JP2020048952A - Fusion promotion device - Google Patents

Abstract

To provide a fusion promotion device that can reduce risk of suture failure after surgery such as surgical operation.SOLUTION: A fusion promotion device 10 includes: a body part 20 formed of a biodegradable sheet with multiple through-holes 25 and promoting fusion of biological tissues; a hole part 40 formed in the body part and having a hole diameter that is larger than the through-hole; and a soft part 30 for increasing flexibility on a side of the hole part more than that on a side of an outer edge in the body part.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a fusion promoting device.

  2. Description of the Related Art In the medical field, a technique for joining living organs by a surgical operation (for example, anastomosis of a digestive tract) is known. It is also known that when such a procedure is performed, it is important as a postoperative prognostic determinant that delay of fusion does not occur at a joint where living organs are joined.

  Various methods and medical instruments are used in a procedure for joining a living organ. For example, a method of suturing a living organ with a biodegradable suture or a mechanical anastomosis apparatus for performing an anastomosis with a stapler (see Patent Document 1). ) Has been proposed. In particular, when performing an anastomosis using a mechanical anastomosis device, the joining force between living organs at the joint can be increased as compared with a method using a suture, thereby reducing the risk of suture failure. It becomes possible.

JP 2007-505708 A

  However, the degree of progress of the fusion at the joint also depends on the state of the living tissue at the joint target site (joint site) of the patient. Therefore, for example, even when an anastomosis device such as that described in Patent Literature 1 is used, the risk of suture failure may not be sufficiently reduced depending on the state of the living tissue of the patient.

  Accordingly, an object of the present invention is to provide a fusion promoting device that can reduce the risk of suture failure after surgery such as surgery.

  The fusion promoting device according to one embodiment of the present invention includes a main body formed of a biodegradable sheet having a plurality of through holes and promoting fusion of living tissue, and a hole diameter formed in the main body and larger than the through hole. It has a hole formed large and a flexible portion that makes the flexibility of the main body portion on the side of the hole portion higher than the outer edge side.

  According to the present invention, the fusion promoting device increases the flexibility of the hole portion side of the main body portion from the outer edge side by the flexible portion, so that the region of the hole portion is more flexible than the region of the outer edge side. Deformable. As a result, when a treatment jig or the like is inserted into the hole of the main body, the area on the side of the hole is more flexibly deformed than the area on the outer edge side, so that the entire fusion promoting device is not distorted or misaligned. The occurrence can be suppressed. In addition, during the operation of sandwiching the fusion promoting device between the target sites of the living organ, even if the protruding portion of the target site pulls the main body, the area on the hole side is more flexible than the area on the outer edge side. As a result, it is possible to suppress the occurrence of deformation and displacement in the entire fusion promoting device. Therefore, the risk of suture failure after surgery such as surgery can be reduced.

It is a perspective view showing one form of the fusion promotion device of the present invention. FIG. 2 is an enlarged cross-sectional view showing a part of a cross-section taken along line 2-2 of FIG. 1. FIGS. 3A and 3B are views showing various forms of the flexible portion in the fusion promoting device. 4 (A) and 4 (B) are cross-sectional views schematically showing various forms of the flexible portion in the fusion promoting device. It is a flowchart which shows each procedure of the treatment method using the fusion promoting device. It is a flowchart which shows the procedure of embodiment (colorectal anastomosis) of a treatment method. It is a typical sectional view for explaining a large intestine anastomosis. It is a typical sectional view for explaining a large intestine anastomosis. It is a typical sectional view for explaining a large intestine anastomosis.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that the dimensional ratios in the drawings are exaggerated for the sake of explanation, and may differ from the actual ratios.

  FIG. 1 is a perspective view showing one embodiment of the fusion promoting device 10, and FIG. 2 is a cross-sectional view showing a part of a cross section taken along line 2-2 of FIG.

  The illustrated fusion promoting device 10 can be used, for example, in a method of joining a predetermined portion of a living organ to be joined (for example, anastomosis of a digestive tract). Briefly, the fusion promoting device 10 is formed from a biodegradable sheet having a plurality of through holes 25 and promotes fusion of living tissue, and is formed in the main body 20 and has a larger hole diameter than the through holes 25. And a hole 40 formed. The fusion promoting device 10 further has a flexible portion 30 that makes the body portion 20 more flexible on the side of the hole portion 40 than on the outer edge side. The details will be described below.

<Main unit 20>
The main body 20 can be formed from a thin biodegradable sheet. A plurality of through holes 25 are formed in the main body 20. As shown in FIG. 1, the plurality of through holes 25 are provided regularly and periodically in the surface direction of the main body 20. The plurality of through holes 25 may be provided, for example, randomly in the main body 20.

  As shown in FIG. 2, the plurality of through holes 25 are provided vertically along the thickness direction of the main body 20 (the vertical direction in FIG. 2). The plurality of through holes 25 are provided substantially vertically between the front surface 21 and the back surface 23 of the main body 20. However, the plurality of through holes 25 may be provided so as to be curved between the front surface 21 and the back surface 23 in the thickness direction of the main body 20.

  The thickness (the size T shown in FIG. 2) of the main body 20 is not particularly limited, but is preferably 0.05 to 0.3 mm, and more preferably 0.1 to 0.2 mm. If the thickness of the main body 20 is 0.05 mm or more (particularly 0.1 mm or more), it is possible to ensure sufficient strength that the main body 20 is not damaged when the fusion promoting device 10 is handled. On the other hand, if the thickness of the main body 20 is 0.3 mm or less (especially 0.2 mm or less), the main body 20 adheres closely to the living tissue to which the main body 20 is applied, and follows the living tissue. Enough flexibility can be ensured.

  As shown in FIG. 1, the main body 20 has a circular shape in plan view. However, the outer shape of the main body 20 is not particularly limited, and may be, for example, a substantially rectangular shape or an elliptical shape.

  The main body 20 has a value of a ratio of the hole diameter D (the distance D shown in FIG. 2) of the plurality of through holes 25 to the pitch P (the distance P shown in FIG. 2) of the plurality of through holes 25. It is preferred that If the shape of the through hole 25 in a plan view is a perfect circle, the hole diameter D of the through hole 25 is equal to the diameter of the perfect circle. On the other hand, when the shape of the through-hole 25 in a plan view is not a perfect circle, a true shape having the same area as the area of the opening of the through-hole 25 (the portion of the through-hole 25 facing the front surface 21 or the back surface 23) is provided. The diameter of the circle (equivalent circle diameter) can be used as the hole diameter D of the through hole 25.

  The main body 20 has a plurality of through holes 25. Therefore, the main body 20 has a plurality of values of the hole diameter D corresponding to each through hole 25. In the present embodiment, when calculating the value of the above-described ratio, the arithmetic mean value of two or more values of the hole diameter D corresponding to each of the plurality of through holes 25 is used as a representative value of the hole diameter D. On the other hand, the “pitch P” of the plurality of through holes 25 refers to the shortest distance between the openings of the two through holes 25. Regarding the value of the pitch P, there are a plurality of values of the pitch P corresponding to the combination of the adjacent through holes 25. Therefore, in the present embodiment, when calculating the value of the ratio described above, the arithmetic mean of two or more values of the pitch P corresponding to the combination of the adjacent through holes 25 is used as the representative value of the pitch P. And

  The pitch P, the hole diameter D, the ratio of the hole diameter D to the pitch P, and the like of the through holes 25 are merely examples, and are not limited thereto.

  The main body 20 can be made of a biodegradable material. The constituent material of the main body 20 is not particularly limited, and examples thereof include a biodegradable resin. As the biodegradable resin, for example, known tables such as those described in JP-T-2011-528275, JP-T-2008-514719, International Publication No. 2008-1952, JP-T-2004-509205 and the like Biodegradable (co) polymers can be used. Specifically, it is selected from the group consisting of (1) aliphatic polyester, polyester, polyanhydride, polyorthoester, polycarbonate, polyphosphazene, polyphosphate, polyvinyl alcohol, polypeptide, polysaccharide, protein, and cellulose. Polymers: (2) Copolymers composed of one or more monomers constituting the above (1). That is, the biodegradable sheet is selected from the group consisting of aliphatic polyester, polyester, polyanhydride, polyorthoester, polycarbonate, polyphosphazene, polyphosphate, polyvinyl alcohol, polypeptide, polysaccharide, protein, and cellulose. It is preferable to include at least one biodegradable resin selected from the group consisting of a polymer and a copolymer composed of one or more monomers constituting the polymer.

  The method for manufacturing the main body 20 is not particularly limited. For example, a method in which a fiber made of the biodegradable resin described above is manufactured and a mesh-shaped sheet is manufactured using the fiber. The method for producing a fiber made of a biodegradable resin is not particularly limited, and examples thereof include an electrospinning method (electrospinning method / electrospinning method) and a melt blow method. As the main body 20, only one of the above methods may be selected and used, or two or more may be selected and appropriately combined.

  Here, the electrospinning method is a method of forming microfibers made of resin while a high voltage (for example, about 20 kV) is applied between a syringe filled with a resin solution and a collector electrode. When this method is employed, the solution extruded from the syringe is charged and scatters in the electric field, but as time passes, the solvent contained in the scattered solution evaporates, and as a result, a thinned solute appears. . The thinned solute becomes fine fibers made of resin and adheres to a collector such as a substrate.

  By using a mesh-like substrate made of stainless steel (SUS) steel or the like as a collector of the electrospinning method, fine fibers made of a biodegradable resin as a thinned solute adhere to a substantial part of the mesh, and Mesh is formed. The biodegradable sheet can be manufactured by peeling the resin mesh thus obtained from the mesh base material. By appropriately adjusting the size (pore diameter, pitch) of the mesh base material, it is possible to control the shape (pore diameter, pitch of through holes) of the biodegradable sheet made of the resin mesh to be produced.

  Similarly, as another example of a manufacturing method using the electrospinning method, a resin sheet having a uniform thickness by scattering the above solution on a flat base material surface that is not a mesh shape and attaching the microfibers thereto. A method of forming a through-hole after obtaining the same may also be adopted. In this case, for example, by irradiating the resin sheet with laser light condensed using a condensing lens, it is possible to form a through-hole at the irradiated portion. The shape (pore diameter, pitch) of the biodegradable sheet made of the resin mesh to be produced can be controlled by adjusting the energy of the laser light to be irradiated, the irradiation time, the interval between the irradiation sites, and the like. It is possible.

  In addition, as still another example of the method of manufacturing the main body 20, a fiber made of the above-described biodegradable resin is spun according to an ordinary method, and the obtained fiber is knitted into a mesh to produce a biodegradable sheet. Is also good.

  The main body section 20 causes a biological reaction by a constituent material such as a biodegradable resin constituting the main body section 20. The main body 20 induces the expression of a biological component such as fibrin by this action. The biocomponents thus induced are accumulated by penetrating through the through-hole 25 of the main body 20 to promote fusion. For example, by disposing the main body 20 of the fusion promoting device 10 between living organs to be joined (anastomosis target), fusion is promoted by the above mechanism.

  The main body 20 has a hole 40 (center hole) formed with a hole diameter d1 larger than the through hole 25 at a substantially central position in plan view. The hole diameter of the hole 40 can be, for example, 5 mm to 25 mm. Further, the outer shape of the hole 40 can be formed, for example, in a perfect circle, but may be elliptical, rectangular, or any other shape.

<Flexible part 30>
The flexible portion 30 is provided to make the flexibility of the hole portion 40 side of the main body portion 20 higher than that of the outer edge side. As shown in FIG. 1, the flexible portion 30 includes at least one cut 31 formed in the biodegradable sheet from the inner edge of the hole 40. In the illustrated example, eight cuts 31 are formed at equal intervals in the circumferential direction. Each notch 31 has a straight shape. Each cut 31 has the same cut length in the radial direction from the inner edge of the hole 40. The cut length is not particularly limited, but is, for example, 0.1 mm to 7.5 mm. The specific shape, length, and number of cuts 31 are not particularly limited. It can be appropriately modified to have the required flexibility. Further, in the case where a plurality of cuts 31 are formed, the present invention is not limited to a form in which the plurality of cuts 31 are arranged at equal intervals, and may be formed with a bias.

  Since the main body 20 is formed from a mesh sheet, the main body 20 is very soft. For this reason, when a treatment jig or the like is inserted into the hole 40 of the main body 20, the entire fusion promoting device is likely to be distorted or misaligned. In addition, a slight bulge is generated in the joint target portion of the living organ where the fusion promoting device is arranged due to a drawstring suture operation or the like. When using the fusion promoting device, the ridge is located in the hole in the body and in the area around the hole. During the operation of sandwiching the fusion promoting device between the joining target portions of the living organ, the mesh sheet is pulled by the protruding portion of the joining target portion, and the entire fusion promoting device is likely to be distorted or misaligned.

  Therefore, in the fusion promoting device 10 of the present embodiment, the flexibility on the side of the hole 40 in the main body 20 is increased by the flexible portion 30 from the side of the outer edge, so that the region on the side of the hole 40 has the outer edge. It can be deformed more flexibly than the area on the side. Thereby, when a treatment jig or the like is inserted into the hole 40 of the main body 20, the region on the side of the hole 40 is more flexibly deformed than the region on the outer edge side. It is possible to suppress the occurrence of displacement and displacement. Also, when the fusion promoting device 10 is sandwiched between the joining target sites of the living body organ, even if the ridge of the joining target site pulls the mesh sheet, the area on the side of the hole 40 is smaller than the area on the outer edge side. Since it is deformed flexibly, it is possible to suppress the occurrence of deformation and displacement in the entire fusion promoting device 10.

  By forming the notch 31, the flexibility on the side of the hole portion 40 can be more easily increased than on the side of the outer edge, and it is possible to easily suppress the occurrence of twisting and displacement in the entire fusion promoting device 10. .

  The method of creating the cut 31 is not particularly limited. For example, when the hole 40 is formed in the main body 20 by the cutting blade, the hole 40 can be formed by the cutting blade at the same time.

  Various forms of the flexible portion in the fusion promoting device will be described with reference to FIGS. 3A and 3B and FIGS. 4A and 4B.

  The flexible portion 30A in the fusion promoting device 10A of FIG. 3A includes a plurality of cuts 32, 33 formed in the biodegradable sheet from the inner edge of the hole 40. The plurality of cuts include a straight first cut 32 having one length and a straight second cut 33 having a length different from the one length. The first cut 32 is similar to the cut 31 shown in FIG. The length of the second cut 33 is not particularly limited, but is longer than the first cut 32, for example, 0.2 mm to 7.5 mm. The fusion promoting device 10A can be more flexibly deformed in the direction in which the second cut 33 extends (in the vertical and horizontal directions in FIG. 3A). As described above, the region on the side of the hole 40 is more flexibly deformed than the region on the side of the outer edge, so that it is possible to suppress the occurrence of deformation and displacement in the entire fusion promoting device 10A.

  The flexible portion 30B in the fusion promoting device 10B of FIG. 3B includes at least one cut 34 formed in the biodegradable sheet from the inner edge of the hole 40. The notch 34 has a shape having an opening 34 a which is cut off a part of the biodegradable sheet and opened toward the hole 40. The shape for cutting off a part of the biodegradable sheet is not particularly limited. For example, in the case of the illustrated triangular shape, the width of the opening 34a is 0.1 mm to 15 mm, and the height of the triangle is 0.1 mm to 7.5 mm. Since a portion of the biodegradable sheet is cut off, the fusion promoting device 10B can be more flexibly deformed than when the straight cuts 31, 32, and 33 are formed. As described above, since the region on the side of the hole 40 is more flexibly deformed than the region on the outer edge side, it is possible to suppress the occurrence of deformation and displacement in the entire fusion promoting device 10B.

  The main body 20 in the fusion promoting device 10C in FIG. 4A has at least two regions where the densities of the biodegradable sheets are different. In the illustrated example, the main body 20 has an area 20A where the density of the biodegradable sheet is high and an area 20B where the density of the biodegradable sheet is low. The region 20B corresponds to a region where the density of the biodegradable sheet on the side of the hole 40 is smaller than that on the side of the outer edge. And the flexible part 30C is comprised from the area | region 20B. Since the density of the biodegradable sheet on the side of the hole 40 is reduced, the fusion promoting device 10C can be more flexibly deformed than when it has the same density. As described above, the region on the side of the hole 40 is more flexibly deformed than the region on the side of the outer edge, so that it is possible to suppress the occurrence of deformation or displacement in the entire fusion promoting device 10C.

  The specific form in which the density of the biodegradable sheet on the side of the hole 40 is smaller than that on the side of the outer edge is not particularly limited, but the following two forms can be exemplified.

  First, region 20B has a lower polymer molecular weight than remaining region 20A. The method of preparation is not particularly limited. For example, first, a mesh sheet is prepared from a polymer having a large molecular weight. Next, a portion corresponding to the region 20A other than the inside is masked. Next, by immersing the mesh sheet in hot water, only the portion corresponding to the region 20B, which is the inner portion, is hydrolyzed. Then, by removing the masking after the hydrolysis, the main body 20 having the region 20B having a smaller molecular weight of the polymer than the region 20A can be formed. By reducing the polymer molecular weight of region 20B, region 20B becomes more fragile and more flexibly deformable.

  Second, in the region 20B, the distance (pitch P (the distance P shown in FIG. 2)) between the adjacent through holes 25B is made smaller than the distance (pitch P) between the adjacent through holes 25A in the region 20A. The opening area of the through hole 25B per area is larger than the remaining area (the part corresponding to the area 20A) (see FIG. 4A). The hole diameters (D (the distance D shown in FIG. 2)) of the through holes 25A and 25B are equal. By increasing the opening area ratio of the region 20B (the ratio of the opening area of the through-hole 25B per unit area), it becomes possible to deform more flexibly than in the case where the area ratio is the same. In the region 20B, the pitch P of the through holes 25A and 25B is made equal, and the hole diameter (D) of the through hole 25B is made larger than the hole diameter (D) of the through hole 25A. Can be made larger than the remaining region (the portion corresponding to the region 20A). In the region 20B, the distance (pitch P) of the through hole 25B is smaller than the distance (pitch P) of the through hole 25A, and the hole diameter (D) of the through hole 25B is larger than the hole diameter (D) of the through hole 25A. Also, by increasing the opening area, the opening area of the through hole 25B per unit area can be made larger than the remaining area (the part corresponding to the area 20A).

  The main body 20 in the fusion promoting device 10D of FIG. 4B has at least two regions having different thicknesses Tc and Td. In the illustrated example, the main body 20 has a region 20C having a large thickness Tc and a region 20D having a small thickness Td. The region 20D corresponds to a region where the thickness Td on the side of the hole 40 is smaller than that on the outer edge side. And the flexible part 30D is comprised from the area | region 20D. Since the fusion promoting device 10D has a small thickness Td on the side of the hole 40, it can be deformed more flexibly than when it has the same thickness. As described above, since the region of the mesh sheet on the side of the hole portion 40 is more flexibly deformed than the region of the outer edge side, it is possible to suppress the occurrence of the deformation and the displacement of the entire fusion promoting device 10D.

  As described above, the fusion promoting devices 10, 10 A, 10 B, 10 C, and 10 D are formed from a biodegradable sheet having a plurality of through holes 25 and promote the fusion of living tissue with the main body 20. A hole 40 formed with a larger hole diameter than the through hole, and flexible portions 30, 30A, 30B, 30C, 30D that make the flexibility of the hole 40 side of the main body 20 higher than the outer edge side, Having. According to the fusion promoting device 10-10D configured as described above, the flexibility on the side of the hole 40 in the main body 20 is made higher than that on the outer edge side by the flexible portion 30-30D, and the flexibility of the hole 40 in the main body 20 is increased. The area on the side is more flexibly deformable than the area on the outer edge. Accordingly, when a treatment jig or the like is inserted into the hole 40, the region on the side of the hole 40 is more flexibly deformed than the region on the outer edge side. Deviation can be suppressed. Further, when the fusion promoting device 10-10 </ b> D is sandwiched between the joining target portions of the living body organ, the ridge of the joining target portion may pull the main body 20. Even in such a case, since the region on the side of the hole 40 is more flexibly deformed than the region on the outer edge side, it is possible to suppress the occurrence of a warp or a displacement in the entire fusion promoting device 10-10D. . Therefore, the risk of suture failure after surgery such as surgery can be reduced.

  The flexible portions 30, 30A, 30B include at least one cut 31, 32, 33, 34 formed in the biodegradable sheet from the inner edge of the hole 40. With this configuration, the flexibility on the side of the hole 40 can be more easily increased than on the side of the outer edge, and it is possible to easily suppress the occurrence of twisting and displacement in the entire fusion promoting device 10-10B. Can be.

  The cuts 31, 32, 33, and 34 are straight shapes (FIGS. 1 and 3A) or have a cutout portion of the biodegradable sheet and have an opening 34a opened toward the hole 40 (FIG. 3 (B)). The shape of the cuts 31-34 can be appropriately adopted according to the required flexibility.

  The flexible portion 30A includes a plurality of cuts 32, 33 formed in the biodegradable sheet from the inner edge of the hole 40, and the plurality of cuts includes a straight first cut 32 having one length and one cut. And a straight-shaped second cut 33 having a length different from the length. The shapes of the cuts 32 and 33 can be appropriately adopted according to the required flexibility.

  The main body 20 has a region 20B in which the density of the biodegradable sheet on the side of the hole 40 is smaller than that on the side of the outer edge, and the flexible portion 30C includes the region 20B. With such a configuration, the fusion promoting device 10C has a lower density of the biodegradable sheet on the side of the hole 40, and thus is more flexibly deformed than a case where the density is the same. It becomes possible. As described above, the region on the side of the hole 40 is more flexibly deformed than the region on the side of the outer edge, so that it is possible to suppress the occurrence of deformation or displacement in the entire fusion promoting device 10C.

  The region 20B has a smaller polymer molecular weight than the remaining region 20A. Thus, by reducing the polymer molecular weight, region 20B becomes more fragile and more flexibly deformable.

  In the region 20B, the opening area of the through hole 25B per unit area is larger than that of the remaining region 20A by reducing the distance between the adjacent through holes 25B or increasing the hole diameter of the through hole 25B. As described above, by increasing the opening area ratio (the ratio of the opening area of the through holes 25B per unit area), the region 20B can be deformed more flexibly than in the case where the region 20B has the same opening area ratio. Becomes

  The main body 20 has a region 20D where the thickness dimension Td on the side of the hole 40 is smaller than that on the outer edge side, and the flexible portion 30 is composed of the region 20D. Since the fusion promoting device 10D has a small thickness Td on the side of the hole 40, it can be deformed more flexibly than when it has the same thickness. As described above, since the area on the side of the hole 40 is more flexibly deformed than the area on the outer edge side, it is possible to prevent the entire fusion promoting device 10D from being distorted or misaligned.

  Although the example of the configuration of the fusion promoting device 10-10D has been described above, the fusion promotion device 10-10D according to the present invention includes a sheet-shaped main body 20 having a function of promoting the fusion of living tissue, and a main body 20. The specific configuration is not limited as long as the flexibility on the side of the hole 40 is made higher than that on the outer edge side by the flexible portions 30-30D. As another modified example, for example, the fusion promoting device 10 may have a communication hole exposed on the side surface of the main body 20. Further, the fusion promoting device 10 may have a shape in which a part of the through-hole 25 formed in the main body 20 is widened in a direction intersecting the thickness direction of the main body 20 (the vertical direction in FIG. 2). Further, the fusion promoting device 10 may have a shape in which a part of the through-hole 25 formed in the main body 20 is narrowed in a direction intersecting the thickness direction of the main body 20 (the vertical direction in FIG. 2).

  Next, a treatment method using the fusion promoting device will be described.

  FIG. 5 is a flowchart showing each procedure of a treatment method using the fusion promoting device.

  In the treatment method, a fusion promoting device including a sheet-shaped main body that promotes fusion of a living tissue is arranged between one of the joints to be joined to the living organ and the other joint to be joined (S11). Joining one joined portion and the other joined portion in a state where at least a part of the main body of the fusion promoting device is arranged between the one joined portion and the other joined portion (S12). ,including.

  The living organ to be joined by the treatment method and the site to be joined in the living organ are not particularly limited, and can be arbitrarily selected. However, in the following description, a description will be given using the colon anastomosis as an example. In addition, as the fusion promoting device used in each of the procedures described below, for example, any one of the above-described fusion promoting devices can be selected, and other fusion promoting devices can be selected. Can also. However, in the following description, a usage example of a specific fusion promoting device will be described as a typical example that can be suitably used for each procedure. In addition, in each of the procedures described below, detailed descriptions of known procedures, known medical devices, medical instruments, and the like are appropriately omitted.

  Hereinafter, in the description of the present specification, "disposing the fusion promoting device between the living organs" means that the fusion promoting device is placed in direct or indirect contact with the living organ, The fusion promoting device is placed with a spatial gap formed between them, or the fusion promoting device is placed in both states (for example, when the fusion promoting device contacts And that the fusion promoting device is not in contact with the other living organ). Further, in the description of the present specification, “periphery” does not define a strict range (region), but a predetermined range (region) as long as the purpose of treatment (joining of living organs) can be achieved. Means In addition, the procedure described in each treatment method can be appropriately rearranged as long as the purpose of the treatment can be achieved. In addition, in the description of the present specification, “relatively approaching” means both approaching two or more objects to be approached to each other, and approaching only one to only the other.

<Embodiment of treatment method (colorectal anastomosis)>
FIG. 6 is a flowchart showing a procedure of an embodiment (a large intestine anastomosis) of a treatment method, and FIGS. 7 to 9 are diagrams for explaining the large intestine anastomosis.

  In the treatment method according to the present embodiment, the living organ to be joined is the large intestine that has been cut along with the resection of the cancer tumor. Specifically, the living organs to be joined are the mouth A1 of the severed large intestine and the anal side A2 of the severed large intestine. In the following description, the procedure for joining the periphery of the mouth of the cut large intestine A1 (one to-be-joined site) and the part of the intestinal wall of the cut colon large intestine A2 (the other to-be-joined site) will be described. explain. In this embodiment, an example of use of the fusion promoting device 10 shown in FIG. 1 will be described.

  As shown in FIG. 6, in the treatment method according to the present embodiment, the fusion promoting device 10 is arranged between the periphery of the mouth of the large intestine and the intestinal wall of the large intestine (S101). Relatively approaching the wall (S102), sandwiching the main body 20 of the fusion promoting device 10 between the periphery of the large intestine and the intestinal wall of the large intestine (S103), the periphery of the large intestine and the large intestine Bonding with the body 20 of the fusion promoting device being sandwiched between the wall and the wall (S104), placing the body of the fusion promoting device between the periphery of the mouth of the large intestine and the intestinal wall of the large intestine (S105) ),including.

  Next, a treatment method according to the present embodiment will be specifically described with reference to FIGS.

  As shown in FIG. 7, an operator such as a doctor (hereinafter, referred to as an operator) inserts the first engagement device 710 of the anastomosis device 700 into the mouth A1 of the large intestine. The surgeon places the second engagement device 720 of the anastomosis device 700 on the anal side A2 of the large intestine. Prior to placing the second engagement instrument 720 on the anal side A2 of the large intestine, the surgeon forms a through hole A21 for inserting the second engagement instrument 720 of the anastomosis device 700 in the anal side A2 of the large intestine. Keep it. Note that the timing of forming the through hole A21 is not particularly limited as long as it is before the second engagement device 720 is arranged.

  As the anastomosis device 700, for example, a known device used for a large intestine anastomosis can be used. The anastomosis device 700 is configured such that the first engagement device 710 and the second engagement device 720 are engaged with each other, and the living tissue disposed between the first engagement device 710 and the second engagement device 720 is removed. The periphery of the excised living tissue is sutured circumferentially with staples. The first engaging device 710 is, for example, a device having a cylindrical engaged portion 711, and the second engaging device 720 is inserted into and engaged with the engaged portion 711 of the first engaging device 710, for example. It is a device including an engaging pin 721 to be combined. The living tissue near the center of the second engagement device 720 is slightly raised due to the operation of the purse string suturing when the second engagement device 720 is fixed.

  Next, as shown in FIG. 7, the surgeon places the fusion promoting device 10 between the oral side A1 of the large intestine and the anal side A2 of the large intestine. In the present embodiment, a fusion promoting device 10 (see FIG. 1) in which a hole (center hole) 40 is formed in the main body 20 is used. When arranging the fusion promoting device 10, the surgeon passes the hole 40 formed in the main body 20 through the engaging pin 721 provided in the second engaging instrument 720. At this time, the surgeon brings the main body 20 of the fusion promoting device 10 into contact with the vicinity of the anal side A2 of the large intestine where the through-hole A21 is formed. The surgeon may place the fusion promoting device 10 on the mouth A1 of the large intestine by passing the hole 40 formed in the main body 20 through the engaged portion 711 provided in the first engagement instrument 710. Good.

  Next, as shown in FIG. 8, the surgeon relatively engages the first engagement device 710 and the second engagement device 720 to engage with each other. The surgeon places the first engagement device 710 and the second engagement device 720 around the mouth on the oral side A1 of the large intestine, the main body 20 of the fusion promoting device 10, and the intestinal wall on the anal side A2 of the large intestine. The periphery of the formed through hole A21 is sandwiched. By operating the anastomosis apparatus 700, the surgeon operates the anastomosis device 700 to cause a part of the mouth A1 of the large intestine to be sandwiched between the first engagement device 710 and the second engagement device 720. And a part of the anal side A2 of the large intestine are excised, and the periphery of the excised site is joined by staples (not shown).

  Next, as shown in FIG. 9, the surgeon removes the anastomosis device 700 from the anal side A2 of the large intestine to the outside of the body via the anus, for example. In addition, the surgeon places the fusion promoting device 10 in a state where a part of the main body 20 of the fusion promoting device 10 is sandwiched between the periphery of the mouth on the oral side A1 of the large intestine and the intestinal wall on the anal side A2 of the large intestine. Detain.

  As described above, in the treatment method according to the present embodiment, the vicinity of the mouth of the large intestine and the intestinal wall of the large intestine are joined. According to this treatment method, the body part 20 of the fusion promoting device 10 disposed between the periphery of the mouth A1 of the large intestine and the intestinal wall of the anal side A2 of the large intestine is combined with the biological tissue around the mouth A1 of the large intestine. Healing of the living tissue of the intestinal wall on the anal side A2 of the large intestine can be promoted, and the risk of suture failure after colorectal anastomosis can be reduced.

  According to such a treatment method, a joining technique (for example, gastrointestinal tract) is performed by a simple method in which a sheet-shaped main body provided in the fusion promoting device is sandwiched between one to-be-joined part and the other to-be-joined part. The risk of suture failure after anastomosis is reduced.

  In addition, in the fusion promoting device 10 to be used, the flexibility on the side of the hole 40 in the main body 20 is made higher than that on the side of the outer edge by the flexible portion 30 so that the region on the side of the hole 40 becomes the region on the side of the outer edge. It is more flexible and deformable. Thereby, when a treatment jig or the like is inserted into the hole 40 of the main body 20, the region on the side of the hole 40 is more flexibly deformed than the region on the outer edge side. It is possible to suppress the occurrence of displacement and displacement. In addition, during the operation of sandwiching the fusion promoting device 10 between the joining target portions of the living body organ, the raised portion of the joining target portion may pull the main body 20. Even in such a case, the area on the side of the hole 40 is more flexibly deformed than the area on the outer edge side, so that it is possible to suppress the occurrence of twisting and displacement in the entire fusion promoting device 10. Therefore, the risk of suture failure after surgery such as surgery can be reduced.

10, 10A-10D fusion promoting device,
20 body,
20B Area where the density of the biodegradable sheet on the hole side is smaller than that on the outer edge side (flexible part);
20D area where the thickness dimension on the side of the hole is smaller than that on the side of the outer edge (flexible part),
21 surface,
23 Back,
25, 25B through hole,
30, 30A-30D flexible part,
31 Cut,
32 First cut,
33 Second cut,
34 Cut,
34a open mouth,
40 holes,
Tc thickness dimension on the outer edge side,
Td Thickness dimension on the side of the hole.

Claims (8)

A main body formed from a biodegradable sheet having a plurality of through-holes and promoting fusion of living tissue,
A hole formed in the main body and having a hole diameter larger than the through hole,
A flexible portion that makes the body portion more flexible on the side of the hole than on the outer edge side.   The fusion promoting device according to claim 1, wherein the flexible part includes at least one cut formed in the biodegradable sheet from an inner edge of the hole.   The fusion promoting device according to claim 2, wherein the cut has a straight shape or a shape having an opening that is formed by cutting off a part of the biodegradable sheet and opening the hole. The flexible portion includes a plurality of cuts formed in the biodegradable sheet from the inner edge of the hole,
The fusion promoting device according to claim 1, wherein the plurality of cuts include a straight first cut having a length and a straight second cut having a length different from the one. The main body has an area where the density of the biodegradable sheet on the side of the hole is smaller than that on the side of the outer edge,
The fusion promoting device according to claim 1, wherein the flexible portion is configured from the region.   The fusion promoting device according to claim 5, wherein the region has a lower polymer molecular weight than the remaining region.   6. The area according to claim 5, wherein an opening area of the through hole per unit area is larger than a remaining area by reducing a distance between adjacent through holes or increasing a diameter of the through hole. 7. Fusion promoting device. The main body has a region in which the thickness of the hole is smaller than that of the outer edge,
The fusion promoting device according to claim 1, wherein the flexible portion is configured from the region.