Degradable high polymer material closing clamp and manufacturing method, using method and application thereof

Abstract

The embodiment of the invention provides a degradable high polymer material closing clamp and a manufacturing method, using method and application thereof.The degradable high polymer material closing clamp comprises a first clamping arm, a second clamping arm and a connecting piece, the first clamping arm is provided with a first connecting end and a first closing end, and the second clamping arm is provided with a second connecting end and a second closing end; the first connecting end and the second connecting end are connected into a whole through a connecting piece and form a V-shaped structure, the first closed end is provided with a protruding column, a padlock groove is formed in the middle of the surface of the protruding column, the second closed end is provided with a padlock, and the padlock and the padlock groove are installed in a matched mode. The connecting piece comprises an outer side connecting band and an inner side connecting band, a gap exists between the outer side connecting band and the inner side connecting band, and the outer side connecting band is thicker than the inner side connecting band; the degradable high polymer material comprises polyhydroxyalkanoate. The closure clip provided by the invention is excellent in mechanical property, stable in degradation period, free of imaging examination interference, low in storage cost, good in biocompatibility and free of inflammation stimulation.

Description

Technical Field

[0001] The invention relates to a degradable polymer material closing clip and a manufacturing method, a using method and an application thereof, belonging to the technical field of medical devices. Background Art

[0002] Tissue closure clips are instruments used to temporarily close tissue incisions during surgical operations. In minimally invasive surgeries such as laparoscopy, tissue closure clips are crucial for clamping blood vessels and other tissues. They can effectively grasp the ligation target and reduce the separation of the ligated tissue area. They are widely used because they cause minimal damage to vascular tissue.

[0003] Existing polymer closure clips are divided into two categories according to material properties: degradable closure clips and non-degradable closure clips. Among them, the main material of the degradable closure clip is polydioxanone polyester (PPDO), and the main material of the non-degradable closure clip is polyoxymethylene (POM).

[0004] At present, the non-degradable polymer closure clips on the market are mainly Hem-o-Lok clips designed and produced by Wick Corporation in the United States. They are made of POM material. Due to their excellent mechanical properties, chemical stability and structural design, they have been widely used in the field of medical devices. However, the main disadvantages of non-degradable closure clips including POM materials are as follows:

[0005] (1) Permanent retention in the body: Non-degradable polymer closure clips will remain permanently in the patient's body because they will not degrade in the body, which may cause long-term foreign body reactions, tissue inflammation and side effects.

[0006] (2) Interference with imaging examinations: Non-degradable metal closure clips can easily cause interference during MRI and X-ray examinations, affecting the accuracy of the examinations.

[0007] (3) Risks of using an electrocoagulator: When an electrocoagulator is used for electrocoagulation during surgery, the metal titanium ligation clip can easily conduct electric current and may damage surrounding tissues.

[0008] (4) Postoperative complications: As the edema of the clamped tissue gradually subsides after surgery, the non-degradable ligation clip may become loose, move, or fall off prematurely, failing to effectively ligate and close the area, which may cause bile leakage or bleeding, thereby causing abdominal infection.

[0009] (5) Removal requires a second surgery: Since the closure clip is non-degradable, a second surgery may be required to remove it, which increases the patient's pain and financial burden.

[0010] (6) Structural design issues: The V-shaped buckle structure of the Hem-o-Lok clip can play an effective clamping role during surgery. However, due to its non-degradable nature, it can easily get stuck on the blood vessel wall during the postoperative recovery period, leading to postoperative bleeding. In addition, it is a non-fully enclosed structure, which is inconvenient to use and has the risk of falling off.

[0011] At present, the most common biodegradable polymer closure clips on the market are ABSOLOK*EXTRA biodegradable polymer closure clips produced by Johnson & Johnson Medical Devices, Inc., USA. The material is polydioxanone polyester (PPDO). The main disadvantages are as follows:

[0012] (1) Insufficient mechanical properties: Compared with ligation clips made of non-absorbable polymer materials such as POM, ligation clips made of PPDO may have insufficient mechanical strength during the clamping process, which may cause deformation and ineffective closure, resulting in the phenomenon of clip jumping or slipping. In order to improve the mechanical strength and clamping force of PPDO closure clips, some manufacturers need to modify PPDO by using polymer modifiers to increase the strength of the material and the stability of the structure. Due to the instability of PPDO material degradation, its production and processing processes also need to be precisely controlled to ensure product quality and performance, and the product also needs to be cryopreserved, which increases production complexity and cost.

[0013] (2) Complex operation: This closed clip structure is a special mechanical structure designed for the properties of PPDO material, and the clip removal process is relatively complicated. If the clip position is incorrect during the operation, a special clip remover is required.

[0014] (3) Uncertainty of degradation cycle: The degradation cycle of the PPDO closure clip needs to be precisely controlled to ensure that sufficient mechanical support is provided within an appropriate time and to avoid problems caused by excessive degradation.

[0015] (4) Potential biocompatibility issues: Although PPDO has good biocompatibility, some acidic small molecule intermediates may aggregate during the degradation process, causing complications such as acidification of the environment around the closure clip and inflammatory stimulation reactions.

[0016] (5) Interference with imaging examinations: Although the PPDO closure clip has less interference with imaging examinations than metal clips, it may still cause certain interference with CT or MRI scans in some cases.

[0017] (6) Risk of complications: The use of PPDO closure clips may lead to some complications, such as postoperative bleeding, pain, anastomotic stenosis, anastomotic separation, etc.

[0018] Therefore, providing a novel biodegradable polymer material closure clip and its manufacturing method, use method and application has become a technical problem that needs to be solved urgently in the field. Summary of the invention

[0019] In view of this, the technical problem to be solved by the present invention is to provide a degradable polymer material closure clip and its production method, use method and application, which solves the problems of the currently used closure clips, such as poor mechanical properties, unstable degradation cycle, interference with imaging examinations, high storage costs, poor biocompatibility, and inflammatory stimulation.

[0020] In order to solve the above technical problems, a specific embodiment of the present invention provides a biodegradable polymer material closing clamp, comprising a first clamp arm, a second clamp arm and a connecting piece, wherein the first clamp arm has a first connecting end and a first closed end, the second clamp arm has a second connecting end and a second closed end, the first connecting end of the first clamp arm and the second connecting end of the second clamp arm are connected into one piece by the connecting piece and form a V-shaped structure (that is, the overall original state of the biodegradable polymer material closing clamp before closing is a V-shape with good toughness), wherein the first closed end is provided with a protuberance column, the middle part of the surface of the protuberance column is provided with a buckle lock groove, the second closed end is provided with a buckle lock, and the buckle lock is installed in cooperation with the buckle lock groove;

[0021] Wherein, the connecting member comprises an outer connecting belt and an inner connecting belt, and there is a gap between the outer connecting belt and the inner connecting belt, and the thickness of the outer connecting belt is greater than the thickness of the inner connecting belt;

[0022] Wherein, the degradable polymer material includes polyhydroxyalkanoate.

[0023] In one embodiment of the present invention, the thickness of the outer connecting belt is 0.8±0.05 mm, and the thickness of the inner connecting belt is 0.2±0.01 mm.

[0024] In the degradable polymer material closing clamp of the present invention, the connecting piece includes an outer connecting belt and an inner connecting belt, which can play a deformation buffering connection role. The outer connecting belt and the inner connecting belt have different thicknesses, and the thickness of the outer connecting belt is greater than the thickness of the inner connecting belt, which can ensure that the connecting piece will not break due to stress deformation of the first clamp arm and the second clamp arm when the degradable polymer material closing clamp is closed, thereby improving the overall mechanical properties of the degradable polymer material closing clamp.

[0025] In one embodiment of the present invention, the width of the gap between the outer connecting belt and the inner connecting belt is 0.2±0.01 mm.

[0026] In one embodiment of the present invention, the outer connecting belt and the inner connecting belt are both arc-shaped.

[0027] In the present invention, the "outside" and "inside" in the outer connecting belt and the inner connecting belt refer to the direction away from the closed side of the degradable polymer material closing clamp and the direction toward the closed side of the degradable polymer material closing clamp, respectively.

[0028] In one embodiment of the present invention, the polyhydroxyalkanoate includes a polymer formed by one or more of 3-hydroxybutyric acid (3HB), 4-hydroxybutyric acid (4HB), 3-hydroxyvaleric acid (3HV), 3-hydroxyhexanoic acid (3HH) and 3-hydroxyoctanoic acid (3HO);

[0029] Preferably, the polyhydroxyalkanoic acid ester includes one or a combination of poly 3-hydroxybutyric acid-4-hydroxybutyrate (P3HB4HB, i.e. P34HB), poly 3-hydroxybutyric acid-3-hydroxyvalerate (P3HB3HV), poly 3-hydroxybutyrate (PHB), poly 3-hydroxybutyric acid 3-hydroxyhexanoate (PHBHHx), a copolymer of 3-hydroxybutyric acid, 3-hydroxyhexanoic acid and 3-hydroxyvaleric acid (PHBVHHx), polyhydroxyhexanoate (PHHx) and poly 3-hydroxyhexanoic acid-3-hydroxyoctanoate (P3HHx3HO).

[0030] In one embodiment of the present invention, the closing side of the first clamp arm and the closing side of the second clamp arm are staggered / displaced with a plurality of anti-slip teeth. When the degradable polymer material closing clamp is used, the first clamp arm and the second clamp arm are relied on to clamp the patient's target tissue (such as blood vessels). At this time, the provision of the anti-slip teeth can increase the friction between the degradable polymer material closing clamp and the target tissue it clamps, so that the anti-slip teeth can clamp the target tissue, ensuring that the target tissue will not move or fall off after clamping, thereby achieving anti-slipping after the closing clamp is clamped, making it more stable during clinical use. Among them, the material of the anti-slip teeth is also polyhydroxyalkanoate.

[0031] In one embodiment of the present invention, when a plurality of anti-slip teeth are staggered / displaced, the height of the anti-slip teeth is 0.05±0.01 mm.

[0032] In one embodiment of the present invention, the closed side of the first clamp arm is provided with a plurality of anti-slip teeth, and the closed side of the second clamp arm is correspondingly provided with a plurality of anti-slip tooth grooves, and the anti-slip teeth and the anti-slip tooth grooves are installed in coordination.

[0033] In one embodiment of the present invention, the closing side of the first clamp arm and the closing side of the second clamp arm are respectively provided with a first groove and a second groove, and the first groove and the second groove are both provided with a rubber pad, the anti-slip teeth are arranged on the bottom wall of the first groove, the upper end of the anti-slip teeth passes through the through hole of the surface of the rubber pad in the first groove (i.e., the surface of the rubber pad in the first groove facing the second groove), the anti-slip tooth groove is arranged on the surface of the rubber pad in the second groove (i.e., the surface of the rubber pad in the second groove facing the first groove), and the anti-slip teeth and the anti-slip tooth groove are installed in coordination. At this time, the setting of the rubber pad can reduce the pain caused to the patient by the degradable polymer material closing clamp; and the anti-slip teeth and the anti-slip tooth groove can also increase the friction between the degradable polymer material closing clamp and the target tissue it clamps, so that the anti-slip teeth can clamp the target tissue, ensuring that the target tissue will not move or fall off after clamping, realizing the anti-slipping of the closing clamp after clamping, making it more stable during clinical use. Among them, the material of the anti-slip teeth is also polyhydroxyalkanoate.

[0034] In an embodiment of the present invention, when a plurality of anti-skid teeth and a plurality of anti-skid tooth grooves are provided correspondingly, the height of the anti-skid teeth is also 0.05±0.01 mm.

[0035] In one embodiment of the present invention, the outer arc surface of the buckle lock and the inner wall of the buckle lock groove are both provided with anti-slip stripes, so that the buckle lock and the buckle lock groove can be more firmly connected.

[0036] In an embodiment of the present invention, the shape of the buckle includes a triangle or an irregular shape.

[0037] In one embodiment of the present invention, the protrusion column is cylindrical or irregular in shape.

[0038] The specific embodiment of the present invention also provides a method for making the above-mentioned degradable polymer material closing clip, wherein the method comprises: using polyhydroxyalkanoate as a raw material, adopting a molten deposition free-form manufacturing method or an integral injection molding method to make the degradable polymer material closing clip. The molten deposition free-form manufacturing method and the integral injection molding method are both existing conventional technologies, and their operation steps and process parameters used can be reasonably adjusted as needed.

[0039] The specific embodiment of the present invention also provides a method for using the above-mentioned degradable polymer material closure clip, wherein the method for using comprises:

[0040] When in use, the biodegradable polymer material closing clip and the clip applier are assembled so that the protuberance column and the buckle lock are respectively clamped in the upper mounting groove and the lower mounting groove of the clip applier, so that the position between the clip applier and the biodegradable polymer material closing clip is fixed, and the first closing end of the first clamp arm and the second closing end of the second clamp arm are pushed closer to each other by the clip applier, and the target tissue of the patient is clamped by the clamping of the buckle lock and the buckle lock groove;

[0041] When the degradable polymer material closing clamp needs to be disassembled, the disassembly action is completed by using the loose clamp. The disassembly process can be carried out according to conventional operations. The specific operation can be as follows: the degradable polymer material closing clamp is placed in the jaws of the loose clamp, so that the outer side of the first clamp arm (relative to the closed side) and the outer side of the second clamp arm (relative to the closed side) in the degradable polymer material closing clamp are respectively in contact with the upper and lower sides of the jaws, and the jaws of the loose clamp are aligned with the release mechanism of the closing clamp (the central part of the closing clamp), the loose clamp is operated gently and steadily to avoid damage to the surrounding tissues, the handle of the loose clamp is pinched until the closing clamp shows an obvious bounce feeling, and then the handle of the loose clamp is gradually opened until the outer side of the first clamp arm and the second clamp arm are completely separated to complete the disassembly action.

[0042] The specific embodiment of the present invention also provides the use of the above-mentioned degradable polymer material closure clip in clamping the target tissue during surgery.

[0043] Compared with the prior art, the technical solution of the present invention can achieve at least the following beneficial technical effects:

[0044] From the material point of view, the material of the degradable polymer material closure clip provided by the present invention includes polyhydroxyalkanoate. Therefore, firstly, the degradable polymer material closure clip has excellent mechanical properties, and its mechanical properties are significantly better than the closure clip of PPDO material currently commonly used in the field, and can complete in vivo degradation while ensuring sufficient mechanical strength; secondly, the degradation cycle of the degradable polymer material closure clip is stable, the degradation speed can be adjusted, and there is no interference from imaging examinations; thirdly, the degradable polymer material closure clip has good biocompatibility with the target tissue during use and no inflammatory stimulation; finally, the degradable polymer material closure clip can be stored at room temperature, with low storage cost, which is convenient for storage in medical institutions, and it can maintain stable performance for a long time during storage.

[0045] From a structural point of view, the connector in the degradable polymer material closing clamp provided by the present invention includes an outer connecting belt and an inner connecting belt, and there is a gap between the outer connecting belt and the inner connecting belt, and the thickness of the outer connecting belt is greater than the thickness of the inner connecting belt. When the degradable polymer material closing clamp is closed, the outer connecting belt and the inner connecting belt can accommodate the extrusion deformation caused by the bending of the connector, so that the closing clamp is closed smoothly and the connector will not be broken by extrusion, thereby improving the overall mechanical properties of the degradable polymer material closing clamp. In addition, after clamping, the degradable polymer material closing clamp can be adapted to the commonly used clinical loosening forceps for rapid clamp removal, and the removal process is very easy.

[0046] It should be understood that the above general description and the following detailed description are merely exemplary and illustrative and are not intended to limit the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] The accompanying drawings below are part of the specification of the present invention, and illustrate exemplary embodiments of the present invention. Together with the description of the specification, the accompanying drawings are used to explain the principles of the present invention.

[0048] Figure 1 A schematic diagram of the front cross-section structure of a degradable polymer material closing clamp provided in a specific embodiment of the present invention.

[0049] Description of reference numerals:

[0050] 1 connecting piece; 2 first clamping arm;

[0051] 3. Second clamp arm; 4. Buckle lock;

[0052] 5. Protuberance column; 6. Locking slot;

[0053] 7 first groove; 8 second groove;

[0054] 9 rubber pad; 10 anti-slip teeth;

[0055] 11 anti-slip grooves; 12 anti-slip stripes;

[0056] 13 outer connecting belt; 14 inner connecting belt;

[0057] 15 gaps. DETAILED DESCRIPTION

[0058] In order to make the objectives, technical solutions and advantages of the embodiments of the present invention more clearly understood, the spirit of the contents disclosed by the present invention will be clearly explained with the accompanying drawings and detailed descriptions below. After understanding the embodiments of the contents of the present invention, any technician in the relevant technical field can change and modify the techniques taught by the contents of the present invention without departing from the spirit and scope of the contents of the present invention.

[0059] The exemplary embodiments and descriptions of the present invention are used to explain the present invention, but are not intended to limit the present invention. In addition, elements / components with the same or similar reference numerals used in the drawings and embodiments are used to represent the same or similar parts.

[0060] The terms “first”, “second”, etc. used in this document do not particularly refer to an order or sequence, nor are they used to limit the present invention. They are only used to distinguish elements or operations described with the same technical terms.

[0061] The directional terms used in this document, such as inside, outside, up, down, left, right, front or back, etc., are only used to refer to the directions of the drawings. Therefore, the directional terms used are used to illustrate and not to limit the invention.

[0062] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0063] As used herein, "and / or" includes any or all combinations of the items described.

[0064] As used herein, “plurality” includes “two” and “more than two”; as used herein, “plurality groups” includes “two groups” and “more than two groups”.

[0065] The terms "substantially" and "approximately" used herein are used to modify any quantity or error that may vary slightly, but these slight changes or errors do not change their essence. Generally speaking, the range of slight changes or errors modified by such terms may be 20% in some embodiments, 10% in some embodiments, 5% in some embodiments, or other values. Those skilled in the art should understand that the aforementioned values ​​can be adjusted according to actual needs and are not limited thereto.

[0066] All terms (including technical and scientific terms) used herein have the meanings commonly understood by those skilled in the art, unless otherwise defined. It should be noted that the terms used herein should be interpreted as having a meaning consistent with the context of this specification, and should not be interpreted in an idealized or overly rigid manner.

[0067] In the case of using expressions such as "at least one of A, B, and C, etc.", it should generally be interpreted in accordance with the meaning of the expression generally understood by those skilled in the art (for example, "a system having at least one of A, B, and C" should include but not be limited to a system having A alone, B alone, C alone, A and B, A and C, B and C, and / or A, B, C, etc.). In the case of using expressions such as "at least one of A, B, or C, etc.", it should generally be interpreted in accordance with the meaning of the expression generally understood by those skilled in the art (for example, "a system having at least one of A, B, or C" should include but not be limited to a system having A alone, B alone, C alone, A and B, A and C, B and C, and / or A, B, C, etc.). Those skilled in the art should also understand that any transitional conjunctions and / or phrases that substantially indicate two or more optional items, whether in the specification, claims, or drawings, should be understood to give the possibility of including one of these items, either of these items, or both of these items. For example, the phrase "A or B" should be understood to include the possibilities of "A" or "B", or "A and B".

[0068] "Scope" disclosed in the present invention is given in the form of lower limit and upper limit. It can be one or more lower limits, and one or more upper limits respectively. A given range is defined by selecting a lower limit and an upper limit. The selected lower limit and upper limit define the boundaries of a particular range. All ranges defined in this way are combinable, i.e. any lower limit can be combined with any upper limit to form a range. For example, for a specific parameter, a range of 60-120 and 80-110 is listed, and it is understood that a range of 60-110 and 80-120 is also expected. In addition, if the minimum range values ​​listed are 1 and 2, and the maximum range values ​​listed are 3, 4 and 5, then the following ranges can all be expected: 1-3, 1-4, 1-5, 2-3, 2-4 and 2-5.

[0069] In the present invention, unless otherwise specified, the numerical range "ab" represents an abbreviation of any real number combination between a and b, where a and b are real numbers. For example, the numerical range "0-5" means that all real numbers between "0-5" have been listed in the present invention, and "0-5" is just an abbreviation of these numerical combinations.

[0070] In the present invention, unless otherwise specified, all steps mentioned herein may be performed sequentially or randomly, but are preferably performed sequentially. For example, the method includes steps (a) and (b), which means that the method may include steps (a) and (b) performed sequentially, or may include steps (b) and (a) performed sequentially. For example, the method may further include step (c), which means that step (c) may be added to the method in any order, for example, the method may include steps (a), (b) and (c), or may include steps (a), (c) and (b), or may include steps (c), (a) and (b), etc.

[0071] If no specific conditions are specified in the examples of the present invention, the experiments were carried out under conventional conditions or conditions recommended by the manufacturer. If no manufacturer is specified for the reagents or instruments used, they are all conventional products that can be purchased commercially.

[0072] Example 1

[0073] The present embodiment provides a closed clamp made of a degradable polymer material, comprising a first clamp arm 2, a second clamp arm 3 and a connecting piece 1, wherein the first clamp arm 2 has a first connecting end and a first closed end, and the second clamp arm 3 has a second connecting end and a second closed end, the first connecting end of the first clamp arm 2 and the second connecting end of the second clamp arm 3 are connected as a whole through the connecting piece 1, and the first closed end and the second closed end are separated from each other to form a V-shaped structure, wherein the first closed end is provided with a ridge column 5, the middle part of the surface of the ridge column 5 is provided with a buckle lock groove 6, the second closed end is provided with a buckle lock 4, the buckle lock 4 is installed in cooperation with the buckle lock groove 5, and the outer arc surface of the buckle lock 4 and the inner wall of the buckle lock groove 5 are provided with anti-slip stripes 12;

[0074] The connecting member 1 includes an outer connecting belt 13 and an inner connecting belt 14, and there is a gap between the outer connecting belt 13 and the inner connecting belt 14, and the thickness of the outer connecting belt 13 is greater than the thickness of the inner connecting belt 14; in this embodiment, the thickness of the outer connecting belt 13 is 0.8±0.05mm, the thickness of the inner connecting belt 14 is 0.2±0.01mm, and the width of the gap 15 between the outer connecting belt 13 and the inner connecting belt 14 is 0.2±0.01mm;

[0075] The closed side of the first clamp arm 2 and the closed side of the second clamp arm 3 are respectively provided with a first groove 7 and a second groove 8, the first groove 7 and the second groove 8 are both provided with a rubber pad 9, and an anti-skid tooth 10 is arranged on the bottom wall of the first groove 7, the upper end of the anti-skid tooth 10 passes through the through hole on the surface of the rubber pad 9 in the first groove 7, and the anti-skid tooth groove 11 is arranged on the surface of the rubber pad 9 in the second groove 8, and the anti-skid tooth 10 and the anti-skid tooth groove 11 are installed in coordination; in this embodiment, the thickness of the anti-skid tooth 10 is 0.05±0.01mm;

[0076] Wherein, the degradable polymer material is medical grade P34HB.

[0077] Example 2

[0078] This embodiment provides a closure clip made of a degradable polymer material, which differs from the embodiment 1 only in that:

[0079] Neither the first groove 7 nor the second groove 8 is provided on the closed side of the first clamp arm 2 nor the closed side of the second clamp arm 3 , and correspondingly, no rubber pad 9 is provided. Instead, a plurality of anti-slip teeth 10 are alternately provided on the closed side of the first clamp arm 2 and the closed side of the second clamp arm 3 .

[0080] Comparative Example 1

[0081] This comparative example provides a degradable polymer material closure clip, which differs from Example 2 only in that:

[0082] The connecting member 1 comprises only one connecting strip, and the thickness of the connecting strip is 0.8±0.05 mm.

[0083] Comparative Example 2

[0084] This comparative example provides a degradable polymer material closure clip, which differs from Example 2 only in that:

[0085] Although the connector 1 includes an outer connecting belt 13 and an inner connecting belt 14, and there is a gap between the outer connecting belt 13 and the inner connecting belt 14, the thickness of the outer connecting belt 13 is the same as the thickness of the inner connecting belt 14. In this comparative example, the thickness of the outer connecting belt 13 and the inner connecting belt 14 are both 0.4±0.01 mm, and the width of the gap 15 between the outer connecting belt 13 and the inner connecting belt 14 is 0.2±0.01 mm.

[0086] Comparative Example 3

[0087] This comparative example provides a degradable polymer material closure clip, which differs from Example 2 only in that:

[0088] The degradable polymer material is PPDO.

[0089] The method for using the degradable polymer material closure clip provided in the embodiment of the present invention is as follows:

[0090] When in use, the biodegradable polymer material closing clip and the clip applier are assembled so that the protuberance column and the buckle lock are respectively clamped in the upper mounting groove and the lower mounting groove of the clip applier, so that the position between the clip applier and the biodegradable polymer material closing clip is fixed, and the first closing end of the first clamp arm and the second closing end of the second clamp arm are pushed closer to each other by the clip applier, and the target tissue of the patient is clamped by the clamping connection between the buckle lock and the buckle lock groove;

[0091] When the degradable polymer material closing clamp needs to be disassembled, the disassembly action is completed by using the loose clamp. The disassembly process can be carried out according to conventional operations. The specific operation can be as follows: the degradable polymer material closing clamp is placed in the jaws of the loose clamp, so that the outer side of the first clamp arm (relative to the closed side) and the outer side of the second clamp arm (relative to the closed side) in the degradable polymer material closing clamp are respectively in contact with the upper and lower sides of the jaws, and the jaws of the loose clamp are aligned with the release mechanism of the closing clamp (the central part of the closing clamp), the loose clamp is operated gently and steadily to avoid damage to the surrounding tissues, the handle of the loose clamp is pinched until the closing clamp shows an obvious bounce feeling, and then the handle of the loose clamp is gradually opened until the outer side of the first clamp arm and the second clamp arm are completely separated to complete the disassembly action.

[0092] Test Example 1

[0093] This test example uses conventional methods in the art to evaluate the degradability, mechanical properties and other properties of the degradable polymer material closure clips provided in Example 2 of the present invention and Comparative Examples 1 to 3, respectively. The evaluation and judgment standards of the mechanical properties are carried out with reference to sections 5.6-5.10 of the industry standard "YYT 1906-2023 Disposable Sterile Closure Clips".

[0094] The experimental results obtained in this test example are shown in Table 1 below.

[0095] Table 1

[0096]

[0097] From the perspective of mechanical properties, compared with Example 2 of the present invention, the connector 1 in Comparative Example 1 only includes one connecting belt, and the biodegradable polymer material closing clamp provided by it has poor resilience during the disassembly process, resulting in it being unable to open; although the connector 1 in Comparative Example 2 includes an outer connecting belt 13 and an inner connecting belt 14, and there is a gap between the outer connecting belt 13 and the inner connecting belt 14, the thickness of the outer connecting belt 13 is the same as that of the inner connecting belt 14, and the biodegradable polymer material closing clamp provided by it is prone to breakage during operation.

[0098] In summary, from a structural point of view, the connecting piece in the degradable polymer material closing clamp provided by the embodiment of the present invention includes an outer connecting belt and an inner connecting belt, and there is a gap between the outer connecting belt and the inner connecting belt, and the thickness of the outer connecting belt is greater than the thickness of the inner connecting belt. Compared with Comparative Examples 1-2, during use, the outer connecting belt and the inner connecting belt can pull the first connecting end of the first clamp arm and the second connecting end of the second clamp arm, so that the first closed end of the first clamp arm and the second closed end of the second clamp arm can be elastically opened. When the first clamp arm and the second clamp arm of the degradable polymer material closing clamp are subjected to the pressure of the closing direction of the clamp jaws, the elasticity of the two ends of the outer connecting belt and the inner connecting belt can pull the first clamp arm and the second clamp arm of the degradable polymer material closing clamp outward, thereby enhancing the tension of the first clamp arm and the second clamp arm of the closing clamp, so as to keep the protuberance column and the buckle lock of the degradable polymer material closing clamp fixed in the mounting groove of the clamp, and prevent the clamp from falling off.

[0099] From the material point of view, the material of the degradable polymer material closure clip provided in the embodiment of the present invention includes polyhydroxyalkanoate. Therefore, compared with comparative example 3, firstly, the degradable polymer material closure clip provided in the embodiment of the present invention has excellent mechanical properties, and its mechanical properties are significantly better than the closure clip of PPDO material currently commonly used in the field, and can complete in vivo degradation while ensuring sufficient mechanical strength; secondly, the degradation cycle of the degradable polymer material closure clip is stable, the degradation speed can be controlled, and there is no interference with imaging examination; thirdly, the degradable polymer material closure clip has good biocompatibility with the target tissue during use and no inflammatory stimulation; finally, the degradable polymer material closure clip can be stored at room temperature, the storage cost is low, it is convenient for storage in medical institutions, and it can maintain stable performance for a long time during storage.

[0100] It will be appreciated by those skilled in the art that the features described in the various embodiments and / or claims of the present invention may be combined and / or combined in various ways, even if such combinations and / or combinations are not explicitly described in the present invention. In particular, the features described in the various embodiments and / or claims of the present invention may be combined and / or combined in various ways without departing from the spirit and teachings of the present invention. All of these combinations and / or combinations fall within the scope of the present invention.

[0101] The embodiments of the present invention are described above. However, these embodiments are only for the purpose of illustration, and are not intended to limit the scope of the present invention. Although each embodiment is described above, it does not mean that the measures in each embodiment cannot be used in combination. The scope of the present invention is defined by the attached claims and their equivalents. Without departing from the scope of the present invention, those skilled in the art may make various substitutions and modifications, which should all fall within the scope of the present invention.

Claims

1. A biodegradable polymer material closed clamp, comprising a first clamp arm, a second clamp arm and a connecting piece, wherein the first clamp arm has a first connecting end and a first closed end, the second clamp arm has a second connecting end and a second closed end, the first connecting end of the first clamp arm and the second connecting end of the second clamp arm are connected to form a V-shaped structure through the connecting piece, characterized in that: The first closed end is provided with a protuberance column, a buckle lock groove is provided in the middle of the surface of the protuberance column, and the second closed end is provided with a buckle lock, and the buckle lock is installed in cooperation with the buckle lock groove; Wherein, the connecting member comprises an outer connecting belt and an inner connecting belt, and there is a gap between the outer connecting belt and the inner connecting belt, and the thickness of the outer connecting belt is greater than the thickness of the inner connecting belt; Wherein, the degradable polymer material includes polyhydroxyalkanoate.

2. The degradable polymer material closing clip according to claim 1, characterized in that: The thickness of the outer connecting belt is 0.8±0.05 mm, and the thickness of the inner connecting belt is 0.2±0.01 mm.

3. The degradable polymer material closing clip according to claim 1 or 2, characterized in that: The width of the gap between the outer connecting band and the inner connecting band is 0.2±0.01 mm.

4. The degradable polymer material closing clip according to claim 1, characterized in that: The polyhydroxyalkanoic acid ester includes a polymer formed by one or more of 3-hydroxybutyric acid, 4-hydroxybutyric acid, 3-hydroxyvaleric acid, 3-hydroxyhexanoic acid and 3-hydroxyoctanoic acid; Preferably, the polyhydroxyalkanoic acid ester includes one or a combination of poly 3-hydroxybutyric acid-4-hydroxybutyrate, poly 3-hydroxybutyric acid-3-hydroxyvalerate, poly 3-hydroxybutyrate, poly 3-hydroxybutyric acid 3-hydroxyhexanoate, 3-hydroxybutyric acid, a copolymer of 3-hydroxyhexanoic acid and 3-hydroxyvaleric acid, polyhydroxyhexanoate and poly 3-hydroxyhexanoic acid-3-hydroxyoctanoate.

5. The degradable polymer material closing clip according to any one of claims 1-2 and 4, characterized in that: The closed side of the first clamp arm and the closed side of the second clamp arm are alternately provided with a plurality of anti-slip teeth.

6. The degradable polymer material closing clip according to claim 5, characterized in that: The height of the anti-slip teeth is 0.05±0.01 mm.

7. The degradable polymer material closing clip according to any one of claims 1-2 and 4, characterized in that: The closed side of the first clamp arm is provided with a plurality of anti-skid teeth, and the closed side of the second clamp arm is correspondingly provided with a plurality of anti-skid tooth grooves, and the anti-skid teeth and the anti-skid tooth grooves are installed in a coordinated manner.

8. The degradable polymer material closing clip according to claim 7, characterized in that: The closed side of the first clamp arm and the closed side of the second clamp arm are respectively provided with a first groove and a second groove, and rubber pads are provided inside the first groove and the second groove. The anti-slip teeth are arranged on the bottom wall of the first groove, and the upper ends of the anti-slip teeth pass through the through holes on the surface of the rubber pad in the first groove. The anti-slip tooth grooves are arranged on the surface of the rubber pad in the second groove, and the anti-slip teeth and the anti-slip tooth grooves are installed in coordination.

9. The degradable polymer material closing clip according to claim 7, characterized in that: The height of the anti-slip teeth is 0.05±0.01 mm.

10. The degradable polymer material closing clip according to any one of claims 1-2 and 4, characterized in that: The outer arc surface of the buckle and the inner wall of the buckle groove are both provided with anti-slip stripes.

11. The degradable polymer material closing clip according to any one of claims 1-2 and 4, characterized in that: The buckle lock has a shape of a triangle or an irregular shape.

12. The degradable polymer material closing clip according to any one of claims 1 to 2 and 4, characterized in that: The protuberance column is cylindrical or irregular in shape.

13. The method for making the degradable polymer material closing clip according to any one of claims 1 to 12, characterized in that: The manufacturing method comprises: using polyhydroxyalkanoate as a raw material, adopting a molten deposition free manufacturing method or an integral injection molding method to manufacture the degradable polymer material closing clip.

14. The method for using the degradable polymer material closing clip according to any one of claims 1 to 12, characterized in that: The method of use includes: When in use, the biodegradable polymer material closing clip and the clip applier are assembled so that the protuberance column and the buckle lock are respectively clamped in the upper mounting groove and the lower mounting groove of the clip applier, so that the position between the clip applier and the biodegradable polymer material closing clip is fixed, and the first closing end of the first clamp arm and the second closing end of the second clamp arm are pushed closer to each other by the clip applier, and the target tissue of the patient is clamped by the clamping of the buckle lock and the buckle lock groove; When the degradable polymer material closing clamp needs to be disassembled, the disassembly action is completed by using a clamp loosening pliers.

15. Use of the degradable polymer material closure clip according to any one of claims 1 to 12 for clamping a target tissue in a surgical operation.

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