Tissue reinforcement material and tissue reinforcement material application kit for automatic staplers

Abstract

To provide a tissue reinforcing material for an automatic suture device allowing to correctly and easily mount it on the automatic suture device in a short time, while suppressing slippage, by using a tissue reinforcing material mounting tool, and tissue reinforcing material mounting kit consisting of the tissue reinforcing material for the automatic suture device and tissue reinforcing material mounting tool.SOLUTION: A tissue reinforcing material for use in a tissue reinforcing material mounting tool, has a structure formed by laminating and integrating a cloth-like body layer made of a bioabsorbable material, and a sponge layer formed of water-soluble polymer, where a side in contact with a fixing part of the tissue reinforcing material, of the tissue reinforcing material mounting tool has a wave shape, and the wave is so formed as to be engaged with the fixing part.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a tissue reinforcement material for automatic staplers, which can be used in a tissue reinforcement material attachment device to be attached to an automatic stapler accurately and easily in a short time while suppressing displacement, and to a tissue reinforcement material attachment kit comprising the tissue reinforcement material for automatic staplers and a tissue reinforcement material attachment device. [Background technology]

[0002] Traditionally, automatic staplers with numerous embedded staples have been used for suturing tissues. However, when applied to the lungs and other tissues, there have been problems with air leakage from the suture site, and when applied to soft tissues, problems such as tissue damage and rupture have occurred.

[0003] Therefore, bioabsorbable reinforcing materials are used with automatic staplers to prevent air leakage, fluid leakage, and tissue damage (for example, Patent Documents 1 and 2). The reinforcing materials in Patent Documents 1 and 2 are formed into a tubular structure by sewing together two opposing sides of a single bioabsorbable nonwoven fabric, or by layering two bioabsorbable nonwoven fabrics or one bioabsorbable nonwoven fabric with one stretch knitted fabric and sewing together two opposing sides. The end of the cartridge of the automatic stapler is then inserted into the tubular structure to attach it to the automatic stapler, and the tissue is reinforced by being sutured together with the tissue. Furthermore, after reinforcement, unnecessary parts can be separated by pulling the threads extending from the reinforcing material, resulting in high work efficiency. Moreover, since the reinforcing material is made of bioabsorbable nonwoven fabric, it is ultimately absorbed into the body after reinforcement is no longer needed. [Prior art documents] [Patent Documents]

[0004] [Patent Document 1] Japanese Patent Application Publication No. 08-047526 [Patent Document 2] Patent No. 4675237 [Overview of the project] [Problems that the invention aims to solve]

[0005] Conventional automatic staplers use reinforcing materials that combine a reinforcing fabric with an elastic fabric to form a tubular shape, ensuring a tight fit against the stapler and preventing shifting during operation. However, since stapler cartridges come in various sizes, depending on the cartridge size, the reinforcing material may not be able to fit snugly against the stapler, leading to shifting. Furthermore, even when using reinforcing materials that are sized to fit the cartridge, gaps may form near the seams of the fabric, potentially causing shifting.

[0006] On the other hand, in endoscopic surgery using an automatic stapler, multiple tubular ports are punctured into the patient's body, and instruments such as endoscopes and automatic staplers are inserted through these ports. In this case, conventional reinforcing materials are attached so as to surround the cartridge part of the automatic stapler, which can cause the reinforcing material to get caught when inserting the automatic stapler into the port. Also, because the presence of the reinforcing material surrounding the cartridge part makes the automatic stapler with the reinforcing material attached larger, it is not possible to pass the automatic stapler through a port with a larger diameter than the size of the automatic stapler itself. From the perspective of reducing the burden on the patient, there is a need for reinforcing materials that can be passed through a smaller diameter port.

[0007] Therefore, the applicant proposes a suture tissue reinforcement material for automatic staplers (hereinafter simply referred to as "tissue reinforcement material") which is a laminated and integrated material comprising a fabric layer made of a bioabsorbable material and a sponge layer made of a water-soluble polymer. Such a tissue reinforcement material can be attached to an automatic stapler by being attached to the cartridge part, as the sponge layer absorbs moisture and generates adhesive force. It can be used with automatic staplers of all sizes, and it has high portability, making it less likely to shift when the automatic stapler is operated.

[0008] Furthermore, the applicant has also proposed a tissue reinforcement material attachment device for easily attaching the above-mentioned tissue reinforcement material to an automatic stapler. This tissue reinforcement material attachment device has recesses on opposing positions on both sides of a plate-shaped member, and the recesses have claw-shaped fixing parts that clamp and secure the tissue reinforcement material. By attaching the tissue reinforcement material to the recesses on both sides of the member and immersing it in water, and then clamping the automatic stapler into the recesses, the tissue reinforcement material can be easily and reliably attached to the predetermined position.

[0009] However, while such tissue reinforcement device attachments provide sufficient fixation in the width direction by being sandwiched between the fixing parts, the tissue reinforcement may shift in the longitudinal direction perpendicular to these parts. Therefore, from the perspective of accurate attachment, there is a need for a method that can further suppress the shifting of the tissue reinforcement.

[0010] The present invention aims to provide a tissue reinforcement material for automatic staplers that can be used in a tissue reinforcement material attachment device to be attached to an automatic stapler accurately and easily in a short time while suppressing displacement, and a tissue reinforcement material attachment kit comprising the tissue reinforcement material for automatic staplers and a tissue reinforcement material attachment device. [Means for solving the problem]

[0011] The tissue reinforcement material for automatic suturers of the present invention (hereinafter also simply referred to as tissue reinforcement material) is a tissue reinforcement material used in a tissue reinforcement material attachment device. By using it in a tissue reinforcement material attachment device, displacement during attachment to the tissue reinforcement material attachment device is suppressed, allowing for accurate attachment of the tissue reinforcement material to the designated position on the automatic stapler. The tissue reinforcement material of the present invention and the tissue reinforcement material attachment device to which it is used will be described in detail below, but first, the tissue reinforcement material of the present invention will be described in detail.

[0012] The tissue reinforcement material of the present invention has a fabric-like layer made of a bioabsorbable material. By using bioabsorbable materials as tissue reinforcement materials, the materials are eventually absorbed into the body after reinforcement is no longer needed, thus preventing the retention of foreign substances in the body for extended periods and ensuring high safety. In this invention, "automatic stapler" includes not only automatic staplers but also automatic anastomotic devices.

[0013] Examples of the above-mentioned bioabsorbable materials include synthetic absorbent polymers such as polyglycolide, polylactide (D, L, DL isomers), glycolyde-lactide (D, L, DL isomers) copolymers, glycolyde-ε-caprolactone copolymers, lactide (D, L, DL isomers)-ε-caprolactone copolymers, poly(p-dioxanone), glycolyde-lactide (D, L, DL isomers)-ε-caprolactone copolymers, and α-hydroxy acid polymer polymers, as well as natural absorbent polymers such as collagen, gelatin, chitosan, and chitin. These may be used individually or in combination of two or more. For example, when using the above-mentioned synthetic absorbent polymers as the bioabsorbable material, natural absorbent polymers may be used in combination. Among these, polyglycolic acid, polylactic acid, or copolymers of lactic acid and caprolactone are preferred due to their high strength.

[0014] When using polyglycolide (a homopolymer or copolymer of glycolide) as the bioabsorbable material described above, the preferred lower limit of the weight-average molecular weight of the polyglycolide is 30,000, and the preferred upper limit is 1,000,000. If the weight-average molecular weight of the polyglycolide is 30,000 or higher, tissue reinforcement can be achieved more reliably, and if it is 1,000,000 or lower, foreign body reactions can be further suppressed. A more preferred lower limit of the weight-average molecular weight of the polyglycolide is 50,000, and a more preferred upper limit is 300,000.

[0015] The form of the above-mentioned fabric-like layer is not particularly limited and may be any form, such as knitted fabric, woven fabric, nonwoven fabric, or film. Among these, nonwoven fabric is preferred from the viewpoint of flexibility, breathability, and ease of staple passage.

[0016] If the above-mentioned fabric-like layer is a nonwoven fabric, the basis weight of the nonwoven fabric is not particularly limited, but a preferred lower limit is 3 g / m².2 , a preferable upper limit is 300 g / m 2 is as follows. When the basis weight of the nonwoven fabric is 3 g / m 2 or more, the tissue can be more reliably reinforced. When it is 300 g / m 2 or less, the adhesiveness to the tissue can be further enhanced. A more preferable lower limit of the basis weight of the bioabsorbable nonwoven fabric is 5 g / m 2 , and a more preferable upper limit is 100 g / m 2 .

[0017] The method for producing the nonwoven fabric is not particularly limited. For example, conventionally known methods such as electrospinning deposition method, melt blowing method, needle punching method, spunbond method, flash spinning method, hydroentangling method, airlaid method, thermal bonding method, resin bonding method, wet method, etc. can be used.

[0018] The tissue reinforcing material of the present invention has a sponge layer made of a water-soluble polymer. Since the water-soluble polymer exhibits adhesiveness when it contains moisture, by providing a layer made of a water-soluble polymer on the fabric layer, after immersing the automatic suturing device in physiological saline, the tissue reinforcing material can be simply attached to the working surface of the automatic suturing device, enabling it to be mounted on the automatic suturing device, and making it difficult for the tissue reinforcing material to shift during the operation of the automatic suturing device. Further, by forming the water-soluble polymer into a sponge shape, it can easily absorb moisture and quickly exhibit adhesiveness. Also, since it can be mounted simply by attaching it to the working surface of the automatic suturing device, there is no need to make the tissue reinforcing material into a conventional cylindrical shape, and it can be used for automatic suturing devices of any size. Furthermore, since there is no tissue reinforcing material outside the working surface of the automatic suturing device, the tissue reinforcing material will not get caught when inserting the automatic suturing device into the port, and the automatic suturing device can be passed through a port with a smaller diameter. Here, the sponge shape refers to a structure having a large number of voids.

[0019] Examples of the water-soluble polymer include natural polymers such as polysaccharide-based materials and protein-based materials, and synthetic polymers such as polyacrylic acid and polyvinyl alcohol. Since the suture tissue reinforcing material for the automatic suturing device is implanted in the body, a material with high biocompatibility is required. Among them, since it is difficult for displacement to occur during the operation of the automatic suturing device and it has an adhesive force that allows easy peeling at the end of suturing, the water-soluble polymer is preferably a polysaccharide-based material or a protein-based material. Examples of the polysaccharide-based material include hydroxypropylmethylcellulose, pullulan, sodium alginate, carboxymethylcellulose, etc., and examples of the protein-based material include gelatin, collagen peptide, water-soluble elastin, etc.

[0020] It is desirable that the viscosity of the water-soluble polymer when made into an aqueous solution with a concentration of 2% is 1 mPa·s or more and 500 mPa·s or less. By using the water-soluble polymer within the above range, when made into a sponge layer, it has appropriate softness, and after water penetrates, it exhibits appropriate adhesiveness and can be easily attached to the automatic suturing device.

[0021] The sponge layer is preferably a lyophilized product. By forming the sponge layer by freeze-drying, the sponge layer can be formed without using a pore-forming agent, so it is not necessary to remove the pore-forming agent, and a sponge layer with high material purity can be formed. The freeze-drying method is not particularly limited, and a conventionally known method can be used.

[0022] The thickness of the sponge layer is preferably 0.5 mm or more and 10 mm or less. By setting the thickness of the sponge layer within the above range, it is possible to further suppress displacement during the operation of the automatic suturing device and to easily adjust the adhesive force to an appropriate level that allows for easy peeling after suturing. The thickness of the sponge layer is preferably 1.5 mm or more and preferably 5.0 mm or less. When the sponge layer is formed by freeze-drying, the thickness of the sponge layer can be adjusted by the amount of the water-soluble polymer solution in which the cloth-like layer is immersed. Here, the thickness of the sponge layer refers to the average of the thicknesses measured at intervals of 1 location / cm using a dial gauge (for example, SMD-565J-L manufactured by Techlock Co., Ltd.) over the entire area of the sponge layer. 2 This refers to the average of the thicknesses measured at intervals of 1 location / cm using a dial gauge (for example, SMD-565J-L manufactured by Techlock Co., Ltd.) over the entire area of the sponge layer.

[0023] The density of the sponge layer is not particularly limited, but is preferably 0.04 g / cm 3 or more and 0.2 g / cm 3 or less. By setting the density of the sponge layer within the above range, it is possible to further suppress displacement during the operation of the automatic suturing device and to easily adjust the adhesive force to an appropriate level that allows for easy peeling after suturing.

[0024] In the tissue reinforcing material of the present invention, the cloth-like layer and the sponge layer are laminated and integrated. The sponge layer that exhibits the adhesive force is laminated and integrated with the cloth-like layer, which improves the handling property and allows the tissue reinforcing material to be easily attached to the automatic suturing device at the surgical site. Here, lamination and integration means joining the two layers so that peeling hardly occurs between the cloth-like layer and the sponge layer even when a force is applied. As a method of laminating and integrating the cloth-like layer and the sponge layer, a method of floating the cloth-like body on the water-soluble polymer solution that is the raw material of the sponge layer and then performing freeze-drying can be mentioned. In order to enhance the interfacial adhesion between the cloth-like layer and the sponge layer, it is preferable to perform a hydrophilic treatment on the cloth-like body using a plasma treatment device or the like to improve the permeability of the water-soluble polymer solution into the cloth-like body.

[0025] The tissue reinforcement material of the present invention has a wavy shape on the edge that contacts the fixing portion of the tissue reinforcement material in the tissue reinforcement material attachment device, and the waves are formed to interlock with the fixing portion. The aforementioned fixing parts are multiple parts provided along a pair of edges of the tissue reinforcement material to sandwich and fix the tissue reinforcement material (details will be described later). The edges of the tissue reinforcement material that are sandwiched in the fixing parts are wavy, and the waves interlock with the fixing parts, that is, the peaks of the waves are located between the fixing parts formed along the edges of the tissue reinforcement material. This shape allows the protruding parts of the waves to catch on the fixing parts, thereby preventing the tissue reinforcement material from shifting.

[0026] The shape of the wave described above is not particularly limited as long as it is a shape that can catch on the fixing part, and examples include sinusoidal waves, rectangular waves, triangular waves, sawtooth waves, polygonal waves, and combinations thereof. Among these, a sinusoidal wave shape is preferred because it needs to be fixed by contacting the end of the fixing part of the tissue reinforcement material attachment machine and detached after the tissue reinforcement material is attached to the automatic stapler. Note that the shapes listed above include those that are roughly similar in shape, and for example, a wave made of curves is included in the sinusoidal wave category even if the amplitude and wavelength are not constant.

[0027] The height of the wave (the length that protrudes from the inner surface of the fixation part) is not particularly limited as long as it can suppress displacement of the tissue reinforcement material and does not protrude from the automatic stapler to which it is attached, but it is preferably 10 mm or more and 12 mm or less. By keeping the wave height within the above range, the material can function as a tissue reinforcement while suppressing displacement. The wave height is more preferably 10.5 mm or more, and even more preferably 11.0 mm or less.

[0028] The number of waves (number of peaks) and spacing described above are not particularly limited and are determined appropriately according to the number of fixing points provided on the tissue reinforcement material attachment device. Furthermore, the waves do not necessarily need to be formed so that a peak exists between all fixing points; the number of waves may be less than the number of points between fixing points as long as displacement of the tissue reinforcement material is suppressed.

[0029] The tissue reinforcement material of the present invention preferably has a protruding portion that is narrower than the rest of the material at the end that comes into contact with the base of the automatic stapler when attached to the automatic stapler. By having a narrower projection at the base end of the automatic stapler compared to other parts, the tissue reinforcement material can be applied to staples located deep inside the base of the automatic stapler. Here, width refers to the length of the side not clamped by the automatic stapler attachment device, and generally corresponds to the length of the shorter side.

[0030] The length of the above-mentioned protrusion is not particularly limited, but from the viewpoint of ease of handling and more reliable attachment to the automatic stapler, it is preferably 2.0 mm or longer and preferably 5.0 mm or shorter.

[0031] The width of the above-mentioned protrusion is not particularly limited, but from the viewpoint of reliably covering the tissue reinforcement material with the staples of the automatic stapler, it is preferably 8.0 mm or more and preferably 9.0 mm or less.

[0032] The tissue reinforcement material of the present invention has an adhesive strength of 1.5 N / cm when attached to an automatic stapler. 2 It is preferable that the above conditions are met. The adhesive strength when attached to the automatic stapler is within the above range, which further reduces displacement during operation of the automatic stapler. The above adhesive strength is 3.0 N / cm². 2 It is more preferable that the above is true. The upper limit of the above adhesive strength is not particularly limited, but from the viewpoint of facilitating peeling after suturing is 30 N / cm. 2 The following is preferable. Specifically, the adhesive strength can be measured by the following method. Cut the tissue reinforcement material to an 8mm wide x 40mm long strip. Attach only 10mm of the strip to the working surface (anvil side) of an automatic stapler (e.g., Ethicon Endopath Stapler ECHELON FLEX 60) that has been pre-soaked in saline solution, and press down for 3 minutes to allow it to adhere. Next, attach the handle of the automatic stapler to the lower chuck of a tensile testing machine (e.g., Autograph Precision Universal Tester AG-X Plus, Shimadzu Corporation), and attach the end of the tissue reinforcement material protruding from the automatic stapler to the upper chuck of the tensile testing machine. Then, perform a tensile test at a tensile speed of 100mm / min, and the maximum load at which shearing occurs will be defined as the adhesive strength.

[0033] The method for manufacturing the tissue reinforcing material of the present invention is not particularly limited. For example, it may be manufactured by laminating and integrating the fabric layer and the sponge layer using the method described above, or it may be obtained by laying the fabric on the bottom surface, pouring the water-soluble polymer solution onto the fabric while ensuring that the water-soluble polymer solution does not flow to the underside of the fabric, and forming a sponge layer by freeze-drying.

[0034] Next, a tissue reinforcement device used in conjunction with the tissue reinforcement material of the present invention will be described. The tissue reinforcement material applicator of the present invention preferably has recesses at opposing positions on both sides of the plate-shaped member. By providing recesses on opposing positions on both sides of a plate-shaped member and holding the tissue reinforcement material in these recesses, the handling of the tissue reinforcement material during transport and storage can be improved. Furthermore, by immersing the tissue reinforcement material, along with the tissue reinforcement material holder, in water and clamping the recesses with an automatic stapler, two tissue reinforcement materials can be attached to the automatic stapler simultaneously. Here, "plate-shaped" refers to a flat shape with a thickness sufficient to be clamped by an automatic stapler.

[0035] Each of the recesses has a shape corresponding to the shape of the part of the automatic stapler to which the tissue reinforcement material is attached, and it is preferable that each recess is continuous to the same end of the member. By making the shape of the recesses described above, particularly the shape of the portion between the fixing parts described later, correspond to the shape of the area where the tissue reinforcement material of the automatic stapler is attached, the tissue reinforcement material can be accurately attached to the predetermined position. Furthermore, since the two recesses are continuous to the same end of the member, the automatic stapler can be clamped from the side where the recesses are continuous. Each recess may be continuous with one end of the member, or with multiple ends.

[0036] Each of the above-mentioned recesses has one or more claw-shaped fixing parts on its bottom surface for sandwiching and fixing the above-mentioned tissue reinforcing material, and it is preferable that the upper surface of the fixing part is inclined toward the center of the recess. By providing at least one pair of claws on the bottom surface of the recess, the tissue reinforcement material can be securely held in place by sandwiching it between these claws. Furthermore, the upper surface of the fixing part, that is, the surface facing the bottom surface of the recess, is inclined toward the center of the recess, resulting in a V-shaped cross-section between the fixing parts. As a result, the inclined surface of the fixing part acts as a guide, making it easier to grip the automatic stapler, and also making it less likely for the automatic stapler to get caught when releasing it. Here, "claw-shaped" refers to a shape that does not connect to anything other than the bottom surface of the recess, protrudes in the height direction of the recess, and has a sloped surface facing the bottom surface of the recess. While it is sufficient for at least one pair of the above-mentioned fixing parts to be present in each recess, from the viewpoint of more securely holding the tissue reinforcement material, it is preferable for each recess to have 3 to 6 pairs of the above-mentioned fixing parts, and more preferably 5 pairs or less. Furthermore, the length and spacing of each fixing part can be appropriately adjusted according to the size of the tissue reinforcement material and the desired strength of fixation.

[0037] The height of the fixing portion is not particularly limited, but it is preferable that the height of the inner surface of the fixing portion (the surface on the center side of the recess) is 0.5 mm or more and 2.0 mm or less, and the height of the outer surface of the fixing portion (the surface on the side of the recess) is 3.0 mm or more and 8.0 mm or less. The height of the fixing portion being within the above range allows it to better serve as a guide for the automatic stapler and to hold the tissue reinforcement material more securely. The height of the inner surface of the fixing portion is more preferably 1.0 mm or more, and more preferably 2.0 mm or less. The height of the outer surface of the fixing portion is more preferably 3.5 mm or more, and more preferably 6.0 mm or less.

[0038] The distance between the outer surface of the fixing portion and the side surface of the recess is preferably 1 mm or more and 5 mm or less. Having a gap of the above range between the side of the recess and the fixing part allows the fixing part to tilt toward the side of the recess when the automatic stapler is inserted, thus more reliably releasing the tissue reinforcement material. The distance between the outer surface of the fixing part and the side of the recess is more preferably 2 mm or more, and more preferably 4 mm or less.

[0039] The distance between the bottoms of the above-mentioned recesses is preferably 0.5 mm or more and 4.0 mm or less. When the distance between the bottoms of the recesses is within the above range, the automatic stapler can be more securely clamped into the recesses, and as a result, the tissue reinforcement material can be more securely attached to the automatic stapler. The distance between the bottoms of the recesses is more preferably 1 mm or more, even more preferably 2 mm or more, and most preferably 3 mm or less.

[0040] The thickness of the outer edge of the above-mentioned tissue reinforcement device is preferably 5.0 mm or more and 10.0 mm or less. Because the thickness of the outer edge is within the above range, bending deformation is less likely to occur when handling the tissue reinforcement material applicator, and the tissue reinforcement material can be held more securely.

[0041] In the tissue reinforcement material applicator of the present invention, it is preferable that at the end of the member continuous with the recess, the portions on both sides of the recess protrude from the end of the recess. At the end of the recess that is continuous with the outside, the portions on both sides of the recess protrude from the end of the recess; in other words, the shape of the end of the member where the recess is continuous is concave. As a result, the protruding portions on both sides of the recess act as guides for the automatic stapler, allowing the tissue reinforcement material to be attached to the automatic stapler more reliably in the predetermined position. The length of the protrusion of the portions on both sides of the recess is not particularly limited, but from the viewpoint of guiding performance to the automatic stapler and ease of handling, it is preferably between 10 mm and 50 mm. Furthermore, it is desirable that the end portion of the above-mentioned member that is continuous with the recess also has a protruding portion in the center of the recess. The protruding portion in the center acts as a guide for the automatic stapler when inserted into the back of the mouth of the automatic stapler, so that the tissue reinforcement material can be attached to the automatic stapler in the predetermined position more reliably. The length of the protrusions on both sides of the recess is not particularly limited, but it is preferable that it be 10 mm or less from the viewpoint of the depth of the mouth of the automatic stapler and the guiding performance.

[0042] The material of the above-mentioned component, that is, the material of the tissue reinforcement material attacher of the present invention, is not particularly limited, but it is preferable that it has a certain degree of cushioning properties in order to reliably attach the tissue reinforcement material by an automatic suturer. Examples of such materials include foamed polyethylene, foamed polypropylene, foamed ethylene-vinyl acetate copolymer resin, foamed polyvinyl chloride, foamed polystyrene, foamed polyurethane, etc., as well as silicone rubber, urethane rubber, acrylic rubber, etc. Among these, silicone rubber is preferred because it has high durability, requiring heat resistance and dimensional stability when the adhesive-type reinforcement material is held in place during manufacturing, sterilization, and packaging.

[0043] Here, the embodiments and usage of the tissue reinforcement material of the present invention will be described in detail with reference to the figures. Figure 1 is a schematic diagram showing an example of the tissue reinforcement material of the present invention. Figure 1 shows an example where the wave shape is sinusoidal. As shown in Figure 1, the tissue reinforcement material 1 of the present invention has a structure in which a fabric-like layer 11 made of a bioabsorbable material that serves to reinforce tissue and a sponge layer 12 made of a water-soluble polymer for adhesion to an automatic stapler are laminated and integrated. In addition, the edge (the long side in Figure 1) that contacts the fixing part of the tissue reinforcement material in the tissue reinforcement material attachment device is wavy.

[0044] Figures 2 and 3 schematically illustrate how the tissue reinforcement material of the present invention is used. First, an example of the structure of the tissue reinforcement material attachment device will be described. As shown in Figure 2, the tissue reinforcement material attachment device 2 has recesses 3 at opposing positions on both sides of a plate-shaped member. The two recesses 3 have claw-shaped fixing parts 4 on their bottom surfaces, the upper surfaces of which are inclined toward the center of the recesses 3, and the adhesive-type tissue reinforcement material is held between each fixing part 4. If there are only recesses 3 and no fixing parts 4, it is possible to hold the adhesive-type tissue reinforcement material, but it becomes difficult to hold the adhesive-type tissue reinforcement material with even and appropriate force, which may cause unintended detachment. Furthermore, since the two recesses 3 are continuous to the same end of the member (tissue reinforcement material attachment device 2), if an automatic stapler is inserted from the end where the recesses 3 of the tissue reinforcement material attachment device 2 are continuous so that it completely interlocks with the fixing parts 4, two adhesive-type tissue reinforcement materials can be accurately attached to the predetermined position on the automatic stapler at the same time. Furthermore, if the portions on both sides of the recess 3 protrude from the end of the member that is continuous with the recess 3 (i.e., have protruding portions), these protruding portions act as guides for the automatic suturing device, allowing the adhesive tissue reinforcement material to be attached to the desired position more reliably.

[0045] Next, the method of using the tissue reinforcement material of the present invention will be described. First, as shown in Figure 2, the tissue reinforcement material 1 is placed between the fixing parts 4 of the tissue reinforcement material attachment device with the sponge layer 12 facing outwards. At this time, the peaks of the waves of the tissue reinforcement material 1 are located between the fixing parts 4, so even if a force is applied to the tissue reinforcement material 1 to cause it to shift in the direction of its long side, the peaks of the waves will catch on the sides of the fixing parts, thereby preventing the tissue reinforcement material 1 from shifting. The operation of holding the tissue reinforcement material may be performed at the surgical site, or the tissue reinforcement material 1 may be held during manufacturing for sterilization, packaging, transportation, and storage. Next, the tissue reinforcement material 1 together with the tissue reinforcement material attachment device 2 is immersed in sterile water. After that, it is removed from the sterile water, and as shown in Figure 3, the automatic stapler 5 is inserted from the end side where the recesses 3 are continuous, and the two tissue reinforcement materials 1 are attached to the automatic stapler 5 simultaneously by sandwiching them between the fixing parts 4. In this case, the tissue reinforcement material attachment device of the present invention has an upper surface of the fixing part 4 that is inclined toward the center of the recess 3. This inclined surface acts as a guide, allowing the automatic stapler to be smoothly clamped, and preventing snagging when releasing the automatic stapler. Furthermore, since the fixing part 4 exists independently inside the recess, when the tissue reinforcement material is clamped by the automatic stapler, the fixing part 4 tilts outward, allowing the tissue reinforcement material to be smoothly released from the tissue reinforcement material attachment device. Moreover, if the tissue reinforcement material attachment device 2 has a protruding part, the protruding part acts as a guide when clamping the automatic stapler 5, allowing the tissue reinforcement material 1 to be attached to the predetermined position more reliably.

[0046] As described above, the tissue reinforcement material attachment device of the present invention allows for the tissue reinforcement material to be held in place at the surgical site, but by transporting and storing the tissue reinforcement material while it is held in the recess, the handling of the tissue reinforcement material can be improved and the work at the surgical site can be further simplified. A tissue reinforcement attachment kit in which the tissue reinforcement material of the present invention is held in the recess of the tissue reinforcement material attachment device described above is also one aspect of the present invention.

[0047] The method for manufacturing the tissue reinforcement device of the present invention is not particularly limited, and conventionally known methods such as injection molding, press molding, and cutting can be used without any particular limitation. [Effects of the Invention]

[0048] According to the present invention, it is possible to provide a tissue reinforcement material for automatic staplers that can be used in a tissue reinforcement material attachment device to be attached to an automatic stapler accurately and easily in a short time while suppressing displacement, and a tissue reinforcement material attachment kit consisting of the tissue reinforcement material for automatic staplers and a tissue reinforcement material attachment device. [Brief explanation of the drawing]

[0049] [Figure 1] This is a schematic diagram illustrating an example of the tissue reinforcement material of the present invention. [Figure 2] This diagram schematically illustrates how the tissue reinforcement material of the present invention is used. [Figure 3] This diagram schematically illustrates how the tissue reinforcement material of the present invention is used. [Modes for carrying out the invention]

[0050] The embodiments of the present invention will be described in more detail below with reference to the figures, but the present invention is not limited to these embodiments.

[0051] (Example 1) (1) Manufacturing of tissue reinforcement materials Hydroxypropyl methylcellulose (HPMC) (viscosity grade 6: AN6, 2% solution viscosity: 5.1 mPa / s, manufactured by Mitsubishi Chemical Foods) was mixed with distilled water to prepare an 8 wt% HPMC aqueous solution, and 10 g was added to a φ100 mm petri dish. Next, a sheet of polyglycolic acid (PGA) nonwoven fabric, cut to φ100 mm, was floated on top of the petri dish containing the HPMC aqueous solution as a fabric layer. After confirming that the HPMC aqueous solution had permeated the nonwoven fabric sheet, the petri dish was placed in a -80°C freezer for 15 minutes to freeze the HPMC aqueous solution. Subsequently, the frozen HPMC aqueous solution was dried in a vacuum freeze-dryer to form an HPMC sponge layer (adhesive layer) on the nonwoven fabric. Subsequently, the resulting fabric-like material and the laminated sponge layer were cut to obtain a tissue-reinforced material with a long side length of 60 mm, having five wave shapes along the long side, with a maximum wave width of 10.5 mm and a minimum wave width of 10.0 mm, and a short side length of 10 mm.

[0052] (2) Manufacturing of tissue reinforcement device and adhesive tissue reinforcement kit An injection molding die for a tissue reinforcement device, as shown in Figure 1, was fabricated, and a two-component liquid silicone rubber (QP1-250 LIQUID SILICONE RUBBER, manufactured by DuPont-Toray Specialty Materials Co., Ltd.) was poured into the die and cured to obtain the tissue reinforcement device. The tissue reinforcement device, as shown in Figure 2, consisted of a plate-shaped silicone rubber with 20mm x 70mm x 2mm recesses formed on both sides, and five pairs of fixing parts (claws) on the bottom surface of the recesses. The fixing parts had a height of 4mm on the outer surface of the recess (the side surface of the recess) and a height of 1mm on the inner surface of the recess (the surface towards the center of the recess), and had a rectangular cross-sectional shape that sloped inward towards the recess. Furthermore, each fixing part was formed with a spacing of 9.5mm in the short side direction and 12.5mm in the long side direction, and a distance of 3.25mm between the side of the recess and the outer surface of the fixing part. In addition, the length of the protruding part was set to 20mm. Next, the obtained tissue reinforcement material was positioned with the adhesive layer facing upwards and held so that the peaks of the waves interlocked with the fixing part, thus forming a tissue reinforcement material attachment kit. When the tissue reinforcement material was pulled in the direction of its long side, the peaks of the waves caught on the fixing part, and the tissue reinforcement material did not shift significantly.

[0053] (3) Attachment to an automatic stapler The obtained tissue reinforcement kit was immersed in physiological saline (Otsuka Saline Injection, Otsuka Pharmaceutical Co., Ltd.) for 5 seconds. Then, as shown in Figure 3, an automatic stapler (Ethicon Endopath Stapler ECHELON FLEX 60, Ethicon Corporation) was inserted from the side where the recess of the fixation part was connected to the end, and the fixation part was clamped for 5 seconds. After that, the attachment site of the tissue reinforcement material with the automatic stapler was checked, and the adhesive tissue reinforcement material was attached in the designated position without shifting. The time from immersion in physiological saline to completion of attachment was approximately 20 seconds.

[0054] (Comparative Example 1) The adhesive tissue reinforcement material manufactured in Example 1 was cut to match the shape of the automatic stapler. Then, it was immersed in saline solution for 5 seconds, attached to the designated positions (2 locations) on the automatic stapler, and secured by pressing down with a 2mm thick foamed polyethylene sheet for 5 seconds. The adhesive tissue reinforcement material was secured without shifting, and the time from immersion in saline solution to completion of attachment was approximately 90 seconds. [Industrial applicability]

[0055] According to the present invention, it is possible to provide a tissue reinforcement material for automatic staplers that can be used in a tissue reinforcement material attachment device to be attached to an automatic stapler accurately and easily in a short time while suppressing displacement, and a tissue reinforcement material attachment kit consisting of the tissue reinforcement material for automatic staplers and a tissue reinforcement material attachment device. [Explanation of Symbols]

[0056] 1. Tissue reinforcement material 11 Fabric layer 12 sponge layers 2. Tissue reinforcement material attachment device 3 recesses 4 Fixed part 5. Automatic stapler

Claims

1. A tissue reinforcing material used in a tissue reinforcing material attachment device, The tissue reinforcement material attachment device has recesses on opposing positions on both sides of a plate-shaped member that correspond to the shape of the part of the automatic suture device for attaching the tissue reinforcement material, and each recess has one or more pairs of claw-shaped fixing parts on its bottom surface along the long side of one pair of tissue reinforcement materials for clamping and fixing the tissue reinforcement material. The tissue reinforcing material has a structure in which a fabric-like layer made of a bioabsorbable material and a sponge layer made of a water-soluble polymer are laminated and integrated. The shape of the pair of long sides that are in contact with the fixed portion is wavy, The aforementioned pair of long-side edges are formed such that the peaks of the waves protrude from the inner surface of the fixing parts between the fixing parts and interlock with the fixing parts. Tissue reinforcement material for automatic staplers.

2. The tissue reinforcing material according to claim 1 is held between the fixed portions. Tissue reinforcement material application kit.

3. The tissue reinforcement material attachment device has recesses at opposing positions on both sides of a plate-shaped member. Each of the recesses has a shape corresponding to the shape of the part of the automatic stapler where the tissue reinforcement material is attached. Each of the recesses extends to the same end of the member. Each of the recesses has one or more claw-shaped fixing parts on its bottom surface for sandwiching and securing the tissue reinforcing material. The upper surface of the fixing portion is inclined toward the center of the recess. The tissue reinforcement material attachment kit according to claim 2.

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