Medical member

Abstract

To prevent or restrain a medical member from getting twisted by being subjected to an external force when anastomosis is performed by using the sheet-like medical member on an anastomotic site.SOLUTION: A medical member 100 according to the present invention comprises a sheet-like body part 10 which can be arranged in an anastomotic site of a biological organ and which at least partially includes a bioabsorbable material, and a buffer part 40 within which a space part 41 is provided. The space part of the buffer part is surrounded by a buffer member 42 which constitutes an omnidirectional buffer part in a cross-section crossing a circumferential direction of the body part.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] The present invention relates to a medical device. [Background technology]

[0002] In the medical field, there are known surgical procedures for joining biological organs together (e.g., anastomosis of the digestive tract). When such procedures are performed, it is known that the absence of delayed healing at the joint where the biological organs are joined is an important factor in determining the postoperative prognosis.

[0003] Various methods and medical instruments are used in the procedure of anastomosis of biological organs, and for example, a method of suturing biological organs with biodegradable sutures and a method of using a mechanical anastomosis device that performs anastomosis with a stapler (see Patent Document 1) have been proposed. In particular, when performing anastomosis using a mechanical anastomosis device, the joining strength between biological organs at the joint can be increased compared to a method using sutures, making it possible to reduce the risk of suture failure. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 2008-516678 Summary of the Invention [Problem to be solved by the invention]

[0005] In the anastomosis device of Patent Document 1, a sheet-like member such as a support structure (hereinafter referred to as a medical member) is sandwiched to prevent leakage or tearing at the anastomosis site, thereby promoting healing of the anastomosis site. Such medical members are usually relatively thin and soft. The present inventors have focused on the fact that the medical member may become twisted due to the application of external force when anastomosing the digestive tract or the like using the above-mentioned medical member. If the medical member becomes twisted, this may affect the effect of promoting healing of the anastomosis site.

[0006] Therefore, the present invention has been made to solve the above-mentioned problems, and aims to prevent or suppress twisting of the medical component due to the application of external force when performing anastomosis using a sheet-shaped medical component at the anastomosis site. [Means for solving the problem]

[0007] One aspect of the present invention is a medical device having a main body and a buffer. The main body is configured in a sheet shape, and can be placed at an anastomosis of a biological organ, and at least a portion of the main body is made of a bioabsorbable material. The buffer has a space therein, and the space is configured to be surrounded by a buffer material constituting an omnidirectional buffer in a cross section intersecting the circumferential direction of the main body. Another aspect of the present invention is a medical device having a main body and a buffer that is provided to cover at least a portion of the outer surface of the main body, and has a cross section intersecting the circumferential direction of the main body in a polygonal shape other than a rectangle. Effect of the Invention

[0008] According to the medical device according to one aspect of the present invention, it is possible to prevent or suppress twisting of the medical device caused by application of an external force when performing anastomosis using a sheet-shaped medical device at an anastomosis site. [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 is a schematic perspective view showing a medical device according to a first embodiment. [Diagram 2] FIG. 2 is a plan view showing the medical device according to FIG. [Diagram 3] 2 is a cross-sectional view of the medical device in FIG. 1 taken along an axial direction passing through the center of a main body. [Figure 4] 13A and 13B are diagrams showing through holes in a main body portion of a medical device. [Diagram 5] FIG. 1 is a diagram showing a medical instrument used for anastomosis of medical components. [Figure 6] 6 is a diagram showing the tip portion of a first engaging device and a second engaging device which constitute the medical device in FIG. 5. FIG. [Figure 7] 4 is a flowchart showing a method of using the medical device according to the first embodiment. [Figure 8] 13 is a flowchart showing an example of use of the medical device (colon anastomosis). [Figure 9] 13A and 13B are views showing the state in which the shaft of the positioning portion of the first engagement device of the medical instrument is engaged with the shaft of the second engagement device. [Figure 10] FIG. 13 is a view showing a state in which a medical member is clamped together with a biological organ by a first engaging device and a second engaging device. [Figure 11] FIG. 1 is a diagram showing an anastomosis of biological organs. [Figure 12] FIG. 4 is a cross-sectional view showing a medical device according to a first modified example of the first embodiment, and corresponds to FIG. [Figure 13] FIG. 4 is a cross-sectional view showing a medical device according to a second modified example of the first embodiment, and corresponds to FIG. [Figure 14] FIG. 4 is a cross-sectional view showing a medical device according to a third modified example of the first embodiment, the cross-sectional view corresponding to FIG. [Figure 15] FIG. 11 is a cross-sectional view showing a medical device according to a fourth modified example of the first embodiment, the cross-sectional view corresponding to FIG. [Figure 16] 5 is a cross-sectional view showing a medical device according to a second embodiment, the cross-sectional view corresponding to FIG. [Figure 17] FIG. 4 is a cross-sectional view showing a medical device according to a first modified example of the second embodiment, and corresponds to FIG. [Figure 18] FIG. 7 is a cross-sectional view showing a medical device according to a second modification of the second embodiment, corresponding to FIG. [Figure 19] FIG. 11 is a cross-sectional view showing a medical device according to a third modified example of the second embodiment, the cross-sectional view corresponding to FIG. [Figure 20] FIG. 11 is a plan view showing a medical device according to a third embodiment and corresponds to FIG. [Figure 21] FIG. 11 is a plan view showing a medical device according to a first modified example of the third embodiment, and corresponds to FIG. 2. [Figure 22] FIG. 13 is a plan view showing a medical device according to a second modified example of the third embodiment, and corresponds to FIG. 2. [Figure 23] FIG. 13 is a plan view corresponding to FIG. 2, showing a medical device according to a third modified example of the third embodiment. [Figure 24] FIG. 11 is a plan view showing a medical device according to a fourth embodiment, and corresponds to FIG. [Diagram 25] FIG. 25 is a side view showing the medical device according to FIG. 24. [Figure 26] FIG. 11 is a cross-sectional view showing a medical device according to a fifth embodiment, the cross-sectional view corresponding to FIG. [Figure 27] 4 is a cross-sectional view corresponding to FIG. 3, showing a modified example of a medical device including a buffer portion with a space portion. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] Hereinafter, the embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiments shown here are merely illustrative in order to embody the technical idea of ​​the present invention, and do not limit the present invention. Furthermore, all other possible embodiments, examples, and operating techniques that can be conceived by those skilled in the art without departing from the gist of the present invention are included in the scope and gist of the present invention, and are included in the scope of the inventions described in the claims and their equivalents.

[0011] Furthermore, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be represented diagrammatically with appropriate changes in scale, aspect ratio, shape, etc. from the actual product; however, these are merely examples and are not intended to limit the interpretation of the present invention.

[0012] In the following description, ordinal numbers such as "first" and "second" are used, but unless otherwise specified, these are used for convenience and do not dictate any order.

[0013] In the following, a coordinate system is shown in the drawings. X in the Cartesian coordinate system is along the axial direction or thickness direction of the main body 10 constituting the medical device 100, and is referred to as the axial direction X. Y and Z are planes intersecting with the axial direction X, and are referred to as the planar directions YZ.

[0014] In the cylindrical coordinate system, r is a direction extending radially or radially from the center of the main body 10 of the medical device 100 along the planar direction YZ, and is referred to as the radial direction r. θ is a direction extending circumferentially or angularly from the main body 10 in the planar direction YZ intersecting with the axial direction X of the main body 10, and is referred to as the circumferential direction θ.

[0015] First Embodiment Fig. 1 is a schematic perspective view showing a medical member 100 according to the first embodiment, and Fig. 2 is a plan view showing the medical member 100. Fig. 3 is a cross-sectional view taken along the axial direction X passing through the center of the main body portion 10 of the medical member 100, and Fig. 4 is a diagram showing a through-hole 11 in the main body portion 10 of the medical member 100. Fig. 5 is a diagram showing a medical instrument 200 used in a procedure using the medical member 100. Fig. 6 is a diagram showing a tip portion of a first engaging instrument 210 and a second engaging instrument 270 constituting the medical instrument 200.

[0016] 7 to 11 are diagrams for explaining a procedure for performing anastomosis of the digestive tract, taking the large intestine as an example, using the medical device 100. FIG.

[0017] 9 to 11, the medical component 100 can be applied to a procedure for joining predetermined biological organs together (for example, digestive tract anastomosis). As described later, in this specification, colon anastomosis will be described as an example of a procedure using the medical component 100, but the site where the healing promotion device according to the present invention can be used is not limited to the large intestine.

[0018] Before describing the medical component 100, the medical instrument 200 will be described.

[0019] <Medical Equipment 200> The medical instrument 200 joins one part to be joined (first part to be joined), which is a biological organ in biological tissue, to another part to be joined (second part to be joined) facing the first part to be joined. The medical instrument 200 includes a first engaging instrument 210 and a second engaging instrument 270 capable of clamping the medical member 100 via the first part to be joined and the second part to be joined. The medical instrument 200 may be called a circular stapler. The configuration of each part will be described below.

[0020] 10 etc., the first engaging instrument 210 is disposed on one side of the medical component 100 when the medical component 100 is anastomosed to biological tissue. The first engaging instrument 210 is configured to be able to come into contact with the first joined portion.

[0021] The second engaging instrument 270 is disposed on the opposite side of the first engaging instrument 210 with respect to the medical component 100 during anastomosis, and is configured to be able to abut against the second joined portion. Details will be described later. The first engaging instrument 210 may be called a trocar, and the second engaging instrument 270 may be called an anvil. Details will be described below.

[0022] <First engagement tool> As shown in FIGS. 5 and 6, the first engagement device 210 includes an elongated member 220, a positioning portion 230, a releasing portion 240, a punching portion 250, and an operating portion 260.

[0023] The elongated member 220 corresponds to the main body of the first engagement device 210. The elongated member 220 has a space S at the end in the longitudinal direction in which the shaft of the positioning portion 230 can relatively move forward and backward, as shown in Fig. 6. The cross section of the elongated member 220 intersecting the axial direction is configured to be hollow and circular.

[0024] In this embodiment, the elongated member 220 extends linearly in the longitudinal direction and has bent portions, but as long as the anastomosis function and punching function described below can be realized, the elongated member does not need to have bent portions.

[0025] The positioning part 230 includes a long shaft. The shaft of the positioning part 230 is configured to be relatively movable forward and backward from the space S at the tip in the longitudinal direction of the long member 220 as shown in Fig. 6. The positioning part 230 is configured to be insertable into a hole part 30 that may be formed in the approximate center of the medical device 100 and into an inner cavity of a shaft 310 of a second engagement device 270 described later.

[0026] The release section 240 is configured to be capable of releasing a plurality of staples in a substantially annular shape, which joins the first and second joined portions. The release section 240 is formed in a substantially disk shape at the tip side in the longitudinal direction of the elongated member 220. The release section 240 is configured by providing a plurality of staple release points along the circumferential direction at the tip of the elongated member 220.

[0027] The punching portion 250 is disposed radially inward from the discharge portion 240 at the tip of the elongated member 220, and is configured to punch out the radially inward portions of the first and second joined portions. The punching portion 250 is configured to have an annular blade that punches out the first and second joined portions radially inward from the discharge portion 240, as shown in Fig. 6. The shape of the punching portion 250 can be configured to be a perfect circle when viewed in a plan view from the longitudinal direction, but the shape of the punching portion 250 may be an ellipse or the like as long as it can punch out portions not required for promoting healing.

[0028] The operating unit 260 is configured to be able to operate the positioning unit 230, the discharging unit 240, and the punching unit 250. The operating unit 260 includes a rotating unit 261 and a handle 262, as shown in FIG.

[0029] The rotating part 261 is provided at the base end (base end side) in the longitudinal direction of the elongated member 220. The rotating part 261 is configured to be rotatable relative to the elongated member 220 with the longitudinal direction at the base end side of the elongated member 220 as a rotation axis. The rotating part 261 is configured to be able to move the first engaging device 210 and the second engaging device 270 relatively closer to or farther away from each other by rotating relative to the elongated member 220 in a state in which the second engaging device 270 is engaged with the first engaging device 210.

[0030] The handle 262 is configured to be grippable by a user together with the base end (base end side) of the elongated member 220. The handle 262 is rotatably connected to the elongated member 220 by a rotating shaft 263. When gripped by a user, the handle 262 rotates about the rotating shaft 263 and approaches relatively close to the elongated member 220. This allows the staples to be released from the release portion 240 and the annular blade of the punching portion 250 to protrude from the tip of the elongated member 220.

[0031] <Second engagement device> The second engaging device 270 is configured to be able to clamp the medical member 100 together with the first engaging device 210 via the first and second joined portions. The second engaging device 270 includes a head 280, an abutment portion 290, and a shaft 310, as shown in FIG.

[0032] The head 280 is disposed adjacent to the elongated member 220 of the first engagement device 210, particularly the tip side, when the first engagement device 210 and the second engagement device 270 are engaged with each other. In this embodiment, the head 280 is configured in a substantially circular plate shape as shown in Figures 5 and 6, and the cross-sectional shape is configured to be the same as or similar to the circular shape of the elongated member 220.

[0033] The contact portion 290 corresponds to the side of the first engaging device 210 in the head 280, and is configured to be able to contact a plurality of staples discharged from the discharge portion 240. The staples discharged from the discharge portion 240 come into contact with the contact portion 290 and deform to join the first and second joined portions.

[0034] The shaft 310 is configured so as to be insertable through a hole 30 that may be formed in the approximate center of the medical component 100 described below. The shaft 310 is configured so as to be engageable with the shaft of the positioning portion 230 of the first engagement device 210.

[0035] The shaft 310 is provided with a space for accommodating the shaft of the positioning portion 230 of the first engagement device 210. The shaft 310 is configured to fit with the shaft of the positioning portion 230, which allows the first engagement device 210 and the second engagement device 270 to be aligned with each other.

[0036] <Medical Materials 100> The medical device 100 is placed between biological organs to be anastomosed, and is flattened and has multiple through-holes 11. The medical device 100 includes a main body portion 10, a fixing portion 20, a hole portion 30, and a buffer portion 40, as shown in FIG.

[0037] <Main body> The main body portion 10 is disposed between the biological organs to be anastomosed, and is configured in a sheet shape capable of following the movements of the biological organs to be anastomosed.

[0038] The main body 10 is formed in a circular shape as shown in Fig. 1 as an example, and has a plurality of through holes 11 formed so as to pass through the circular shape in the thickness direction (axial direction X) as shown in Fig. 4. The size of the through holes 11 of the main body 10 is preferably 0.1 to 6 mm, more preferably 0.3 to 4 mm, and even more preferably 0.6 to 1.5 mm. The main body 10 can be configured so that the ratio of the dimension D of the through holes 11 to the pitch P is 0.25 or more and less than 40. Note that the (perfect) circle described as the shape of the main body 10 is an example, and the main body 10 may be configured to include shapes other than the above, such as an ellipse, a polygon such as a rectangle, a star, and the like.

[0039] The thickness of the main body 10 (dimension T shown in FIG. 4) is not particularly limited, but is preferably 0.05 to 0.3 mm, and more preferably 0.1 to 0.2 mm.

[0040] The main body 10 can be made of a biodegradable material (bioabsorbable material). There are no particular limitations on the material of the main body 10, and examples of the material include biodegradable resins.

[0041] Specifically, examples of the polymer include: (1) a polymer selected from the group consisting of aliphatic polyesters, polyesters, polyanhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose; and (2) a copolymer composed of one or more monomers constituting the above (1).

[0042] That is, it is preferable that the biodegradable sheet contains at least one biodegradable resin selected from the group consisting of polymers selected from the group consisting of aliphatic polyesters, polyesters, polyanhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose, as well as copolymers composed of one or more monomers that constitute the above-mentioned polymers.

[0043] The method for producing the main body 10 is not particularly limited, and examples thereof include a method of producing fibers made of the above-mentioned biodegradable resin and using the fibers to produce a mesh-shaped sheet. The method for producing fibers made of biodegradable resin is not particularly limited, and examples thereof include electrospinning (electric field spinning / electrostatic spinning) and melt-blowing. The main body 10 may be produced by selecting only one of the above methods, or by selecting and combining two or more of them appropriately. As further examples of the method for producing the main body 10, there may be mentioned a method for producing a biodegradable sheet according to the present invention by spinning fibers made of the above-mentioned biodegradable resin according to a conventional method and knitting the obtained fibers into a mesh shape, a method for producing the biodegradable sheet by compressing the fibers, and a method for producing the biodegradable sheet by intertwining the fibers without weaving them.

[0044] The main body 10 induces a biological reaction by the constituent materials, such as biodegradable resin, that compose the main body 10. Through this action, the main body 10 induces the expression of biological components, such as fibrin. The biological components induced in this way can be accumulated so as to penetrate the through-holes 11 of the main body 10, thereby promoting healing. Therefore, by placing the main body 10 of the medical device 100 between the biological organs to be joined, the promotion of healing occurs through the above-mentioned mechanism.

[0045] <Fixed part> The fixing part 20 is provided for fixing the medical member 100 to the shaft 310 of the second engaging device 270 in order to suppress displacement, falling off, etc. of the medical member 100 when, for example, the medical device 200 places the medical member 100 between the first joined portion and the second joined portion. The fixing part 20 is formed along the inner periphery of the hollow circular body part 10.

[0046] In this embodiment, the fixing part 20 is configured to have a shape in which the through-hole 11 is not provided in the main body part 10. However, the specific shape of the fixing part 20 is not limited to the above as long as the main body part 10 can be easily deployed and the deployed state can be maintained. The fixing part 20 is preferably made of a bioabsorbable material such as a thermoplastic resin such as PGA (polyglycolic acid), PLA (polylactic acid), PLGA (polylactic acid-glycolic acid copolymer), PDS (polydioxanone), PCL (polycaprolactone), etc. However, the fixing part 20 may contain a material that is not bioabsorbable. In addition, the fixing part 20 may be made of a metal material other than the above. The material of the fixing part 20 may or may not have elasticity.

[0047] The fixing part 20 may be provided around the entire circumference inside the main body part 10, or may be provided partially around the entire circumference. The fixing part 20 is configured coaxially with the inner edge, but the center position may be offset from the main body part 10 as long as it does not enter the healing region. The inner diameter of the fixing part 20 is approximately the same as or slightly larger than the outer diameter of the shaft 310 of the second engaging device 270 of the medical device 100.

[0048] <hole> The main body 10 has a hole 30 formed in a substantially central portion spaced apart in the radial direction r from the outer peripheral edge of the main body 10 when viewed in a plan view from the axial direction X by the fixing part 20. The hole 30 is configured so that a shaft 310 of the medical instrument 200 can be inserted therethrough.

[0049] In this embodiment, the hole 30 is configured to have a substantially circular shape when viewed from the axial direction X. However, as long as the main body 10 can promote healing of biological tissue, the specific shape of the hole is not limited to a circular shape. The cross section of the hole 30 is preferably a perfect circle, but may also be configured to have a linear, elliptical, triangular, rectangular, concave, convex, cross, or other notch shape.

[0050] <Buffer section> The buffer section 40 is configured to prevent or suppress distortion or the like of the main body section 10 by buffering external forces that may act on the main body section 10. In this embodiment, the buffer section 40 is provided on the outer periphery (outer edge) of the main body section 10 in the radial direction r as shown in FIG.

[0051] In this embodiment, the buffer section 40 is configured to have a space 41 that can be filled with a fluid such as a gas, as shown in Fig. 3. The space 41 is configured to be surrounded in all directions by the buffer members 42 that constitute the buffer section 40 in a cross section that intersects with the circumferential direction θ of the main body section 10. In this embodiment, one space 41 is provided continuously in the circumferential direction θ so as to surround the main body section 10, as shown in Fig. 2.

[0052] Such a configuration can facilitate molding of the buffer section 40. The buffer section 40 including the space section 41 is configured to have more cushioning properties and to be easily restored than the main body section 10. Here, cushioning properties refer to the property of absorbing a load that may act on the medical device 100, and restoring properties refer to the property of the buffer section 40 returning or attempting to return to the shape it had before the external force was applied when the external force is removed, even if an external force is applied to the buffer section 40.

[0053] The thick portion of the buffer member 42 in the buffer section 40 that separates the space section 41 from the outside is configured to be thicker than the main body section 10. This improves the buffer function of the buffer section 40, making the main body section 10 less likely to deform when an external force is applied to the medical device 100, and preventing or suppressing twisting of the main body section 10. The buffer section 40 fills the space section 41 with a gas or the like so as to seal it, and in this embodiment, the thick portion of the buffer member 42 that isolates the space section 41 from the outside is configured to be uniform regardless of the location. The cross-sectional shape of the outer wall surface and inner wall surface along the axial direction X of the buffer member 42 that constitutes the buffer section 40 and forms the space section 41 is configured to be approximately a perfect circle in this embodiment as shown in FIG. 3.

[0054] If the space 41 is configured to be relatively harder while having better cushioning than the main body 10, not only will it be less likely to be deformed by an external force, but it will also have relatively high restoring ability. On the other hand, if the space 41 is configured to be relatively softer while having better cushioning than the main body 10, it will be able to absorb external forces and make it easier to reduce the external forces applied to the main body 10.

[0055] The buffer member 42 constituting the buffer section 40 is formed in an annular shape so as to orient the circumference at any position in the radial direction r of the main body section 10, and in this embodiment, is disposed on the outer periphery of the main body section 10. The buffer member 42 is configured to include an elastically deformable member, and is configured to have a higher restoring force than the main body section 10. The buffer member 42 preferably includes a bioabsorbable material such as a thermoplastic resin such as PGA (polyglycolic acid), PLA (polylactic acid), PLGA (polylactic acid-glycolic acid copolymer), PDS (polydioxanone), or PCL (polycaprolactone). Of the above-mentioned materials, it is more preferable that the buffer member 42 includes PLGA or PCL in particular from the viewpoint of expressing a restoring force. In addition, in order to seal the gas filled in the space section 41 with the buffer member 42, it is preferable that the buffer member 42 uses a material with a lower gas permeability than the main body section 10.

[0056] In this embodiment, the cushioning member 42 is formed as a separate member from the main body portion 10. However, as long as the cushioning member can cushion external forces that may act on the sheet-like main body portion 10, it may be formed of the same member as the main body portion 10 by, for example, rolling the outer periphery of the main body portion. When the cushioning member 42 is formed as a separate member from the main body portion 10, the method of joining the main body portion 10 and the cushioning member 42 is not particularly limited, and adhesives, heat fusion, sewing with thread, needle punching, etc. can be used.

[0057] The method for forming the buffer section 40 is not particularly limited, but for example, several sheets are joined by needle punching, heat fusion, etc. to increase the thickness, and then cut into the desired shape. The sheet is then wrapped around a core bar, covered with a shrink tube, and heated. The polymer is then melted and poured into a mold to form the buffer section 40 with the space 41.

[0058] <Treatment Method> Next, a description will be given of a treatment method using the medical component 100. Fig. 7 is a flow chart showing each procedure of the treatment method using the medical component 100.

[0059] The treatment method includes disposing (S11) a medical component 100 having a sheet-like main body 10 that promotes healing of biological tissues between a first joined portion on one side and a second joined portion on the other side, which are to be joined of biological organs, as shown in Fig. 7. The treatment method includes joining one first joined portion to the other second joined portion in a state in which at least a part of the main body 10 of the medical component 100 is disposed between the one first joined portion and the other second joined portion (S12).

[0060] The biological organs to be joined by the treatment method and the parts of the biological organs to be joined are not particularly limited and can be selected arbitrarily. However, in the following description, a colon anastomosis is taken as an example. In addition, detailed descriptions of known procedures and known joining devices for each procedure described below are omitted as appropriate.

[0061] Hereinafter, in the description of this specification, "placing a medical component between biological organs (hereinafter referred to as the above description)" may mean that the medical component is placed in direct or indirect contact with the biological organs.

[0062] The above description may also mean that the medical device is placed with a spatial gap formed between the medical device and the biological organ, or that the medical device is placed in both of these states (for example, the medical device is placed in contact with one biological organ and not in contact with the other biological organ).

[0063] Furthermore, in the description of this specification, the term "periphery" does not specify a strict range (area), but rather means a predetermined range (area) as long as the purpose of the treatment (joining of biological organs) can be achieved.

[0064] In addition, the order of the procedure steps 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, "relatively approaching" means both bringing two or more objects to be brought close to each other and bringing only one object close to the other object.

[0065] Fig. 8 is a flow chart showing the procedure of an embodiment of the treatment method (colon anastomosis).Figs. 9 to 11 are views for explaining colon anastomosis.

[0066] In the treatment method according to this embodiment, the biological organ to be joined is the large intestine that has been cut following the resection of a cancer tumor. Specifically, the biological organ to be joined is the oral side A1 of the cut large intestine and the anal side A2 of the cut large intestine. In the following description, a procedure for joining a part of the intestinal wall on the oral side A1 of the cut large intestine (one part to be joined) and a part of the intestinal wall on the anal side A2 of the cut large intestine (the other part to be joined) will be described.

[0067] 8, the treatment method according to this embodiment includes arranging the medical member 100 between the oral side A1 of the large intestine and the anal side A2 of the large intestine (S101), and bringing the oral side A1 of the large intestine and the anal side A2 of the large intestine relatively close to each other (S102). The treatment method includes sandwiching the main body portion 10 of the medical member 100 between the oral side A1 of the large intestine and the anal side A2 of the large intestine (S103), and joining the main body portion 10 of the medical member 100 in a sandwiched state between the oral side A1 of the large intestine and the anal side A2 of the large intestine (S104). This will be described in detail below.

[0068] First, the surgeon prepares the medical device 200, forms a hole-like portion called a port around the navel, and inflates the patient's abdomen.

[0069] Next, the surgeon makes an incision (not shown) around the navel, and excises the affected part of the colon, such as cancer, from the incision using a medical device called a linear stapler, and the cut part of the colon is automatically sutured by a staple member. In this state, the colon is separated into an oral side A1 and an anal side A2. Then, the surgeon takes the oral side A1 of the colon out of the body through the incision, and inserts the second engagement tool 270 of the medical tool 200 into the oral side A1 of the colon. The surgeon inserts the second engagement tool 270 into the oral side A1 of the colon, and performs purse-string suture with the shaft 310 protruding, to form the sutured part A11. The outer surface of the sutured part A11 is shaped to partially protrude to the convex side as a result of the suturing (see FIG. 9).

[0070] Next, the surgeon inserts the shaft 310 of the second engagement tool 270 into the hole 30 located approximately in the center of the main body portion 10 .

[0071] Next, the surgeon places the living tissue on the oral side A1 of the large intestine on which the medical device 100 is placed into the abdominal cavity through the incision. Next, the surgeon uses forceps or the like to bring the tip of the second engagement instrument 270 close to the anal side A2 of the large intestine.

[0072] Next, the surgeon inserts the first engagement instrument 210 from the anus, thereby placing the first engagement instrument 210 of the medical instrument 200 on the anal side A2 of the large intestine. As the first engagement instrument 210 is placed (inserted) on the anal side A2 of the large intestine, the positioning portion 230 (shaft) of the first engagement instrument 210 penetrates the sutured portion A11 near the anal side A2 of the large intestine, and a through hole A21 is formed on the anal side A2 of the large intestine. The timing of forming the through hole A21 is not particularly limited as long as it is before the first engagement instrument 210 is placed.

[0073] Next, while maintaining the state in which the main body portion 10 is held against the mouth side A1 of the large intestine, the surgeon engages the positioning portion 230 with the shaft 310 of the second engagement instrument 270 at a spaced position (S101). Then, the rotating portion 261 is rotated to bring the first engagement instrument 210 and the second engagement instrument 270 relatively close to each other as shown in Fig. 12 (S102). This brings the vicinity of the mouth of the large intestine and the intestinal wall of the large intestine relatively close to each other.

[0074] Next, the surgeon clamps the intestinal wall on the oral side A1 of the large intestine, the main body 10 of the medical device 100, and the area around the through-hole A21 formed in the intestinal wall on the anal side A2 of the large intestine between the first engagement instrument 210 and the second engagement instrument 270 (S103).

[0075] The surgeon rotates the handle 262 of the operating unit 260 of the medical instrument 200 around the rotation axis 263 to project the annular blade of the punching unit 250. Then, a part of the oral side A1 of the large intestine, which is sandwiched between the first engaging instrument 210 and the second engaging instrument 270, the radially inner side of the main body portion 10, and a part of the anal side A2 of the large intestine are excised, and the periphery of the excised portion is joined in a substantially annular shape with staples (not shown) (S104).

[0076] Next, the surgeon removes the medical device 200 from the anal side A2 of the large intestine via the anus to the outside of the living body, for example, as shown in Fig. 11. At this time, the region configured on the inner side of the outer diameter d of the punched portion 250 of the first engagement device 210 is removed to the outside of the living body together with the medical device 200. As a result, the portion of the medical member 100 located on the inner side of the punched portion 250 in the radial direction r is removed without remaining in the body. Note that if the main body portion 10 and the fixing portion 20 are not made of a bioabsorbable material, the main body portion 10 and the fixing portion 20 are removed from the above-mentioned port.

[0077] By sandwiching and retaining the main body portion 10 of the medical device 100 between the biological organs to be joined, it is possible to promote healing of the biological organs to be joined through the through hole 11 or the main body portion 10 at a portion located radially outward of the punched portion 250 of the main body portion 10 in the radial direction r.

[0078] According to this treatment method, the risk of suture failure after a joining procedure (e.g., digestive tract anastomosis) can be reduced by the simple method of sandwiching the sheet-like main body portion 10 between the first and second joining areas.

[0079] As described above, the medical device 100 according to this embodiment includes the main body 10 and the buffer section 40. The main body 10 can be placed at an anastomosis of a biological organ, and is formed in a sheet shape, with at least a portion of the main body 10 containing a bioabsorbable material. The buffer section 40 is configured to have a space 41 provided therein.

[0080] Since the main body portion 10 is relatively thin and contains a soft material, there is a risk of the main body portion 10 becoming twisted when it is inserted into the incision or when it is pulled. In such a case, there is a risk of affecting the healing effect of the main body portion when anastomosis of a biological organ is performed. In contrast, since the medical device 100 according to this embodiment is provided with the buffer portion 40 as described above, it is possible to prevent or suppress the application of an external force to the main body portion 10, thereby preventing or suppressing the occurrence of twisting in the main body portion 10.

[0081] Moreover, the space 41 of the buffer section 40 is configured to be surrounded in all directions by the buffer members 42 that configure the buffer section 40 in a cross section intersecting with the circumferential direction θ of the main body section 10. With this configuration, even if an external force acts on the main body section 10 and the main body section 10 is deformed, the restoring force of the buffer section 40 causes the main body section 10 to return to its original shape, so that it is possible to prevent or suppress the occurrence of twisting of the main body section 10.

[0082] In addition, the buffer section 40 is configured to seal the gas in the space section 41. By configuring in this manner, even if an external force acts on the main body section 10 and the main body section 10 is deformed, the restoring force of the buffer section 40 makes it easier for the main body section 10 to restore to its original shape, so that the occurrence of twisting of the main body section 10 can be further prevented or suppressed.

[0083] In addition, the buffer section 40 is configured to have a higher restoring force than the main body section 10. By configuring it in this way, even if an external force acts on the main body section 10 and the main body section 10 is deformed, the restoring force of the buffer section 40 makes it easier for the main body section 10 to restore to its original shape, so that the occurrence of twisting of the main body section 10 can be more effectively prevented or suppressed.

[0084] Furthermore, the main body 10 has a plurality of through holes 11, and when applied to an anastomosis of a biological organ, biological components of the biological organ penetrate through the through holes 11 of the main body 10 and accumulate, promoting healing of the anastomosis. With this configuration, it is possible to promote joining of the anastomosis.

[0085] The buffer section 40 is configured to be disposed on the outer periphery of the main body section 10. By configuring it in this way, it is possible to buffer an external force that may act on the main body section 10 from approximately the outside to the inside in the radial direction r, and to prevent or suppress the occurrence of twisting that may occur in the main body section 10.

[0086] Moreover, the main body portion 10 is configured to have a hole portion 30 through which the shaft 310 of the second engaging instrument 270 of the medical instrument 200 can be inserted in the axial direction X of the main body portion 10. By configuring in this manner, the medical member 100 including the main body portion 10 can be quickly inserted into the shaft 310 of the second engaging instrument 270 to perform an anastomosis operation of a biological organ.

[0087] (Modifications 1 to 4 of the First Embodiment) 12 to 15 are cross-sectional views along the axial direction X of the medical devices 100a, 100b, 100c, and 100d according to Modifications 1 to 4 of the first embodiment. In the first embodiment, it has been described that the buffer member 42 constituting the buffer section 40 of the medical device 100 is formed to have a perfect circle in cross section. However, the specific shape of the buffer section 40 is not limited to a perfect circle as long as it can buffer an external force that may act on the main body section 10 from any direction.

[0088] In addition to the above, the buffer member 42a of the buffer section 40a that forms the space 41a in the medical device 100a may be formed so that the outer and inner wall surfaces have an elliptical shape in a cross section along the axial direction X as shown in FIG. 12 (variation example 1).

[0089] In addition, the buffer member 42b of the buffer section 40b forming the space 41b in the medical device 100b may be formed so that the outer and inner wall surfaces in a cross section along the axial direction X have a polygonal shape such as a rectangle or a triangle (Modification 2) as shown in Fig. 13. By configuring in this way, the main body section 10 is stably disposed at the joined portion, and it is possible to prevent or suppress the occurrence of displacement of the main body section 10.

[0090] Furthermore, the buffer section 40c in the medical device 100c may be arranged such that two or more annular components are stacked and arranged in the axial direction X, like the buffer members 42c and 43c shown in Fig. 14 and Fig. 15. The buffer member 42c having a space portion 41c and the buffer member 43c having a space portion 44c that constitute the buffer section 40c can be arranged to sandwich the main body portion 10 as shown in Fig. 14. By arranging two or more annular buffer members so as to be stacked and arranged in the axial direction X and sandwiching the main body portion 10 between the two annular buffer members 42c and 43c, deformation of the main body portion 10 can be further prevented or suppressed.

[0091] Furthermore, the buffer member 42d constituting the buffer portion 40d of the medical device 100d and forming the space portion 41d and the buffer member 43d constituting the space portion 44d may be arranged side by side on one side of the main body portion 10 in the axial direction X as shown in Fig. 15. This configuration can also prevent or suppress twisting of the main body portion 10.

[0092] Furthermore, the cross-sectional shape of the buffer member constituting the buffer section is not limited to those shown in Figs. 12 to 15, and may be a star shape, a concave-convex shape, or the like. The configurations of the medical members 100a, 100b, 100c, and 100d according to Modifications 1 to 4 other than the buffer sections 40a, 40b, 40c, and 40d and the method of using the medical members 100a, 100b, 100c, and 100d are the same as those of the first embodiment. Furthermore, in the following embodiments and modifications, the configurations of the medical members other than the buffer sections and the method of using the medical members are basically the same as those of the first embodiment. Therefore, the description common to the first embodiment will be omitted.

[0093] Second embodiment 16 is a cross-sectional view of the medical device 100e according to the second embodiment taken along the axial direction X and passing through the approximate center of the main body 10. In the first embodiment, the thickness of the buffer portion 40 is uniform regardless of the location. However, as long as it can buffer an external force that may act on the main body 10 from at least a specific direction, the thickness of the buffer member 42e constituting the buffer portion 40e of the medical device 100e may not be uniform regardless of the location, and the space portion 41e may be different. In this embodiment, the cross-sectional shape of the buffer portion 40e is configured to be approximately a perfect circle as shown in FIG.

[0094] The thickness of the buffer member 42e constituting the buffer portion 40e is configured to vary depending on the position in the radial direction r. In this embodiment, the buffer portion 40e can be configured so that the inner thickness is thicker than the outer thickness in the radial direction r of the main body portion 10. This configuration can also prevent or suppress the occurrence of twisting in the main body portion 10. In particular, if the buffer portion 40e adjacent to the main body portion 10 is configured to have a relatively large thickness, it can be expected to better buffer external forces that may act on the main body portion 10.

[0095] (Modifications 1 to 3 of the second embodiment) 17 to 19 are cross-sectional views along the axial direction X of medical devices 100f, 100g, and 100h according to Modifications 1 to 3 of the second embodiment, cut to pass through the center of the main body 10. In the second embodiment, it has been described that the thickness of the buffer member 42e constituting the buffer part 40e is not uniform depending on the part, and the outer shape of the cross section along the axial direction X of the buffer part 40e is substantially a perfect circle. However, the specific shape of the buffer part is not limited to a perfect circle as long as it can buffer an external force that may act on the main body 10 from any direction.

[0096] In addition to the above, in a buffer section 40f of a medical device 100f having an uneven thickness, the cross-sectional shape of the outer and inner wall surfaces of a buffer member 42f forming a space 41f may be configured to be elliptical as shown in Fig. 17 (Modification 1). In addition, in a buffer section 40g of a medical device 100g having an uneven thickness, the cross-sectional shape of the outer and inner wall surfaces of a buffer member 42g forming a space 41g may be configured to be polygonal, such as triangular, as shown in Fig. 18 (Modification 2).

[0097] In addition, the cross-sectional shape of the buffer portion 40h of the medical device 100h may be substantially circular as shown in FIG. 19, and may be configured by arranging in the axial direction X a buffer member 42h having space portions 41h so that the thickness varies depending on the part, and a buffer member 43h having space portions 44h provided in the same manner as the space portions 41h.

[0098] Third embodiment 20 is a plan view showing a medical device 100k according to the third embodiment. In the first embodiment, the buffer section 40 is provided on the outer periphery of the main body section 10, and the buffer section 40 provides the hollow space section 41 in a continuous circular shape so as to surround the outer periphery of the main body section 10. However, as long as it can buffer an external force that may act on the main body section 10 from any direction, the space section that constitutes the internal space of the buffer section is not limited to being provided in a continuous manner as in the first embodiment.

[0099] The buffer section 40k of the medical device 100k may be disposed on the outer periphery of the main body section 10, and may include a buffer member 42k having a plurality of spaces 41k, 44k, 45k, 46k constituting an internal space, which are intermittently provided in the circumferential direction θ so as to divide the outer periphery of the main body section 10 (see FIG. 20). In this embodiment, the buffer section 40k includes a row of buffer members 42k each having four internal spaces, such as spaces 41k, 44k, 45k, 46k, arranged in the radial direction r, and the spaces 41k, 44k, 45k, 46k are arranged symmetrically when viewed from above as shown in FIG.

[0100] With this configuration, when an external force acts on multiple points of the medical component at almost the same time, it is possible to reduce unevenness in the cushioning properties and recovery properties of the buffer section, thereby improving the effect of preventing twisting of the main body section 10 (the same applies to Figs. 21 to 24 and Fig. 27). In the case where the spaces in the buffer section are discontinuous, the spaces can be made uniform in size and the spacing between them can be made uniform, such as spaces 41k, 44k, 45k, and 46k as shown in Fig. 20, so that the spaces are not made uneven, and the effect of preventing twisting can be improved accordingly.

[0101] (Modifications 1 to 3 of the third embodiment) 21 to 23 are plan views showing medical devices 100m, 100n, and 100p according to Modifications 1 to 3 of the third embodiment. In the third embodiment, it has been described that the spaces 41k, 44k, 45k, and 46k are provided symmetrically as the internal spaces constituting the buffer section 40k of the medical device 100k.

[0102] However, the spaces corresponding to the internal space of the buffer part do not have to be arranged symmetrically as long as they can buffer an external force that may act on the main body part 10 from any direction. As shown in Fig. 21, the spaces 41m, 44m, and 45m of the buffer member 42m constituting the buffer part 40m included in the medical device 100m may be arranged asymmetrically in a plan view. The spaces 41m, 44m, and 45m of the buffer member 42m constituting the buffer part 40m may be arranged at equal angular intervals in the circumferential direction θ (Modification 1).

[0103] In the third embodiment, the buffer section 40k is disposed on the outer periphery of the main body section 10. However, as long as it can buffer an external force that may act from any direction and avoids the anastomosis region, the buffer member 42n constituting the buffer section 40n of the medical device 100n may be disposed on the inner periphery (approximately the center) of the main body section 10 as shown in FIG. 22 (Modification 2). In this modification, the buffer section 40n may be disposed adjacent to the fixing section 20 in the axial direction X. In this modification, the buffer members 42n constituting the buffer section 40n are disposed approximately symmetrically with respect to the spaces 41n, 44n, but the specific shape and arrangement of the spaces are not limited to those shown in FIG. 22 as long as it can buffer an external force that may act on the main body section 10.

[0104] In the third embodiment, the buffer section 40k has been described as having one row (one circumference) of buffer members 42k arranged in the radial direction r. However, the buffer section 40p of the medical device 100p may have multiple rows (multiple circumferences) of buffer members 42p, 43p arranged, such as two rows, in the radial direction r as shown in Fig. 23 (Modification 3). The buffer section 40p has annular buffer members 42p, 43p arranged adjacent to each other in the radial direction r.

[0105] The cushioning member 42p has spaces 41p, 44p, 45p, and 46p arranged at equal angular intervals in the circumferential direction θ. The cushioning member 43p has spaces 47p, 48p, 49p, and 51p arranged at equal angular intervals in the circumferential direction θ. The spaces 41p, 44p, 45p, and 46p and the spaces 47p, 48p, 49p, and 51p can be arranged so that their positions in the circumferential direction θ are shifted from each other.

[0106] In this way, by providing the buffer members 42p, 43p for a plurality of turns in the radial direction r, the strength of the buffer portion 40p can be improved, and the effect of preventing the main body portion 10 from twisting can be improved.

[0107] (Fourth embodiment) Fig. 24 is a plan view showing a medical device 100r according to a fourth embodiment, and Fig. 25 is a side view showing the medical device 100r of Fig. 24. In the third embodiment, a plurality of spaces are provided in one annular outer shape constituting the buffer part. However, the outer shape of the buffer part is not limited to the above as long as it can buffer an external force that may act on the main body part 10 from any direction.

[0108] In addition to the above, the buffer section 40r of the medical device 100r may be a plurality of substantially spherical buffer members 42r having spaces 41r, arranged like beads in the circumferential direction θ and connected together as shown in Figures 24 and 25. The method of connecting the buffer members 42r constituting the buffer section 40r is not particularly limited, and they may be connected with a member such as a thread or string, or may be bonded with an adhesive or the like.

[0109] The thickness of the buffer member 42r may be uniform regardless of the location as in the first embodiment, or may be different depending on the location as in the second embodiment. By arranging the multiple buffer members 42r constituting the buffer section 40r in the circumferential direction θ in this manner, when an external force is applied to the buffer section 40r, the buffer members 42r may be crushed or may move so that the positions of the buffer members 42r are shifted, so that the buffer members 42r may buffer each other. This makes it possible to absorb the external force applied to the medical device 100r and prevent or suppress twisting of the main body section 10.

[0110] Fifth embodiment FIG. 26 is a cross-sectional view showing the buffer part 40s of the medical device 100s according to the fifth embodiment, taken along the axial direction X and passing through the approximate center of the main body part 10. In the first embodiment, it has been described that the buffer part 40 has a space part 41 so as to buffer the external force acting on the main body part 10. However, as long as it can buffer the external force that may act on the main body part 10 from any direction, the buffer part 40 does not necessarily have an internal space, and may be configured to include a buffer member 42s such as a polygonal shape such as a triangle or trapezoid (excluding a rectangle) as shown in FIG. 26, which is solid and has a cushioning property higher than the main body part 10 and is an elastic member with high restoring property. This configuration can also prevent or suppress the occurrence of twisting in the main body part 10. In addition, by providing a portion where the cross section of the buffer member 42s constituting the buffer part 40s can be parallel to the contact surface with the biological organ, such as one side of a triangle, the contact area with one side of the anastomosis site can be relatively wide, and the stability of the medical device can be improved.

[0111] The present invention is not limited to the above-described embodiment, and various modifications are possible within the scope of the claims. Fig. 27 is a cross-sectional view of a medical device 100t including a buffer portion 40t having a space portion 41t according to a modified example, taken along the axial direction X passing through the center of the main body portion 10.

[0112] In the first to third embodiments, the number of spaces constituting the buffer section is relatively small, such as one to four. However, as long as it can buffer an external force that may act on the main body section 10 from any direction, the buffer section 40t may be configured to include a buffer member 42t in which countless minute spaces 41t that are extremely small compared to the outer shape of the buffer section are arranged randomly, as shown in Fig. 27. Note that the specific number of spaces 41t is not particularly limited as long as they are isolated from the outside, and the spaces may or may not be connected to each other internally. [Explanation of symbols]

[0113] 10 Main body, 11 through hole, 30 holes, 40 buffer, 41, 44d, 45k space section, 42 Cushioning material, 100 Medical parts, θ circumferential direction, X-axis direction (thickness direction of the main body).

Claims

1. a sheet-like main body portion that can be placed at an anastomosis of a biological organ and at least a portion of which includes a bioabsorbable material; A buffer section having a space therein, The space of the buffer portion is surrounded in all directions by buffer members constituting the buffer portion in a cross section intersecting with the circumferential direction of the main body portion.

2. The medical device according to claim 1 , wherein the buffer portion has a space filled with a gas so as to be hermetically sealed.

3. The medical device according to claim 1 or 2, wherein the buffer portion has a polygonal shape in a cross section intersecting with a circumferential direction of the main body portion.

4. The medical device according to claim 1 or 2, wherein the buffer portion is provided so as to overlap two or more rings.

5. The medical device according to claim 1 , wherein the buffer portion has a thickness that divides the space from the outside and the thickness of the buffer portion varies depending on the location.

6. 3. The medical device according to claim 1, wherein the buffer portion comprises a plurality of substantially spheres each having the space therein, the substantially spheres being connected together along a circumferential direction of the main body.

7. The medical device according to claim 1 or 2, wherein the buffer portion has two or more intermittent spaces.

8. a sheet-like main body portion that can be placed at an anastomosis of a biological organ and at least a portion of which includes a bioabsorbable material; A medical device comprising: a buffer portion that is provided so as to cover at least a portion of the outer surface of the main body portion, and whose cross section intersecting the circumferential direction of the main body portion is a polygonal shape other than a rectangle.

9. The medical device according to claim 1 , wherein the buffer portion is configured to have a higher restoring force than the main body portion.

10. The medical device according to any one of claims 1 to 9, wherein the main body portion has a plurality of through holes, and when applied to the anastomosis of the biological organ, biological components of the biological organ penetrate the through holes of the main body portion and accumulate therein, thereby promoting healing of the anastomosis.

11. The medical device according to claim 1 , wherein the buffer portion is disposed on an outer periphery of the main body portion.

12. The medical device according to claim 1 , wherein the main body portion has a hole portion in a thickness direction of the main body portion through which a shaft of a medical instrument can be inserted.

Images