Device for attaching sheet-shaped material to living body

Abstract

Provided is a device that has a novel structure for transporting and adhering a sheetlike material within a living body.　A device 30 for transporting and adhering a sheetlike material 32 within a living body, having: a hollow outer cylinder 34, a distal end side thereof being inserted into the living body; and an inner member 36 that is inserted into the outer cylinder 34, wherein a sheet mounting part 38 to which the sheetlike material 32 is mounted is provided to the distal end side of the inner member 36. The sheet mounting part 38 can be housed in the outer cylinder 34 in a curved condition, and the sheet mounting part 38 can protrude from the outer cylinder 34 to the distal end side and unfurl. The invention is provided with a manipulation force transmission mechanism 78 that, when the sheet mounting part 38 is in an unfurled condition, applies a manipulation force inputted from outside of the living body to the sheet mounting part 38 within the living body and causes the sheet mounting part 38 to deform.

Description

[Technical Field]

[0001] The present disclosure relates to a device for delivering and applying a sheet-like material to a living body. [Background technology]

[0002] In recent years, various therapeutic techniques involving the transplantation of cell sheets such as artificial cell membranes have been proposed. Currently, thoracotomy or laparotomy is the mainstream method for transplanting or administering sheet-like therapeutic materials such as cell sheets to affected areas. However, thoracotomy or laparotomy has the disadvantages of placing a heavy burden on the human body and requiring a long recovery time. On the other hand, endoscopic surgery is a minimally invasive surgical method for the human body. For this reason, attempts have been made to administer sheet-type therapeutic materials to patients using endoscopic surgery. However, sheet-type therapeutic materials are fragile and prone to self-adhesion, making it difficult to deliver the sheet-type therapeutic material to the affected area while preventing self-adhesion.

[0003] Patent Document 1 discloses a delivery and administration device in which a sheet support member for holding a sheet-form therapeutic substance is shaped into a cylindrical shape and stored in an outer cylinder, and in this state the sheet-form therapeutic substance can be delivered to an affected area. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2009-511 Summary of the Invention [Problem to be solved by the invention]

[0005] In recent years, various treatment methods using sheet-like physiologically active substances, such as cell sheets, have been developed, and there is a demand for devices that can stably place (implant) sheet-like physiologically active substances. In particular, the present inventors have focused on a new problem: it is difficult to deliver sheet-like substances to a predetermined site in the body while preventing breakage. Furthermore, they have discovered the problem that after using a device to place (contact) a sheet-like physiologically active substance at an affected area, it is difficult to gently peel off the device while keeping the sheet-like physiologically active substance in place at the affected area. In one aspect, the present disclosure provides a device that can improve the stability of the attachment (transplantation) of a sheet-like physiologically active substance, such as a cell sheet, etc. It goes without saying that the device of the present disclosure is not limited to this one aspect, and can be used for the delivery and attachment of various types of sheet-like materials for treatment into the body based on the knowledge of those skilled in the art. [Means for solving the problem]

[0006] The following describes preferred embodiments for understanding the present disclosure, but the embodiments described below are merely examples and may be appropriately combined with one another. Multiple components described in each embodiment may be recognized and employed independently to the greatest extent possible, and may also be appropriately combined with any of the components described in other embodiments. Accordingly, the present disclosure is not limited to the embodiments described below, and various other embodiments may be realized.

[0007] A first aspect of the present disclosure is a device for transporting and applying a therapeutic sheet-like material inside a living body, comprising a hollow outer tube whose tip end is inserted into the living body, and an inner member that is inserted into the outer tube, the tip end of the inner member being provided with a sheet mounting section on which the sheet-like material is placed, the sheet mounting section being capable of being stored in the outer tube in a curved state, and the sheet mounting section being capable of being expanded by protruding from the outer tube towards the tip end, and an operating force transmission mechanism being provided that, when the sheet mounting section is in the expanded state, applies an operating force input from outside the living body to the sheet mounting section inside the living body, thereby deforming the sheet mounting section.

[0008] According to this aspect, when applying a sheet-like material in a living body, for example, the sheet-like material for treatment placed on the sheet-placing portion is delivered to a treatment site in the living body and applied thereto, and then an operating force for deforming the sheet-placing portion is applied by the operating force transmission mechanism, so that the sheet-like material can be gently separated (peeled) from the sheet-like material while the sheet-like material is applied to the treatment site in the living body, thereby enabling the sheet-like material for treatment to be stably applied to the treatment site in the living body.

[0009] A second aspect of the present disclosure is a device according to the first aspect, wherein the tip portion of the outer tube is provided with a protruding piece that protrudes from the inner surface of the cylindrical peripheral wall into the inner cavity, and the sheet support surface on which the sheet placing portion stored in a curved state in the outer tube is superimposed is configured to include the protruding piece.

[0010] According to this aspect, when the sheet placing portion is stored in the outer tube, the sheet placing portion deforms along the sheet support surface, and therefore, by providing a protruding piece that protrudes into the inner cavity of the outer tube and configuring the sheet support surface to include this protruding piece, the area of ​​the sheet support surface can be increased compared to when the sheet support surface is configured only by the inner circumferential surface of the outer tube, for example. Therefore, a larger sheet-like material can be used as the sheet material to be stored in the outer tube, and even when a large sheet-like material is used, the sheet-like material can be stably stored in the outer tube.

[0011] A third aspect of the present disclosure is a device according to the first or second aspect, wherein the internal member is made of synthetic resin, and at least the internal member is disposable together with the sheet placing portion.

[0012] According to this aspect, disposable internal components can be easily manufactured, and by making the sheet-receiving portion that comes into contact with the living body also disposable, the risk of infection and the like between multiple patients can be easily and more reliably prevented.

[0013] A fourth aspect of the present disclosure is a device according to any one of the first to third aspects, wherein a gripping portion is provided on the base end side of the outer tube, and the gripping portion is provided with a first operating portion that moves the inner member relative to the outer tube in the axial direction, and a second operating portion that deforms the sheet placing portion via the operating force transmission mechanism, each of which can be operated separately.

[0014] According to this aspect, the first operating unit can move the inner member relative to the outer tube, and the second operating unit can deform the sheet loading section independently, which can improve the operability of each unit and the freedom to set each operating state.

[0015] A fifth aspect of the present disclosure is a device according to the fourth aspect, wherein the operating force transmission mechanism is constituted by an operating wire connected to the sheet placing portion, and the second operating portion pulls the operating wire from the base end side of the device, thereby exerting an operating force on the sheet placing portion via the operating wire and deforming the sheet placing portion.

[0016] According to this aspect, deformation of the sheet placing portion (detachment from the sheet material) can be achieved by a simple mechanism in which the second operating portion pulls the operating wire connected to the sheet placing portion from the base end side.

[0017] A sixth aspect of the present disclosure is a device according to the fourth or fifth aspect, wherein the inner member has an input portion at the base end portion to which a longitudinal driving force is applied, and the first operating portion includes either a slide operating portion that directly applies a longitudinal sliding force of the inner member to the input portion, or a rotation operating portion that converts a rotation operating force into a linear driving force using a gear mechanism and indirectly applies the rotation operating force to the input portion.

[0018] According to this aspect, the axial movement operation of the inner member relative to the outer cylinder can be realized with good operability by the sliding operation or rotation operation of the first operating portion.

[0019] A seventh aspect of the present disclosure is a device according to any one of the first to sixth aspects, which is provided with an operating force retaining mechanism that retains the operating force applied to the sheet loading portion by the operating force transmission mechanism when the inner member moves relative to the outer tube in the longitudinal direction.

[0020] According to this aspect, the inner member can be moved axially relative to the outer tube while the sheet placement portion provided at the tip of the inner member is maintained in a deformed state. Therefore, even when the inner member is moved axially relative to the outer tube after the sheet placement portion is deformed and peeled off from the sheet-like material, the deformed state of the sheet placement portion can be maintained, and inadvertent re-contact of the sheet placement portion with the sheet-like material can be effectively prevented.

[0021] An eighth aspect of the present disclosure is a device for transporting and applying a therapeutic sheet-like material inside a living body, the device comprising: a hollow outer tube whose distal end is inserted into the living body; and an inner member that is inserted into the outer tube; a sheet placing section on which the sheet-like material is placed is provided at the distal end of the inner member; the sheet placing section is capable of being stored in the outer tube in a curved state; and the sheet placing section protrudes from the outer tube toward the distal end and is deployable; the distal portion of the outer tube in which the sheet placing section is stored is provided with a protruding piece that protrudes from the inner surface of the peripheral wall into the inner cavity; the protruding piece has a cross-sectional shape that curves to fit along the inner surface of the outer tube and protrudes circumferentially; and a sheet support surface on which the sheet placing section is superimposed is constituted by the inner surface of the peripheral wall of the outer tube and the curved inner surface of the protruding piece.

[0022] In the device according to this aspect, the protruding pieces protrude circumferentially in a curved manner along the inner peripheral surface of the outer tube, away from the inner peripheral surface. By appropriately adjusting the protruding length of the protruding pieces, the circumferential length of the sheet support surface formed in cooperation with the inner peripheral surface of the outer tube can be adjusted with a high degree of freedom. Specifically, by increasing the protruding length of the protruding pieces, it is possible to form a sheet support surface with a shape such as a generally spiral shape. As a result, it is possible to increase the width of the sheet placement portion that is supported by the sheet support surface. Furthermore, since the protruding pieces can extend from the inner peripheral surface of the outer tube in a direction closer to a tangent to the outer tube than a radial line, the bending angle or radius of curvature of the protruding pieces rising from the inner peripheral surface of the outer tube can be reduced, thereby reducing or avoiding local bending and resulting breakage of the sheet material that is placed over that portion.

[0023] A ninth aspect of the present disclosure relates to a device for applying a sheet-like physiologically active substance to a living body, the device comprising a cylindrical outer tube, a cylindrical inner member, a sheet mounting portion provided at the distal end of the inner member, and an operating portion provided at the proximal end of the inner member. In the device of the present disclosure, the inner member has an axial length longer than that of the outer tube and is provided inside the outer tube so as to be movable in the axial direction of the outer tube, the sheet mounting portion is configured to be exposed while protruding outward from one end side of the outer tube, and when the inner member is moved toward the proximal end along the axial direction of the outer tube, it elastically deforms into a shape that conforms to the inside of the outer tube and can be stored within the outer tube, and the operating portion is configured to be operable to bend the sheet mounting portion and / or adjust the fixing force between the sheet mounting portion and the inner member.

[0024] A tenth aspect of the present disclosure is a device according to the ninth aspect, further comprising an operating wire having one end connected to the tip side of the sheet placing portion and the other end connected to the operating unit, the operating wire being configured so that the sheet placing portion can be bent by pulling the operating wire through operation of the operating unit.

[0025] An eleventh aspect of the present disclosure is a device according to the ninth or tenth aspect, further comprising a connecting member connecting the sheet placing portion and the inner member, and an operating wire connecting the connecting member and the operating portion, wherein the connecting member and the operating wire are configured to be able to adjust the fixing force between the sheet placing portion and the inner member in conjunction with the operation of the operating portion.

[0026] A twelfth aspect of the present disclosure is a device according to any one of the ninth to eleventh aspects, wherein an elastically deformable reinforcing member is provided on the surface of the sheet loading section opposite the sheet loading surface.

[0027] A thirteenth aspect of the present disclosure is a device according to any one of the ninth to twelfth aspects, further comprising a tube having an outlet at its tip, the tube being inserted into the inner member and positioned on the sheet loading surface side of the sheet loading section with the tip of the outlet protruding from the tip of the inner member. [Effects of the Invention]

[0028] In one or more embodiments, the device of the present disclosure allows a sheet-shaped material to be stably attached (transplanted) to an affected area. In one or more embodiments, the device of the present disclosure allows the sheet-shaped material to be placed (transplanted) at a predetermined position, and then the device (sheet placement portion) can be gently peeled off while the sheet-shaped material is maintained at that position. [Brief explanation of the drawings]

[0029] [Figure 1] FIG. 1 is a diagram showing an embodiment (first embodiment) of the device of the present disclosure, showing a state in which a sheet placement portion 13 protrudes from the tip of an outer tube 11. As shown in FIG. [Figure 2] FIG. 2 is a diagram showing an embodiment of the device of the present disclosure, showing a state in which the sheet placement section 13 is housed in the outer cylinder 11. As shown in FIG. [Figure 3]FIG. 3 is a plan view of the device in a state where the sheet placement portion 13 of FIG. 1 protrudes from the tip of the outer cylinder 11. FIG. [Figure 4] FIG. 4 is a side view of the device in a state where the sheet placement portion 13 of FIG. 1 protrudes from the tip of the outer cylinder 11. FIG. [Figure 5] 5A to 5C are partial perspective views showing the state in which the sheet placement portion 13 is being stored in the outer tube 11 from the state in which it protrudes from the tip of the outer tube 11. FIG. [Figure 6] FIG. 6 is a partial perspective view showing the operation unit 14. As shown in FIG. [Figure 7] Figures 7A and 7B are partial oblique views showing the state in which the sheet placing section 13 is curved, where Figure 7A shows the state in which the sheet placing section 13 is unfolded, and Figure 7B shows the state in which the operating wire 15 is pulled and the sheet placing surface 13a side of the sheet placing section 13 is curved outward. [Figure 8] Figures 8A and 8B are partial oblique views showing the state in which the fixing force between the sheet placing section 13 and the inner member 12 is adjusted in another embodiment (second embodiment) of the device of the present disclosure, where Figure 8A shows the state in which the fixing force between the sheet placing section 13 and the inner member 12 is strengthened, and Figure 8B shows the state in which the fixing force between the sheet placing section 13 and the inner member 12 is weakened. [Figure 9] Figures 9A and 9B are partial oblique views showing the state in which a reinforcing member 18 is installed on the surface 13d opposite the sheet placing surface 13a of the sheet placing section 13, and Figure 9B shows the state in which the sheet placing surface 13a of the sheet placing section 13 is pressed against the affected area (the area to be transplanted). [Figure 10] FIG. 10 is a diagram showing yet another embodiment (third embodiment) of the device of the present disclosure. [Figure 11] FIG. 11 is a perspective view showing yet another embodiment (fourth embodiment) of the device of the present disclosure, showing the device in an unfolded state in which the sheet placement portion protrudes from the tip of the outer tube. [Figure 12] FIG. 12 is a plan view of the device shown in FIG. [Figure 13] FIG. 13 is a bottom view of the device shown in FIG. [Figure 14]FIG. 14 is an exploded perspective view of the device shown in FIG. [Figure 15] FIG. 15 is an enlarged longitudinal sectional view showing a cross section taken along line XV-XV in FIG. [Figure 16] FIG. 16 is an enlarged cross-sectional view showing the XVI-XVI section in FIG. [Figure 17] FIG. 17 is an enlarged cross-sectional view showing the XVII-XVII section in FIG. [Figure 18] FIG. 18 is an enlarged cross-sectional view showing the XVIII-XVIII cross section in FIG. [Figure 19] FIG. 19 is a perspective view showing a storage state in which the sheet placement portion is stored in the outer cylinder in the device shown in FIG. [Figure 20] FIG. 20 is an enlarged cross-sectional view of the device shown in FIG. 19, cut along a cross section corresponding to the XVI-XVI cross section in FIG. 12, and corresponds to FIG. [Figure 21] FIG. 21 is a perspective view showing yet another embodiment (fifth embodiment) of the device of the present disclosure, showing the device in an unfolded state in which the sheet placement portion protrudes from the tip of the outer tube. [Figure 22] FIG. 22 is an enlarged longitudinal cross-sectional view of the device shown in FIG. [Figure 23] FIG. 23 is a perspective view showing yet another embodiment (sixth embodiment) of the device of the present disclosure, showing the device in an unfolded state in which the sheet placement portion protrudes from the tip of the outer tube. [Figure 24] FIG. 24 is an enlarged longitudinal cross-sectional view of the device shown in FIG. [Figure 25] FIG. 25 is a perspective view showing yet another embodiment (seventh embodiment) of the device of the present disclosure, showing the device in an unfolded state in which the sheet placement portion protrudes from the tip of the outer tube. [Figure 26] FIG. 26 is an enlarged longitudinal cross-sectional view of the device shown in FIG. [Figure 27]FIG. 27 is a perspective view showing a storage state in which the sheet placement portion is stored in the outer cylinder in the device shown in FIG. [Figure 28] FIG. 28 is an enlarged longitudinal cross-sectional view of the device shown in FIG. [Figure 29] FIG. 29 shows photographs showing MSC sheet transplantation using a cardiac model. [Figure 30] FIG. 30 is a photograph showing MSC sheet transplantation into a pig heart. [Figure 31] 31A and 31B are enlarged perspective views of a sheet placement portion of a device according to another embodiment of the present disclosure, with FIG. 31A showing the sheet placement portion in an unfolded state and FIG. 31B showing the sheet placement portion in a deformed state. [Figure 32] FIG. 32 is an explanatory diagram for explaining a gun-type device according to another embodiment of the present disclosure in a model form. DETAILED DESCRIPTION OF THE INVENTION

[0030] The device disclosed herein is for applying a sheet-like physiologically active substance to a living body, and includes a cylindrical outer tube, a cylindrical inner member, a sheet mounting portion provided at a distal end of the inner member, and an operating portion provided at a proximal end of the inner member. In the device disclosed herein, the inner member has an axial length longer than that of the outer tube and is provided inside the outer tube so as to be movable in the axial direction of the outer tube. The sheet mounting portion is configured to be exposed while protruding outward from one end of the outer tube, and when the inner member is moved axially toward the proximal end of the outer tube, it elastically deforms into a shape that conforms to the inside of the outer tube and can be stored within the outer tube. The operating portion is configured to be operable to bend the sheet mounting portion and / or adjust the fixing force between the sheet mounting portion and the inner member.

[0031] In one or more embodiments, the device of the present disclosure is used to attach (transplant) a sheet-shaped physiologically active substance to a predetermined location in a living body. According to the device of the present disclosure, in one or more embodiments, it is possible to reduce breakage or dislocation of a sheet-form physiologically active substance when the sheet-form physiologically active substance is applied (transplanted), thereby improving the stability and reliability of the application (transplantation) of the sheet-form physiologically active substance.

[0032] In one or more embodiments, the device of the present disclosure allows a sheet-shaped physiologically active substance to be minimally invasively delivered and / or attached (transplanted) into a living body. Thus, in one or more embodiments, the device of the present disclosure allows a sheet-shaped physiologically active substance to be stably attached (transplanted) to a desired position in a living body with little strain on the human body and with high accuracy.

[0033] In the present disclosure, the term "minimally invasive" refers to a procedure that places less strain on the patient than open thoracotomy or abdominal surgery. In one or more embodiments, "minimally invasive surgery" includes a method in which an instrument is inserted into the body or the lumen of an organ through a small incision made on the body surface, and examples of such a procedure include endoscopic surgery and laparoscopic surgery.

[0034] In the present disclosure, in one or more embodiments, the term "sheet-shaped bioactive material" refers to a sheet-shaped active material used for treating, preventing, reducing the severity of, reducing the likelihood of onset or inhibiting progression of, or alleviating the effects of a disease or injury. In one or more embodiments, sheet-shaped bioactive materials include cell sheets, grafts, cell membranes, and biodegradable biomaterials. In one or more embodiments, examples of cell sheets include cell aggregates (cell sheets) containing cells and extracellular matrix, and layered cell sheet-like structures (cell aggregates) further containing biodegradable or non-biodegradable substances. In one or more embodiments, examples of biodegradable biomaterials include synthetic polymer materials such as polylactic acid, polyglycolic acid, poly(DL-lactide-co-glycolide), poly(lactic acid-co-glycolic acid), and derivatives thereof, as well as natural polymer materials such as gelatin, collagen, alginic acid, hyaluronic acid, agarose, chitosan, fibrin, and fibroin. In one or more embodiments, the biodegradable biomaterial may or may not contain one or more types of physiologically active substances.

[0035] In one aspect, the device of the present disclosure further includes an operating wire connected to the sheet mounting portion and the operating portion, respectively, for operating the bending movement of the sheet member. In one or more embodiments, the operating wire is attached to one end of the sheet mounting portion and connected to the other end of the operating portion, and is configured so that the sheet mounting portion can be bent by pulling the operating wire through operation of the operating portion, in other words, so that the sheet mounting portion can be bent in the direction of the surface opposite the sheet mounting surface of the sheet mounting portion. According to this aspect, in one or more embodiments, after using the device to place (contact) a sheet-like physiologically active substance on an affected area, the sheet mounting portion can be more gently peeled off while the sheet-like physiologically active substance is retained on the affected area, further improving the stability and reliability of application (transplantation) of the sheet-like physiologically active substance.

[0036] In one or more embodiments, one end of the operating wire is attached near the tip of the sheet loading section, and the other end passes through the surface opposite the sheet loading surface of the sheet loading section and the inside of the inner member and is attached to the operating section.

[0037] In one embodiment, the operating unit is rotatably connected to the base end of the inner member. This embodiment makes it easier to control the bending movement of the sheet mounting unit, allows the sheet mounting unit to be more gently detached from the affected area, and further improves the stability and reliability of the application (transplantation) of the sheet-like physiologically active substance. The connection between the operating unit and the inner member is not particularly limited as long as it has a male-female fastening structure. In one or more embodiments, a female thread is formed on the inner surface of the base end of the inner member, and a male thread is formed on the outer surface of the operating unit, although the reverse is also possible. Note that the above embodiment is merely an example, and the structure of the operating unit is not particularly limited as long as it is a structure that can pull or loosen the operating wire.

[0038] In one aspect, the device of the present disclosure further includes a connecting member that connects the sheet mounting portion and the internal member, and an operating wire that connects the connecting member and the operating portion. The connecting member and the operating wire are configured to be able to adjust the fixing force between the sheet mounting portion and the internal member in conjunction with the operation of the operating portion. According to this aspect, in one or more embodiments, even if the site where the sheet-shaped physiologically active substance is to be applied (transplanted) is a pulsating organ such as the heart, the sheet mounting portion can be brought into contact with the pulsation, thereby allowing the sheet-shaped physiologically active substance to be applied (transplanted) while reducing pressure and strain on the organ, further improving the stability and reliability of the application (transplantation) of the sheet-shaped physiologically active substance.

[0039] In one or more embodiments, the connecting member may be a hinge, etc. In one or more embodiments, the fixing force can be adjusted by applying tension to the wire by operating the operating unit to strengthen the fixing force between the sheet placing portion and the inner member, and by releasing the tension to weaken the fixing force between the sheet placing portion and the inner member.

[0040] In one aspect, the device of the present disclosure further includes a connecting member that connects the operating unit and the operating wire. In one aspect, the connecting member has a movable part that can rotate about the axial direction of the inner member (operating unit). This makes it possible to prevent twisting of the operating wire due to operation (rotational movement) of the operating unit, movement (displacement) of the position of the sheet placement unit, etc. Examples of the connecting member include a tip-side rotating joint such as a swivel.

[0041] In one aspect of the device disclosed herein, an elastically deformable reinforcing member is provided on the surface of the sheet mounting portion opposite the sheet mounting surface. According to this aspect, in one or more embodiments, the pressure of the sheet mounting member can be increased when the sheet-shaped physiologically active substance is brought into contact with the affected area, thereby further improving the stability and reliability of application (transplantation) of the sheet-shaped physiologically active substance. In one or more embodiments, the reinforcing member is not particularly limited as long as it has a shape that allows the sheet placing portion to be stored inside the outer cylinder. In one or more embodiments, the reinforcing member may be a strip-shaped reinforcing member that extends from the tip end side of the sheet placing portion to the base end side.

[0042] In one aspect, the device of the present disclosure further includes a liquid supply means. In one or more embodiments, the liquid supply means may be a tube having a discharge port at its tip, the tube being inserted into the inner member and arranged on the sheet placement surface side of the sheet placement section with the discharge port protruding from the tip of the inner member. The present inventors have found that the moist state of the sheet-form physiologically active substance and / or the affected area (transplantation target area) when the sheet-form physiologically active substance is brought into contact with the affected area (transplantation target area) contributes to the stability and reliability of the application (transplantation) of the sheet-form physiologically active substance. Furthermore, they have found that by moistening both the sheet-form physiologically active substance and the affected area (transplantation target area) when bringing the sheet-form physiologically active substance into contact with the affected area (transplantation target area), the sheet-mounting portion can be peeled off from the affected area with high accuracy while the sheet-form physiologically active substance is retained in place at the affected area. According to this aspect, in one or more embodiments, after using the device to place (contact) a sheet-shaped physiologically active substance on the affected area, supplying a liquid to the contact surface allows the sheet-mounting portion to be more gently peeled off from the contact surface, further improving the stability and reliability of the application (transplantation) of the sheet-shaped physiologically active substance.

[0043] Hereinafter, embodiments of the present disclosure will be described with reference to the drawings.

[0044] First Embodiment 1 and 2 are diagrams showing a device 1 according to a first embodiment of the present disclosure, in which Fig. 1 is a diagram showing a state in which the sheet placement section 13 protrudes from the tip of the outer tube 11, and Fig. 2 is a diagram showing a state in which the sheet placement section 13 is housed within the outer tube 11. Fig. 3 is a plan view of the device 1, and Fig. 4 is a side view of the device 1. In the present disclosure, the side of the device 1 facing the sheet placement section 13 is referred to as the tip side, the side opposite the sheet placement section 13 (the side facing the operation section 14) is referred to as the base end, and the "axial direction" refers to the axial direction (longitudinal direction) of the outer tube 11.

[0045] As shown in FIGS. 1 to 4, the device 1 in the first embodiment includes an outer cylinder 11, an inner member 12, a sheet placement section 13, an operation section 14, and an operation wire 15.

[0046] The outer cylinder 11 is a hollow cylindrical member that extends straight, and the inner member 12 can be inserted inside. In one or more embodiments, the material of the outer cylinder 11 may be a metal material such as stainless steel, or a resin material. In one or more embodiments, the outer diameter of the outer cylinder 11 is 30 mm or less, which reduces the size of the incision hole and further reduces the burden on the human body. In one or more embodiments, the inner diameter of the outer cylinder 11 can be appropriately determined depending on the size of the sheet-like physiologically active substance held in the sheet mounting section 13. In one or more embodiments, the inner diameter of the outer cylinder 11 is 7 mm or more, or 28 mm or less.

[0047] The inner member 12 is a straight, hollow, cylindrical member. The inner member 12 is provided inside the outer cylinder 11, coaxially with the outer cylinder 11 and spaced apart from the outer cylinder 11 in the axial direction. The inner member 12 is movable back and forth in the axial direction of the outer cylinder 11. The inner member 12 has a sheet placement section 13 attached to one end (tip end) thereof and an operation section 14 attached to the other end (base end). In one or more embodiments, the material of the inner member 12 may be a metal material such as stainless steel, or a resin material. In one or more embodiments, the outer diameter of the inner member 12 can be appropriately determined depending on the inner diameter of the outer cylinder 11. In one or more embodiments, the outer diameter of the inner member 12 is 5 mm or more or 15 mm or less from the viewpoint of operability.

[0048] The sheet mounting portion 13 holds a sheet-like physiologically active substance. The sheet mounting portion 13 has a sheet mounting surface 13a capable of holding a sheet-like physiologically active substance. A through-hole 13b for fixing the tip of the operating wire 15 is formed at the tip of the sheet mounting portion 13, and a through-hole 13c for passing the operating wire 15 through is formed at the base end. The sheet placement portion 13 is attached to the inner member 12. The sheet placement portion 13 can be attached to the inner member 12 such that the base end of the sheet placement portion 13 is fitted inside the inner member 12.

[0049] The sheet placement portion 13 is a flexible, elastically deformable plate-like member. In one or more embodiments, the material of the sheet placement portion 13 is not particularly limited as long as it is a material having rubber elasticity, and may be an elastomer or a non-elastomer. In one or more embodiments, examples of the material of the sheet placement portion 13 include polyethylene, nylon, polyurethane, polyethylene terephthalate (PET), ethylene vinyl acetate (EVA), and silicone rubber.

[0050] In one or more embodiments, the shape of the sheet placement portion 13 may be a rounded square shape or a round (oval) shape. The sheet placement portion 13 may have a shape that is symmetrical with respect to the axis of the outer cylinder 11, or may have an asymmetrical shape. In one or more embodiments, the sheet placement surface 13a of the sheet placement portion 13 may be a flat surface or a gently concave surface. In one or more embodiments, the size of the sheet mounting section 13 can be appropriately determined depending on the size of the sheet-like active substance to be applied (transplanted), and it need only be large enough to be able to be elastically deformed into a cylindrical shape and stored inside the outer tube 11.

[0051] The operating part 14 is attached to the base end of the inner member 12 so as to be rotatable in the axial direction of the inner member. Figure 6 is a partially enlarged view of the base end of the inner member 12. The operating part 14 is a male screw, and a female screw thread is formed on the inner surface of the base end of the inner member 12 so as to be engageable with the male screw.

[0052] The operating wire 15 is provided to control the bending angle (curving operation) of the sheet placing portion. One end of the operating wire 15 is connected to a through hole 13b formed near the tip of the sheet placing portion 13, and the other end is connected to a swivel (not shown) provided at the tip (tip side of the inner member 12) of the operating portion 14. This makes it possible to prevent twisting of the operating wire 15 due to operation (rotation operation) of the operating portion 14, movement (displacement) of the position of the sheet placing portion 13, etc. The operating wire 15 is arranged on a surface 13d of the sheet placing portion 13 opposite to the sheet placing surface 13a, and is further inserted into the inside of the inner member 12 through a through-hole 13c provided on the base end side of the sheet placing portion 13. This makes it possible to curve (bend) the sheet placing portion 13 so that the sheet placing surface 13a is warped. In one or more embodiments, the operating wire 15 may be a wire, a string, or the like.

[0053] When the operating unit 14 is rotated so that the tip of the operating unit 14 moves from the tip of the internal member toward the base end (in the direction in which the screw loosens), the operating wire 15 is wound up and the length of the operating wire 15 is shortened, and the sheet placing portion 13 is elastically deformed and curved so that the sheet placing surface 13a warps, and when the operating unit 14 is rotated so that the tip of the operating unit 14 moves toward the tip (from the base end of the internal member toward the tip) (in the direction in which the screw tightens), the length of the operating wire 15 can be lengthened, and by returning the length of the operating wire 15 to its original length, the elastic deformation of the sheet placing portion 13 is released and it is unfolded into a flat surface.

[0054] The following describes how to use the device 1 of the first embodiment. First, a sheet-like physiologically active substance 16 such as a cell sheet is placed on the sheet mounting surface 13a of the sheet mounting section 13 (see FIG. 5A). At this time, the sheet mounting section 13 is exposed and protrudes from the tip side of the outer tube 11 (FIG. 1). The sheet mounting section 13, unfolded flat, has a width greater than the inner and outer diameters of the outer tube 11. To accommodate and transport the sheet-like physiologically active substance 16 within the outer tube 11, the inner member 12 is slid from the distal end toward the proximal end (the direction of arrow S in FIG. 2 ) to accommodate the sheet-like physiologically active substance holding portion 13 within the outer tube 11. FIGS. 5A-5C show the process of the sheet-like physiologically active substance 13 being accommodated within the outer tube 11 from its flat, unfolded state. As shown in FIGS. 5A-5C , when the inner member 12 is slid to retract the sheet-like physiologically active substance 13 into the outer tube 11, the sheet-like physiologically active substance 16 contacts the inner surface of the outer tube 11, and a force is applied to the sheet-like physiologically active substance 13 to roll it into a cylindrical shape. The sheet-like physiologically active substance 16 is accommodated within the outer tube 11 by elastic deformation as it is rolled into a cylindrical shape that conforms to the inner shape of the outer tube 11, with the sheet-like physiologically active substance 16 arranged on the sheet-like physiologically active substance 16 facing inward. This allows the sheet-like physiologically active substance to be transported to a desired location while minimizing damage to the sheet-like physiologically active substance.

[0055] With the sheet mounting portion 13 housed within the outer tube 11, the device 1 is inserted into the body. The device 1 can be inserted via a trocar or the like that has been inserted into the body in advance during laparoscopic or thoracoscopic surgery. When the tip of the device 1 (outer tube 11) reaches the vicinity of the affected area (the site where the sheet is to be transplanted), the inner member 12 is slid from the base end toward the tip (the opposite direction of arrow S in Figure 2) to expose the sheet mounting portion 13 in a protruding state from the tip of the outer tube 11. At this time, the sheet mounting portion 13 recovers from its elastic deformation and is unfolded into a flat state.

[0056] The orientation of device 1 is adjusted so that the sheet-like physiologically active substance placed on sheet placing section 13 faces the affected area, and sheet placing surface 13a of sheet placing section 13 is brought into contact with the affected area. Next, with sheet placing surface 13a in contact with the affected area, operating section 14 is rotated so that the tip of operating section 14 moves from the tip of inner member 12 toward the base end, thereby slowly curving sheet placing section 13 (warping sheet placing surface 13a), and sheet placing section 13 can be gently removed from the affected area while retaining the sheet-like physiologically active substance on the affected area.

[0057] Once the implantation of the sheet-like physiologically active substance is complete, the inner member 12 can be slid to store the sheet mounting portion 13 inside the outer tube 11, and the device 1 can be withdrawn from the body, or it can be withdrawn from the body in its original state.

[0058] As described above, according to the device 1 of the first embodiment, the sheet-like physiologically active substance can be transported to the affected area (the area to be transplanted with the sheet) while being shaped like a cylinder and housed within the outer tube 11, thereby further reducing the burden on the human body and enabling a minimally invasive procedure. Furthermore, damage and deformation of the sheet-like physiologically active substance during transportation can be suppressed. Furthermore, according to the device 1 of the first embodiment, after the sheet mounting portion 13 is brought into contact with the affected area, the sheet mounting portion 13 can be peeled off from the affected area by bending the sheet mounting portion 13 and changing the angle of curvature. This allows the sheet mounting portion 13 to be peeled off more gently from the contact surface, further improving the stability and reliability of the application (transplantation) of the sheet-like physiologically active substance.

[0059] <Second embodiment> 8A and 8B are partial enlarged views of a device according to a second embodiment of the present disclosure. As shown in FIGS. 8A and 8B, the device according to the second embodiment further includes a connecting member 17 that connects the sheet placement portion 13 to an internal member (not shown), and an operating wire (not shown) that connects the connecting member 17 to an operating portion (not shown). The device according to the second embodiment differs from the device according to the first embodiment in that the sheet placement portion 13 and the internal member (not shown) are connected via the connecting member 17, and the fixing force between the sheet placement portion 13 and the internal member can be controlled by the operating wire and the operating portion. The second embodiment will be described below, focusing on the differences from the first embodiment.

[0060] The sheet placement section 13 is integrally provided with the inner member 12 via a connecting member 17. An operating wire (not shown) is attached to the connecting member 17. The sheet placement section 13 is movable around the connecting member 17 in conjunction with changes in the tension of the operating wire due to operation of the operating section 14. By rotating the operating section so that the tip of the operating section moves from the tip of the inner member toward the base end, the operating wire is wound up and the length of the operating wire is shortened, thereby strengthening the fixing force between the sheet placement section 13 and the inner member 12. By rotating the operating section in the opposite direction (from the base end of the inner member toward the tip end), the length of the operating wire is lengthened, thereby weakening the fixing force between the sheet placement section 13 and the inner member. According to this aspect, in one or more embodiments, even if the location where the sheet-shaped physiologically active substance is to be attached (transplanted) is a pulsating organ such as the heart, the sheet mounting portion 13 can be brought into contact with the organ in response to the pulsation, so that the sheet-shaped physiologically active substance can be attached (transplanted) while minimizing pressure and strain on the organ, thereby further improving the stability and reliability of the attachment (transplantation) of the sheet-shaped physiologically active substance. In one or more embodiments, the connecting member 17 may be a hinge or the like.

[0061] The following describes how to use the device of the second embodiment. The process of placing a sheet-like physiologically active substance on the device and moving it to the vicinity of the affected area (the site where the sheet will be transplanted) can be carried out in the same manner as in the first embodiment. Note that, when placing and transporting the sheet-like physiologically active substance, it is preferable to do so with the fixing force between the sheet mounting portion 13 and the internal member 12 strengthened.

[0062] The orientation of the device 1 is adjusted so that the sheet-like physiologically active substance placed on the sheet placing section 13 faces the affected area, and the sheet placing surface 13a of the sheet placing section 13 is brought into contact with the affected area while the fixing force between the sheet placing section 13 and the internal member 12 is weakened.

[0063] After the sheet placing portion 13 is brought into contact with the affected area, the fixing force between the sheet placing portion 13 and the inner member 12 is strengthened, and the sheet placing portion 13 is removed from the affected area. At this time, as in the first embodiment, the fixing force between the sheet placing portion 13 and the inner member 12 may be strengthened, and the sheet placing portion 13 may be curved and removed.

[0064] As described above, according to the device of the second embodiment, the fixing force between the sheet placement portion 13 and the internal member 12 can be controlled, so that the sheet placement portion 13 can be brought into contact with the affected area more gently. Furthermore, even if the affected area is a pulsating organ, the sheet placement portion 13 can be brought into contact with the affected area while suppressing pressure and strain on the affected area.

[0065] <Third embodiment> Fig. 10 is a diagram showing a device 2 according to a third embodiment of the present disclosure. As shown in Fig. 10, the device 1 according to the third embodiment includes an outer tube 11, an inner member 12, a sheet placement section 13, an operation section 14, an operation wire 15, and a tube 20 having a discharge outlet 21 at its tip. The device 2 according to the third embodiment differs from the device 1 according to the first embodiment in that it further includes a tube 20 having a discharge outlet 21 at its tip. The third embodiment will be described below, focusing on the differences from the first embodiment.

[0066] The tube 20 is inserted into the inner member 12 through a hole 19 provided in the side surface of the inner member 12, and is disposed on the base end side of the sheet placing surface 13a of the sheet placing section 13 with a discharge port 21 at the tip of the tube 20 protruding from the tip of the inner member 12. A syringe 22 is attached to the other end of the tube 20 via a connection section 23. This allows the liquid to be supplied to the sheet-like physiologically active substance held on the sheet placing surface 13a and the affected area, and allows for gentler detachment of the affected area (site to which the sheet is to be transplanted) from the sheet placing section 13, further improving the stability and reliability of application (transplantation) of the sheet-like physiologically active substance.

[0067] The following describes how to use the device 2 of the third embodiment. The process can be carried out in the same manner as in the first embodiment, from placing a sheet-shaped physiologically active substance on the device to moving it near the affected area (the site where the sheet will be transplanted).

[0068] The orientation of device 1 is adjusted so that the sheet placed on sheet placing section 13 faces the affected area, and liquid is supplied from outlet 21 to the sheet-like physiologically active substance placed on sheet placing section 13 to moisten the sheet-like physiologically active substance placed on sheet placing section 13. For example, a liquid such as physiological saline can be used as the liquid. With the sheet-like physiologically active substance in a moistened state, sheet placing surface 13a of sheet placing section 13 is brought into contact with the affected area. At this time, liquid may also be supplied to the affected area into which the sheet-like physiologically active substance is to be transplanted, and the sheet placing surface 13a of sheet placing section 13 may be brought into contact with the affected area in a moistened state.

[0069] Next, as in the first embodiment, with the sheet placing surface 13a in contact with the affected area, the operating unit 14 is rotated so that the tip of the operating unit 14 moves from the tip of the inner member 12 toward the base end, thereby slowly curving (warping) the sheet placing surface 13a of the sheet placing unit 13, and the sheet placing unit 13 can be gently removed from the affected area while retaining the sheet-like physiologically active substance in the affected area.

[0070] As described above, according to the device 2 of the third embodiment, a liquid is supplied to the sheet-shaped physiologically active substance before transplantation into the affected area, and the sheet-shaped physiologically active substance can be brought into contact with the affected area in a moistened state, which allows the sheet-mounting portion 13 to be peeled off more gently from the contact surface, further improving the stability and reliability of the application (transplantation) of the sheet-shaped physiologically active substance.

[0071] Although not specifically mentioned in the above first to third embodiments, when placing the sheet-form physiologically active substance on the sheet mounting section 13, a sheet different from the sheet-form physiologically active substance (for example, a nylon mesh) may be placed between the sheet-form physiologically active substance and the sheet mounting surface 13a, and the sheet-form physiologically active substance may be brought into contact with the affected area together with the sheet. This can further reduce breakage, deformation, or dislocation of the sheet-form physiologically active substance during transplantation, and can further improve the stability and reliability of application (transplantation) of the sheet-form physiologically active substance.

[0072] In the first to third embodiments, the outer tube and the inner member are described as having a straight shape, but the shapes of the outer tube and the inner member are not limited to this. In one or more embodiments, the outer tube and the inner member may have a curved shape or a bendable structure. Furthermore, in one or more embodiments, the material of the outer tube and the inner member may be an elastic material.

[0073] In the present disclosure, the second embodiment and the third embodiment may be combined.

[0074] In another aspect, the present disclosure relates to a method for applying a sheet-shaped therapeutic substance. In one or more embodiments, the method for applying the sheet-shaped therapeutic material of the present disclosure can be performed using the device of the present disclosure. In one or more embodiments, the method for applying the sheet-form therapeutic substance of the present disclosure includes bringing the sheet-form physiologically active substance retained on the sheet-mounting section of the device of the present disclosure into contact with the affected area (the area to be transplanted with the sheet) and peeling the sheet-mounting section from the contact surface by bending the sheet-mounting section. According to the application method of the present disclosure, the sheet-mounting portion can be more gently peeled off from the contact surface, and the stability and reliability of application (transplantation) of a sheet-like physiologically active substance can be further improved.

[0075] In one or more embodiments, the method for applying a sheet-type therapeutic substance of the present disclosure further includes contacting the sheet-mounting surface of the sheet-mounting part with the affected area (site to which the sheet is to be transplanted) while the fixing force between the sheet-mounting part and the inner member is weakened, thereby further reducing damage, deformation, or dislocation of the sheet-type physiologically active substance during transplantation and further improving the stability and reliability of application (transplantation) of the sheet-type physiologically active substance.

[0076] In one or more embodiments, the method for applying a sheet-form therapeutic substance of the present disclosure further includes supplying a liquid to the sheet-form physiologically active substance held in the sheet-mounting section, and contacting the sheet-form physiologically active substance moistened with the liquid with the affected area (the site to which the sheet is to be transplanted). This can further reduce damage, deformation, or dislocation of the sheet-form physiologically active substance during transplantation, and can further improve the stability and reliability of application (transplantation) of the sheet-form physiologically active substance.

[0077] In one or more embodiments, the method for applying a sheet-form therapeutic substance of the present disclosure further comprises supplying a liquid to the affected area (the area to which the sheet is to be transplanted) prior to contacting the sheet-form physiologically active substance, and contacting the affected area (the area to which the sheet is to be transplanted) moistened with the liquid, thereby further reducing damage, deformation, or dislocation of the sheet-form physiologically active substance during transplantation and further improving the stability and reliability of application (transplantation) of the sheet-form physiologically active substance.

[0078] In one or more embodiments, the method for applying a sheet-form therapeutic substance of the present disclosure further includes supplying a liquid to the sheet-form physiologically active substance held on the sheet mounting section and to the affected area (site to which the sheet is to be transplanted), and contacting the sheet-form physiologically active substance moistened by the supply of the liquid with the affected area (site to which the sheet is to be transplanted) that has also been moistened by the supply of the liquid. This can further reduce damage, deformation, or dislocation of the sheet-form physiologically active substance during transplantation, and can further improve the stability and reliability of application (transplantation) of the sheet-form physiologically active substance.

[0079] In one or more embodiments, the method for applying a sheet-shaped therapeutic substance of the present disclosure includes using the device of the present disclosure in combination with an endoscope.

[0080] In another aspect, the present disclosure relates to a method for operating a device for applying a sheet-like physiologically active substance to a living body. The method for operating a device disclosed herein is a method for operating a device comprising a device for attaching a sheet-like physiologically active substance to a living body and an apparatus for remotely operating the device using a manipulator, The device comprises: The sheet stacking device has a sheet stacking means at its tip end, and an operating means for controlling the bending operation of the sheet stacking means. a receiving means at a rear end for receiving an operation signal from a remote control device; a step of transmitting an operation signal for the manipulator by a transmitting means provided in the remote control device; a step of receiving an operation signal from a remote control device by a receiving means of the device; and a step of operating a sheet placement means and an operation means of the device based on the received signal;

[0081] The actuation step includes a step of actuating the sheet-mounting means of the device based on the received signal so as to bring the sheet-shaped physiologically active substance held in the sheet-mounting means into contact with the affected area, and a step of actuating the sheet-mounting means so as to peel the sheet-mounting portion from the affected area while curving the sheet-mounting surface of the sheet-mounting portion outward.

[0082] the device further comprises a liquid supply means at the tip; The actuating step includes a step of actuating a liquid supplying means based on the received signal so as to supply liquid to the sheet-shaped physiologically active substance held on the sheet placing means and / or the affected area.

[0083] The present disclosure may relate to one or more of the following embodiments: [1] A device for applying a sheet-shaped physiologically active substance to the body, A cylindrical outer cylinder; A cylindrical inner member; a sheet placement portion provided at a tip end of the inner member; an operating portion provided at a base end portion of the inner member, the inner member has an axial length longer than the axial length of the outer cylinder, and is provided inside the outer cylinder so as to be movable in the axial direction of the outer cylinder; the sheet placement portion is configured to be exposed in a state in which it protrudes outward from one end side of the outer tube, and when the inner member is moved toward the base end side along the axial direction of the outer tube, it is elastically deformed into a shape that conforms to the inside of the outer tube and can be stored within the outer tube, The operating unit is configured to be able to operate the bending movement of the sheet placement unit and / or adjust the fixing force between the sheet placement unit and the internal member. [2] An operating wire is further provided, one end of which is connected to the leading end side of the sheet placement portion and the other end of which is connected to the operating portion, The device according to [1], wherein the operating wire is configured to be able to bend the sheet placement portion by pulling the operating wire through operation of the operating portion. [3] A connecting member that connects the sheet placement portion and the inner member; further comprising an operating wire connecting the connecting member and the operating portion; The device described in [1] or [2], wherein the connecting member and the operating wire are configured to be able to adjust the fixing force between the sheet placement section and the inner member in conjunction with the operation of the operating section. [4] A device according to any one of [1] to [3], wherein an elastically deformable reinforcing member is provided on the surface of the sheet placement section opposite to the sheet placement surface. [5] Further comprising a tube having a discharge port at its tip, A device described in any of [1] to [4], wherein the tube is inserted into the inner member and positioned on the sheet placement surface side of the sheet placement section with the tip of the outlet protruding from the tip of the inner member.

[0084] <Fourth embodiment> 11 to 18 show a device 30 according to a fourth embodiment of the present disclosure. This device 30 is a device for delivering and applying a therapeutic sheet-like material 32 to a living body. The device 30 has a hollow outer tube 34, the distal end of which is inserted into the living body, and an inner member 36 that is inserted into the outer tube 34. A sheet placing section 38 on which the sheet-like material 32 is placed is provided on the distal end of the inner member 36. In the following description, the vertical direction refers to the vertical direction in FIG. 15. In addition, in the drawings referred to in the following description, the dimensions of some components may be exaggerated for clarity.

[0085] The outer tube 34 has a cylindrical, straight peripheral wall 40. The outer tube 34 is formed of a hard material such as metal or synthetic resin. In this embodiment, the outer tube 34 is formed of stainless steel. While the diameter of the outer tube 34 is not limited, it is preferable that the outer diameter of the outer tube 34 be φ15 mm or less, e.g., φ6 mm or more. This allows at least the outer tube 34 portion of the device 30 to be inserted into a port of an endoscope (not shown). In this embodiment, as shown in FIG. 16 , a coating 44 of resin or the like is applied to the entire inner peripheral surface 42 of the outer tube 34 (peripheral wall 40), at least at the distal end portion, to improve slipperiness relative to the sheet placement portion 38. In particular, in this embodiment, a PTFE resin coating layer is formed.

[0086] A protruding member 48 is fixedly positioned in the lumen 46 of the outer tube 34. Like the outer tube 34, the protruding member 48 is formed of a hard material such as metal or synthetic resin. The protruding member 48 has a recessed groove 50 that opens upward over its entire length. The base end side of the protruding member 48 forms a holding portion 52 that extends straight and has a generally crescent-shaped cross section that opens upward. In this embodiment, the holding portion 52 extends from the base end of the protruding member 48 to approximately the center or slightly beyond the center toward the tip side.

[0087] The protruding member 48 has a portion distal to the retaining portion 52 that is thinner than the retaining portion 52 and forms a protruding piece 56 that extends straight and has a generally J-shaped curved cross section (see FIGS. 16 and 17). The protruding member 48 is inserted into the inner cavity 46 of the outer tube 34 and fixedly assembled thereto, so that the protruding piece 56 protrudes from the inner circumferential surface 42 of the peripheral wall 40 into the inner cavity 46. That is, as shown in FIGS. 16 and 17, in cross section, the protruding piece 56 is in general contact with the inner circumferential surface of the outer tube 34 at one end in the curved direction, and then separates from the inner circumferential surface of the outer tube 34 and extends in the circumferential direction along the inner circumferential surface of the outer tube 34.

[0088] In addition, a flange-shaped portion 58 that protrudes outward is provided at the base end of the protruding member 48, and the protruding member 48 and the outer tube 34 are aligned in the axial direction by abutting the flange-shaped portion 58 against the outer tube 34.

[0089] Furthermore, the recessed groove 50 in the protruding member 48 extends straight with a substantially constant cross-sectional shape over the entire axial length from the retaining portion 52 to the protruding piece 56. The inner member 36 inserted into the outer tube 34 is positioned within this recessed groove 50 and is arranged to be movable in the axial direction while being guided by the recessed groove 50.

[0090] The inner member 36 has a generally circular cross section and is shaped like a rod that extends in a generally straight line, and is formed from a hard material such as metal or synthetic resin. In this embodiment, the inner member 36 is formed from synthetic resin. The inner member 36 has a small diameter portion 60 at its distal end, and a large diameter portion 62 that is larger in diameter than the small diameter portion 60 at its proximal end. The proximal end of the inner member 36 (the proximal end of the large diameter portion 62) has a flat surface at its upper end, and as will be described later, the proximal end portion of the inner member 36 forms an input portion 64 to which an external sliding force in the axial direction is applied.

[0091] Support recesses 66, 66 that open to the outer periphery are provided on both left and right sides of the outer periphery of the inner member 36. These support recesses 66, 66 extend over the entire length of the inner member 36 and are open to both axial end surfaces. The specific shapes and sizes of these support recesses 66, 66 are not limited, and they may have different shapes. However, in this embodiment, a pair of support recesses 66, 66 have approximately the same shape. The support recesses 66 are provided independently of each other, and as can be seen from FIGS. 16 to 18 , in this embodiment, the pair of support recesses 66, 66 that faced each other in the diametric direction at the base end of the inner member 36 are slightly inclined circumferentially along the length of the inner member 36 so that they face each other at a position offset upward at the tip end of the inner member.

[0092] A tubular body is disposed in each of these support recesses 66, and the tubular body disposed along one support recess 66 (the left one in FIGS. 16 to 18 in this embodiment) serves as a liquid delivery tube 68, while the tubular body disposed along the other support recess 66 serves as an insertion tube 70 through which an operating wire 78 (described later) is inserted. The number of liquid delivery tubes 68 is not limited, and when arranging multiple liquid delivery tubes 68, a corresponding number of support recesses 66 may be provided, or multiple liquid delivery tubes 68 may be disposed in one support recess 66. The use of the liquid delivery tube 68 is not limited, and it may be used for, for example, delivery and suction of liquids such as water or physiological saline, as well as supply of biological glue or medicine.

[0093] The liquid supply tube 68 has a length dimension longer than the inner member 36. When the liquid supply tube 68 is assembled to the inner member 36, as shown in FIGS. 13 and 15, the tip of the liquid supply tube 68 protrudes distally beyond the inner member 36 on the underside of the sheet placing section 38 (a sheet placing surface 74, described later) to form a discharge port 72 for the liquid flowing inside. The base end of the liquid supply tube 68 extends further proximally than a gripping portion 84, described later, provided at the base end of the outer tube 34. As shown in FIG. 10, for example, a syringe 22 filled with liquid can be connected to the base end. Meanwhile, the insertion tube 70 has a length dimension substantially equal to that of the inner member 36 and opens at the distal end and proximal end faces of the inner member 36. The liquid supply tube 68 and the insertion tube 70 are fitted into the respective support recesses 66 and disposed in an unattached state, but may be fixed with an adhesive or the like, if necessary. In this embodiment, the tip portions of the liquid supply tube 68 and the insertion tube 70 are fixed to the tip of the inner member 36 at a connection portion 73 of the sheet loading portion 38 described later, so that when the inner member 36 described later moves, the liquid supply tube 68 and the insertion tube 70 move integrally with the inner member 36.

[0094] In Figure 14, the inner member 36 is shown as a separate unit in order to clearly show the shapes of the inner member 36, the liquid delivery tube 68, the insertion tube 70, etc., but in this embodiment, the base end portion of the sheet loading portion 38 is fixed to the tip portion of the small diameter portion 60 of the inner member 36.

[0095] The sheet placement portion 38 is generally thin and preferably made of an elastomer such as a soft synthetic resin or synthetic rubber, thereby exhibiting elasticity. While the material of the sheet placement portion 38 is not limited, suitable materials include, for example, "Pebax (registered trademark)" manufactured by Arkema Inc., polyurethane, and other materials with a relatively low Shore D hardness. While the Shore D hardness of the sheet placement portion 38 is not limited, it is preferably less than 40, and more preferably 35 or less. By forming the sheet placement portion 38 from a flexible material, unwanted bending of the sheet placement portion 38 is prevented, for example, even when the sheet placement portion 38 is stored and held in a curved state in the outer tube 34. Furthermore, the sheet placement portion 38 is preferably made of a transparent (including translucent) material. This allows the peeling of the sheet placement portion 38 from the sheet-like material 32 to be confirmed through the endoscope camera.

[0096] The shape and size of the area in the sheet placing section 38 where the sheet-like material 32 is placed are determined taking into consideration the sheet-like material to be used, the in vivo environment, and the like, including elasticity and shape retention characteristics, and are not limited thereto, but in this embodiment, the shape is a distorted, approximately hexagonal shape when viewed from above in the unfolded state shown in Figures 12 and 13, taking into consideration the ease of storage in the outer tube 34. The base end portion of the sheet placing section 38 where the width dimension is narrowed serves as a connecting section 73 that is connected to the inner member 36 (small diameter section 60).

[0097] That is, the tip end portion of the underside of the sheet placement section 38 where the width dimension is wider is the sheet placement surface 74 on which the sheet material 32 is placed. The base end side of the sheet placement surface 74 is provided with inclined side portions 76, 76 on both the left and right sides, with the width dimension gradually decreasing toward the base end side.

[0098] In this embodiment, in the plan view shown in FIG. 12 , the sheet back surface 82, which is the opposite side of the sheet placement surface 74, extends more to the right than to the left with respect to the center line L (shown by the dashed line in FIG. 12 ) of the outer tube 34 (inner member 36). That is, the sheet placement surface 74 (sheet placement portion 38) shown in FIG. 13 has an asymmetrical shape with respect to the center line L of the outer tube 34. Note that in this embodiment, a nylon mesh 77 (shown by the dashed line in FIG. 13 ) is disposed between the sheet placement surface 74 and the sheet material 32. The sheet material 32 is supported on the nylon mesh 77 to maintain its shape, and is placed on the sheet placement surface 74 together with the nylon mesh 77. The shape and size of the nylon mesh 77 are appropriately determined taking into consideration the shapes and sizes of the sheet material 32 and the sheet placement surface 74, and are not limited thereto. However, in this embodiment, the nylon mesh 77 is larger than the sheet material 32 and smaller than the sheet placement portion 38 (sheet placement surface 74).

[0099] Furthermore, the connecting portion 73 located on the base end side of the sheet placing surface 74 in the sheet placing section 38 is positioned in a stepped manner slightly lower than the sheet placing surface 74, and has a generally semicircular arc shape that is curved so as to be convex upward, as shown in Figures 14 and 16. The connecting portion 73 is fixed to the tip portion of the inner member 36 (small diameter portion 60) including the liquid delivery tube 68 and the insertion tube 70, for example, by adhesive, welding, or a crimping member, in a state where it covers the tip portion.

[0100] Furthermore, an operating wire 78, which is inserted through the insertion tube 70 and constitutes an operating force transmission mechanism described below, is connected to the sheet placement portion 38, and an external operating force is applied via the operating wire 78 to curve and deform the sheet placement portion 38. The material of the operating wire 78 is not limited, but in this embodiment, silk thread, which is generally used as surgical suture thread, is used. The operating wire is inserted through the insertion tube 70 and extends forward and backward by a predetermined length, and it is sufficient that the operating wire can transmit an operating force applied to the base end side as a tensile force to the sheet placement portion 38 on the distal end side, and although the specific structure is not limited, in this embodiment, an operating wire 78 in which both ends of a silk thread are tied together to form an endless loop is used.

[0101] That is, the operating wire 78 of this embodiment has two silk threads extending between the base end and the tip end, and the folded end of the silk thread at the base end is fixed to the winding section 110 of the second operating section 120 described later, while the folded portion of the silk thread at the tip end is connected to the sheet placing section 38 by being inserted into through holes 80, 80 formed near the tip of the sheet placing section 38.

[0102] The operating wires 78 extending from the tip of the insertion tubes 70 extend on the side of the sheet back surface 82 opposite the sheet placing surface 74, and the tensile force exerted through the operating wires 78 pulls the tip portion of the sheet placing section 38 toward the back surface side (the side opposite the sheet placing surface 74) and bends it downward. In this embodiment, since the tip of the insertion tubes 70 opens on the sheet placing surface 74 side, the operating wires 78 extending from the tip of the insertion tubes 70 are passed from the sheet placing surface 74 side to the sheet back surface 82 side through the respective insertion holes provided in the base end portion of the sheet placing section 38, and then run along the sheet back surface 82 to reach the through holes 80, 80 provided in the tip portion of the sheet placing section 38.

[0103] As a result, the operating wire 78 extends from near the base end of the sheet placement portion 38 to near the tip end, but only the base end of the sheet placement portion 38 and the folded-back portion of the operating wire 78 between the through holes 80, 80 on the tip side protrude toward the sheet placement surface 74. Since the operating wire 78 is not present in the central portion of the sheet placement surface 74, it is possible to ensure a wide area of ​​the placement surface for the sheet material 32 while avoiding any adverse effects of the operating wire 78. Moreover, at the tip end of the sheet placement portion 38, the tensile force exerted by the operating wire 78 is exerted at two points, the through holes 80, 80, which are spaced apart in the width direction. Therefore, compared to, for example, when the operating wire 78 is connected at only one point, the tensile force can be efficiently exerted in the deformation direction that warps the sheet placement portion 38, and the sheet placement portion 38 can be deformed more stably.

[0104] In this embodiment, the operating wires 78, 78 extending from the insertion tube 70 are inclined so as to move away from each other toward both sides in the left-right width direction from the center line L on the seat back surface 82, and are inserted into through-holes 80, 80 spaced apart in the seat width direction. In particular, in this embodiment, the pair of through-holes 80, 80 through which the operating wire 78 is inserted and to which the operating force via the operating wire 78 is exerted are substantially symmetrical with respect to the center line L. This makes the operating wires 78 on both sides extending from the pair of through-holes 80, 80 symmetrical, which can improve the transmission efficiency of the operating force.

[0105] The positions of the through holes 80, 80 in the sheet placement portion 38 are not limited. For example, as shown in the partially enlarged view at the bottom of FIG. 12 , a pair of through holes 81, 81 may be provided on both the left and right widthwise sides of a center line M extending through the center of the width direction of the leading end portion of the sheet placement portion 38, and the folded-back portion of the leading end side of the operating wire 78 may be inserted through the through holes 81, 81. The enlarged view is based on the partially enlarged view of FIG. 12 , and the through holes 80, 80 and the operating wire 78 inserted therethrough are those of the device 30 as the fourth embodiment. By inserting the operating wire 78 through the through holes 81, 81, it is possible to efficiently apply the tensile force via the operating wire 78 to approximately the center of the width direction of the leading end portion of the sheet placement portion 38, thereby improving the stability of the deformation of the sheet placement portion 38.

[0106] Furthermore, a grip portion 84 for gripping and operating the device 30 is provided on the proximal end side of the outer tube 34. The grip portion 84 has a hollow, generally elongated rectangular box shape extending in the length direction of the outer tube 34. The grip portion 84 is provided with a hard housing 86 made of synthetic resin, metal, or the like, and in this embodiment, the housing 86 is formed by overlapping a first housing 88 and a second housing 90 in the left-right width direction and fixing them together with a fixing pin 92.

[0107] Inside the housing 86, there is provided a storage space 94 that houses the operating wire 78 and the winding section 110 described later for winding up the operating wire 78, and at the tip portion of the housing 86, there is formed an insertion hole 96 through which the base end portion of the inner member 36 is inserted.

[0108] The gripping portion 84 also has a slide operation portion 100 at its upper end portion that is slidable in the length direction of the gripping portion 84 (the length direction of the outer cylinder 34). The slide operation portion 100 is disposed on the outside of the upper wall portion of the housing 86, and, for example, the outer surface of the slide operation portion 100 serves as a slide operation surface 106 that can be slid by placing the thumb of the hand holding the gripping portion 84 in the palm of the hand over it.

[0109] The slide operation unit 100 has legs 104 formed integrally therewith that protrude downward, and the legs 104 are inserted into insertion windows 102 formed in the upper wall of the housing 86 and protrude into the storage space 94. The slide operation unit 100 is coupled to the base end of the internal member 36 by engaging with the legs 104. That is, the slide operation unit 100 is attached to the base end of the internal member 36 by coupling the legs 104 to the input portion 64 of the internal member 36 that extends into the storage space 94 through an insertion hole 96 formed in the front wall of the housing 86.

[0110] The insertion window 102 of the housing 86 extends in the shape of a slit in the length direction of the housing 86. The leg portion 104 and therefore the slide operating unit 100 are movable along the insertion window 102, and as the slide operating unit 100 moves, the inner member 36 moves relative to the housing 86 and therefore the outer cylinder 34 in the axial direction.

[0111] A compression coil spring 108 is disposed between the tip of the slide operating part 100 and the input part 64 of the internal member 36. The elastic force of this coil spring 108 generates sliding resistance due to contact between the slide operating part 100 and the upper wall of the housing 86. The sliding resistance acting on the slide operating part 100 prevents the slide operating part 100 and, therefore, the internal member 36 from moving in the axial direction, with a predetermined sense of resistance.

[0112] 14 and other figures, in this embodiment, the inner wall surface on both sides in the width direction of the slit-shaped insertion window 102 is formed with engagement recesses 109a, 109b near the front and rear ends, respectively, which open to the inner surface of the housing 86. Meanwhile, the leg portion 104 of the slide operation unit 100 inserted into the insertion window 102 is formed with a plate-like portion that extends to both sides in the width direction within the housing 86 to prevent the leg portion 104 from slipping out of the insertion window 102, and further, each of these plate-like portions is formed with an engagement protrusion 105 that protrudes upward toward the inner wall surface on both sides in the width direction of the insertion window 102. Then, based on the engagement of the engagement protrusion 105 with the engagement recesses 109a, 109b, the operator is given a sense of moderation and a positioning action is exhibited at the movement end of the slide operation unit 100 toward the front end (the extended and deployed position of the sheet placement unit 38) and the movement end toward the rear end (the retracted and stored position of the sheet placement unit 38).

[0113] In particular, the biasing force of the coil spring 108 disposed between the slide operation unit 100 and the inner member 36 (input unit 64) is exerted in a direction pressing the plate-shaped portion of the leg portion 104 against the inner surface of the housing 86, thereby exerting a locking effect that maintains the engagement state of the engagement protrusion 105 with the engagement recesses 109a, 109b. In this locked state, the operator presses the slide operation unit 100 downward (toward the housing 86) with his or her fingers to release the engagement state of the engagement protrusion 105 with the engagement recesses 109a, 109b, and then slides the slide operation unit 100 along the insertion window 102. Therefore, the positioning effect of the slide operation unit 100 toward the leading end or the trailing end in the sliding operation direction can be more effectively exerted.

[0114] Furthermore, a winding section 110 for winding up the operating wire 78 is provided in the storage space 94 of the housing 86. The winding section 110 has a generally disc-shaped reel structure and is provided with a winding shaft 112 on a rotation center axis extending in the left-right width direction of the housing 86. The shaft 112 is connected to a dial section 114 attached to the outer surface of a side wall of the housing 86 by a connecting shaft that penetrates the side wall of the housing 86 so as not to rotate relative to the dial section 114. The dial section 114 is disposed biased forward on one of the left and right side walls of the housing 86 and can be turned with the thumb or index finger of the hand holding the grip section 84 in the palm of the hand.

[0115] Furthermore, a folded end of the operating wire 78 is fixed to the outer peripheral surface of the shaft portion 112, and the operating wire 78 is wound up or let out by rotating the winding portion 110 through the turning operation of the dial portion 114. Note that guide protrusions, rollers, tubes, etc. for guiding the operating wire 78 are provided within the housing 86 as necessary, and a wiring path is set from the opening of the insertion tube 70 to the winding portion 110 for the operating wire 78 extending from the opening on the base end side of the insertion tube 70 within the housing 86. By appropriately setting such a wiring path, it is possible to suppress slack in the operating wire 78 and to ensure a stable and accurate amount of operation by winding or pulling out the operating wire 78.

[0116] When using the device 30 of this embodiment, a sheet-like material 32 supported by a nylon mesh 77 or the like is placed on the sheet placement section 38 (sheet placement surface 74) of the device 30 in its initial state as shown in FIG. 11 etc. The sheet-like material 32 is intended to be attached to an affected area in a living body for treatment, and examples thereof include the sheet-like physiologically active substance described above, a cell sheet (MSC sheet), an anticancer drug gel sheet, and other therapeutic sheets. Thereafter, as shown in FIG. 19 , the slide manipulation unit 100 is moved proximally to move the inner member 36 axially so as to retract it into the outer tube 34. As a result, the sheet placement section 38 attached to the tip of the inner member 36 moves proximally together with the inner member 36, and the sheet-like material 32 is housed within the outer tube 34.

[0117] That is, the gripping portion 84 is provided with a first operating portion 116 (slide operating portion 100) that moves the inner member 36, which is an inner member, in the axial direction relative to the outer tube 34, and an input portion 64 to which a driving force in the longitudinal direction is applied is provided on the base end side of the inner member 36. The slide operating force of the slide operating portion 100 is applied directly to the input portion 64 of the inner member 36.

[0118] Here, a protruding piece 56 that protrudes from the inner circumferential surface 42 into the cavity 46 is provided at the tip portion of the inner cavity 46 of the outer tube 34, and when the sheet placing portion 38 is stored in the outer tube 34, it is stored in a curved state, overlapping the inner circumferential surface 42 (specifically, the inner circumferential surface of the coating 44) of the outer tube 34 (circumferential wall 40) and the protruding piece 56, as shown in Figure 20. Therefore, a sheet support surface 118 on which the sheet placing portion 38 stored in a curved state in the cavity 46, which is the hollow interior of the outer tube 34, is overlapped is configured to include not only the inner circumferential surface 42 of the peripheral wall 40 but also the inner circumferential surface of the protruding piece 56.

[0119] In addition, in this embodiment, inclined sides 76, 76 are provided at the base end of the sheet placement surface 74, and when the inner member 36 is slid toward the base end relative to the outer tube 34 to store the sheet placement portion 38 inside the outer tube 34, the inclined sides 76, 76 abut against the periphery of the opening of the outer tube 34, causing smooth deformation. Furthermore, the sheet placement portion 38, which bulges out more on one side in the left-right width direction with respect to the center line L (in this embodiment, on the right side rather than the left side), is supported by being superimposed on the curved inner surface of the protruding piece 56 at one end side in the left-right width direction (in this embodiment, the left end side).

[0120] As a result, even if the width dimension of the sheet placement section 38 is greater than the circumferential length of the inner circumferential surface of the outer tube 34, both widthwise end portions of the sheet-like material 32 can be prevented from directly overlapping each other, and the sheet-like material 32 can be stably supported by the inner circumferential surfaces of the outer tube 34 and the protruding pieces 56 while contained in the outer tube 34. Furthermore, the support surface of the protruding pieces 56 rises circumferentially from the inner circumferential surface of the outer tube 34 at a smaller inclination angle (for example, an inclination angle of 60 degrees or less, more preferably 45 degrees or less, relative to the tangent direction of the inner circumferential surface of the outer tube 34) than the support surface protruding radially from the outer tube 34. Therefore, the bending angle or radius of curvature of the support surface at the portion of the protruding pieces 56 rising from the inner circumferential surface of the outer tube 34 can be set small, preventing local bending of the sheet-like material 32 overlapping this portion and resulting breakage, facilitating normal and stable delivery of the sheet-like material 32.

[0121] 19 and 20 , with the sheet-like material 32 placed and the sheet placement portion 38 housed within the outer tube 34, the outer tube 34 of the device 30 is inserted into a camera port of an endoscope (not shown), and the distal end of the outer tube 34 is delivered to the vicinity of a treatment site within the living body. Thereafter, by moving the slide operation portion 100 so as to push it toward the distal end, the inner member 36 together with the slide operation portion 100 slides toward the distal end relative to the outer tube 34. As a result, the sheet placement portion 38 moves toward the distal end together with the inner member 36, and the sheet placement portion 38 protrudes distally beyond the outer tube 34. As a result, the sheet placement portion 38, with the sheet-like material 32 still placed thereon, elastically returns to its initial expanded state shown in FIG. 11 and other figures within the living body due to its restoring deformation.

[0122] Thereafter, the device 30 is tilted as necessary, etc., so that the sheet-like material 32 placed on the sheet placing section 38 is superimposed on the treatment site in the living body and attached. At this time, before and / or after attachment of the sheet-like material 32, water, physiological saline, or the like filled in a syringe 22 or the like may be discharged from the discharge port 72 through the liquid supply tube 68 to moisten the treatment site, making it easier to attach the sheet-like material 32 due to the surface tension of the liquid, etc.

[0123] Then, with the sheet-like material 32 attached to the treatment site, for example, the thumb placed on the slide operation surface 106 is moved to the dial portion 114, and the dial portion 114 is rotated about its central axis, thereby winding the operating wire 78 onto the winding portion 110. As a result, the operating wire 78, the distal end of which is connected to the sheet mounting portion 38, is pulled toward the proximal end, causing the sheet mounting portion 38 to deform and bend back toward its rear surface, and the sheet mounting portion 38 is peeled off from the sheet-like material 32 attached to the treatment site. In this way, the attachment of the sheet-like material 32 to the treatment site is completed. Note that when attaching the sheet-like material 32, the nylon mesh 77 may be left on the sheet mounting portion 38 side, or it may be attached to the living body together with the sheet-like material 32 and the nylon mesh 77 may be peeled off and collected from the sheet-like material 32 afterwards, as needed.

[0124] That is, in this embodiment, an operating force transmission mechanism is provided that applies an operating force input from outside the body to the sheet placing portion 38 inside the body, thereby deforming the sheet placing portion 38, with the sheet-like material 32 placed on the sheet placing portion 38 in the unfolded state and attached to a treatment site inside the body. Particularly in this embodiment, this operating force transmission mechanism is configured by an operating wire 78 connected to the sheet placing portion 38. Then, a second operating unit 120 that deforms the sheet placing portion 38 via the operating force transmission mechanism (operating wire 78) is configured including the dial unit 114 and the winding unit 110. Therefore, in this embodiment, the first operating unit 116 that moves the inner member 36 relative to the outer tube 34 in the axial direction and the second operating unit 120 that deforms the sheet placing portion 38 via the operating force transmission mechanism (operating wire 78) are provided to be separately operable on the gripping portion 84.

[0125] After the sheet placement portion 38 has been peeled off from the sheet-like material 32 attached to the treatment site, the operating wire 78 can be fed out, for example, by rotating the dial portion 114 in the reverse direction, and the sheet placement portion 38 can be returned to its initial expanded state as shown in FIG. 11 etc. as the sheet placement portion 38 elastically deforms. From this state, the slide operation portion 100 can be slid toward the proximal end to re-store the sheet placement portion 38 within the outer tube 34. The device 30 may then be withdrawn from the camera port of the endoscope with the sheet placement portion 38 re-stored within the outer tube 34. However, since deformation of the sheet placement portion 38 does not pose a problem after the sheet-like material 32 has been attached to the treatment site, the device 30 may be withdrawn from the camera port of the endoscope without re-stored within the outer tube 34 (while the sheet placement portion 38 remains in its expanded state protruding from the outer tube 34), or the device 30 may be withdrawn together with the endoscope from the patient.

[0126] The device 30 removed from the patient may be discarded in its entirety, or it may be disassembled and, for example, the sheet support portion 38, inner member 36, fluid delivery tube 68, insertion tube 70, operating wire 78, etc. may be disposable, while the outer tube 34, protruding member 48, and even housing 86, which are made of metal, may be sterilized and reused.

[0127] The device 30 of this embodiment, configured as described above, achieves the same effects as the previously described embodiment. Furthermore, in this embodiment, a protruding piece 56 is provided that protrudes from the inner circumferential surface 42 of the outer tube 34 into the lumen 46. The protruding piece 56 constitutes the sheet support surface 118 on which the sheet placement portion 38 is placed. Therefore, compared to a case where only the inner circumferential surface of the outer tube is used as the sheet support surface, the outer diameter of the outer tube 34 can be reduced while ensuring a large area for the sheet support surface. Even when a larger sheet material 32 is used, it can be accommodated within the outer tube 34 without overlapping. Furthermore, because the protruding piece 56 extends along the inner circumferential surface 42 of the outer tube 34, the circumferential length of the protruding piece 56 (the length of protrusion from the inner circumferential surface 42 of the outer tube 34) can be freely set. Therefore, the protruding length of the protruding piece 56 can be appropriately set depending on the widthwise size of the sheet placement portion 38 to be used. In other words, it is easy to use sheet placement portions 38 of various sizes.

[0128] In this embodiment, the inner member 36 is made of synthetic resin and is disposable together with the sheet placement portion 38 that comes into contact with the patient. That is, it is economical because an inexpensively formed portion is disposable, and it is also hygienic because the portion that comes into contact with the patient is also disposable.

[0129] The grip portion 84 is provided with a first operating unit 116 that moves the inner member 36 in the axial direction relative to the outer tube 34, and a second operating unit 120 that deforms the sheet placement portion 38 via an operating force transmission mechanism (operating line 78), each of which can be operated separately. This improves the operational reliability of each operation. In particular, in this embodiment, the first operating unit 116 is provided above the grip portion 84, and the second operating unit 120 is provided on the side (left) of the grip portion 84. For example, the user can switch between operating the first operating unit 116 and operating the second operating unit 120 simply by shifting the position of the thumb, without changing the way the grip portion 84 is held. This improves the ease of use of the device 30 by the user.

[0130] In this embodiment, the operating force transmission mechanism is configured by the operating wire 78, and by rotating the winding portion 110 of the second operating portion 120, it is possible to wind up the operating wire 78 and deform the sheet placing portion 38. This makes it possible to easily achieve deformation of the sheet placing portion 38.

[0131] In this embodiment, the first operating unit 116 has a slide operating unit 100, and by moving the slide operating unit 100 toward the tip end and the base end, it is possible to switch between a state in which the sheet placing unit 38 protrudes from the outer tube 34 and is deployed, and a state in which the sheet placing unit 38 is stored in the outer tube 34. Therefore, the sheet placing unit 38 can be quickly switched between the deployed state and the stored state with a simple structure, and it is also easy to accurately grasp the amount of movement of the sheet placing unit 38 as the amount of movement of the slide operating unit 100 intuitively.

[0132] <Fifth embodiment> 21 and 22 show a device 130 according to a fifth embodiment of the present disclosure in an unfolded state with the sheet placement portion 38 protruding from the outer tube 34. The device 130 of this embodiment differs from the device 30 described in the fourth embodiment only in the position of the second operating portion 134 provided on the grip portion 132, and the structure of other portions and the basic method of use are similar to those of the device 30 described in the fourth embodiment. Therefore, in the following description, differences from the device 30 described in the fourth embodiment will be described, and detailed description of components and parts that are substantially the same as those of the fourth embodiment will be omitted by assigning the same reference numerals in the drawings to those of the fourth embodiment.

[0133] Similar to the fourth embodiment, the grip portion 132 of this embodiment is provided with a first operating portion 116 (slide operating portion 100) at its upper portion that moves the inner member 36 in the axial direction relative to the outer tube 34, and a second operating portion 134 is provided on the grip portion 132 closer to the tip end than the first operating portion 116. In the fourth embodiment, the dial portion 114 constituting the second operating portion 120 was provided on the side surface (left side) of the grip portion 84, and the central axis of the dial portion 114 extended in the left-right direction, but in this embodiment, the dial portion 136 is substantially cylindrical, and the central axis of the dial portion 136 extends in the length direction of the outer tube 34. A portion of the circumference of the dial portion 136 is exposed from the grip portion 132, and it is possible to rotate the dial portion 136 about its central axis by, for example, placing a thumb on the outer peripheral surface of the dial portion 136.

[0134] A winding portion 138 for winding up the operating wire 78 is formed integrally with the base end of the dial portion 136, and the operating wire 78 is fixed to the outer peripheral surface of the winding portion 138. As a result, by rotating the dial portion 136 around the central axis and winding up the operating wire 78, an operating force is applied to the sheet placing portion 38 via the operating wire 78, and the sheet placing portion 38 can be deformed.

[0135] In use of the device 130 of this embodiment, the sheet material 32 is placed on the sheet placement portion 38, optionally via a nylon mesh 77, and then the slide operation portion 100 constituting the first operation unit 116 is slid toward the proximal end. This causes the inner member 36 and the sheet placement portion 38 to slide toward the proximal end together with the slide operation portion 100, and the sheet placement portion 38 is housed in the distal end portion of the outer tube 34. The subsequent operation method is the same as that described in the fourth embodiment. In this embodiment, the proximal end portion of the inner member 36 is inserted through the bores of the dial portion 136 and the winding portion 138, so that the dial portion 136 and the winding portion 138 do not interfere with each other when the inner member 36 slides toward the proximal end.

[0136] Therefore, in the device 130 of this embodiment, by applying an operating force input from outside the body to the sheet mounting portion 38 in an unfolded state via the operating force transmission mechanism (operating wire 78), the sheet mounting portion 38 can be deformed so as to peel off from the sheet-like material 32 attached to the treatment area, and therefore the same effect as the device 30 described in the fourth embodiment can be achieved.

[0137] Sixth Embodiment 23 and 24 show a device 140 according to a sixth embodiment of the present disclosure in an unfolded state in which the sheet placement portion 38 protrudes from the outer tube 34. The device 140 of this embodiment differs from the devices 30 and 130 described in the fourth and fifth embodiments in the structures of the first operating portion 144 and the second operating portion 146 provided on the grip portion 142, but the structures of other portions and the basic method of use are similar to those of the devices 30 and 130 described in the fourth and fifth embodiments. Therefore, in the following description, differences from the device 30 described in the fourth embodiment will be described, and detailed descriptions of components and parts that are substantially the same as those in the fourth embodiment will be omitted by assigning the same reference numerals in the drawings to those in the fourth embodiment.

[0138] In this embodiment, a rack portion 150 that constitutes a rack-and-pinion with a gear (a pinion portion 152 described later) provided in the first operating portion 144 is provided on the upper side of the base end portion of the internal member 148 serving as the internal member, as an input portion to which a driving force in the longitudinal direction is applied. That is, spur tooth-shaped concaves and convexes are provided continuously in the longitudinal direction of the outer tube 34 on the upper side of the base end portion of the internal member 148, and the rack portion 150 is provided over a certain length from the base end of the internal member 148.

[0139] The first operating unit 144 is provided in the accommodation space 94 with a pinion unit 152, which is a gear corresponding to the rack unit 150, and a rotation operating unit 154 that is provided coaxially with the pinion unit 152 and is rotatable together with the pinion unit 152. The pinion unit 152 has a plurality of teeth on its outer circumferential surface that can mesh with the rack unit 150, and its central axis extends in the left-right direction. The rotation operating unit 154 is a generally circular disk that is larger than the pinion unit 152, with a portion of its circumference protruding upward from the grip unit 142 and the remaining portion of its circumference housed within the accommodation space 94. The pinion unit 152 and the rotation operating unit 154 are configured to rotate together around a first rotation shaft 156 that extends in the left-right direction. Therefore, by rotating the rotation operation unit 154 from the outside, the rotation operation unit 154 and the pinion unit 152 rotate integrally around the first rotation shaft unit 156 fixed to the housing 86 as the rotation center axis. As the pinion unit 152 rotates, the gear of the pinion unit 152 meshes with the teeth of the rack unit 150, allowing the inner member 148 having the rack unit 150 to move in the axial direction relative to the outer cylinder 34. In other words, the first operation unit 144 of this embodiment converts the rotation operation force applied to the rotation operation unit 154 into a linear driving force by a gear mechanism consisting of a rack and pinion, and indirectly applies the linear driving force to the rack unit 150, which is the input unit.

[0140] The rotation operation unit 154 has an uneven portion 158 with a plurality of continuous uneven portions on its outer circumferential surface, and an engagement protrusion 160 that protrudes upward into the accommodation space 94 is provided at the bottom of the grip portion 142. As the rotation operation unit 154 is performed around the central axis, the engagement protrusion 160 repeatedly moves over the convex portions and moves into the concave portions of the uneven portion 158 provided on the outer circumferential surface of the rotation operation unit 154, allowing the rotation operation unit 154 to be rotated in stages with a click feeling.

[0141] The second operating part 146 also includes a winding part 162 to which the operating wire 78 is fixed within the accommodation space 94 and which rotates to wind up the operating wire 78. The winding part 162 is generally cylindrical, and the operating wire 78 is fixed to the outer peripheral surface of the winding part 162. The second operating part 146 also includes a dial part 164 that is provided coaxially with the winding part 162 and is rotatable together with the winding part 162. The dial part 164 is generally disk-shaped and larger than the winding part 162, with a portion of its circumference protruding upward from the grip part 142 and the remaining portion of its circumference being accommodated within the accommodation space 94. The winding part 162 and the dial part 164 are rotatable together around a second rotation shaft 166 that extends in the left-right direction. Therefore, by rotating the dial portion 164 from the outside, the dial portion 164 and the winding portion 162 rotate integrally around the second rotating shaft portion 166 fixed to the housing 86 as the central axis of rotation. As the winding portion 162 rotates, the operating wire 78 is wound up, and the sheet placing portion 38 can be deformed so as to peel off from the sheet-like material 32 attached to the treatment site.

[0142] The dial portion 164 has an outer peripheral surface 168 provided with a plurality of rough surfaces (or concaves and convexes), and a contact protrusion 170 is provided at the bottom of the grip portion 142, protruding into the accommodation space 94 and contacting the outer peripheral surface 168 of the dial portion 164. Based on the contact, sliding contact, or engagement action of the contact protrusion 170 with the dial portion 164 (outer peripheral surface 168), it is possible to appropriately adjust, for example, the rotational operation feel of the dial portion 164. More specifically, for example, as the rotational operation feel of the dial portion 164, a substantially constant slight rotational resistance can be applied to achieve smooth rotation of the dial portion 164, or a predetermined click feeling can be applied, particularly in the rotation direction that applies a pulling force, to facilitate fine adjustments when peeling off the sheet placement portion 38, or it is also possible to maintain the rotational position of the dial portion 164 and thereby maintain the pulling force on the sheet placement portion 38.

[0143] In the device 140 of this embodiment having the above-described structure, by applying an operating force input from outside the body to the sheet mounting portion 38 in the unfolded state via the operating force transmission mechanism (operating wire 78), the sheet mounting portion 38 can be deformed so as to peel off from the sheet-like material 32 attached to the treatment area, and therefore the same effect as the device 30 described in the fourth embodiment can be achieved.

[0144] Seventh Embodiment 25 and 26 show a device 180 according to a seventh embodiment of the present disclosure in an unfolded state with the sheet placement portion 38 protruding from the outer tube 34. The device 180 of this embodiment differs from the devices 30 and 130 described in the fourth and fifth embodiments in the structures of the first operating portion 184 and the second operating portion 186 provided on the grip portion 182, as in the sixth embodiment, but the structures of other parts and the basic method of use are similar to those of the devices 30 and 130 described in the fourth and fifth embodiments. Therefore, the following description will focus on the differences from the device 30 described in the fourth embodiment, and detailed descriptions of components and parts that are substantially the same as those in the fourth embodiment will be omitted by assigning the same reference numerals in the drawings to those in the fourth embodiment.

[0145] In this embodiment, a housing 190 constituting the grip portion 182 is connected to the base end side of the outer tube 34, through which an internal member 188 as an internal member and the protruding member 48 are inserted. That is, the outer tube 34 is inserted into and fixed to an insertion hole 96 at the tip of the housing 190, and the base end of the inner member 188 protrudes further to the base end side than the base end of the outer tube 34 within the inner hole of the housing 190. Also, an input portion 192 is fixedly attached to the base end of the inner member 188, and the operating wire 78, which is connected to the sheet placement portion 38 at the tip side, extends to the base end side through the insertion tube 70, penetrates the input portion 192, and reaches a point further to the base end side than the input portion 192.

[0146] Furthermore, a slide operation member 194 having a first operating portion 184 and a rotation operation member 196 having a second operating portion 186 are inserted into the inner hole of the housing 190 from the base end side, with their respective tip portions being inserted. The slide operation member 194 is generally cylindrical overall, and its tip portion is a first small-diameter cylindrical portion 198 having a thin-walled cylindrical shape large enough to be inserted into the inner hole from the base end side of the housing 190. The base end portion of the slide operation member 194 is generally rectangular cylindrical with a larger diameter than the first small-diameter cylindrical portion 198, and protrudes toward the base end of the housing 190. The base end portion of the slide operation member 194 forms the first operating portion 184 that can be grasped by a user and slid axially toward the base end.

[0147] The slide operation member 194 is assembled to the housing 190 so as to be non-rotatable about the central axis but movable in the direction of the central axis. A connecting portion 200 is provided at the tip of the first small diameter cylindrical portion 198, and is fixed to and connected to the input portion 192 at the base end of the inner member 188 so as to be non-rotatable relative to the housing 190. A female thread 202 is formed on the base end portion of the inner circumferential surface of the slide operation member 194 (for example, the inner circumferential surface of the portion that forms the large diameter cylindrical portion).

[0148] Furthermore, the rotation operation member 196 is generally cylindrical overall, with its tip end portion being a second small-diameter cylindrical portion 204 of a size that can be inserted into the inner hole of the slide operation member 194, and its base end portion being a cylindrical portion with a larger diameter than the second small-diameter cylindrical portion 204 and an outer circumferential surface that is non-circular, such as polygonal, and protruding toward the base end of the slide operation member 194. A male thread 206 that screws into the female thread 202 of the slide operation member 194 is formed on the outer circumferential surface of the second small-diameter cylindrical portion 204 over a predetermined length, and when a user grasps the large-diameter cylindrical portion at the base end of the rotation operation member 196 and rotates the rotation operation member 196 relative to the slide operation member 194, the screw mechanism of the male thread 206 and the female thread 202 causes the rotation operation member 196 to move relative to the slide operation member 194 in the central axial direction.

[0149] Furthermore, a generally annular or disc-shaped connecting part 208 is attached to the tip of the second small diameter cylindrical part 204 so as to be rotatable relative to the second small diameter cylindrical part 204 and so as not to be detachable in the axial direction. The operating wire 78 extending further to the base end side than the input part 192 is connected to the second small diameter cylindrical part 204 within the first small diameter cylindrical part 198 of the slide operating member 194 via the connecting part 208.

[0150] When using the device 180 of this embodiment, the sheet material 32 is placed on the sheet placement portion 38, with the nylon mesh 77 interposed between them if necessary, and then, as shown in FIGS. 27 and 28 , the first operating portion 184 is gripped and the slide operating member 194 is slid toward the proximal end relative to the housing 190. Because the slide operating member 194 is connected to the inner member 188 via the connecting portion 200, the inner member 188 and the sheet placement portion 38 slide toward the proximal end together with the slide operating member 194, and the sheet placement portion 38 is housed in the distal portion of the outer tube 34. Thereafter, the distal portion of the outer tube 34 of the device 180 is delivered to the vicinity of the treatment site in the living body, and then the first operating portion 184 is gripped and the slide operating member 194 is slid toward the distal end, causing the sheet placement portion 38 to protrude from the outer tube 34 and assume an expanded state, as shown in FIGS. Then, after the sheet material 32 has been attached to the treatment site, the second operating portion 186 is grasped and rotated, and the rotation operating member 196 is screwed toward the base end relative to the slide operating member 194. As a result, the operating wire 78 connected to the rotation operating member 196 via the connecting portion 208 is pulled toward the base end, and the sheet placing portion 38 is deformed so as to be peeled off from the sheet material 32. The subsequent operating method is the same as that described in the fourth embodiment.

[0151] In this embodiment, the rotation operation member 196 is moved proximally relative to the slide operation member 194 to peel the sheet placement portion 38 from the sheet material 32, and then the slide operation member 194 is slid proximally relative to the housing 190 together with the rotation operation member 196, whereby the inner member 188 and the sheet placement portion 38 move proximally together with the slide operation member 194, and the sheet placement portion 38 can be retracted into the outer tube 34. However, as in the above-described embodiment, after peeling the sheet placement portion 38 from the sheet material, the entire device including the outer tube 34 may be removed from the endoscope port with the sheet placement portion 38 still protruding, without retracting the sheet placement portion 38 into the outer tube 34.

[0152] In this embodiment, even when the slide operation member 194 is moved proximally to move the inner member 188 proximally, the tensile force applied to the sheet placing portion 38 via the operation wire 78 is maintained substantially constant. That is, in this embodiment, when the inner member 188 moves in the longitudinal direction relative to the outer tube 34, an operation force holding mechanism 209 that holds the operation force applied to the sheet placing portion 38 by the operation force transmission mechanism (operation wire 78) is configured by connecting the operation wire 78 to the rotation operation member 196 that moves together with the inner member 188 via the slide operation member 194. In other words, in this embodiment, the operation wire 78 is not connected to the outer tube 34 and the housing 190, but is connected to the rotation operation member 196, which is a member on the inner member 188 side, which is an inner member. In addition, such an operation force holding mechanism can also be configured by connecting the operation wire 15 to the operation unit 14 on the inner member 12 side in the first to third embodiments described above.

[0153] By providing such an operating force retaining mechanism 209, it is possible to prevent slack in the operating wire 78, for example, when the internal member 188 moves in the length direction relative to the external tube 34, thereby preventing malfunctions due to snagging or tangling of the operating wire 78. It is also possible to prevent the tensile force applied to the sheet placement portion 38 via the operating wire 78 from being inadvertently released as the internal member 188 moves in the length direction relative to the external tube 34, for example, and to prevent the deformation of the sheet placement portion 38 from being unintentionally released.

[0154] In the device 180 of this embodiment having the above-described structure, the sheet mounting portion 38 in the unfolded state can be deformed so as to peel off from the sheet-like material 32 attached to the treatment area by applying an operating force input from outside the body to the sheet mounting portion 38 via the operating force transmission mechanism (operating wire 78), thereby achieving the same effect as the device 30 described in the fourth embodiment. [Example]

[0155] The present disclosure will be described in more detail below with reference to examples, but these are merely illustrative and the present disclosure is not limited to these examples. All references cited in this disclosure are incorporated herein by reference.

[0156] [Device fabrication] Device 2 shown in FIG. 10 was fabricated. The device 2 comprises an outer tube 11 (length: 20 cm, outer diameter: 18 mm, thickness: 1 mm, material: stainless steel), a sheet support portion 13 (5 × 3 cm, thickness: 1 mm, rounded square, material: polyethylene elastomer), a hollow cylindrical inner member 12 (length: 35 cm, outer diameter: 10 mm, thickness: 1 mm, material: stainless steel), and a tube 20 with a discharge port 21 attached to one end and a syringe 22 attached to the other end. The outer tube 11 is hollow and cylindrical. The inner member 12 is hollow and cylindrical, with the sheet support portion 13 attached to its distal end and the operating portion 14 attached to its proximal end. The operating portion 14 is male-threaded, and a female-threaded screw is formed on the inner surface of the proximal end of the inner member 12 to allow engagement with the male-threaded screw. A hole 19 is formed in the side of the inner member 12, and the tube 20 is inserted into the inner member 12 through this hole. The tube 20 was positioned so that the discharge port 21 attached to one end (tip side) thereof was on the sheet placement surface side of the sheet placement section 13 and protruded from the tip of the inner member 12. One end of the operating wire 15 was attached to a through-hole formed on the tip side of the sheet placement section 13. The other end of the operating wire 15 passed from the surface of the sheet placement section 13 opposite the sheet placement surface 13a through a through-hole provided on the base end side of the sheet placement section 13, passed through the inside of the inner member 12, and was connected to the operating unit 14 via a swivel (not shown). The operating wire 15 and the operating unit 14 were configured so that when the operating unit 14 (male screw) abutting the inner member 12 was rotated in the direction opposite to the tip while the sheet placement section 13 protruded from the outer tube 11, the operating wire 15 was pulled, and the sheet placement section 13 was elastically deformed and curved with the sheet placement surface 13a facing outward.

[0157] [Preparation of MSC sheets] We created a cell sheet (MSC sheet) mimicking cardiac tissue using immortalized human mesenchymal stem cells (TERT-hMSCs) transfected with the telomerase reverse transcriptase (TERT) gene. TERT-hMSCs were cultured in αMEM supplemented with 10% fetal bovine serum (FBS), 5.5 mmol / L 2-mercaptoethanol, and 0.5 ml penicillin on uncoated dishes (10 cm) in a humidified atmosphere of 5% CO2 / 95% air at 37°C. For maintenance of TERT-hMSCs, the culture medium was changed every 2 days. TERT-hMSCs were removed from the dishes and dissociated into single cells by incubation with 0.25% trypsin / ethylenediaminetetraacetic acid (EDTA) solution for 3 minutes. Single-cell dissociated cells (TERT-hMSCs) and a temperature-responsive culture surface dish (UpCell®, CellSeed, Inc.) were used to prepare cell sheets (MSC sheets) according to conventional methods. Five to six million TERT-hMSCs were seeded onto a 10 cm dish (UpCell®, CellSeed, Inc.) coated with α-MEM + 10% FBS and incubated at 37°C in a humidified atmosphere of 5% CO2 / 95% air. On day 4, the MSC sheets were harvested from the UpCell® dish at room temperature.

[0158] [MSC sheet transplantation using a cardiac model 1] First, a heart model was prepared using UV-equipped inkjet 3D printer technology. Next, using an appropriately cut nylon mesh (holes 35 μm), the MSC sheet was transferred from the culture dish to the sheet mounting surface 13a of the device's sheet mounting section 13. At this time, the nylon mesh and MSC sheet were set in this order on the sheet mounting section 13 so that the nylon mesh was in contact with the sheet mounting surface 13a, and the MSC sheet was prevented from coming into direct contact with the sheet mounting surface 13a. The sheet mounting unit 13 containing the MSC sheet and nylon mesh was brought into contact with the surface of the heart model, and then the operating unit 14 was rotated in one direction to pull the operating wire 15 and bend the sheet mounting unit 13, thereby attaching the MSC sheet and nylon mesh to the heart model at a predetermined position. Next, the nylon mesh was peeled off while the MSC sheet was still held on the heart model. This allowed the MSC sheet to be attached to the heart model.

[0159] [MSC sheet transplantation using a cardiac model 2] Before contacting the sheet mounting unit 13 with the surface of the heart model, sufficient water was sprayed onto the surface of the heart model to ensure it was wet. As in MSC sheet transplantation 1 using a heart model, the MSC sheet and nylon mesh were placed on the sheet mounting unit 13, and then water was supplied through the outlet 21 to moisten the MSC sheet and nylon mesh (Figure 29(i)). The sheet mounting unit 13 with the MSC sheet and nylon mesh placed on it was then brought into contact with the surface of the heart model (Figure 29(ii)). The operating unit 14 was then rotated in one direction to pull the operating wire 15 and bend the sheet mounting unit 13 (Figure 29(iii)). The MSC sheet and nylon mesh were then attached to the heart model at the desired positions. After sufficient water was sprayed onto the surface of the nylon mesh (heart model), the nylon mesh was gently peeled off from the surface of the heart model (Figures 29(iv) and (v)). In this way, by contacting the well-moistened MSC sheet and nylon mesh with the well-watered surface of the heart model, and by thoroughly watering the surface of the heart model before peeling off the nylon mesh, the success rate of detaching the nylon mesh from the sheet mounting section 13 and the success rate of peeling off the nylon mesh from the MSC sheet improved. The transplant success rate was 100% (n = 20, p = 0.0197).

[0160] [MSC sheet transplantation into pig hearts] The procedure was the same as in [MSC sheet transplantation using a cardiac model 2], except that a pig heart was used instead of the cardiac model. The procedure is shown in Figure 30. As a result, the success rate of detaching the nylon mesh from the sheet mounting section 13 was 100% (n = 10), and the success rate of peeling the nylon mesh from the MSC sheet while the MSC sheet was held on the surface of the pig heart was 100% (n = 10).

[0161] [Endoscopic transplantation of MSC sheets using a cardiac model] A thoracic cavity model (pericardium, lungs, bone, muscle, and skin) was created using vacuum casting, and a heart model was placed inside it. Using this model, we attempted endoscopic transplantation of MSC sheets into the anterior and lateral wall regions of the left ventricle (LV) of the heart model. As a result, the MSC sheet was successfully transplanted into the heart model in both the anterior and lateral LV wall regions without tearing, distortion, or dislocation of the MSC sheet.

[0162] Although the embodiments and examples of the present disclosure have been described in detail above, the present disclosure is not limited to the specific descriptions.

[0163] The manner in which the operating wire is connected to the sheet placement portion is not limited to that exemplified in the above-described embodiment. For example, the deformation of the sheet placement portion due to the action of an external force is not limited to the deformation in which the leading end portion is pulled toward the back surface and bent back as in the above-described embodiment, but may be any deformation that pulls the sheet placement portion away from the sheet-like material placed on the sheet placement surface and attached to the living body. Furthermore, the manner in which the operating wire is connected to the sheet placement portion may be appropriately set depending on the deformation caused by the sheet placement portion, and is not limited to the above-described embodiment.

[0164] An example of a specific modified embodiment is shown in Fig. 31A. In the modified embodiment of Fig. 31A, two operating wires 212a and 212b are connected to the sheet placement portion 210. In Fig. 31, components and parts that are substantially the same as those in the above embodiment are denoted by the same reference numerals as in the fourth embodiment, and detailed description thereof will be omitted. That is, in Fig. 31A, the insertion tube 70 extends onto the sheet back surface 82 of the sheet placement portion 210, and a folded-back portion on the tip side of one endless looped operating wire 212a extends rightward from the insertion tube 70 and is connected to the right end portion of the sheet placement portion 210 in the width direction, and a folded-back portion on the tip side of the other endless looped operating wire 212b extends leftward from the insertion tube 70 and is connected to the left end portion of the sheet placement portion 210 in the width direction. In this embodiment, both operating wires 212a, 212b are fixed at their folded-back portions on the proximal end side to the winding unit or the like of the above embodiment, and when they are wound and pulled on the proximal end side of the device, a tensile force is applied to the backside of the right and left ends of the sheet placing portion 210, causing the sheet placing portion 210 to deform as shown in FIG. 31B. In the embodiment shown in FIG. 31, the lower surface in the figure is the sheet placing surface 74 on which the sheet-like substance (biologically active substance) is placed, and is the surface that is superimposed on the treatment site when the sheet-like substance is applied. Therefore, in this embodiment, after the sheet-like substance is applied, the sheet placing portion 210 is deformed so that both left and right widthwise ends of the sheet placing portion 210 are deformed so as to be peeled off from the sheet-like substance 32, thereby peeling the sheet placing portion 210 from the sheet-like substance 32.

[0165] In the embodiment shown in Figure 31, the axis of the sheet placement portion 210 when it is deformed into a curved or bent shape (a line that remains straight even when it is bent) is approximately parallel to the central axis of the outer tube 34. Therefore, compared to the other embodiments described above in which the axis of the sheet placement portion 210 when it is deformed is approximately perpendicular to the central axis of the outer tube 34, when the sheet placement portion 210 is to be re-stored in the outer tube 34 after being deformed, it is easier to store the sheet placement portion 210 in its deformed state in the outer tube 34. That is, in the other embodiments described above, when the sheet placement portion is to be re-stored in the outer tube 34, it is necessary to release the deformation of the deformed sheet placement portion or reduce the degree of deformation as necessary. However, in the embodiment shown in Figure 31, the sheet placement portion 210 can be re-stored in the outer tube 34 without the need for such an operation.

[0166] 31, the insertion tube 70 is disposed so as to extend from the base end toward the tip end of the sheet placement portion 210 at approximately the middle in the width direction of the sheet placement portion 210, thereby improving the shape stability of the sheet placement portion 210 and also improving the support stability of the sheet material. Furthermore, as can be seen from FIG. 31B, when peeling from the sheet material, peeling starts from both side edge portions in the width direction, which makes peeling from the sheet material more reliable and can also shorten the time required for peeling.

[0167] Furthermore, the protruding piece that protrudes from the inner peripheral surface of the outer cylinder and constitutes part of the sheet support surface is not essential, but even if the protruding piece is provided, the protruding form of the protruding piece is not limited to the forms described in the fourth to seventh embodiments, and may protrude from below toward above, for example, as shown in Figure 17 of Patent Document 1. In such a case, for example, a sheet placing portion that is symmetrical with respect to the central axis of the outer cylinder in a plan view may be employed.

[0168] The device according to the present disclosure is not limited to the shapes exemplified in the above-described embodiments and may be, for example, a gun-type device such as the device 220 shown in FIG. 32 . That is, a user may grasp the grip portion 222 of the gun-type device 220 and, for example, pull a trigger 224 with their index finger, thereby moving an inner member 226 connected to the trigger 224 toward the base end, and retract the sheet placement portion 38 that protruded from the outer tube 34 into the outer tube 34. Alternatively, the trigger 224 may be moved toward the tip end and returned to its initial position, causing the sheet placement portion 38 to protrude from the outer tube 34. Furthermore, a second operating unit 228 for winding up the operating wire 78 so as to peel the unfolded sheet placement portion 38 from the sheet-like material 32 may be provided near the grip portion 222. In this case, the second operating unit 228 may be configured to include a winding unit 230 and a dial unit 232 to which the operating wire 78 is connected at the base end of the device 220, as in the fourth embodiment. In addition, the sheet placement portion 38 may be configured to protrude from the outer tube 34 by pulling the trigger 224, and such a configuration can be realized, for example, by connecting the trigger 224 and the outer tube 34, so that by pulling the trigger 224, the outer tube 34 can be moved toward the base end relative to the sheet placement portion 38 and the inner member 226. [Explanation of symbols]

[0169] 1 Device (First Embodiment) 2 Device (Third embodiment) 11 Outer cylinder 12 Internal material 13 Sheet placement section 13a Sheet placement surface 13b,13c through hole 13d Opposite side 14 Control section 15 Operating Line 16 Physiologically active substances 17 Connecting member 18 Reinforcement member 19 holes 20 tubes 21 Discharge port 22 syringe 23 Connection 30 Device (Fourth embodiment) 32 Sheet-like materials 34 outer cylinder 36 Internal material 38 Sheet placement section 40 Peripheral wall 42 Inner surface 44 Coating 46 Lumen 48 Protruding member 50 groove 52 Holding part 56 Projecting piece 58 Flange-shaped part 60 Small diameter section 62 Large diameter section 64 Input section 66 Support recess 68 Fluid supply tube (tube) 70 Insertion tube 72 Discharge port 73 Connection 74 Sheet placement surface 76 Slope side 77 Nylon Mesh 78 Operating wire (operating force transmission mechanism) 80 through holes 81 Through hole 82 Back of seat 84 Gripping part 86 Housing 88 First Housing 90 Second Housing 92 Fixing pin 94 Containment Space 96 Insertion hole 100 Slide operation unit 102 Insertion window 104 Legs 105 Engagement protrusion 106 Slide operation surface 108 coil spring 109a, 109b Engagement recess 110 Winding section 112 Shaft 114 Dial section 116 First operation section 118 Sheet support surface 120 Second operation section 130 Device (Fifth embodiment) 132 Gripping part 134 Second operation section 136 Dial section 138 Winding section 140 Device (Sixth embodiment) 142 Gripping part 144 First operation section 146 Second operation section 148 Internal materials 150 Rack section (input section) 152 Pinion section 154 Rotation control unit 156 First rotating shaft 158 Uneven part 160 Engagement protrusion 162 Winding section 164 Dial section 166 Second rotating shaft 168 Outer surface 170 Contact protrusion 180 Device (Seventh embodiment) 182 Gripping part 184 First operation section 186 Second operation section 188 Internal materials 190 Housing 192 Input section 194 Slide operating member 196 Rotation operating member 198 First small diameter cylinder part 200 Connection part 202 Internal thread 204 Second small diameter cylinder part 206 Male thread 208 Connection 209 Operation force retention mechanism 210 Sheet placement section 212a,212b Operation line 220 devices 222 Gripping part 224 Trigger 226 Internal materials 228 Second operation section 230 Winding section 232 Dial section L (Outer cylinder) center line M (sheet placement area) widthwise center line

Claims

1. A device for delivering and applying a therapeutic sheet material to a living body, The distal end side has a hollow outer tube that is inserted into a living body, and an inner member that is inserted into the outer tube, a sheet placing section on which the sheet-like material is placed is provided at the tip end side of the inner member, the sheet placing section being capable of being stored in the outer tube in a curved state, and the sheet placing section being capable of being deployed by protruding from the outer tube towards the tip end side; a protruding piece protruding from the inner circumferential surface of the peripheral wall into the cavity is provided at the tip portion of the outer cylinder in which the sheet placing portion is housed, and the protruding piece has a cross-sectional shape that curves along the inner circumferential surface of the outer cylinder and protrudes in the circumferential direction, The protruding piece extends in a curved manner in a circumferential direction, spaced apart from the inner peripheral surface of the outer cylinder in cross section, a sheet support surface on which the sheet placing portion is placed is configured, the sheet support surface including an inner peripheral surface of the peripheral wall of the outer cylinder and a curved inner surface of the protruding piece, The device has a sheet support surface configured in a spiral shape that overlaps twice with a gap in the radial direction.

2. A device for applying a sheet-shaped physiologically active substance to a living body, A cylindrical outer cylinder; A cylindrical inner member; a sheet placement portion provided at a tip end of the inner member; an operating portion provided at a base end portion of the inner member, the inner member has an axial length longer than the axial length of the outer cylinder, and is provided inside the outer cylinder so as to be movable in the axial direction of the outer cylinder; the sheet placement portion is configured to be exposed in a state in which it protrudes outward from one end side of the outer tube, and when the inner member is moved toward the base end side along the axial direction of the outer tube, it is elastically deformed into a shape that conforms to the inside of the outer tube and can be stored within the outer tube, The operation unit is configured to be able to operate the bending movement of the sheet placement unit and / or adjust the fixing force between the sheet placement unit and the inner member, The device further includes a tube having a discharge port at its tip, the tube is inserted into the inner member and is disposed on the sheet placement surface side of the sheet placement section with a tip of the discharge port protruding from a tip of the inner member, The device has a sheet placement surface protruding from the inner member, and the fluid is discharged through the discharge port onto the sheet placement surface.

3. an operating wire having one end connected to the leading end side of the sheet placement portion and the other end connected to the operating portion; The device according to claim 2 , wherein the operating wire is configured so that the sheet placement portion can be bent by pulling the operating wire through operation of the operating portion.

4. a connecting member that connects the sheet placement portion and the inner member; further comprising an operating wire connecting the connecting member and the operating portion; The device according to claim 2 or 3, wherein the connecting member and the operating wire are configured to be capable of adjusting a fixing force between the sheet placement portion and the inner member in conjunction with an operation of the operating portion.

5. 5. The device according to claim 2, wherein an elastically deformable reinforcing member is provided on a surface of the sheet placement portion opposite to the sheet placement surface.

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