Medical device and method for delivering a sheet-like delivery object to a target site

Abstract

To provide a medical device for delivering a sheet-like object to a target portion while keeping its shape by a simple mechanism and an easy work.SOLUTION: The medical device for delivering a sheet-like object to a target portion comprises: a body having an arch-shaped portion; and a slider which slides so as to fold back an outer surface and inner surface of the arch-shaped portion. The slider has a low-adhesive peeling part and folds back the slider with the sheet-like delivery object placed thereon, at a tip of the body, thereby, enabling projecting the arch-shaped sheet-like delivery object toward the tip side of the body.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a medical device and method for delivering a sheet-like delivery object to a target site.

Background Art

[0002] In recent years, attempts have been made to transplant various cells for the repair of damaged tissues and the like. For example, for the repair of myocardial tissue damaged by ischemic heart diseases such as angina pectoris and myocardial infarction, the use of fetal cardiomyocytes, skeletal myoblasts, mesenchymal stem cells, cardiac stem cells, ES cells, iPS cells, etc. has been attempted (Non-Patent Document 1).

[0003] As part of such attempts, cell constructs formed using scaffolds and sheet-like cell cultures in which cells are formed into sheets have been developed (Non-Patent Document 2). Regarding the application of sheet-like cell cultures to treatment, studies have been conducted on the use of cultured epidermal sheets for skin damage caused by burns, etc., the use of corneal epithelial sheet-like cell cultures for corneal damage, the use of oral mucosal sheet-like cell cultures for endoscopic resection of esophageal cancer, etc., and some of them have entered the stage of clinical application.

[0004] Regarding the surgical method for administering a sheet-like cell culture to a target site, endoscopic surgery is widely used as a minimally invasive surgical method for the human body, and various instruments for delivering and administering a sheet-like cell culture to a target site have been proposed. For example, the transport and administration instrument described in Patent Document 1 can reduce the degree of invasion to the human body by making the sheet support member cylindrical and storing it in an outer cylinder, and transport a sheet-like therapeutic substance to the transplantation site.

[0005] The sheet sticking device described in Patent Document 2 can peel off a rod-shaped member arranged along the surface of the sheet support part by moving it along the surface of the sheet support part, and stick a sheet-like substance to the target site. The conveying and administering device described in Patent Document 3 can administer a sheet by means of a sheet detachment means capable of applying a negative pressure for adsorbing and holding a sheet-like therapeutic substance to a sheet support and a positive pressure for detaching the sheet-like therapeutic substance from the sheet support. The transfer device described in Patent Document 4 includes a displaceable body provided so as to be displaceable with respect to a main body portion, and a belt body wound so as to cover the displaceable body and connected to the main body portion. By displacing the displaceable body, a biological graft placed on the belt body can be transferred.

Prior Art Documents

Patent Documents

[0006]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Non-Patent Documents

[0007]

Non-Patent Document 1

Non-Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0008] The inventors of the present invention have faced problems such as it being difficult to efficiently deliver to the target site while maintaining the shape of the sheet-like delivery object as described above. Therefore, an object of the present invention is to solve such problems and realize a medical device for delivering a sheet-like delivery object to a target site with a simple mechanism and simple operation while maintaining the shape of the sheet-like delivery object.

Means for Solving the Problems

[0009] In the process of earnestly researching to solve the above problems, the inventors of the present invention have first found that by using a sliding body that slides on a main body having an arch-shaped part, it is possible to efficiently deliver to the target site while maintaining the shape of the sheet-like delivery object. As a result of further continuing research based on such findings, the present invention has been completed.

[0010] That is, the present invention relates to the following. [1] A medical device for delivering a sheet-like delivery object to a target site, comprising a main body having an arch-shaped part and a sliding body that slides so as to fold back the outer surface and the inner surface of the arch-shaped part, and by sliding the sliding body on which the sheet-like delivery object is placed, the sheet-like delivery object can be moved to an application position on the outer surface and a protection position on the inner surface. Said medical device. [2] The medical device according to [1], wherein the sliding body has a convex part extending in the sliding direction. [3] The medical device according to [1] or [2], wherein the sliding body has a hole and the fluid placed between the sliding body and the main body can be discharged from the hole. [4] The medical device according to any one of [1] to [3], further comprising an elongated body connected to the inner end of the sliding body. [5] The medical device according to any one of [1] to [4], further comprising a cylindrical body connected to the outer end of the sliding body.

[0011] [6] The medical device according to any one of [1] to [5], wherein the sliding body is expandable and contractible in the circumferential direction. [7] A method for delivering a sheet-like delivery object to a target site, comprising the steps of providing a medical device according to any one of [1] to [6], placing the sheet-like delivery object on a slider, moving the sheet-like delivery object to a protection position, bringing the medical device close to the target site, and moving the sheet-like delivery object to an application position. [8] The method according to [7], wherein the proximity to the target site is performed by inserting the medical device through a cylindrical body inserted transperitoneally into the body cavity. [9] The method according to [7] or [8] for delivering a sheet-like delivery object into the body cavity transperitoneally and delivering it to a target site.

[0012]

[10] A medical device for delivering a sheet-like delivery object to a target site, comprising a main body having an arch-shaped portion and a slider that slides so as to fold back the outer and inner surfaces of the arch-shaped portion. The slider has a low-adhesion peeling portion, and by folding back the peeling portion on which the sheet-like delivery object is placed at the tip of the main body, the arch-shaped sheet-like delivery object can protrude from the tip side of the main body.

[11] The medical device according to

[10] , wherein the peeling portion has elasticity.

[12] The medical device according to

[10] or

[11] , wherein the peeling portion has a plurality of convex portions.

[13] The medical device according to any one of

[10] to

[12] , wherein the peeling portion is folded back at the tip of the main body and detached from the sheet-like delivery object.

[14] The medical device according to any one of

[10] to

[13] , which is configured such that the sheet-like delivery object can be placed on the inner surface of the arch-shaped portion.

[15] The medical device according to any one of

[10] to

[14] , wherein the slider is expandable.

[0013]

[16] A method for delivering a sheet-like delivery object to a target site, comprising the steps of providing a medical device according to any one of

[11] to

[15] , placing the sheet-like delivery object on the peeling portion, bringing the medical device close to the target site, and protruding the sheet-like delivery object from the tip side of the main body.

[17] The method according to

[16] , wherein proximity to the target site is achieved by inserting a medical device through a tubular body inserted transperitoneally into the body cavity.

[18] The method according to

[16] or

[17] for delivering a sheet-like delivery object into the body cavity transperitoneally and delivering it to the target site.

[0014]

[19] A medical device for delivering a sheet-like delivery object to a target site, comprising a main body having an arch-shaped portion, a sliding body that slides so as to fold back the outer and inner surfaces of the arch-shaped portion, and a support body that is detachable from the sliding body. By attaching the support body on which the sheet-like delivery object is placed to the sliding body and sliding it, the sheet-like delivery object can be moved between an application position on the outer surface and a protection position on the inner surface.

[20] The medical device according to

[19] , wherein the support body has flexibility, one end of the support body is attached to the sliding body, and by sliding the sliding body, the support body can protrude to the tip side of the main body.

[21] The medical device according to

[20] , which can be rotated on the outer surface of the main body from a state where the support body protrudes to the tip side of the main body.

[22] The medical device according to

[19] , wherein the support body has flexibility, the lower surface of the support body is attached to the sliding body, and by sliding the sliding body, the support body can be folded back at the tip side of the main body.

[0015]

[23] The medical device according to any one of

[19] to

[22] , wherein the support body has holes.

[24] A method for delivering a sheet-like delivery object to a target site, comprising the steps of providing a medical device according to any one of

[19] to

[23] , placing the sheet-like delivery object on the support body, moving the support body to the protection position, bringing the medical device close to the target site, and moving the sheet-like delivery object to the application position.

[25] The method according to

[24] , wherein proximity to the target site is achieved by inserting a medical device through a tubular body inserted transperitoneally into the body cavity.

[26] The method according to

[24] or

[25] for transabdominally inserting a sheet-like delivery object into a body cavity and delivering it to a target site.

Advantages of the Invention

[0016] According to the present invention, with a simple mechanism and simple operation, while maintaining the shape of the sheet-like delivery object, it can be efficiently delivered to the target site, so there are great advantages in terms of workability and manufacturing cost.

Brief Description of the Drawings

[0017]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Modes for Carrying Out the Invention

[0018] In the present invention, the "sheet-like delivery product" means a sheet-like pharmaceutical product, a product for regenerative medicine, a medical device, etc. that is delivered to a living body and used for treatment or the like. The sheet-like form includes a film-like form and a membrane-like form (high-viscosity object). The sheet-like pharmaceutical products include tissue adhesives, local anesthetics, etc. The sheet-like products for regenerative medicine, etc. include grafts, cell cultures, etc. The sheet-like medical devices include adhesion preventives, hemostatic agents, wound covering materials, etc. In the present invention, the "graft" means a structure for transplantation into a living body, and particularly means a transplantation structure containing living cells as constituent components. Examples of the graft of the present invention include, but are not limited to, a sheet-like cell culture, a spheroid, a cell aggregate, etc., preferably a sheet-like cell culture or a spheroid, more preferably a sheet-like cell culture.

[0019] In the present invention, the "sheet-like cell culture" refers to a structure in which cells are connected to each other to form a sheet. The cells may be connected to each other directly (including those via cell elements such as adhesion molecules) and / or via an intervening substance. The intervening substance is not particularly limited as long as it can connect cells to each other at least physically (mechanically), and examples thereof include an extracellular matrix. The intervening substance is preferably derived from cells, particularly from the cells constituting the cell culture. The cells are at least physically (mechanically) connected, but may be further functionally connected, for example, chemically or electrically. The sheet-like cell culture may be composed of one cell layer (single layer) or may be composed of two or more cell layers (laminated (multilayer) body, for example, two layers, three layers, four layers, five layers, six layers, etc.). Further, the sheet-like cell culture may have a three-dimensional structure having a thickness exceeding the thickness of one cell without the cells showing a clear layer structure. For example, in the vertical cross-section of the sheet-like cell culture, the cells may be present in a non-uniform (for example, mosaic-like) arrangement without being uniformly aligned in the horizontal direction.

[0020] The sheet-shaped cell culture preferably does not contain a scaffold (support). A scaffold may be used in the art to attach cells on its surface and / or inside thereof and maintain the physical integrity of the sheet-shaped cell culture. The sheet-shaped cell culture of the present invention can maintain its physical integrity even without such a scaffold. Further, the physical strength of the sheet-shaped cell culture of the present invention can also be reinforced by applying fibrin or the like.

[0021] The cells constituting the sheet-shaped cell culture are not particularly limited as long as they can form a sheet-shaped cell culture, and include, for example, adherent cells (adhesive cells). Adherent cells include, for example, adherent somatic cells (e.g., cardiomyocytes, fibroblasts, epithelial cells, endothelial cells, hepatocytes, pancreatic cells, renal cells, adrenal cells, periodontal ligament cells, gingival cells, periosteal cells, skin cells, synovial cells, chondrocytes, etc.) and stem cells (e.g., tissue stem cells such as myoblasts and cardiac stem cells, pluripotent stem cells such as embryonic stem cells and iPS (induced pluripotent stem) cells, mesenchymal stem cells, etc.). The somatic cells may be those differentiated from stem cells, particularly iPS cells (iPS cell-derived adherent cells). Non-limiting examples of the cells constituting the sheet-shaped cell culture include, for example, myoblasts (e.g., skeletal myoblasts, etc.), mesenchymal stem cells (e.g., those derived from bone marrow, adipose tissue, peripheral blood, skin, hair follicles, muscle tissue, endometrium, placenta, umbilical cord blood, etc.), cardiomyocytes, fibroblasts, cardiac stem cells, embryonic stem cells, iPS cells, synovial cells, chondrocytes, epithelial cells (e.g., oral mucosal epithelial cells, retinal pigment epithelial cells, nasal mucosal epithelial cells, etc.), endothelial cells (e.g., vascular endothelial cells, etc.), hepatocytes (e.g., liver parenchymal cells, etc.), pancreatic cells (e.g., pancreatic islet cells, etc.), renal cells, adrenal cells, periodontal ligament cells, gingival cells, periosteal cells, skin cells, etc. Non-limiting examples of iPS cell-derived adherent cells include iPS cell-derived cardiomyocytes, fibroblasts, epithelial cells, endothelial cells, hepatocytes, pancreatic cells, renal cells, adrenal cells, periodontal ligament cells, gingival cells, periosteal cells, skin cells, synovial cells, chondrocytes, etc.

[0022] In the present invention, the "medical device" refers to mechanical devices and the like that are intended to be used for diagnosing, treating, or preventing diseases of humans or animals, or for affecting the structure or function of the body of humans or animals.

[0023] In the present invention, the "target site" refers to the part to which the sheet-like delivery material is applied (attached). Examples of the target site include the surface of an organ, an injured site of an organ, an anastomosis site of an organ, etc. The target site is typically the heart, the surface of the heart, an injured site of the heart, an anastomosis site of the heart, etc. In addition, the target site includes a site where an injury (wound) exists in a luminal organ, for example, an injured site inside the luminal wall, or the opposite side of the luminal wall corresponding to the site where the injury exists. The "luminal organ" means an organ having a lumen housed in a body cavity, that is, an organ having a tubular or bag-like structure, and examples include organs of the digestive system, circulatory system, urinary system, respiratory system, and genital system.

[0024] Examples of the organs of the digestive system include the esophagus, stomach, duodenum, pancreas, gallbladder, bile duct, small intestine, large intestine, rectum, etc. Among them, the duodenum is most preferred because the luminal wall is thin, the risk of perforation is high, and the deterioration of the injury tends to progress due to being in a harsh environment exposed to various digestive juices.

[0025] In one aspect, the sheet-like delivery material is immersed in a protective liquid. The "sheet-like delivery material" is not particularly limited as long as it is a liquid that can maintain the shape and function of the graft, and examples include liquids such as physiological saline, phosphate buffer solution (PBS), Hank's balanced salt solution, cell culture solution, water, or mixtures thereof.

[0026] In the present invention, "delivering the sheet-like delivery material to the target site" means moving the sheet-like delivery material from the proximal end side of the main body to the distal end side closer to the target site. The proximal end side of the main body is the side where the operator operates the medical device, and the distal end side of the main body is the opposite side of the proximal end side, closer to the target site and the side where the sheet-like delivery material is delivered. In the present invention, the "main body" refers to a plate-like member having a surface capable of supporting a sheet-like delivery object. The main body has an arch-shaped portion (arch-shaped part), and the arch-shaped part has an inner surface and an outer surface on the opposite side of the inner surface. When the main body has, for example, a cylindrical shape with a square cross-section formed by connecting four plate-like members, the arch-shaped part is a reversed C shape including a U shape, and the inner concave surface is the inner surface, and the outer protruding surface on the opposite side is the outer surface.

[0027] When the main body has, for example, a cylindrical shape with a circular cross-section formed by rounding a single plate-like member into a circular shape, the arch-shaped part is a reversed C shape including an O shape, and the inner surface and the outer surface are curved surfaces. When the main body has, for example, a semi-cylindrical shape with a semi-circular cross-section formed by rounding a single plate-like member into a semi-circular shape, the arch-shaped part is a C shape, and the inner surface and the outer surface are curved surfaces. That is, the arch-shaped part refers to the arch-shaped part in the main body in the shape of a reversed C, U, O, or C. The reversed C shape includes the U shape, and the O shape includes the C shape. In the present invention, the concave side of the arch-shaped part may be referred to as the inner surface, concave surface, inner side, inside, and the protruding side of the arch-shaped part may be referred to as the outer surface, convex surface, outer side, outside. The arch shape includes the arc shape.

[0028] Either one of the inner surface and the outer surface of the arch-shaped part may be a flat surface. For example, the inner surface may be a concave surface and the outer surface may be a flat surface, or the inner surface may be a flat surface and the outer surface may be a convex surface. The main body has rigidity, and by arranging the sheet-like delivery object on its concave surface, the sheet-like delivery object can be protected from external forces, and by arranging the sheet-like delivery object on the convex surface or the concave surface, the sheet-like delivery object can be held in a convex or concave shape. The main body only needs to have at least a part of an arch-shaped part having a concave surface and / or a convex surface, and may be a member with a semi-circular, circular, square, or polygonal cross-section. The main body is preferably long so that a plurality of sheet-like delivery objects can be linearly supported.

[0029] The material of the main body is not particularly limited, and various known materials can be used alone or in combination. Such materials include, for example, metals, soft vinyl chloride resins, polyurethane resins, silicone rubbers, natural rubbers, synthetic rubbers, styrene-ethylene-butylene-styrene copolymers (SEBS), styrene-ethylene-propylene-styrene copolymers (SEPS), ethylene-vinyl acetate copolymers (EVA), polyamide resins such as nylon and polyamide elastomers, polyester resins such as polyethylene terephthalate (PET) and polyester elastomers, olefin resins such as polyethylene, fluororubbers, fluororesins, polystyrene, polymethyl methacrylate, polycarbonate, polyimide, polyetherimide, polyether ether ketone, etc. One or more of these can be used in combination.

[0030] In the present invention, the "sliding body" refers to a belt-shaped body on which a sheet-shaped delivery object can be placed on the surface while maintaining its shape. The sliding body can slide along the surface shape of the main body. When sliding on the outer surface (convex surface), it deforms into a convex shape along the convex surface, and when sliding on the inner surface (concave surface), it deforms into a concave shape along the concave surface. The belt-shaped body has a length that can slide along the main body, and one sheet-shaped delivery object can be supported on it, or a plurality of sheet-shaped delivery objects can be linearly supported. The sliding body slides along the long axis direction of the main body and is folded back at the tip of the main body, so as to move from the inner surface to the outer surface and from the outer surface to the inner surface. That is, the sliding body is turned upside down by being folded back, and the support surface on which the sheet-shaped delivery object is placed is also turned upside down.

[0031] The material of the sliding body is not particularly limited, and various known materials can be used alone or in combination. Examples of such materials include metals, soft vinyl chloride resins, polyurethane resins, silicone rubbers, natural rubbers, synthetic rubbers, styrene-ethylene-butylene-styrene copolymers (SEBS), styrene-ethylene-propylene-styrene copolymers (SEPS), ethylene-vinyl acetate copolymers (EVA), polyamide resins such as nylon and polyamide elastomers, polyester resins such as polyethylene terephthalate (PET) and polyester elastomers, olefin resins such as polyethylene, fluorine rubbers, fluorine resins, etc. One or more of these can be used in combination.

[0032] In the present invention, the "hole" refers to one or more through-holes provided in the support surface on which sheet-like delivery objects such as sliding bodies and supports are placed. By feeding fluid from the opposite side of the surface supporting the sheet-like delivery object and discharging the fluid through the holes, the sheet-like delivery object can be peeled off from the support surface and attached. The holes only need to be able to discharge fluid. If at least one hole is provided in the portion near the edge of the sheet-like delivery object on the support surface, the peeling of the sheet-like delivery object can be performed from near its edge.

[0033] The holes are preferably arranged in a plurality of discrete positions on the support surface so as to be able to adjust the peeling position of the sheet-like delivery object. For example, at least one of the plurality of holes is provided near the edge of the sheet-like delivery object, and the sheet-like delivery object is peeled from near the edge, and then fluid is discharged from other holes, so that the sheet-like delivery object can be peeled step by step. The arrangement of the plurality of holes can be, for example, a matrix arrangement of rows and columns such as 2×2 to 40×40, 5×5 to 20×20, the interval between the holes can be, for example, 0.05 mm to 10 mm, 0.5 mm to 2 mm, and the diameter of the holes can be, for example, 0.05 mm to 10 mm, 0.3 to 0.6 mm, but it is not limited thereto, and those skilled in the art can freely select according to the size of the sheet-like delivery object, the degree of adhesion between the sheet-like delivery object and the support surface, etc. By making the structure of the support surface a mesh structure, a matrix arrangement of a plurality of holes can also be achieved.

[0034] In the present invention, the "fluid" refers to the general term for gas and liquid that can be extruded and peeled without damaging the sheet-like delivery object. The liquid is composed of at least one component, and the component is not particularly limited, but is composed of, for example, liquids such as water, aqueous solution, non-aqueous solution, suspension, emulsion. The component constituting the liquid is not particularly limited as long as it has little influence on the sheet-like delivery object. When the sheet-like delivery object is a film made of a bio-derived material, the component constituting the liquid is preferably biocompatible, that is, it does not cause undesirable effects such as an inflammatory reaction, an immune reaction, or a toxic reaction on living tissues and cells, or at least such effects are small.

[0035] In the present invention, the "support" refers to a plate-like body having a plane capable of supporting a sheet-like delivery object while maintaining its shape. The support has flexibility and can be curved while supporting the sheet-like delivery object and stored along the inside of the main body or the like. When exposed from the main body, it can be unfolded into a planar shape due to its resilience. The material of the support is not particularly limited, and various known materials can be used alone or in combination. Such materials include, for example, metals, soft vinyl chloride resins, polyurethane resins, silicone rubbers, natural rubbers, synthetic rubbers, styrene-ethylene-butylene-styrene copolymers (SEBS), styrene-ethylene-propylene-styrene copolymers (SEPS), ethylene-vinyl acetate copolymers (EVA), polyamide resins such as nylon and polyamide elastomers, polyester resins such as polyethylene terephthalate (PET) and polyester elastomers, olefin resins such as polyethylene, fluorine rubbers, fluorine resins, etc., and one or more of these can be used in combination.

[0036] In the present invention, the "cylindrical body (tubular body)" refers to a pipe-shaped long object having a space inside. The cylindrical body has openings at both ends and can deliver the delivery object to the tip side through the internal space. The cylindrical body is not particularly limited as long as it has a rigidity sufficient to protect the delivery object from external forces, and any commercially available cylindrical body can be used. Examples of the material of the cylindrical body include, but are not limited to, polyethylene, polypropylene, fluorine resin, polyethylene terephthalate, polymethyl methacrylate, polyamide resin, polystyrene, polycarbonate, polyimide, polyetherimide, polyetheretherketone, glass, metals (e.g., iron, stainless steel, aluminum, copper, brass), etc.

[0037] The cylindrical body may be made of a flexible material. In this case, even if the passage for insertion into the body during laparoscopic surgery or thoracoscopic surgery is curved, it can be bent according to the shape of the passage or bent to adjust the relative angle between the cylindrical body and the target site. The outer diameter of the cylindrical body is not particularly limited, but can be, for example, 2.2 to 25 mm, preferably 5 to 20 mm. The inner diameter of the cylindrical body is not particularly limited, but can be, for example, 2 to 20 mm, preferably 3 to 15 mm.

[0038] In the present invention, the "peeling portion" refers to the portion of the sliding body on which the sheet-like delivery object is placed, and the "low adhesion" means that the adhesion between the sheet-like delivery object and the peeling portion is low. The peeling portion of the sliding body can be realized by making it of a low-adhesion material or by applying a low-adhesion material to the surface. The degree of low adhesion can be quantified, for example, by applying a tensile load to the sheet-like delivery object on the peeling portion and measuring the load at the time of peeling. The peeling load is typically 0.0001 N to 0.5 N, preferably 0.001 N to 0.1 N. A person skilled in the art can find the optimal low-adhesion material by examining the adhesion between the sheet-like delivery object and the peeling portion using various materials.

[0039] The low-adhesion peeling portion can also be realized by processing the portion of the sliding body on which the sheet-like delivery object is placed. For example, a plurality of convex portions are formed on a part of the sliding body, and the contact area is reduced by the contact between the sheet-like delivery object and the plurality of convex portions, so that the low-adhesion peeling portion can be realized. The low-adhesion peeling portion can also be realized by giving elasticity to the portion of the sliding body on which the sheet-like delivery object is placed. That is, for example, when the elastic peeling portion is folded back from the outside to the inside at the tip of the main body, the peeling portion pulled inward stretches. When the peeling portion stretches (the area increases), the non-stretching sheet-like delivery object placed thereon detaches from the peeling portion. The elastic peeling portion can be configured to stretch to a length that is, for example, 1.1 to 5 times, 1.8 to 4 times, or about 2 to 3 times the original length. A person skilled in the art can find the optimal stretchable material by examining the adhesion between the sheet-like delivery object and the peeling part using various materials.

[0040] The sizes and materials of the main body, sliding body, convex part, hole, long body, cylindrical body, support body, cylindrical tube, etc. can be freely selected in consideration of the size and type of the sheet-like delivery object to be delivered to the target site, the number of multiple sheet-like delivery objects to be continuously delivered, the distance from the target site, operability, weight, cost, etc. When the sheet-like delivery object is, for example, a sheet-like cell culture with a diameter of about 60 mm, the diameter of the main body can be 2.2 to 25 mm, preferably 5 to 20 mm, more preferably 10 to 15 mm.

[0041] Hereinafter, a medical device according to a preferred embodiment of the present invention will be described in detail with reference to the drawings. FIG. 1 is a conceptual diagram showing a medical device according to a first embodiment of the present invention, FIG. 2 is a diagram showing a usage example of the medical device according to the first embodiment, FIG. 3 is a conceptual diagram showing a first modification of the medical device of the first embodiment, FIG. 4 is a conceptual diagram showing a second modification of the medical device of the first embodiment, FIG. 5 is a diagram showing a usage example of the medical device according to a second embodiment of the present invention, FIG. 6 is a diagram showing a usage example of the medical device according to a third embodiment of the present invention, and FIG. 7 is a diagram showing a usage example of a first modification of the medical device of the third embodiment. In each of the drawings in the present application, for the sake of easy explanation, the sizes of the respective members are emphasized as appropriate, and the members shown in the drawings do not indicate the actual sizes.

[0042] First Embodiment First, a first embodiment of the present invention will be described. As shown in FIG. 1, the medical device M according to the first embodiment of the present invention includes a main body 1 and a sliding body 2. The main body 1 is a long cylindrical body having a cylindrical shape, and the inner surface of the arch-shaped portion in the shape of О is a concave curved surface, and the outer surface is a convex curved surface. The sliding body 2 is a long strip having a cylindrical shape and has an inner diameter larger than the outer diameter of the main body 1. The sliding body 2 can be slid so as to fold back the outer surface and the inner surface of the main body 1, and deforms along the outer surface shape and the inner surface shape of the main body 1. It is desirable that the tip end portion of the main body 1 has an R-shaped cross section in order to smooth the sliding of the sliding body 2 and suppress the wear of the sliding body 2.

[0043] For example, the sliding body 2 can be passed through from the proximal end side (the right side in FIG. 1) of the main body 1 to the outside, pulled in the distal end direction (the left direction in FIG. 1), folded back inside at the tip end portion of the main body 1, and the folded-back portion is pulled in the proximal end direction, whereby the inner surface and the outer surface of the main body 1 can be covered. Then, by pulling the inner end portion 21 of the sliding body 2 in the proximal end direction of the main body 1, the sliding body 2 can be slid from the outer surface of the main body 1 to the inner surface, and conversely, by pulling the outer end portion 22 of the sliding body 2 in the proximal end direction of the main body 1, the sliding body 2 can be slid so as to fold back from the inner surface of the main body 1 to the outer surface.

[0044] The inner end portion 21 of the sliding body 2 can be connected to a long body 3 that can advance and retreat axially inside the main body 1 (at the portion indicated by the oblique lines). The outer end portion 22 of the sliding body 2 can be connected to a cylindrical body 4 that can advance and retreat axially outside the main body 1 (at the portion indicated by the oblique lines). That is, the long body 3 and the cylindrical body 4 function as operation portions for operating the sliding body 2, and by pushing or pulling these in the distal end direction or the proximal end direction of the main body 1, the sliding body 2 can be slid with respect to the main body 1.

[0045] As shown in Fig. 1, when installing the sheet-like delivery object S on the medical device M, first place the sheet-like delivery object S on the support surface of the slider 2 on the outer surface of the main body 1 (placement position). Next, as shown in Fig. 2a, by pulling the elongated body 3 in the proximal direction, the support surface is drawn into the inner surface of the main body 1. The support surface is folded back at the tip of the main body 1 and turned upside down from the outer surface side to the inner surface side, and the sheet-like delivery object S is protected from external forces on the inner surface (concave surface) while maintaining its shape (protection position).

[0046] Next, with the sheet-like delivery object S held on the inner surface of the main body 1, by inserting the medical device M transabdominally into the body cavity, the sheet-like delivery object S can be brought close to the target site T while maintaining its shape. Then, as shown in Fig. 2b, grasp the cylindrical body 4 inserted into the body cavity with a finger or the like, push the elongated body 3 into the main body 1, expose the support surface of the slider 2 from the inside to the outside of the main body 1 (application position), peel off the sheet-like delivery object S, and apply it to the target site T.

[0047] When applying a plurality of sheet-like delivery objects S to the target site T, place the plurality of sheet-like delivery objects S linearly in the sliding direction of the slider 2 and perform the same operation as in Fig. 2a to protect the plurality of sheet-like delivery objects S on the concave surface of the main body 1. Then, by operating the medical device M inserted into the body cavity in the same manner as in Fig. 2b, move the plurality of sheet-like delivery objects S from the inside to the outside of the main body 1 and apply the plurality of sheet-like delivery objects S to the target site T.

[0048] The application of the sheet-like delivery object S to the target site T can be realized by rotating the main body 1 so that the support surface of the slider 2 supporting the sheet-like delivery object S faces the target site T side, pressing the sheet-like delivery object S against the target site T and peeling it off, using forceps C or the like to peel off the sheet-like delivery object S from the slider 2 and placing it on the target site T. When applying a plurality of sheet-like delivery objects S to the target site T, they can be applied to the target site T while moving the sheet-like delivery objects S one by one from the inside to the outside of the main body 1.

[0049] The main body 1 may have any shape as long as it has a concave surface that can protect the sheet-like delivery object S from external forces. Even if the main body 1 is, for example, a plate-like member with a semi-circular (C-shaped) or U-shaped cross-section, and the slider 2 is a ribbon-shaped strip, while moving the slider 2 to the inner surface (concave surface) side of the arch-shaped part, the main body 1 can be used like a spatula to scoop up and place the sheet-like delivery object S to appropriately protect it. And as shown in Fig. 2a, by moving the cylindrical body 4 to the tip side of the main body 1 to cover the sheet-like delivery object S, the sheet-like delivery object S can be more appropriately protected.

[0050] Fig. 3 is a conceptual diagram showing a first modification example of the medical device M. In this modification example, the slider 2 has a plurality of convex portions 23. When the slider 2 is on the outer surface of the main body 1, it contracts in diameter according to the outer diameter of the main body 1, and when it is on the inner surface of the main body 1, it contracts in diameter according to the inner diameter of the main body 1. That is, the sheet-like delivery object S drawn into the inner surface of the main body 1 can be more securely fixed to the slider 2 by being gripped in a state where the distance between the convex portions 23 is narrowed.

[0051] Fig. 4 is a conceptual diagram showing a second modification example of the medical device M. In this modification example, the slider 2 has holes 24 in the support surface, and by sending fluid from the side opposite to the surface supporting the sheet-like delivery object S, the sheet-like delivery object S can be detached from the slider 2 and dropped onto the target site T. Fig. 4a shows the case where the proximal end side of the main body 1 is closed by the valve V and fluid is sent from the port P on the side surface of the main body 1 toward the inner end portion 21 of the slider 2, and Fig. 4b shows the case where the proximal end side of the cylindrical body 4 is closed by the valve V and fluid is sent from the port P on the side surface of the cylindrical body 4 toward the outer end portion 22 of the slider 2.

[0052] The use of the medical device M in the first embodiment can be sequentially performed by the following steps. (1) Provide the medical device M (2) Place the sheet-like delivery object S on the slider 2 (3) Move the sheet-like delivery object S to the protection position (4) Bring the medical device M close to the target site T (5) Move the sheet-like delivery object S to the application position (6) Peel off the sheet-like delivery object S (7) Apply the sheet-like delivery object S to the target site T

[0053] By steps (1) to (5), the sheet-like delivery object S can be delivered to the target site T. In (2), the sheet-like delivery object S can be placed on the inner sliding body 2 or the outer sliding body 2 inside the main body 1. In (3), the sheet-like delivery object S can also be covered with the cylindrical body 4. In (4), the medical device M can be inserted through the cylindrical body inserted transabdominally into the body cavity and brought close to the target site T. In (7), the sheet-like delivery object S can also be dropped and applied to the target site T.

[0054] As described above, according to the present invention, with a simple mechanism and simple operation, while maintaining the shape of the sheet-like delivery object, it can be efficiently delivered to the target site, so there are great advantages in terms of workability and manufacturing cost.

[0055] Second Embodiment Hereinafter, the medical device according to the second preferred embodiment of the present invention will be described in detail with reference to the drawings. As shown in FIG. 5, the medical device M according to the second embodiment of the present invention includes a main body 1 and a ribbon-shaped sliding body 2. The sliding body 2 has a peeling portion for supporting the sheet-like delivery object S. The peeling portion is a portion of the sliding body 2 that supports the sheet-like delivery object S, and its surface has low adhesion. As shown in FIG. 5a, when installing the sheet-like delivery object S on the medical device M, first, move the peeling portion of the sliding body 2 to the outer surface of the arch-shaped portion of the main body 1 (placement position) and place the sheet-like delivery object S on the peeling portion.

[0056] As shown in Fig. 5b, by pulling the elongated body 3 in the proximal direction, the peeling portion is drawn into the inner surface of the main body 1. While the peeling portion is folded back at the tip of the main body 1 and turned upside down from the outer surface side to the inner surface side, the sheet-like delivery object S protrudes from the tip side of the main body 1 without being reversed. That is, the sheet-like delivery object S held in an arch shape on the outer surface moves in the tip direction together with the peeling portion, and when the peeling portion is folded back at the tip portion, the sheet-like delivery object S detaches from the peeling portion with low adhesion. The sheet-like delivery object S having an arch shape and a certain strength protrudes from the tip side of the main body 1 while maintaining its shape (application position). In order to give the sheet-like delivery object S a certain strength, fibrin or the like can also be applied to the sheet-like delivery object S for reinforcement.

[0057] That is, as shown in Fig. 5b, since the sheet-like delivery object S protrudes from the sliding body 2 in a detached state on the tip side, it can be easily grasped (clamped) with forceps C or the like and applied to the target site T. Also, as shown in Fig. 5c, the main body 1 can be rotated so that the sheet-like delivery object S faces the target site T side, and the sheet-like delivery object S can be placed on the target site T, or the tip (sheet-like delivery object S) of the main body 1 can be pressed against the target site T without rotation. It is also possible to further protrude the sheet-like delivery object S from the state of Fig. 5b, detach the sheet-like delivery object S from the sliding body 2, and drop it onto the target site T.

[0058] Contrary to Fig. 5a, the sheet-like delivery object S can also be placed in a state where the peeling portion of the sliding body 2 is moved to the inner surface of the arch-shaped portion of the main body 1. That is, when a part of the arch-shaped portion of the main body 1 is open like a U-shape or a C-shape, in a state where the peeling portion is moved to the inner surface (placement position), the main body 1 can be used like a spatula to scoop up and place the sheet-like delivery object S. Thereby, the sheet-like delivery object S is protected on the inner surface (protection position), and by sliding the peeling portion so as to be folded back from the inside to the outside of the main body 1, the arch-shaped sheet-like delivery object S can also be protruded from the tip side of the main body 1 (application position). When a part of the main body 1 is open, the sliding body 2 can be connected to a cylindrical body 4 (not shown), the cylindrical body 4 can be moved to the tip side of the main body 1, and the sheet-like delivery object S can be more appropriately protected.

[0059] The use of the medical device M of the present invention can be sequentially performed by the following steps. (1) Provide the medical device M (2) Place the sheet-like delivery object S on the peeling part (3) Bring the medical device M close to the target site T (4) Push out the sheet-like delivery object S in the tip direction of the main body 1 (5) Apply the sheet-like delivery object S to the target site T

[0060] By steps (1) to (4), the sheet-like delivery object S can be delivered to the target site T. In (2), the sheet-like delivery object S can be placed on the peeling part inside or outside the main body 1. When connecting the sliding body 2 to the cylindrical body 4, in (3), the cylindrical body 4 can also be moved to the tip side of the main body 1 to cover the sheet-like delivery object S. In (3), the medical device M can also be inserted through the cylindrical body inserted transabdominally into the body cavity and brought close to the target site T. Between (4) and (5), step (6) of detaching the sheet-like delivery object S from the sliding body 2 may be included. In (5), the sheet-like delivery object S can also be dropped and applied to the target site T.

[0061] As described above, according to the present invention, with a simple mechanism and simple operations, the sheet-like delivery object can be efficiently delivered to the target site while maintaining its shape, so there are great advantages in terms of workability and manufacturing cost.

[0062] Third Embodiment Hereinafter, the medical device according to the third preferred embodiment of the present invention will be described in detail with reference to the drawings. As shown in FIG. 6, the medical device M according to the third embodiment of the present invention includes a main body 1, a sliding body 2, and a support body 5. The sliding body 2 is a ribbon-shaped strip, and is wound along the axial direction between the base end portion and the tip end portion of the main body 1. A part of the sliding body 2 can be connected to the long body 3, and by advancing and retreating the long body 3 with respect to the main body 1, the sliding body 2 can be slid in the tip direction or the base end direction.

[0063] The support body 5 can be connected to the sliding body 2 through a connection part 51 at one end thereof, and can slide on the outer and inner surfaces of the main body 1 so as to follow the sliding of the sliding body 2. As shown in FIG. 6a, the support body 5 has flexibility. When the support body 5 protrudes toward the tip end side of the main body 1, it is unfolded flatly, and the sheet-like delivery object S can be placed on its surface. When placing the sheet-like delivery object S, the support body 5 on which the sheet-like delivery object S is placed can also be attached to the sliding body 2.

[0064] Next, as shown in FIG. 6b, by pulling the long body 3 to which the sliding body 2 is connected in the proximal direction, the support body 5 is drawn into the inner surface of the arch-shaped portion of the main body 1. The support body 5 is curved by being pressed against the tip end portion of the main body 1, and is stored on the inner surface of the main body 1 while supporting the sheet-like delivery object S inside. Next, with the sheet-like delivery object S held on the inner surface of the main body 1, by inserting the medical device M transabdominally into the body cavity, it is possible to efficiently approach the target site T while maintaining the shape of the sheet-like delivery object S.

[0065] Then, as shown in FIG. 6c, by pushing the long body 3 to which the sliding body 2 is connected into the main body 1 and protruding and unfolding the support body 5 toward the tip end side of the main body 1, the sheet-like delivery object S can be applied to the target site T (application position). Further, as shown in FIG. 6d, by pushing the long body 3 further in the tip end direction of the main body 1 and inverting one end (connection part 51) of the support body 5 connected to the sliding body 2 to the outside of the arch-shaped portion of the main body 1, the support body 5 can also be pivoted on the outer surface of the main body 1 (application position).

[0066] As shown in FIG. 6c, when the support body 5 is on the outer surface of the main body 1, since the sheet-like delivery object S faces the target site T side, it is not necessary to rotate the main body 1 and the operation is simple. The support body 5 may have a hole (not shown), and by discharging a fluid through the hole from the side opposite to the surface of the support body 5 that supports the sheet-like delivery object S, the sheet-like delivery object S can be detached from the support body 5 and dropped onto the target site T.

[0067] FIG. 7 is a conceptual diagram showing a first modification of the medical device M according to the third embodiment. In this modification, the support 5 has flexibility, and the connecting portions 51 at both ends thereof can be connected to the slider 2. As shown in FIG. 7a, when placing the sheet-like delivery object S, the slider 2 (support 5) is moved onto the outer surface of the main body 1 and placed (placement position). Next, as shown in FIG. 7c, by pulling the slider 2 to which the support 5 is connected into the inner surface of the main body 1, the sheet-like delivery object S is protected on the inner surface (protection position).

[0068] With the sheet-like delivery object S held on the inner surface of the main body 1, by inserting the medical device M transabdominally into the body cavity, while maintaining the shape of the sheet-like delivery object S, it is possible to efficiently approach the target site T. Then, as shown in FIG. 7e, by pushing the elongate body 3 in the distal direction of the main body 1 and inverting the support 5 onto the outer surface of the main body 1 (application position), the sheet-like delivery object S can be peeled off and applied to the target site T.

[0069] In FIG. 6d, the flexible support 5 turns greatly as indicated by the arrow, whereas in FIGS. 7b and 7d, when the slider 2 is folded back at the distal end portion of the main body 1, the flexible support 5 follows and turns (is folded back) slightly as indicated by the arrow. By the small turning of the support 5, problems such as the support 5 inadvertently damaging the target site T can be prevented.

[0070] The use of the medical device M according to the third embodiment can be sequentially performed by the following steps. (1) Provide the medical device M (2) Place the sheet-like delivery object S on the support 5 (3) Move the support 5 to the protection position (4) Approach the medical device M to the target site T (5) Move the sheet-like delivery object S to the application position (6) Peel off the sheet-like delivery object S (7) Apply the sheet-like delivery object S to the target site T

[0071] By the operations (1) to (5), the sheet-like delivery object S can be delivered to the target site T. In (2), the support 5 on which the sheet-like delivery object S is placed may be attached to the slider 2, or the sheet-like delivery object S may be placed in a state where the support 5 attached to the slider 2 protrudes from the tip side of the main body 1. In (3), the support 5 can also be covered with the cylindrical body 4. In (4), the medical device M can be inserted through the cylindrical body inserted transperitoneally into the body cavity and brought close to the target site T.

[0072] (6), the sheet-like delivery object S can also be peeled off from the support 5 by discharging fluid from the holes provided in the support 5. In (7), the sheet-like delivery object S can also be dropped onto the target site T for application. Between (5) and (6), (8) a step of gripping the support 5 with forceps C or the like and removing it from the slider 2 may be included. In (7), the removed support 5 can also be dropped onto the target site T to apply the sheet-like delivery object S.

[0073] When connecting one end of the support 5, the application position in (5) can take a state where the support 5 protrudes from the tip side of the main body 1 (Fig. 6c), or a state where the support 5 is swiveled on the outer surface of the main body 1 (Fig. 6d). When discharging fluid from the holes provided in the support 5, it is preferably performed in a state where the support 5 protrudes from the tip side of the main body 1. When connecting both ends of the support 5, since the application position is in a state where the support 5 is swiveled on the outer surface of the main body 1 (Fig. 7e), the sheet-like delivery object S can be applied by pressing the support 1 side of the main body 1 against the target site T.

[0074] As described above, according to the present invention, with a simple mechanism and simple operations, it is possible to efficiently deliver to the target site while maintaining the shape of the sheet-like delivery object, so there are great advantages in terms of workability and manufacturing cost.

[0075] The present invention has been described above with respect to the illustrated embodiments, but the present invention is not limited thereto. The configurations of the first to third embodiments can be combined as appropriate. In the present invention, each component can be replaced with any component that can exhibit the same function, or any component can be added.

[0076] As a modification, for example, as shown in FIG. 8a, the outer periphery of the sliding body 2 can be made expandable so as to be larger than the diameter of the sheet-like delivery object S, and the sheet-like delivery object S can be placed and applied. Then, as shown in FIG. 8b, by contracting the sliding body 2 to reduce the outer diameter, a minimally invasive medical device M can also be realized. Since it is necessary to inject fluid to expand the sliding body 2, a valve body V is provided in the elongated body 3 and the cylindrical body 4, and an injection port P is provided in at least one of them.

[0077] Also, as a modification, in order to efficiently accommodate the sliding body 2 that has expanded significantly in diameter compared to the outer diameter of the main body 1 and the large-area sheet-like delivery object S placed thereon on the inner surface of the main body 1 (FIG. 8c), as shown in FIG. 9, by providing a serrated wavy unevenness at the tip of the main body 1, the sliding body 2 can be accommodated so as to be wrinkled in a folded star shape on the inner surface of the main body 1. By making the cross-section of the inner surface of the main body 1 serrated (not shown), the same effect can also be exhibited.

Explanation of Reference Numerals

[0078] 1 Main body 2 Sliding body 21 Inner end 22 Outer end 23 Protrusion 24 Hole 3 Elongated body 4 Cylindrical body 5 Support 51 Connection part S Sheet-like delivery object T Target site C Forceps

Claims

1. A medical device for delivering a sheet-like delivery object to a target site, comprising a main body having an arch-shaped portion and a sliding body that slides so as to fold back the outer and inner surfaces of the arch-shaped portion. The sliding body has a low-adhesion peeling portion. By folding back the peeling portion on which the sheet-like delivery object is placed at the tip of the main body, an arch-shaped sheet-like delivery object can be projected to the tip side of the main body. The sliding body passes from the proximal end side of the main body to the outside of the main body, is folded back to the inside of the main body at the tip of the main body, covers the inner and outer surfaces of the main body, and the inner end of the sliding body is connected to a long body that advances and retreats axially inside the main body. By pushing and pulling the long body, the sliding body can be slid with respect to the main body. The medical device.

2. The medical device according to claim 1, wherein the peeling portion has elasticity.

3. The medical device according to claim 1 or 2, wherein the peeling portion has a plurality of convex portions.

4. The medical device according to any one of claims 1 to 3, wherein the peeling portion is folded back at the tip of the main body and separated from the sheet-like delivery object.

5. The medical device according to any one of claims 1 to 4, which is configured such that a sheet-like delivery object can be placed on the inner surface of the arch-shaped portion.

6. The medical device according to any one of claims 1 to 5, wherein the sliding body is expandable.

7. The degree of low adhesion is configured such that the peeling load is 0.0001 N to 0.5 N. The medical device according to any one of claims 1 to 6.

8. The main body and the sliding body are cylindrical bodies, and the sliding body is configured to cover the entire inner and outer surfaces of the main body. The medical device according to any one of claims 1 to 7.

Images