Tissue reinforcement material application device and tissue reinforcement material application kit
The tissue reinforcing material applicator with grooves and convex portions addresses size compatibility and port entanglement issues by facilitating rapid and secure attachment of adhesive materials to automatic suturing devices, enhancing surgical efficiency.
Patent Information
- Application Number
- JP2020201774
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2020-12-04
- Publication Date
- 2025-01-23
- Estimated Expiration
- 2040-12-04
AI Technical Summary
Conventional cylindrical tissue reinforcement materials for automatic suturing devices face issues with size compatibility, displacement, and misalignment, especially when used with instruments of varying sizes, and can get caught in surgical ports, necessitating a solution for accurate and easy attachment.
A tissue reinforcing material applicator with grooves and convex portions on a plate-like member facilitates precise attachment of adhesive tissue reinforcement materials to automatic suturing devices, ensuring compatibility across sizes and preventing slippage.
Enables rapid, accurate, and secure attachment of adhesive tissue reinforcement materials to automatic suturing devices, improving handling and reducing the risk of displacement and port entanglement.
Smart Images

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Abstract
Description
[Technical field]
[0001] The present invention relates to a tissue reinforcement material applicator that can quickly, accurately and easily attach a patch-type tissue reinforcement material to an automatic suture instrument, and a tissue reinforcement material attachment kit that uses said tissue reinforcement material applicator. [Background technology]
[0002] Conventionally, stapler-type automatic suturing devices with many embedded staples have been used to suture tissues. However, when used on lungs, etc., there is a problem of air leakage from the sutured area, and when used on soft tissues, there are problems such as damage and tearing of the tissue.
[0003] Therefore, in order to prevent air leakage, body fluid leakage, and tissue damage, a bioabsorbable reinforcing material is used together with an automatic suturing device (for example, Patent Documents 1 and 2). The reinforcing material in Patent Documents 1 and 2 is formed into a tubular structure by sewing two opposing sides of one piece of bioabsorbable nonwoven fabric together, or by overlapping two pieces of bioabsorbable nonwoven fabric or one piece of bioabsorbable nonwoven fabric and one piece of stretchable knitted fabric and sewing two opposing sides together. The end of the cartridge of the automatic suturing device is inserted into the tube to attach it to the automatic suturing device, and the tissue is reinforced by being sutured together with the tissue. In addition, after reinforcement, unnecessary parts can be separated by pulling the thread extending from the reinforcing material, so that the workability is high. Furthermore, since the reinforcing material is made of a bioabsorbable nonwoven fabric, it is eventually absorbed into the living body after the 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 Summary of the Invention [Problem to be solved by the invention]
[0005] In order to prevent slippage during operation of the automatic stapler, the reinforcing material used in the conventional automatic stapler is made by combining a fabric that reinforces the tissue with a fabric that has elasticity to form a tube, and is then attached to the automatic stapler. However, since cartridges for automatic staplers come in various sizes, depending on the size of the cartridge, the reinforcing material may not be able to be attached sufficiently to the automatic stapler, causing slippage. Even if a reinforcing material that matches the size of the cartridge is used, gaps may be created near the stitches of the fabric, causing slippage.
[0006] On the other hand, in endoscopic surgery using an automatic stapler, multiple cylindrical ports are inserted into the patient's body, and instruments such as an endoscope and an automatic stapler are inserted through the ports. In this case, since the conventional reinforcing material is attached so as to surround the cartridge part of the automatic stapler, the reinforcing material may get caught when the automatic stapler is inserted into the port. In addition, since the reinforcing material exists so as to surround the cartridge part, the size of the automatic stapler equipped with the reinforcing material becomes large, so the automatic stapler cannot be passed through unless a port with a larger diameter is used than the size of the automatic stapler itself. From the viewpoint of reducing the burden on the patient, a reinforcing material that can be passed through a port with a smaller diameter is required.
[0007] Therefore, the applicant of the present application has proposed a suture prosthesis for an automatic suture instrument in which a cloth layer made of a bioabsorbable material and a sponge layer made of a water-soluble polymer are laminated together. This type of suture prosthesis for an automatic suture instrument generates adhesive force when the sponge layer absorbs moisture, and can be attached to the automatic suture instrument by attaching it to the cartridge part, so it can be used with automatic suture instruments of all sizes, has high port passability, and is less likely to slip when the automatic suture instrument is operated.
[0008] However, such adhesive tissue reinforcement materials are soaked in water before being attached to an automatic suturing device, which makes attachment more complicated than conventional cylindrical tissue reinforcement materials. Also, if the attachment position shifts, it must be removed and reattached, so there is a demand for a method for easily and accurately attaching an adhesive tissue reinforcement material to an automatic suturing device.
[0009] In view of the above problems, the present invention aims to provide a tissue reinforcement material applicator that can quickly, accurately and easily attach a patch-type tissue reinforcement material to an automatic suture instrument, and a tissue reinforcement material attachment kit that uses said tissue reinforcement material applicator. [Means for solving the problem]
[0010] The present invention is a tissue reinforcement material applicator for fixing a patch-type tissue reinforcement material to an automatic stapler, which has grooves at opposing positions on both sides of a plate-shaped member, each of the grooves having a shape corresponding to the shape of the part of the automatic stapler where the patch-type tissue reinforcement material is to be attached, each of the grooves continuing to the same end of the member, and the opposing side surfaces of each of the grooves each having a protrusion for fixing the patch-type tissue reinforcement material. The present invention will be described in detail below.
[0011] The tissue reinforcement material applicator of the present invention and the patch-type tissue reinforcement material for which it is used will be described in detail below, but first the tissue reinforcement material applicator of the present invention will be described in detail. The tissue reinforcement material applicator of the present invention is a tissue reinforcement material applicator for fixing a patch-type tissue reinforcement material to an automatic suture instrument. The adhesive tissue reinforcement material has the advantage that it hardly gets caught on the port compared to conventional cylindrical tissue reinforcement materials, and can be used regardless of the size of the tissue reinforcement material. However, in order to attach the adhesive tissue reinforcement material to the automatic suture device, it must be attached to a specified position on the automatic suture device, which makes it difficult to attach it accurately in a short time. By using the tissue reinforcement material attachment device of the present invention, the adhesive tissue reinforcement material can be attached to the automatic suture device accurately and easily in a short time, regardless of the skill level of the person attaching it. In the present invention, the "automatic suture device" includes not only an automatic suture device but also an automatic anastomosis device.
[0012] The tissue reinforcement material applicator of the present invention has grooves at opposing positions on both sides of a plate-like member. By providing grooves at opposing positions on both sides of a plate-like member and holding a patch-type tissue reinforcement material in the grooves, the handleability of the patch-type tissue reinforcement material during transportation and storage can be improved, and by soaking the patch-type tissue reinforcement material together with the tissue reinforcement material applicator in water and sandwiching the grooves with an automatic suturing device, two patch-type tissue reinforcement materials can be attached to the automatic suturing device at the same time. Note that the term "plate-like" as used herein refers to a flat shape that is thick enough to sandwich the automatic suturing device.
[0013] Each of the grooves has a shape corresponding to the shape of the portion of the automatic stapler to which the adhesive tissue reinforcement material is attached, and each of the grooves continues to the same end of the member. By making the shape of the groove correspond to the shape of the part of the automatic stapler where the adhesive tissue reinforcement material is to be attached, the adhesive tissue reinforcement material can be attached accurately to a predetermined position. In addition, by having the two grooves continue to the same end of the member, the automatic stapler can be sandwiched from the side where the grooves are continuous. Note that each groove may be continuous with one end of the member, or may be continuous with multiple ends.
[0014] The opposing side surfaces of each of the grooves have a protrusion for fixing the adhesive tissue reinforcing material. By providing convex portions on the opposing side surfaces of the groove and sandwiching and holding the patch-type tissue reinforcing material between these convex portions, the patch-type tissue reinforcing material can be held more reliably than in grooves with flat sides. At least two of the convex portions may be present on the opposing side surfaces of each groove, but from the viewpoint of holding the patch-type tissue reinforcing material more reliably, each side surface preferably has three or more and ten or less of the convex portions, more preferably six or less. The convex portions are not particularly limited as long as they have a protruding shape, and may be a pointed shape such as a V-shape or a gentle shape such as a semicircle.
[0015] The distance between the bottoms of the grooves is preferably 0.5 mm or more and 5.0 mm or less. By setting the distance between the bottoms of the grooves within the above range, the automatic stapler can be more reliably sandwiched in the grooves, and as a result, the patch-type tissue reinforcement material can be more reliably attached to the automatic stapler. The distance between the bottoms of the grooves is more preferably 1 mm or more, even more preferably 2 mm or more, and even more preferably 3 mm or less.
[0016] The depth of the groove is preferably 0.5 mm or more and 5.0 mm or less. By setting the depth of the groove within the above range, the patch-type tissue reinforcing material can be more reliably held. The depth of the groove is preferably the thickness of the patch-type tissue reinforcing material ±0.5 mm, and when the thickness of the patch-type tissue reinforcing material is 1.0 mm or more and 1.5 mm or less, it is more preferably 0.5 mm or more and 2.0 mm or less.
[0017] In the tissue reinforcement material applicator of the present invention, it is preferable that at an end portion of the member continuing from the groove portion, portions on both sides of the groove portion protrude beyond the end portion of the groove portion. At the end portion continuing to the outside of the groove, the portions on both sides of the groove protrude beyond the ends of the groove, i.e., the shape of the end portion where the groove of the member is continuing is concave, so that the protruding portions on both sides of the groove act as guides for the automatic stapler, and the adhesive tissue reinforcement material can be more reliably attached to the automatic stapler at a predetermined position. The protruding length of the portions on both sides of the groove is not particularly limited, but is preferably 10 mm or more and 50 mm or less from the viewpoint of guiding performance to the automatic stapler and ease of handling. Furthermore, it is desirable that the end of the member connected to the groove also has a protruding portion in the center of the groove. The protruding portion in the center serves as a guide for the automatic stapler by being inserted into the back of the mouth of the automatic stapler, so that the adhesive tissue reinforcement material can be more reliably attached to the automatic stapler at a predetermined position. The protruding length of the portions on both sides of the groove is not particularly limited, but is preferably 10 mm or less from the viewpoint of the depth of the mouth of the automatic stapler and the guide performance.
[0018] The material of the above-mentioned member, that is, the material of the tissue reinforcement material application device of the present invention is not particularly limited, but it is preferable that the material has a certain degree of cushioning property so that the patch-type tissue reinforcement material can be securely applied by an automatic suture device. Examples of such materials include foamed polyethylene, foamed polypropylene, foamed ethylene-vinyl acetate copolymer resin, foamed polyvinyl chloride, foamed polystyrene, foamed polyurethane, silicone rubber, urethane rubber, acrylic rubber, etc. When the patch-type reinforcement material is held during production and sterilized and packaged, heat resistance and dimensional stability are required, so highly durable silicone rubber is preferable.
[0019] Here, the embodiment and usage of the tissue reinforcement material fitting device of the present invention will be described in detail with reference to the drawings. FIG. 1 is a schematic diagram showing an example of the tissue reinforcement material fitting device of the present invention. As shown in FIG. 1(a), the tissue reinforcement material fitting device 1 of the present invention has grooves 2 at opposing positions on both sides of a plate-like member. The two grooves 2 have convex portions 3 on opposing sides, and a patch-type tissue reinforcement material is held between the convex portions 3 on each side. In addition, since the two grooves 2 are continuous to the same end of the member (tissue reinforcement material fitting device 1), if an automatic stapler is sandwiched so as to completely engage with the grooves 2 from the end of the tissue reinforcement material fitting device 1 where the grooves 2 are continuous, two sheets of patch-type tissue reinforcement materials can be accurately fitted to a predetermined position of the automatic stapler at the same time. Furthermore, as shown in Fig. 1(b), if the portions on both sides of the groove 2 at the end of the member that is continuous with the groove 2 protrude beyond the end of the groove 2 (hereinafter, the protruding portions are referred to as protruding portions 4), the protruding portions 4 act as a guide for the automatic stapler, so that the patch-type tissue reinforcement material can be more reliably attached to the desired position. Note that, although the shape of the groove is rectangular in Fig. 1(a) and (b), this can be changed as appropriate depending on the shape of the portion of the automatic stapler where the patch-type tissue reinforcement material is to be attached.
[0020] 2 and 3 are schematic diagrams showing the use of the tissue reinforcement material attachment of the present invention. As shown in FIG. 2, the method of using the tissue reinforcement material attachment 1 of the present invention is to first hold the adhesive tissue reinforcement material 5 between the convex parts 3 of the two groove parts 2. The tissue reinforcement material attachment machine of the present invention holds the adhesive tissue reinforcement material between the convex parts, so that it can hold the adhesive tissue reinforcement material more reliably than holding the adhesive tissue reinforcement material between flat side surfaces. The operation of holding the adhesive tissue reinforcement material may be performed at the surgical site, or the adhesive tissue reinforcement material 5 may be held during production and sterilized, packaged, transported and stored. Next, the adhesive tissue reinforcement material 5 together with the tissue reinforcement material attachment 1 is immersed in sterile water. After that, it is taken out of the sterile water, and as shown in FIG. 3, an automatic suture device 6 is inserted from the end side where the groove parts 2 are continuous, and the two groove parts 2 are sandwiched, so that the two adhesive tissue reinforcement materials 5 are attached to the automatic suture device 6 at the same time. In this case, if the tissue reinforcement material application device 1 has a protruding portion 4, the protruding portion 4 acts as a guide when clamping the automatic suture device 6, allowing the adhesive tissue reinforcement material 5 to be more reliably applied to the specified position.
[0021] As described above, the tissue reinforcement material applicator of the present invention may hold the patch-type tissue reinforcement material at the surgical site, but by transporting and storing the patch-type tissue reinforcement material with the patch-type tissue reinforcement material held in the groove, the handleability of the patch-type tissue reinforcement material can be improved and the work at the surgical site can be further simplified. The present invention also includes a tissue reinforcement material application kit in which the adhesive tissue reinforcement material is held in the groove of the tissue reinforcement material application device of the present invention.
[0022] The method for producing the tissue reinforcement material applicator of the present invention is not particularly limited, and any conventionally known method such as injection molding, press molding, cutting, etc. can be used without any particular limitation.
[0023] Next, the patch-type tissue reinforcing material will be described in detail. The adhesive tissue reinforcement material means a tissue reinforcement material fixed to an automatic suturing device by adhesive force. The adhesive tissue reinforcement material is not particularly limited as long as it is an adhesive tissue reinforcement material such as a conventional tissue reinforcement material coated or laminated with an adhesive substance, or a tissue reinforcement material itself that has adhesiveness, but it is preferably an adhesive tissue reinforcement material in which a cloth layer made of a bioabsorbable material and a sponge layer made of a water-soluble polymer are laminated together. When such an adhesive tissue reinforcement material is used, the effect of the present invention is greatly exhibited. Hereinafter, an adhesive tissue reinforcement material in which a cloth layer made of a bioabsorbable material and a sponge layer made of a water-soluble polymer are laminated together will be described.
[0024] The cloth layer serves as a tissue reinforcement material, and since it is made of a bioabsorbable material, it is eventually absorbed into the body after reinforcement is no longer necessary, and does not leave a foreign body in the body for a long period of time, making it highly safe. The sponge layer serves to impart adhesiveness to the patch-type tissue reinforcement material, and the water-soluble polymer exhibits adhesiveness by absorbing water. Note that the term "sponge-like" refers to a structure having many voids.
[0025] The term "laminated and integrated" refers to bonding the cloth-like layer and the sponge layer to such an extent that separation between the two layers is unlikely to occur even when force is applied. A method for laminating the cloth-like layer and the sponge layer together includes a method of floating the cloth-like layer on a water-soluble polymer solution that is the raw material for the sponge layer, followed by freeze-drying. In order to increase the interfacial adhesion between the cloth-like layer and the sponge layer, it is preferable to subject the cloth-like layer to a hydrophilic treatment using a plasma treatment device or the like to improve the permeability of the water-soluble polymer solution into the cloth-like layer.
[0026] Examples of the bioabsorbable material include synthetic absorbable polymers such as α-hydroxy acid polymers such as polyglycolide, polylactide (D,L,DL), glycolide-lactide (D,L,DL) copolymer, glycolide-ε-caprolactone copolymer, lactide (D,L,DL)-ε-caprolactone copolymer, poly(p-dioxanone), glycolide-lactide (D,L,DL)-ε-caprolactone copolymer, and natural absorbable polymers such as collagen, gelatin, chitosan, and chitin. These may be used alone or in combination of two or more. For example, when the synthetic absorbable polymer is used as the bioabsorbable material, a natural absorbable polymer may be used in combination. Among them, polyglycolic acid, polylactic acid, or a copolymer of lactic acid and caprolactone is preferable because of its high strength.
[0027] When polyglycolide (homopolymer or copolymer of glycolide) is used as the bioabsorbable material, the weight-average molecular weight of polyglycolide has a preferable lower limit of 30,000 and a preferable upper limit of 1,000,000. When the weight-average molecular weight of the polyglycolide is 30,000 or more, tissue can be reinforced more reliably, and when it is 1,000,000 or less, foreign body reaction can be more suppressed. The more preferable lower limit of the weight-average molecular weight of the polyglycolide is 50,000 and a more preferable upper limit is 300,000.
[0028] The form of the cloth-like material layer is not particularly limited, and may be any form, such as knitted fabric, woven fabric, nonwoven fabric, film, etc. Among these, nonwoven fabric is preferred from the viewpoints of flexibility, breathability, ease of staple passage, etc.
[0029] When the cloth-like material layer is a nonwoven fabric, the basis weight of the nonwoven fabric is not particularly limited, but the preferred lower limit is 3 g / m 2 , the preferred upper limit is 300 g / m 2 The weight of the nonwoven fabric is 3 g / m 2 If the thickness is more than 300g / m, the tissue can be reinforced more reliably. 2When the weight per unit area of the bioabsorbable nonwoven fabric is 5 g / m or less, the adhesiveness to tissue can be further increased. 2 , and a more preferable upper limit is 100 g / m 2 It is.
[0030] The method for producing the nonwoven fabric is not particularly limited, and any conventional method can be used, such as electrospinning deposition, melt-blowing, needle punching, spunbonding, flash spinning, hydroentanglement, airlaid, thermal bonding, resin bonding, or a wet method.
[0031] 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 tissue reinforcement material for the automatic suturing device is embedded in the body, a highly biocompatible material is required. Among them, the water-soluble polymer is preferably a polysaccharide-based material or a protein-based material, since it is difficult to come off during the operation of the automatic suturing device and has an adhesive strength that allows easy peeling at the end of suturing. 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.
[0032] The above water-soluble polymer should desirably have a viscosity of 1 mPa·s or more and 500 mPa·s or less when made into a 2% aqueous solution. By using a water-soluble polymer in this range, the sponge layer will have an appropriate softness and will exhibit appropriate adhesiveness after water has penetrated into it, making it possible to easily attach it to an automatic suture instrument.
[0033] The sponge layer is preferably in a freeze-dried form. By forming the sponge layer by freeze-drying, the sponge layer can be formed without using a pore-forming agent, so there is no need 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 any conventionally known method can be used.
[0034] 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 prevent slippage during operation of the automatic stapler, and it is also possible to easily adjust the adhesive strength to an appropriate level that allows easy peeling after suturing is completed. 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 water-soluble polymer solution with which the cloth layer is soaked. The thickness of the sponge layer is measured by measuring the total area of the sponge layer at 1 point / cm using a dial gauge (e.g., SMD-565J-L manufactured by Techclock, etc.). 2 This refers to the average thickness measured at intervals of .
[0035] The density of the sponge layer is not particularly limited, but is preferably 0.04 g / cm 3 More than 0.2g / cm 3 It is preferable that: By having the density of the sponge layer within the above range, it is possible to further prevent slippage during operation of the automatic stapler, and it is also easy to adjust the adhesive strength to an appropriate level that allows easy peeling after suturing is completed.
[0036] The adhesive tissue reinforcement material has an adhesive strength of 1.5 N / cm when attached to an automatic suture device. 2 More preferably, it is equal to or greater than this. By having an adhesive strength within the above range when attached to an automatic stapler, it is possible to further prevent the automatic stapler from slipping during operation. The above adhesive strength is 3.0 N / cm 2 The upper limit of the adhesive strength is not particularly limited, but is preferably 30 N / cm from the viewpoint of facilitating peeling after suturing. 2 It is preferable that the adhesive strength is not more than 100%. The adhesive strength can be specifically measured by the following method. The adhesive tissue reinforcement material is cut to 8 mm wide x 40 mm long, and 10 mm long is attached to the working surface (anvil side) of an automatic stapler (e.g., Ethicon, Endopath Stapler ECHELON FLEX 60, etc.) that has been soaked in physiological saline in advance, and pressed down for 3 minutes to adhere. Next, the handle part of the automatic stapler is attached to the lower chuck of a tensile tester (e.g., Autograph Precision Universal Tester AG-X Plus, Shimadzu Corporation, etc.), and the end of the adhesive tissue reinforcement material that protrudes from the automatic stapler is attached to the upper chuck of the tensile tester. Then, a tensile test is performed at a tensile speed of 100 mm / min, and the maximum load at which slippage occurs is taken as the adhesive strength.
[0037] The method for producing the above-mentioned patch-type tissue reinforcement material is not particularly limited, and it may be produced by the above-mentioned method, or it may be obtained by laying a cloth-like body on the bottom surface, pouring the water-soluble polymer solution onto the cloth-like body while taking care not to let the water-soluble polymer solution flow onto the underside of the cloth-like body, and then forming a sponge layer by freeze-drying. Effect of the Invention
[0038] According to the present invention, it is possible to provide a tissue reinforcement material applicator that can quickly, accurately and easily attach a patch-type tissue reinforcement material to an automatic suture instrument, and a tissue reinforcement material attachment kit that uses the tissue reinforcement material applicator. [Brief description of the drawings]
[0039] [Figure 1] FIG. 2 is a schematic diagram showing an example of a tissue reinforcement material applicator of the present invention. [Diagram 2] FIG. 1 is a schematic diagram showing the state of using the tissue reinforcement material applicator of the present invention. [Diagram 3] FIG. 1 is a schematic diagram showing the state of using the tissue reinforcement material applicator of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0040] The embodiments of the present invention will be described in more detail below with reference to the drawings, but the present invention is not limited to these embodiments.
[0041] Example 1 (1) Manufacturing of adhesive tissue reinforcement materials Hydroxypropyl methylcellulose (HPMC) (viscosity grade 6: AN6, 2% solution viscosity: 5.1 mPa / s, manufactured by Mitsubishi Chemical Foods Corporation) was added to distilled water to prepare an 8 wt% HPMC aqueous solution, and 10 g of the solution was added to a φ100 mm petri dish. Next, a sheet-like nonwoven fabric made of polyglycolic acid (PGA) cut to φ100 mm was floated on the petri dish containing the HPMC aqueous solution as a cloth-like layer. After confirming that the HPMC aqueous solution had permeated the sheet-like nonwoven fabric, the petri dish was placed in a -80°C freezer for 15 minutes to freeze the HPMC aqueous solution. The frozen HPMC aqueous solution was then dried in a vacuum freeze dryer to form an HPMC sponge layer (adhesive layer) on the nonwoven fabric, and a patch-type tissue reinforcement material was produced.
[0042] (2) Manufacturing of tissue reinforcement material application devices and patch-type tissue reinforcement material application kits A 6 mm thick plate of foamed polyethylene (Sunperca L-1000, Sanwa Kako) was cut to obtain a tissue reinforcement material applicator with a groove of 70 mm x 14 mm x 1.5 mm formed on both sides of the plate of foamed polyethylene, with five convex parts on each opposing side (long side) as shown in Figure 1 (b). The grooves were formed so that the shape of the convex parts was hemispherical with a height of 2.15 mm and a radius of 3 mm, the distance between the apexes of the opposing convex parts was 9.7 mm, and the intervals between the apexes of the convex parts in the long side direction were 14 mm, 13 mm, 13 mm, and 14 mm. The length of the part protruding from the end of the groove was 20 mm. Next, the obtained patch-type tissue reinforcement material was cut to a size that fit the groove and held in the groove with the adhesive layer facing upward to obtain a patch-type tissue reinforcement material attachment kit.
[0043] (3) Attaching to an automatic stapler The obtained patch-type tissue reinforcement attachment kit was immersed in physiological saline (Otsuka saline injection, manufactured by Otsuka Pharmaceutical Co., Ltd.) for 5 seconds. Then, as shown in FIG. 3, an automatic suture device (Ethicon, Endopath Stapler ECHELON FLEX 60) was inserted from the side where the groove of the fixing part was connected to the end, and the groove was clamped for 5 seconds. After that, when the attachment site of the tissue reinforcement material of the automatic suture device was checked, the patch-type tissue reinforcement material was attached without shifting from the specified position. In addition, the time from immersion in physiological saline to completion of attachment was about 30 seconds.
[0044] Comparative Example 1 The adhesive tissue reinforcement material produced in Example 1 was cut to fit the shape of the automatic stapler. It was then immersed in saline for 5 seconds, attached to the specified positions (2 positions) of the automatic stapler, and pressed down for 5 seconds using a 2 mm thick polyethylene foam sheet to attach the adhesive tissue reinforcement material. The adhesive tissue reinforcement material was attached without shifting from the specified position, but it took about 90 seconds from immersion in saline to completion of attachment. [Industrial Applicability]
[0045] According to the present invention, it is possible to provide a tissue reinforcement material applicator that can quickly, accurately and easily attach a patch-type tissue reinforcement material to an automatic suture instrument, and a tissue reinforcement material attachment kit that uses the tissue reinforcement material applicator. [Explanation of symbols]
[0046] 1 Tissue reinforcement material attachment device 2 Groove 3 Convex 4. Protruding Part 5. Adhesive tissue reinforcement material 6 Automatic suture device
Claims
1. A tissue reinforcement material attachment device for fixing a patch-type tissue reinforcement material to an automatic suture instrument by clamping the tissue reinforcement material from an open longitudinal end side with the automatic suture instrument, The tissue reinforcement material applicator is composed of a plate-shaped member, The member has a pair of grooves for receiving the automatic stapler, the grooves extending in a longitudinal direction and a lateral direction of the member at opposing positions on both sides along a clamping direction of the automatic stapler, The groove portion has a protrusion portion that protrudes in a direction approaching each other in a short side direction of the groove portion and holds the adhesive-type tissue reinforcing material in the short side direction of the groove portion, The opposing side surfaces of the groove are continuous with the bottom of the groove, The convex portion is integral with the member and has a V-shape or a semicircular shape. Tissue reinforcement material applicator.
2. A tissue reinforcement material application kit, comprising a tissue reinforcement material application device according to claim 1, and a patch-type tissue reinforcement material held in said groove portion.
Citation Information
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