WO2022154092A1 - Tissue reinforcement material loader and tissue reinforcement material loading kit - Google Patents

Abstract

The purpose of the present invention is to provide: a tissue reinforcement material loader with which it is possible to load a patch-type tissue reinforcement material on an autosuture device accurately and easily in a short period of time; and a tissue reinforcement material loading kit using said tissue reinforcement material loader. The tissue reinforcement material loader according to the present invention for fixing a patch-type tissue reinforcement material on an autosuture device, is characterized in that: recesses are formed at opposing positions on both surfaces of a plate-like member; the recesses are each formed in a shape that conforms to the shape of the site of the autosuture device where the patch-type tissue reinforcement material is to be loaded; the recesses are successively disposed to the same end of said member; the recesses each have, at the bottom surface thereof, one or more pairs of tab-like fixation parts for clamping and fixing the patch-type tissue reinforcement material; and the fixation parts each have a top surface that is slanted toward the direction of the center of the recess.

Description

Tissue Reinforcement Attacher and Tissue Reinforcement Mounting Kit

The present invention relates to a tissue reinforcing material mounting device capable of mounting a sticking type tissue reinforcing material to an automatic suture device in a short time, accurately and easily, and a tissue reinforcing material mounting kit using the tissue reinforcing material mounting device.

Conventionally, a stapler-type automatic suture device in which a large number of staples are embedded has been used for suturing tissue. However, when applied to the lungs and the like, there is a problem of air leakage from the sutured portion, and when applied to soft tissues, problems such as tissue damage and tearing may occur.

Therefore, a bioabsorbable reinforcing material is used together with an automatic suturing device in order to prevent air leakage, body fluid leakage, and tissue damage (for example, Patent Documents 1 and 2). The reinforcing materials of Patent Documents 1 and 2 are sewn on two opposite sides of one bioabsorbable non-woven fabric, or two bioabsorbable non-woven fabrics or one bioabsorbable non-woven fabric and one stretchable knitted fabric. The two opposite sides are sewn together to form a tubular structure. Then, the end of the cartridge of the automatic suture device is inserted into the cylinder to be attached to the automatic suture device, and the tissue is sewn together with the tissue to reinforce the tissue. Further, after reinforcement, unnecessary parts can be separated by pulling a thread extending from the reinforcing material, so that workability is high. Further, since the reinforcing material is made of a bioabsorbable non-woven fabric, it is finally absorbed into the living body after the reinforcement becomes unnecessary.

Japanese Unexamined Patent Publication No. 08-047526 Japanese Patent No. 4675237

The reinforcing material used in the conventional automatic suturing device is made into a cylindrical shape by combining a fabric that reinforces the tissue and a fabric having elasticity in order to prevent displacement when the automatic suturing device is operated. So, it is in close contact with the automatic suture device. However, since there are various sizes of cartridges for the automatic suturing device, the reinforcing material cannot be sufficiently brought into close contact with the automatic suturing device depending on the size of the cartridge, and the cartridge may be displaced. Further, even when a reinforcing material suitable for the size of the cartridge is used, a gap may occur in the vicinity of the seam of the fabric, which may cause a deviation.

On the other hand, in endoscopic surgery using an automatic suturing device, a plurality of tubular ports are punctured into the patient's body, and an instrument such as an endoscope or an automatic suturing device is inserted through these ports. At this time, since the conventional reinforcing material is attached so as to surround the cartridge portion of the automatic suturing device, the reinforcing material may be caught when the port of the automatic suturing device is inserted. In addition, since the size of the automatic suture device equipped with the reinforcing material becomes large due to the presence of the reinforcing material so as to surround the cartridge part, a port having a diameter larger than the size of the automatic suturing device itself is used. Without it, the automatic suture device cannot be passed. From the viewpoint of reducing the burden on the patient, a reinforcing material that can be passed through a port having a smaller diameter is required.

Therefore, the applicant of the present application has proposed a suture prosthesis material for an automatic suturing device in which a cloth-like body layer made of a bioabsorbable material and a sponge layer made of a water-soluble polymer are laminated and integrated. Such suture prostheses for automatic sutures generate adhesive strength when the sponge layer absorbs water, and can be attached to the automatic suture device by attaching it to the cartridge part, so that automatic suture devices of all sizes can be attached. In addition to being highly passable through the port, it is possible to prevent slippage when operating the automatic suturing device.

However, since such a stick-type tissue reinforcing material is soaked in water and then stuck to the automatic suture device, it becomes more complicated to attach than the conventional cylindrical tissue-reinforcing material. Further, if the mounting position is displaced, it is necessary to peel it off and then reattach it. Therefore, there is a demand for a method of easily and accurately attaching the attachment type tissue reinforcing material to the automatic suture device.

In view of the above problems, the present invention has a tissue reinforcing material mounting device capable of mounting a sticking type tissue reinforcing material on an automatic suture device in a short time, accurately and easily, and a tissue reinforcing material mounting using the tissue reinforcing material mounting device. The purpose is to provide a kit.

The present invention is a tissue reinforcing material mounting device for fixing a sticking type tissue reinforcing material to an automatic suturing device, and has recesses at opposite positions on both sides of a plate-shaped member, and each of the recesses is said to be automatically sutured. It has a shape corresponding to the shape of the portion of the vessel to which the stick-type tissue reinforcing material is attached, each recess is continuous to the same end of the member, and each recess sandwiches the stick-type tissue reinforcement on the bottom surface. The fixing portion is a tissue reinforcing material mounting device having one or more pairs of claw-shaped fixing portions for fixing with the above, and the upper surface thereof is inclined toward the center of the recess.

Hereinafter, the tissue reinforcing material mounting device of the present invention and the sticking type tissue reinforcing material to be used thereof will be described in detail. First, the tissue reinforcing material mounting device of the present invention will be described in detail.
The tissue reinforcing material mounting device of the present invention is a tissue reinforcing material mounting device for fixing the sticking type tissue reinforcing material to the automatic suture device.
The stick-on tissue reinforcing material has an advantage that it is hardly caught in the port as compared with the conventional cylindrical tissue reinforcing material, and it is not necessary to make the shape corresponding to the cross-sectional shape of the automatic suture device. However, in order to attach the stick-on tissue reinforcing material to the automatic suture device, it must be attached to a predetermined position of the automatic suture device, so that there is a problem that accurate attachment in a short time is difficult. By using the tissue reinforcing material mounting device of the present invention, the sticking type tissue reinforcing material can be mounted on the automatic suturing device in a short time, accurately and easily regardless of the skill level of the wearer. In the present invention, the "automatic suturing device" includes not only an automatic suturing device but also an automatic anastomosis device.

The tissue reinforcing material mounting device of the present invention has recesses at opposite positions on both sides of the plate-shaped member.
By providing recesses at opposite positions on both sides of the plate-shaped member and holding the stick-type tissue reinforcing material in the recesses, it is possible to improve the handleability of the stick-type tissue reinforcing material during transportation and storage. By immersing the sticking type tissue reinforcing material together with the tissue reinforcing material mounting device in water and sandwiching the recess with the automatic suturing device, two sticking type tissue reinforcing materials can be mounted on the automatic suturing device at the same time. Here, the plate shape refers to a flat shape having a thickness sufficient to sandwich the automatic suturing device.

Each of the recesses has a shape corresponding to the shape of the portion of the automatic suture device to which the sticky tissue reinforcing material is attached, and each recess is continuous to the same end of the member.
By making the shape of the concave portion correspond to the shape of the portion to which the stick-type tissue reinforcing material of the automatic suture device is mounted, the stick-type tissue reinforcing material can be accurately mounted at a predetermined position. Further, since the two recesses are continuous to the same end of the member, the automatic suturing device can be sandwiched from the side where the recesses are continuous. Each recess may be continuous with one end of the member or may be continuous with a plurality of ends.

Each of the recesses has one or more pairs of claw-shaped fixing portions for fixing the sticking type tissue reinforcing material on the bottom surface, and the upper surface of the fixing portions is inclined toward the center of the recesses.
By providing at least one pair of fixing portions (claw) on the bottom surface of the recess, the sticking type tissue reinforcing material can be sandwiched between the claws and securely held. Further, the upper surface of the fixed portion, that is, the surface facing the bottom surface of the concave portion is inclined toward the center of the concave portion, so that the cross-sectional shape between the fixed portions becomes V-shaped. As a result, since the inclined surface of the fixed portion serves as a guide, the automatic suture device can be more easily pinched, and the automatic suture device can be less likely to be caught when the automatic suture device is released.
Here, the claw shape is a shape that is not connected to anything other than the bottom surface of the recess and protrudes in the height direction of the recess, and the surface facing the bottom surface of the recess is inclined, in other words, the upper surface is It refers to a columnar shape that is inclined toward the center of the recess.
It is sufficient that at least one pair of the fixing portions exists in each recess, but from the viewpoint of more reliably holding the sticking type tissue reinforcing material, each recess may have three pairs or more and six pairs or less of each of the fixing portions. It is preferable to have 5 pairs or less. Further, the length and spacing of each fixing portion can be appropriately adjusted according to the size of the sticking type tissue reinforcing material and the desired fixing strength.

The height of the fixed portion is not particularly limited, but the height of the inner surface (the surface on the center side of the recess) of the fixed portion is 0.5 mm or more and 2.0 mm or less, and the outer surface of the fixed portion (the side surface side of the recess). The height of the surface) is preferably 3.0 mm or more and 8.0 mm or less.
When the height of the fixed portion is within the above range, the upper surface of the fixed portion is inclined so as to be able to more effectively serve as a guide for the automatic suture device, and the stick-on tissue reinforcing material can be held more reliably. 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.

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.
By having a gap in the above range between the side surface of the recess and the fixing portion, the fixing portion will fall more toward the side surface of the recess when the automatic suture device is sandwiched, so that the adhesive tissue reinforcing material can be released more reliably. Can be done. The distance between the outer surface of the fixing portion and the side surface of the recess is more preferably 2 mm or more, and more preferably 4 mm or less.

The distance between the bottom surfaces of the recesses is preferably 0.5 mm or more and 4.0 mm or less.
When the distance between the bottom surfaces of the recesses is within the above range, the tip of the automatic suture device can be more reliably sandwiched in the recesses, and as a result, the adhesive tissue reinforcing material can be more reliably attached to the automatic suture device. .. The distance between the bottom surfaces of the recesses is more preferably 1 mm or more, further preferably 2 mm or more, and even more preferably 3 mm or less.

The depth of the recess is preferably 0.5 mm or more and 5.0 mm or less.
When the depth of the recess is within the above range, the sticking type tissue reinforcing material can be held more reliably. The depth of the recess is preferably ± 0.5 mm in the thickness of the sticking type tissue reinforcing material, and when the thickness of the sticking type tissue reinforcing material is 1.0 mm or more and 1.5 mm or less, 0.5 mm or more. It is more preferably 2.0 mm or less.

The fixed portion preferably has a cross-sectional shape in which the upper surface protrudes from the surface on the center side of the recess.
Since the upper surface of the fixed part has a cross-sectional shape protruding from the inner surface, that is, the upper surface has a cross-sectional shape protruding like a roof, the sticking type tissue reinforcing material can be hooked on the protruding part. The sticking type tissue reinforcing material can be reliably held, and unintentional dropping can be suppressed.

The protruding width of the upper surface of the fixed portion, that is, the length from the protruding end of the upper surface of the fixed portion to the inner surface of the fixed portion is preferably 0.2 mm or more, preferably 0.4 mm or more. It is more preferably 0.8 mm or less, and more preferably 0.6 mm or less. By setting the protrusion width within the above range, it is possible to more reliably hold the sticking type tissue reinforcing material and to prevent it from being caught at the time of release.

In the tissue reinforcing material mounting device of the present invention, it is preferable that at the end portion continuous with the recessed portion of the member, the portions on both sides of the recessed portion protrude from the end portion of the recessed portion.
At the end continuous with the outside of the recess, the parts on both sides of the recess protrude from the end of the recess, that is, the shape of the end where the recess of the member is continuous becomes concave when viewed from the upper surface. As a result, the protruding recesses on both sides serve as guides for the automatic suture device, so that the stick-on tissue reinforcing material can be more reliably attached to the automatic suture device at a predetermined position. The protrusion length of the portions on both sides of the recess is not particularly limited, but is preferably 10 mm or more and 50 mm or less from the viewpoint of guide performance to the automatic suturing device and handleability.
Further, it is desirable that there is a protruding portion in the central portion of the concave portion at the end portion continuous with the concave portion of the member. Since the protruding portion in the central portion supports the sticking type tissue reinforcing material and prevents deformation, the sticking type tissue reinforcing material can be more reliably attached to the automatic suture device at a predetermined position. The protrusion length of the central portion of the recess is not particularly limited, but is preferably 10 mm or less in relation to the depth of the mouth portion of the automatic suture device.

The thickness of the outer edge portion of the tissue reinforcing material mounting device of the present invention is preferably 5.0 mm or more and 10.0 mm or less.
When the thickness of the outer edge portion is within the above range, bending deformation is less likely to occur when handling the tissue reinforcing material mounting device, and the sticking type tissue reinforcing material can be held more reliably.

The material of the above member, that is, the material of the tissue reinforcing material mounting device of the present invention is not particularly limited, but it is preferable to have a certain degree of cushioning property in order to securely mount the sticking type tissue reinforcing material by the automatic suturing device. Examples of such a material include foamed polyethylene, foamed polypropylene, foamed ethylene / vinyl acetate copolymer resin, foamed polyvinyl chloride, foamed polystyrene, foamed polyurethane and the like, silicone rubber, urethane rubber, acrylic rubber and the like. In particular, when sterilizing and packaging by holding a stick-on type reinforcing material at the time of manufacturing, heat resistance and dimensional stability are required, so highly durable silicone rubber is preferable.

The tissue reinforcing material mounting device of the present invention preferably has a handle on the side surface of the member.
By providing the handle on the side surface of the member, the automatic suture device can be sandwiched between the other hand while grasping the handle with one hand, so that the stick-on tissue reinforcing material can be more easily attached to the automatic suture device. The size and shape of the handle are not particularly limited as long as they are easy to grasp by hand. The position of the handle is not particularly limited as long as it is easy to work, but it is preferably provided on the side surface on the long side. Here, the long side refers to a side parallel to the traveling direction of the concave portion when the member is a flat surface.

The tissue reinforcing material mounting device of the present invention preferably has notch grooves for cutting the tissue reinforcing material mounting device at both ends in the short side direction of the member.
If the above member has cut grooves at both ends in the short side direction, the tissue reinforcing material mounting device can be cut according to the length of the suture length of the automatic suture device. It can be used for automatic suturing machines of various sizes. Further, since the notch groove serves as a guide for the blade, the tissue reinforcing material mounting device can be cut easily and accurately. The short side direction means a direction perpendicular to the traveling direction of the recess when the member is a flat surface.

Here, FIG. 1 shows a schematic view showing an example of the tissue reinforcing material mounting device of the present invention. As shown in FIG. 1, the tissue reinforcing material mounting device 1 of the present invention has recesses 2 at opposite positions on both sides of a plate-shaped member. The two recesses 2 have a claw-shaped fixing portion 3 whose upper surface is inclined toward the center of the recess 2 on the bottom surface, and a sticking type tissue reinforcing material is held between the fixing portions 3. If only the recess 2 does not have the fixing portion 3, it is possible to hold the sticking type tissue reinforcing material itself, but it is difficult to hold the sticking type tissue reinforcing material evenly and with an appropriate force. Dropout may occur. Further, since the two recesses 2 are continuous to the same end of the member (tissue reinforcing material mounting device 1), the automatic suturing device is fixed from the end where the recesses 2 of the tissue reinforcing material mounting device 1 are continuous. By sandwiching the parts 3 so as to completely mesh with each other, it is possible to accurately attach the two sticking type tissue reinforcing materials to the predetermined positions of the automatic suture device at the same time. Further, as shown in FIG. 1, at the end portion continuous with the concave portion 2 of the member, when the portions on both sides of the concave portion 2 protrude from the end portion of the concave portion 2 (having the protruding portion 4), the protruding portion Since No. 4 serves as a guide for the automatic suturing device, the stick-on tissue reinforcing material can be more reliably attached to the desired position. The shape of the recess and the arrangement of the fixing portion are appropriately changed depending on the shape of the sticking type tissue reinforcing material to be fixed and the shape of the automatic suture device.

Further, FIG. 4 shows a schematic view showing one aspect of the tissue reinforcing material mounting device of the present invention. FIG. 4A is a perspective view showing one aspect of the tissue reinforcing material mounting device of the present invention. FIG. 4B is a cross-sectional view when the tissue reinforcing material mounting of FIG. 4A is cut along the line AA, and shows the cross-sectional shape of the fixed portion. As shown in FIGS. 4A and 4B, the tissue reinforcing material mounting device 1 of the present invention has a roof-like cross section in which the upper surface of the fixing portion 3 protrudes from the inner surface (center side of the recess 2). It has a shape. By hooking the stick-on tissue reinforcing material on the protruding portion, the stick-on tissue reinforcing material can be held more reliably, and unintentional dropping can be suppressed. Further, by providing the handle 8 on the side surface of the member, the automatic suture device can be sandwiched between the other hand while sandwiching the handle with one hand, so that the stick-on tissue reinforcing material can be more easily attached to the automatic suture device. Can be done. Further, if notch grooves 5 for cutting the tissue reinforcing material mounting device are provided at both ends in the short side direction of the member, the tissue reinforcing material mounting device can be cut accurately and easily according to the size of the automatic suture device. Therefore, it can be used for automatic suturing devices of various sizes. Although only one pair of notch grooves 5 is provided in FIG. 4, the number of notch grooves 5 is not particularly limited, and the larger the number of notch grooves 5, the easier it is to support an automatic suturing device of a larger size. .. The handle 8 and the notch groove 5 can also be provided in the aspect of FIG.

FIGS. 2, 3, 5 and 6 are diagrams schematically showing the use of the tissue reinforcing material mounting device of the present invention. As shown in FIGS. 2 and 5, in the method of using the tissue reinforcing material mounting device 1 of the present invention, first, the sticking type tissue reinforcing material 6 is held between the fixing portions 3 of the two recesses 2. When the upper surface of the fixing portion 3 has a cross-sectional shape protruding from the inner surface, the sticking type tissue reinforcing material 6 is held so as to be hooked on the protruding portion of the upper surface of the fixing portion 3, so that it may fall off unintentionally. It is suppressed and the sticking type tissue reinforcing material 6 can be held more reliably. In the case of a simple recessed groove, the functions of both the retention of the sticking type tissue reinforcing material and the release property after bonding with the automatic suture device cannot be satisfied. Reinforcing material can be held moderately and released. The operation of holding the stick-type tissue reinforcing material may be performed at the surgical site, or the stick-type tissue reinforcing material 6 may be held at the time of manufacture for sterilization, packaging, transportation, and storage. Next, the stick-on tissue reinforcing material 6 is immersed in sterilized water together with the tissue reinforcing material mounting device 1. After that, it is taken out from sterilized water, and as shown in FIGS. 6 is simultaneously attached to the automatic suturing device 7. At this time, in the tissue reinforcing material mounting device of the present invention, since the upper surface of the fixing portion 3 is inclined toward the center of the recess 2, the automatic suturing device can be smoothly sandwiched by using this inclined surface as a guide. It is possible to suppress catching even when the automatic suturing device is released. Further, since the fixing portion 3 exists independently inside the recess, the fixing portion 3 falls outward when the sticking type tissue reinforcing material is sandwiched by the automatic suture device, so that the tissue reinforcing material is used as the tissue reinforcing material mounting device. Will be released smoothly from. Further, when the tissue reinforcing material mounting device 1 has the protruding portion 4, the protruding portion 4 serves as a guide when sandwiching the automatic suture device 7, so that the sticking type tissue reinforcing material 6 can be more reliably placed in a predetermined position. Can be attached.

As described above, in the tissue reinforcing material mounting device of the present invention, the sticking type tissue reinforcing material may be held at the surgical site, but the sticking type tissue reinforcing material is transported and stored in a state of being held between the fixing portions. As a result, the handleability of the patch-type tissue reinforcing material can be improved, and the work at the surgical site can be further simplified.
Such a tissue reinforcing material mounting kit in which the sticking type tissue reinforcing material is held between the fixing portions of the tissue reinforcing material mounting device of the present invention is also one of the present inventions.

The method for manufacturing the tissue reinforcing material mounting 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 particular limitation. In particular, since it is easy to sterilize and can be manufactured at low cost, it is preferably manufactured by integrally molding the material of the above member.

Next, the stick-on tissue reinforcing material will be described in detail.
The stick-on tissue reinforcing material means a tissue reinforcing material that is fixed to the automatic suture device by adhesive force. The above-mentioned stick-type tissue reinforcing material is particularly limited as long as it is a tissue reinforcing material having adhesiveness such as a conventional tissue reinforcing material coated or laminated with an adhesive substance or a tissue reinforcing material itself having adhesiveness. However, it is preferable that it is a sticking type tissue reinforcing material in which a cloth-like body layer made of a bioabsorbable material and a sponge layer made of a water-soluble polymer are laminated and integrated. When such a stick-type tissue reinforcing material is used, the effect of the present invention is greatly exhibited. Hereinafter, a sticking-type tissue reinforcing material in which a cloth-like body layer made of a bioabsorbable material and a sponge layer made of a water-soluble polymer are laminated and integrated will be described.

The cloth-like body layer plays a role as a tissue reinforcing material, and since it uses a bioabsorbable material, it is finally absorbed into the living body after the reinforcement becomes unnecessary, and foreign substances are absorbed into the body. It does not remain for a long time and is highly safe. The sponge layer plays a role of imparting adhesiveness to the sticking type tissue reinforcing material, and the water-soluble polymer exhibits adhesiveness when it contains water. Here, the sponge-like structure refers to a structure having a large number of voids.

The laminating integration means joining both layers to the extent that peeling is unlikely to occur between the cloth-like body layer and the sponge layer even when a force is applied. Examples of the method for laminating and integrating the cloth-like body layer and the sponge layer include a method in which the cloth-like body is floated on a water-soluble polymer solution as a raw material of the sponge layer and then freeze-dried. .. In order to improve the interfacial adhesion between the cloth-like body layer and the sponge layer, the cloth-like body may be subjected to hydrophilic treatment with a plasma treatment device or the like to improve the permeability of the water-soluble polymer solution into the cloth-like body. preferable.

Examples of the bioabsorbable material include polyglycolide, polylactide (D, L, DL form), glycolide-lactide (D, L, DL form) copolymer, glycolide-ε-caprolactone copolymer, and lactide (D). , L, DL form) -ε-caprolactone copolymer, poly (p-dioxanone), glycolide-lactide (D, L, DL form) -ε-caprolactone copolymer, etc. Examples thereof include synthetic absorbent polymers and naturally absorbent 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 absorbent polymer is used as the bioabsorbable material, the naturally absorbent polymer may be used in combination. Of these, polyglycolic acid, polylactic acid, or a copolymer of lactic acid and caprolactone is preferable because it exhibits high strength.

When polyglycolide (a homopolymer or copolymer of glycolide) is used as the bioabsorbable material, the preferable lower limit of the weight average molecular weight of the polyglycolide is 30,000, and the preferable upper limit is 1,000,000. When the weight average molecular weight of the polyglycolide is 30,000 or more, the tissue can be reinforced more reliably, and when it is 1,000,000 or less, the foreign body reaction can be further suppressed. The more preferable lower limit of the weight average molecular weight of the polyglycolide is 50,000, and the more preferable upper limit is 300,000.

The form of the cloth-like body layer is not particularly limited, and may be any form such as a knitted fabric, a woven fabric, a non-woven fabric, and a film. Of these, a non-woven fabric is preferable from the viewpoints of flexibility, breathability, ease of staple passage, and the like.

When the cloth-like body layer is a non-woven fabric, the basis weight of the non-woven fabric is not particularly limited, but the preferable lower limit is 3 g / m ² and the preferable upper limit is 300 g / m ² . When the basis weight of the non-woven fabric is 3 g / m ² or more, the structure can be reinforced more reliably, and when it is 300 g / m ² or less, the adhesiveness to the structure can be further enhanced. The more preferable lower limit of the basis weight of the bioabsorbable non-woven fabric is 5 g / m ² , and the more preferable upper limit is 100 g / m ² .

The method for producing the above-mentioned non-woven fabric is not particularly limited, and for example, an electrospinning deposition method, a melt blow method, a needle punch method, a spunbond method, a flash spinning method, a water flow confounding method, an airlaid method, a thermal bond method, a resin bond method, etc. Conventionally known methods such as a wet method can be used.

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 reinforcing 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 because it is unlikely to come off when the automatic suturing device is operated and has an adhesive force that can be easily peeled off at the end of suturing. Examples of the polysaccharide-based material include hydroxypropylmethyl cellulose, pullulan, sodium alginate, carboxymethyl cellulose and the like, and examples of the protein-based material include gelatin, collagen peptide, water-soluble elastin and the like.

It is desirable that the water-soluble polymer has a viscosity of 1 mPa · s or more and 500 mPa · s or less when made into an aqueous solution having a concentration of 2%. By using a water-soluble polymer in the above range, it has an appropriate softness when formed into a sponge layer, develops an appropriate adhesiveness after water permeates, and can be easily attached to an automatic suture device. It will be possible.

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

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 the deviation during the operation of the automatic suture device, and it is possible to easily adjust the adhesive strength to an appropriate level so that the sponge layer can be easily peeled off after the suture 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 the water-soluble polymer solution immersed in the cloth-like body layer. Further, here, the thickness of the sponge layer is the average of the thickness obtained by measuring the entire area of the sponge layer with a dial gauge (for example, SMD-565J-L manufactured by Teclock) at an interval of 1 point / cm ² . Point to.

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.
When the density of the sponge layer is within the above range, the deviation during the operation of the automatic suture device can be further suppressed, and the adhesive strength can be easily adjusted to an appropriate level so that the sponge layer can be easily peeled off after the suture is completed.

The sticking type tissue reinforcing material preferably has an adhesive strength of 1.5 N / cm ² or more when stuck to an automatic suture device.
When the adhesive strength when attached to the automatic suturing device is within the above range, it is possible to further suppress the deviation during the operation of the automatic suturing device. The adhesive strength is more preferably 3.0 N / cm ² or more. The upper limit of the adhesive strength is not particularly limited, but is preferably 30 N / cm ² or less from the viewpoint of facilitating peeling after the completion of suturing. Specifically, the adhesive strength can be measured by the following method.
On the working surface (anvil side) of an automatic suture device (for example, Ethicon Inc., endpass stapler ECHELIN FLEX 60, etc.) that has been cut into a stick-on tissue reinforcing material to a width of 8 mm and a length of 40 mm and soaked in physiological saline in advance. Stick only 10 mm long and press for 3 minutes to adhere. Next, the handle of the automatic suture device is attached to the lower chuck of a tensile tester (for example, Autograph Precision Universal Testing Machine AG-X Plus, manufactured by Shimadzu Corporation, etc.) to reinforce the sticking type tissue protruding from the automatic suture device. Attach the end of the material to the upper chuck of the tensile tester. After that, a tensile test is performed at a tensile speed of 100 mm / min, and the maximum load when a deviation occurs is taken as the adhesive strength.

The method for producing the stick-type tissue reinforcing material is not particularly limited, and for example, it may be produced by the above method, or after the cloth-like body is laid on the bottom surface, a water-soluble polymer solution is applied to the lower surface of the cloth-like body. It can be obtained by pouring a water-soluble polymer solution onto a cloth-like body after preventing it from flowing in, and forming a sponge layer by freeze-drying.

According to the present invention, there is provided a tissue reinforcing material mounting device capable of mounting a sticking type tissue reinforcing material on an automatic suture device in a short time, accurately and easily, and a tissue reinforcing material mounting kit using the tissue reinforcing material mounting device. can do.

It is a schematic diagram which showed an example of the tissue reinforcement material mounting device of this invention. It is a figure which represented the state of use of the tissue reinforcing material mounting device of this invention schematically. It is a figure which represented the state of use of the tissue reinforcing material mounting device of this invention schematically. FIG. 4A is a perspective view showing one aspect of the tissue reinforcing material mounting device of the present invention. FIG. 4B is a cross-sectional view of the tissue reinforcing material mounting device of FIG. 4A when one aspect is cut along the line AA. It is a figure which represented the state of use of the tissue reinforcing material mounting device of this invention schematically. It is a figure which represented the state of use of the tissue reinforcing material mounting device of this invention schematically.

Hereinafter, aspects of the present invention will be described in more detail with reference to the drawings, but the present invention is not limited to these aspects.

(Example 1)
(1) Production of stick-on tissue reinforcing material Add distilled water to hydroxypropylmethylcellulose (HPMC) (viscosity grade 6: AN6, 2% solution viscosity: 5.1 mPa · s, manufactured by Mitsubishi Chemical Foods Co., Ltd.) to add 8% by weight. An HPMC aqueous solution was prepared, and 10 g was added to a φ100 mm chalet. Next, a sheet-like non-woven fabric made of polyglycolic acid (PGA) cut to φ100 mm as a cloth-like body layer was floated on a petri dish to which an HPMC aqueous solution was added. After confirming that the HPMC aqueous solution had permeated into the sheet-like non-woven fabric, the HPMC aqueous solution was frozen by putting the petri dish in a freezer at −80 ° C. for 15 minutes. Then, the frozen HPMC aqueous solution was dried by a vacuum freeze-dryer to form a sponge layer (adhesive layer) of HPMC on the non-woven fabric to prepare a sticking type tissue reinforcing material.

(2) Manufacture of tissue reinforcing material mounting device and tissue reinforcing material mounting kit A mold for injection molding for the tissue reinforcing material mounting device is manufactured, and a two-component curing type liquid silicone rubber (QP1-250 LIQUID SILICONE SUBBER, DuPont Toray) By pouring and curing (manufactured by Specialty Material Co., Ltd.), 20 mm x 70 mm x 2 mm recesses are formed on both sides of a plate-shaped silicone rubber with a thickness of 6 mm as shown in Fig. 1, and 5 pairs are formed on the bottom surface of the recesses. A tissue reinforcing material mounting device having a fixed portion (claw) of the above was obtained. The fixed portion has a height of 4 mm on the outer surface of the recess (the surface on the side surface of the recess) and 1 mm on the inner surface of the recess (the surface on the center direction side of the recess), and is a quadrangle inclined inward of the recess. The cross-sectional shape was set to. In addition, each fixed portion has a short side distance (distance between opposite fixed parts) of 9.5 mm, a long side distance (distance between fixed parts arranged in the traveling direction of the recess) of 12.5 mm, and a recess. The distance between the side surface of the fixed portion and the outer surface of the fixed portion is 3.25 mm. Further, the length of the protruding portion was set to 20 mm.
Next, the stick-on tissue reinforcing material obtained in Example 1 was cut to a size of 10 mm × 60 mm and held between the fixing portions so that the adhesive layer was facing upward to obtain a tissue reinforcing material mounting kit.

(3) Mounting on an automatic suture device The obtained tissue reinforcing material mounting kit was immersed in physiological saline (Otsuka Raw Food Injection, manufactured by Otsuka Pharmaceutical Co., Ltd.) for 5 seconds. After that, as shown in FIG. 3, an automatic suture device (Ethicon Inc. endpass stapler ECHELIN FLEX 60) was inserted from the side where the concave portion of the fixed portion was connected to the end portion, and the fixed portion was sandwiched between the fixed portions for 5 seconds. After that, when the mounting site of the tissue reinforcing material of the automatic suture device was confirmed, the sticking type tissue reinforcing material was mounted without shifting the predetermined position. In addition, the time from immersion in physiological saline to completion of mounting was about 20 seconds.

(Example 2)
(1) Manufacture of tissue reinforcing material mounting device and tissue reinforcing material mounting kit A mold for injection molding for the tissue reinforcing material mounting device is manufactured, and a two-component curing type liquid silicone rubber (QP1-250 LIQUID SILICONE RUBBER, DuPont Toray) By pouring and curing (manufactured by Specialty Material Co., Ltd.), 20 mm x 70 mm x 2 mm recesses and 5 pairs of fixing parts are formed on both sides of a member made of plate-shaped silicone rubber with a thickness of 6 mm as shown in FIG. A tissue reinforcing material mounter having (claw), a pair of notch grooves, and a handle was obtained. The fixed portion had a roof-like cross-sectional shape in which the upper surface was inclined inward of the concave portion and protruded from the inner surface of the concave portion of the fixed portion. Further, the height of the outer surface of the concave portion (the surface on the side surface side of the concave portion) of the fixing portion is 3 mm, the height of the inner surface of the concave portion (the surface on the central direction side of the concave portion) is 1 mm, and the concave portion is formed from the end of the protruding upper surface. The length to the inner surface (protruding width) was set to 0.48 mm. Further, the depth of the notch groove in the thickness direction of the member was 1 mm, the depth in the short side direction was 2 mm, and the width was 2 mm. Further, the arrangement of the fixing portion and the protruding portion were the same as in Example 1.
Next, the sticking type tissue reinforcing material obtained in Example 1 is cut to a size of 10 mm × 60 mm, and the fixing portion is hooked so that the adhesive layer faces upward and is hooked on the portion protruding from the inner surface of the fixing portion. It was held in between to form a tissue reinforcement mounting kit. At this time, even if a strong vibration was applied to the woven reinforcing material mounting kit, the tissue reinforcing material did not shift or fall off.

(2) Mounting on an automatic suture device The obtained tissue reinforcing material mounting kit was immersed in physiological saline (Otsuka Raw Food Injection, manufactured by Otsuka Pharmaceutical Co., Ltd.) for 5 seconds. After that, as shown in FIG. 6, an automatic suture device (Ethicon Inc. endpass stapler ECHELIN FLEX 60) was inserted from the side where the concave portion of the fixed portion was connected to the end portion, and the fixed portion was sandwiched between the fixed portions for 5 seconds. At this time, the automatic suturing device was sandwiched while holding the handle with one hand. After that, when the mounting site of the tissue reinforcing material of the automatic suture device was confirmed, the sticking type tissue reinforcing material was mounted without shifting the predetermined position. In addition, the time from immersion in physiological saline to completion of mounting was about 20 seconds.

(Comparative Example 1)
The patch-type tissue reinforcing material produced in Example 1 was cut according to the shape of the automatic suture device. Then, it was immersed in physiological saline for 5 seconds, attached to predetermined positions (2 places) of the automatic suture device, and pressed for 5 seconds using a foamed polyethylene sheet having a thickness of 2 mm to attach the adhesive tissue reinforcing material. The stick-on tissue reinforcing material was attached without shifting the predetermined position, but the time from immersion in physiological saline to completion of attachment was about 90 seconds.

According to the present invention, there is provided a tissue reinforcing material mounting device capable of mounting a sticking type tissue reinforcing material on an automatic suture device in a short time, accurately and easily, and a tissue reinforcing material mounting kit using the tissue reinforcing material mounting device. can do.

1 Tissue reinforcement mounting device 2 Recessed part 3 Fixed part 4 Protruding part 5 Notch groove 6 Sticking type tissue reinforcing material 7 Automatic suture device 8 Handle

Claims (7)

1. It is a tissue reinforcing material mounting device for fixing the sticking type tissue reinforcing material to the automatic suture device.
   It has recesses on both sides of the plate-shaped member at opposite positions.
   Each of the recesses has a shape corresponding to the shape of the portion of the automatic suturing device to which the stick-type tissue reinforcing material is attached.
   Each recess is continuous to the same end of the member
   Each recess has one or more pairs of claw-shaped fixing portions on the bottom surface for sandwiching and fixing the stick-type tissue reinforcing material.
   The fixing portion is a tissue reinforcing material mounting device whose upper surface is inclined toward the center of the recess.
2. The tissue reinforcing material mounting device according to claim 1, wherein at an end portion continuous with the recessed portion of the member, portions on both sides of the recessed portion protrude from the end portion of the recessed portion.
3. The tissue reinforcing material mounting device according to claim 1 or 2, wherein the fixing portion has 3 pairs or more and 6 pairs or less.
4. The tissue reinforcing material mounting device according to any one of claims 1 to 3, wherein the fixing portion has a cross-sectional shape in which the upper surface protrudes from the surface on the center side of the recess.
5. The tissue reinforcing material mounting device according to any one of claims 1 to 4, wherein the member has a handle on a side surface.
6. The tissue reinforcing material mounting device according to any one of claims 1 to 5, wherein the member has cut grooves for cutting the tissue reinforcing material mounting device at both ends in the short side direction.
7. A tissue reinforcing material mounting kit according to any one of claims 1 to 6, wherein the sticking type tissue reinforcing material is held between the fixing portions of the tissue reinforcing material mounting device.
   
   

Images