the first surgical clip 100 at the surgical site. Other mechanisms for separating the first surgical clip 100 from the shaft 12 are also envisioned.

[0034] Separating the first surgical clip 100 from the shaft 12 allows the elastic member 108 of the first surgical clip 100 to transition from a stored state, in which the elastic member 108 is constrained within the shaft 12, to a deployed state. In the stored state, the elastic member 108 assumes a generally straight shape, and in the deployed state, the elastic member 108 moves to its predefined arcuate shape such that the elastic member 108 deflects outwardly from the proximal body portion 102.

[0035] The second surgical instrument 50 with the second surgical clip 200 attached thereto may be introduced into the endoscope and advanced through the working channel until the distal end of the second surgical clip 200 is visible. The first jaw member 204 and the second jaw member 206 of the second surgical clip 200 are opened. The second surgical instrument 50 or the endoscope is then manipulated to grasp the elastic member 108 of the first surgical clip 100 with the jaw members 204, 206 of the second surgical clip 200. While holding the elastic member 108 of the first surgical clip 100 with the jaw members 204, 206 of the second surgical clip 200, the second surgical instrument 50 is moved away from the first surgical clip 200 until the elastic member 108 flattens (e.g., transitions to a retracted state) and presses against the tissue. By flattening the elastic member 108, the outward bias of the elastic member 108 lifts the first surgical clip 100 attached to the lesion, separating the lesion from the tissue wall. Separation of the lesion from the tissue wall aids during the lesion resection procedure. The jaw members 204, 206 of the second surgical clip 200 are closed around the second target tissue (e.g., healthy tissue), whereby the second surgical clip 200 simultaneously grasps the healthy tissue and the elastic member 108 of the first surgical clip 100. Once proper positioning is confirmed, the second surgical clip 200 is detached from the remainder of the second surgical instrument 50.

[0036] Upon completion of use of the system 1, the second surgical clip 200 may be separated from the tissue by pulling on the second surgical clip 200 with forceps or other available endoscopic tools. Because the distal tips 204c, 206c of the jaw members 204, 206 of the second surgical clip 200 are blunt, pulling on the second surgical clip 200 does not tear or otherwise damage the tissue. After separating the second surgical clip 200 from the tissue, the second surgical clip 200, the first surgical clip 100, and the excised tissue are removed together from the patient.

[0037] It is to be understood that the various aspects disclosed herein may be combined in different combinations than those specifically set forth in the description and accompanying drawings. It is also to be understood that, depending on the embodiment, certain acts or events of any process or method described herein may be performed in a different order, added, combined, or omitted entirely (e.g., not all described acts or events may be required to implement the techniques).

Claims

1. 1. A surgical system for performing endoscopic submucosal dissection, comprising: The surgical system includes a first surgical clip and a second surgical clip; The first surgical clip comprises: a first jaw member and a second jaw member configured to move between an open configuration and a closed configuration to grasp tissue between the first jaw member and the second jaw member; a resilient member attached to one of the first jaw member or the second jaw member, the resilient member configured to transition between a stored state and a deployed state, wherein in the deployed state, the resilient member bends outward; Including, the second surgical clip includes a first jaw member and a second jaw member, the first jaw member and the second jaw member of the second surgical clip configured to move between an open configuration and a closed configuration to grasp tissue between the first jaw member of the second surgical clip and the second jaw member of the second surgical clip; A surgical system wherein a distal tip of each of the first and second jaw members of the second surgical clip has a flat or arcuate distal most edge, and the distal tips are free of any sharp points or abrupt protrusions that may damage tissue.

2. The surgical system of claim 1 , wherein the distal tip of each of the first and second jaw members of the second surgical clip has a planar distal-most edge.

3. The surgical system of claim 1 , wherein the distal tip of each of the first and second jaw members of the second surgical clip has an arcuate distal most edge.

4. Each of the first and second jaw members of the second surgical clip comprises: A proximal end portion; a distal end portion having the distal tip; The surgical system of claim 1 .

5. The surgical system of claim 4 , wherein the distal tips of each of the first and second jaw members of the second surgical clip curve inwardly toward one another.

6. The surgical system of claim 4 , wherein the proximal ends of each of the first and second jaw members of the second surgical clip have chamfered proximal ends.

7. 7. The surgical system of claim 6, wherein the second surgical clip includes a proximal body portion, the first and second jaw members of the second surgical clip being coupled to the proximal body portion, a gap being defined between a distal edge of the proximal body portion and the beveled proximal ends of each of the first and second jaw members of the second surgical clip.

8. 2. The surgical system of claim 1, wherein the first jaw member of the first surgical clip has a proximal end defining a pair of holes, the resilient member being attached to the first jaw member of the first surgical clip via the pair of holes.

9. The surgical system of claim 8 , wherein each of the pair of holes has a diameter greater than a diameter of the elastic member.

10. The surgical system of claim 8 , wherein the resilient member is a monolithically formed wire having first and second ends crimped together.

11. The surgical system of claim 10 , wherein the wire is fabricated from a shape memory material.

12. 2. The surgical system of claim 1, wherein the first surgical clip includes a proximal body portion, the first jaw member and the second jaw member of the first surgical clip are movably coupled to the proximal body portion, and the second surgical clip includes a proximal body portion, the first jaw member and the second jaw member of the second surgical clip are movably coupled to the proximal body portion of the second surgical clip.

13. The surgical system of claim 1 , wherein at least one of the first or second jaw members of the first surgical clip has a pointed distal tip.

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