Ligation clip including a flexible insertion assembly
By introducing flexible insertion components and materials with different stiffnesses into the ligation clip, the deformation problem of polymer clamps during compression storage was solved, improving the performance and stability of the clamps and reducing plastic deformation.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- COVIDIEN LP
- Filing Date
- 2021-03-16
- Publication Date
- 2026-07-10
AI Technical Summary
When existing polymer ligation clips are stored in a compressed or partially compressed state, the strain and creep of the material affect the condition and performance of the clips, especially in the area of the moving hinge, leading to adverse performance.
A ligation clamp comprising a first arm, a second arm, and a hinge section is designed. The hinge section has a flexible insertion component to reduce deformation at stress points. The components are formed using materials with different stiffnesses to improve the clamp's switching performance.
It effectively reduces plastic deformation of the clamp during the transformation process, improves the performance stability and reliability of the clamp, and reduces the effects of material strain and creep.
Smart Images
Figure CN117015350B_ABST
Abstract
Description
Technical Field
[0001] This disclosure relates generally to surgical devices, and more specifically to surgical ligation clips including flexible insertion components to reduce deformation within the surgical ligation clip. Background Technology
[0002] Polymer ligation clips typically comprise a first beam and a second beam, which are joined at one end by a pivotable connector (e.g., a movable hinge) such that the first and second beams can move relative to each other between an open configuration and a clamped configuration. The ligation clip can be applied to tissue via an endoscope through a small-diameter incision or by a small-diameter cannula positioned through that incision, minimizing trauma to the patient during surgery.
[0003] Typically, when polymer clamps are applied to tissue through a cannula and / or stored within an endoscopic clamp applicator, the clamps are supported in a compressed or partially compressed state to minimize the overall size of the clamp and facilitate delivery through the cannula or incision. Storing polymer clamps in a compressed or partially compressed state can affect the clamp's condition, which may affect its performance. More specifically, storing polymer clamps in a compressed or partially compressed state can lead to strain and / or creep of the polymer clamp material, particularly in the area of the moving hinge, which may adversely affect the condition and / or performance of the polymer clamp. Summary of the Invention
[0004] According to this disclosure, the ligation clip includes a first arm and a second arm, and a hinge portion interconnecting the first and second arms. The first arm includes a first clamping surface and a first latching structure. The second arm includes a second clamping surface and a second latching structure. The hinge portion defines an aperture and includes a body portion and a flexible insertion assembly having a first insert, a second insert, and a third insert. The first and second arms are switchable between an open configuration and a clamping configuration, in which the first and second arms are spaced apart, and in the clamping configuration, the first and second latching structures of the first and second arms engage with each other to clamp tissue between the first and second clamping surfaces. The first and second arms have a first stiffness. The body portion of the hinge portion has a second stiffness less than the first stiffness. One of the first, second, or third inserts of the flexible insertion assembly of the hinge portion has a third stiffness less than the second stiffness.
[0005] On one hand, when the first arm and the second arm are in the open configuration, the hole in the hinge portion can have a crescent shape.
[0006] On the other hand, the second and third flexible inserts of the flexible insert assembly may be disposed adjacent to the respective ends of the holes in the hinge portion.
[0007] On another front, the first insert of the flexible insert assembly can partially define the hole in the hinge portion.
[0008] In another aspect, the first insert may include an anchoring portion configured to inhibit movement of the first insert relative to the body portion of the hinge portion.
[0009] On the one hand, the anchoring part can have an arrow shape.
[0010] On the other hand, the first latching structure or the second latching structure can be a hook.
[0011] On the other hand, the stiffness of the first insert may differ from that of the second or third insert.
[0012] On the other hand, the stiffness of the second and third inserts of the flexible insert assembly can be different.
[0013] In another respect, the first insert, the second insert, or the third insert may be formed of a polymer.
[0014] On the one hand, ligation clips can be formed from absorbable polymers.
[0015] On the other hand, at least one of the second or third inserts may have a semi-circular shape.
[0016] In another aspect, the first or second clamping surface may include teeth to clamp tissue.
[0017] According to another aspect of this disclosure, the ligation clip includes a first arm and a second arm, and a hinge portion interconnecting the first arm and the second arm. The first arm and the second arm each include a first clamping surface and a second clamping surface. The first arm is movable relative to the second arm to move the ligation clip from an open configuration to a clamping configuration, in which the first clamping surface and the second clamping surface are spaced apart, and in the clamping configuration, at least portions of the first arm and the second arm engage with each other to clamp tissue between the first clamping surface and the second clamping surface. The hinge portion includes a body portion and flexible inserts embedded in the body portion. The flexible inserts have a stiffness less than that of the body portion. The flexible inserts are circumferentially arranged around the hinge portion and spaced apart from each other.
[0018] On one hand, the first arm and the second arm may include corresponding latching portions that engage with each other when the ligation clip is in the clamping configuration to keep the first arm and the second arm in the clamping configuration.
[0019] On the other hand, the flexible insert may include a pair of semi-circular inserts.
[0020] On the other hand, the hinge portion can define the hole.
[0021] On the other hand, when the ligation clip is in the open configuration, the hole in the hinge portion can have a crescent shape.
[0022] In another aspect, the flexible insert may include a center insert positioned adjacent to the hole.
[0023] In another aspect, the center insert may include an anchoring portion configured to inhibit movement of the center insert relative to the body portion of the hinge portion. Attached Figure Description
[0024] The following description, with reference to the accompanying drawings, illustrates various aspects of the ligation clip, in which:
[0025] Figure 1 A perspective view of the ligation clip according to this disclosure;
[0026] Figure 2 It is shown as a dashed line. Figure 1 Perspective view of the flexible insertion component of the ligation clip;
[0027] Figure 3 yes Figure 2 A magnified view of the indicated detail area;
[0028] Figure 4 yes Figure 1 The ligation clip along Figure 1 The cross-sectional view taken by section line 4-4; and
[0029] Figure 5 yes Figure 4 A cross-sectional view of the ligation clip, showing the clamping configuration. Detailed Implementation
[0030] The disclosed ligation clip will now be described in detail with reference to the accompanying drawings, wherein in each of the several views, the same reference numerals denote the same or corresponding elements. However, it should be understood that the disclosed aspects of the ligation clip are merely illustrative of this disclosure and may be embodied in various forms. Well-known functions or constructions have not been described in detail so as not to obscure this disclosure with unnecessary detail. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but merely form the basis of the claims and serve as a representative basis for teaching those skilled in the art to apply this disclosure differently with virtually any suitable specific construction. Furthermore, directional terms such as upper, lower, top, bottom, and similar terms are used to aid understanding of the description and are not intended to limit this disclosure.
[0031] In this description, the term "endoscope" is generally used to refer to endoscopy, laparoscopy, arthroscopy, and / or any other procedures performed through small-diameter incisions or cannulas. Furthermore, the term "clinician" is generally used to refer to healthcare professionals, including physicians, nurses, and support staff. Finally, the term "substantially" is generally used to refer to 90% to 110% of the reference parameters.
[0032] According to this disclosure, surgical ligation clips are used in... Figures 1 to 5 The ligation clip 10 is shown as a whole in the image. The ligation clip 10 can be delivered to a surgical site for application to tissue, such as a blood vessel. The ligation clip 10 includes a first arm 100 and a second arm 200, and a hinge portion 300 interconnecting the first arm 100 and the second arm 200. The first arm 100 and the second arm 200 can move to a clamping configuration during application of the ligation clip 10 to body tissue. Figure 5 The ligation clip also includes a flexible insertion component 400. Specifically, the flexible insertion component 400 is positioned, for example, at stress points along the hinge portion 300 (the stress points can be obtained through finite element analysis), as will be described below. The flexible insertion component 400 reduces deformation of the ligation clip 10, for example, during tissue clamping and storage.
[0033] Figure 1 It shows the open configuration ( Figure 1 The ligation clip 10, in its open configuration, has a first arm 100 and a second arm 200 spaced apart to define a gap "G" for receiving tissue (e.g., a body vascular "BV"). The ligation clip 10 can be formed as a single, integral configuration with a V-shaped shape. The first distal portion 102 and the second distal portion 202 have latching portions 103, 203 that are movable to engage with each other to hold the ligation clip 10 in a clamped configuration. Figure 5 The first distal portion 102 defines a recess 104, and the second distal portion 202 has a hook portion 204 configured to be received in the recess 104 to secure the first arm 100 and the second arm 200 together so as to clamp tissue between the first arm 100 and the second arm 200.
[0034] Additionally, the first arm 100 includes an inner clamping surface 120 having a plurality of teeth 122. The second arm 200 includes an inner clamping surface 220 defining a plurality of grooves 222 to receive the plurality of teeth 122 of the first arm 100. In this configuration, slippage of the target tissue can be reduced. In some aspects of this disclosure, the first distal portion 102 and the second distal portion 202 may include a post 405 having a generally circular shape. The post 405 may be received within a recess in the jaws of the applicator to keep the ligation clip 10 within the applicator before applying it to the tissue.
[0035] Figure 1A hinge portion 300 receiving the first arm 100 and the second arm 200 is also shown. The hinge portion 300 defines a hole 302 having, for example, a crescent shape or a semi-circular shape, to improve the deflection of the hinge portion 300 during clamping of the tissue. Specifically, the shape of the hole 302 may correspond to the curvature of the hinge portion 300. The hole 302 may also be defined centered relative to the hinge portion 300.
[0036] Figure 2 and Figure 3A hinge portion 300 comprising a main body portion 350 and a flexible insertion assembly 400 is shown. The flexible insertion assembly 400 includes a first insert 402, a second insert 404, and a third insert 406 disposed at stress points on the main body portion 350 that occur during clamping of the ligation clip 10. These stress points along the main body portion 350 can be obtained through finite element analysis. The first insert 402, the second insert 404, and the third insert 406 can be embedded in the main body portion 350, for example, by injection molding. Specifically, the first insert 402 communicates with a hole 302 and extends at least partially around the outer periphery of the hole 302. The first insert 402 includes opposing wings 407a, 407b extending laterally from the hole 302 and an inner wall 409 defining a portion of the hole 302. Opposite wings 407a, 407b include corresponding anchoring portions 403 that inhibit relative movement between the first insert 402 and the body portion 350 of the hinge portion 300. Second inserts 404 and third inserts 406 are spaced apart on opposite sides of the adjacent hole 302 and define a portion of the outer surface of the ligation clip 10. The second insert 404 and third insert 406 may be mirror images of each other. Specifically, the second insert 404 and third insert 406 may have, for example, a semi-circular shape. The first arm 100 and the second arm 200 may be formed of a first material having a first stiffness or flexibility. The body portion 350 of the hinge portion 300 may be formed of a second material having a second stiffness or flexibility different from the first stiffness or flexibility. The flexible insert assembly 400 may be formed of a third material having a third stiffness or flexibility different from the first stiffness or flexibility and / or the second stiffness or flexibility. For example, the flexible insert assembly 400 may be formed of a material that is more flexible than the body portion 350 of the hinge assembly 300. The main body 350 may be more flexible than the first arm 100 and the second arm 200. Additionally, the first insert 402 may be more flexible than the second insert 404 and the third insert 406, or vice versa. The second insert 404 and the third insert 406 may be formed of the same material having the same flexibility. However, it is contemplated that the second insert 404 and the third insert 406 may be formed of different materials with different flexibility. In this configuration, when the first arm 100 and the second arm 200 are transformed into a clamping configuration, the flexible insert assembly 400 facilitates the deflection of the hinge portion 300 and reduces or eliminates, for example, plastic deformation of the ligation clip 10 at stress points occupied by the first insert 402, the second insert 404, and the third insert 406.
[0037] The aforementioned ligation clip 10 is formed of an elastic material that allows it to switch between an open configuration and a clamping configuration. In the open configuration, the first distal portion 102 and the second distal portion 202 of the ligation clip 10 define a mouth or opening. In the clamping configuration, the second distal portion 202 of the second arm 200 is releasably secured to the first distal portion 102 of the first arm 100 to clamp tissue between the first arm 100 and the second arm 200. In the clamping configuration, the inner clamping surfaces 120 and 220 of the first arm 100 and the second arm 200 are aligned side-by-side.
[0038] In some aspects of this disclosure, the ligation clip 10 is formed of a polymeric material such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyoxymethylene (POM), or other thermoplastic materials with similar properties, which can be injection molded, extruded, or otherwise processed. It is also contemplated that portions of the ligation clip 10 may be formed of other materials, including metals. Each of the first arm 100 and the second arm 200 of the ligation clip 10 may be at least partially formed of an elastic, bioabsorbable, and / or biocompatible polymeric material. Examples of suitable bioabsorbable and / or biocompatible polymeric materials include polyoxymethylene acetal (POM), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyoxymethylene, polyetheretherketone (PEEK), polypropylene, and polyethylene, or other injection-moldable thermoplastic materials with similar properties. The ligation clip 10 may also be at least partially made of a polymeric material or a material combined with a radiation-permeable metal alloy. Alternatively, other materials can be used to form ligation clips 10 that include biocompatible metals, plastics, and composite materials.
[0039] The ligation clip 10 can be used, for example, in anastomosis procedures. Anastomosis is the artificial connection of two vascular segments performed by a surgeon and is required when a diseased portion of a vascular segment (e.g., an artery, vein, or intestine) is removed from the vascular segment and the remaining vascular segment is rejoined. In use, it is envisioned that the first arm 100 and the second arm 200 will be delivered to the surgical site by an applicator (not shown), wherein the first arm 100 and the second arm 200 of the ligation clip 10 are supported in the applicator in a spaced-apart relationship. It is also envisioned that the first arm 100 and the second arm 200 will be aligned by the applicator (not shown) and aligned within the applicator before application to the tissue. As described above, one or both of the posts 405 may be received in a groove or slot in the applicator to support and / or guide the ligation clip 10 within and along the applicator.
[0040] Initially, the ligation clip 10 can be in the open configuration. Figure 4This is to accommodate the blood vessel "BV" between the first arm 100 and the second arm 200. The latching portions 103 and 203 of the first arm 100 and the second arm 200 can engage with each other; that is, the hook portion 204 of the second arm 200 can be received in the recess 104 of the first arm 100. (BV) Figure 5 The ligation clip 10 is compressed between the inner clamping surfaces 120 and 220 of the first arm 100 and the second arm 200 to ligate the body's blood vessels (BV). At this time, the first insert 402, the second insert 4004, and the third insert 406 flex to facilitate clamping of the ligation clip 10 without causing, for example, plastic deformation of the ligation clip 10. Specifically, when the first insert 402 flexes, the wings 407a and 407b are substantially overlapping each other, and the hole 302 conforms to the flexion of the hinge portion 300. This configuration facilitates the flexion of the ligation clip 10 to enhance the transition between the open and clamping configurations without causing, for example, plastic deformation of the ligation clip 10.
[0041] Those skilled in the art will understand that the apparatuses and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary aspects of this disclosure. It is contemplated that elements and features shown or described in conjunction with one exemplary aspect of this disclosure may be combined with elements and features of another aspect without departing from the scope of this disclosure. Similarly, those skilled in the art will understand further features and advantages of this disclosure based on the foregoing aspects. Therefore, this disclosure is not limited to what has been specifically shown and described, unless indicated by the appended claims.
Claims
1. A ligation clip, comprising: A first arm, the first arm including a first clamping surface and a first latching structure; The second arm includes a second clamping surface and a second latching structure; and A hinge portion interconnecting a first arm and a second arm, defining an aperture and including a body portion and a flexible insertion assembly having a first insert, a second insert, and a third insert, wherein the first arm and the second arm are convertible between an open configuration and a clamping configuration, wherein in the open configuration the first arm and the second arm are spaced apart, and in the clamping configuration the first latching structure of the first arm and the second latching structure of the second arm engage with each other to clamp tissue between a first clamping surface and a second clamping surface, wherein the first arm and the second arm have a first stiffness, the body portion of the hinge portion has a second stiffness less than the first stiffness, and one of the first insert, the second insert, or the third insert of the flexible insertion assembly of the hinge portion has a third stiffness less than the second stiffness.
2. The ligation clip according to claim 1, wherein when the first arm and the second arm are in the open configuration, the hole in the hinge portion has a crescent shape.
3. The ligation clip of claim 1, wherein the second insert and the third insert of the flexible insertion assembly are disposed at corresponding ends of the hole adjacent to the hinge portion.
4. The ligation clip of claim 1, wherein the first insert of the flexible insertion assembly partially defines the hole of the hinge portion.
5. The ligation clip of claim 1, wherein the first insert includes an anchoring portion configured to inhibit movement of the first insert relative to the body portion of the hinge portion.
6. The ligation clip according to claim 5, wherein the anchoring portion has an arrow shape.
7. The ligation clip according to claim 1, wherein the first latching structure or the second latching structure is a hook.
8. The ligation clip according to claim 1, wherein the stiffness of the first insert is different from the stiffness of the second insert or the third insert.
9. The ligation clip according to claim 1, wherein the second insert and the third insert of the flexible insertion assembly have different stiffnesses.
10. The ligation clip of claim 1, wherein the first insert, the second insert, or the third insert is formed of a polymer.
11. The ligation clip of claim 1, wherein the ligation clip is formed of an absorbable polymer.
12. The ligation clip of claim 1, wherein at least one of the second insert or the third insert has a semi-circular shape.
13. The ligation clip of claim 1, wherein the first clamping surface or the second clamping surface includes teeth to clamp tissue.
14. A ligation clip, comprising: A first arm and a second arm, the first arm and the second arm respectively including a first clamping surface and a second clamping surface, the first arm being movable relative to the second arm to move the ligation clip from an open configuration to a clamping configuration, in the open configuration the first clamping surface and the second clamping surface are spaced apart, in the clamping configuration at least a portion of the first arm and the second arm engages with each other to clamp tissue between the first clamping surface and the second clamping surface; and The hinge portion interconnects the first arm and the second arm. The hinge portion includes a main body portion and flexible inserts embedded in the main body portion. The flexible inserts have a stiffness less than that of the main body portion. The flexible inserts are arranged circumferentially around the hinge portion and spaced apart from each other.
15. The ligation clip of claim 14, wherein the first arm and the second arm include corresponding latch portions that engage with each other to retain the first arm and the second arm in the clamping configuration when the ligation clip is in the clamping configuration.
16. The ligation clip of claim 14, wherein the flexible insert comprises a pair of semi-circular inserts.
17. The ligation clip of claim 14, wherein the hinge portion defines a hole.
18. The ligation clip of claim 17, wherein when the ligation clip is in the open configuration, the hole in the hinge portion has a crescent shape.
19. The ligation clip of claim 17, wherein the flexible insert comprises a central insert disposed adjacent to the hole.
20. The ligation clip of claim 19, wherein the central insert includes an anchoring portion configured to inhibit movement of the central insert relative to the body portion of the hinge portion.