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CN120360626B - Anastomotic stoma reinforcement device and preparation method and application thereof - Google Patents

Anastomotic stoma reinforcement device and preparation method and application thereof

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Publication number
CN120360626B
CN120360626B CN202510838526.5A CN202510838526A CN120360626B CN 120360626 B CN120360626 B CN 120360626B CN 202510838526 A CN202510838526 A CN 202510838526A CN 120360626 B CN120360626 B CN 120360626B
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CN
China
Prior art keywords
material layer
adhesive layer
layer
anastomotic
hydrophobic
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Application number
CN202510838526.5A
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Chinese (zh)
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CN120360626A (en
Inventor
张丽
杨军
丁香雨
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Shanghai Cingular Biotech Corp
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Shanghai Cingular Biotech Corp
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Priority to CN202510838526.5A priority Critical patent/CN120360626B/en
Publication of CN120360626A publication Critical patent/CN120360626A/en
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Publication of CN120360626B publication Critical patent/CN120360626B/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

本发明提供了一种吻合口加固装置及其制备方法与应用,所述吻合口加固装置包括依次层叠设置的加固材料层、连接材料层与离型膜;其中,所述连接材料层包括依次层叠设置的疏水胶层、载体层与防水胶层,所述疏水胶层与所述加固材料层相接触。将本发明所述吻合口加固装置的离型膜剥离,借助防水胶层,可以将加固材料层固定在吻合器的钉仓面和/或钉砧面,由于加固材料层具有吸湿性,与组织表面的液体接触后,会被完全润湿,进而导致加固材料层与疏水胶层之间发生分离,但是吻合器的材质均不吸湿,连接材料层仍然与吻合器牢固粘贴不易分开,待吻合器取出时,连接材料层随同吻合器一起被取出,避免了连接材料残留导致的术后恢复缓慢等问题。

The present invention provides an anastomotic reinforcement device and its preparation method and application, wherein the anastomotic reinforcement device comprises a reinforcing material layer, a connecting material layer and a release film stacked in sequence; wherein the connecting material layer comprises a hydrophobic adhesive layer, a carrier layer and a waterproof adhesive layer stacked in sequence, and the hydrophobic adhesive layer is in contact with the reinforcing material layer. The release film of the anastomotic reinforcement device of the present invention is peeled off, and the reinforcing material layer can be fixed to the stapler surface and/or the anvil surface of the stapler with the help of the waterproof adhesive layer. Since the reinforcing material layer is hygroscopic, it will be completely wetted after contacting the liquid on the tissue surface, thereby causing separation between the reinforcing material layer and the hydrophobic adhesive layer. However, the material of the stapler is not hygroscopic, and the connecting material layer is still firmly adhered to the stapler and is not easy to separate. When the stapler is taken out, the connecting material layer is taken out together with the stapler, avoiding problems such as slow postoperative recovery caused by residual connecting material.

Description

Anastomotic stoma reinforcement device and preparation method and application thereof
Technical Field
The invention relates to the technical field of medical instruments, in particular to a anastomotic stoma strengthening device, a preparation method and application thereof.
Background
The anastomat is a medical instrument which is commonly used in operation and replaces manual suturing, compared with manual suturing, the anastomat can avoid the defects of too sparse and too tight manual suturing, too tight ligation, too loose ligation and the like, ensure good healing of tissues, reduce bleeding complications, is simple and convenient to operate, and can greatly shorten operation time. Anastomat is used for cutting and anastomosis of operation parts such as esophagus, stomach, intestine, pancreas, lung, trachea and the like in clinic. However, with the clinical popularization of anastomat, the leakage and bleeding of tissue at the anastomat can not be completely avoided only by combining the hard nails of the anastomat. The anastomotic nail is of a rigid structure, the flexibility of the anastomotic nail is not completely matched with that of soft tissues of a human body, and due to the fact that the soft tissue properties of different areas are different, the strength of some soft tissues (such as lungs) is low, or the anastomotic part is extremely fragile due to the fact that tissues such as oedema and the like are present, the problems of air leakage, blood leakage, irregular stapling and the like can occur at the anastomotic part formed after stapling, even the anastomotic part and fragile tissues above and below are torn by the anastomotic nail, the anastomotic part heals or is not closed well, and then complications such as anastomotic fistula, anastomotic leakage, liquid seepage and anastomotic hemorrhage are caused, and the surgical effect is affected.
In order to solve the problem, a plurality of reinforcement products for the anastomat opening have been developed in the market at present, and the reinforcement products mainly comprise reinforcement materials and connection materials, wherein the reinforcement materials can be fixed on tissues of an anastomat part together with anastomat nails, and the connection materials are used for respectively installing the reinforcement materials on a nail bin surface and a nail anvil surface of a nail box of the anastomat. When the anastomat provided with the reinforcement product is used for cutting and stapling wound surfaces, titanium nails in a nail box of the anastomat are excited, reinforcement materials are fixed on target anastomotic tissues from two sides, the reinforcement materials block nail holes of the anastomat, and meanwhile, the strength of the anastomat is improved, so that leakage and bleeding of the anastomat are avoided. Reinforcing materials used in such products are mainly divided into two types, one type is a synthetic material and the other type is a biological tissue material. A meta-analysis of a large sample containing 16967 documents (56309 cases of related research cases of anastomotic stoma leakage and 41864 cases of related research cases of anastomotic stoma bleeding) shows that the anastomotic stoma strengthening product is applied to sleeve-shaped gastric resection and gastric bypass surgery, the incidence rate of bleeding and anastomotic stoma leakage can be remarkably reduced, and the use of biological materials for strengthening materials is superior to that of synthetic materials.
The mounting mode of the anastomotic stoma reinforced product mainly comprises clamping and mounting and pipe sleeve mounting, wherein the clamping and mounting is to properly bond and fix the reinforced material on the nail bin surface and the nail anvil surface of the anastomat nail box respectively by using adhesive connecting materials such as glue, the pipe sleeve mounting is to detachably connect the reinforced material and sheet connecting materials with certain shapes into pipe sleeves with at least one open end through wires, and the pipe sleeves are sleeved on the nail bin and the nail anvil end of the anastomat nail box respectively before use, so that the reinforced material is positioned on the nail bin surface and the nail anvil surface respectively. The time consumption of the clamping and installing mode in clinical practice is less, and the convenience is far higher than that of the pipe sleeve installing mode. At present, a biological material is designed into a anastomosis reinforcing product which can be clamped and installed in the market, the biological material usually selects animal tissues rich in collagen such as bovine pericardium or porcine small intestine submucosa, and the connecting material is usually acrylic-based glue or resin glue. However, such products have problems in that the connecting material is fixed to the tissue together with the reinforcing material, and the wound may be slow to heal due to the presence of the glue, or the surrounding tissue may adhere, which is disadvantageous for postoperative recovery.
In order to solve the above problems, a novel anastomotic stoma reinforcement device, and a preparation method and application thereof are needed to be developed.
Disclosure of Invention
In view of the problems in the prior art, the invention provides the anastomat reinforcing device, the preparation method and the application thereof, the anastomat reinforcing device can be installed on an anastomat in a clamping installation mode, after anastomat nails are excited, a connecting material layer of the anastomat reinforcing device can be separated from a reinforcing material layer along with the anastomat, the anastomat reinforcing material layer cannot be nailed on tissues, and the problems of slow postoperative recovery and the like caused by connecting material residues are avoided.
To achieve the purpose, the invention adopts the following technical scheme:
The invention aims to provide a anastomotic stoma strengthening device which comprises a strengthening material layer, a connecting material layer and a release film which are sequentially stacked, wherein the connecting material layer comprises a hydrophobic adhesive layer, a carrier layer and a waterproof adhesive layer which are sequentially stacked, and the hydrophobic adhesive layer is in contact with the strengthening material layer.
As a preferable technical scheme of the invention, the material of the reinforcing material layer is biological tissue material, and the inside of the reinforcing material layer is in a loose porous structure.
As a preferable technical scheme of the invention, the thickness of the reinforcing material layer is 0.1mm-1.0mm.
As a preferable technical scheme of the invention, the waterproof glue layer is made of silica gel.
As a preferable technical scheme of the invention, the thickness of the waterproof adhesive layer is 0.05-0.25mm.
As a preferable technical scheme of the invention, the material of the hydrophobic adhesive layer comprises hydrophobic acrylate adhesive.
As a preferable technical scheme of the invention, the thickness of the hydrophobic adhesive layer is 0.01-0.10mm.
As a preferable technical scheme of the invention, the material of the carrier layer comprises PE, PET, TPE or any one of high-molecular polymers of PTFE, and the thickness of the carrier layer is 0.01-0.10mm.
The second object of the present invention is to provide a method for manufacturing the anastomotic stoma reinforcement device, which comprises the following steps:
(1) Preparing a carrier layer, respectively arranging a waterproof adhesive layer and a hydrophobic adhesive layer on two side surfaces of the carrier layer, and respectively arranging release films on the surfaces of the waterproof adhesive layer and the hydrophobic adhesive layer to obtain a connecting material layer with a double-sided adhesive structure;
(2) Preparing a reinforcing material layer, stripping the release film which is close to the hydrophobic adhesive layer in the connecting material layer with the double-sided adhesive structure obtained in the step (1), and contacting and pressurizing the reinforcing material layer with the hydrophobic adhesive layer to obtain the anastomotic reinforcing sheet.
The invention further provides an application of the anastomotic stoma reinforcement device, wherein the anastomotic stoma reinforcement device is prepared, a release film on the surface of the anastomotic stoma reinforcement device is peeled off and stuck on a nail bin surface and/or a nail anvil surface of an anastomat for nailing tissues on two sides, and the anastomotic stoma reinforcement device is prepared by one of the anastomotic stoma reinforcement devices or two of the preparation methods for the anastomotic stoma reinforcement device.
Compared with the prior art, the invention has at least the following beneficial effects:
in the practical application process, the release film of the anastomat reinforcing device is peeled off, the reinforcing material layer can be fixed on the nail bin surface and/or the nail anvil surface of the anastomat by means of the waterproof adhesive layer, and the reinforcing material layer is completely wetted after being contacted with liquid on the tissue surface due to hygroscopicity, so that the reinforcing material layer and the hydrophobic adhesive layer are separated, but the materials of the nail bin surface and the nail anvil surface of the anastomat are not hygroscopic, the connecting material layer (the hydrophobic adhesive layer, the carrier layer and the waterproof adhesive layer which are sequentially laminated) is still firmly adhered to the nail bin surface and/or the nail anvil surface and is not easy to separate, and when the anastomat is taken out, the connecting material layer is taken out along with the anastomat, so that the problems of slow postoperative recovery and the like caused by residual connecting material are avoided.
Drawings
Fig. 1 is a schematic structural view of a stoma reinforcement apparatus according to an embodiment of the present invention.
Fig. 2 is a schematic perspective view of a stoma reinforcement apparatus according to another embodiment of the invention after application.
Fig. 3 is an exploded view of a three-dimensional structure of a stoma reinforcement device after application in accordance with yet another embodiment of the present invention.
In the figure, the material comprises a 1-reinforcing material layer, a 2-connecting material layer, a 21-hydrophobic adhesive layer, a 22-carrier layer, a 23-waterproof adhesive layer, a 3-release film, a nail bin surface of a 100-anastomat, a nail anvil surface of a 200-anastomat and a 300-anastomat reinforcing device.
Detailed Description
The technical scheme of the invention is further described below by the specific embodiments with reference to the accompanying drawings.
The embodiment of the invention provides a anastomotic stoma strengthening device, which comprises a strengthening material layer 1, a connecting material layer 2 and a release film 3 which are sequentially stacked, wherein the connecting material layer 2 comprises a hydrophobic adhesive layer 21, a carrier layer 22 and a waterproof adhesive layer 23 which are sequentially stacked, and the hydrophobic adhesive layer 21 is in contact with the strengthening material layer 1.
In the invention, the waterproof adhesive layer refers to an adhesive layer which can resist water immersion or wetting without losing adhesive property, and the hydrophobic adhesive layer refers to an adhesive layer with hydrophobic property on the surface, wherein the surface can be tightly adhered to a dry surface but cannot be adhered to a wet surface.
In the practical application process, the release film of the anastomat reinforcing device is peeled off, the reinforcing material layer can be fixed on the nail bin surface and/or the nail anvil surface of the anastomat by means of the waterproof adhesive layer, and the reinforcing material layer is completely wetted after being contacted with liquid on the tissue surface due to hygroscopicity, so that the reinforcing material layer and the hydrophobic adhesive layer are separated, but the materials of the nail bin surface and the nail anvil surface of the anastomat are not hygroscopic, the connecting material layer (the hydrophobic adhesive layer, the carrier layer and the waterproof adhesive layer which are sequentially laminated) is still firmly adhered to the nail bin surface and/or the nail anvil surface and is not easy to separate, and when the anastomat is taken out, the connecting material layer is taken out along with the anastomat, so that the problems of slow postoperative recovery and the like caused by residual connecting material are avoided.
Preferably, the material of the reinforcement material layer is biological tissue material, and the inside of the reinforcement material layer is in a loose porous structure.
The biological tissue material may be a polymer material or an animal-derived tissue material, preferably an animal-derived tissue material subjected to an immunogen removal treatment, for example, a submucosa material, preferably a small intestine submucosa material or a bladder submucosa material, or an organ envelope, preferably a pericardium. The reinforcing material layer is made of animal tissues rich in collagen, which have good biocompatibility, can be processed into a dry sheet with an internal loose porous structure, has good hygroscopicity, and can be fully wetted after 1 minute in water.
Preferably, the thickness of the reinforcing material layer is 0.1mm-1.0mm, for example 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm or 1.0mm, etc., but is not limited to the recited values, and other non-recited values within the above-recited range are equally applicable.
Preferably, the waterproof glue layer is made of silica gel.
It should be noted that, the nail bin surface of the anastomat is generally high-temperature nylon or medical grade LCP, the nail anvil surface of the anastomat is generally alloy or stainless steel, and the silica gel can be tightly adhered to the two materials and has waterproof performance, thus the anastomat belongs to a good waterproof adhesive layer material.
Preferably, the thickness of the waterproof glue layer is 0.05-0.25mm, for example 0.05mm, 0.07mm, 0.10mm, 0.13mm, 0.15mm, 0.18mm, 0.20mm, 0.23mm or 0.25mm, etc., but not limited to the recited values, and other non-recited values within the above-mentioned range are equally applicable.
Preferably, the material of the hydrophobic adhesive layer comprises hydrophobic acrylate adhesive.
It should be noted that the hydrophobic acrylate adhesive can be tightly adhered to most of the dry surfaces, but cannot be adhered to wet surfaces, so that the completely wetted reinforcing material layer and the connecting material layer can be separated in the practical application process, and the problems of slow postoperative recovery and the like caused by the residual connecting material are avoided.
Preferably, the thickness of the hydrophobic adhesive layer is 0.01-0.10mm, for example 0.01mm, 0.02mm, 0.03mm, 0.04mm, 0.05mm, 0.06mm, 0.07mm, 0.08mm, 0.09mm or 0.10mm, etc., but not limited to the recited values, other non-recited values within the above-mentioned range are equally applicable.
Preferably, the material of the carrier layer includes PE, PET, TPE or any polymer of PTFE, and the thickness of the carrier layer is 0.01-0.10mm, for example, 0.01mm, 0.02mm, 0.03mm, 0.04mm, 0.05mm, 0.06mm, 0.07mm, 0.08mm, 0.09mm, or 0.10mm, etc., but not limited to the recited values, and other non-recited values within the above range are equally applicable.
It should be noted that, the staples in the anastomat are usually titanium staples, but the carrier layer is made of high polymer and has a relatively thin thickness, so that the staples can easily penetrate the carrier layer and the normal operation of the anastomat is not affected.
It should be noted that if the connecting material layer is set to be a simple adhesive layer, the reinforcing material layer is fixed on the nail bin surface and/or the nail anvil surface of the anastomat only through the adhesive layer, and because the groove structures exist on both the nail bin surface and the nail anvil surface, the liquid on the tissue surface can infiltrate into the groove structures, which is very easy to cause the adhesive layer to be peeled off from the anastomat and be stapled on the tissue along with the reinforcing material layer, and therefore, the adhesive layer material can be hydrophilic adhesive (such as hydrophilic acrylate adhesive) with biocompatibility, so that the irritation to the skin is reduced, and the histocompatibility is promoted.
However, the residual adhesive layer still may cause problems such as slow recovery after operation, and in this invention, the connecting material layer includes a hydrophobic adhesive layer (for example, hydrophobic acrylate adhesive), a carrier layer and a waterproof adhesive layer which are sequentially stacked, the hydrophobic adhesive layer is in contact with the reinforcing material layer, separation between the reinforcing material layer and the hydrophobic adhesive layer can be realized in the stapling process of the stapler, the connecting material layer (the hydrophobic adhesive layer, the carrier layer and the waterproof adhesive layer which are sequentially stacked) is still firmly adhered to the nail bin surface and/or the nail anvil surface and is not easy to separate, and when the stapler is taken out, the connecting material layer is taken out along with the stapler, so that the problems such as slow recovery after operation caused by residual connecting material are avoided.
Another embodiment of the present invention provides a method for manufacturing a stoma reinforcement apparatus, the method comprising the steps of:
(1) Preparing a carrier layer, respectively arranging a waterproof adhesive layer and a hydrophobic adhesive layer on two side surfaces of the carrier layer, and respectively arranging release films on the surfaces of the waterproof adhesive layer and the hydrophobic adhesive layer to obtain a connecting material layer with a double-sided adhesive structure;
(2) Preparing a reinforcing material layer, stripping the release film which is close to the hydrophobic adhesive layer in the connecting material layer with the double-sided adhesive structure obtained in the step (1), and contacting and pressurizing the reinforcing material layer with the hydrophobic adhesive layer to obtain the anastomotic stoma reinforcing device.
In the preparation method of the anastomotic stoma strengthening device, the connecting material layer with the double-sided adhesive structure is prepared, namely, the adhesive surfaces are protected by the release films on both sides, the corresponding release films can be removed when in use, the customization of the connecting material layer on the anastomotic stoma strengthening device is improved, and a customer can customize the connecting material layer of the anastomotic stoma strengthening device according to actual application conditions. For example, the connecting material layer may be cut into the same shape and the same size as the reinforcing material layer, or may be cut into a narrow strip having a smaller width and fixed to the middle of the reinforcing material layer. Through experimental study, the larger the area of the connecting material layer is, the longer the separating time from the reinforcing material layer is, when the lengths of the connecting material layer and the reinforcing material layer are the same, the width is 7mm, after the reinforcing material is soaked, the separating time is about 90 seconds, when the lengths of the connecting material layer and the reinforcing material layer are the same, but the width of the connecting material layer is reduced to 5mm, after the reinforcing material is soaked, the separating time is about 40 seconds, when the lengths of the connecting material layer and the reinforcing material layer are the same, but the width of the connecting material layer is reduced to 3mm, and after the reinforcing material is soaked, the separating time is about 20 seconds.
The invention further provides an application of the anastomotic stoma strengthening device, which comprises the steps of preparing the anastomotic stoma strengthening device, peeling off a release film on the surface of the anastomotic stoma strengthening device, adhering the anastomotic stoma strengthening device to a nail bin surface and/or a nail anvil surface of an anastomat for nailing tissues on two sides, wherein the anastomotic stoma strengthening device is prepared by the anastomotic stoma strengthening device in one embodiment or the anastomotic stoma strengthening device is prepared by the preparation method in the other embodiment.
For example, two anastomotic stoma reinforcing devices are prepared, release films on the surfaces of the anastomotic stoma reinforcing devices are respectively peeled off and adhered to a nail bin surface and a nail anvil surface of an anastomat for stapling tissues on two sides, a three-dimensional structure diagram after application is shown in fig. 2, and a three-dimensional structure explosion diagram after application is shown in fig. 3, and it can be seen that the peeled off release films of the anastomotic stoma reinforcing devices 300 can be respectively adhered to the nail bin surface 100 and the nail anvil surface 200 of the anastomat, wherein notches are cut in advance at the end parts of the anastomotic stoma reinforcing devices 300, and the positions of the notches are convenient for cutting by an anastomat cutting tool bit.
In the practical application process, the anastomotic stoma strengthening device is arranged on the nail bin surface and/or the nail anvil surface of the anastomat in a clamping and mounting mode, then tissue is clamped from two sides, the anastomotic nails in the nail bin are excited, and sequentially penetrate through the connecting material layer, the strengthening material layer and the tissue, so that the strengthening material is nailed to the tissue.
In summary, the invention provides a anastomotic stoma reinforcement device, a preparation method and application thereof, wherein the anastomotic stoma reinforcement device comprises a reinforcement material layer, a connecting material layer and a release film which are sequentially stacked, the connecting material layer comprises a hydrophobic adhesive layer, a carrier layer and a waterproof adhesive layer which are sequentially stacked, and the hydrophobic adhesive layer is in contact with the reinforcement material layer. The release film of the anastomat reinforcing device is peeled off, the reinforcing material layer can be fixed on the nail bin surface and/or the nail anvil surface of the anastomat by means of the waterproof adhesive layer, and the reinforcing material layer is completely wetted after being contacted with liquid on the tissue surface due to hygroscopicity, so that the reinforcing material layer and the hydrophobic adhesive layer are separated, but the nail bin surface and/or the nail anvil surface of the anastomat are not hygroscopic, the connecting material layer is firmly adhered to the nail bin surface and/or the nail anvil surface of the anastomat and is not easy to separate, and when the anastomat is taken out, the connecting material layer is taken out along with the anastomat, so that the problems of slow postoperative recovery and the like caused by residual connecting material are avoided.
The detailed structural features of the present invention are described in the above embodiments, but the present invention is not limited to the above detailed structural features, that is, it does not mean that the present invention must be implemented depending on the above detailed structural features. It should be apparent to those skilled in the art that any modifications of the present invention, equivalent substitutions of selected components of the present invention, addition of auxiliary components, selection of specific modes, etc., are within the scope of the present invention and the scope of the disclosure.
The preferred embodiments of the present invention have been described in detail above, but the present invention is not limited to the specific details of the above embodiments, and various simple modifications can be made to the technical solution of the present invention within the scope of the technical concept of the present invention, and all the simple modifications belong to the protection scope of the present invention.
In addition, the specific features described in the above embodiments may be combined in any suitable manner, and in order to avoid unnecessary repetition, various possible combinations are not described further.
Moreover, any combination of the various embodiments of the invention can be made without departing from the spirit of the invention, which should also be considered as disclosed herein.

Claims (9)

1.一种吻合口加固装置,其特征在于,所述吻合口加固装置包括依次层叠设置的加固材料层、连接材料层与离型膜;其中,所述连接材料层包括依次层叠设置的疏水胶层、载体层与防水胶层,所述疏水胶层与所述加固材料层相接触;1. An anastomotic reinforcement device, characterized in that the anastomotic reinforcement device comprises a reinforcing material layer, a connecting material layer, and a release film stacked in sequence; wherein the connecting material layer comprises a hydrophobic adhesive layer, a carrier layer, and a waterproof adhesive layer stacked in sequence, and the hydrophobic adhesive layer is in contact with the reinforcing material layer; 其中,所述防水胶层指的是能够耐受水浸或者润湿情况而不失去粘接性能的胶粘层,所述疏水胶层指的是表面具有疏水性能的胶层,表面可以紧密粘贴于干燥表面,但是无法粘贴于湿润表面;The waterproof adhesive layer refers to an adhesive layer that can withstand water immersion or wetting without losing its adhesive properties, and the hydrophobic adhesive layer refers to an adhesive layer with a hydrophobic surface that can be tightly adhered to a dry surface but cannot be adhered to a wet surface; 其中,在实际应用过程中,借助所述防水胶层,将所述加固材料层固定在吻合器的钉仓面和/或钉砧面,所述加固材料层具有吸湿性,与组织表面的液体接触后,会被完全润湿,进而导致所述加固材料层与所述疏水胶层之间发生分离,所述连接材料层仍然与钉仓面和/或钉砧面牢固粘贴不易分开,待吻合器取出时,连接材料层随同吻合器一起被取出。Among them, in actual application, with the help of the waterproof adhesive layer, the reinforcing material layer is fixed on the stapler's stapler surface and/or staple anvil surface. The reinforcing material layer is hygroscopic and will be completely wetted after contacting the liquid on the tissue surface, thereby causing separation between the reinforcing material layer and the hydrophobic adhesive layer. The connecting material layer is still firmly adhered to the stapler surface and/or staple anvil surface and is not easy to separate. When the stapler is taken out, the connecting material layer is taken out together with the stapler. 2.根据权利要求1所述的吻合口加固装置,其特征在于,所述加固材料层的材质为生物组织材料。2. The anastomotic reinforcement device according to claim 1 is characterized in that the reinforcement material layer is made of biological tissue material. 3.根据权利要求1或2所述的吻合口加固装置,其特征在于,所述加固材料层的厚度为0.1mm-1.0mm。3 . The anastomotic reinforcement device according to claim 1 , wherein the thickness of the reinforcement material layer is 0.1 mm to 1.0 mm. 4.根据权利要求1所述的吻合口加固装置,其特征在于,所述防水胶层的材质包括硅胶。4. The anastomotic reinforcement device according to claim 1, characterized in that the material of the waterproof adhesive layer includes silicone. 5.根据权利要求1或4所述的吻合口加固装置,其特征在于,所述防水胶层的厚度为0.05-0.25mm。5. The anastomotic reinforcement device according to claim 1 or 4, characterized in that the thickness of the waterproof adhesive layer is 0.05-0.25 mm. 6.根据权利要求1所述的吻合口加固装置,其特征在于,所述疏水胶层的材质包括疏水性丙烯酸酯胶。6 . The anastomotic reinforcement device according to claim 1 , wherein the hydrophobic adhesive layer is made of hydrophobic acrylic adhesive. 7.根据权利要求1或6所述的吻合口加固装置,其特征在于,所述疏水胶层的厚度为0.01-0.10mm。7 . The anastomotic reinforcement device according to claim 1 , wherein the thickness of the hydrophobic adhesive layer is 0.01-0.10 mm. 8.根据权利要求1所述的吻合口加固装置,其特征在于,所述载体层的材质包括PE、PET、TPE或PTFE中的任意一种高分子聚合物,所述载体层的厚度为0.01-0.10mm。8. The anastomotic reinforcement device according to claim 1, characterized in that the material of the carrier layer comprises any one of PE, PET, TPE or PTFE polymers, and the thickness of the carrier layer is 0.01-0.10 mm. 9.一种权利要求1-8任一项所述吻合口加固装置的制备方法,其特征在于,所述制备方法包括如下步骤:9. A method for preparing the anastomotic reinforcement device according to any one of claims 1 to 8, characterized in that the method comprises the following steps: (1)准备载体层,在所述载体层的两个侧面分别设置防水胶层、疏水胶层,在所述防水胶层与所述疏水胶层的表面分别设置离型膜,得到呈双面胶结构的连接材料层;(1) preparing a carrier layer, disposing a waterproof adhesive layer and a hydrophobic adhesive layer on two sides of the carrier layer, and disposing release films on the surfaces of the waterproof adhesive layer and the hydrophobic adhesive layer, respectively, to obtain a connecting material layer with a double-sided adhesive structure; (2)准备加固材料层,将步骤(1)所得呈双面胶结构的连接材料层中靠近所述疏水胶层的离型膜剥离,将所述加固材料层与所述疏水胶层相接触并加压,得到吻合口加固装置。(2) preparing a reinforcement material layer, peeling off the release film close to the hydrophobic adhesive layer in the connecting material layer with a double-sided adhesive structure obtained in step (1), bringing the reinforcement material layer into contact with the hydrophobic adhesive layer and applying pressure to obtain an anastomotic reinforcement device.
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