Absorbable closure clip

Abstract

The present invention belongs to the field of medical devices, and specifically relates to an absorbable closing clamp. It includes an upper arm, a lower arm and a one-piece hinge, and the upper arm and the lower arm are connected into one body through the one-piece hinge to form an absorbable closing clamp; the upper arm is provided with an upper arm back and an upper arm inner abdomen, and a locking hole is provided at one end of the upper arm away from the one-piece hinge, and an upper arm clamping pile is provided at the upper end of the upper arm away from the one-piece hinge for installation of a closing clamp and a clamping device; the lower arm is provided with a lower arm back and a lower arm inner abdomen, and a locking nail is provided at one end of the lower arm away from the one-piece hinge, and the locking nail cooperates with the locking hole provided in the upper arm to make the absorbable closing clamp form a fully locked closure, and a lower arm clamping pile is provided at the upper end of the lower arm away from the one-piece hinge for installation of a closing clamp and a clamping device.

Description

Technical Field

[0001] The invention belongs to the field of medical devices, and in particular relates to an absorbable closure clip. Background Art

[0002] During medical surgery, many luminal tissues in the body cavity need to be ligated and closed for a long time or temporarily, among which there are many small and medium-sized lumens such as bile ducts, arteries and veins. With the continuous development of science and technology, laparoscopic minimally invasive surgery has been widely used, and correspondingly, higher miniaturization requirements have been put forward for closure clips. The main manufacturing materials of the micro-closure clips currently used in surgical laparoscopic surgery are stainless steel metal, titanium alloy metal, non-degradable polymer materials and degradable biomaterials. Among them, closure clips made of metal materials and non-degradable polymer materials cannot be degraded and absorbed. Long-term retention in the body may cause foreign body reactions or irritate tissues to cause inflammation, pain and discomfort. In addition, metal materials also have the characteristics of interfering with computer X-ray tomography or magnetic resonance imaging. Closure clips made of degradable biomaterials appeared in the 1980s, and the materials used are mainly polymers such as glycolide and lactide.

[0003] An absorbable hemostatic ligation clip, patent application number: 200610051687.7, adopts an inner and outer double-layer structure with one end open, the inner layer is made of polydioxanone or polydioxanone-lactide copolymer material, and the outer layer is made of polyglycolide material; polydioxanone or polydioxanone-lactide copolymer is a hydrophilic flexible material, which is beneficial to protecting human tissue; but the one-end open structure increases the risk of independent split parts being out of position, ligation and closure failure, and falling from the luminal tissue after clamping.

[0004] Another absorbable ligation clip is made of polydioxanone polyester. This type of ligation closure clip is composed of a single part and uses a buckle-type locking hook. Because it uses similar materials that are easily softened when exposed to water, the final closure strength is difficult to ensure, resulting in a small scope of application, the need for complete tissue stripping to cause complicated surgery, and insufficient safety performance during and after the operation. Summary of the invention

[0005] The purpose of the present invention is to provide an absorbable closure clip in view of the above-mentioned deficiencies. The absorbable closure clip is made of degradable biomaterials. Compared with metal or non-degradable polymer products, it no longer permanently retains foreign matter in the body and does not interfere with radiographic examinations, thereby reducing the risk of lesions and improving human comfort. It adopts a single-piece structure to reduce production and assembly costs, reduce production quality risks, and reduce the probability of failure in use. It adopts a fully locked closed structure to prevent the risks of dislocation and falling off of double-layer open and buckle lock hook closure clips.

[0006] The absorbable closure clip is realized by adopting the following technical solutions:

[0007] The absorbable closure clip comprises an upper arm, a lower arm and a conjoined hinge, wherein the upper arm and the lower arm are connected into one body through the conjoined hinge to form the absorbable closure clip.

[0008] The upper arm is provided with an upper arm back and an upper arm inner abdomen, and a lock hole is provided at one end of the upper arm away from the one-piece hinge. An upper arm clamping pile is provided at the upper end of the upper arm away from the one-piece hinge for installing the closing clamp and the clamping device.

[0009] The upper arm inner abdomen portion in contact with human tissue is provided with upper arm spurs, which are distributed at intervals throughout the inner abdomen and have the function of increasing friction with tissues and preventing slippage and displacement.

[0010] The lower arm is provided with a lower arm back and a lower arm inner abdomen, and a locking nail is provided at one end of the lower arm away from the one-piece hinge. The locking nail cooperates with the locking hole provided in the upper arm to make the absorbable closing clip form a fully locked closure. A lower arm clamping pile is provided at the upper end of the lower arm away from the one-piece hinge for installing the closing clip and the clamping device.

[0011] The part of the lower arm inner abdomen that contacts the human body tissue is provided with lower arm spurs, which are distributed at intervals throughout the entire inner abdomen to increase the friction between the lower arm and the tissue and prevent slippage and displacement.

[0012] The upper arm spurs and the lower arm spurs are staggered when the upper arm and the lower arm are closed.

[0013] The parts of the absorbable closing clip where the upper arm inner abdomen and the lower arm inner abdomen contact with human tissue are provided with rounded corners to prevent cutting of tissue.

[0014] The one-piece hinge is provided with a slot hole, which is an elastic hole for enhancing the elasticity of the absorbable closing clip. The slot hole of the one-piece hinge is also used to accommodate the plastic deformation of the hinge of the closing clip after closing to prevent the hinge from cracking.

[0015] The absorbable closure clip is V-shaped, which is convenient for clamping and fully locking the closed tissue.

[0016] The upper arm and the lower arm of the absorbable closure clip are in the same direction and have a certain curvature, which can increase the closure ability when ligating human tissues with uneven thickness. In addition, the certain arc curvature can guide the stress dispersion when closing the tissue, and has a certain function of preventing breakage.

[0017] The locking nail is a "T"-shaped structure, with a larger "T"-shaped top and a smaller "T"-shaped root, and is divided into multiple layers. The outer layer is a tough material, which is connected to the inner abdomen of the lower arm; the inner layer is a high-strength material, which is connected to the back of the lower arm. A sharp cutting edge is provided on the top of the "T"-shaped structure of the locking nail to improve the puncture performance when closed.

[0018] The absorbable closure clip is made of degradable biomaterials, such as polydioxanone and its copolymers, polyglycolic acid, polylactic acid and its copolymers, and their blends. The degradation products are components that can be completely absorbed by the human body, and no foreign matter remains in the body for a long time.

[0019] The absorbable closure clip is a double-armed fully locked micro closure clip. The closure clip has puncture and closure functions, and can meet the delivery and clamping functions under laparoscope through a matching clip application device, meeting the needs of minimally invasive surgery.

[0020] The upper arm and lower arm of the absorbable closure clip are made of two or more biomaterials. The high-strength material is located at the back and inner core of the upper arm and lower arm, and the tough material is located at the inner abdomen and the wrapping ring of the upper arm and lower arm. The high-strength material and the tough material are mutually embedded and cannot be separated without degradation. The high-strength material is polyglycolic acid, polylactic acid or their copolymers and blends. The tough material is polydioxanone or its copolymers and blends.

[0021] Working principle:

[0022] When the absorbable closure clip is used in a surgical operation, a special clamping instrument is inserted into the base equipped with the absorbable closure clip, so that the clamp head of the clamping instrument and the clamping pile of the absorbable closure clip are engaged. When the clamping instrument is pulled out of the base, the absorbable closure clip is firmly connected with the clamp head of the clamping instrument, and the absorbable closure clip is in an open state. The extension tube and clamp head of the clamping instrument carry the absorbable closure clip through the body wall to approach the tissue or lumen to be ligated and closed. Continue to push the clamping instrument to allow the freed tissue or lumen to enter the open opening of the absorbable closure clip (at this time, it should be noted that the selected absorbable closure clip model must be able to fully cover the tissue or lumen to be ligated and closed), and try to make the tissue or lumen to be ligated and closed at the bottom of the open opening of the absorbable closure clip (the open direction of the absorbable closure clip can be adjusted by rotating the extension tube and clamp head of the clamping instrument synchronously). The trigger mechanism of the clip applicator moves continuously and quickly, so that the clamp head of the clip applicator is pressed together, driving the upper and lower arms of the absorbable closing clip to approach, and the locking nail passes through the tissue or the rear of the lumen into the locking hole. The trigger mechanism of the clip applicator moves to the bottom, and cooperates with the locking nail of the absorbable closing clip to penetrate the locking hole to form a full lock closure, and at the same time, the tissue or lumen in the containing space is compressed and closed. Release the trigger mechanism of the clip applicator, the clamp head opens, and the absorbable closing clip after full lock closure can be separated from the clamp head and firmly attached to the tissue or lumen.

[0023] An absorbable closure clip has the following notable features:

[0024] 1. The closure clip of the present invention is made of a combination of multiple completely degradable biomaterials, which solves the risk of long-term retention of metal and non-degradable polymer products in the body; the degradation products of the biomaterials used in the present invention can be completely absorbed by the human body, which improves biological safety and human comfort;

[0025] 2. The present invention adopts a single-piece structure in which high-strength rigid materials and tough soft materials are simultaneously solidified and molded into one piece;

[0026] 3. The single-piece structure of the multi-material integrated solidification molding of the present invention improves production efficiency and reduces quality risks such as assembly errors, storage loss, transportation damage, and falling off during use of the multi-part structure during production;

[0027] 5. The single-piece structure of the multi-material integrated solidification molding of the present invention solves the problems of easy separation, easy dislocation, and easy falling off of the double-layer structure with one end open;

[0028] 6. The single-piece structure of the multi-material integrated curing molding of the present invention solves the problem that a single material is too hard to damage tissue or too soft to have insufficient closure strength;

[0029] 7. The fully closed lock structure of the present invention solves the risk of ligation failure caused by the buckle-type lock hook being easily unhooked when subjected to a large force;

[0030] 8. The fully closed locking structure of the present invention improves the stability of ligation closure after the movement ability of organs and luminal tissues is restored during the postoperative healing period;

[0031] 9. The surface of the closure clip of the present invention that contacts the luminal tissue is provided with an anti-slip dislocation piercing mechanism. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The present invention will be further described below in conjunction with the accompanying drawings:

[0033] Figure 1 is a schematic diagram of the absorbable closure clip.

[0034] Figure 2 is a schematic diagram of the absorbable closure clip structure.

[0035] Figure 3 is a cross-sectional view of an absorbable closure clip.

[0036] Figure 4 is a side view of the absorbable closure clip.

[0037] Figure 5 It is a fully locked closure diagram with an absorbable closure clip.

[0038] In the figure: 1, upper arm, 2, lower arm, 3, one-piece hinge, 4, locking pin, 5, locking hole; 1-1, back of upper arm, 1-2, inner abdomen of upper arm, 1-3, upper arm stake; 1-4, upper arm stab; 2-1, back of lower arm, 2-2, inner abdomen of lower arm, 2-3, lower arm stake, 2-4, lower arm stab; 3-1, rounded corner, 3-2, slot. DETAILED DESCRIPTION

[0039] See attached Figure 1-5 The absorbable closure clip comprises an upper arm 1, a lower arm 2 and a conjoined hinge 3, and the upper arm 1 and the lower arm 2 are connected together through the conjoined hinge 3 to form the absorbable closure clip.

[0040] The upper arm 1 is provided with an upper arm back 1-1 and an upper arm inner abdomen 1-2, and a lock hole 5 is provided at one end of the upper arm 1 away from the one-piece hinge 3. An upper arm clamping pile 1-3 is provided at the upper end of the upper arm 1 away from the one-piece hinge 3 for installing a closing clamp and a clamping device.

[0041] The upper arm inner abdomen 1-2 is provided with upper arm protrusions 1-4 at the contact part with human tissue. The upper arm protrusions 1-4 are distributed at intervals in the entire inner abdomen to increase the friction between the tissue and prevent slippage and displacement.

[0042] The lower arm 2 is provided with a lower arm back 2-1 and a lower arm inner abdomen 2-2, and a locking nail 4 is provided at one end of the lower arm 2 away from the joint hinge 3. The locking nail 4 cooperates with the locking hole 5 provided in the upper arm 1, so that the absorbable closing clip forms a fully locked closure. A lower arm clamping pile 2-3 is provided at the upper end of the lower arm 1 away from the joint hinge 3, which is used for installing the closing clip and the clamping device.

[0043] The lower arm inner abdomen 2-2 is provided with lower arm protrusions 2-4 at the part in contact with human tissue. The lower arm protrusions 2-4 are distributed at intervals throughout the inner abdomen to increase friction with tissues and prevent slippage and displacement.

[0044] The upper arm spurs 1-4 and the lower arm spurs 2-4 are staggered when the upper arm 1 and the lower arm 2 are closed.

[0045] The locking nail 4 is a "T"-shaped structure, with a larger "T"-shaped top and a smaller "T"-shaped root, and is divided into multiple layers. The outer layer is a tough material, which is connected to the lower arm inner abdomen 2-2 of the lower arm 2; the inner layer is a high-strength material, which is connected to the back of the lower arm 2. The top of the "T"-shaped structure of the locking nail 4 is provided with a sharp edge, which is used to improve the puncture performance when closed.

[0046] The locking hole 5 is made of a tough material and is connected to the inner abdomen 1-2 of the upper arm 1. The shape of the locking hole 5 is adapted to the root of the locking nail 4. When the locking nail 4 passes through the locking hole 5, the larger "T"-shaped top is stuck, forming a fully locked closure, which greatly ensures the closure ability and improves the safety of treatment.

[0047] The upper arm inner abdomen 1-2 and the lower arm inner abdomen 2-2 of the absorbable closure clip are provided with rounded corners 3-1 at the parts in contact with human tissue to prevent cutting of tissue.

[0048] The one-piece hinge 3 is provided with a slot 3-2, which is an elastic hole for enhancing the elasticity of the absorbable closing clip. The slot of the one-piece hinge is also used to accommodate the plastic deformation of the hinge of the closing clip after closing to prevent the hinge from cracking.

[0049] The absorbable closure clip is V-shaped, which is convenient for clamping and fully locking the closed tissue.

[0050] The upper arm 1 and the lower arm 2 of the absorbable closure clip are in the same direction and have a certain curvature, which can increase the closure ability when ligating human tissues with uneven thickness. In addition, the certain arc curvature can guide the stress dispersion when closing the tissue and has a certain function of preventing breakage.

[0051] The absorbable closure clip is made of degradable biomaterials, such as polydioxanone and its copolymers, polyglycolic acid, polylactic acid and its copolymers, and their blends. The degradation products are components that can be completely absorbed by the human body, and no foreign matter remains in the body for a long time.

[0052] The absorbable closure clip is a double-armed fully locked micro closure clip. The closure clip has puncture and closure functions, and can meet the delivery and clamping functions under laparoscope through a matching clip application device, meeting the needs of minimally invasive surgery.

[0053] The upper arm 1 and the lower arm 2 of the absorbable closure clip are made of two or more biomaterials. The high-strength material is located at the back and inner core of the upper arm and the lower arm, and the tough material is located at the inner abdomen and the wrapping ring of the upper arm and the lower arm. The high-strength material and the tough material are mutually embedded and cannot be separated without degradation. The high-strength material is polyglycolic acid, polylactic acid or their copolymers and blends. The tough material is polydioxanone or its copolymers and blends.

[0054] The tough material of the upper arm 1 and the lower arm 2 of the absorbable closure clip is connected at one end to form a connected hinge 3. The upper arm 1 and the lower arm 2 can rotate close to and away from each other around the connected hinge 3 to achieve the action of opening and closing.

[0055] The upper arm clamping piles 1-3 can be arranged on both sides of the upper arm 1, or on the back of the upper arm 1;

[0056] The upper arm clamping piles 1 - 3 can be higher than the upper arm 1 , or can be recessed in the upper arm 1 .

[0057] The lower arm clamping piles 2-3 can be arranged on both sides of the lower arm 2, or on the back of the lower arm 2;

[0058] The lower arm clamping pile 2 - 3 can be higher than the lower arm 2 , or can be recessed in the lower arm 2 .

[0059] The biomaterials used in the absorbable closure clip have different degradation cycles, and can meet the needs of different treatment stages.

[0060] The absorbable closure clip is made of high-strength material with a short degradation period, and can provide greater closure strength before the human body lumen tissue heals.

[0061] The absorbable closure clip is made of a tough material with a long degradation cycle. After the high-strength material degrades and loses its greater closure strength, it can continue to maintain a lower closure strength, thereby improving the blood supply capacity of the affected area and promoting healing; it can also reduce the risk of leakage during the recovery period of patients with poor healing ability.

[0062] The absorbable closure clip is manufactured by an integrated thermoplastic curing molding method.

[0063] The absorbable closure clip is manufactured by an integrated thermoplastic curing molding method, which realizes co-injection of multiple raw materials. No manual participation is required during the molding process, and no consideration is required for assembly and coordination, thereby improving quality uniformity.

[0064] The absorbable closure clip is manufactured by an integrated thermoplastic curing molding method, which realizes full-automatic production, improves production efficiency, reduces manual participation, and can reduce production costs.

Claims

1. An absorbable closure clip, It is characterized in that It includes an upper arm, a lower arm and a one-piece hinge, wherein the upper arm and the lower arm are connected into one body through the one-piece hinge to form an absorbable closed clip; The upper arm is provided with an upper arm back and an upper arm inner abdomen, a locking hole is provided at one end of the upper arm away from the one-piece hinge, and an upper arm clamping pile is provided at the upper end of the upper arm away from the one-piece hinge for installation of a closing clamp and a clamping device; The lower arm is provided with a lower arm back and a lower arm inner abdomen, and a locking nail is provided at one end of the lower arm away from the one-piece hinge, and the locking nail cooperates with the locking hole provided in the upper arm to make the absorbable closing clip form a fully locked closure, and a lower arm clamping pile is provided at the upper end of the lower arm away from the one-piece hinge for installing the closing clip and the clamping device; The locking nail is a "T"-shaped structure, with a larger "T"-shaped top and a smaller "T"-shaped root, and is divided into multiple layers. The outer layer is made of tough material and is connected to the inner abdomen of the lower arm; the inner layer is made of high-strength material and is connected to the back of the lower arm. A sharp blade is provided on the top of the "T"-shaped structure of the locking nail to improve the puncture performance when closed. The upper arm and lower arm of the absorbable closure clip are made of two biomaterials, wherein the high-strength material is located at the back of the upper arm and the back of the lower arm, and the tough material is located at the inner abdomen of the upper arm and the inner abdomen of the lower arm; the high-strength material and the tough material are fused to each other and cannot be separated without degradation, the high-strength material is made of polyglycolic acid, polylactic acid, their copolymers or their blends, and the tough material is made of polydioxanone.

2. The absorbable closure clip according to claim 1, It is characterized in that The upper arm inner abdomen portion in contact with human tissue is provided with upper arm spurs, which are distributed at intervals throughout the inner abdomen and have the function of increasing friction with tissues and preventing slippage and displacement.

3. The absorbable closure clip according to claim 2, It is characterized in that The part of the lower arm inner abdomen that contacts the human body tissue is provided with lower arm spurs, which are distributed at intervals throughout the entire inner abdomen to increase the friction between the lower arm and the tissue and prevent slippage and displacement.

4. The absorbable closure clip according to claim 3, It is characterized in that The upper arm spurs and the lower arm spurs are staggered when the upper arm and the lower arm are closed.

5. The absorbable closure clip according to claim 1, It is characterized in that The portions of the absorbable closing clip where the upper arm inner abdomen and the lower arm inner abdomen contact with human tissue are provided with rounded corners to prevent cutting of the tissue.

6. The absorbable closure clip according to claim 1, It is characterized in that The one-piece hinge is provided with a slot hole, which is an elastic hole for enhancing the elasticity of the absorbable closing clip. The slot hole of the one-piece hinge is also used to accommodate the plastic deformation of the hinge of the closing clip after closing to prevent the hinge from cracking.

7. The absorbable closure clip according to claim 1, It is characterized in that The absorbable closure clip is V-shaped, which is convenient for clamping the fully locked closure tissue.

8. The absorbable closure clip according to claim 1, It is characterized in that The upper arm and the lower arm of the absorbable closure clip are in the same direction of arcs with a certain curvature, which increases the closure ability when ligating human tissues with uneven thickness. The certain arc curvature guides the stress dispersion when closing the tissue and has a certain function of preventing breakage.

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