Structural assembly for forming a connective tissue body and method for forming a connective tissue body
The structural assembly for forming connective tissue bodies, featuring a cylindrical support member and housing member with separable coupling and a communication portion, addresses the challenges of complex implantation and tissue quality, achieving efficient and stable connective tissue formation in non-human living bodies.
Patent Information
- Application Number
- JP2021017567
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-02-07
- Filing Date
- 2021-02-05
- Publication Date
- 2025-06-26
- Estimated Expiration
- 2041-02-05
AI Technical Summary
Current methods for forming connective tissue bodies in living bodies, such as humans or animals, face challenges including complex implantation procedures, difficulty in increasing substrate size or quantity, and issues with stability and quality of the connective tissue mass.
A structural assembly for forming a connective tissue body, comprising a cylindrical support member and a housing member, arranged in parallel with separable coupling between structures, and a communication portion for forming a connective tissue body. This assembly allows for easy insertion, removal, and stability post-implantation, while enabling mass production of connective tissue bodies.
The structural assembly facilitates easy and stable implantation of connective tissue bodies in non-human living bodies, improving productivity and reducing the burden on animals, while ensuring high-quality tissue formation.
Smart Images

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Abstract
Description
Technical Field
[0001] The present disclosure relates to a structural assembly for forming a connective tissue body and a method for forming a connective tissue body.
Background Art
[0002] In recent years, research on regenerative medicine for restoring the functions of cells, tissues, organs, etc. lost due to diseases or accidents using artificial materials or cells has been actively conducted.
[0003] For example, when a foreign object penetrates deep into the living body, fibroblasts gradually gather around the foreign object, and a connective tissue body mainly composed of fibroblasts and collagen, etc. is formed. Utilizing such a reaction, techniques for implanting a foreign object into the living body to form a connective tissue body have been studied.
[0004] For example, Patent Document 1 describes a base material that can be installed in an environment where a biological tissue material exists and can form a film-like connective tissue body on the surface of the base material. The tissue formation surfaces on two sides for forming the connective tissue are provided facing each other across a tissue formation space so as to form the both sides of the film-like connective tissue body in contact with the surface of the base material, and a slit for communicating the tissue formation space with the outside of the base material is formed on at least one of the tissue formation surfaces. A connective tissue body forming base material is described. Further, a plurality of central base materials having the tissue formation surface set on the outer peripheral surface and a housing base material having a plurality of housing portions for housing the central base materials and having the tissue formation surface set on the inner peripheral surface are provided, and a connective tissue body forming base material having the slit formed in the housing base material is also described.
[0005] In Patent Document 1, a base material for forming a connective tissue body is implanted into a living body such as a human or installed in a culture device as a foreign object, and a connective tissue body is formed inside the base material for forming a connective tissue body. Then, it is described that the base material for forming a connective tissue body is taken out from the living body or the culture device to obtain a connective tissue body.
[0006] When performing so-called autotransplantation or allotransplantation to form a connective tissue mass in a human body, procedures such as making an incision and inserting a substrate for forming a connective tissue mass into the human body, suturing the incision after insertion, making an incision again to remove the substrate for forming a connective tissue mass from the body, and suturing the incision again are required. The burden on humans due to multiple procedures is large. Also, since the substrate for forming a connective tissue mass is implanted in the human body, it is difficult to increase the size or quantity of the substrate for forming a connective tissue mass, and it is difficult to mass-produce a connective tissue mass with a single implantation of the substrate for forming a connective tissue mass.
[0007] As a powerful means of mass-producing a connective tissue mass, it has been considered to implant a large-sized substrate for forming a connective tissue mass in an animal that can have a larger implantation area than a human to produce a sheet-shaped connective tissue mass with a large area. However, unlike humans, it is difficult to control the movements of animals other than humans. Therefore, the force generated during walking is very large, and a part of the substrate for forming a connective tissue mass during implantation may break through the skin of a large animal and protrude outside. A part of the substrate for forming a connective tissue mass that has protruded outside may remain caught on the fence of a pasture and the animal may walk with it, causing the skin to tear, or the connective tissue mass formed on the substrate from the torn wound or the animal may be infected with bacteria. Therefore, when using a substrate for forming a connective tissue mass having a plurality of connected accommodating portions as in Patent Document 1, the substrate for forming a connective tissue mass during implantation may break through the skin or be damaged in the living body, and problems such as the above-mentioned skin laceration may occur, making it difficult to grow the connective tissue mass or maintain the quality of the connective tissue mass.
[0008] Also, when forming a connective tissue mass with a culture device, extremely expensive equipment is required compared to the method of implanting the substrate for forming a connective tissue mass in the living body.
Prior Art Documents
Patent Documents
[0009]
Patent Document 1
Summary of the Invention
Problems to be Solved by the Invention
[0010] An object of the present disclosure is to provide a structure assembly for forming a connective tissue body that is implanted and used in a living body other than a human, and further has at least one of ease of insertion into the living body, ease of removal from the living body, stability after implantation into the living body, and productivity of the connective tissue body, and a method for forming the connective tissue body.
Means for Solving the Problems
[0011] [1] A structure assembly for forming a connective tissue body having a plurality of structures for forming a connective tissue body including a cylindrical support member and a housing member for housing the support member, the plurality of structures for forming a connective tissue body being arranged in parallel, at least one of the plurality of structures for forming a connective tissue body being separably coupled to an adjacent structure for forming a connective tissue body, a connective tissue body forming space capable of forming a connective tissue body being provided between the support member and the inner surface of the housing member, and the housing member being provided with a communication portion communicating the connective tissue body forming space with the outside of the structure for forming a connective tissue body. [2] The structure assembly for forming a connective tissue body according to [1] above, wherein the plurality of structures for forming a connective tissue body are arranged two-dimensionally. [3] The structure assembly for forming a connective tissue body according to [1] or [2] above, wherein at least one of the plurality of structures for forming a connective tissue body is separably coupled to an adjacent structure for forming a connective tissue body via a weak adhesive portion. [4] The structure assembly for forming a connective tissue body according to [1] or [2] above, wherein at least one of the plurality of structures for forming a connective tissue body is separably coupled to an adjacent structure for forming a connective tissue body via a connecting portion. [5] The structure assembly for forming a connective tissue body according to [4] above, wherein the density of the connecting portion is smaller than the density of the housing member. [6] The structure assembly for forming a connective tissue body according to any one of [1] to [5] above, wherein at least one of the spaces between the plurality of structures for forming a connective tissue body is provided with a groove portion extending along the longitudinal direction of the support member. [7] All of the structures for forming the connective tissue bodies are a structure assembly for forming connective tissue bodies according to any one of [1] to [6] above, which are separably coupled to adjacent structures for forming connective tissue bodies. [8] At least one of the plurality of structures for forming the connective tissue bodies is a structure assembly for forming connective tissue bodies according to any one of [1] to [7] above, which is movably coupled to an adjacent structure for forming a connective tissue body. [9] All of the structures for forming the connective tissue bodies are a structure assembly for forming connective tissue bodies according to any one of [1] to [8] above, which are movably coupled to adjacent structures for forming connective tissue bodies.
[10] Among the plurality of structures for forming the connective tissue bodies arranged in parallel, at least one end corner of the housing member constituting the structure for forming the connective tissue body arranged at the end is provided with a corner inclined surface connecting the adjacent end side surface and the end surface between the adjacent end side surface and the end surface, in a structure assembly for forming a connective tissue body according to any one of [1] to [9] above.
[11] A structure assembly for forming a connective tissue body according to
[10] above, wherein a coating portion made of a material softer than the housing member is provided on at least the corner inclined surface of the housing member.
[12] A method for forming a connective tissue body, comprising: a step (S-1) of inserting and implanting the structure assembly for forming a connective tissue body according to any one of [1] to
[11] above into a living body other than a human; a step (S-2) of forming a connective tissue body in the connective tissue body forming space of the structure assembly for forming a connective tissue body implanted in the living body; and a step (S-3) of taking out from the living body the structure assembly for forming a connective tissue body containing the connective tissue body formed in the connective tissue body forming space.
[13] In the step (S-3), the method for forming a connective tissue body according to
[12] above, wherein each of the structures for forming a connective tissue body constituting the structure assembly for forming a connective tissue body is taken out from one take-out portion.
Advantages of the Invention
[0012] According to the present disclosure, there can be provided a structural assembly for forming a connective tissue body that is implanted and used in a living body other than a human, and further has excellent performance in at least one of ease of insertion into the living body, ease of removal from the living body, stability after implantation into the living body, and productivity of the connective tissue body, and a method for forming the connective tissue body.
Brief Description of the Drawings
[0013]
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[0014] Hereinafter, a detailed description will be given based on the embodiment.
[0015] As a result of intensive research, the present inventors optimized the configurations of a plurality of structures for forming a connective tissue assembly that constitute the structure assembly for forming a connective tissue assembly, and used the structure assembly for forming a connective tissue assembly in a living body other than a human. Furthermore, the inventors found that the structure assembly is excellent in at least one of ease of insertion into a living body, ease of removal from a living body, stability after implantation into a living body, and productivity of a connective tissue assembly, and based on such findings, the present disclosure has been completed.
[0016] The structure assembly for forming a connective tissue assembly according to the embodiment has a plurality of structures for forming a connective tissue assembly each having a cylindrical support member and a housing member that houses the support member. The plurality of structures for forming a connective tissue assembly are arranged in parallel, and at least one of the plurality of structures for forming a connective tissue assembly is separably coupled to an adjacent structure for forming a connective tissue assembly. A connective tissue assembly formation space capable of forming a connective tissue assembly is provided between the support member and the inner surface of the housing member, and the housing member is provided with a communication portion that communicates the connective tissue assembly formation space with the outside of the structure for forming a connective tissue assembly.
[0017] FIG. 1 is a perspective view showing an example of the structure assembly for forming a connective tissue assembly according to the embodiment.
[0018] As shown in FIG. 1, the structure assembly 1 for forming a connective tissue assembly has a plurality of structures 10 for forming a connective tissue assembly. The plurality of structures 10 for forming a connective tissue assembly each have a support member 20 and a housing member 30 and are arranged in parallel. In the structure assembly 1 for forming a connective tissue assembly, at least two or more structures 10 for forming a connective tissue assembly are continuously arranged in parallel.
[0019] The support member 20 that constitutes each connective tissue formation structure 10 is cylindrical and supports from the inside the connective tissue formed in the connective tissue formation space 32 as described later. For the purpose of uniformizing the shape of the hollow cylindrical connective tissue formed in the connective tissue formation space 32, it is preferable that the outer dimension in the short direction of the cylindrical support member 20 is constant over the longitudinal direction L perpendicular to the short direction of the support member 20. Further, in order to reduce the area difference between the inner surface and the outer surface of the formed hollow cylindrical connective tissue, the support member 20 is preferably cylindrical. When the support member 20 is a solid body, it becomes easy to clean the support member 20. When the support member 20 is a hollow body, the weight of the connective tissue formation structure assembly 1 and the connective tissue formation structure 10 can be reduced, and the material cost can be reduced. When the connective tissue formation structure assembly 1 and the connective tissue formation structure 10 become lighter, the burden on a living body other than a human (hereinafter, also simply referred to as a living body) is reduced, and it is possible to suppress the position of the connective tissue formation structure assembly 1 during implantation in the living body from dropping due to gravity.
[0020] The housing member 30 that constitutes each connective tissue formation structure 10 houses the support member 20 over the longitudinal direction L of the support member 20. The housing member 30 that houses the support member 20 inside is a hollow cylindrical body extending along the longitudinal direction L of the support member 20, for example, a hollow rectangular cylindrical body as shown in FIG. 1. The housing member 30 houses the support member 20 as a whole, but one end of the support member 20 may protrude from the opening 31 provided in one end wall of the housing member 30.
[0021] The other end of the support member 20 is connected to the inside of the other end wall facing the one end wall where the opening 31 of the housing member 30 is provided. For example, the other end of the support member 20 may be integrally connected to the housing member 30, may be connected to the housing member 30 via a connecting member (not shown), or may be screwed with the housing member 30.
[0022] In a plurality of structures 10 for forming connective tissue bodies, a connective tissue body formation space 32 is provided between the side surface 21 of the support member 20 and the inner surface 41 of the housing member 30. The side surface 21 of the support member 20 extends along the longitudinal direction L between both end portions of the support member 20. The inner surface 41 of the housing member 30 extends along the longitudinal direction L inside the housing member 30 and faces the side surface 21 of the support member 20. The inner surface 41 of the housing member 30 covers the side surface 21 of the support member 20 from the outside with a distance d between the side surface 21 of the support member 20 and the inner surface 41 of the housing member 30. The connective tissue body formation space 32 extends annularly along the longitudinal direction L of the support member 20 between the side surface 21 of the support member 20 and the inner surface 41 of the housing member 30 inside the housing member 30. The connective tissue body formation space 32 is a space capable of forming a connective tissue body.
[0023] The shape of the inner surface 41 of the housing member 30 may be appropriately changed according to the outer shape of the support member 20. It is preferable that the distance d between the side surface 21 of the support member 20 and the inner surface 41 of the housing member 30 is constant so that the thickness of the hollow cylindrical connective tissue body formed in the connective tissue body formation space 32 is uniform. Here, since the support member 20 is cylindrical, preferably, the inner surface 41 of the housing member 30 is cylindrical, and in that case, the connective tissue body formation space 32 extends in an annular shape along the longitudinal direction L of the support member 20.
[0024] In a plurality of structures 10 for forming connective tissue bodies, at least one communication portion 33 is provided in the side wall 42 of the housing member 30. The side wall 42 of the housing member 30 extends along the longitudinal direction L of the support member 20. The communication portion 33 provided in the housing member 30 penetrates the side wall 42 of the housing member 30 and communicates the connective tissue body formation space 32 with the outside of the structure 10 for forming a connective tissue body. The communication portion 33 penetrating the side wall 42 extends, for example, along the longitudinal direction L and is provided in one side wall 42.
[0025] The configuration of the communication part 33 is not particularly limited. For example, a plurality of communication parts 33 may be provided discontinuously. When a plurality of communication parts 33 are provided discontinuously, the plurality of communication parts 33 may extend along the same direction or along different directions. From the viewpoint of forming a high-quality connective tissue body, as shown in FIG. 1, the communication part 33 preferably extends over the entire surface in the longitudinal direction L with respect to the side surface 21 of the support member 20. The communication part 33 is connected to, for example, an opening 31 provided in one end wall of the housing member 30.
[0026] When the structure assembly 1 for forming a connective tissue body is implanted into a living body other than a human, connective tissue enters the connective tissue body formation space 32 from the outside of the connective tissue body formation structure 10 through the communication part 33, and a connective tissue body extending in a tubular shape along the longitudinal direction L of the support member 20 is formed in the connective tissue body formation space 32. The connective tissue body is composed of, for example, extracellular matrix such as fibroblasts and collagen. The connective tissue body is used as a tubular shape or a sheet shape and is used for transplantation into humans, companion animals, livestock animals, and rare animals on display, such as the pericardium, dura mater, skin, valve, cornea, blood vessel, digestive tract, and trachea.
[0027] The materials constituting the support member 20 and the housing member 30 are not particularly limited, but have a strength (hardness) that can suppress large deformation during implantation into the living body, chemical stability, resistance to sterilization treatment such as autoclaving, and do not release substances that have an adverse effect on the formed connective tissue body or the living body, or do not release such substances in large quantities. From such a viewpoint, the materials constituting the support member 20 and the housing member 30 are preferably resin materials such as acrylic resin and silicone resin, and highly rust-resistant metal materials such as stainless steel, titanium, cobalt, chromium, and nickel-titanium alloy. Further, the support member 20 and the housing member 30 may have surfaces covered with the above resin materials or metal materials. The above resin materials have a faster formation rate of connective tissue bodies in the living body than the above metal materials.
[0028] In the structural assembly 1 for forming a connective tissue body, it is preferable that the side surface 21 of the support member 20 is formed of a resin material that easily forms a connective tissue, and the outer surface of the housing member 30 is formed of a metal material that hardly forms a connective tissue. In the structural assembly 1 for forming a connective tissue body having such a configuration, the formation rate of the connective tissue body formed in the connective tissue body formation space 32 is faster than the formation rate of the connective tissue formed on the outer surface of the housing member 30. The metal material constituting the outer surface of the housing member 30 slows down the occlusion of the communication portion 33 by the connective tissue formed on the outer surface of the housing member 30. Before the communication portion 33 is occluded by the connective tissue, the connective tissue body is formed in the connective tissue body formation space 32. Therefore, a connective tissue body having a desired shape corresponding to the shape of the connective tissue body formation space 32 can be easily formed.
[0029] As shown in FIG. 1, the structural assembly 1 for forming a connective tissue body includes a plurality of connective tissue body forming structures 10 that are smaller than the structural assembly 1 for forming a connective tissue body. At least one of the plurality of connective tissue body forming structures 10 is separably coupled to an adjacent connective tissue body forming structure 10. As shown in FIG. 1, in the structural assembly 1 for forming a connective tissue body, two adjacent side walls 42a that do not have the communication portion 33 of the housing member 30 are separably coupled to each other.
[0030] The bonding force by which the adjacent structure bodies 10 for forming a connective tissue body are detachably bonded is such that, without using a cutting machine or a shearing machine and without applying a strong force, for example, during the implantation of the structure assembly 1 for forming a connective tissue body into a living body, due to abnormal movements of the living body or collisions between the living body and obstacles such as a fence of a pasture, a force greater than that during normal activities is generated, or due to an intentional normal force by a human hand, etc., the adjacent structure bodies 10 for forming a connective tissue body can be easily separated from the two side walls 42a. When such a force is applied to the structure bodies 10 for forming a connective tissue body that are detachably bonded to each other, the structure bodies 10 for forming a connective tissue body may be completely separated individually, but it is preferable that the structure bodies 10 for forming a connective tissue body partially maintain the bond. In such a case, the adjacent structure bodies 10 for forming a connective tissue body are not completely separated and are partially bonded. Therefore, all the structure bodies 10 for forming a connective tissue body constituting the structure assembly 1 for forming a connective tissue body can be taken out by a single incision procedure, and the structure assembly 1 for forming a connective tissue body can be easily taken out from the living body.
[0031] The structure assembly 1 for forming a connective tissue body is implanted and used in a living body other than a human. Examples of living bodies other than humans include mammalian animals such as dogs, cows, pigs, horses, goats, sheep, rabbits, etc., birds, fish, and other animals. Among them, cows, horses, pigs, and goats, which can have a larger implantation area than humans, can produce a large amount of connective tissue bodies by a single implantation, and are preferably used as livestock.
[0032] The location where the structure assembly 1 for forming a connective tissue body is implanted in the living body is the subcutaneous tissue such as the limbs, shoulders, back, and abdomen. After peeling a part of the epidermis and dermis (hereinafter also referred to as skin) outside the subcutaneous tissue from the living body, the structure assembly 1 for forming a connective tissue body is inserted into the subcutaneous tissue so as to be inserted, and then the partially peeled skin is sutured to the living body to implant the structure assembly 1 for forming a connective tissue body in the subcutaneous tissue.
[0033] A removable lid 34 may be provided on an end face 43 having an opening 31 of the housing member 30. The lid 34 covers the end face 43 of the housing member 30 from the outside and closes the plurality of openings 31. For example, a plurality of recesses (not shown) are provided at positions on the inner surface 34b of the lid 34 covering the end face 43 so as to face the respective openings 31. Each recess of the lid 34 closes each opening 31. The bottom surface of each recess abuts against one end face 22 of the support member 20. The material constituting the lid 34 is the same as that of the housing member 30. When the plurality of connective tissue formation structures 10 are separated from each other from the side wall 42a, the lid 34 separates along a surface 34a where separation is easy.
[0034] As described above, the connective tissue formation structure assembly 1 includes a plurality of connective tissue formation structures 10. When inserting the connective tissue formation structure assembly 1 including the plurality of connective tissue formation structures 10 into a living body, the connective tissue formation structure assembly 1 including the plurality of connective tissue formation structures 10 can be implanted at one location in the subcutaneous tissue by one incision procedure and the insertion of the connective tissue formation structure assembly 1 from one incision. In this way, the connective tissue formation structure assembly 1 can be easily inserted into the living body by a short-time and simple operation, and the productivity of the connective tissue can be improved.
[0035] Also, during the implantation of the connective tissue formation structure assembly 1, a force larger than that during normal activities may be accidentally applied to the connective tissue formation structure assembly 1 due to abnormal behavior of the living body or a collision between the living body and an obstacle. When such a force is applied, if the force is small, the connective tissue formation structure 10 constituting the connective tissue formation structure assembly 1 during implantation is not completely separated but is partially joined, and the joined state is maintained. Therefore, the connective tissue formation structure assembly 1 can be easily taken out by one incision procedure. Further, since the force applied to the connective tissue formation structure assembly 1 is small, damage to the subcutaneous tissue, skin, etc. caused by the connective tissue formation structure assembly 1 during implantation is suppressed.
[0036] Moreover, if the above force is large, due to this force, the structure 10 for forming a connective tissue aggregate that constitutes the structure aggregate 1 for forming a connective tissue aggregate is easily separated from the side wall 42a. In this way, the force applied to the structure aggregate 1 for forming a connective tissue aggregate and the structure 10 for forming a connective tissue aggregate is reduced by the separation of the structure 10 for forming a connective tissue aggregate. Furthermore, damage to the structure aggregate 1 for forming a connective tissue aggregate during implantation is suppressed. The separation of the structure 10 for forming a connective tissue aggregate has a buffering effect of reducing the force applied to the structure aggregate 1 for forming a connective tissue aggregate. Therefore, the structure 10 for forming a connective tissue aggregate that is smaller than the structure aggregate 1 for forming a connective tissue aggregate can be prevented from piercing through the skin and protruding outside the living body, and damage to the subcutaneous tissue, skin, etc. can be suppressed. In this way, the structure aggregate 1 for forming a connective tissue aggregate is excellent in stability after implantation. Also, even when the structure 10 for forming a connective tissue aggregate is separated, the state where a plurality of structures 10 for forming a connective tissue aggregate are implanted at one location in the subcutaneous tissue is maintained. Therefore, all the structures 10 for forming a connective tissue aggregate that constitute the structure aggregate 1 for forming a connective tissue aggregate can be easily taken out by a single incision procedure. In this way, the structure aggregate 1 for forming a connective tissue aggregate can be easily taken out from the living body.
[0037] On the other hand, conventional base materials for forming connective tissue aggregates are used for humans and are also implanted into the abdominal cavity. Furthermore, the plurality of accommodating portions that constitute the conventional base material for forming a connective tissue aggregate are not detachably connected but are integrally formed. Therefore, when the conventional base material for forming a connective tissue aggregate is implanted into the subcutaneous tissue, even if the base material for forming a connective tissue aggregate during implantation receives a larger force than usual, the plurality of accommodating portions are not separated, and in some cases, the base material for forming a connective tissue aggregate may be damaged. Such a base material for forming a connective tissue aggregate that has received such a large force is likely to damage the subcutaneous tissue, skin, etc., and in some cases, may pierce through the skin and at least a part of the base material for forming a connective tissue aggregate may protrude outside the living body. When the base material for forming a connective tissue aggregate pierces through the skin and protrudes outside the living body, the growth of the connective tissue aggregate becomes insufficient, and it becomes difficult to form a connective tissue aggregate with good quality. In this way, the conventional base material for forming a connective tissue aggregate does not have good stability after implantation into the living body.
[0038] In addition, when forming a plurality of connective tissue bodies using a conventional substrate for forming a connective tissue body that does not include a plurality of accommodating portions, since one connective tissue body is formed from one substrate for forming a connective tissue body, it is necessary to implant a plurality of substrates for forming a connective tissue body by performing insertion operations a plurality of times. In some cases, a plurality of incision procedures are performed to implant a plurality of substrates for forming a connective tissue body at a plurality of locations in the living body. Therefore, for the conventional substrate for forming a connective tissue body, the burden on animals is large, the operation is complicated, and mass production of connective tissue bodies is not easy.
[0039] As described above, unlike the conventional substrate for forming a connective tissue body, the structural assembly 1 for forming a connective tissue body according to the embodiment focuses on the configuration of a plurality of structural bodies for forming a connective tissue body that constitute the structural assembly for forming a connective tissue body. The structural assembly 1 for forming a connective tissue body can be separated into a plurality of structural bodies 10 for forming a connective tissue body and miniaturized. From the perspective of improving the productivity of connective tissue bodies, the structural assembly 1 for forming a connective tissue body is used for a living body other than a human and implanted in the subcutaneous tissue. By performing one incision procedure and inserting the structural assembly 1 for forming a connective tissue body, that is, by performing one implantation operation of the structural assembly 1 for forming a connective tissue body, a plurality of connective tissue bodies can be formed. Therefore, the structural assembly 1 for forming a connective tissue body provided with a plurality of structural bodies 10 for forming a connective tissue body can be easily inserted into the living body and can improve the productivity of connective tissue bodies. In addition, the structural body 1 for forming a connective tissue body in the living body can maintain a partial connection of the structural body 10 for forming a connective tissue body or separate into a structural body 10 for forming a connective tissue body smaller than the structural body 1 for forming a connective tissue body according to the magnitude of the force received, thereby reducing the force applied to the subcutaneous tissue, skin, etc. Damage to the structural assembly 1 for forming a connective tissue body in the living body is suppressed. Thus, since the structural assembly 1 for forming a connective tissue body is excellent in stability after implantation, a connective tissue body can be stably formed in the living body. Further, even if the structural body 1 for forming a connective tissue body is separated, the plurality of structural bodies 10 for forming a connective tissue body continue to be implanted in one part of the living body. Therefore, the structural body 1 for forming a connective tissue body can be easily taken out from the living body by one incision procedure.
[0040] Further, as shown in FIG. 1, in the structure assembly 1 for forming a connective tissue body, it is preferable that the plurality of structures 10 for forming a connective tissue body are arranged two-dimensionally. In the configuration where the plurality of structures 10 for forming a connective tissue body are arranged two-dimensionally, the plurality of structures 10 for forming a connective tissue body are arranged continuously in parallel. When the plurality of structures 10 for forming a connective tissue body are arranged two-dimensionally, the structure assembly 1 for forming a connective tissue body becomes sheet-shaped. The sheet-shaped structure assembly 1 for forming a connective tissue body can be easily inserted into the subcutaneous tissue. For example, the structure assembly 1 for forming a connective tissue body is inserted into the living body from an insertion portion formed by incising the living body. The sheet-shaped structure assembly 1 for forming a connective tissue body can be inserted while cutting open the subcutaneous tissue during insertion. Further, since the insertion portion for inserting the sheet-shaped structure assembly 1 for forming a connective tissue body is linear, the insertion portion can be formed by an easy incision procedure. For these reasons, the insertion of the structure assembly 1 for forming a connective tissue body into the living body becomes easier. Furthermore, since the sheet-shaped structure assembly 1 for forming a connective tissue body easily adheres to the living body during implantation, the stability of the structure assembly 1 for forming a connective tissue body after implantation is improved, and a connective tissue body with excellent quality can be formed. From the viewpoints of improving the productivity of the connective tissue body, the ease of inserting the structure 10 for forming a connective tissue body, and the stability after implantation, it is preferable that 2 to 10 structures 10 for forming a connective tissue body are arranged continuously in parallel.
[0041] In addition, in the configuration where the plurality of structures 10 for forming a connective tissue body are arranged two-dimensionally, as long as the ease of insertion of the structure assembly 1 for forming a connective tissue body and the stability after implantation are not reduced, for example, as shown in FIG. 2, apart from the plurality of structures for forming a connective tissue body arranged continuously in parallel, on side walls different from the adjacent side walls 42a in the structures for forming a connective tissue body arranged continuously in parallel, one or more separate structures 10 for forming a connective tissue body may be detachably connected. In this case, the shape of the lid portion 34 is appropriately set according to the arrangement configuration of the structures 10 for forming a connective tissue body so as to close all the openings 31.
[0042] Also, as shown in FIG. 3, at least one of the plurality of connective tissue formation structures 10 is preferably separably coupled to an adjacent connective tissue formation structure 10 via a weak adhesive portion 50 having a mechanical strength weaker than that of the connective tissue formation structure 10. The weak adhesive portion 50 is provided between adjacent connective tissue formation structures 10. The bonding force with which the weak adhesive portion 50 bonds adjacent connective tissue formation structures 10 is weaker than the bonding force with which the adjacent connective tissue formation structures 10 are separably coupled. For example, as shown in FIG. 3, the weak adhesive portion 50 extends along the longitudinal direction L of the support member 20 between the side walls 42a of the adjacent housing members 30. The weak adhesive portion 50 is composed of a weak adhesive having weak adhesiveness. For example, from the viewpoints of curing at room temperature, water resistance, non-toxicity for in-vivo use, etc., the weak adhesive is preferably a silicone-based adhesive or the like. When the connective tissue formation structure assembly 1 is inserted into the living body, the weak adhesive portion 50 separably couples the plurality of connective tissue formation structures 10 to such an extent that the plurality of connected connective tissue formation structures 10 do not separate. When a force greater than that during normal activity is applied to the connective tissue formation structure assembly 1 during implantation, the plurality of connective tissue formation structures 10 are easily separated from the weak adhesive portion 50. Thus, the buffering effect due to the separation of the connective tissue formation structures 10 is improved, and damage to subcutaneous tissue, skin, etc. can be further suppressed, so that the stability of the connective tissue formation structure assembly 1 after implantation is further improved.
[0043] Further, as shown in FIG. 4, at least one of the plurality of structures 10 for forming connective tissue bodies is preferably detachably coupled to an adjacent structure 10 for forming a connective tissue body via a connecting portion 60. The connecting portion 60 is provided between adjacent structures 10 for forming connective tissue bodies. The connecting portion 60 extends along the longitudinal direction L of the support member 20 between the side walls 42a of the adjacent accommodating members 30. One end 60a of the connecting portion 60 is connected to one adjacent accommodating member 30, and the other end 60b of the connecting portion 60 is connected to the other adjacent accommodating member 30. A portion 60b of the connecting portion 60 excluding both ends (one end 60a and the other end 60c) is detachably coupled to at least one adjacent accommodating member 30 with a force less than the coupling force by which the adjacent structures 10 for forming connective tissue bodies are detachably coupled. The connecting portion 60 is preferably flexible rather than rigid and has a shape such as a string or a wire, for example. For example, the density of the connecting portion 60 is smaller than the density of the accommodating member 30. From the viewpoints of water resistance, non-toxicity, biodegradation resistance, biocompatibility, etc., the connecting portion 60 is composed of a resin having biocompatibility such as polytetrafluoroethylene or polyetheretherketone, a highly rust-resistant metal material such as stainless steel, titanium, cobalt, chromium, or nickel-titanium alloy.
[0044] When the structure assembly 1 for forming a connective tissue body is inserted into a living body, the connecting portion 60 connects the plurality of structures 10 for forming a connective tissue body in a separable manner so that the plurality of structures 10 for forming a connective tissue body that are connected do not separate. When a force greater than that during normal activity is applied to the structure assembly 1 for forming a connective tissue body during implantation, the side wall 42a that connects to the portion 60b other than both ends (one end 60a and the other end 60c) of the connecting portion 60 separates, but the connection between both ends (one end 60a and the other end 60c) of the connecting portion 60 and the side wall 42a is maintained. In such a state, the adjacent structures 10 for forming a connective tissue body can move freely via the connecting portion 60. That is, the adjacent structures 10 for forming a connective tissue body are connected by the connecting portion 60 even if they are separated by the side wall 42a. Therefore, the structure assembly 1 for forming a connective tissue body can be easily taken out by a single incision procedure. In this way, the buffering effect due to the separation of the structures 10 for forming a connective tissue body is improved, and since the structures 10 for forming a connective tissue body are connected without being separated, the stability after implantation of the structure assembly 1 for forming a connective tissue body and the ease of removal from the living body are further improved.
[0045] Further, as shown in FIG. 5, it is preferable that at least one of the plurality of connective tissue formation structures 10 is provided with a groove portion 70 extending along the longitudinal direction L of the support member 20. At least one of the plurality of connective tissue formation structures 10 is separably coupled to an adjacent connective tissue formation structure 10 via the groove portion 70. The groove portion 70 is provided on a side surface between adjacent connective tissue formation structures 10. For example, as shown in FIG. 5, in a state where a plurality of housing members 30 are adjacent to each other, the groove portion 70 is on a side surface between adjacent housing members 30, in other words, on a side surface including two side walls 42a that are separably coupled to each other, and extends along the longitudinal direction L of the support member 20. The groove portion 70 is provided on each of two opposing side surfaces between adjacent housing members 30. For example, when the connective tissue formation structure assembly 1 has the above-described weak adhesive portion 50, the groove portion 70 is provided on a side surface including two side walls 42a (and in some cases, the weak adhesive portion 50 as well). When the connective tissue formation structure assembly 1 has a groove portion provided on a side surface between adjacent connective tissue formation structures 10, the connective tissue formation structure 1 during implantation, which receives a force greater than during normal activities, can be separated from the connective tissue formation structure 10 starting from the groove portion 70. In this way, the buffering effect due to the separation of the connective tissue formation structure 10 is improved, and damage to subcutaneous tissue, skin, etc. can be further suppressed, so that the stability of the connective tissue formation structure assembly 1 after implantation is further improved.
[0046] Further, in the above-described connective tissue formation structure assembly 1, it is preferable that all of the connective tissue formation structures 10 are separably coupled to adjacent connective tissue formation structures 10. When all adjacent connective tissue formation structures 10 are separably coupled to each other, the ease of inserting the connective tissue formation structure assembly 1 into the living body and the stability after implantation into the living body are further improved.
[0047] Also, as shown in FIGS. 6 and 7, at least one of the plurality of structures 10 for forming connective tissue bodies is preferably movably coupled to an adjacent structure 10 for forming connective tissue bodies, and more preferably separably movably coupled to an adjacent structure 10 for forming connective tissue bodies. For example, as shown in FIGS. 6 and 7, a plurality of adjacent structures 10 for forming connective tissue bodies are movably coupled or separably movably coupled to each other at adjacent edges 421a or 421b that are adjacent to each other on the same side and extend along the longitudinal direction L of the support member 20 on the side wall 42a of the housing member 30. On the adjacent side walls 42a, only one of the edges 421a and 421b that are adjacent to each other on the same side is coupled, rather than both of the edges 421a and 421b being coupled. In FIG. 6, the plurality of structures 10 for forming connective tissue bodies are coupled only at the edge 421a, and in FIG. 7, the plurality of structures 10 for forming connective tissue bodies are alternately coupled at the edges 421a and 421b.
[0048] When the adjacent structures 10 for forming connective tissue bodies are movably coupled or separably movably coupled, it becomes easier to insert the structure assembly 1 for forming connective tissue bodies into the subcutaneous tissue. Further, since the structures 10 for forming connective tissue bodies that constitute the structure assembly 1 for forming connective tissue bodies are movable, damage to the subcutaneous tissue and the like received from the structure assembly 1 for forming connective tissue bodies during implantation is further suppressed, and the adhesion between the structure assembly 1 for forming connective tissue bodies and the living body during implantation is further improved. Further, in some cases, even if the structure assembly 1 for forming connective tissue bodies during implantation receives a large force from the living body, the structure assembly 1 for forming connective tissue bodies is not separated by the movement of the structures 10 for forming connective tissue bodies, so the structure assembly 1 for forming connective tissue bodies can be easily taken out. Thus, the ease of insertion and removal of the structure assembly 1 for forming connective tissue bodies, as well as the stability after implantation, are further improved.
[0049] For example, as shown in FIG. 8, at least one of the plurality of structures 10 for forming a connective tissue body is separably coupled to an adjacent structure 10 for forming a connective tissue body via a movable portion 80. The movable portion 80 is provided between adjacent structures 10 for forming a connective tissue body. For example, as shown in FIG. 8, the movable portion 80 extends along the longitudinal direction L of the support member 20 between the edges 421a of the side walls 42a of the adjacent housing members 30. For example, the movable portion 80 may have a hinge structure or may be an elastic body. Adjacent structures 10 for forming a connective tissue body are movably coupled rotatably about the movable portion 80 as a rotation center.
[0050] Also, it is preferable that all of the structures 10 for forming a connective tissue body are movably coupled to an adjacent structure 10 for forming a connective tissue body, and it is more preferable that they are separably and movably coupled to an adjacent structure 10 for forming a connective tissue body. When all adjacent structures 10 for forming a connective tissue body are movably coupled to each other or separably and movably coupled to each other, the ease of insertion and removal of the structure assembly 1 for forming a connective tissue body, as well as the stability after implantation, are further improved.
[0051] Also, as shown in FIG. 9, at least one terminal corner 44 of the housing member 30a that constitutes the structure 10a for forming a connective tissue body disposed at the end among the plurality of structures 10 for forming a connective tissue body arranged in parallel is preferably provided with a corner inclined surface 45 that connects to the adjacent terminal side surface 42b and the end surface 43 between the adjacent terminal side surface 42b and the end surface 43. The terminal side surface 42b of the housing member 30a disposed at the end constitutes the side surface of the outer edge of the structure assembly 1 for forming a connective tissue body. The corner inclined surface 45 connects to the adjacent terminal side surface 42b and the end surface 43 of the housing member 30a at an angle of 90 degrees or more, respectively. The terminal corner 44 having the corner inclined surface 45 is not a right-angled shape like the terminal corner 44 without the corner inclined surface 45, and the corner inclined surface 45 is an angled surface that connects to the terminal side surface 42b and the end surface 43 of the housing member at an angle of 90 degrees or more, respectively. Here, the corner inclined surface 45 is planar, but it may also be curved or may have a shape in which a plane and a curved surface are mixed.
[0052] When the sheet-like structural assembly 1 for forming a connective tissue body is inserted into the living body so as to be inserted from the terminal corner portion 44 having the corner inclined surface 45, the corner inclined surface 45 is located on the front surface in the insertion direction of the structural assembly 1 for forming a connective tissue body. When the sheet-like structural assembly 1 for forming a connective tissue body is inserted into the living body, the structural assembly 1 for forming a connective tissue body can be prevented from getting caught, particularly the terminal corner portion 44 having the corner inclined surface 45, with respect to the subcutaneous tissue, skin, the part where the subcutaneous tissue and skin are not peeled off, etc., so that the operability during the insertion of the structural assembly 1 for forming a connective tissue body is improved. In particular, as shown in FIG. 9, when the corner inclined surface 45 is provided between the end surface facing the end surface having the opening 31 and the terminal side surface 42b, since the end surface 43 connected to the corner inclined surface 45 is smooth, the insertion of the structural assembly 1 for forming a connective tissue body into the living body becomes even easier. Further, since the damage caused by the corner inclined surface 45 of the structural assembly 1 for forming a connective tissue body during implantation to the skin and subcutaneous tissue can be suppressed, the stability of the structural assembly 1 for forming a connective tissue body after implantation is further improved.
[0053] Further, the angle α formed between the corner inclined surface 45 and the terminal side surface 42b, and the angle β formed between the corner inclined surface 45 and the end surface 43 are preferably each greater than 90 degrees and less than 180 degrees, and more preferably both the angles α and β are 135 degrees. When the angles α and β are within the above ranges, the catching of the terminal corner portion 44 having the corner inclined surface 45 during the insertion of the structural assembly 1 for forming a connective tissue body is further suppressed, and the damage to the subcutaneous tissue, etc. caused by the terminal corner portion 44 having the corner inclined surface 45 during the implantation of the structural assembly 1 for forming a connective tissue body is further suppressed. Therefore, the ease of insertion of the structural assembly 1 for forming a connective tissue body and the stability after implantation are further improved.
[0054] Further, as shown in Fig. 10, the corner inclined surface 45 is preferably provided at the two terminal corners 44. Here, the corner inclined surfaces 45 are respectively provided between the end surface facing the end surface having the opening 31 and each terminal side surface 42b. For the structure assembly 1 for forming a connective tissue body having corner inclined surfaces 45 at a plurality of terminal corners 44 like this, in addition to insertion from the terminal corner 44 having the corner inclined surface 45, even if it is inserted so as to be inserted into the living body from the end surface 43 sandwiched between two adjacent corner inclined surfaces 45, the end surface 43 and the two corner inclined surfaces 45 become the front surface in the insertion direction of the structure assembly 1 for forming a connective tissue body, and since the catching during the insertion of the structure assembly 1 for forming a connective tissue body is suppressed, the insertion of the structure assembly 1 for forming a connective tissue body into the living body becomes even easier. Further, since the corner inclined surfaces 45 are provided at a plurality of terminal corners 44, damage to subcutaneous tissue and the like is further suppressed, and the stability after implantation of the structure assembly 1 for forming a connective tissue body is further improved.
[0055] Further, as shown in Fig. 11, it is more preferable that the corner inclined surface 45 is provided at the three terminal corners 44. Here, the corner inclined surfaces 45 are respectively provided between the end surface facing the end surface having the opening 31 and each terminal side surface 42b, and between the end surface having the opening 31 and the terminal side surface 42b. For the structure assembly 1 for forming a connective tissue body having corner inclined surfaces 45 at three adjacent terminal corners 44 like this, when removing the implanted structure assembly 1 for forming a connective tissue body from the living body from the corner inclined surface 45 on the end surface side having the opening 31 which is the rear surface side in the insertion direction, the catching of the terminal corner 44 having the corner inclined surface 45 on the rear surface side is suppressed. Therefore, the operability at the time of removing the structure assembly 1 for forming a connective tissue body from the living body is improved. Further, since the number of terminal corners 44 having the corner inclined surface 45 increases, damage to subcutaneous tissue and the like during implantation is further suppressed.
[0056] Further, as shown in FIG. 12, it is more preferable that the corner inclined surfaces 45 are provided at the four terminal corners 44. For the structure assembly 1 for forming a connective tissue body having the corner inclined surfaces 45 at all the terminal corners 44 in this way, no matter in which direction the structure assembly 1 for forming a connective tissue body is inserted into the living body and taken out from the living body, the catching of the structure assembly 1 for forming a connective tissue body is suppressed. Therefore, for the structure assembly 1 for forming a connective tissue body, the insertion into the living body and the extraction from the living body become easier. Further, since the corner inclined surfaces 45 are provided at all the terminal corners 44, the damage to the subcutaneous tissue and the like during implantation is further suppressed.
[0057] Further, as shown in FIG. 13, it is preferable that the respective corner inclined surfaces 45 provided at a plurality of adjacent terminal corners 44 are connected to each other. Here, the corner inclined surfaces 45 are respectively provided between the end surface facing the end surface having the opening 31 and each terminal side surface 42b, and the two corner inclined surfaces 45 are connected to each other. The end surface facing the end surface having the opening 31 is substantially composed of two corner inclined surfaces 45. For the structure assembly 1 for forming a connective tissue body having the corner inclined surfaces 45 connected continuously to each other in this way, when it is inserted into the living body so as to be inserted from the two corner inclined surfaces 45, the catching of the structure assembly 1 for forming a connective tissue body during the insertion of the structure assembly 1 for forming a connective tissue body is suppressed, so that the insertion of the structure assembly 1 for forming a connective tissue body into the living body becomes easier. Further, since the corner inclined surfaces 45 are provided at a plurality of terminal corners 44, the damage to the subcutaneous tissue and the like during implantation is further suppressed.
[0058] Further, in the structure assembly 1 for forming a connective tissue body shown in FIG. 13, the angle a formed between the two corner inclined surfaces 45 is preferably more than 90 degrees and less than 180 degrees, and more preferably 120 degrees or more and less than 180 degrees. When the formed angle a is within the above range, the ease of insertion and extraction of the structure assembly 1 for forming a connective tissue body, as well as the stability after implantation, are further improved.
[0059] Further, as shown in FIG. 14, at the terminal corner portion 44 having the corner inclined surface 45, it is preferable that a convex curved side wall inclined surface 46 that connects the corner inclined surface 45 and the side surface 42c is provided between the corner inclined surface 45 and the side surface 42c. The side surface 42c of the accommodating member 30a is a side surface that connects to the terminal side surface 42b. The side wall inclined surface 46 is a chamfered surface that connects to the corner inclined surface 45 and the side surface 42c at an angle of 90 degrees or more. When the structure assembly 1 for forming a connective tissue body includes the side wall inclined surface 46 in this way, the snagging of the structure assembly 1 for forming a connective tissue body and the damage to subcutaneous tissue and the like during implantation are further suppressed.
[0060] Further, as shown in FIG. 15, it is preferable that a covering portion 90 made of a material softer than the accommodating member 30 is provided on at least the corner inclined surface 45 of the accommodating member 30. When the structure assembly 1 for forming a connective tissue body includes the covering portion 90 in this way, even if the terminal corner portion 44 having the corner inclined surface 45 catches on the living body, in addition to suppressing damage to the living body, the damage to subcutaneous tissue and the like during implantation is further suppressed.
[0061] Next, a method for forming a connective tissue body according to the embodiment will be described. The method for forming a connective tissue body according to the embodiment includes a step (S-1) of inserting and implanting the above-described structure assembly 1 for forming a connective tissue body into a living body other than a human, a step (S-2) of forming a connective tissue body in the connective tissue body formation space 32 of the structure assembly 1 for forming a connective tissue body implanted in the living body, and a step (S-3) of removing the structure assembly 1 for forming a connective tissue body containing the connective tissue body formed in the connective tissue body formation space 32 from the living body.
[0062] In step (S-1), the structure assembly 1 for forming a connective tissue body is inserted into a predetermined site in a living body other than a human so as to be implanted into the living body. The structure assembly 1 for forming a connective tissue body is implanted into the subcutaneous tissue such as the limb part, shoulder part, back part, abdominal part, etc. As an example, a part of the skin such as the epidermis and dermis that covers the subcutaneous tissue from the outside is peeled off from the living body, the structure assembly 1 for forming a connective tissue body is inserted into the subcutaneous tissue so as to be inserted, and the partially peeled skin is sutured to the living body, whereby the structure assembly 1 for forming a connective tissue body is implanted into the subcutaneous tissue.
[0063] In step (S-2) performed after step (S-1), the structure assembly 1 for forming a connective tissue body is implanted into the living body for a predetermined time, and a hollow cylindrical connective tissue body is formed in the connective tissue body forming space 32 of the structure assembly 1 for forming a connective tissue body. During the implantation of the structure assembly 1 for forming a connective tissue body, the connective tissue in the living body enters the connective tissue body forming space 32 from the communication part 33 of the structure assembly 1 for forming a connective tissue body, and the connective tissue in the connective tissue body forming space 32 grows, whereby the connective tissue body is formed in the connective tissue body forming space 32. The connective tissue body is composed of extracellular matrix such as fibroblasts and collagen.
[0064] In step (S-3) performed after step (S-2), the structure assembly 1 for forming a connective tissue body containing the connective tissue body formed in the connective tissue body forming space 32 is taken out from the living body. In some cases, as the structure assembly 1 for forming a connective tissue body, a plurality of separated structure bodies 10 for forming a connective tissue body are taken out. When the connective tissue body formed in the connective tissue body forming space 32 is combined with the living tissue existing around the structure assembly 1 (structure body 10 for forming a connective tissue body) for forming a connective tissue body, the surrounding living tissue and the structure assembly 1 for forming a connective tissue body are cut, and the structure assembly 1 for forming a connective tissue body is taken out from the living body.
[0065] Also, in step (S-3), it is preferable to take out each connective tissue formation structure 10 constituting the connective tissue formation structure aggregate 1 from one extraction part. One extraction part can be easily formed in the living body by a single incision procedure. The extraction part is provided using the location of the insertion part used when inserting the connective tissue formation structure aggregate 1 into the living body in step (S-1) as a landmark. When a plurality of connective tissue formation structures 10 do not separate, or when a plurality of connective tissue formation structures 10 are connected via the connecting part 60 shown in FIG. 4, the connective tissue formation structure aggregate 1 can be taken out from one extraction part. Further, even when the connective tissue formation structures 10 are separated, since all the connective tissue formation structures 10 continue to be implanted in one part of the living body, all the connective tissue formation structures 10 can be taken out from one extraction part. Thus, since the connective tissue formation structure aggregate 1 and the connective tissue formation structures 10 continue to be implanted in one part of the living body, the connective tissue formation structure aggregate 1 and the connective tissue formation structures 10 can be easily taken out from one extraction part without providing a plurality of extraction parts.
[0066] Also, the method for forming the connective tissue of the embodiment may further include a step (S-4) of separating the connective tissue from the connective tissue formation space 32 of the connective tissue formation structure aggregate 1 (connective tissue formation structure 10) taken out from the living body after step (S-3). In step (S-4) performed after step (S-3), the connective tissue is separated from the connective tissue formation space 32 of the connective tissue formation structure aggregate 1 taken out from the living body to obtain a tubular connective tissue. When the connective tissue is formed on the outer surface of the connective tissue formation structure aggregate 1, after removing the connective tissue from the outer surface of the connective tissue formation structure aggregate 1, the connective tissue is separated from the connective tissue formation space 32.
[0067] In addition, when using the obtained connective tissue construct for xenotransplantation in humans or the like, in order to prevent rejection after transplantation, it is preferable to perform immunogen removal treatments such as decellularization treatment, dehydration treatment, and fixation treatment on the connective tissue construct. Examples of decellularization treatment include methods of eluting and washing the extracellular matrix by ultrasonic treatment, surfactant treatment, enzyme treatment such as collagenase, and the like. Examples of dehydration treatment include methods of washing with water-soluble organic solvents such as methanol, ethanol, and isopropyl alcohol. Examples of fixation treatment include methods of treating with aldehyde compounds such as glutaraldehyde and formaldehyde.
[0068] According to the embodiment described above, by optimizing the configuration of the plurality of connective tissue construct-forming structures 10 that are separably coupled to each other to form the connective tissue construct-forming structure assembly 1, the connective tissue construct-forming structure assembly 1 can be suitably implanted into a living body larger than a human. Furthermore, at least one of the ease of insertion into the living body, the ease of removal from the living body, the stability after implantation into the living body, and the productivity of the connective tissue construct is good for the connective tissue construct-forming structure assembly 1.
[0069] In the above, an example in which the support member 20 has a cylindrical shape has been shown, but the support member 20 may have a rectangular tubular shape. In this case, the shape of the inner surface 41 of the housing member 30 is appropriately set according to the outer shape of the support member 20 so that the distance d between the side surface 21 of the support member 20 and the inner surface 41 of the housing member 30 becomes constant.
[0070] In the above, an example in which the other end of the support member 20 is connected to the inside of the end wall of the housing member 30 has been shown, but one end of the support member 20 may be connected to the inner surface 34b of the lid portion 34. In this case, the other end of the support member 20 may or may not be connected to the inside of the end wall of the housing member 30.
[0071] In the above, an example in which the communication portion 33 is provided in one side wall 42 of each housing member 30 has been shown, but the communication portion 33 may be provided in a plurality of side walls 42 of each housing member 30.
[0072] In addition, in the above description, as shown in FIG. 5, an example in which the groove portion 70 extends over the entire surface in the longitudinal direction L of the support member 20 has been shown. However, as long as the stability after implantation of the structure assembly 1 for forming a connective tissue body is not reduced, for example, the groove portion 70 may extend partially along the longitudinal direction L of the support member 20. Further, the groove portions 70 may be provided on both opposing surfaces as shown in FIG. 5, or may be provided on only one surface.
[0073] In addition, in the above description, an example in which the outer shape of the housing member 30 is a square tube shape has been shown. However, as for the configuration of the housing member 30, cylindrical housing members 30 may be arranged as shown in FIG. 16, triangular tube-shaped housing members 30 may be arranged in parallel as shown in FIG. 17, or triangular tube-shaped housing members 30 may be arranged by alternately turning them upside down as shown in FIG. 18.
[0074] In addition, in the above description, examples in which a plurality of structures 10 for forming a connective tissue body are regularly joined alternately at the edges 421a and 421b have been shown as shown in FIG. 7. However, the plurality of structures 10 for forming a connective tissue body may be irregularly joined at the edges 421a and 421b. The joining arrangement of the structures 10 for forming a connective tissue body by the edges 421a and 421b can be appropriately set according to the shape in the living body.
[0075] In addition, in the above description, as shown in FIG. 14, an example in which the terminal corner portion 44 includes one side wall inclined surface 46 has been shown. However, the terminal corner portion 44 may include two side wall inclined surfaces. In this case, the two side wall inclined surfaces face each other via the corner inclined surface 45. When the terminal corner portion 44 includes two side wall inclined surfaces, the catching of the structure assembly 1 for forming a connective tissue body and the damage to subcutaneous tissue and the like during implantation are further suppressed.
[0076] Further, as shown in FIG. 19, a cover tube 23 extending along the longitudinal direction L may be provided on the side surface 21 of the support member 20. The cover tube 23 is cylindrical and covers the periphery of the side surface 21 of the support member 20. Similar to the support member 20, one end of the cover tube 23 may protrude from the opening 31 of the housing member 30.
[0077] Further, the lid portion 34 may have one or more through holes that communicate the connective tissue formation space 32 and the outside of the structure 10 for forming the connective tissue body. Through the communication portion 33 and the through holes, connective tissue enters the connective tissue formation space 32 from the outside of the structure 10 for forming the connective tissue body, so that a good cylindrical connective tissue body can be easily formed in the connective tissue formation space 32.
[0078] Further, at least one of the four corners of the lid portion 34 may be curved. When the structure assembly 1 for forming a connective tissue body is inserted into the living body from the curved corner of the lid portion 34, the operability during insertion of the structure assembly 1 for forming a connective tissue body is improved. In addition, since damage to the skin and subcutaneous tissue caused by the curved corner of the lid portion 34 in the structure assembly 1 for forming a connective tissue body during implantation can be suppressed, the stability of the structure assembly 1 for forming a connective tissue body after implantation is further improved. From the viewpoint of improving the operability during insertion of the structure assembly 1 for forming a connective tissue body and the stability after implantation of the structure assembly 1 for forming a connective tissue body, for the lid portion 34, it is preferable that one corner is curved, more preferably that two corners are curved, even more preferably that three corners are curved, and most preferably that all corners are curved.
[0079] Although the embodiments have been described above, the present invention is not limited to the above embodiments, includes all aspects included in the concept of the present disclosure and the scope of the claims, and can be variously modified within the scope of the present disclosure.
Explanation of Reference Numerals
[0080] 1 Structure assembly for forming a connective tissue body 10 Structure for forming a connective tissue body Structure for forming connective tissue body disposed at the terminal 10a 20 Support member 21 Side surface of the support member 22 End face of the support member 23 Cover tube 30 Housing member 30a Housing member disposed at the terminal 31 Opening 32 Connective tissue body formation space 33 Communication part 34 Cover part 34a Surface where the cover part can be easily separated 34b Inner surface of the cover part 41 Inner surface of the housing member 42, 42a Side walls of the housing member 421a, 421b Edges of the side walls of the housing member 42b Terminal side surface of the housing member 42c Side surface of the housing member 43 End face of the housing member 44 Terminal corner 45 Corner inclined surface 46 Side wall inclined surface 50 Weak adhesion part 60 Connecting part 60a One end of the connecting part 60b Portion excluding both ends of the connecting part 60c The other end of the connecting part 70 Groove part 80 Movable part 90 Coating part L Longitudinal direction of the support member
Claims
1. It has a plurality of connective tissue body forming structures having a cylindrical support member and a housing member for housing the support member, The plurality of connective tissue body forming structures are arranged in parallel, At least one of the plurality of connective tissue body forming structures is separably coupled to the adjacent connective tissue body forming structure during implantation into a living body, A connective tissue body forming space capable of forming a connective tissue body is provided between the support member and the inner surface of the housing member, The housing member is provided with a communication portion that communicates the connective tissue body forming space with the outside of the connective tissue body forming structure A structural assembly for forming a connective tissue body, characterized by the above.
2. The structural assembly for forming a connective tissue body according to claim 1, wherein the plurality of connective tissue body forming structures are arranged two-dimensionally.
3. The structural assembly for forming a connective tissue body according to claim 1 or 2, wherein at least one of the plurality of connective tissue body forming structures is separably coupled to the adjacent connective tissue body forming structure via a weak adhesive portion.
4. The structural assembly for forming a connective tissue body according to claim 1 or 2, wherein at least one of the plurality of connective tissue body forming structures is separably coupled to the adjacent connective tissue body forming structure via a connecting portion.
5. The structural assembly for forming a connective tissue body according to claim 4, wherein the density of the connecting portion is smaller than the density of the housing member.
6. The structural assembly for forming a connective tissue body according to any one of claims 1 to 5, wherein at least one of the plurality of connective tissue body forming structures is provided with a groove portion extending along the longitudinal direction of the support member.
7. The structural assembly for forming a connective tissue body according to any one of claims 1 to 6, wherein all of the connective tissue body forming structures are separably coupled to the adjacent connective tissue body forming structures.
8. The structural assembly for forming a connective tissue body according to any one of claims 1 to 7, wherein at least one of the plurality of connective tissue body forming structures is movably coupled to the adjacent connective tissue body forming structure.
9. The structural assembly for forming a connective tissue body according to any one of claims 1 to 8, wherein all of the connective tissue body forming structures are movably coupled to the adjacent connective tissue body forming structures.
10. Among the plurality of connective tissue formation structure bodies arranged in parallel, at least one end corner of the housing member constituting the connective tissue formation structure body arranged at the end is provided with a corner inclined surface connecting the adjacent end side surface and the end surface between the adjacent end side surface and the end surface. The connective tissue formation structure assembly according to any one of claims 1 to 9.
11. On at least the corner inclined surface of the housing member, a coating portion made of a material softer than the housing member is provided. The connective tissue formation structure assembly according to claim 10.
12. A step (S-1) of inserting and implanting the connective tissue formation structure assembly according to any one of claims 1 to 11 into a living body other than a human; A step (S-2) of forming a connective tissue body in the connective tissue body formation space of the connective tissue formation structure assembly implanted in the living body; A step (S-3) of taking out from the living body the connective tissue formation structure assembly containing the connective tissue body formed in the connective tissue body formation space Characterized by having a method for forming a connective tissue body.
13. In the step (S-3), each connective tissue formation structure body constituting the connective tissue formation structure assembly is taken out from one take-out portion. The method for forming a connective tissue body according to claim 12.
Citation Information
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