WO2023032693A1 - Medical member - Google Patents

Medical member Download PDF

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Publication number
WO2023032693A1
WO2023032693A1 PCT/JP2022/031177 JP2022031177W WO2023032693A1 WO 2023032693 A1 WO2023032693 A1 WO 2023032693A1 JP 2022031177 W JP2022031177 W JP 2022031177W WO 2023032693 A1 WO2023032693 A1 WO 2023032693A1
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WO
WIPO (PCT)
Prior art keywords
medical member
medical
main body
pressure resistance
resistance improving
Prior art date
Application number
PCT/JP2022/031177
Other languages
French (fr)
Japanese (ja)
Inventor
直希 荒巻
美穂 甲斐
美朱帆 白石
美利亜 鈴木
Original Assignee
テルモ株式会社
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Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2023032693A1 publication Critical patent/WO2023032693A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis in a single operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

Definitions

  • the present invention relates to a medical member applied to the anastomosis of biological organs.
  • anastomosis for joining digestive tracts
  • the degree of progress of fusion at the anastomotic site also depends on the condition of the living tissue at the site of the patient's anastomosis. Therefore, even if an anastomosis device such as that described in Patent Document 1 is used, the risk of suture failure may not be sufficiently reduced depending on the patient's living tissue condition.
  • Patent Document 2 In order to address the above problems, the use of a medical member described in Patent Document 2 below has been proposed in anastomosis for joining living organs.
  • the medical member described in Patent Document 2 is composed of a sheet-like member having through holes.
  • the above-described medical device When the above-described medical device is placed between biological organs to be anastomosed, it promotes fusion of the anastomosis by accumulating biological components in the through-holes. Therefore, by performing an anastomosis using the above medical member, it is possible to effectively increase the joining force at the anastomosis.
  • burst pressure a threshold pressure at which the anastomosis becomes a starting point of adhesion and the state where the sealability of the anastomosis is not maintained. It is required to have pressure resistance to increase.
  • Patent Document 2 can sufficiently exhibit the function of forming the starting point of adhesion with the through-hole described above. However, it can be said that there is room for further improvement in terms of the function of improving pressure resistance.
  • An object of the present invention is to provide a medical member capable of promoting fusion of an anastomotic site and improving pressure resistance of the anastomotic site.
  • a medical member according to one aspect of the present invention is formed with a plurality of through-holes, is applied to an anastomosis of a biological organ, thereby inducing the expression of a biological component, and the induced biological component passes through the through-hole.
  • a medical member comprising a mesh-like main body that promotes fusion of the anastomosis by penetrating and accumulating, The main body is A pressure resistance improving portion having a breaking strength of 0.2 [N] or more in a direction intersecting the planar direction of the main body and a compressive elongation rate of 152 [%] or more in the planar direction of the main body.
  • a medical member capable of promoting the fusion of an anastomotic site and increasing the pressure resistance of the anastomotic site.
  • FIG. 1 is a perspective view of a medical device according to one embodiment of the present invention
  • FIG. 2 is a partial cross-sectional view of the medical device taken along line 2-2 shown in FIG. 1
  • FIG. 1 is a plan view of a medical member
  • FIG. 2 It is a figure for demonstrating the test method of the burst pressure measurement test of an Example. It is a figure for demonstrating the testing method of the tensile strength test of an Example.
  • FIG. 2 is a diagram schematically showing a part of a sample medical member (sample 100S2) used in Examples.
  • FIG. 2 is a diagram schematically showing a part of a sample medical member (sample 100S3) used in Examples.
  • FIG. 2 is a diagram schematically showing a part of a sample medical member (samples 100S4, 100S5, and 100S9) used in Examples.
  • FIG. 2 is a diagram schematically showing a part of a sample medical member (samples 100S6, 100S7, and 100S8) used in Examples.
  • FIG. 4 is a chart showing the burst pressure of the medical device for each sample;
  • FIG. 4 is a chart showing the relationship between compression elongation and breaking strength of the medical member for each sample.
  • 4 is a flow chart showing procedures of a treatment method using a medical member.
  • 1 is a flow chart showing the procedure of an embodiment of a treatment method (colonic anastomosis).
  • FIG. 4 is a schematic cross-sectional view for explaining colon anastomosis.
  • FIG. 4 is a schematic cross-sectional view for explaining colon anastomosis.
  • FIG. 4 is a schematic cross-sectional view for explaining colon anastomosis.
  • FIG. 1 is a perspective view showing a medical member 100 according to this embodiment.
  • FIG. 2 is a cross-sectional view showing an enlarged part of the medical device 100 taken along line 2-2 shown in FIG.
  • FIG. 3 is a plan view of the medical member 100 viewed from the surface 111 side.
  • the medical member 100 can be applied to procedures for joining predetermined living organs. As will be described later, in the description of this specification, colon anastomosis will be described as an example of a procedure using the medical device 100 .
  • the medical member 100 functions as a fusion promoting device that promotes fusion of the living tissues of the two living organs by being indwelled between two or more living organs to be anastomosed.
  • the medical member 100 induces the expression of the biocomponents of the living organ by being applied to the anastomosis of the living organ.
  • the medical device 100 allows the biological component whose expression is induced to pass through the through-hole 112 and accumulate, thereby promoting fusion of the anastomosis.
  • the medical member 100 includes a mesh-like main body 110 in which a plurality of through holes 112 are formed.
  • the plurality of through-holes 112 penetrate between the front surface 111 of the main body portion 110 and the rear surface 113 of the main body portion 110 along the thickness direction of the main body portion 110 (vertical direction in FIG. 2).
  • the same reference numeral 112 is used for "plurality of through holes” and "through holes”.
  • the main body part 110 can be composed of a sheet-like member having a circular shape in plan view shown in FIG. Note that the planar shape of the main body portion 110 is not particularly limited, and may be, for example, an elliptical shape or a polygonal shape (rectangular, triangular, etc.).
  • the body portion 110 has a hole portion 114 .
  • An engaged portion 711 of a first engaging device 710 of a joining device 700 which will be described later, can be inserted through the hole portion 114 (see FIG. 14).
  • the operator can cause the first engaging device 710 to hold the medical member 100 by inserting the engaged portion 711 through the hole 114 .
  • Each through-hole 112 formed in the body portion 110 is provided regularly and periodically in the surface direction of the body portion 110, as shown in FIG. However, each through-hole 112 may be provided at random in each portion of the body portion 110 in the plane direction.
  • each through-hole 112 extends substantially perpendicularly between the front surface 111 and the back surface 113 along the thickness direction of the body portion 110 (vertical direction in FIG. 2). Note that each through-hole 112 may be bent or curved in a zigzag shape between the front surface 111 and the rear surface 113 in a cross section along the thickness direction of the main body portion 110 .
  • Each through-hole 112 has a substantially circular planar shape.
  • the planar shape of each through hole 112 is not particularly limited, and may be, for example, an oval, polygonal (rectangular, triangular, etc.), irregular planar shape, or the like.
  • each through-hole 112 may have a different planar shape or a different cross-sectional shape.
  • the thickness (dimension T shown in FIG. 2) of the body portion 110 is not particularly limited, but is preferably 0.05 to 0.3 mm, more preferably 0.1 to 0.2 mm.
  • the body part 110 can be provided with strength to the extent that the body part 110 does not break when the medical member 100 is handled.
  • the thickness of the body portion 110 is 0.3 mm or less (especially when it is 0.2 mm or less)
  • the body portion 110 adheres to the living tissue to which the body portion 110 is applied and follows the living tissue. You can have enough flexibility.
  • the body portion 110 has a pitch P of the through-holes 112 (the distance P shown in FIG. 2, which is the distance between adjacent through-holes 112; corresponds to the “wire diameter” in the examples described later). It is preferable that the ratio of the pore diameters D (the distance D shown in FIG. 2) is 0.25 or more and less than 40. In addition, when the planar shape of the through-hole 112 is a perfect circle, the hole diameter D of the through-hole 112 is equal to the diameter of the perfect circle.
  • the diameter of a perfect circle having the same area as the area of the opening of the through-hole 112 (the portion of the through-hole 112 facing the front surface 111 or the back surface 113) ( Equivalent circle diameter) can be used as the hole diameter D of the through hole 112 .
  • the hole diameters D shall be used as a representative value of the pore diameter D.
  • the pitch P of the plurality of through holes 112 is defined as the shortest distance between the openings of the two through holes 112 .
  • the pitch P value there are a plurality of pitch P values corresponding to combinations of adjacent through holes 112 . Therefore, in the present embodiment, when calculating the value of the ratio described above, the arithmetic mean value of two or more pitch P values corresponding to combinations of adjacent through holes 112 is used as the representative value of the pitch P.
  • the pitch P of the through holes 112, the hole diameter D, the ratio of the hole diameter D to the pitch P, and the like are merely examples, and are not limited to these.
  • the body part 110 can be made of, for example, a biodegradable material.
  • a biodegradable material There are no particular restrictions on the constituent material of the body portion 110, and examples include biodegradable resins.
  • biodegradable resins include those described in Japanese Patent Publication No. 2011-528275, Japanese Patent Publication No. 2008-514719, International Publication No. 2008-1952, Japanese Patent Publication No. 2004-509205, etc.
  • Biodegradable (co)polymers can be used.
  • the manufacturing method of the main body part 110 is not particularly limited, but for example, a method of manufacturing fibers made of the biodegradable resin described above and manufacturing a mesh-shaped sheet using the fibers can be mentioned.
  • a method for producing fibers made of a biodegradable resin is not particularly limited, but examples thereof include an electrospinning method (electrospinning method/electrostatic spinning method) and a meltblowing method.
  • the body part 110 may be used by selecting only one of the above methods, or by selecting two or more methods and combining them as appropriate.
  • a method for manufacturing the main body 110 by spinning fibers made of the above-described biodegradable resin according to a conventional method and knitting the obtained fibers into a mesh shape, A method of manufacturing the main body portion 110 by compressing the fibers and a method of manufacturing the main body portion 110 by intertwining the fibers without weaving can be mentioned.
  • the main body part 110 induces a biological reaction with a constituent material such as a biodegradable resin. By this action, main body 110 induces the expression of biological components such as fibrin.
  • the biological components induced in this manner penetrate through the through-holes 112 of the main body 110 and accumulate, thereby promoting the fusion. Therefore, by arranging the body part 110 of the medical member 100 between living organs to be joined, the fusion is promoted by the above mechanism.
  • the material of the body part 110 does not have to be biodegradable as long as it can promote healing.
  • a hole portion 114 formed in the body portion 110 has a hole diameter larger than that of each through hole 112 .
  • the hole portion 114 can be formed in a range that includes the central portion O1 in the plane direction of the main body portion 110 (the central position on the plan view shown in FIG. 3).
  • Center O1 is the center of rotation of main body 110 when main body 110 has a rotationally symmetrical shape.
  • the hole 114 has a circular planar shape.
  • the hole diameter of the hole portion 114 can be formed to be 5 mm to 25 mm, for example.
  • the planar shape of the hole 114 is not particularly limited, and may be, for example, an elliptical shape or a polygonal shape (rectangular, triangular, etc.). Also, the size of the hole 114 is not particularly limited.
  • the hole portion 114 may be formed in the main body portion 110 in advance, or may be formed by the operator while performing the anastomosis.
  • the operator can select various modifications regarding the shape, structure, etc. of the main body 110 according to the progress of the procedure.
  • the body portion 110 has a pressure resistance improving portion 110A and an easily breakable portion 110B.
  • the pressure resistance improving portion 110A can be formed in part or the whole of the body portion 110.
  • the pressure resistance improving portion 110A is arranged closer to the outer peripheral side of the body portion 110 than the center portion O1 of the body portion 110 in the plane direction.
  • peripheral portion of the main body portion 110 can be defined as an arbitrary and predetermined range located along the outer peripheral edge of the main body portion 110 and extending from the outer peripheral edge side toward the central portion O1 side.
  • the breakable portion 110B is arranged so as to surround a hole portion 114 formed in a range including the central portion O1 of the body portion 110.
  • the pressure resistance improving portion 110A is arranged concentrically with the easily breakable portion 110B so as to surround the easily breakable portion 110B.
  • the pressure resistance improving part 110A has a function of increasing the burst pressure at the anastomotic part when it is sandwiched between living organs to be anastomosed and indwelled.
  • the pressure resistance improving portion 110A suppresses the separation of the biological organs anastomosed with the pressure resistance improving portion 110A interposed therebetween, thereby improving the sealing performance at the anastomosis.
  • Preferred physical properties and the like of the pressure resistance improving portion 110A will be described through Examples described later.
  • the easily breakable portion 110B breaks the body portion 110 when a force is applied in a direction that intersects the plane direction of the body portion 110 (for example, a direction perpendicular to the front surface 111 and the back surface 113 of the body portion 110). is easily induced.
  • the operator can easily punch out the body portion 110 by including the easily breakable portion 110B in the punching target region (Fig. 15).
  • the function of the easily breakable portion 110B depends on the compressive elongation rate (flexibility) in the plane direction and the breaking strength (brittleness) in the plane direction of the easily breakable portion 110B. This is for the following reasons.
  • the easily breakable portion 110B can be easily broken. Further, when the easily breakable portion 110B has a small strength, the easily breakable portion 100B can be easily broken by the cutter when the cutter is pressed against the easily breakable portion 110B.
  • Examples of the method of providing the easily breakable portion 110B in the body portion 110 include a method of applying heat to a portion or the whole of the body portion 110, and a method of providing a portion or the whole of the body portion 110 with a predetermined compressive elongation and breaking strength. A method of forming from a material, etc. can be mentioned. However, there is no particular limitation on the specific method for providing the breakable portion 110B on the main body portion 110 .
  • the first area E1 is an area where the first engaging device 710 and the second engaging device 720 of the joining device 700 overlap each other.
  • the second region E2 is a portion that is punched by the joining device 700 in order to form an opening that communicates with the lumen of a living organ to be anastomosed (for example, the large intestine).
  • Each engagement tool 710, 720 provided in the joining device 700 has a cutter (blade portion).
  • the joining device 700 engages the engaging tools 710 and 720 to punch out the breakable portion 110B at the same time as suturing (see FIGS. 15 and 16). Therefore, it is preferable to dispose at least part of the easily breakable portion 110B with improved breakability in the second region E2.
  • the third region E3 corresponds to a joint site (a site where an anastomosis is formed) that is left in a state of being sandwiched between living organs when the living organs are joined together by the engaging instruments 710 and 720. .
  • the third region E3 promotes fusion of the anastomosis by being indwelled between living organs.
  • the joining device 700 supplies a joining member (for example, staple) to the third region E3 to join the third region E3 to the living organ. Therefore, it is preferable to dispose at least part of the pressure resistance improving section 110A, which has a function of improving the burst pressure of the anastomosis, in the third region E3.
  • an easy-to-break portion with enhanced breaking workability is provided in a predetermined range surrounding the central portion O1 of the main body portion 110.
  • the portion 110B is arranged, and the pressure resistance improving portion 110A for improving the burst pressure of the anastomotic portion is arranged in a predetermined range on the outer peripheral side surrounding the easily rupturable portion 110B.
  • the medical member 100 is not limited to a specific structure as long as the main body portion 110 has the pressure resistance improving portion 110A formed on at least a portion thereof.
  • the body portion 110 does not have to be provided with the breakable portion 110B.
  • the position where the pressure resistance improving portion 110A is arranged in the main body portion 110 is not limited to the region located on the outer peripheral side of the central portion O1 of the main body portion 110 .
  • the pressure resistance improving portion 110A can be arranged in a region including the central portion O1 of the main body portion 110, or in an arbitrary region between the central portion O1 and the outer peripheral portion.
  • the outer peripheral portion of the body portion 110 may be provided with a reinforcing portion that prevents deformation such as twisting of the body portion 110 .
  • the reinforcing portion can be made of a material harder than the pressure resistance improving portion 110A and the breakable portion 110B, for example.
  • the pressure resistance improving portion 110A has a breaking strength of 0.2 [N] or more in a direction (perpendicular to the front surface 111 and/or the rear surface 113) intersecting the surface direction of the main body portion 110. and the compressive elongation in the plane direction of the main body 110 (the plane direction parallel to the front surface 111 and/or the back surface 113) is 152[%] or more.
  • the medical member 100 can increase the burst pressure at the anastomosis by including the pressure resistance improving portion 110A configured as described above.
  • the pressure resistance improving portion 110A has a breaking strength of 2.2 [N] or more and a compressive elongation rate of 517 [%] or more.
  • the medical device 100 can more effectively increase the burst pressure at the anastomotic site by including the pressure resistance improving section 110A configured as described above.
  • the tensile strength of the pressure resistance improving portion 110A in the first direction along the surface direction of the body portion 110 is Ts1 [N]
  • the direction along the surface direction of the body portion 110 is where Ts2 [N] is the tensile strength of the pressure resistance improving portion 110A in the second direction perpendicular to the first direction
  • the medical device 100 can further effectively increase the burst pressure at the anastomotic site by including the pressure resistance improving section 110A configured as described above.
  • the relationship between the tensile strength Ts1 [N] and the tensile strength Ts2 [N] of the medical member 100 satisfies the following formula (2): Ts2/Ts1 ⁇ 2.0 (2).
  • the medical device 100 can more effectively increase the burst pressure at the anastomotic site by including the pressure resistance improving section 110A configured as described above.
  • polyglycolic acid is contained in the constituent material of the pressure resistance improving portion 110A.
  • the pressure resistance improving section 110A can effectively increase the burst pressure at the anastomotic site by including polyglycolic acid in the constituent material.
  • the pressure resistance improving part 110A can be made of a nonwoven fabric containing polyglycolic acid as a constituent material.
  • the pressure resistance improving portion 110A configured in this way exerts the effect of improving the burst pressure at the anastomosis and is biodegradable. Therefore, applicability to anastomosis for anastomosing living organs is improved.
  • the pressure resistance improving part 110A can be composed of a heated part obtained by heat-treating a nonwoven fabric containing polyglycolic acid as a constituent material.
  • the medical device 100 can further effectively increase the burst pressure at the anastomotic site by configuring the pressure resistance improving section 110A as a heated section.
  • ⁇ Burst pressure measurement test> A burst pressure measurement test was performed using a sample intestinal segment. A burst pressure measurement test was performed by the method described below. A test method will be described with reference to FIG.
  • Anastomosis Procedure> A first intestinal piece 410A and a second intestinal piece 410B for testing were prepared. Each intestinal segment 410A, 410B is the intestinal tract of a test animal. The first intestinal piece 410A and the second intestinal piece 410B were anastomosed using a mechanical joining device.
  • the joining device is a known stapler-type anastomotic device that includes an anvil and trocar.
  • the sample medical member 100S is mounted on the anvil side, and a predetermined amount of biocompatible urethane-based adhesive is applied.
  • the agent was applied to the anastomosis area (the area forming the anastomosis) on the trocar side. ⁇ After wetting the living tissue on the anvil side with physiological saline, the anvil and the trocar were connected. Furthermore, after wetting the periphery of the anastomosis region with physiological saline, it was allowed to stand for 3 minutes. After 3 minutes had passed, the first intestinal piece 410A and the second intestinal piece 410B were joined to form an anastomosis 415 using a joining device. The first intestinal piece 410A and the second intestinal piece 410B were anastomosed with a plurality of staples supplied to a portion corresponding to the third region E3 (see FIG.
  • FIG. - The portions of the first intestinal piece 410A and the second intestinal piece 410B that were open to the outside other than the anastomosis 415 were closed with a purse string suture.
  • a non-beveled needle 440 was inserted into the opening located at one end of the purse-string sutured first intestinal segment 410A.
  • a non-beveled needle 440 was connected to a syringe pump 460 through a predetermined tube 450 .
  • Burst pressure measurement procedure> With the intestinal pieces 410A and 410B submerged in water 480 filled in a predetermined container 470, a syringe pump 460 was used to perform constant-rate pressurization (1200 mL/h). The pressure at which air leakage from the anastomotic portion 415 was confirmed was defined as burst pressure [mmHg].
  • Sample medical materials The burst pressure measurement test was performed on Sample 1, in which an anastomosis was formed without using the sample medical member 100S, and Samples 2 to 9, in which a plurality of types of sample medical members 100S were applied to the anastomosis. implemented.
  • FIG. 10 shows the burst pressure of the anastomosis 415 when using the medical member 100S for each sample.
  • sample medical member 100S used for the burst pressure measurement test and the test results will be explained.
  • each medical member used in the examples will be collectively referred to as “sample medical member 100S”.
  • Sample 1 measures the burst pressure of the anastomosis 415 for comparison experiments. Sample 1 does not use the sample medical member 100S.
  • a sample medical member 100S2 (hereinafter referred to as “medical member 100S2”) is used in the anastomotic portion 415 of the sample 2 .
  • the details of the medical member 100S2 are as follows. - A sheet including a mesh-like body portion 110 made of nonwoven fabric made of polyglycolic acid (PGA) was prepared. The medical member 100S2 was constructed by stacking three of the above sheets. - In FIG. 6, the schematic diagram which expanded a part of said sheet
  • the three sheets forming the medical member 100S2 are arranged such that the through holes 112 formed in each sheet overlap when viewed from above.
  • the hole diameter of the through holes 112 of the one sheet is 0.6 mm
  • the wire diameter (pitch) is 0.2 mm
  • the thickness is 0.1 mm.
  • the medical member 100S2 is formed with a heated portion forming the pressure resistance improving portion 110A.
  • the heated portion was formed under the following conditions. (1) A hot press was pressed against the front surface 111 (or the rear surface 113) of the main body 110 to perform hot pressing. (2) The press pressure was set to 40 MPa. (3) Press time was set to 20 minutes. (4) The heating temperature was set to 170°C.
  • a sample medical member 100S3 (hereinafter referred to as “medical member 100S3”) is used in the anastomotic portion 415 of the sample 3 .
  • the details of the medical member 100S3 are as follows. - As the medical member 100S3, a sheet including a mesh-like body portion 110 made of glycolic acid/lactic acid polyester (ratio of glycolic acid: lactic acid polyester is 90:10) was prepared.
  • the medical member 100S3 is a knitted sheet.
  • FIG. 7 the schematic diagram which expanded a part of medical member 100S3 is shown.
  • the sheet used for the medical member 100S3 has a plurality of through-holes 112 that are regularly arranged.
  • the through holes 112 of the medical member 100S3 have a hole diameter of 0.3 mm to 0.7 mm, a wire diameter (pitch) of 0.1 mm to 0.2 mm, and a thickness of 0.2 mm. -
  • the medical member 100S3 is not heat-treated. Therefore, an arbitrary portion of the medical member 100S3 is set as the pressure resistance improving portion 110A.
  • a sample medical member 100S4 (hereinafter referred to as “medical member 100S4”) is used in the anastomotic portion 415 of the sample 4 .
  • the details of the medical member 100S4 are as follows.
  • a sheet including a mesh-like body portion 110 made of nonwoven fabric made of polyglycolic acid (PGA) was prepared. This sheet was immersed in physiological saline and stored in a constant temperature bath at 60° C. for 6 days, and used as medical member 100S4.
  • the sheet is composed of two sheets made of coarse nonwoven fabric. The two sheets are stacked in the thickness direction. Each sheet has randomly shaped through-holes formed between the fibers that make up the sheet. The two sheets penetrate between the front surface and the back surface at positions where the through holes of each sheet overlap in the surface direction. This penetrating portion forms a through hole 112 of the medical member 100S4.
  • FIG. 8 the schematic diagram which expanded a part of medical member 100S4 is shown.
  • the through holes 112 of the medical member 100S4 have a hole diameter of 0.2 mm to 0.8 mm, a wire diameter (pitch) of 0.1 mm to 0.2 mm, and a thickness of 0.1 mm to 0.2 mm. -
  • the medical member 100S4 is not heat-treated. Therefore, an arbitrary portion of the medical member 100S4 is set as the pressure resistance improving portion 110A.
  • a sample medical member 100S5 (hereinafter referred to as “medical member 100S5”) is used in the anastomotic portion 415 of the sample 5 .
  • the details of the medical member 100S5 are as follows. - As the medical member 100S5, a sheet including a mesh-like main body 110 made of nonwoven fabric made of polyglycolic acid (PGA) was prepared. The aforementioned medical member 100S4 is obtained by subjecting the above sheet to a predetermined immersion treatment. In other words, the above sheet that was not dipped was used as the medical member 100S5. Therefore, the medical member 100S5 is substantially the same as the medical member 100S4 except that the immersion treatment is not performed.
  • FIG. 8 shows a schematic diagram in which a part of the medical member 100S5 is enlarged. - The medical member 100S5 is not heat-treated. Therefore, an arbitrary portion of the medical member 100S5 is set as the pressure resistance improving portion 110A.
  • a sample medical member 100S6 (hereinafter referred to as “medical member 100S6”) is used in the anastomosis portion 415 of the sample 6 .
  • the details of the medical member 100S6 are as follows. - As the medical member 100S6, a sheet including a mesh-like body portion 110 made of nonwoven fabric made of polyglycolic acid (PGA) was prepared. - The sheet is a single sheet made of coarse nonwoven fabric. In other words, the medical member 100S6 is obtained by peeling one sheet from the above-described medical member 100S5 composed of two sheets.
  • PGA polyglycolic acid
  • FIG. 9 shows a schematic diagram in which a part of the medical member 100S6 is enlarged.
  • the through holes 112 of the medical member 100S6 have a hole diameter of 0.2 mm to 1.4 mm, a wire diameter (pitch) of 0.1 mm to 0.2 mm, and a thickness of 0.1 mm.
  • the medical member 100S6 is formed with a heated portion forming the pressure resistance improving portion 110A. The heated portion was formed under the following conditions. (1) A hot press was pressed against the front surface 111 (or the rear surface 113) of the main body 110 to perform hot pressing. (2) Press pressure was set to 20 MPa. (3) Press time was set to 30 minutes. (4) The heating temperature was set to 150°C.
  • a sample medical member 100S7 (hereinafter referred to as “medical member 100S7”) is used in the anastomotic portion 415 of the sample 7 .
  • the details of the medical member 100S7 are as follows. - The above-described medical member 100S6 having no heated portion was prepared as the medical member 100S7. Therefore, an arbitrary portion of the medical member 100S6 is set as the pressure resistance improving portion 110A.
  • the medical member 100S7 is substantially the same as the medical member 100S6 described above, except that the heated portion is not formed.
  • FIG. 9 shows a schematic diagram in which a part of the medical member 100S7 is enlarged.
  • a sample medical member 100S8 (hereinafter referred to as “medical member 100S8”) is used in the anastomotic portion 415 of the sample 8 .
  • the details of the medical member 100S8 are as follows. - A sheet similar to the medical member 100S6 described above was prepared. However, the heating conditions for forming the heated portion (pressure resistance improving portion 110A) were changed as follows.
  • FIG. 9 shows a schematic diagram in which a part of the medical member 100S8 is enlarged. (1) A hot press was pressed against the front surface 111 (or the rear surface 113) of the main body 110 to perform hot pressing. (2) The press pressure was set to 40 MPa. (3) Press time was set to 30 minutes. (4) The heating temperature was set to 200°C.
  • a sample medical member 100S9 (hereinafter referred to as “medical member 100S9”) is used in the anastomotic portion 415 of the sample 9 .
  • the details of the medical member 100S9 are as follows.
  • the medical member 100S9 is composed of a sheet similar to the sheet forming the medical member 100S5, which is subjected to pretreatment and heat treatment for forming the heated portion (the pressure resistance improving portion 110A). There is Radiation irradiation was performed as a pretreatment, and hot press heating was performed as a heat treatment. Other configurations are the same as those of the medical member 100S5.
  • FIG. 8 shows a schematic diagram in which a part of the medical member 100S9 is enlarged. ⁇ Electron beam irradiation with a dose of 100 kGy was adopted as radiation heating. - After carrying out radiation heating, hot press heating was carried out under the following conditions. (1) A hot press was pressed against the front surface 111 (or the rear surface 113) of the main body 110 to perform hot pressing. (2) Press pressure was set to 20 MPa. (3) Press time was set to 30 minutes. (4) The heating temperature was set to 150°C.
  • FIG. 10 shows the burst pressure measurement results of each sample. Note that the results shown in FIG. 10 are the average values of the test results of three burst pressure measurement tests. This average value corresponds to the average value shown in Table 1, which will be described later.
  • the effect of increasing the burst pressure of the anastomotic part 415 differs among the medical members 100S2 to 100S9 used for each sample.
  • the quality of the material constituting the main body 110, the presence or absence of pretreatment, the presence or absence of heat treatment, the heating method, the heating temperature, and the arrangement of the through holes 112 etc. are different. Therefore, it is presumed that the effect of increasing the burst pressure of the medical device 100 is affected by these factors.
  • the inventors determined the “strength (breaking strength)” and “compression elongation (in the plane direction)” of each medical member 100S2 to 100S9, which are considered to have an effect on the improvement of the burst pressure. Elastic modulus indicating flexibility)” was measured.
  • test method of the breaking strength test the test method of the elastic modulus measurement test, and the results of those tests performed on each medical member 100S2 to 100S9 will be described below.
  • a sample was prepared by cutting each medical member 100S2 to 100S9 into a square shape with a side of 15 mm, and set it on a predetermined fixing jig.
  • the fixture has an opening that exposes the center of the sample in the plane direction.
  • a fixture on which the sample was set was attached to the bottom of the creep meter.
  • a cylindrical jig with a diameter of 3 mm ( ⁇ 7 mm 2 ) was used as a pushing jig for transmitting a pushing force to the sample through the opening of the fixture.
  • a cylindrical jig was attached to the top of the creep meter.
  • a cylindrical jig was brought closer to the opening of the fixing jig, and a pressing force was applied at a constant speed (5 mm/sec) to the sample through the opening of the fixing jig.
  • the maximum load obtained in this test was calculated as the breaking strength of the sample (breaking strength in the direction perpendicular to the surface direction).
  • a commercially available software for breaking strength analysis was used to calculate the breaking strength.
  • Table 1 shows the burst pressure, breaking strength, compression elongation, compression elongation/breaking strength ratio, and handling strength of the medical members 100S2 to 100S9 used for each sample. Note that sample 1 shown in Table 1 shows the test results of the burst pressure of the anastomotic part 415 measured without using the medical member 100, and samples 2 to 9 show the anastomosis using each medical member 100S2 to 100S9. It shows test results regarding the burst pressure of the portion 415 and the physical properties of each medical member 100S2 to 100S9.
  • Table 1 The average values shown in Table 1 are the average values of the results of tests conducted three times for each item. Standard deviations are values from triplicate tests.
  • the breaking strength of the medical member 100 is preferably 0.2 N (breaking strength of sample 4) or more.
  • the compressive elongation of the medical device 100 is preferably 152% (the compressive elongation of sample 2) or more from the viewpoint of improving the burst pressure.
  • the burst pressure at the anastomosis 415 after colon anastomosis should be 30.75 mmHg or more in order to obtain a stable postoperative therapeutic effect.
  • samples 7, 8, and 9, which have a burst pressure of 30.75 mmHg or more are more preferable as the medical member to be applied to the anastomotic portion 415 .
  • the breaking strength of the medical member 100 was 2.2 N (the breaking strength of sample 8) or more, and the compression elongation was 517% (the compression elongation of sample 8) or more. I can confirm that one is more preferable.
  • the medical device 100 should have a breaking strength of 0.2 N or more and a compression elongation of 152% or more from the viewpoint of effectively exhibiting the function of improving the burst pressure at the anastomotic portion 415. is preferable, and in order to secure the desired burst pressure medically recommended (hereinafter referred to as "recommended burst pressure"), the breaking strength is 2.2 N or more and the compression elongation is 517% or more. It was confirmed that it is more preferable to be
  • “Handling strength” shown in Table 1 is an evaluation item that examines the handling (operability) when the tester operates the sample medical member 100S during the burst pressure measurement test.
  • Samples with a handling strength evaluation of ⁇ were twisted or broken when the tester manipulated the sample medical member 100S by gripping it with their fingers.
  • Samples with a handling strength evaluation of 0 did not twist or break when the tester manipulated the sample medical member 100S by gripping it with fingers.
  • Fig. 11 shows the relationship between the breaking strength (Y-axis) and the compression elongation (X-axis) of each sample obtained by the breaking strength measurement test and the elastic modulus measurement test.
  • the dashed line I in the chart shown in FIG. 11 indicates a value of 0.2 N, which is a suitable breaking strength threshold for increasing the burst pressure. It shows a value of 152%. Further, the broken line II in the chart shown in FIG. 11 indicates a value of 2.2 N, which is a suitable breaking strength threshold value for securing the recommended burst pressure, and the broken line II′ indicates a suitable threshold value for securing the recommended burst pressure. A value of 517%, which is the threshold value of the compression elongation, is shown.
  • the medical member 100 having physical properties within the range on the chart that includes samples 2, 3, 4, and 6) is an anastomosis in which the aforementioned sample medical member 100S is not used. From the comparison experiment with the sample 1 having the portion 415, it can be inferred that the effect of increasing the burst pressure of the anastomosis portion 415 is exhibited.
  • the range where the breaking strength is 2.2 or more and the compression elongation is 517% or more on the chart shown in FIG. The range including samples 5, 7, 8, and 9 above) is assumed to be able to increase the burst pressure of the anastomosis 415 to the recommended burst pressure. can.
  • ⁇ Tensile strength measurement test> A tensile strength measurement test was performed in order to confirm the effect of the tensile strength in the surface direction of the medical device 100 on the burst pressure.
  • the tensile strength measurement test was performed on medical member 100S5 and medical member 100S9.
  • the medical member 100S5 is a sample that has the function of increasing the burst pressure
  • the medical member 100S9 is a sample that can ensure the recommended burst pressure.
  • a known creep meter was used for the tensile strength measurement test, similar to the breaking strength measurement test and the elastic modulus measurement test.
  • Each medical member 100S5 and 100S9 was cut into a rectangle with one side of 5 mm x 20 mm, and set on a predetermined fixing jig so that the thickness was 10 mm.
  • a fixing jig in which each medical member 100S5 and 100S9 was set was attached to the lower part of the creep meter.
  • a first direction (longitudinal direction indicated by arrows a1-a2 in FIG. 5) along the plane direction (direction parallel to the front surface 111 or the back surface 113) of each medical member 100S5 and 100S9, and a first direction orthogonal to the first direction in plan view.
  • Tensile in two directions (horizontal direction indicated by arrows b1-b2 in FIG. 4) and third direction (diagonal direction indicated by arrows c1-c2 in FIG. 5) crossing each of the first and second directions gave power.
  • the peak strength at break of each medical member 100S5 and 100S9 was calculated as the tensile strength [N].
  • Commercially available software for breaking strength analysis was used to calculate the tensile strength.
  • the medical member 100S5 had a tensile strength ratio (Ts2/Ts1) of tensile strength Ts1 in the first direction and tensile strength Ts2 in the second direction of 4.3.
  • the medical member 100S9 had a tensile strength ratio (Ts2/Ts1) of tensile strength Ts1 in the first direction and tensile strength Ts2 in the second direction of 2.0. .
  • the tensile strength ratio (Ts2/Ts1) of the medical member 100S5 was 4.3, if the tensile strength ratio (Ts2/Ts1) is about 4.3, the function of increasing the burst pressure of the medical member 100S5 is considered to be sufficiently demonstrated.
  • the tensile strength ratio (Ts2/Ts1) of the medical member 100S9 capable of ensuring the recommended burst pressure was 2.0, the medical member 100 has a higher tensile strength ratio (Ts2/Ts1). It is considered that the smaller the value, the more effectively the function of increasing the burst pressure is exhibited.
  • the medical device 100 can increase the burst pressure when the tensile strength ratio (Ts2/Ts1) of the pressure resistance improving portion 110A formed in the body portion 110 is 4.3 or less. Therefore, it is considered possible to secure the recommended burst pressure when the tensile strength ratio (Ts2/Ts1) of the pressure resistance improving portion 110A is 2.0 or less. Therefore, from the viewpoint of increasing the burst pressure, the pressure resistance improving section 110A preferably satisfies Ts2/Ts1 ⁇ 4.3, and more preferably satisfies Ts2/Ts1 ⁇ 2.0.
  • the medical member 100 is formed with a plurality of through holes 112 and is applied to the anastomosis of a biological organ to induce the expression of the biological component, and the induced biological component has a mesh-like main body portion 110 that promotes fusion of the anastomosis by passing through the through-holes 112 and accumulating.
  • the body portion 110 has a breaking strength of 0.2 [N] or more in a direction intersecting the plane direction of the body portion 110, and a compression elongation rate of 152 [%] in the plane direction of the body portion 110. It has the pressure resistance improving portion 110A described above.
  • the medical member 100 that can promote the fusion of the anastomotic site and increase the pressure resistance of the anastomotic site.
  • the breaking strength of the pressure resistance improving portion 110A is 2.2 [N] or more and the compressive elongation rate of the pressure resistance improving portion 110A is 517 [%] or more, the anastomotic portion bursts. Pressure can be increased to the recommended burst pressure.
  • the tensile strength of the pressure resistance improving portion 110A in the first direction along the surface direction of the body portion 110 is Ts1 [N]
  • the direction along the surface direction of the body portion 110 is , where Ts2 [N] is the tensile strength of the pressure resistance improving portion 110A in the second direction perpendicular to the first direction, the relationship Ts2/Ts1 ⁇ 4.3 (1) is satisfied. be able to.
  • the medical device 100 configured in this manner can effectively increase the burst pressure at the anastomotic site by the pressure resistance improving portion 110A.
  • the medical member 100 is configured such that the relationship between the tensile strength Ts1 [N] and the tensile strength Ts2 [N] of the pressure resistance improving portion 110A satisfies the relationship Ts2/Ts1 ⁇ 2.0 (2). can do.
  • the medical device 100 configured in this manner can increase the burst pressure at the anastomotic site to the recommended burst pressure by the pressure resistance improving portion 110A.
  • the pressure resistance improving portion 110A can be arranged closer to the outer peripheral side of the body portion 110 in the plane direction than the central portion O1 of the body portion 110 in the plane direction.
  • the medical member 100 configured in this way, when performing an anastomosis using the joining device 700 (see FIG. 14), the outer periphery in the plane direction of the body portion 110 is located closer to the center portion O1 in the plane direction than the center portion O1 in the plane direction. Burst pressure at the anastomotic site can be effectively increased by indwelling the pressure resistance improving section 110A located on the side of the body so as to be sandwiched between the living organs.
  • the pressure resistance of the body portion 110 of the medical member 100 can be effectively improved.
  • the pressure resistance of the main body portion 110 of the medical member 100 is further improved. can be made
  • the pressure resistance improving part 110A is composed of a heated part subjected to heat treatment, the pressure resistance of the main body part 110 of the medical member 100 can be improved more effectively.
  • FIG. 12 is a flow chart showing each procedure of a treatment method using a medical member.
  • the treatment method consists of arranging a medical member having a main body portion that promotes the fusion of living tissues in one of the parts to be joined to which the living organs are to be joined (S11); (S12).
  • the living organ to be joined by the treatment method of this embodiment and the site to be joined of the living organ are not particularly limited, and can be arbitrarily selected.
  • colon anastomosis will be taken as an example.
  • the medical member used in the procedure described below for example, one having the structure illustrated in FIG. 1 can be selected.
  • the specific configuration of the medical member is not particularly limited. Further, in the procedures described below, detailed descriptions of known procedure procedures, known medical devices, medical instruments, etc. will be omitted as appropriate.
  • arranging a medical member between a living organ means that the medical member is arranged in a state in which the medical member is in direct or indirect contact with the living organ. Arrangement of the medical member with a spatial gap formed, or arrangement of the medical member with both of the states (for example, the medical member is in contact with one biological organ and the other is The medical device is arranged in a state in which the medical device is not in contact with the living organ).
  • the term "periphery" does not define a strict range (region), but rather a predetermined range (region) as long as the purpose of treatment (bonding of living organs) can be achieved. means.
  • FIG. 13 is a flow chart showing procedures of an embodiment of the treatment method (colon anastomosis).
  • 14 to 16 are diagrams for explaining colon anastomosis.
  • the living organ to be joined is the large intestine that has been cut along with the resection of the cancer tumor.
  • the living organs to be joined are the oral side A1 of the cut large intestine and the anal side A2 of the cut large intestine.
  • the procedure for joining the oral periphery (one site to be joined) of the mouth side A1 of the cut large intestine and a part of the intestinal wall on the anal side A2 of the cut large intestine (the other site to be joined) will be described. explain.
  • the treatment method according to the present embodiment includes disposing a medical member around the mouth of the large intestine (S101), bringing the mouth of the large intestine and the intestinal wall of the large intestine relatively close to each other. (S102), sandwiching the main body of the medical member between the periphery of the mouth of the large intestine and the wall of the large intestine (S103); (S104).
  • FIG. 14 to 16 the treatment method according to this embodiment will be specifically described with reference to FIGS. 14 to 16.
  • the operator forms a port (introduction part for moving various medical devices into and out of the living body) around the navel of the patient and inflates the patient's abdomen.
  • the operator forms an incision (not shown) around the navel, takes out the affected part on the oral side A1 from the incision, and attaches the first engaging device of the joining device 700 to the oral side A1 of the large intestine.
  • Insert 710 The operator inserts the engaged portion 711 of the first engaging instrument 710 into the mouth side A1 of the large intestine, and performs purse-string suture with the engaged portion 711 protruded to form the sutured portion A11.
  • the outer surface of the sutured portion A11 becomes uneven as it is sutured.
  • the joining device 700 for example, a known device used for large intestine anastomosis can be used.
  • the joining device 700 excises the living tissue arranged between the first engagement device 710 and the second engagement device 720, The circumference of the resected body tissue is sutured with staples in a circumferential shape.
  • the first engaging device 710 is, for example, a device having a tubular engaged portion 711
  • the second engaging device 720 is, for example, inserted into and engaged with the engaged portion 711 of the first engaging device 710 .
  • the device is provided with an engagement pin 721 that is mated.
  • the operator places the medical member 100 on the living tissue on the oral side A1 of the large intestine (S101).
  • the operator inserts the engaged portion 711 of the first engaging device 710 into the hole portion 114 (see FIG. 1 ) formed in the body portion 110 of the medical member 100 . let through At this time, the operator sets the medical member 100 so that the back surface 113 of the medical member 100 contacts the outer surface of the sutured portion A11.
  • the operator introduces the mouth side A1 of the large intestine where the medical member 100 is arranged into the patient's body through the incision.
  • the operator places the second engaging device 720 of the joining device 700 on the anal side A2 of the large intestine.
  • a through hole A21 is formed on the anal side A2 of the large intestine.
  • the operator engages the engaged portion 711 of the first engaging device 710 with the engaging pin 721 of the second engaging device 720 while maintaining the state of holding the body portion 110 on the mouth side A1 of the large intestine.
  • the medical member 100 can be placed between the oral side A1 of the large intestine and the anal side A2 of the large intestine.
  • the operator holds the medical device 100 against the sutured portion A11 on the mouth side A1 of the large intestine, while maintaining the first engaging device 710 and the second engaging device 710.
  • the engaging tools 720 are brought relatively close to engage (S102).
  • the operator moves around the mouth on the mouth side A1 of the large intestine, the main body 110 of the medical device 100, and the anal side A2 of the large intestine.
  • the periphery of the through hole A21 formed in the intestinal wall is sandwiched (S103).
  • the operator moves a portion of the oral side A1 of the large intestine sandwiched between the first engaging device 710 and the second engaging device 720, the body portion 110 of the medical device 100, and the anal side of the large intestine.
  • a portion of A2 is cut by a joining device 700 so as to be punched out.
  • the operator operates the joining device 700 to join the periphery of the resected site with staples (not shown) (S104).
  • the breakable portion 110B with improved breakability is formed in the body portion 110, so that part of the body portion 110 can be smoothly punched out. can.
  • the main body portion 110 is punched out, it is possible to prevent the occurrence of a punching failure in which a part of the main body portion 110 is frayed.
  • the operator takes out the joining device 700 from the anal side A2 of the large intestine to the outside of the body through the anus.
  • the operator moves a portion of the mouth side A1 of the large intestine located inside the second region E2 (see FIG. 3) punched out by the joining device 700 and a portion of the body portion 110 of the medical member 100.
  • a portion (at least part of which includes the easily rupturable portion 110B) and a portion of the anal side A2 of the large intestine can be taken out of the living body together with the joining device 700 .
  • the pressure resistance improving portion 110A of the main body portion 110 arranged closer to the outer peripheral side than the second region E2 is sandwiched between the mouth portion on the mouth side A1 of the large intestine and the intestinal wall on the anal side A2 of the large intestine. It is placed in the body in a Therefore, the pressure resistance improving portion 110A of the main body portion 110 exhibits a function of promoting fusion between the mouth portion periphery of the large intestine on the mouth side A1 and the intestinal wall on the anal side A2 of the large intestine to be joined, and also promotes fusion of the large intestine. The burst pressure between the mouth periphery on the oral side A1 and the intestinal wall on the anal side A2 of the large intestine can be effectively increased.
  • an anastomosis for example, colon anastomosis
  • a simple method of sandwiching the mesh-like main body of the medical member between one site to be joined and the other site to be joined. ) can reduce the risk of post-suture failure.
  • the living organ to be joined, the site to be joined, the specific procedure, etc. are not limited to those described in the embodiment.
  • the material, size, shape, specific structure, etc. of the medical device are not particularly limited as long as the main body portion of the medical member has the function of promoting the fusion of the living tissue of the joined site.

Abstract

[Problem] To provide a medical member capable of promoting concrescence of an anastomosis site and enhancing pressure resistance of the anastomosis site. [Solution] A medical member 100 comprises a mesh-shaped main body part 110 that promotes concrescence of an anastomosis site. The main body part has a pressure resistance enhancing part 110A, wherein the rupture strength of the pressure resistance enhancing part in a direction intersecting with the plane direction of the main body part is 0.2 [N] or more, and the compressive extension rate of the pressure resistance enhancing part in the plane direction of the main body part is 152 [%] or more.

Description

医療用部材Medical parts
　本発明は、生体器官の吻合部に適用される医療用部材に関する。 The present invention relates to a medical member applied to the anastomosis of biological organs.
　医療の分野において、生体器官を外科的手術により接合する手技（例えば、消化管を接合する吻合術）が知られている。上記のような手技が行われた場合、生体器官同士が接合された接合部（以下、「吻合部」とも記載する）における癒合の遅延が生じないことが術後の予後決定因子として重要であることも知られている。 In the medical field, techniques for surgically joining living organs (for example, anastomosis for joining digestive tracts) are known. When the above procedure is performed, it is important as a postoperative prognostic factor that there is no delay in union at the junction where living organs are joined (hereinafter also referred to as "anastomosis"). It is also known that
　生体器官を接合する手技では種々の方法や医療器具が用いられるが、例えば、生分解性の縫合糸により生体器官を縫合する方法や、ステープラーによる吻合を行う機械式の吻合装置（特許文献１を参照）を利用する方法が提案されている。特に、機械式の吻合装置を利用して吻合術を行う場合、縫合糸を用いた方法と比較して吻合部における生体器官同士の接合力を高めることができるため、縫合不全のリスクを低減させることが可能になる。 Various methods and medical instruments are used in procedures for joining living organs. ) has been proposed. In particular, when performing anastomosis using a mechanical anastomosis device, the risk of suture failure can be reduced because the joining force between living organs at the anastomosis can be increased compared to the method using suture thread. becomes possible.
　しかしながら、吻合部における癒合の進行の程度は、患者の吻合対象部位における生体組織の状態等にも依存する。そのため、例えば、特許文献１に記載されているような吻合装置を使用した場合においても、患者の生体組織の状態によっては、縫合不全のリスクを十分に低減させることができない可能性もある。 However, the degree of progress of fusion at the anastomotic site also depends on the condition of the living tissue at the site of the patient's anastomosis. Therefore, even if an anastomosis device such as that described in Patent Document 1 is used, the risk of suture failure may not be sufficiently reduced depending on the patient's living tissue condition.
　上記のような課題に対応するために、生体器官を接合する吻合術において、下記特許文献２に記載された医療用部材の使用が提案されている。 In order to address the above problems, the use of a medical member described in Patent Document 2 below has been proposed in anastomosis for joining living organs.
　特許文献２に記載された医療用部材は、貫通孔が形成されたシート状の部材で構成されている。上記の医療用部材は、吻合対象となる生体器官の間に挟まれた状態で留置されると、生体成分を貫通孔に集積させることによって吻合部の癒合を促進する。そのため、上記の医療用部材を使用して吻合術を実施することにより、吻合部における接合力を効果的に高めることが可能になる。 The medical member described in Patent Document 2 is composed of a sheet-like member having through holes. When the above-described medical device is placed between biological organs to be anastomosed, it promotes fusion of the anastomosis by accumulating biological components in the through-holes. Therefore, by performing an anastomosis using the above medical member, it is possible to effectively increase the joining force at the anastomosis.
特表２００７－５０５７０８号公報Japanese Patent Publication No. 2007-505708 国際公開第２０１９／１５６２３０号WO2019/156230
　吻合術に使用される上記の医療用部材には、吻合部において癒着の起点になることと、吻合部のシール性が維持されない状態となる閾値圧力（以下、「バースト圧」とする。）を高めるための耐圧性を備えることが要求される。 The above medical members used for anastomosis have a threshold pressure (hereinafter referred to as "burst pressure") at which the anastomosis becomes a starting point of adhesion and the state where the sealability of the anastomosis is not maintained. It is required to have pressure resistance to increase.
　特許文献２の医療用部材は、前述した貫通孔によって癒着の起点を形成する機能を十分に発揮しうる。ただし、耐圧性を向上させる機能については、さらなる向上の余地があると言える。 The medical member of Patent Document 2 can sufficiently exhibit the function of forming the starting point of adhesion with the through-hole described above. However, it can be said that there is room for further improvement in terms of the function of improving pressure resistance.
　本発明は、吻合部の癒合を促進させることができ、かつ吻合部の耐圧性を向上させることが可能な医療用部材を提供することを目的とする。 An object of the present invention is to provide a medical member capable of promoting fusion of an anastomotic site and improving pressure resistance of the anastomotic site.
　本発明の一形態に係る医療用部材は、複数の貫通孔が形成され、生体器官の吻合部に適用されることによって生体成分の発現を誘導し、誘導された前記生体成分が前記貫通孔を貫通して集積することにより前記吻合部の癒合を促進するメッシュ状の本体部を備える医療用部材であって、
　前記本体部は、
　前記本体部の面方向に対して交差する方向における破断強度が０．２［Ｎ］以上であり、かつ、前記本体部の面方向における圧縮伸び率が１５２［％］以上である耐圧性向上部を有する。 A medical member according to one aspect of the present invention is formed with a plurality of through-holes, is applied to an anastomosis of a biological organ, thereby inducing the expression of a biological component, and the induced biological component passes through the through-hole. A medical member comprising a mesh-like main body that promotes fusion of the anastomosis by penetrating and accumulating,
The main body is
A pressure resistance improving portion having a breaking strength of 0.2 [N] or more in a direction intersecting the planar direction of the main body and a compressive elongation rate of 152 [%] or more in the planar direction of the main body. have
　本発明の一形態によれば、吻合部の癒合を促進させることができ、かつ吻合部の耐圧性を高めることが可能な医療用部材を提供することができる。 According to one aspect of the present invention, it is possible to provide a medical member capable of promoting the fusion of an anastomotic site and increasing the pressure resistance of the anastomotic site.
本発明の一形態に係る医療用部材の斜視図である。1 is a perspective view of a medical device according to one embodiment of the present invention; FIG. 図１に示す２－２線に沿う医療用部材の部分断面図である。2 is a partial cross-sectional view of the medical device taken along line 2-2 shown in FIG. 1; FIG. 医療用部材の平面図である。1 is a plan view of a medical member; FIG. 実施例のバースト圧測定試験の試験方法を説明するための図である。It is a figure for demonstrating the test method of the burst pressure measurement test of an Example. 実施例の引張強度試験の試験方法を説明するための図である。It is a figure for demonstrating the testing method of the tensile strength test of an Example. 実施例に使用したサンプル用の医療用部材（サンプル１００Ｓ２）の一部を模式的に示す図である。FIG. 2 is a diagram schematically showing a part of a sample medical member (sample 100S2) used in Examples. 実施例に使用したサンプル用の医療用部材（サンプル１００Ｓ３）の一部を模式的に示す図である。FIG. 2 is a diagram schematically showing a part of a sample medical member (sample 100S3) used in Examples. 実施例に使用したサンプル用の医療用部材（サンプル１００Ｓ４、１００Ｓ５、１００Ｓ９）の一部を模式的に示す図である。FIG. 2 is a diagram schematically showing a part of a sample medical member (samples 100S4, 100S5, and 100S9) used in Examples. 実施例に使用したサンプル用の医療用部材（サンプル１００Ｓ６、１００Ｓ７、１００Ｓ８）の一部を模式的に示す図である。FIG. 2 is a diagram schematically showing a part of a sample medical member (samples 100S6, 100S7, and 100S8) used in Examples. 各サンプル用の医療用部材のバースト圧を示すチャートである。FIG. 4 is a chart showing the burst pressure of the medical device for each sample; FIG. 各サンプル用の医療用部材の圧縮伸び率と破断強度の関係を示すチャートである。4 is a chart showing the relationship between compression elongation and breaking strength of the medical member for each sample. 医療用部材を使用した処置方法の手順を示すフローチャートである。4 is a flow chart showing procedures of a treatment method using a medical member. 処置方法の実施形態（大腸吻合術）の手順を示すフローチャートである。1 is a flow chart showing the procedure of an embodiment of a treatment method (colonic anastomosis). 大腸吻合術を説明するための模試的な断面図である。FIG. 4 is a schematic cross-sectional view for explaining colon anastomosis. 大腸吻合術を説明するための模試的な断面図である。FIG. 4 is a schematic cross-sectional view for explaining colon anastomosis. 大腸吻合術を説明するための模試的な断面図である。FIG. 4 is a schematic cross-sectional view for explaining colon anastomosis.
　（実施形態）
　以下、添付した図面を参照して、本発明の実施形態を説明する。なお、図面の説明において同一の要素には同一の符号を付し、重複する説明を省略する。また、図面の寸法比率は、説明の都合上誇張されており、実際の比率とは異なる場合がある。 (embodiment)
Hereinafter, embodiments of the present invention will be described with reference to the attached drawings. In the description of the drawings, the same elements are denoted by the same reference numerals, and overlapping descriptions are omitted. Also, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may differ from the actual ratios.
　＜医療用部材＞
　図１は、本実施形態に係る医療用部材１００を示す斜視図である。図２は、図１に示す２－２線に沿う医療用部材１００の一部を拡大して示す断面図である。図３は、医療用部材１００を表面１１１側から見た平面図である。 <Medical parts>
FIG. 1 is a perspective view showing a medical member 100 according to this embodiment. FIG. 2 is a cross-sectional view showing an enlarged part of the medical device 100 taken along line 2-2 shown in FIG. FIG. 3 is a plan view of the medical member 100 viewed from the surface 111 side.
　医療用部材１００は、図１４～図１６に示すように、所定の生体器官同士を接合する手技に適用することができる。後述するように、本明細書の説明では、医療用部材１００を使用した手技例として大腸吻合術を説明する。 As shown in FIGS. 14 to 16, the medical member 100 can be applied to procedures for joining predetermined living organs. As will be described later, in the description of this specification, colon anastomosis will be described as an example of a procedure using the medical device 100 .
　医療用部材１００は、吻合対象となる二つ以上の生体器官の間に留置されることにより、二つの生体器官の生体組織の癒合を促進する癒合促進用デバイスとしての機能を持つ。 The medical member 100 functions as a fusion promoting device that promotes fusion of the living tissues of the two living organs by being indwelled between two or more living organs to be anastomosed.
　具体的には、医療用部材１００は、生体器官の吻合部に適用されることによって、生体器官の生体成分の発現を誘導する。医療用部材１００は、発現が誘導された生体成分を貫通孔１１２に貫通させて集積することにより、吻合部の癒合を促進させることができる。 Specifically, the medical member 100 induces the expression of the biocomponents of the living organ by being applied to the anastomosis of the living organ. The medical device 100 allows the biological component whose expression is induced to pass through the through-hole 112 and accumulate, thereby promoting fusion of the anastomosis.
　＜本体部＞
　医療用部材１００は、図１、図２に示すように、複数の貫通孔１１２が形成されたメッシュ状の本体部１１０を備える。 <Body part>
As shown in FIGS. 1 and 2, the medical member 100 includes a mesh-like main body 110 in which a plurality of through holes 112 are formed.
　複数の貫通孔１１２は、本体部１１０の厚み方向（図２の上下方向）に沿って、本体部１１０の表面１１１と本体部１１０の裏面１１３との間を貫通している。なお、本明細書においては説明の便宜上、「複数の貫通孔」及び「貫通孔」には同一の符号１１２を使用する。 The plurality of through-holes 112 penetrate between the front surface 111 of the main body portion 110 and the rear surface 113 of the main body portion 110 along the thickness direction of the main body portion 110 (vertical direction in FIG. 2). In this specification, for convenience of explanation, the same reference numeral 112 is used for "plurality of through holes" and "through holes".
　本体部１１０は、図３に示す平面視において、円形を有するシート状の部材で構成することができる。なお、本体部１１０の平面形状は、特に限定されず、例えば、楕円形や多角形（矩形や三角形等）であってもよい。 The main body part 110 can be composed of a sheet-like member having a circular shape in plan view shown in FIG. Note that the planar shape of the main body portion 110 is not particularly limited, and may be, for example, an elliptical shape or a polygonal shape (rectangular, triangular, etc.).
　本体部１１０は、孔部１１４を有する。 The body portion 110 has a hole portion 114 .
　孔部１１４には、後述する接合装置７００の第１係合器具７１０の被係合部７１１を挿通させることができる（図１４を参照）。術者は、孔部１１４に被係合部７１１を挿通させることにより、第１係合器具７１０に医療用部材１００を保持させることができる。 An engaged portion 711 of a first engaging device 710 of a joining device 700, which will be described later, can be inserted through the hole portion 114 (see FIG. 14). The operator can cause the first engaging device 710 to hold the medical member 100 by inserting the engaged portion 711 through the hole 114 .
　本体部１１０に形成された各貫通孔１１２は、図１に示すように、本体部１１０の面方向において規則的かつ周期的に設けられている。ただし、各貫通孔１１２は、本体部１１０の面方向の各部においてランダムに設けられていてもよい。 Each through-hole 112 formed in the body portion 110 is provided regularly and periodically in the surface direction of the body portion 110, as shown in FIG. However, each through-hole 112 may be provided at random in each portion of the body portion 110 in the plane direction.
　各貫通孔１１２は、図２に示すように、本体部１１０の厚み方向（図２の上下方向）に沿って表面１１１と裏面１１３との間で略垂直に延びている。なお、各貫通孔１１２は、本体部１１０の厚み方向に沿う断面において、表面１１１と裏面１１３との間でジグザグ状に屈曲していたり、湾曲していたりしてもよい。 As shown in FIG. 2, each through-hole 112 extends substantially perpendicularly between the front surface 111 and the back surface 113 along the thickness direction of the body portion 110 (vertical direction in FIG. 2). Note that each through-hole 112 may be bent or curved in a zigzag shape between the front surface 111 and the rear surface 113 in a cross section along the thickness direction of the main body portion 110 .
　各貫通孔１１２は、略円形の平面形状を有する。ただし、各貫通孔１１２の平面形状は、特に限定されず、例えば、楕円形や多角形（矩形や三角形等）、不規則な平面形状等であってもよい。また、貫通孔１１２ごとに平面形状や断面形状が異なっていてもよい。 Each through-hole 112 has a substantially circular planar shape. However, the planar shape of each through hole 112 is not particularly limited, and may be, for example, an oval, polygonal (rectangular, triangular, etc.), irregular planar shape, or the like. In addition, each through-hole 112 may have a different planar shape or a different cross-sectional shape.
　本体部１１０の厚み（図２に示す寸法Ｔ）は特に制限されないが、好ましくは０．０５～０．３ｍｍであり、より好ましくは０．１～０．２ｍｍである。本体部１１０の厚みが０．０５ｍｍ以上である場合（特に０．１ｍｍ以上である場合）、医療用部材１００の取り扱い時に本体部１１０が破損しない程度の強度を備えさせることができる。一方、本体部１１０の厚みが０．３ｍｍ以下である場合（特に０．２ｍｍ以下である場合）、本体部１１０が適用される生体組織に本体部１１０が密着して生体組織に追随するのに十分な柔軟性を備えさせることができる。 The thickness (dimension T shown in FIG. 2) of the body portion 110 is not particularly limited, but is preferably 0.05 to 0.3 mm, more preferably 0.1 to 0.2 mm. When the thickness of the body part 110 is 0.05 mm or more (especially when it is 0.1 mm or more), the body part 110 can be provided with strength to the extent that the body part 110 does not break when the medical member 100 is handled. On the other hand, when the thickness of the body portion 110 is 0.3 mm or less (especially when it is 0.2 mm or less), the body portion 110 adheres to the living tissue to which the body portion 110 is applied and follows the living tissue. You can have enough flexibility.
　本体部１１０は、貫通孔１１２のピッチＰ（図２に示す距離Ｐであり、隣接する貫通孔１１２の間の距離。後述する実施例の「線径」に相当する。）に対する貫通孔１１２の孔径Ｄ（図２に示す距離Ｄ）の比の値が、０．２５以上４０未満であることが好ましい。なお、貫通孔１１２の平面形状が真円である場合、貫通孔１１２の孔径Ｄは真円の直径に等しくなる。一方、貫通孔１１２の平面形状が真円ではない場合には、貫通孔１１２の開口部（貫通孔１１２において表面１１１又は裏面１１３に面した部分）の面積と同じ面積を有する真円の直径（円相当径）を当該貫通孔１１２の孔径Ｄとすることができる。 The body portion 110 has a pitch P of the through-holes 112 (the distance P shown in FIG. 2, which is the distance between adjacent through-holes 112; corresponds to the “wire diameter” in the examples described later). It is preferable that the ratio of the pore diameters D (the distance D shown in FIG. 2) is 0.25 or more and less than 40. In addition, when the planar shape of the through-hole 112 is a perfect circle, the hole diameter D of the through-hole 112 is equal to the diameter of the perfect circle. On the other hand, when the planar shape of the through-hole 112 is not a perfect circle, the diameter of a perfect circle having the same area as the area of the opening of the through-hole 112 (the portion of the through-hole 112 facing the front surface 111 or the back surface 113) ( Equivalent circle diameter) can be used as the hole diameter D of the through hole 112 .
　本体部１１０は、複数の貫通孔１１２を有するため、各貫通孔１１２に対応する孔径Ｄの値が複数存在する。そこで、本実施形態（後述する実施例で示す各サンプル用の医療用部材１００Ｓ２～１００Ｓ９についても同様）では、上述した比の値を算出するにあたっては、複数の貫通孔１１２にそれぞれ対応する孔径Ｄの値の２点以上の算術平均値を孔径Ｄの代表値として用いるものとする。一方、複数の貫通孔１１２のピッチＰは、２つの貫通孔１１２の開口部同士の最短距離で定義する。ただし、ピッチＰの値についても隣接する貫通孔１１２の組み合わせに対応するピッチＰの値が複数存在する。したがって、本実施形態では、上述した比の値を算出するにあたっては、隣接する貫通孔１１２の組み合わせにそれぞれ対応するピッチＰの値の２点以上の算術平均値をピッチＰの代表値として用いるものとする。 Since the body part 110 has a plurality of through holes 112, there are a plurality of values of the hole diameter D corresponding to each through hole 112. Therefore, in the present embodiment (the same applies to the medical members 100S2 to 100S9 for each sample shown in Examples to be described later), in calculating the above-described ratio values, the hole diameters D shall be used as a representative value of the pore diameter D. On the other hand, the pitch P of the plurality of through holes 112 is defined as the shortest distance between the openings of the two through holes 112 . However, as for the pitch P value, there are a plurality of pitch P values corresponding to combinations of adjacent through holes 112 . Therefore, in the present embodiment, when calculating the value of the ratio described above, the arithmetic mean value of two or more pitch P values corresponding to combinations of adjacent through holes 112 is used as the representative value of the pitch P. and
　なお、上記の貫通孔１１２のピッチＰ、孔径Ｄ、ピッチＰに対する孔径Ｄの比等は、一例であり、これに限定されることはない。 The pitch P of the through holes 112, the hole diameter D, the ratio of the hole diameter D to the pitch P, and the like are merely examples, and are not limited to these.
　本体部１１０は、例えば、生分解性の材料で構成することができる。本体部１１０の構成材料について特に制限はなく、例えば、生分解性樹脂が挙げられる。生分解性樹脂としては、例えば、特表２０１１－５２８２７５号公報、特表２００８－５１４７１９号公報、国際公報第２００８－１９５２号、特表２００４－５０９２０５号公報等に記載されるものなどの公知の生分解性（共）重合体が使用できる。具体的には、（１）脂肪族ポリエステル、ポリエステル、ポリ酸無水物、ポリオルソエステル、ポリカーボネート、ポリホスファゼン、ポリリン酸エステル、ポリビニルアルコール、ポリペプチド、多糖、タンパク質、セルロースからなる群から選択される重合体；（２）上記（１）を構成する一以上の単量体から構成される共重合体などが挙げられる。すなわち、本体部１１０は、脂肪族ポリエステル、ポリエステル、ポリ酸無水物、ポリオルソエステル、ポリカーボネート、ポリホスファゼン、ポリリン酸エステル、ポリビニルアルコール、ポリペプチド、多糖、タンパク質、セルロースからなる群から選択される重合体、ならびに前記重合体を構成する一以上の単量体から構成される共重合体からなる群より選択される少なくとも１種の生分解性樹脂を含むことが好ましい。 The body part 110 can be made of, for example, a biodegradable material. There are no particular restrictions on the constituent material of the body portion 110, and examples include biodegradable resins. Examples of biodegradable resins include those described in Japanese Patent Publication No. 2011-528275, Japanese Patent Publication No. 2008-514719, International Publication No. 2008-1952, Japanese Patent Publication No. 2004-509205, etc. Biodegradable (co)polymers can be used. Specifically, (1) selected from the group consisting of aliphatic polyesters, polyesters, polyacid anhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose Polymer; (2) a copolymer composed of one or more monomers constituting the above (1); That is, the main body 110 is made of a polymer selected from the group consisting of aliphatic polyesters, polyesters, polyacid anhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose. It is preferable to include at least one biodegradable resin selected from the group consisting of coalescence and copolymers composed of one or more monomers constituting the polymer.
　本体部１１０の製造方法は特に限定されないが、例えば、上述した生分解性樹脂からなる繊維を作製し、当該繊維を用いてメッシュ形状のシートを製造する方法が挙げられる。生分解性樹脂からなる繊維を作製する方法としては、特に限定されないが、例えば、エレクトロスピニング法（電界紡糸法・静電紡糸法）や、メルトブロー法等が挙げられる。本体部１１０は、上記の方法のうち１種のみを選択して用いてもよいし、２種以上を選択し適宜組み合わせてもよい。なお、本体部１１０の製造方法のさらに別の例として、上述した生分解性樹脂からなる繊維を常法に従って紡糸し、得られた繊維をメッシュ状に編むことによって本体部１１０を製造する方法、該繊維を圧縮することによって該本体部１１０を製造する方法、該繊維を織らずに絡み合わせることによって該本体部１１０を製造する方法を挙げることができる。 The manufacturing method of the main body part 110 is not particularly limited, but for example, a method of manufacturing fibers made of the biodegradable resin described above and manufacturing a mesh-shaped sheet using the fibers can be mentioned. A method for producing fibers made of a biodegradable resin is not particularly limited, but examples thereof include an electrospinning method (electrospinning method/electrostatic spinning method) and a meltblowing method. The body part 110 may be used by selecting only one of the above methods, or by selecting two or more methods and combining them as appropriate. As still another example of the method for manufacturing the main body 110, a method for manufacturing the main body 110 by spinning fibers made of the above-described biodegradable resin according to a conventional method and knitting the obtained fibers into a mesh shape, A method of manufacturing the main body portion 110 by compressing the fibers and a method of manufacturing the main body portion 110 by intertwining the fibers without weaving can be mentioned.
　本体部１１０は、生分解性樹脂等の構成材料によって生体反応を惹起させる。本体部１１０は、この作用により、フィブリン等の生体成分の発現を誘導する。このようにして誘導された生体成分は、本体部１１０の貫通孔１１２を貫通するようにして集積することで、癒合を促進することができる。したがって、接合対象となる生体器官同士の間に医療用部材１００の本体部１１０を配置することにより、上記のメカニズムによる癒合の促進が生じる。 The main body part 110 induces a biological reaction with a constituent material such as a biodegradable resin. By this action, main body 110 induces the expression of biological components such as fibrin. The biological components induced in this manner penetrate through the through-holes 112 of the main body 110 and accumulate, thereby promoting the fusion. Therefore, by arranging the body part 110 of the medical member 100 between living organs to be joined, the fusion is promoted by the above mechanism.
　なお、本体部１１０の材質は、癒合を促進させることが可能であれば、生分解性でなくてもよい。 It should be noted that the material of the body part 110 does not have to be biodegradable as long as it can promote healing.
　本体部１１０に形成された孔部１１４は、各貫通孔１１２よりも大きな孔径を備える。孔部１１４は、本体部１１０の面方向の中心部Ｏ１（図３に示す平面図上における中心位置）が含まれる範囲に形成することができる。なお、中心部Ｏ１は、本体部１１０が回転対称な形状を有する場合、本体部１１０の回転中心である。 A hole portion 114 formed in the body portion 110 has a hole diameter larger than that of each through hole 112 . The hole portion 114 can be formed in a range that includes the central portion O1 in the plane direction of the main body portion 110 (the central position on the plan view shown in FIG. 3). Center O1 is the center of rotation of main body 110 when main body 110 has a rotationally symmetrical shape.
　孔部１１４は、円形の平面形状を有する。孔部１１４の孔径は、例えば、５ｍｍ～２５ｍｍに形成することができる。なお、孔部１１４の平面形状は、特に限定されず、例えば、楕円形や多角形（矩形や三角形等）であってもよい。また、孔部１１４の大きさも特に限定されない。 The hole 114 has a circular planar shape. The hole diameter of the hole portion 114 can be formed to be 5 mm to 25 mm, for example. The planar shape of the hole 114 is not particularly limited, and may be, for example, an elliptical shape or a polygonal shape (rectangular, triangular, etc.). Also, the size of the hole 114 is not particularly limited.
　孔部１１４は、本体部１１０に予め作成されていてもよいし、吻合術を実施している間に術者が作成してもよい。 The hole portion 114 may be formed in the main body portion 110 in advance, or may be formed by the operator while performing the anastomosis.
　また、術者は、手技の進行等に応じて、本体部１１０の形状や構造等に関する種々の変形を選択することができる。 In addition, the operator can select various modifications regarding the shape, structure, etc. of the main body 110 according to the progress of the procedure.
　本体部１１０は、図１、図３に示すように、耐圧性向上部１１０Ａと易破断部１１０Ｂを有する。 As shown in FIGS. 1 and 3, the body portion 110 has a pressure resistance improving portion 110A and an easily breakable portion 110B.
　耐圧性向上部１１０Ａは、本体部１１０の一部又は全体に形成することができる。 The pressure resistance improving portion 110A can be formed in part or the whole of the body portion 110.
　本実施形態では、耐圧性向上部１１０Ａは、本体部１１０の面方向の中心部Ｏ１よりも本体部１１０の外周部側に配置している。 In this embodiment, the pressure resistance improving portion 110A is arranged closer to the outer peripheral side of the body portion 110 than the center portion O1 of the body portion 110 in the plane direction.
　上記の「本体部１１０の外周部」とは、本体部１１０の外周縁に沿って位置し、かつ外周縁側から中心部Ｏ１側に向かう任意かつ所定の範囲で定義することができる。 The above-mentioned "peripheral portion of the main body portion 110" can be defined as an arbitrary and predetermined range located along the outer peripheral edge of the main body portion 110 and extending from the outer peripheral edge side toward the central portion O1 side.
　易破断部１１０Ｂは、本体部１１０の中心部Ｏ１を含む範囲に形成された孔部１１４の周囲を囲むように配置されている。 The breakable portion 110B is arranged so as to surround a hole portion 114 formed in a range including the central portion O1 of the body portion 110.
　耐圧性向上部１１０Ａは易破断部１１０Ｂの周囲を囲むように、易破断部１１０Ｂと同心状に配置されている。 The pressure resistance improving portion 110A is arranged concentrically with the easily breakable portion 110B so as to surround the easily breakable portion 110B.
　耐圧性向上部１１０Ａは、吻合対象となる生体器官の間に挟み込まれて留置された際に、吻合部におけるバースト圧を高める機能を持つ。耐圧性向上部１１０Ａは、耐圧性向上部１１０Ａを間に挟んで吻合された生体器官の間の分離を抑制し、吻合部におけるシール性を向上させる。なお、耐圧性向上部１１０Ａの好ましい物性等については、後述する実施例を通じて説明する。 The pressure resistance improving part 110A has a function of increasing the burst pressure at the anastomotic part when it is sandwiched between living organs to be anastomosed and indwelled. The pressure resistance improving portion 110A suppresses the separation of the biological organs anastomosed with the pressure resistance improving portion 110A interposed therebetween, thereby improving the sealing performance at the anastomosis. Preferred physical properties and the like of the pressure resistance improving portion 110A will be described through Examples described later.
　易破断部１１０Ｂは、本体部１１０の面方向と交差する方向（例えば、本体部１１０の表面１１１及び裏面１１３に対して垂直な方向）に対して力を付与した際に、本体部１１０の破断が容易に誘導される物性を備える。術者は、接合装置７００により本体部１１０を面方向と交差する方向に向けて打ち抜く際、易破断部１１０Ｂを打ち抜き対象部位に含ませることにより、本体部１１０を容易に打ち抜くことができる（図１５を参照）。 The easily breakable portion 110B breaks the body portion 110 when a force is applied in a direction that intersects the plane direction of the body portion 110 (for example, a direction perpendicular to the front surface 111 and the back surface 113 of the body portion 110). is easily induced. When punching out the body portion 110 in the direction intersecting the plane direction with the bonding device 700, the operator can easily punch out the body portion 110 by including the easily breakable portion 110B in the punching target region (Fig. 15).
　易破断部１１０Ｂの機能は、易破断部１１０Ｂの面方向における圧縮伸び率（柔軟性）及び面方向における破断強度（脆性）に依存する。これは、次のような理由による。 The function of the easily breakable portion 110B depends on the compressive elongation rate (flexibility) in the plane direction and the breaking strength (brittleness) in the plane direction of the easily breakable portion 110B. This is for the following reasons.
　易破断部１１０Ｂの圧縮伸び率が小さい場合、伸長し難くなるため、接合装置７００のカッター等が押し当てられた際、カッターを押し当てる力が易破断部１１０Ｂの厚み方向（面と交差する方向）に対して伝わり易くなる。それにより、易破断部１１０Ｂを容易に破断させることができる。また、易破断部１１０Ｂの強度が小さい場合、易破断部１１０Ｂにカッターを押し当てた際、カッターによって易破断部１００Ｂを容易に破断させることが可能になる。 If the compressive elongation rate of the easy-to-break portion 110B is small, it becomes difficult to elongate. ). Thereby, the easily breakable portion 110B can be easily broken. Further, when the easily breakable portion 110B has a small strength, the easily breakable portion 100B can be easily broken by the cutter when the cutter is pressed against the easily breakable portion 110B.
　本体部１１０に易破断部１１０Ｂを設ける方法としては、例えば、本体部１１０の一部又は全体に熱を付与する方法、本体部１１０の一部又は全体を所定の圧縮伸び率及び破断強度を備える材料で構成する方法等を挙げることができる。ただし、本体部１１０に易破断部１１０Ｂを設けるための具体的な方法について特に制限はない。 Examples of the method of providing the easily breakable portion 110B in the body portion 110 include a method of applying heat to a portion or the whole of the body portion 110, and a method of providing a portion or the whole of the body portion 110 with a predetermined compressive elongation and breaking strength. A method of forming from a material, etc. can be mentioned. However, there is no particular limitation on the specific method for providing the breakable portion 110B on the main body portion 110 .
　図３の平面図を参照して、本体部１１０の各部１１０Ａ、１１０Ｂと吻合術に使用される接合装置７００の各部の位置関係について説明する。なお、図３では、貫通孔１１２の図示を省略している。 The positional relationship between the parts 110A and 110B of the main body part 110 and the parts of the joining device 700 used for anastomosis will be described with reference to the plan view of FIG. It should be noted that illustration of the through hole 112 is omitted in FIG. 3 .
　第１領域Ｅ１は、接合装置７００の第１係合器具７１０と第２係合器具７２０とが互いに重なる領域である。 The first area E1 is an area where the first engaging device 710 and the second engaging device 720 of the joining device 700 overlap each other.
　第２領域Ｅ２は、吻合対象となる生体器官（例えば、大腸）の内腔と連通する開口部を形成するために、接合装置７００により打ち抜き加工がなされる部分である。接合装置７００が備える各係合器具７１０、７２０は、カッター（刃部）を備えている。接合装置７００は、生体器官を接合する際、各係合器具７１０、７２０同士を係合させて、縫合と同時に易破断部１１０Ｂを打ち抜く（図１５、図１６を参照）。そのため、第２領域Ｅ２には、破断加工性が向上された易破断部１１０Ｂの少なくとも一部を配置することが好ましい。 The second region E2 is a portion that is punched by the joining device 700 in order to form an opening that communicates with the lumen of a living organ to be anastomosed (for example, the large intestine). Each engagement tool 710, 720 provided in the joining device 700 has a cutter (blade portion). When joining living organs, the joining device 700 engages the engaging tools 710 and 720 to punch out the breakable portion 110B at the same time as suturing (see FIGS. 15 and 16). Therefore, it is preferable to dispose at least part of the easily breakable portion 110B with improved breakability in the second region E2.
　第３領域Ｅ３は、各係合器具７１０、７２０により生体器官同士を接合する際に、生体器官の間に挟み込まれた状態で留置される接合箇所（吻合部が形成される箇所）に相当する。第３領域Ｅ３は、生体器官の間に留置されることにより、吻合部の癒合を促進する。接合装置７００では、第３領域Ｅ３に対して接合部材（例えば、ステープル）を供給し、第３領域Ｅ３を生体器官に対して接合する。そのため、第３領域Ｅ３には、吻合部のバースト圧を向上させる機能を持つ耐圧性向上部１１０Ａの少なくとも一部を配置することが好ましい。 The third region E3 corresponds to a joint site (a site where an anastomosis is formed) that is left in a state of being sandwiched between living organs when the living organs are joined together by the engaging instruments 710 and 720. . The third region E3 promotes fusion of the anastomosis by being indwelled between living organs. The joining device 700 supplies a joining member (for example, staple) to the third region E3 to join the third region E3 to the living organ. Therefore, it is preferable to dispose at least part of the pressure resistance improving section 110A, which has a function of improving the burst pressure of the anastomosis, in the third region E3.
　上記のように、医療用部材１００では、吻合術で使用される接合装置７００の構造を考慮し、本体部１１０の中心部Ｏ１の周囲を囲む所定の範囲に破断加工性が高められた易破断部１１０Ｂを配置し、易破断部１１０Ｂの周囲を囲む外周部側の所定の範囲に吻合部のバースト圧を向上させる耐圧性向上部１１０Ａを配置している。 As described above, in the medical member 100, in consideration of the structure of the joining device 700 used in anastomosis, an easy-to-break portion with enhanced breaking workability is provided in a predetermined range surrounding the central portion O1 of the main body portion 110. The portion 110B is arranged, and the pressure resistance improving portion 110A for improving the burst pressure of the anastomotic portion is arranged in a predetermined range on the outer peripheral side surrounding the easily rupturable portion 110B.
　なお、医療用部材１００は、本体部１１０の少なくとも一部に耐圧性向上部１１０Ａが形成されている限り、具体的な構造は限定されない。 It should be noted that the medical member 100 is not limited to a specific structure as long as the main body portion 110 has the pressure resistance improving portion 110A formed on at least a portion thereof.
　例えば、本体部１１０には易破断部１１０Ｂを設けなくてもよい。また、本体部１１０において耐圧性向上部１１０Ａを配置する位置は、本体部１１０の中心部Ｏ１よりも外周部側に位置する領域のみに限定されない。例えば、耐圧性向上部１１０Ａは、本体部１１０の中心部Ｏ１を含む領域や、中心部Ｏ１と外周部の間の任意の領域に配置することも可能である。 For example, the body portion 110 does not have to be provided with the breakable portion 110B. In addition, the position where the pressure resistance improving portion 110A is arranged in the main body portion 110 is not limited to the region located on the outer peripheral side of the central portion O1 of the main body portion 110 . For example, the pressure resistance improving portion 110A can be arranged in a region including the central portion O1 of the main body portion 110, or in an arbitrary region between the central portion O1 and the outer peripheral portion.
　また、例えば、本体部１１０の外周部には、本体部１１０のヨレ等の変形を防止する補強部を設けてもよい。補強部は、例えば、耐圧性向上部１１０Ａ及び易破断部１１０Ｂよりも硬質な材料で構成することができる。 Further, for example, the outer peripheral portion of the body portion 110 may be provided with a reinforcing portion that prevents deformation such as twisting of the body portion 110 . The reinforcing portion can be made of a material harder than the pressure resistance improving portion 110A and the breakable portion 110B, for example.
　＜耐圧性向上部＞
　本実施形態に係る耐圧性向上部１１０Ａは、本体部１１０の面方向に対して交差する方向（表面１１１及び／又は裏面１１３に対して垂直な方向）における破断強度が０．２［Ｎ］以上であり、かつ、本体部１１０の面方向（表面１１１及び／又は裏面１１３に平行な面方向）における圧縮伸び率が１５２［％］以上である。 <Pressure resistance improvement part>
The pressure resistance improving portion 110A according to the present embodiment has a breaking strength of 0.2 [N] or more in a direction (perpendicular to the front surface 111 and/or the rear surface 113) intersecting the surface direction of the main body portion 110. and the compressive elongation in the plane direction of the main body 110 (the plane direction parallel to the front surface 111 and/or the back surface 113) is 152[%] or more.
　医療用部材１００は、上記のように構成された耐圧性向上部１１０Ａを備えることにより、吻合部におけるバースト圧を高めることができる。 The medical member 100 can increase the burst pressure at the anastomosis by including the pressure resistance improving portion 110A configured as described above.
　また、耐圧性向上部１１０Ａは、破断強度が２．２［Ｎ］以上であり、かつ圧縮伸び率が５１７［％］以上であることがより好ましい。 More preferably, the pressure resistance improving portion 110A has a breaking strength of 2.2 [N] or more and a compressive elongation rate of 517 [%] or more.
　医療用部材１００は、上記のように構成された耐圧性向上部１１０Ａを備えることにより、吻合部におけるバースト圧をより一層効果的に高めることができる。 The medical device 100 can more effectively increase the burst pressure at the anastomotic site by including the pressure resistance improving section 110A configured as described above.
　また、医療用部材１００は、本体部１１０の面方向に沿う第１方向における耐圧性向上部１１０Ａの引張強度をＴｓ１［Ｎ］とし、本体部１１０の面方向に沿う方向であって、平面視において第１方向と直交する第２方向における耐圧性向上部１１０Ａの引張強度をＴｓ２［Ｎ］とした場合に、下記式（１）を満たすことが好ましい
　Ｔｓ２／Ｔｓ１≦４．３・・・（１）。 In the medical member 100, the tensile strength of the pressure resistance improving portion 110A in the first direction along the surface direction of the body portion 110 is Ts1 [N], and the direction along the surface direction of the body portion 110 is where Ts2 [N] is the tensile strength of the pressure resistance improving portion 110A in the second direction perpendicular to the first direction, it is preferable to satisfy the following formula (1): Ts2/Ts1 ≤ 4.3 ( 1).
　医療用部材１００は、上記のように構成された耐圧性向上部１１０Ａを備えることにより、吻合部におけるバースト圧をさらに効果的に高めることができる。 The medical device 100 can further effectively increase the burst pressure at the anastomotic site by including the pressure resistance improving section 110A configured as described above.
　なお、上記の「第１方向」及び「第２方向」の定義は後述する実施例で説明する。 The definitions of the above "first direction" and "second direction" will be explained later in the examples.
　また、医療用部材１００は、引張強度Ｔｓ１［Ｎ］と引張強度Ｔｓ２［Ｎ］の関係が下記式（２）を満たすことがより好ましい
　Ｔｓ２／Ｔｓ１≦２．０・・・（２）。 Further, it is more preferable that the relationship between the tensile strength Ts1 [N] and the tensile strength Ts2 [N] of the medical member 100 satisfies the following formula (2): Ts2/Ts1≦2.0 (2).
　医療用部材１００は、上記のように構成された耐圧性向上部１１０Ａを備えることにより、吻合部におけるバースト圧をより一層効果的に高めることができる。 The medical device 100 can more effectively increase the burst pressure at the anastomotic site by including the pressure resistance improving section 110A configured as described above.
　耐圧性向上部１１０Ａの構成材料にはポリグリコール酸が含まれていることが好ましい。耐圧性向上部１１０Ａは、構成材料にポリグリコール酸が含まれていることにより、吻合部におけるバースト圧を効果的に高めることができる。 It is preferable that polyglycolic acid is contained in the constituent material of the pressure resistance improving portion 110A. The pressure resistance improving section 110A can effectively increase the burst pressure at the anastomotic site by including polyglycolic acid in the constituent material.
　耐圧性向上部１１０Ａは、ポリグリコール酸を構成材料に含む不織布で構成することができる。このように構成された耐圧性向上部１１０Ａは、吻合部におけるバースト圧を向上させる効果を発揮するとともに、生分解性を備えるものとなる。そのため、生体器官同士を吻合する吻合術への適用性が向上する。 The pressure resistance improving part 110A can be made of a nonwoven fabric containing polyglycolic acid as a constituent material. The pressure resistance improving portion 110A configured in this way exerts the effect of improving the burst pressure at the anastomosis and is biodegradable. Therefore, applicability to anastomosis for anastomosing living organs is improved.
　耐圧性向上部１１０Ａは、ポリグリコール酸を構成材料に含む不織布に対して加熱処理を施した被加熱部で構成することができる。医療用部材１００は、耐圧性向上部１１０Ａが被加熱部で構成されることにより、吻合部におけるバースト圧をより一層効果的に高めることができる。 The pressure resistance improving part 110A can be composed of a heated part obtained by heat-treating a nonwoven fabric containing polyglycolic acid as a constituent material. The medical device 100 can further effectively increase the burst pressure at the anastomotic site by configuring the pressure resistance improving section 110A as a heated section.
　（実施例）
　以下、本発明の実施例を説明する。なお、本発明の特許請求の範囲は、以下に説明する実施例の内容に限定されることはない。 (Example)
Examples of the present invention will be described below. In addition, the scope of claims of the present invention is not limited to the contents of the embodiments described below.
　＜バースト圧測定試験＞
　サンプル用の腸管片を用いてバースト圧測定試験を実施した。バースト圧測定試験は下記に説明する方法で実施した。図４を参照して試験方法を説明する。 <Burst pressure measurement test>
A burst pressure measurement test was performed using a sample intestinal segment. A burst pressure measurement test was performed by the method described below. A test method will be described with reference to FIG.
　＜１．吻合手順＞
・試験用の第１腸管片４１０Ａと第２腸管片４１０Ｂを準備した。各腸管片４１０Ａ、４１０Ｂは、試験用動物の腸管である。機械式の接合装置を使用して、第１腸管片４１０Ａと第２腸管片４１０Ｂを吻合した。接合装置は、アンビルとトロッカーを備える公知のステープラー式の吻合装置である。
・上記の接合装置を使用して第１腸管片４１０Ａと第２腸管片４１０Ｂを吻合する際、サンプル用の医療用部材１００Ｓをアンビル側に装着し、生体適合性を備える所定量のウレタン系接着剤をトロッカー側の吻合領域（吻合部を形成する領域）に塗布した。
・アンビル側の生体組織を生理食塩水で濡らした後、アンビルとトロッカーを接続した。さらに、吻合領域の外周を生理食塩水で濡らした後、３分間放置した。３分経過した後、接合装置を使用して第１腸管片４１０Ａと第２腸管片４１０Ｂを接合して吻合部４１５を形成した。第１腸管片４１０Ａと第２腸管片４１０Ｂは、本体部１１０の第３領域Ｅ３（図３を参照）に相当する箇所に供給された複数個のステープルで吻合した。
・第１腸管片４１０Ａと第２腸管片４１０Ｂにおいて吻合部４１５以外の外部に開口した箇所は巾着縫合で閉鎖した。巾着縫合した第１腸管片４１０Ａの一端部に位置する開口部にはノンベベル針４４０を挿入した。ノンベベル針４４０は所定のチューブ４５０を介してシリンジポンプ４６０と接続した。 <1. Anastomosis Procedure>
- A first intestinal piece 410A and a second intestinal piece 410B for testing were prepared. Each intestinal segment 410A, 410B is the intestinal tract of a test animal. The first intestinal piece 410A and the second intestinal piece 410B were anastomosed using a mechanical joining device. The joining device is a known stapler-type anastomotic device that includes an anvil and trocar.
- When anastomosing the first intestinal piece 410A and the second intestinal piece 410B using the joining device, the sample medical member 100S is mounted on the anvil side, and a predetermined amount of biocompatible urethane-based adhesive is applied. The agent was applied to the anastomosis area (the area forming the anastomosis) on the trocar side.
・After wetting the living tissue on the anvil side with physiological saline, the anvil and the trocar were connected. Furthermore, after wetting the periphery of the anastomosis region with physiological saline, it was allowed to stand for 3 minutes. After 3 minutes had passed, the first intestinal piece 410A and the second intestinal piece 410B were joined to form an anastomosis 415 using a joining device. The first intestinal piece 410A and the second intestinal piece 410B were anastomosed with a plurality of staples supplied to a portion corresponding to the third region E3 (see FIG. 3) of the main body 110. As shown in FIG.
- The portions of the first intestinal piece 410A and the second intestinal piece 410B that were open to the outside other than the anastomosis 415 were closed with a purse string suture. A non-beveled needle 440 was inserted into the opening located at one end of the purse-string sutured first intestinal segment 410A. A non-beveled needle 440 was connected to a syringe pump 460 through a predetermined tube 450 .
　＜２．バースト圧の測定手順＞
・所定の容器４７０内に満たした水４８０に各腸管片４１０Ａ、４１０Ｂを沈めた状態で、シリンジポンプ４６０を使用して定速加圧（１２００ｍＬ／ｈ）を実施した。吻合部４１５からの空気の漏れが確認されたときの圧力をバースト圧［ｍｍＨｇ］とした。 <2. Burst pressure measurement procedure>
- With the intestinal pieces 410A and 410B submerged in water 480 filled in a predetermined container 470, a syringe pump 460 was used to perform constant-rate pressurization (1200 mL/h). The pressure at which air leakage from the anastomotic portion 415 was confirmed was defined as burst pressure [mmHg].
　＜サンプル用の医療用部材＞
　バースト圧測定試験は、サンプル用の医療用部材１００Ｓを使用せずに吻合部を形成したサンプル１と、複数の種類のサンプル用の医療用部材１００Ｓを吻合部に適用したサンプル２～９に対して実施した。 <Sample medical materials>
The burst pressure measurement test was performed on Sample 1, in which an anastomosis was formed without using the sample medical member 100S, and Samples 2 to 9, in which a plurality of types of sample medical members 100S were applied to the anastomosis. implemented.
　図１０には、各サンプル用の医療用部材１００Ｓを使用した際の吻合部４１５のバースト圧を示す。 FIG. 10 shows the burst pressure of the anastomosis 415 when using the medical member 100S for each sample.
　バースト圧の測定試験に使用したサンプル用の医療用部材１００Ｓ及び試験結果を説明する。以下では、実施例に使用した各医療用部材を総称して「サンプル用の医療用部材１００Ｓ」とも記載する。 The sample medical member 100S used for the burst pressure measurement test and the test results will be explained. Hereinafter, each medical member used in the examples will be collectively referred to as "sample medical member 100S".
　＜サンプル１＞
　サンプル１は、比較実験用の吻合部４１５のバースト圧を測定したものである。サンプル１では、サンプル用の医療用部材１００Ｓを使用してない。 <Sample 1>
Sample 1 measures the burst pressure of the anastomosis 415 for comparison experiments. Sample 1 does not use the sample medical member 100S.
　＜サンプル２＞
　サンプル２は、吻合部４１５にサンプル用の医療用部材１００Ｓ２（以下、「医療用部材１００Ｓ２」とする）が使用されている。医療用部材１００Ｓ２の詳細は下記の通りである。
・ポリグリコール酸（ＰＧＡ）からなる不織布で構成されたメッシュ状の本体部１１０を備えるシートを準備した。医療用部材１００Ｓ２は、上記のシートを３枚重ねたもので構成した。
・図６には、上記シートの一部を拡大した模式図を示す。上記シートは、本体部１１０に規則的に配列された複数の貫通孔１１２を備える。貫通孔１１２は、隣接する貫通孔１１２との間に９０°の角度をなすように千鳥格子状に配列されている。医療用部材１００Ｓ２を構成する３枚のシートは、各シートに形成された貫通孔１１２が平面視上において重なるように配置されている。
・上記１枚のシートの貫通孔１１２の孔径は０．６ｍｍ、線径（ピッチ）は０．２ｍｍ、厚みは０．１ｍｍである。
・医療用部材１００Ｓ２には耐圧性向上部１１０Ａをなす被加熱部を形成した。被加熱部は下記の条件で形成した。
（１）熱プレス機を本体部１１０の表面１１１（又は裏面１１３）に押し付けて熱プレスした。
（２）プレス圧は４０ＭＰａに設定した。
（３）プレス時間は２０分に設定した。
（４）加熱温度は１７０℃に設定した。 <Sample 2>
A sample medical member 100S2 (hereinafter referred to as “medical member 100S2”) is used in the anastomotic portion 415 of the sample 2 . The details of the medical member 100S2 are as follows.
- A sheet including a mesh-like body portion 110 made of nonwoven fabric made of polyglycolic acid (PGA) was prepared. The medical member 100S2 was constructed by stacking three of the above sheets.
- In FIG. 6, the schematic diagram which expanded a part of said sheet|seat is shown. The sheet includes a plurality of through holes 112 regularly arranged in the body portion 110 . The through-holes 112 are arranged in a houndstooth pattern with an angle of 90° between adjacent through-holes 112 . The three sheets forming the medical member 100S2 are arranged such that the through holes 112 formed in each sheet overlap when viewed from above.
The hole diameter of the through holes 112 of the one sheet is 0.6 mm, the wire diameter (pitch) is 0.2 mm, and the thickness is 0.1 mm.
- The medical member 100S2 is formed with a heated portion forming the pressure resistance improving portion 110A. The heated portion was formed under the following conditions.
(1) A hot press was pressed against the front surface 111 (or the rear surface 113) of the main body 110 to perform hot pressing.
(2) The press pressure was set to 40 MPa.
(3) Press time was set to 20 minutes.
(4) The heating temperature was set to 170°C.
　＜サンプル３＞
　サンプル３は、吻合部４１５にサンプル用の医療用部材１００Ｓ３（以下、「医療用部材１００Ｓ３」とする）が使用されている。医療用部材１００Ｓ３の詳細は下記の通りである。
・医療用部材１００Ｓ３として、グリコール酸／乳酸ポリエステル（グリコール酸の比率：乳酸ポリエステルの比率は、９０：１０）からなるメッシュ状の本体部１１０を備えるシートを準備した。医療用部材１００Ｓ３は、ニット（編物）型のシートである。
・図７には、医療用部材１００Ｓ３の一部を拡大した模式図を示す。医療用部材１００Ｓ３に使用したシートは、規則的に配列された複数の貫通孔１１２を備える。
・医療用部材１００Ｓ３の貫通孔１１２の孔径は０．３ｍｍ～０．７ｍｍ、線径（ピッチ）は０．１ｍｍ～０．２ｍｍ、厚みは０．２ｍｍである。
・医療用部材１００Ｓ３には加熱処理を施していない。そのため、医療用部材１００Ｓ３の任意の部分を耐圧性向上部１１０Ａに設定した。 <Sample 3>
A sample medical member 100S3 (hereinafter referred to as “medical member 100S3”) is used in the anastomotic portion 415 of the sample 3 . The details of the medical member 100S3 are as follows.
- As the medical member 100S3, a sheet including a mesh-like body portion 110 made of glycolic acid/lactic acid polyester (ratio of glycolic acid: lactic acid polyester is 90:10) was prepared. The medical member 100S3 is a knitted sheet.
- In FIG. 7, the schematic diagram which expanded a part of medical member 100S3 is shown. The sheet used for the medical member 100S3 has a plurality of through-holes 112 that are regularly arranged.
The through holes 112 of the medical member 100S3 have a hole diameter of 0.3 mm to 0.7 mm, a wire diameter (pitch) of 0.1 mm to 0.2 mm, and a thickness of 0.2 mm.
- The medical member 100S3 is not heat-treated. Therefore, an arbitrary portion of the medical member 100S3 is set as the pressure resistance improving portion 110A.
　＜サンプル４＞
　サンプル４は、吻合部４１５にサンプル用の医療用部材１００Ｓ４（以下、「医療用部材１００Ｓ４」とする）が使用されている。医療用部材１００Ｓ４の詳細は下記の通りである。 <Sample 4>
A sample medical member 100S4 (hereinafter referred to as “medical member 100S4”) is used in the anastomotic portion 415 of the sample 4 . The details of the medical member 100S4 are as follows.
　・ポリグリコール酸（ＰＧＡ）からなる不織布で構成されたメッシュ状の本体部１１０を備えるシートを準備した。このシートを生理食塩水に浸漬させた状態で６０℃の恒温槽で６日間保管したものを医療用部材１００Ｓ４として使用した。
・上記シートは、目の粗い不織布で構成された二枚のシートで構成されている。二枚のシートは、厚み方向に重ねて配置されている。各シートは、シートを構成する繊維間に形成されたランダムな形状の貫通孔を備える。二枚のシートは、各シートの貫通孔が面方向で重なる位置で表面と裏面との間を貫通している。この貫通した部分により、医療用部材１００Ｓ４の貫通孔１１２が形成されている。
・図８には、医療用部材１００Ｓ４の一部を拡大した模式図を示す。医療用部材１００Ｓ４の貫通孔１１２の孔径は０．２ｍｍ～０．８ｍｍ、線径（ピッチ）は０．１ｍｍ～０．２ｍｍ、厚みは０．１ｍｍ～０．２ｍｍである。
・医療用部材１００Ｓ４には加熱処理を施していない。そのため、医療用部材１００Ｓ４の任意の部分を耐圧性向上部１１０Ａに設定した。 - A sheet including a mesh-like body portion 110 made of nonwoven fabric made of polyglycolic acid (PGA) was prepared. This sheet was immersed in physiological saline and stored in a constant temperature bath at 60° C. for 6 days, and used as medical member 100S4.
- The sheet is composed of two sheets made of coarse nonwoven fabric. The two sheets are stacked in the thickness direction. Each sheet has randomly shaped through-holes formed between the fibers that make up the sheet. The two sheets penetrate between the front surface and the back surface at positions where the through holes of each sheet overlap in the surface direction. This penetrating portion forms a through hole 112 of the medical member 100S4.
- In FIG. 8, the schematic diagram which expanded a part of medical member 100S4 is shown. The through holes 112 of the medical member 100S4 have a hole diameter of 0.2 mm to 0.8 mm, a wire diameter (pitch) of 0.1 mm to 0.2 mm, and a thickness of 0.1 mm to 0.2 mm.
- The medical member 100S4 is not heat-treated. Therefore, an arbitrary portion of the medical member 100S4 is set as the pressure resistance improving portion 110A.
　＜サンプル５＞
　サンプル５は、吻合部４１５にサンプル用の医療用部材１００Ｓ５（以下、「医療用部材１００Ｓ５」とする）が使用されている。医療用部材１００Ｓ５の詳細は下記の通りである。
・医療用部材１００Ｓ５として、ポリグリコール酸（ＰＧＡ）からなる不織布で構成されたメッシュ状の本体部１１０を備えるシートを準備した。前述した医療用部材１００Ｓ４は、上記のシートに所定の浸漬処理を施したものである。つまり、上記のシートに対して浸漬処理が施されていないものを医療用部材１００Ｓ５として使用した。そのため、医療用部材１００Ｓ５は、浸漬処理が施されていない点以外については、医療用部材１００Ｓ４と実質的に同一である。図８には、医療用部材１００Ｓ５の一部を拡大した模式図を示す。
・医療用部材１００Ｓ５には加熱処理を施していない。そのため、医療用部材１００Ｓ５の任意の部分を耐圧性向上部１１０Ａに設定した。 <Sample 5>
A sample medical member 100S5 (hereinafter referred to as “medical member 100S5”) is used in the anastomotic portion 415 of the sample 5 . The details of the medical member 100S5 are as follows.
- As the medical member 100S5, a sheet including a mesh-like main body 110 made of nonwoven fabric made of polyglycolic acid (PGA) was prepared. The aforementioned medical member 100S4 is obtained by subjecting the above sheet to a predetermined immersion treatment. In other words, the above sheet that was not dipped was used as the medical member 100S5. Therefore, the medical member 100S5 is substantially the same as the medical member 100S4 except that the immersion treatment is not performed. FIG. 8 shows a schematic diagram in which a part of the medical member 100S5 is enlarged.
- The medical member 100S5 is not heat-treated. Therefore, an arbitrary portion of the medical member 100S5 is set as the pressure resistance improving portion 110A.
　＜サンプル６＞
　サンプル６は、吻合部４１５にサンプル用の医療用部材１００Ｓ６（以下、「医療用部材１００Ｓ６」とする）が使用されている。医療用部材１００Ｓ６の詳細は下記の通りである。
・医療用部材１００Ｓ６として、ポリグリコール酸（ＰＧＡ）からなる不織布で構成されたメッシュ状の本体部１１０を備えるシートを準備した。
・上記シートは、目の粗い不織布で構成された一枚のシートで構成されている。つまり、医療用部材１００Ｓ６は、二枚のシートで構成された前述の医療用部材１００Ｓ５からシートを一枚剥離したものである。そのため、医療用部材１００Ｓ５は、本体部１１０の平面視において貫通孔１１２が占める面積が前述した医療用部材１００Ｓ５よりも大きい。
・図９には、医療用部材１００Ｓ６の一部を拡大した模式図を示す。医療用部材１００Ｓ６の貫通孔１１２の孔径は０．２ｍｍ～１．４ｍｍ、線径（ピッチ）は０．１ｍｍ～０．２ｍｍ、厚みは０．１ｍｍである。
・医療用部材１００Ｓ６には耐圧性向上部１１０Ａをなす被加熱部を形成した。被加熱部は下記の条件で形成した。
（１）熱プレス機を本体部１１０の表面１１１（又は裏面１１３）に押し付けて熱プレスした。
（２）プレス圧は２０ＭＰａに設定した。
（３）プレス時間は３０分に設定した。
（４）加熱温度は１５０℃に設定した。 <Sample 6>
A sample medical member 100S6 (hereinafter referred to as “medical member 100S6”) is used in the anastomosis portion 415 of the sample 6 . The details of the medical member 100S6 are as follows.
- As the medical member 100S6, a sheet including a mesh-like body portion 110 made of nonwoven fabric made of polyglycolic acid (PGA) was prepared.
- The sheet is a single sheet made of coarse nonwoven fabric. In other words, the medical member 100S6 is obtained by peeling one sheet from the above-described medical member 100S5 composed of two sheets. Therefore, in the medical member 100S5, the area occupied by the through-holes 112 in plan view of the main body 110 is larger than that of the medical member 100S5 described above.
- FIG. 9 shows a schematic diagram in which a part of the medical member 100S6 is enlarged. The through holes 112 of the medical member 100S6 have a hole diameter of 0.2 mm to 1.4 mm, a wire diameter (pitch) of 0.1 mm to 0.2 mm, and a thickness of 0.1 mm.
- The medical member 100S6 is formed with a heated portion forming the pressure resistance improving portion 110A. The heated portion was formed under the following conditions.
(1) A hot press was pressed against the front surface 111 (or the rear surface 113) of the main body 110 to perform hot pressing.
(2) Press pressure was set to 20 MPa.
(3) Press time was set to 30 minutes.
(4) The heating temperature was set to 150°C.
　＜サンプル７＞
　サンプル７は、吻合部４１５にサンプル用の医療用部材１００Ｓ７（以下、「医療用部材１００Ｓ７」とする）が使用されている。医療用部材１００Ｓ７の詳細は下記の通りである。
・前述した医療用部材１００Ｓ６に被加熱部が形成されていないものを医療用部材１００Ｓ７として準備した。そのため、医療用部材１００Ｓ６の任意の部分を耐圧性向上部１１０Ａに設定した。医療用部材１００Ｓ７は被加熱部が形成されていない点以外は、前述した医療用部材１００Ｓ６と実質的に同一である。図９には医療用部材１００Ｓ７の一部を拡大した模式図を示す。 <Sample 7>
A sample medical member 100S7 (hereinafter referred to as “medical member 100S7”) is used in the anastomotic portion 415 of the sample 7 . The details of the medical member 100S7 are as follows.
- The above-described medical member 100S6 having no heated portion was prepared as the medical member 100S7. Therefore, an arbitrary portion of the medical member 100S6 is set as the pressure resistance improving portion 110A. The medical member 100S7 is substantially the same as the medical member 100S6 described above, except that the heated portion is not formed. FIG. 9 shows a schematic diagram in which a part of the medical member 100S7 is enlarged.
　＜サンプル８＞
　サンプル８は、吻合部４１５にサンプル用の医療用部材１００Ｓ８（以下、「医療用部材１００Ｓ８」とする）が使用されている。医療用部材１００Ｓ８の詳細は下記の通りである。
・前述した医療用部材１００Ｓ６と同様のシートを準備した。ただし、被加熱部（耐圧性向上部１１０Ａ）を形成するための加熱条件を下記のように変更した。図９には、医療用部材１００Ｓ８の一部を拡大した模式図を示す。
（１）熱プレス機を本体部１１０の表面１１１（又は裏面１１３）に押し付けて熱プレスした。
（２）プレス圧は４０ＭＰａに設定した。
（３）プレス時間は３０分に設定した。
（４）加熱温度は２００℃に設定した。 <Sample 8>
A sample medical member 100S8 (hereinafter referred to as “medical member 100S8”) is used in the anastomotic portion 415 of the sample 8 . The details of the medical member 100S8 are as follows.
- A sheet similar to the medical member 100S6 described above was prepared. However, the heating conditions for forming the heated portion (pressure resistance improving portion 110A) were changed as follows. FIG. 9 shows a schematic diagram in which a part of the medical member 100S8 is enlarged.
(1) A hot press was pressed against the front surface 111 (or the rear surface 113) of the main body 110 to perform hot pressing.
(2) The press pressure was set to 40 MPa.
(3) Press time was set to 30 minutes.
(4) The heating temperature was set to 200°C.
　＜サンプル９＞
　サンプル９は、吻合部４１５にサンプル用の医療用部材１００Ｓ９（以下、「医療用部材１００Ｓ９」とする）が使用されている。医療用部材１００Ｓ９の詳細は下記の通りである。 <Sample 9>
A sample medical member 100S9 (hereinafter referred to as “medical member 100S9”) is used in the anastomotic portion 415 of the sample 9 . The details of the medical member 100S9 are as follows.
　医療用部材１００Ｓ９は、医療用部材１００Ｓ５を構成するシートと同様のシートに対して被加熱部（耐圧性向上部１１０Ａ）を形成するための事前処理と加熱処理が施されたもので構成している。事前処理として放射線照射を実施し、加熱処理として熱プレス加熱を実施した。その他の構成は、医療用部材１００Ｓ５と同一である。図８には、医療用部材１００Ｓ９の一部を拡大した模式図を示す。
・放射線加熱として、線量１００ｋＧｙの電子線照射を採用した。
・放射線加熱を実施した後、下記の条件で熱プレス加熱を実施した。
（１）熱プレス機を本体部１１０の表面１１１（又は裏面１１３）に押し付けて熱プレスした。
（２）プレス圧は２０ＭＰａに設定した。
（３）プレス時間は３０分に設定した。
（４）加熱温度は１５０℃に設定した。 The medical member 100S9 is composed of a sheet similar to the sheet forming the medical member 100S5, which is subjected to pretreatment and heat treatment for forming the heated portion (the pressure resistance improving portion 110A). there is Radiation irradiation was performed as a pretreatment, and hot press heating was performed as a heat treatment. Other configurations are the same as those of the medical member 100S5. FIG. 8 shows a schematic diagram in which a part of the medical member 100S9 is enlarged.
・Electron beam irradiation with a dose of 100 kGy was adopted as radiation heating.
- After carrying out radiation heating, hot press heating was carried out under the following conditions.
(1) A hot press was pressed against the front surface 111 (or the rear surface 113) of the main body 110 to perform hot pressing.
(2) Press pressure was set to 20 MPa.
(3) Press time was set to 30 minutes.
(4) The heating temperature was set to 150°C.
　＜バースト圧測定試験の試験結果＞
　図１０には、各サンプルのバースト圧の測定結果を示す。なお、図１０に示す結果は、３回実施したバースト圧測定試験の試験結果の平均値である。この平均値は、後述する表１に示す平均値に対応している。 <Results of burst pressure measurement test>
FIG. 10 shows the burst pressure measurement results of each sample. Note that the results shown in FIG. 10 are the average values of the test results of three burst pressure measurement tests. This average value corresponds to the average value shown in Table 1, which will be described later.
　図１０に示す結果より、耐圧性向上部１１０Ａを備えるサンプル用の医療用部材１００Ｓを使用したサンプル２～９は、サンプル用の医療用部材１００Ｓを使用していないサンプル１と比較して、吻合部４１５におけるバースト圧が高くなっていることを確認できた。 From the results shown in FIG. 10, the samples 2 to 9 using the sample medical member 100S having the pressure resistance improving portion 110A were compared with the sample 1 not using the sample medical member 100S. It was confirmed that the burst pressure at the portion 415 was high.
　また、吻合部４１５のバースト圧を高める効果は、各サンプルに使用された医療用部材１００Ｓ２～１００Ｓ９で異なることを確認できた。前述したように、各サンプルに使用された医療用部材１００Ｓ２～１００Ｓ９では、本体部１１０を構成する材料の材質、事前処理の有無、加熱処理の有無や加熱方法、加熱温度、貫通孔１１２の配列等がそれぞれ異なる。そのため、医療用部材１００のバースト圧を高める効果は、これらの影響を受けることが推測される。 In addition, it was confirmed that the effect of increasing the burst pressure of the anastomotic part 415 differs among the medical members 100S2 to 100S9 used for each sample. As described above, in the medical members 100S2 to 100S9 used for each sample, the quality of the material constituting the main body 110, the presence or absence of pretreatment, the presence or absence of heat treatment, the heating method, the heating temperature, and the arrangement of the through holes 112 etc. are different. Therefore, it is presumed that the effect of increasing the burst pressure of the medical device 100 is affected by these factors.
　発明者等は、バースト圧測定試験の結果を踏まえつつ、バースト圧の向上に影響を持つと考えられる各医療用部材１００Ｓ２～１００Ｓ９の「強度（破断強度）」及び「圧縮伸び率（面方向の柔軟性を示す弾性率）」の測定を実施した。 Based on the results of the burst pressure measurement test, the inventors determined the "strength (breaking strength)" and "compression elongation (in the plane direction)" of each medical member 100S2 to 100S9, which are considered to have an effect on the improvement of the burst pressure. Elastic modulus indicating flexibility)” was measured.
　以下に、各医療用部材１００Ｓ２～１００Ｓ９に対して実施した破断強度試験の試験方法、弾性率測定試験の試験方法、及びそれらの試験結果を説明する。 The test method of the breaking strength test, the test method of the elastic modulus measurement test, and the results of those tests performed on each medical member 100S2 to 100S9 will be described below.
　＜破断強度測定試験＞
　破断強度測定試験には、公知のクリープメーターを使用した。 <Breaking strength measurement test>
A known creep meter was used for the breaking strength measurement test.
　各医療用部材１００Ｓ２～１００Ｓ９を一辺が１５ｍｍの正方形状にカットしたサンプルを作成し、所定の固定治具にセットした。固定治具には、サンプルの面方向の中心部を露出する開口部が設けられている。サンプルをセットした固定治具をクリープメーター下部に取り付けた。 A sample was prepared by cutting each medical member 100S2 to 100S9 into a square shape with a side of 15 mm, and set it on a predetermined fixing jig. The fixture has an opening that exposes the center of the sample in the plane direction. A fixture on which the sample was set was attached to the bottom of the creep meter.
　固定治具の開口部を介してサンプルに対して押し込み力を伝える押し込み治具としてφ３ｍｍ（≒７ｍｍ２）の円柱状治具を使用した。円柱状治具をクリープメーター上部に取り付けた。 A cylindrical jig with a diameter of 3 mm (≈7 mm 2 ) was used as a pushing jig for transmitting a pushing force to the sample through the opening of the fixture. A cylindrical jig was attached to the top of the creep meter.
　円柱状治具を固定治具の開口部に向けて接近させ、固定治具の開口部を介してサンプルに対して一定速度（５ｍｍ／ｓｅｃ）の押し込み力を付加した。この試験で得られた最大荷重をサンプルの破断強度（面方向に対して直交する方向の破断強度）として算出した。破断強度の算出には、破断強度解析用の市販のソフトウェアを使用した。 A cylindrical jig was brought closer to the opening of the fixing jig, and a pressing force was applied at a constant speed (5 mm/sec) to the sample through the opening of the fixing jig. The maximum load obtained in this test was calculated as the breaking strength of the sample (breaking strength in the direction perpendicular to the surface direction). A commercially available software for breaking strength analysis was used to calculate the breaking strength.
　＜弾性率測定試験＞
　弾性率測定試験は、破断強度測定試験と同様に、公知のクリープメーターを利用した。破断強度測定試験と同様の条件については説明を省略する。 <Elastic modulus measurement test>
A known creep meter was used for the elastic modulus measurement test as well as for the breaking strength measurement test. Description of the same conditions as in the breaking strength measurement test is omitted.
　弾性率測定試験では、固定治具の開口部を介してサンプルに対して一定荷重（０．１Ｎ）の押し込み力を付加した。この試験で得られた歪率の測定値の最大値を圧縮伸び率として算出した。圧縮伸び率の算出には、弾性解析用の市販のソフトウェアを使用した。 In the elastic modulus measurement test, a constant load (0.1 N) was applied to the sample through the opening of the fixture. The maximum strain rate measurement value obtained in this test was calculated as the compression elongation rate. Commercially available software for elastic analysis was used to calculate the compression elongation.
　表１には、各サンプルに使用された医療用部材１００Ｓ２～１００Ｓ９のバースト圧、破断強度、圧縮伸び率、圧縮伸び率／破断強度の比率、ハンドリング強度を示す。なお、表１に示すサンプル１は医療用部材１００を使用せずに計測した吻合部４１５のバースト圧の試験結果を示しており、サンプル２～９は各医療用部材１００Ｓ２～１００Ｓ９を使用した吻合部４１５のバースト圧、及び各医療用部材１００Ｓ２～１００Ｓ９の物性に関する試験結果を示している。 Table 1 shows the burst pressure, breaking strength, compression elongation, compression elongation/breaking strength ratio, and handling strength of the medical members 100S2 to 100S9 used for each sample. Note that sample 1 shown in Table 1 shows the test results of the burst pressure of the anastomotic part 415 measured without using the medical member 100, and samples 2 to 9 show the anastomosis using each medical member 100S2 to 100S9. It shows test results regarding the burst pressure of the portion 415 and the physical properties of each medical member 100S2 to 100S9.
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001
　表１に示す平均値は各項目について３回実施した試験結果の平均値である。標準偏差は３回実施した試験での値である。 The average values shown in Table 1 are the average values of the results of tests conducted three times for each item. Standard deviations are values from triplicate tests.
　サンプル用の医療用部材１００Ｓを吻合部４１５に適用しなかったサンプル１よりも高いバースト圧を示した各サンプル２～９の破断強度及び圧縮伸び率を参照すると、バースト圧を向上させるためには、医療用部材１００の破断強度は０．２Ｎ（サンプル４の破断強度）以上であることが好ましいことが確認できる。また、バースト圧を向上させる観点より、医療用部材１００の圧縮伸び率は１５２％（サンプル２の圧縮伸び率）以上であることが好ましいことが確認できる。 Referring to the breaking strength and compression elongation of each of Samples 2 to 9, which exhibited a higher burst pressure than Sample 1 in which the sample medical member 100S was not applied to the anastomotic portion 415, it can be seen that in order to improve the burst pressure, , it can be confirmed that the breaking strength of the medical member 100 is preferably 0.2 N (breaking strength of sample 4) or more. Moreover, it can be confirmed that the compressive elongation of the medical device 100 is preferably 152% (the compressive elongation of sample 2) or more from the viewpoint of improving the burst pressure.
　ここで、大腸吻合術後の吻合部４１５におけるバースト圧は、術後の安定的な治療効果を得るために、３０．７５ｍｍＨｇ以上であることが医学分野では推奨されている。このような点を考慮した場合、吻合部４１５に適用する医療用部材としては、バースト圧が３０．７５ｍｍＨｇ以上となるサンプル７、サンプル８、サンプル９であることがより好ましいと言える。具体的には、表１に示す結果より、医療用部材１００の破断強度は２．２Ｎ（サンプル８の破断強度）以上であり、圧縮伸び率が５１７％（サンプル８の圧縮伸び率）以上であることがより好ましいことを確認できる。 Here, it is recommended in the medical field that the burst pressure at the anastomosis 415 after colon anastomosis should be 30.75 mmHg or more in order to obtain a stable postoperative therapeutic effect. In consideration of these points, it can be said that samples 7, 8, and 9, which have a burst pressure of 30.75 mmHg or more, are more preferable as the medical member to be applied to the anastomotic portion 415 . Specifically, from the results shown in Table 1, the breaking strength of the medical member 100 was 2.2 N (the breaking strength of sample 8) or more, and the compression elongation was 517% (the compression elongation of sample 8) or more. I can confirm that one is more preferable.
　以上の結果より、医療用部材１００は、吻合部４１５におけるバースト圧を向上させる機能を効果的に発揮させる観点より、破断強度が０．２Ｎ以上であり、圧縮伸び率が１５２％以上であることが好ましく、さらに医学的に推奨される所望のバースト圧（以下、「推奨バースト圧」とする。）を確保するためには、破断強度が２．２Ｎ以上であり、圧縮伸び率が５１７％以上であることがより好ましいことを確認できた。 From the above results, the medical device 100 should have a breaking strength of 0.2 N or more and a compression elongation of 152% or more from the viewpoint of effectively exhibiting the function of improving the burst pressure at the anastomotic portion 415. is preferable, and in order to secure the desired burst pressure medically recommended (hereinafter referred to as "recommended burst pressure"), the breaking strength is 2.2 N or more and the compression elongation is 517% or more. It was confirmed that it is more preferable to be
　表１に示す「ハンドリング強度」は、バースト圧測定試験時に試験者がサンプル用の医療用部材１００Ｓを操作したときのハンドリング性（操作性）について検討した評価項目である。 "Handling strength" shown in Table 1 is an evaluation item that examines the handling (operability) when the tester operates the sample medical member 100S during the burst pressure measurement test.
　ハンドリング強度の評価が△のサンプルは、試験者がサンプル用の医療用部材１００Ｓを手指で把持等して操作した際に、ヨレや折れが生じたものである。また、ハンドリング強度の評価が〇のサンプルは、試験者がサンプル用の医療用部材１００Ｓを手指で把持等して操作した際に、ヨレや折れが生じなかったものである。今回の試験では、試験者がサンプル用の医療用部材１００Ｓを手指で把持等して操作した際に、破れ等が生じて吻合術への適用が困難になったサンプルは存在しなかった。したがって、バースト圧を向上させる機能を持つサンプル用の医療用部材１００Ｓには、吻合術への適用が困難になる程度のハンドリング性の低下が生じなかったを確認できた。 Samples with a handling strength evaluation of △ were twisted or broken when the tester manipulated the sample medical member 100S by gripping it with their fingers. Samples with a handling strength evaluation of 0 did not twist or break when the tester manipulated the sample medical member 100S by gripping it with fingers. In this test, there were no samples that were difficult to apply to anastomosis due to tearing or the like when the tester manipulated the sample medical member 100S by gripping it with fingers. Therefore, it was confirmed that the sample medical member 100S, which has a function of increasing the burst pressure, did not deteriorate in handleability to the extent that it would be difficult to apply it to anastomosis.
　図１１には、破断強度測定試験及び弾性率測定試験により得られた各サンプルの破断強度（Ｙ軸）と圧縮伸び率（Ｘ軸）の関係を示す。 Fig. 11 shows the relationship between the breaking strength (Y-axis) and the compression elongation (X-axis) of each sample obtained by the breaking strength measurement test and the elastic modulus measurement test.
　図１１に示すチャート中の破線Ｉはバースト圧を高めるための好適な破断強度の閾値となる０．２Ｎの値を示し、破線Ｉ’はバースト圧を高めるための好適な圧縮伸び率の閾値となる１５２％の値を示している。また、図１１に示すチャート中の破線ＩＩは推奨バースト圧を確保するための好適な破断強度の閾値となる２．２Ｎの値を示し、破線ＩＩ’は推奨バースト圧を確保するための好適な圧縮伸び率の閾値となる５１７％の値を示している。 The dashed line I in the chart shown in FIG. 11 indicates a value of 0.2 N, which is a suitable breaking strength threshold for increasing the burst pressure. It shows a value of 152%. Further, the broken line II in the chart shown in FIG. 11 indicates a value of 2.2 N, which is a suitable breaking strength threshold value for securing the recommended burst pressure, and the broken line II′ indicates a suitable threshold value for securing the recommended burst pressure. A value of 517%, which is the threshold value of the compression elongation, is shown.
　図１１に示すチャート上において破断強度が０．２Ｎ以上、２．２Ｎ未満であり、かつ圧縮伸び率が１５２％以上、５１７％未満の範囲（破線Ｉ－Ｉ’と破線ＩＩ－ＩＩ’で囲まれた範囲。チャート上においてサンプル２、サンプル３、サンプル４、サンプル６が含まれる範囲。）にある物性を備える医療用部材１００は、前述したサンプル用の医療用部材１００Ｓが使用されていない吻合部４１５を備えるサンプル１との比較実験より、吻合部４１５のバースト圧を高める効果を発揮することが推測できる。 On the chart shown in FIG. 11, the range where the breaking strength is 0.2 N or more and less than 2.2 N, and the compression elongation is 152% or more and less than 517% (surrounded by the dashed line II' and the dashed line II-II' The medical member 100 having physical properties within the range on the chart that includes samples 2, 3, 4, and 6) is an anastomosis in which the aforementioned sample medical member 100S is not used. From the comparison experiment with the sample 1 having the portion 415, it can be inferred that the effect of increasing the burst pressure of the anastomosis portion 415 is exhibited.
　また、図１１に示すチャート上において破断強度が２．２以上であり、かつ圧縮伸び率が５１７％以上の範囲（破線ＩＩ－ＩＩ’よりもＸ軸及びＹ軸の値が大きくなる範囲。チャート上においてサンプル５、サンプル７、サンプル８、サンプル９が含まれる範囲。）にある物性を備える医療用部材１００は、吻合部４１５のバースト圧を推奨バースト圧まで高めることが可能であることを推測できる。 Further, the range where the breaking strength is 2.2 or more and the compression elongation is 517% or more on the chart shown in FIG. The range including samples 5, 7, 8, and 9 above) is assumed to be able to increase the burst pressure of the anastomosis 415 to the recommended burst pressure. can.
　＜引張強度測定試験＞
　医療用部材１００の面方向における引張強度がバースト圧に対して与える影響を確認するために、引張強度測定試験を実施した。 <Tensile strength measurement test>
A tensile strength measurement test was performed in order to confirm the effect of the tensile strength in the surface direction of the medical device 100 on the burst pressure.
　引張強度測定試験は、医療用部材１００Ｓ５と医療用部材１００Ｓ９に対して実施した。前述したように、医療用部材１００Ｓ５はバースト圧を高める機能を持つサンプルであり、医療用部材１００Ｓ９は推奨バースト圧を確保することが可能なサンプルである。 The tensile strength measurement test was performed on medical member 100S5 and medical member 100S9. As described above, the medical member 100S5 is a sample that has the function of increasing the burst pressure, and the medical member 100S9 is a sample that can ensure the recommended burst pressure.
　図５を参照して、引張強度測定試験の試験方法について説明する。 The test method for the tensile strength measurement test will be described with reference to FIG.
　引張強度測定試験は、破断強度測定試験及び弾性率測定試験と同様に、公知のクリープメーターを利用した。 A known creep meter was used for the tensile strength measurement test, similar to the breaking strength measurement test and the elastic modulus measurement test.
　各医療用部材１００Ｓ５、１００Ｓ９を一辺が５ｍｍ×２０ｍｍの長方形にカットし、厚さが１０ｍｍになるように所定の固定治具にセットした。各医療用部材１００Ｓ５、１００Ｓ９がセットされた固定治具をクリープメーター下部に取り付けた。 Each medical member 100S5 and 100S9 was cut into a rectangle with one side of 5 mm x 20 mm, and set on a predetermined fixing jig so that the thickness was 10 mm. A fixing jig in which each medical member 100S5 and 100S9 was set was attached to the lower part of the creep meter.
　各医療用部材１００Ｓ５、１００Ｓ９の面方向（表面１１１又は裏面１１３に平行な方向）に沿う第１方向（図５の矢印ａ１－ａ２で示す縦方向）、平面視において第１方向と直交する第２方向（図４の矢印ｂ１－ｂ２で示す横方向）、第１方向と第２方向の各々の方向に対して交差する第３方向（図５の矢印ｃ１－ｃ２で示す斜め方向）に引張力を付与した。各医療用部材１００Ｓ５、１００Ｓ９の破断時のピーク強度を引張強度［Ｎ］として算出した。引張強度の算出には、破断強度解析用の市販のソフトウェアを使用した。 A first direction (longitudinal direction indicated by arrows a1-a2 in FIG. 5) along the plane direction (direction parallel to the front surface 111 or the back surface 113) of each medical member 100S5 and 100S9, and a first direction orthogonal to the first direction in plan view. Tensile in two directions (horizontal direction indicated by arrows b1-b2 in FIG. 4) and third direction (diagonal direction indicated by arrows c1-c2 in FIG. 5) crossing each of the first and second directions gave power. The peak strength at break of each medical member 100S5 and 100S9 was calculated as the tensile strength [N]. Commercially available software for breaking strength analysis was used to calculate the tensile strength.
Figure JPOXMLDOC01-appb-T000002
Figure JPOXMLDOC01-appb-T000002
　表２に示すように、医療用部材１００Ｓ５は、第１方向における引張強度Ｔｓ１と第２方向における引張強度Ｔｓ２の引張強度比（Ｔｓ２／Ｔｓ１）が４．３となることを確認できた。 As shown in Table 2, it was confirmed that the medical member 100S5 had a tensile strength ratio (Ts2/Ts1) of tensile strength Ts1 in the first direction and tensile strength Ts2 in the second direction of 4.3.
　また、表２に示すように、医療用部材１００Ｓ９は、第１方向における引張強度Ｔｓ１と第２方向における引張強度Ｔｓ２の引張強度比（Ｔｓ２／Ｔｓ１）が２．０となることを確認できた。 In addition, as shown in Table 2, it was confirmed that the medical member 100S9 had a tensile strength ratio (Ts2/Ts1) of tensile strength Ts1 in the first direction and tensile strength Ts2 in the second direction of 2.0. .
　引張強度試験の結果より、次のような点を確認できた。 From the results of the tensile strength test, we were able to confirm the following points.
　医療用部材１００Ｓ５の引張強度比（Ｔｓ２／Ｔｓ１）が４．３であったことより、引張強度比（Ｔｓ２／Ｔｓ１）が４．３程度であれば、医療用部材１００Ｓ５のバースト圧を高める機能が十分に発揮されると考えられる。また、推奨バースト圧を確保することが可能な医療用部材１００Ｓ９の引張強度比（Ｔｓ２／Ｔｓ１）が２．０であったことより、医療用部材１００は引張強度比（Ｔｓ２／Ｔｓ１）がより小さい方がバースト圧を高める機能が効果的に発揮されるものと考えられる。 Since the tensile strength ratio (Ts2/Ts1) of the medical member 100S5 was 4.3, if the tensile strength ratio (Ts2/Ts1) is about 4.3, the function of increasing the burst pressure of the medical member 100S5 is considered to be sufficiently demonstrated. In addition, since the tensile strength ratio (Ts2/Ts1) of the medical member 100S9 capable of ensuring the recommended burst pressure was 2.0, the medical member 100 has a higher tensile strength ratio (Ts2/Ts1). It is considered that the smaller the value, the more effectively the function of increasing the burst pressure is exhibited.
　上記の結果より、医療用部材１００は、本体部１１０に形成された耐圧性向上部１１０Ａの引張強度比（Ｔｓ２／Ｔｓ１）が４．３以下の場合には、バースト圧を高めることが可能であり、耐圧性向上部１１０Ａの引張強度比（Ｔｓ２／Ｔｓ１）が２．０以下の場合には、推奨バースト圧を確保することが可能になると考えられる。したがって、耐圧性向上部１１０Ａは、バースト圧を高める観点より、Ｔｓ２／Ｔｓ１≦４．３であることが好ましく、Ｔｓ２／Ｔｓ１≦２．０であることがより好ましいと言える。 From the above results, the medical device 100 can increase the burst pressure when the tensile strength ratio (Ts2/Ts1) of the pressure resistance improving portion 110A formed in the body portion 110 is 4.3 or less. Therefore, it is considered possible to secure the recommended burst pressure when the tensile strength ratio (Ts2/Ts1) of the pressure resistance improving portion 110A is 2.0 or less. Therefore, from the viewpoint of increasing the burst pressure, the pressure resistance improving section 110A preferably satisfies Ts2/Ts1≦4.3, and more preferably satisfies Ts2/Ts1≦2.0.
　＜作用効果＞
　以上説明したように、本実施形態に係る医療用部材１００は、複数の貫通孔１１２が形成され、生体器官の吻合部に適用されることによって生体成分の発現を誘導し、誘導された生体成分が貫通孔１１２を貫通して集積することにより吻合部の癒合を促進するメッシュ状の本体部１１０を備える。そして、本体部１１０は、本体部１１０の面方向に対して交差する方向における破断強度が０．２［Ｎ］以上であり、かつ、本体部１１０の面方向における圧縮伸び率が１５２［％］以上である耐圧性向上部１１０Ａを有する。 <Effect>
As described above, the medical member 100 according to the present embodiment is formed with a plurality of through holes 112 and is applied to the anastomosis of a biological organ to induce the expression of the biological component, and the induced biological component has a mesh-like main body portion 110 that promotes fusion of the anastomosis by passing through the through-holes 112 and accumulating. The body portion 110 has a breaking strength of 0.2 [N] or more in a direction intersecting the plane direction of the body portion 110, and a compression elongation rate of 152 [%] in the plane direction of the body portion 110. It has the pressure resistance improving portion 110A described above.
　本実施形態によれば、吻合部の癒合を促進させることができ、かつ吻合部の耐圧性を高めることが可能な医療用部材１００を提供することができる。 According to this embodiment, it is possible to provide the medical member 100 that can promote the fusion of the anastomotic site and increase the pressure resistance of the anastomotic site.
　また、医療用部材１００は、耐圧性向上部１１０Ａの破断強度が２．２［Ｎ］以上であり、耐圧性向上部１１０Ａの圧縮伸び率が５１７［％］以上である場合、吻合部のバースト圧を推奨バースト圧まで高めることができる。 In addition, in the medical device 100, when the breaking strength of the pressure resistance improving portion 110A is 2.2 [N] or more and the compressive elongation rate of the pressure resistance improving portion 110A is 517 [%] or more, the anastomotic portion bursts. Pressure can be increased to the recommended burst pressure.
　また、医療用部材１００は、本体部１１０の面方向に沿う第１方向における耐圧性向上部１１０Ａの引張強度をＴｓ１［Ｎ］とし、本体部１１０の面方向に沿う方向であって、平面視において第１方向と直交する第２方向における耐圧性向上部１１０Ａの引張強度をＴｓ２［Ｎ］とした場合に、Ｔｓ２／Ｔｓ１≦４．３・・・（１）の関係を満たすように構成することができる。このように構成された医療用部材１００は、耐圧性向上部１１０Ａによって吻合部のバースト圧を効果的に高めることができる。 In the medical member 100, the tensile strength of the pressure resistance improving portion 110A in the first direction along the surface direction of the body portion 110 is Ts1 [N], and the direction along the surface direction of the body portion 110 is , where Ts2 [N] is the tensile strength of the pressure resistance improving portion 110A in the second direction perpendicular to the first direction, the relationship Ts2/Ts1 ≤ 4.3 (1) is satisfied. be able to. The medical device 100 configured in this manner can effectively increase the burst pressure at the anastomotic site by the pressure resistance improving portion 110A.
　また、医療用部材１００は、耐圧性向上部１１０Ａの引張強度Ｔｓ１［Ｎ］と引張強度Ｔｓ２［Ｎ］の関係がＴｓ２／Ｔｓ１≦２．０・・・（２）の関係を満たすように構成することができる。このように構成された医療用部材１００は、耐圧性向上部１１０Ａによって吻合部のバースト圧を推奨バースト圧まで高めることができる。 Further, the medical member 100 is configured such that the relationship between the tensile strength Ts1 [N] and the tensile strength Ts2 [N] of the pressure resistance improving portion 110A satisfies the relationship Ts2/Ts1≦2.0 (2). can do. The medical device 100 configured in this manner can increase the burst pressure at the anastomotic site to the recommended burst pressure by the pressure resistance improving portion 110A.
　また、耐圧性向上部１１０Ａの少なくとも一部は、本体部１１０の面方向の中心部Ｏ１よりも本体部１１０の面方向の外周部側に配置することができる。このように構成された医療用部材１００によれば、接合装置７００（図１４を参照）を使用して吻合術を実施する際、本体部１１０の面方向の中心部Ｏ１よりも面方向の外周部側に位置する耐圧性向上部１１０Ａを生体器官の間に挟み込むように留置させることにより、吻合部のバースト圧を効果的に高めることができる。 Also, at least part of the pressure resistance improving portion 110A can be arranged closer to the outer peripheral side of the body portion 110 in the plane direction than the central portion O1 of the body portion 110 in the plane direction. According to the medical member 100 configured in this way, when performing an anastomosis using the joining device 700 (see FIG. 14), the outer periphery in the plane direction of the body portion 110 is located closer to the center portion O1 in the plane direction than the center portion O1 in the plane direction. Burst pressure at the anastomotic site can be effectively increased by indwelling the pressure resistance improving section 110A located on the side of the body so as to be sandwiched between the living organs.
　また、耐圧性向上部１１０Ａの構成材料にポリグルコール酸が含まれている場合、医療用部材１００の本体部１１０の耐圧性を効果的に向上させることができる。 Further, when polyglycolic acid is included in the constituent material of the pressure resistance improving portion 110A, the pressure resistance of the body portion 110 of the medical member 100 can be effectively improved.
　また、耐圧性向上部１１０Ａの構成材料にポリグルコール酸が含まれており、かつ耐圧性向上部１１０Ａが不織布で構成されている場合、医療用部材１００の本体部１１０の耐圧性をより一層向上させることができる。 Further, when polyglycolic acid is included in the constituent material of the pressure resistance improving portion 110A and the pressure resistance improving portion 110A is composed of nonwoven fabric, the pressure resistance of the main body portion 110 of the medical member 100 is further improved. can be made
　また、耐圧性向上部１１０Ａが加熱処理が施された被加熱部で構成されている場合、医療用部材１００の本体部１１０の耐圧性をより一層効果的に向上させることができる。 Further, when the pressure resistance improving part 110A is composed of a heated part subjected to heat treatment, the pressure resistance of the main body part 110 of the medical member 100 can be improved more effectively.
　＜処置方法の実施形態（大腸吻合術）＞
　次に、医療用部材１００（癒合促進デバイス）を用いた処置方法を説明する。 <Embodiment of treatment method (colon anastomosis)>
Next, a treatment method using the medical member 100 (union promoting device) will be described.
　図１２は、医療用部材を用いた処置方法の各手順を示すフローチャートである。 FIG. 12 is a flow chart showing each procedure of a treatment method using a medical member.
　処置方法は、生体器官の接合対象となる一方の被接合部位に生体組織の癒合を促進する本体部を備える医療用部材を配置すること（Ｓ１１）、一方の被接合部位と他方の被接合部位との間に医療用部材の本体部の少なくとも一部を配置した状態で一方の被接合部位と他方の被接合部位とを接合すること（Ｓ１２）、を含む。 The treatment method consists of arranging a medical member having a main body portion that promotes the fusion of living tissues in one of the parts to be joined to which the living organs are to be joined (S11); (S12).
　本実施形態の処置方法により接合される生体器官、及び生体器官の被接合部位は特に限定されず、任意に選択することができる。ただし、以下の説明では、大腸吻合術を例に挙げて説明する。 The living organ to be joined by the treatment method of this embodiment and the site to be joined of the living organ are not particularly limited, and can be arbitrarily selected. However, in the following description, colon anastomosis will be taken as an example.
　以下に説明する手技において使用される医療用部材としては、例えば、図１に例示した構造のものを選択することができる。ただし、医療用部材の具体的な構成については特に限定されない。また、以下に説明する手技において、公知の手技手順や公知の医療装置・医療器具等についての詳細な説明は適宜省略する。 As the medical member used in the procedure described below, for example, one having the structure illustrated in FIG. 1 can be selected. However, the specific configuration of the medical member is not particularly limited. Further, in the procedures described below, detailed descriptions of known procedure procedures, known medical devices, medical instruments, etc. will be omitted as appropriate.
　本明細書の説明において「生体器官の間に医療用部材を配置する」とは、生体器官に医療用部材が直接的又は間接的に接触した状態で配置されること、生体器官との間に空間的な隙間が形成された状態で医療用部材が配置されること、又はその両方の状態で医療用部材が配置されること（例えば、一方の生体器官に医療用部材が接触し、他方の生体器官には医療用部材が接触していない状態で配置されること）の少なくとも一つを意味する。また、本明細書の説明において「周辺」とは、厳密な範囲（領域）を規定するものではなく、処置の目的（生体器官同士の接合）を達成し得る限りにおいて所定の範囲（領域）を意味する。また、各処置方法において説明する手技手順は、処置の目的を達成し得る限り、順番を適宜入れ替えることが可能である。また、本明細書の説明において「相対的に接近させる」とは、接近させる対象となる２つ以上のものを、互いに接近させること、一方のみを他方のみに接近させることの両方の意味を含む。 In the description of this specification, "arranging a medical member between a living organ" means that the medical member is arranged in a state in which the medical member is in direct or indirect contact with the living organ. Arrangement of the medical member with a spatial gap formed, or arrangement of the medical member with both of the states (for example, the medical member is in contact with one biological organ and the other is The medical device is arranged in a state in which the medical device is not in contact with the living organ). In the description of the present specification, the term "periphery" does not define a strict range (region), but rather a predetermined range (region) as long as the purpose of treatment (bonding of living organs) can be achieved. means. In addition, the order of the procedure described in each treatment method can be changed as appropriate as long as the purpose of the treatment can be achieved. In addition, in the description of this specification, the term "relatively approaching" includes both the meaning of bringing two or more objects to be brought closer together and bringing only one closer to the other. .
　＜処置方法の実施形態（大腸吻合術）＞
　図１３は、処置方法の実施形態（大腸吻合術）の手順を示すフローチャートである。図１４～図１６は、大腸吻合術の説明に供する図である。 <Embodiment of treatment method (colon anastomosis)>
FIG. 13 is a flow chart showing procedures of an embodiment of the treatment method (colon anastomosis). 14 to 16 are diagrams for explaining colon anastomosis.
　本実施形態に係る処置方法において、接合対象となる生体器官は、癌腫瘍の切除に伴い切断された大腸である。具体的には、接合対象となる生体器官は、切断した大腸の口側Ａ１と、切断した大腸の肛門側Ａ２である。以下の説明では、切断した大腸の口側Ａ１の口部周辺（一方の被接合部位）と、切断した大腸の肛門側Ａ２の腸壁の一部（他方の被接合部位）を接合する手順を説明する。 In the treatment method according to this 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 oral side A1 of the cut large intestine and the anal side A2 of the cut large intestine. In the following description, the procedure for joining the oral periphery (one site to be joined) of the mouth side A1 of the cut large intestine and a part of the intestinal wall on the anal side A2 of the cut large intestine (the other site to be joined) will be described. explain.
　図１３に示すように、本実施形態に係る処置方法は、大腸の口部周辺に医療用部材を配置すること（Ｓ１０１）、大腸の口部周辺と大腸の腸壁を相対的に接近させること（Ｓ１０２）、大腸の口部周辺と大腸の腸壁との間で医療用部材の本体部を挟み込むこと（Ｓ１０３）、大腸の口部周辺と大腸の腸壁との間に医療用部材の本体部を挟み込んだ状態で接合すること（Ｓ１０４）、を含む。 As shown in FIG. 13, the treatment method according to the present embodiment includes disposing a medical member around the mouth of the large intestine (S101), bringing the mouth of the large intestine and the intestinal wall of the large intestine relatively close to each other. (S102), sandwiching the main body of the medical member between the periphery of the mouth of the large intestine and the wall of the large intestine (S103); (S104).
　次に、図１４～図１６を参照して、本実施形態に係る処置方法を具体的に説明する。 Next, the treatment method according to this embodiment will be specifically described with reference to FIGS. 14 to 16. FIG.
　まず、術者は、患者の臍の周辺部にポート（各種の医療デバイス等を生体内外に移動させるための導入部）を形成し、患者の腹部を膨らませる。 First, the operator forms a port (introduction part for moving various medical devices into and out of the living body) around the navel of the patient and inflates the patient's abdomen.
　次に、術者は、臍の周辺部に切開部（図示省略）を形成し、そこから口側Ａ１の患部を体外に取り出して、大腸の口側Ａ１に接合装置７００の第１係合器具７１０を挿入する。術者は、第１係合器具７１０の被係合部７１１を大腸の口側Ａ１に挿入し、被係合部７１１を突出させた状態で巾着縫合し、縫合部Ａ１１を形成する。縫合部Ａ１１の外表面は、縫合に伴い凹凸形状となる。 Next, the operator forms an incision (not shown) around the navel, takes out the affected part on the oral side A1 from the incision, and attaches the first engaging device of the joining device 700 to the oral side A1 of the large intestine. Insert 710. The operator inserts the engaged portion 711 of the first engaging instrument 710 into the mouth side A1 of the large intestine, and performs purse-string suture with the engaged portion 711 protruded to form the sutured portion A11. The outer surface of the sutured portion A11 becomes uneven as it is sutured.
　接合装置７００としては、例えば、大腸吻合術に使用される公知の装置を用いることができる。接合装置７００は、第１係合器具７１０と第２係合器具７２０の係合に伴い、第１係合器具７１０と第２係合器具７２０との間に配置された生体組織の切除とともに、切除した生体組織の周囲をステープルにより円周状に縫合する。第１係合器具７１０は、例えば、筒状の被係合部７１１を備える器具であり、第２係合器具７２０は、例えば、第１係合器具７１０の被係合部７１１に挿入及び係合される係合ピン７２１を備える器具である。 As the joining device 700, for example, a known device used for large intestine anastomosis can be used. As the first engagement device 710 and the second engagement device 720 are engaged, the joining device 700 excises the living tissue arranged between the first engagement device 710 and the second engagement device 720, The circumference of the resected body tissue is sutured with staples in a circumferential shape. The first engaging device 710 is, for example, a device having a tubular engaged portion 711 , and the second engaging device 720 is, for example, inserted into and engaged with the engaged portion 711 of the first engaging device 710 . The device is provided with an engagement pin 721 that is mated.
　次に、術者は、図１４に示すように、大腸の口側Ａ１の生体組織に医療用部材１００を配置する（Ｓ１０１）。術者は、医療用部材１００を配置する際に、第１係合器具７１０が備える被係合部７１１を医療用部材１００の本体部１１０に形成された孔部１１４（図１を参照）に通す。この際、術者は、医療用部材１００の裏面１１３が縫合部Ａ１１の外表面と接触するように医療用部材１００をセットする。 Next, as shown in FIG. 14, the operator places the medical member 100 on the living tissue on the oral side A1 of the large intestine (S101). When placing the medical member 100 , the operator inserts the engaged portion 711 of the first engaging device 710 into the hole portion 114 (see FIG. 1 ) formed in the body portion 110 of the medical member 100 . let through At this time, the operator sets the medical member 100 so that the back surface 113 of the medical member 100 contacts the outer surface of the sutured portion A11.
　次に、術者は、医療用部材１００が配置された大腸の口側Ａ１を切開部から患者の体内に導入する。 Next, the operator introduces the mouth side A1 of the large intestine where the medical member 100 is arranged into the patient's body through the incision.
　次に、術者は、大腸の肛門側Ａ２に、接合装置７００の第２係合器具７２０を配置する。第２係合器具７２０を大腸の肛門側Ａ２に配置（挿入）するのに伴って、大腸の肛門側Ａ２には貫通孔Ａ２１が形成される。なお、貫通孔Ａ２１を形成する具体的なタイミングについて特に制限はない。 Next, the operator places the second engaging device 720 of the joining device 700 on the anal side A2 of the large intestine. As the second engaging device 720 is placed (inserted) on the anal side A2 of the large intestine, a through hole A21 is formed on the anal side A2 of the large intestine. In addition, there is no particular limitation on the specific timing of forming the through hole A21.
　術者は、大腸の口側Ａ１に本体部１１０を保持した状態を維持しつつ、第１係合器具７１０の被係合部７１１と第２係合器具７２０の係合ピン７２１とを係合させることによって、大腸の口側Ａ１と大腸の肛門側Ａ２との間に医療用部材１００を配置することができる。具体的には、術者は、図１５に示すように、大腸の口側Ａ１の縫合部Ａ１１に対して医療用部材１００を保持した状態を維持しつつ、第１係合器具７１０と第２係合器具７２０を相対的に接近させて係合させる（Ｓ１０２）。 The operator engages the engaged portion 711 of the first engaging device 710 with the engaging pin 721 of the second engaging device 720 while maintaining the state of holding the body portion 110 on the mouth side A1 of the large intestine. By doing so, the medical member 100 can be placed between the oral side A1 of the large intestine and the anal side A2 of the large intestine. Specifically, as shown in FIG. 15, the operator holds the medical device 100 against the sutured portion A11 on the mouth side A1 of the large intestine, while maintaining the first engaging device 710 and the second engaging device 710. The engaging tools 720 are brought relatively close to engage (S102).
　次に、術者は、第１係合器具７１０と第２係合器具７２０との間で、大腸の口側Ａ１の口部周辺、医療用部材１００の本体部１１０、大腸の肛門側Ａ２の腸壁に形成した貫通孔Ａ２１の周辺を挟み込む（Ｓ１０３）。そして、術者は、第１係合器具７１０と第２係合器具７２０との間に挟み込まれた大腸の口側Ａ１の一部と、医療用部材１００の本体部１１０と、大腸の肛門側Ａ２の一部を接合装置７００によって打ち抜くように切断する。また、この際、術者は、接合装置７００を操作することにより、切除した部位の周囲をステープル（図示省略）により接合する（Ｓ１０４）。 Next, between the first engaging device 710 and the second engaging device 720, the operator moves around the mouth on the mouth side A1 of the large intestine, the main body 110 of the medical device 100, and the anal side A2 of the large intestine. The periphery of the through hole A21 formed in the intestinal wall is sandwiched (S103). Then, the operator moves a portion of the oral side A1 of the large intestine sandwiched between the first engaging device 710 and the second engaging device 720, the body portion 110 of the medical device 100, and the anal side of the large intestine. A portion of A2 is cut by a joining device 700 so as to be punched out. Also, at this time, the operator operates the joining device 700 to join the periphery of the resected site with staples (not shown) (S104).
　前述したように、本実施形態に係る医療用部材１００は、破断加工性が向上された易破断部１１０Ｂが本体部１１０に形成されているため、本体部１１０の一部を円滑に打ち抜くことができる。それにより、本体部１１０を打ち抜いた際に、本体部１１０の一部にほつれが生じる打ち抜き不良が発生することを防止できる。 As described above, in the medical member 100 according to the present embodiment, the breakable portion 110B with improved breakability is formed in the body portion 110, so that part of the body portion 110 can be smoothly punched out. can. As a result, when the main body portion 110 is punched out, it is possible to prevent the occurrence of a punching failure in which a part of the main body portion 110 is frayed.
　次に、術者は、図１６に示すように、接合装置７００を、例えば、大腸の肛門側Ａ２から肛門を介して生体外へ取り出す。このとき、術者は、接合装置７００が打ち抜く第２領域Ｅ２（図３を参照）よりも内方側に位置する大腸の口側Ａ１の一部と、医療用部材１００の本体部１１０の一部（易破断部１１０Ｂを少なくとも一部に含む部分）と、大腸の肛門側Ａ２の一部を接合装置７００とともに生体外へ取り出すことができる。一方で、第２領域Ｅ２よりも外周部側に配置された本体部１１０の耐圧性向上部１１０Ａは、大腸の口側Ａ１の口部周辺と大腸の肛門側Ａ２の腸壁との間に挟み込まれた状態で生体内に留置される。そのため、本体部１１０の耐圧性向上部１１０Ａは、接合対象となる大腸の口側Ａ１の口部周辺と大腸の肛門側Ａ２の腸壁に対して癒合を促進する機能を発揮するとともに、大腸の口側Ａ１の口部周辺と大腸の肛門側Ａ２の腸壁の間のバースト圧を効果的に高めることができる。 Next, as shown in FIG. 16, the operator takes out the joining device 700 from the anal side A2 of the large intestine to the outside of the body through the anus. At this time, the operator moves a portion of the mouth side A1 of the large intestine located inside the second region E2 (see FIG. 3) punched out by the joining device 700 and a portion of the body portion 110 of the medical member 100. A portion (at least part of which includes the easily rupturable portion 110B) and a portion of the anal side A2 of the large intestine can be taken out of the living body together with the joining device 700 . On the other hand, the pressure resistance improving portion 110A of the main body portion 110 arranged closer to the outer peripheral side than the second region E2 is sandwiched between the mouth portion on the mouth side A1 of the large intestine and the intestinal wall on the anal side A2 of the large intestine. It is placed in the body in a Therefore, the pressure resistance improving portion 110A of the main body portion 110 exhibits a function of promoting fusion between the mouth portion periphery of the large intestine on the mouth side A1 and the intestinal wall on the anal side A2 of the large intestine to be joined, and also promotes fusion of the large intestine. The burst pressure between the mouth periphery on the oral side A1 and the intestinal wall on the anal side A2 of the large intestine can be effectively increased.
　このような処置方法によれば、医療用部材のメッシュ状の本体部を一方の被接合部位と他方の被接合部位との間に挟み込ませるという簡便な方法により、吻合術（例えば、大腸吻合術）後の縫合不全のリスクを低減させることができる。 According to such a treatment method, an anastomosis (for example, colon anastomosis) is performed by a simple method of sandwiching the mesh-like main body of the medical member between one site to be joined and the other site to be joined. ) can reduce the risk of post-suture failure.
　以上、実施形態を通じて本発明に係る医療用部材を説明したが、本発明は実施形態で説明した内容のみに限定されるものでなく、特許請求の範囲の記載に基づいて適宜変更することが可能である。 Although the medical member according to the present invention has been described above through the embodiments, the present invention is not limited to the contents described in the embodiments, and can be appropriately modified based on the description of the claims. is.
　例えば、接合対象となる生体器官、被接合部位、具体的な手技手順等は、実施形態において説明したものに限定されない。また、医療器具の材質、大きさ、形状、具体的な構造等は、医療用部材が備える本体部により被接合部位の生体組織の癒合を促進する機能を持つ限り、特に限定されない。 For example, the living organ to be joined, the site to be joined, the specific procedure, etc. are not limited to those described in the embodiment. In addition, the material, size, shape, specific structure, etc. of the medical device are not particularly limited as long as the main body portion of the medical member has the function of promoting the fusion of the living tissue of the joined site.
　本出願は、２０２１年９月３日に出願された日本国特許出願第２０２１－１４３９８７号に基づいており、その開示内容は、参照により全体として引用されている。 This application is based on Japanese Patent Application No. 2021-143987 filed on September 3, 2021, the disclosure of which is incorporated by reference in its entirety.
１００　　医療用部材
１１０　　本体部
１１０Ａ　耐圧性向上部
１１０Ｂ　易破断部
１１２　　貫通孔
１１４　　孔部
７００　　接合装置
７１０　　第１係合器具
７１１　　被係合部
７２０　　第２係合器具
７２１　　係合ピン
Ａ１　　　口側
Ａ１１　　縫合部
Ａ２　　　肛門側
Ａ２１　　貫通孔
Ｄ　　　　孔径
Ｏ１　　　本体部の中心部
Ｐ　　　　貫通孔のピッチ
Ｔ　　　　本体部の厚み 100 Medical member 110 Body portion 110A Pressure resistance improving portion 110B Easy breakable portion 112 Through hole 114 Hole portion 700 Joining device 710 First engaging device 711 Engaged portion 720 Second engaging device 721 Engaging pin A1 Mouth side A11 Sutured part A2 Anus side A21 Through hole D Hole diameter O1 Center part P of main body Pitch of through hole T Thickness of main body

Claims (8)

  1. 　複数の貫通孔が形成され、生体器官の吻合部に適用されることによって生体成分の発現を誘導し、誘導された前記生体成分が前記貫通孔を貫通して集積することにより前記吻合部の癒合を促進するメッシュ状の本体部を備える医療用部材であって、
    　前記本体部は、
    　前記本体部の面方向に対して交差する方向における破断強度が０．２［Ｎ］以上であり、かつ、前記本体部の面方向における圧縮伸び率が１５２［％］以上である耐圧性向上部を有する、医療用部材。     A plurality of through-holes are formed and applied to the anastomosis of the biological organ to induce the expression of the biological component, and the induced biological component penetrates the through-hole and accumulates to fuse the anastomosis. A medical device comprising a mesh-like body that promotes
    The main body is
    A pressure resistance improving portion having a breaking strength of 0.2 [N] or more in a direction intersecting the planar direction of the main body and a compressive elongation rate of 152 [%] or more in the planar direction of the main body. A medical member.
  2. 　前記破断強度は２．２［Ｎ］以上であり、
    　前記圧縮伸び率は５１７［％］以上である、請求項１に記載の医療用部材。     The breaking strength is 2.2 [N] or more,
    The medical member according to claim 1, wherein said compressive elongation is 517[%] or more.
  3. 　前記本体部の面方向に沿う第１方向における前記耐圧性向上部の引張強度をＴｓ１［Ｎ］とし、
    　前記本体部の面方向に沿う方向であって、平面視において前記第１方向と直交する第２方向における前記耐圧性向上部の引張強度をＴｓ２［Ｎ］とした場合に、下記式（１）を満たすことを特徴とする請求項１又は請求項２に記載の医療用部材。
    　Ｔｓ２／Ｔｓ１≦４．３・・・（１）     Let Ts1 [N] be the tensile strength of the pressure resistance improving portion in the first direction along the surface direction of the main body,
    When the tensile strength of the pressure resistance improving portion in the second direction perpendicular to the first direction in plan view is Ts2 [N], the following formula (1) is obtained. 3. The medical member according to claim 1 or 2, wherein:
    Ts2/Ts1≤4.3 (1)
  4. 　前記引張強度Ｔｓ１［Ｎ］と前記引張強度Ｔｓ２［Ｎ］の関係が下記式（２）を満たすことを特徴とする請求項３に記載の医療用部材。
    　Ｔｓ２／Ｔｓ１≦２．０・・・（２）     The medical member according to claim 3, wherein the relationship between the tensile strength Ts1 [N] and the tensile strength Ts2 [N] satisfies the following formula (2).
    Ts2/Ts1≦2.0 (2)
  5. 　前記耐圧性向上部の少なくとも一部は、前記本体部の面方向の中心部よりも前記本体部の面方向の外周部側に配置されている、請求項１～４のいずれか１項に記載の医療用部材。 5. The pressure resistance improving portion according to any one of claims 1 to 4, wherein at least part of the pressure resistance improving portion is arranged closer to the outer peripheral side in the plane direction of the main body than to the central portion of the main body in the plane direction. medical components.
  6. 　前記耐圧性向上部の構成材料にはポリグルコール酸が含まれている、請求項１～５のいずれか１項に記載の医療用部材。 The medical member according to any one of claims 1 to 5, wherein the constituent material of the pressure resistance improving portion contains polyglycolic acid.
  7. 　前記本体部は不織布からなる、請求項６に記載の医療用部材。 The medical member according to claim 6, wherein the body portion is made of nonwoven fabric.
  8. 　前記耐圧性向上部は前記本体部に対して加熱処理が施された被加熱部からなる、請求項７に記載の医療用部材。 The medical member according to claim 7, wherein the pressure resistance improving portion comprises a heated portion obtained by subjecting the main body portion to heat treatment.
PCT/JP2022/031177 2021-09-03 2022-08-18 Medical member WO2023032693A1 (en)

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JP2021143987 2021-09-03

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002017760A (en) * 2000-07-04 2002-01-22 Takiron Co Ltd Shank/vertebra healing implant material
WO2019156230A1 (en) * 2018-02-08 2019-08-15 テルモ株式会社 Medical apparatus and adhesion promoting device using same
WO2020067372A1 (en) * 2018-09-27 2020-04-02 テルモ株式会社 Adhesion promotion device
JP2021049191A (en) * 2019-09-25 2021-04-01 テルモ株式会社 Concrescence acceleration device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002017760A (en) * 2000-07-04 2002-01-22 Takiron Co Ltd Shank/vertebra healing implant material
WO2019156230A1 (en) * 2018-02-08 2019-08-15 テルモ株式会社 Medical apparatus and adhesion promoting device using same
WO2020067372A1 (en) * 2018-09-27 2020-04-02 テルモ株式会社 Adhesion promotion device
JP2021049191A (en) * 2019-09-25 2021-04-01 テルモ株式会社 Concrescence acceleration device

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