Anastomotic reinforcement device and preparation method and application thereof

Abstract

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

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an anastomotic reinforcement device and a preparation method and application thereof. Background Art

[0002] Staplers are medical devices commonly used during surgery to replace manual suturing. Compared to manual suturing, staplers can avoid defects such as sparse or dense suturing, or ligatures that are too tight or too loose, ensuring good tissue healing and reducing bleeding complications. Staplers are easy to operate and can significantly shorten surgical time. Staplers are commonly used clinically to cut and staple surgical sites such as the esophagus, stomach, intestines, pancreas, lungs, and trachea. However, as staplers become more common in clinical practice, rigid stapling with staples alone cannot completely prevent leakage and bleeding from the anastomotic tissue. This is because the anastomosis staples are rigid structures and cannot fully match the flexibility of human soft tissues. In addition, due to the differences in soft tissue properties in different areas, some soft tissues (such as the lungs) have low strength, or there are edema and other very fragile tissues at the anastomosis site. The anastomosis formed after stapling often has problems such as air leakage, bleeding, and uneven stapling. Even the fragile tissues above and below the anastomosis are torn by the staples, resulting in poor healing or closure of the anastomosis, and then causing complications such as anastomotic fistula, anastomotic leakage, exudation, and anastomotic bleeding, affecting the surgical effect.

[0003] To address this issue, a number of reinforcement products for anastomosis have been developed on the market. These products are mainly composed of reinforcing materials and connecting materials. The reinforcing materials can be fixed to the tissue at the anastomosis site together with the staples, while the connecting materials install the reinforcing materials on the stapler magazine surface and the anvil surface of the stapler respectively. When using a stapler installed with a reinforcement product to cut and staple the wound, the titanium staples in the stapler magazine are activated to fix the reinforcement materials to the target anastomotic tissue from both sides. The reinforcement materials block the staple holes and increase the strength of the anastomosis, thereby avoiding leakage and bleeding at the anastomosis. The reinforcement materials used in such products are mainly divided into two categories: synthetic materials and biological tissue materials. A large-sample meta-analysis that included 16,967 articles (56,309 cases related to anastomotic leakage and 41,864 cases related to anastomotic bleeding) showed that the use of anastomotic reinforcement products in sleeve gastrectomy and gastric bypass surgery can significantly reduce the incidence of bleeding and anastomotic leakage, and the use of biomaterials as reinforcement materials is superior to synthetic materials.

[0004] The main installation methods for anastomotic reinforcement products are clamping and sleeve installation. Clamping involves using adhesive bonding materials such as glue to secure the reinforcement material to the stapler magazine and anvil surfaces. Sleeve installation involves removably connecting the reinforcement material to a shaped sheet of bonding material using thread to form a sleeve with at least one open end. Before use, the sleeve is placed over the stapler magazine and anvil ends, positioning the reinforcement material on the two surfaces, respectively. In clinical practice, clamping installation is less time-consuming and far more convenient than sleeve installation. Currently, there are anastomotic reinforcement products on the market that utilize biomaterials designed for clamping installation. These biomaterials are typically collagen-rich animal tissues such as bovine pericardium or porcine small intestinal submucosa, and the bonding material is typically an acrylic or resin-based glue. However, a problem with these products is that the bonding material, along with the reinforcement material, becomes fixed to the tissue. The presence of the glue can slow wound healing or cause adhesions to surrounding tissues, hindering postoperative recovery.

[0005] In order to solve the above problems, it is necessary to develop a new type of anastomotic reinforcement device and its preparation method and application. Summary of the Invention

[0006] In view of the problems existing in the prior art, the present invention provides an anastomotic reinforcement device, a preparation method and an application thereof. The anastomotic reinforcement device can be installed on the anastomosis device by a clamping installation method. After the anastomotic staples are activated, the connecting material layer of the anastomotic reinforcement device can be separated from the reinforcing material layer together with the anastomosis device and will not be stapled to the tissue, thereby avoiding problems such as slow postoperative recovery caused by residual connecting material.

[0007] To achieve this object, the present invention adopts the following technical solutions:

[0008] One of the objects of the present invention is to provide an anastomosis reinforcement device, which includes a reinforcement material layer, a connecting material layer and a release film stacked in sequence; wherein the connecting material layer includes 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 reinforcement material layer.

[0009] As a preferred technical solution of the present invention, the reinforcement material layer is made of biological tissue material and has a loose and porous structure inside.

[0010] As a preferred technical solution of the present invention, the thickness of the reinforcement material layer is 0.1mm-1.0mm.

[0011] As a preferred technical solution of the present invention, the material of the waterproof adhesive layer includes silicone.

[0012] As a preferred technical solution of the present invention, the thickness of the waterproof adhesive layer is 0.05-0.25 mm.

[0013] As a preferred technical solution of the present invention, the material of the hydrophobic adhesive layer includes hydrophobic acrylic adhesive.

[0014] As a preferred technical solution of the present invention, the thickness of the hydrophobic adhesive layer is 0.01-0.10 mm.

[0015] As a preferred technical solution of the present invention, the material of the carrier layer includes any one of PE, PET, TPE or PTFE high molecular polymers, and the thickness of the carrier layer is 0.01-0.10 mm.

[0016] A second object of the present invention is to provide a method for preparing the anastomotic reinforcement device according to the first object, the method comprising the following steps:

[0017] (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;

[0018] (2) preparing a reinforcing 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), contacting the reinforcing material layer with the hydrophobic adhesive layer and applying pressure to obtain a matching reinforcing sheet.

[0019] The third object of the present invention is to provide an application of an anastomotic reinforcement device, prepare the anastomotic reinforcement device, peel off the release film on its surface, and stick it to the stapler surface and / or the anvil surface of the stapler for stapling tissues on both sides; wherein the anastomotic reinforcement device is the anastomotic reinforcement device described in the first object, or the anastomotic reinforcement device is prepared by the preparation method described in the second object.

[0020] Compared with the existing technical solutions, the present invention has at least the following beneficial effects:

[0021] During actual application, the release film of the anastomosis reinforcement device described in the present invention is peeled off, and the reinforcement material layer can be fixed on the stapler surface and / or the anvil surface of the stapler with the help of the waterproof adhesive layer. Since the reinforcement material layer is hygroscopic, it will be completely wetted after contacting the liquid on the tissue surface, thereby causing separation between the reinforcement material layer and the hydrophobic adhesive layer. However, the materials of the stapler surface and the anvil surface of the stapler are not hygroscopic, and the connecting material layer (the hydrophobic adhesive layer, the carrier layer and the waterproof adhesive layer stacked in sequence) are still firmly adhered to the stapler surface and / or the anvil surface and are 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1It is a schematic structural diagram of an anastomotic reinforcement device in a specific embodiment of the present invention.

[0023] Figure 2 It is a schematic diagram of the three-dimensional structure after the anastomotic reinforcement device is applied in another specific embodiment of the present invention.

[0024] Figure 3 This is an exploded view of the three-dimensional structure after the anastomotic reinforcement device is applied in another specific embodiment of the present invention.

[0025] In the figure: 1-reinforcement material layer; 2-connection material layer; 21-hydrophobic adhesive layer; 22-carrier layer; 23-waterproof adhesive layer; 3-release film; 100-staple magazine surface of the stapler; 200-staple anvil surface of the stapler; 300-anastomotic reinforcement device. DETAILED DESCRIPTION

[0026] The technical solution of the present invention will be further described below with reference to the accompanying drawings and through specific implementation methods.

[0027] A specific embodiment of the present invention provides an anastomotic reinforcement device, such as Figure 1 As shown, the anastomosis reinforcement device includes a reinforcement material layer 1, a connecting material layer 2 and a release film 3 stacked in sequence; wherein, the connecting material layer 2 includes a hydrophobic adhesive layer 21, a carrier layer 22 and a waterproof adhesive layer 23 stacked in sequence, and the hydrophobic adhesive layer 21 is in contact with the reinforcement material layer 1.

[0028] In the present invention, 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, which can be tightly adhered to a dry surface but cannot be adhered to a wet surface.

[0029] During actual application, the release film of the anastomosis reinforcement device described in the present invention is peeled off, and the reinforcement material layer can be fixed on the stapler surface and / or the anvil surface of the stapler with the help of the waterproof adhesive layer. Since the reinforcement material layer is hygroscopic, it will be completely wetted after contacting the liquid on the tissue surface, thereby causing separation between the reinforcement material layer and the hydrophobic adhesive layer. However, the materials of the stapler surface and the anvil surface of the stapler are not hygroscopic, and the connecting material layer (the hydrophobic adhesive layer, the carrier layer and the waterproof adhesive layer stacked in sequence) are still firmly adhered to the stapler surface and / or the anvil surface and are 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.

[0030] Preferably, the reinforcement material layer is made of biological tissue material, and has a loose porous structure inside.

[0031] It should be noted that the biological tissue material can be a polymer material or an animal-derived tissue material, preferably one that has been treated to remove immunogens; for example, a submucosa material, preferably the small intestinal submucosa material or the bladder submucosa material; or an organ membrane, preferably the pericardium. The reinforcement material layer is made of collagen-rich animal tissue with good biocompatibility. This can be processed into a dry sheet with a loose, porous structure and good hygroscopicity, allowing it to be completely wetted within 1 minute after contact with water.

[0032] Preferably, the thickness of the reinforcement 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 listed values. Other values ​​not listed within the above numerical range are also applicable.

[0033] Preferably, the material of the waterproof adhesive layer includes silicone.

[0034] It should be noted that the stapler's stapler surface is generally made of high-temperature nylon or medical-grade LCP, and the stapler's anvil surface is generally made of alloy or stainless steel. Silicone can adhere tightly to both of these materials and has waterproof properties, making it a good waterproof adhesive layer material.

[0035] Preferably, the thickness of the waterproof adhesive layer is 0.05-0.25 mm, for example, 0.05 mm, 0.07 mm, 0.10 mm, 0.13 mm, 0.15 mm, 0.18 mm, 0.20 mm, 0.23 mm or 0.25 mm, etc., but is not limited to the listed values. Other values ​​not listed within the above numerical range are also applicable.

[0036] Preferably, the material of the hydrophobic adhesive layer includes hydrophobic acrylic adhesive.

[0037] It should be noted that hydrophobic acrylic glue can adhere tightly to most dry surfaces, but cannot adhere to wet surfaces. Therefore, in actual application, the completely wetted reinforcement material layer and the connecting material layer can be separated, avoiding problems such as slow postoperative recovery caused by residual connecting material.

[0038] Preferably, the thickness of the hydrophobic adhesive layer is 0.01-0.10 mm, for example, 0.01 mm, 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm or 0.10 mm, etc., but is not limited to the listed values. Other values ​​not listed within the above numerical range are also applicable.

[0039] Preferably, the material of the carrier layer includes any one of PE, PET, TPE or PTFE, and the thickness of the carrier layer is 0.01-0.10 mm, for example, 0.01 mm, 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm or 0.10 mm, etc., but is not limited to the listed values, and other unlisted values ​​within the above numerical range are also applicable.

[0040] It should be noted that the staples in the stapler are usually made of titanium, while the carrier layer in the present invention is made of a polymer and is relatively thin. The staples can easily penetrate the carrier layer and will not affect the normal operation of the stapler.

[0041] It should be noted that if the connecting material layer is set as a simple adhesive layer, and the reinforcement material layer is fixed to the stapler surface and / or the anvil surface of the stapler simply by the adhesive layer, since there are groove structures on both the stapler surface and the anvil surface, the liquid on the tissue surface will penetrate into the groove structure, which can easily cause the adhesive layer to peel off from the stapler and be stapled to the tissue together with the reinforcement material layer. For this reason, the adhesive layer material will be selected as a hydrophilic glue (such as hydrophilic acrylic glue), which has biocompatibility, reduces irritation to the skin, and promotes tissue compatibility.

[0042] However, the residual adhesive layer may still lead to problems such as slow postoperative recovery. In this regard, the connecting material layer in the present invention includes a hydrophobic adhesive layer (for example, a hydrophobic acrylic adhesive), a carrier layer and a waterproof adhesive layer stacked in sequence. The hydrophobic adhesive layer is in contact with the reinforcing material layer, and the reinforcing material layer and the hydrophobic adhesive layer can be separated during the stapler stapling process. The connecting material layer (the hydrophobic adhesive layer, the carrier layer and the waterproof adhesive layer stacked in sequence) is still firmly adhered to the stapler surface and / or the stapler anvil surface and is not easy to separate. When the stapler is removed, the connecting material layer is removed together with the stapler, thereby avoiding problems such as slow postoperative recovery caused by residual connecting material.

[0043] Another specific embodiment of the present invention provides a method for preparing an anastomotic reinforcement device, the method comprising the following steps:

[0044] (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;

[0045] (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.

[0046] It should be noted that the method for preparing the anastomotic reinforcement device of the present invention first prepares a connecting material layer with a double-sided adhesive structure, that is, both sides have release films to protect the adhesive surface, and the corresponding release films can be removed during use. This improves the customization of the connecting material layer on the anastomotic reinforcement device, and customers can customize the connecting material layer of the anastomotic reinforcement device according to actual application conditions. For example, the connecting material layer can be cut into the same shape and size as the reinforcement material layer, or it can be cut into narrow strips with a smaller width and fixed to the middle of the reinforcement material layer. After experimental research, it was found that the larger the area of ​​the connecting material layer, the longer the separation time from the reinforcement material layer; when the connecting material layer and the reinforcement material layer have the same length and width of 7mm, the separation time is about 90 seconds after the reinforcement material is soaked; when the connecting material layer and the reinforcement material layer have the same length, but the width of the connecting material layer is reduced to 5mm, the separation time is about 40 seconds after the reinforcement material is soaked; when the connecting material layer and the reinforcement material layer have the same length, but the width of the connecting material layer is reduced to 3mm, the separation time is about 20 seconds after the reinforcement material is soaked.

[0047] Another specific embodiment of the present invention provides an application of an anastomotic reinforcement device. The anastomotic reinforcement device is prepared, the release film on its surface is peeled off, and it is adhered to the stapler surface and / or the anvil surface of the stapler for stapling tissues on both sides; wherein, the anastomotic reinforcement device is the anastomotic reinforcement device described in the aforementioned specific embodiment, or the anastomotic reinforcement device is prepared by the preparation method described in the aforementioned other specific embodiment.

[0048] For example, prepare two anastomotic reinforcement devices, peel off the release films on their surfaces, and stick them to the stapler and anvil surfaces of the stapler for stapling tissues on both sides. Figure 2 shows a schematic diagram of the three-dimensional structure after application, Figure 3 An exploded view of the three-dimensional structure after application is shown. It can be seen that the anastomotic reinforcement device 300 of the release film can be respectively adhered to the stapler magazine surface 100 and the anvil surface 200 of the stapler after peeling off; wherein, the ends of the anastomotic reinforcement device 300 are pre-cut with notches, and the position of the notches is convenient for cutting by the stapler cutting head.

[0049] During actual application, the anastomosis reinforcement device is installed on the stapler's stapler surface and / or anvil surface by clamping and installing, clamping the tissue from both sides and stimulating the staples in the stapler. The staples pass through the connecting material layer, the reinforcement material layer, and the tissue in turn, and staple the reinforcement material to the tissue.

[0050] In summary, 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 stapler surface and / or the anvil surface of the stapler are not hygroscopic, and the connecting material layer is still firmly adhered to the stapler surface and / or the anvil surface of 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, thereby avoiding problems such as slow postoperative recovery caused by residual connecting material.

[0051] While the present invention is described through the above-described embodiments to illustrate the detailed structural features of the present invention, the present invention is not limited to these detailed structural features, nor does it necessarily rely on these detailed structural features for implementation. Those skilled in the art should understand that any improvements to the present invention, equivalent replacements for selected components, additions of auxiliary components, and selection of specific embodiments, etc., fall within the scope of protection and disclosure of the present invention.

[0052] The preferred embodiments of the present invention are described in detail above. However, the present invention is not limited to the specific details in the above embodiments. Within the technical concept of the present invention, various simple modifications can be made to the technical solution of the present invention, and these simple modifications all fall within the scope of protection of the present invention.

[0053] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any appropriate manner without contradiction. In order to avoid unnecessary repetition, the present invention will not further describe various possible combinations.

[0054] In addition, the various embodiments of the present invention may be arbitrarily combined, and as long as they do not violate the concept of the present invention, they should also be regarded as the contents disclosed by the present invention.

Claims

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; 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; 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. The anastomotic reinforcement device according to claim 1, characterized in that: The reinforcement material layer is made of biological tissue material.

3. The anastomotic reinforcement device according to claim 1 or 2, characterized in that: The thickness of the reinforcement material layer is 0.1 mm to 1.0 mm.

4. The anastomotic reinforcement device according to claim 1, characterized in that: The material of the waterproof adhesive layer includes silica gel.

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. The anastomotic reinforcement device according to claim 1, characterized in that: The material of the hydrophobic adhesive layer includes hydrophobic acrylic adhesive.

7. The anastomotic reinforcement device according to claim 1 or 6, characterized in that: The thickness of the hydrophobic adhesive layer is 0.01-0.10 mm.

8. The anastomotic reinforcement device according to claim 1, characterized in that: The material of the carrier layer includes any one of PE, PET, TPE or PTFE high molecular polymers, and the thickness of the carrier layer is 0.01-0.10 mm.

9. A method for preparing the anastomotic reinforcement device according to any one of claims 1 to 8, characterized in that: The preparation method comprises the following steps: (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) 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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