JP7783602B2 - Device for attaching sheet-shaped material to living body - Google Patents

Description

The present disclosure relates to a device for delivering and applying a sheet-like material inside a living body.

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.

Patent document 1 discloses a delivery and administration device in which a sheet support member that holds a sheet-like therapeutic substance is shaped into a cylindrical form and stored inside an outer cylinder, allowing the sheet-like therapeutic substance to be delivered to the affected area in this state.

Japanese Patent Application Laid-Open No. 2009-511

In recent years, various treatment methods using sheet-like physiologically active substances, such as cell sheets, have been developed, and therefore 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 site, it is difficult to gently peel off the device while keeping the sheet-like physiologically active substance in place at the affected site.
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 therapeutic materials into the body based on the knowledge of those skilled in the art.

The following describes preferred embodiments for understanding the present disclosure. However, each embodiment described below is an example and may be used in combination with one another as appropriate. The multiple components described in each embodiment may also be recognized and used independently to the greatest extent possible, and may also be used in combination with any of the components described in other embodiments as appropriate. As a result, the present disclosure is not limited to the embodiments described below, and various alternative embodiments may be realized.

A first aspect of the present disclosure is a device for delivering and applying a therapeutic sheet-like material inside a living body, comprising a hollow outer tube whose distal end is inserted into the living body, and an inner member inserted into the outer tube. The distal end of the inner member is provided with a sheet placement section on which the sheet-like material is placed, the sheet placement section being retractable into the outer tube in a curved state and capable of being deployed by protruding from the outer tube toward the distal end. When the sheet placement section is deployed, an operating force transmission mechanism is provided that applies an operating force input from outside the living body to the sheet placement section inside the living body, thereby deforming the sheet placement section.

According to this aspect, when applying a sheet-like material in vivo, for example, the therapeutic sheet-like material placed on the sheet-mounting section is delivered to and applied to a treatment site in the body, and then an operating force that deforms the sheet-mounting section is applied by the operating force transmission mechanism, thereby gently separating (peeling) the sheet-mounting section from the sheet-like material while the sheet-like material remains attached to the treatment site. This allows the therapeutic sheet-like material to be stably attached to the treatment site in the body.

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, which is stored in a curved state in the outer tube, is placed is configured to include the protruding piece.

In this aspect, when the sheet placement portion is stored in the outer tube, the sheet placement portion deforms along the sheet support surface. 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 solely by the inner circumferential surface of the outer tube. This allows for the use of larger sheet-like materials stored in the outer tube, and even when large sheet-like materials are used, the storage state in the outer tube can be achieved stably.

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

According to this aspect, disposable internal components can be easily manufactured, and by making the sheet placement section that comes into contact with the living body disposable, the risk of infection between multiple patients can be easily and more reliably prevented.

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 placement portion via the operating force transmission mechanism, each of which can be operated separately.

According to this aspect, the first operating unit can move the internal member relative to the external cylinder, and the second operating unit can deform the sheet placement section independently, which can improve the operability of each and the freedom to set the operating state of each.

A fifth aspect of the present disclosure is a device according to the fourth aspect, wherein the operating force transmission mechanism is configured by an operating wire connected to the sheet placement 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 placement portion via the operating wire and deforming the sheet placement portion.

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

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

According to this aspect, axial movement of the inner member relative to the outer tube can be achieved with good operability by sliding or rotating the first operating part.

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 holding mechanism that holds the operating force applied to the sheet placement section by the operating force transmission mechanism when the inner member moves relative to the outer tube in the longitudinal direction.

According to this aspect, the sheet placement portion provided at the tip of the inner member can be moved axially relative to the outer tube while maintaining the deformed state. Therefore, even if the inner member is moved axially relative to the outer tube after the sheet placement portion is deformed and peeled off the sheet material, the deformed state of the sheet placement portion can be maintained, effectively preventing the sheet placement portion from accidentally coming into contact with the sheet material again.

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

In the device according to this aspect, the protruding pieces protrude circumferentially, curved along the inner peripheral surface of the outer tube's peripheral wall, 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 configure the 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 section that is supported by the sheet support surface. Moreover, the protruding pieces can extend from the inner peripheral surface of the outer tube in a direction closer to a tangent than a radial line of the outer tube. This allows the bending angle or radius of curvature of the protruding pieces rising from the inner peripheral surface of the outer tube to be reduced, thereby reducing or avoiding localized bending and resulting breakage of the sheet material that is placed in that area.

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 placement 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 the axial length of the outer tube and is disposed inside the outer tube so as to be movable in the axial direction of the outer tube. The sheet placement portion is configured to be exposed while protruding from one end of the outer tube. When the inner member is moved axially toward the proximal end of the outer tube, it elastically deforms to 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 placement portion and/or adjust the fixing force between the sheet placement portion and the inner member.

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 placement portion and the other end connected to the operating unit, the operating wire being configured so that the sheet placement portion can be bent by pulling the operating wire through operation of the operating unit.

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 placement section and the internal member, and an operating wire connecting the connecting member and the operating section, 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 internal member in conjunction with the operation of the operating section.

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

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 placement surface side of the sheet placement section with the tip of the outlet protruding from the tip of the inner member.

In one or more embodiments, the device disclosed herein allows for the sheet-like material to be stably attached (transplanted) to the affected area. In one or more embodiments, the device disclosed herein allows for the sheet-like material to be placed (transplanted) in a predetermined position, and then the device (sheet placement portion) can be gently peeled off while the sheet-like material is maintained in that position.

FIG. 1 is a diagram showing an embodiment (first embodiment) of a device of the present disclosure, illustrating a state in which a sheet placement portion 13 protrudes from the tip of an outer tube 11. As shown in FIG. FIG. 2 is a diagram showing an embodiment of the device of the present disclosure, illustrating a state in which the sheet placement section 13 is housed in the outer cylinder 11. As shown in FIG. 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. 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. 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. FIG. 6 is a partial perspective view showing the operation unit 14. As shown in FIG. Figures 7A and 7B are partial oblique views showing the state in which the sheet loading section 13 is curved, where Figure 7A shows the state in which the sheet loading section 13 is unfolded, and Figure 7B shows the state in which the operating wire 15 is pulled and the sheet loading surface 13a side of the sheet loading section 13 is curved outward. 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. 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). FIG. 10 is a diagram showing yet another embodiment (third embodiment) of the device of the present disclosure. FIG. 11 is a perspective view showing yet another embodiment (fourth embodiment) of the device of the present disclosure, illustrating a deployed state in which the sheet placement portion protrudes from the tip of the outer tube. FIG. 12 is a plan view of the device shown in FIG. FIG. 13 is a bottom view of the device shown in FIG. FIG. 14 is an exploded perspective view of the device shown in FIG. FIG. 15 is an enlarged longitudinal sectional view showing a cross section taken along the line XV-XV in FIG. FIG. 16 is an enlarged cross-sectional view showing the XVI-XVI section in FIG. FIG. 17 is an enlarged cross-sectional view of the XVII-XVII section in FIG. FIG. 18 is an enlarged cross-sectional view showing the XVIII-XVIII cross section in 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. 11. FIG. 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. FIG. 21 is a perspective view showing yet another embodiment (fifth embodiment) of the device of the present disclosure, illustrating a deployed state in which the sheet placement portion protrudes from the tip of the outer tube. FIG. 22 is an enlarged longitudinal cross-sectional view of the device shown in FIG. FIG. 23 is a perspective view showing yet another embodiment (sixth embodiment) of the device of the present disclosure, illustrating a deployed state in which the sheet placement portion protrudes from the tip of the outer tube. FIG. 24 is an enlarged longitudinal cross-sectional view of the device shown in FIG. FIG. 25 is a perspective view showing yet another embodiment (seventh embodiment) of the device of the present disclosure, illustrating a deployed state in which the sheet placement portion protrudes from the tip of the outer tube. FIG. 26 is an enlarged longitudinal cross-sectional view of the device shown in 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. 25. FIG. FIG. 28 is an enlarged longitudinal cross-sectional view of the device shown in FIG. FIG. 29 shows photographs showing MSC sheet transplantation using a cardiac model. FIG. 30 is a photograph showing MSC sheet transplantation into a pig heart. 31A and 31B are enlarged perspective views of the sheet placement portion of a device according to another aspect 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. FIG. 32 is an explanatory diagram for explaining a model of a gun-type device according to another aspect of the present disclosure.

The device disclosed herein is for applying a sheet-like physiologically active substance to the inside of a living body and comprises a cylindrical outer tube, a cylindrical inner member, a sheet placement section provided at the distal end of the inner member, and an operating section provided at the 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 disposed inside the outer tube so as to be movable in the axial direction of the outer tube. The sheet placement section is configured to be exposed while protruding from one end of the outer tube. When the inner member is moved axially toward the proximal end of the outer tube, it elastically deforms to a shape that conforms to the inside of the outer tube and can be stored within the outer tube. The operating section is configured to be able to operate the bending movement of the sheet placement section and/or adjust the fixing force between the sheet placement section and the inner member.

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.
In one or more embodiments, the device of the present disclosure can reduce breakage and 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.

In one or more embodiments, the device disclosed herein allows a sheet-shaped physiologically active substance to be transported and/or attached (transplanted) into the body in a minimally invasive manner. Therefore, in one or more embodiments, the device disclosed herein allows a sheet-shaped physiologically active substance to be attached (transplanted) to a desired location in the body with minimal strain on the human body and with high stability and precision.

In this disclosure, "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 organ cavity through a small incision made on the body surface, such as endoscopic surgery and laparoscopic surgery.

In the present disclosure, in one or more embodiments, the term "sheet-shaped bioactive substance" refers to a sheet-shaped active substance used for the treatment, prevention, reduction of severity, reduction of the likelihood of onset or inhibition of progression of a disease or injury, or mitigation of the effects of a disease. In one or more embodiments, examples of sheet-shaped bioactive substances 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 materials (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.

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, 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-shaped physiologically active substance on an affected area, the sheet mounting portion can be more gently peeled off while the sheet-shaped physiologically active substance is retained on the affected area, further improving the stability and reliability of application (transplantation) of the sheet-shaped physiologically active substance.

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 of the sheet loading section opposite the sheet loading surface and the inside of the inner member and is attached to the operating section.

In one embodiment, the operating unit is rotatably connected to the base end of the inner member. This configuration makes it easier to control the bending motion of the sheet mounting unit, allows for gentler detachment of the sheet mounting unit 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 configuration is merely an example, and the structure of the operating unit is not particularly limited as long as it is capable of pulling or loosening the operating wire.

In one aspect, the device of the present disclosure further includes a connecting member that connects the sheet placement portion to the internal member, and an operating wire that connects the connecting member to the operating unit. The connecting member and operating wire are configured to be able to adjust the fixing force between the sheet placement portion and the internal member in conjunction with the operation of the operating unit. 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 placement portion can be brought into contact with the pulsation, thereby allowing the sheet-shaped physiologically active substance to be applied (transplanted) while minimizing pressure and strain on the organ, further improving the stability and reliability of the application (transplantation) of the sheet-shaped physiologically active substance.

In one or more embodiments, the connecting member may be a hinge or the like. In one or more embodiments, the fixing force can be adjusted by applying tension to the wire by operating the operating unit, thereby strengthening the fixing force between the sheet placing section and the inner member, and by releasing the tension, weakening the fixing force between the sheet placing section and the inner member.

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.

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, it is possible to increase the pressure of the sheet mounting member when contacting the sheet-form physiologically active substance with the affected area, thereby further improving the stability and reliability of application (transplantation) of the sheet-form 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 housed within 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.

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 on 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.

Embodiments of the present disclosure are described below with reference to the drawings.

First Embodiment
1 and 2 are diagrams showing a device 1 according to a first embodiment of the present disclosure, with Fig. 1 showing a state in which the sheet placement section 13 protrudes from the tip of the outer tube 11, and Fig. 2 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 term "axial direction" refers to the axial direction (longitudinal direction) of the outer tube 11.

As shown in Figures 1 to 4, the device 1 in the first embodiment comprises an outer tube 11, an inner member 12, a sheet placement section 13, an operating section 14, and an operating wire 15.

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 in order to reduce the size of the incision hole and further reduce 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 on 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.

The inner member 12 is a straight, hollow, cylindrical member. The inner member 12 is provided inside the outer tube 11, coaxially with the outer tube 11 and spaced apart from the outer tube 11 in the axial direction. The inner member 12 is movable back and forth in the axial direction of the outer tube 11. The inner member 12 has a sheet placement unit 13 attached to one end (tip end) thereof and an operation unit 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.

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.

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 with 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.

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 symmetrical shape 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 elastically deform into a cylindrical shape and be stored inside the outer tube 11.

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 thread, and a female thread is formed on the inner surface of the base end of the inner member 12 so that it can engage with the male thread.

The operating wire 15 is provided to control the bending angle (curving movement) of the sheet placing portion 13. 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 of the operating portion 14 (toward the tip of the inner member 12). This makes it possible to prevent twisting of the operating wire 15 due to operation (rotation movement) of the operating portion 14, movement (displacement) of the position of the sheet placing portion 13, etc.
The operating wire 15 is disposed on a surface 13d of the sheet placing portion 13 opposite 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.

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 (the direction in which the screw loosens), the operating wire 15 is wound up, shortening the length of the operating wire 15, and the sheet placing section 13 is elastically deformed and curved so that the sheet placing surface 13a warps. 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) (the direction in which the screw tightens), the length of the operating wire 15 can be increased, and by returning the length of the operating wire 15 to its original length, the elastic deformation of the sheet placing section 13 is released and it unfolds into a flat surface.

The method of using the device 1 of the first embodiment will be described below.
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. Figures 5A-C 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 Figures 5A-C , 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.

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 similar device 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 area 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 protruding from the tip of the outer tube 11. At this time, the sheet mounting portion 13 recovers its elastic deformation and expands into a flat, planar state.

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

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.

As described above, the device 1 of the first embodiment allows the sheet-like physiologically active substance to 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. It also reduces damage and deformation of the sheet-like physiologically active substance during transport. Furthermore, the device 1 of the first embodiment allows the sheet-like physiologically active substance to be peeled off from the affected area by contacting the sheet-like physiologically active substance with the affected area and then bending the sheet-like physiologically active substance to change the angle of curvature. This allows the sheet-like physiologically active substance 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.

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 unit (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 unit. The second embodiment will be described below, focusing on the differences from the first embodiment.

The sheet placement portion 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 portion 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 unit 14. By rotating the operating unit so that the tip of the operating unit 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 portion 13 and the inner member 12. By rotating the operating unit 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 portion 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 applied (transplanted) is a beating organ such as the heart, the sheet mounting portion 13 can be brought into contact with the organ in response to the beating, so that the sheet-shaped physiologically active substance can be applied (transplanted) while minimizing pressure and strain on the organ, thereby further improving the stability and reliability of the application (transplantation) of the sheet-shaped physiologically active substance.
In one or more embodiments, the connecting member 17 may be a hinge or the like.

The method of using the device of the second embodiment will be described below.
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 Embodiment 1. 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 inner member 12 strengthened.

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.

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

As described above, with the device of the second embodiment, the fixing force between the sheet placement portion 13 and the internal member 12 can be controlled, allowing the sheet placement portion 13 to come 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 minimizing pressure and strain on the affected area.

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.

The tube 20 is inserted into the inner member 12 through a hole 19 provided on the side of the inner member 12, and is positioned on the base end side of the sheet placement surface 13a of the sheet placement section 13, with the outlet 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 liquid to be supplied to the sheet-like physiologically active substance held on the sheet placement surface 13a and to the affected area, allowing for gentler detachment of the affected area (site to receive sheet transplantation) from the sheet placement section 13, further improving the stability and reliability of application (transplantation) of the sheet-like physiologically active substance.

The method of using the device 2 of the third embodiment will be described below.
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).

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

Next, as in the first embodiment, with the sheet mounting 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 mounting surface 13a of the sheet mounting unit 13, allowing the sheet mounting unit 13 to be gently removed from the affected area while retaining the sheet-like physiologically active substance in the affected area.

As described above, according to the third embodiment of the device 2, a liquid can be 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. 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-shaped physiologically active substance.

Although not specifically mentioned in the first to third embodiments above, when placing a sheet-like physiologically active substance on the sheet mounting section 13, a sheet other than the sheet-like physiologically active substance (e.g., nylon mesh) may be placed between the sheet-like physiologically active substance and the sheet mounting surface 13a, and the sheet-like physiologically active substance may be brought into contact with the affected area together with the sheet. This can further reduce damage, deformation, or dislocation of the sheet-like physiologically active substance during transplantation, further improving the stability and reliability of application (transplantation) of the sheet-like physiologically active substance.

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

In the present disclosure, the second and third embodiments may be combined.

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 a sheet-form therapeutic substance of the present disclosure includes contacting the sheet mounting surface of the sheet mounting section of the device of the present disclosure with the affected area (the area to be transplanted with the sheet) while the sheet-form physiologically active substance is held on the sheet mounting section, and peeling the sheet mounting surface 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.

In one or more embodiments, the method for applying a sheet-form therapeutic substance disclosed herein further includes contacting the sheet-mounting surface of the sheet-mounting section with the affected area (the area to be transplanted) while the fixing force between the sheet-mounting section and the inner member is weakened. 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.

In one or more embodiments, the method for applying a sheet-form therapeutic substance disclosed herein further includes supplying a liquid to the sheet-form physiologically active substance held in the sheet placement section, and contacting the sheet-form physiologically active substance moistened with the liquid with the affected area (the area 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 the application (transplantation) of the sheet-form physiologically active substance.

In one or more embodiments, the method for applying a sheet-form therapeutic substance disclosed herein further includes 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 sheet-form physiologically active substance with the affected area (the area to which the sheet is to be transplanted) that has been moistened by 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.

In one or more embodiments, the method for applying a sheet-form therapeutic substance disclosed herein further includes supplying a liquid to the sheet-form physiologically active substance held in the sheet mounting section and to the affected area (the area to which the sheet is to be transplanted), and contacting the sheet-form physiologically active substance moistened by the supply of liquid with the affected area (the area to which the sheet is to be transplanted) moistened by the supply of 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 the application (transplantation) of the sheet-form physiologically active substance.

In one or more embodiments, the method for applying the sheet-shaped therapeutic material of the present disclosure includes using the device of the present disclosure in conjunction with an endoscope.

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 method for operating a microsurgery robot system, comprising the steps of: receiving an operation signal from a remote control device by a receiving means of the device; and operating a sheet placement means and an operation means of the device based on the received signal.

The activation process includes a step of activating the sheet-mounting means of the device based on the received signal so that the sheet-shaped physiologically active substance held in the sheet-mounting means comes into contact with the affected area, and a step of activating the sheet-mounting means so that the sheet-mounting surface of the sheet-mounting section is curved outward while the sheet-mounting section is peeled off from the affected area.

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.

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 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 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 portion and the inner member in conjunction with the operation of the operating portion.
[4] The device according to any one of [1] to [3], wherein an elastically deformable reinforcing member is provided on a surface of the sheet placement section opposite to the sheet placement surface.
[5] Further comprising a tube having a discharge port at its tip,
The device described in any one 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.

<Fourth embodiment>
11 to 18 show a device 30 according to a fourth embodiment of the present disclosure. This device 30 is 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 placement section 38 on which the sheet-like material 32 is placed is provided at 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.

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 an endoscope port (not shown). In this embodiment, as shown in FIG. 16 , a coating 44 of resin or the like is applied around the entire inner surface 42 of the outer tube 34 (peripheral wall 40), at least at the tip portion, to improve slip resistance against the sheet placement portion 38. In particular, in this embodiment, a PTFE resin coating layer is formed.

A protruding member 48 is fixedly positioned within the inner cavity 46 of the outer tube 34. Like the outer tube 34, the protruding member 48 is formed from a hard material such as metal or synthetic resin. The protruding member 48 has a groove 50 that opens upward along its entire length. The base end of the protruding member 48 forms a retaining portion 52 that extends straight and has a generally crescent-shaped cross section that opens upward. In this embodiment, the retaining 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.

The protruding member 48, distal to the retaining portion 52, 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 Figures 16 and 17). The protruding member 48 is inserted into the inner cavity 46 of the outer tube 34 and fixedly assembled, causing the protruding piece 56 to protrude from the inner circumferential surface 42 of the peripheral wall 40 into the inner cavity 46. That is, as shown in Figures 16 and 17, in cross section, the protruding piece 56 is approximately in 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 circumferentially along the inner circumferential surface of the outer tube 34.

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.

The 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 groove 50 and is guided by the groove 50 so that it can move axially.

The inner member 36 has a generally circular cross section and is rod-shaped, extending in a generally straight line. It is made of a hard material, such as metal or synthetic resin. In this embodiment, the inner member 36 is made of synthetic resin. The inner member 36 has a small diameter section 60 at its distal end, and a large diameter section 62, which is larger in diameter than the small diameter section 60, at its proximal end. The proximal end of the inner member 36 (the proximal end of the large diameter section 62) has a flat surface at its upper end. As described below, the proximal end of the inner member 36 forms an input section 64 to which an external axial sliding force is applied.

Support recesses 66, 66 that open to the outer periphery are provided on both left and right sides of the outer peripheral surface of the inner member 36. These support recesses 66, 66 extend the entire length of the inner member 36 and are open to both axial end surfaces. The specific shape and size of these support recesses 66, 66 are not limited, and they may be different shapes. However, in this embodiment, a pair of support recesses 66, 66 have approximately the same shape. Each support recess 66 is provided independently of the other. As can be seen from Figures 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.

A tubular body is disposed in each of these support recesses 66. The tubular body disposed along one support recess 66 (the left one in Figures 16-18 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 below) 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 uses of the liquid delivery tubes 68 are not limited, and they may be used for, for example, the delivery and suction of liquids such as water or saline, as well as the supply of biological glue or medicines.

The liquid supply tube 68 has a length greater than that of the inner member 36. When the liquid supply tube 68 is attached 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 placement section 38 (the sheet placement surface 74, described below), forming a discharge port 72 for the liquid flowing therethrough. The base end of the liquid supply tube 68 extends beyond the gripping portion 84, described below, provided at the base end of the outer tube 34. As shown in FIG. 10, the insertion tube 70 is designed to be connected to, for example, a syringe 22 filled with liquid. The insertion tube 70 has a length approximately equal to that of the inner member 36 and opens at the distal and proximal ends of the inner member 36. The liquid supply tube 68 and the insertion tube 70 are fitted into the respective support recesses 66 and are disposed unattached, but may be attached with 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.

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.

The sheet placement portion 38 is generally thin and preferably made of an elastomer such as a soft synthetic resin or synthetic rubber, providing elasticity. While the material of the sheet placement portion 38 is not limited, suitable materials include Arkema's "Pebax®" (registered trademark) and polyurethane, which have 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, even when the sheet placement portion 38 is stored and held in a curved state within 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 endoscopic camera.

The shape and size of the area in the sheet placement 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 other factors, including elasticity and shape retention characteristics, and are not limited thereto. In this embodiment, however, 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 factors such as ease of storage in the outer tube 34. The base end portion of the sheet placement section 38, where the width dimension is narrowed, serves as a connection section 73 that connects to the inner member 36 (small diameter section 60).

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-like material 32 is placed. The base end side of the sheet placement surface 74 has inclined side portions 76, 76 on both the left and right sides, with the width dimension gradually decreasing toward the base end.

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 is asymmetrical 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 account the shape and size 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).

The connecting portion 73, located on the base end side of the sheet placing surface 74 in the sheet placing section 38, is positioned slightly lower than the sheet placing surface 74 in a stepped manner, and as shown in Figures 14 and 16, has a generally semicircular arc shape that curves upward to form a convex shape. The connecting portion 73 is secured to the distal end of the inner member 36 (small diameter portion 60), including the liquid delivery tube 68 and the insertion tube 70, by, for example, gluing, welding, or a crimping member, while covering the distal end.

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. An external operating force is applied via the operating wire 78, causing the sheet placement portion 38 to bend and deform. While the material of the operating wire 78 is not limited, in this embodiment, silk thread, which is commonly used as surgical suture thread, is used. Furthermore, the operating wire is inserted through the insertion tube 70 and extends forward and backward by a predetermined length. It is sufficient for the operating wire to be able to transmit the operating force applied to the base end to the sheet placement portion 38 at the tip end as a tensile force. While the specific structure is not limited, in this embodiment, an operating wire 78 is used in which both ends of the silk thread are tied together to form an endless loop.

In other words, 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.

The operating wires 78 extending from the tips of the insertion tubes 70 extend along the sheet back surface 82, opposite the sheet placement surface 74, and the tensile force exerted through the operating wires 78 pulls the tip portion of the sheet placement section 38 toward the back surface (the side opposite the sheet placement surface 74), causing it to bend downward. In this embodiment, since the tips of the insertion tubes 70 open toward the sheet placement surface 74, each operating wire 78 extending from the tip of the insertion tube 70 passes through each insertion hole provided at the base end of the sheet placement section 38 from the sheet placement surface 74 side to the sheet back surface 82 side, and then runs along the sheet back surface 82 to the through holes 80, 80 provided at the tip of the sheet placement section 38.

As a result, the operating wire 78 extends from near the base end of the sheet placement section 38 to near the tip end, but only the base end of the sheet placement section 38 and the folded-back portion of the operating wire 78 between the through-holes 80, 80 at the tip end protrude toward the sheet placement surface 74. Because the operating wire 78 is not present in the central portion of the sheet placement surface 74, a large surface area can be secured for the placement of the sheet material 32 while avoiding any adverse effects of the operating wire 78. Furthermore, at the tip end of the sheet placement section 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 exerted more efficiently in the direction of deformation that warps the sheet placement section 38, allowing the sheet placement section 38 to deform more stably.

In this embodiment, the operating wires 78, 78 extending from the insertion tube 70 are inclined away from each other on both sides of the seat back surface 82 in the left-right width direction from the center line L, 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 through which the operating force via the operating wire 78 is exerted are approximately 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 efficiency of transmitting the operating force.

The positions of the through holes 80, 80 in the sheet placement section 38 are not limited. For example, as shown in the partially enlarged view at the bottom of Figure 12, a pair of through holes 81, 81 may be provided on both sides of the center line M extending through the center of the width of the leading edge of the sheet placement section 38, spaced approximately equally apart, and the folded-back portion of the leading edge of the operating wire 78 may be inserted through the through holes 81, 81. Note that the enlarged view is based on the partially enlarged view of Figure 12, and the through holes 80, 80 and the operating wire 78 inserted therethrough are those of the device 30 as the fourth embodiment. Inserting the operating wire 78 through the through holes 81, 81 allows the tensile force via the operating wire 78 to be efficiently applied to approximately the center of the width of the leading edge of the sheet placement section 38, thereby improving the stability of the deformation of the sheet placement section 38.

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

A storage space 94 is provided inside the housing 86 to accommodate the operating wire 78 and the winding section 110 described below for winding up the operating wire 78, and an insertion hole 96 is formed at the tip portion of the housing 86 through which the base end portion of the inner member 36 is inserted.

The gripping portion 84 also includes a slide operation unit 100 at its upper end that is slidable in the length direction of the gripping portion 84 (the length direction of the outer tube 34). The slide operation unit 100 is disposed on the outside of the upper wall of the housing 86, and the outer surface of the slide operation unit 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.

The slide operating unit 100 has a leg 104 formed integrally therewith that protrudes downward. The leg 104 is inserted into an insertion window 102 formed in the upper wall of the housing 86 and protrudes into the storage space 94. The slide operating unit 100 is connected to the base end of the inner member 36 by engaging with the leg 104. In other words, the slide operating unit 100 is attached to the base end of the inner member 36 by connecting the leg 104 to the input portion 64 of the inner member 36, which extends into the storage space 94 through an insertion hole 96 formed in the front wall of the housing 86.

The insertion window 102 of the housing 86 extends in the shape of a slit in the longitudinal direction of the housing 86. The leg 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 axially relative to the housing 86 and therefore the outer tube 34.

A compression coil spring 108 is disposed between the tip of the slide operating unit 100 and the input portion 64 of the internal member 36. The elastic force of this coil spring 108 generates sliding resistance due to contact between the slide operating unit 100 and the upper wall of the housing 86. The sliding resistance exerted on the slide operating unit 100 prevents inadvertent movement of the slide operating unit 100 and, therefore, the internal member 36, allowing the slide operating unit 100 and, therefore, the internal member 36 to be moved axially with a predetermined sense of resistance.

14 and other figures, in this embodiment, the inner wall surface on both sides of the slit-shaped insertion window 102 in the width direction has engagement recesses 109a, 109b near the front and rear ends, respectively, which open onto the inner surface of the housing 86. Meanwhile, the leg portion 104 of the slide operating unit 100 inserted into the insertion window 102 has plate-like portions formed thereon that extend on 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 these plate-like portions are further formed with engagement protrusions 105 that protrude upward toward the inner wall surface on both sides of the insertion window 102 in the width direction. Based on the engagement of the engagement protrusion 105 with the engagement recesses 109a, 109b, the operator is given a sense of restraint and a positioning function is exerted at the end of movement of the slide operating section 100 toward the front end (the extended position of the sheet loading section 38) and the end of movement toward the rear end (the retracted storage position of the sheet loading section 38).

In particular, the biasing force of the coil spring 108 disposed between the slide operating unit 100 and the inner member 36 (input unit 64) acts in a direction that presses the plate-shaped portion of the leg 104 against the inner surface of the housing 86, thereby exerting a locking effect that maintains the engagement of the engagement protrusion 105 with the engagement recesses 109a and 109b. In this locked state, the operator can press the slide operating unit 100 downward (toward the housing 86) with their fingers to release the engagement of the engagement protrusion 105 with the engagement recesses 109a and 109b, and then slide the slide operating unit 100 along the insertion window 102. This more effectively positions the slide operating unit 100 toward the leading or trailing end in the sliding direction.

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 circular reel disk structure and is provided with a winding shaft 112 on a rotational 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 the 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 positioned biased forward on one of the left and right side walls of the housing 86 and can be rotated with the thumb or index finger of the hand holding the grip section 84 in the palm of the hand.

The folded end of the operating wire 78 is fixed to the outer peripheral surface of the shaft 112, and the operating wire 78 is wound or unwound by rotating the winding unit 110 through the rotation of the dial 114. Guide protrusions, rollers, tubes, etc. for guiding the operating wire 78 are provided within the housing 86 as needed, and a wiring path is set for the operating wire 78 extending from the opening on the base end side of the insertion tube 70 within the housing 86, from the opening of the insertion tube 70 to the winding unit 110. By appropriately setting this wiring path, it is possible to reduce slack in the operating wire 78 and ensure a stable and accurate amount of operation by winding or unwinding the operating wire 78.

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 . The sheet-like material 32 is intended, for example, to be attached to an affected area in a living body for treatment, and may include the aforementioned sheet-like physiologically active substance, a cell sheet (MSC sheet), an anticancer drug gel sheet, or other therapeutic sheets. Then, 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.

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 the inner member, in the axial direction relative to the outer tube 34, and an input portion 64 that applies a longitudinal driving force is provided at the base end of the inner member 36. The slide operating force of the slide operating portion 100 is then applied directly to the input portion 64 of the inner member 36.

Here, a protruding piece 56 protruding 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. When the sheet placement portion 38 is stored in the outer tube 34, it is stored in a curved state by overlapping the inner circumferential surface 42 (specifically, the inner circumferential surface of the coating 44) and the protruding piece 56 of the outer tube 34 (peripheral wall 40), as shown in Figure 20. Therefore, the sheet support surface 118 on which the sheet placement portion 38 stored in a curved state in the cavity 46, which is the hollow interior of the outer tube 34, overlaps is composed of not only the inner circumferential surface 42 of the peripheral wall 40 but also the inner circumferential surface of the protruding piece 56.

In addition, in this embodiment, inclined edges 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 within the outer tube 34, the inclined edges 76, 76 abut against the periphery of the opening of the outer tube 34, allowing for smooth deformation. Furthermore, the sheet placement portion 38, which bulges out more on one side in the left-right width direction relative to the center line L (in this embodiment, more on the right side than the left), is supported by being superimposed on the curved inner surface of the protruding piece 56 at one end in the left-right width direction (in this embodiment, the left end).

As a result, even if the width dimension of the sheet placement section 38 is greater than the circumferential length of the inner peripheral surface of the outer tube 34, both widthwise ends of the sheet-like material 32 are prevented from directly overlapping, and the sheet-like material 32 can be stably supported by the inner peripheral surfaces of the outer tube 34 and the protruding piece 56 while contained in the outer tube 34. Furthermore, the support surface of the protruding piece 56 rises from the inner peripheral surface of the outer tube 34 at a smaller inclination angle (e.g., 60 degrees or less, more preferably 45 degrees or less, relative to the tangent to the inner peripheral 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 piece 56 rising from the inner peripheral surface of the outer tube 34 can be set small, preventing local bending and resulting breakage of the sheet-like material 32 overlapping this portion and facilitating normal and stable delivery of the sheet-like material 32.

19 and 20, with the sheet-like material 32 still placed and the sheet placement portion 38 housed within the outer tube 34, the outer tube 34 of the device 30 is inserted into the camera port of an endoscope (not shown), and the distal end of the outer tube 34 is delivered to the vicinity of the treatment site within the living body. The slide operating portion 100 is then moved so as to push it distally, causing the inner member 36 to slide distally along with the slide operating portion 100 relative to the outer tube 34. This causes the sheet placement portion 38 to move distally along with the inner member 36, so that 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 deployed state within the living body, as shown in FIG. 11, etc.

Thereafter, the device 30 is tilted as necessary to overlap and attach the sheet-like material 32 placed on the sheet-mounting section 38 to the treatment area within the living body. Before and/or after application of the sheet-like material 32, water, saline, or the like filled in a syringe 22 or the like may be ejected from the ejection port 72 via the liquid delivery tube 68 to moisten the treatment area, making it easier to attach the sheet-like material 32 due to the surface tension of the liquid, etc.

With the sheet-like material 32 attached to the treatment area, for example, the thumb placed on the slide operation surface 106 is moved to the dial unit 114, which is rotated around its central axis, winding the operating wire 78 onto the winding unit 110. As a result, the operating wire 78, whose distal end is connected to the sheet mounting unit 38, is pulled toward the proximal end, causing the sheet mounting unit 38 to deform and bend toward its rear side, peeling the sheet mounting unit 38 from the sheet-like material 32 attached to the treatment area. In this way, the attachment of the sheet-like material 32 to the treatment area is completed. Note that when attaching the sheet-like material 32, the nylon mesh 77 may be left on the sheet mounting unit 38, or it may be attached to the living body together with the sheet-like material 32 and then peeled and recovered from the sheet-like material 32 afterward, as needed.

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 mounting portion 38 inside the body, thereby deforming the sheet mounting portion 38, with the sheet-like material 32 placed on the sheet mounting portion 38 in the unfolded state and attached to a treatment site inside the body. In particular, in this embodiment, this operating force transmission mechanism is configured by an operating wire 78 connected to the sheet mounting portion 38. Furthermore, a second operating unit 120 that deforms the sheet mounting 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 axially relative to the outer tube 34, and the second operating unit 120 that deforms the sheet mounting portion 38 via the operating force transmission mechanism (operating wire 78) are separately operable on the gripping portion 84.

After peeling the sheet mounting portion 38 from the sheet-like material 32 attached to the treatment site, the operating wire 78 can be advanced, for example, by rotating the dial unit 114 in the reverse direction, causing the sheet mounting portion 38 to elastically deform and return to its initial deployed state as shown in FIG. 11 . From this state, the slide operating unit 100 can be slid proximally to re-store the sheet mounting portion 38 within the outer tube 34. The device 30 may then be withdrawn from the camera port of the endoscope with the sheet mounting portion 38 re-stored within the outer tube 34. However, since deformation of the sheet mounting 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 still in its deployed state protruding from the outer tube 34), or the device 30 may be withdrawn from the patient together with the endoscope.

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 the housing 86, which are made of metal, may be sterilized and reused.

The device 30 of this embodiment, constructed 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. This allows even larger sheet materials 32 to be stored 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, there is a high degree of freedom in setting the circumferential length of the protruding piece 56 (the length of protrusion from the inner circumferential surface 42 of the outer tube 34). Therefore, the protruding length of the protruding piece 56 can be appropriately set depending on the lateral width of the sheet placement portion 38 used. In other words, it is easy to use sheet placement portions 38 of various sizes.

In this embodiment, the inner member 36 is made of synthetic resin and is disposable along with the sheet placement portion 38 that comes into contact with the patient. In other words, it is economical because an inexpensively formed part is disposable, and it is also hygienic because the part that comes into contact with the patient is also disposable.

The grip portion 84 is provided with a first operating unit 116 that moves the inner member 36 axially 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, by simply shifting the position of the thumb, the user can switch between operating the first operating unit 116 and the second operating unit 120 without changing the way the grip portion 84 is held. This improves the user's ease of use of the device 30.

In this embodiment, the operating force transmission mechanism is configured with an operating wire 78, and by rotating the winding portion 110 in the second operating unit 120, the operating wire 78 can be wound up and the sheet placement portion 38 can be deformed. This makes it easy to deform the sheet placement portion 38.

In this embodiment, the first operating unit 116 has a slide operating unit 100, and by moving the slide operating unit 100 toward the distal end and the proximal 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 within the outer tube 34. Therefore, the sheet placing unit 38 can be quickly switched between the deployed state and the stored state using 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.

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 parts 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.

In the same manner as in 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, which moves the inner member 36 axially relative to the outer tube 34. The grip portion 132 also has a second operating portion 134 located distal to the first operating portion 116. In the fourth embodiment, the dial portion 114 constituting the second operating portion 120 was provided on the side (left) of the grip portion 84, and the central axis of the dial portion 114 extended in the left-right direction. However, in this embodiment, the dial portion 136 is generally cylindrical, and the central axis of the dial portion 136 extends in the longitudinal 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 around its central axis by, for example, placing a thumb on the outer periphery of the dial portion 136.

A winding section 138 for winding up the operating wire 78 is integrally formed on the base end side of this dial section 136, and the operating wire 78 is fixed to the outer peripheral surface of the winding section 138. As a result, by rotating the dial section 136 around the central axis and winding up the operating wire 78, an operating force can be applied to the sheet placement section 38 via the operating wire 78, causing the sheet placement section 38 to deform.

When using 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 base end. This causes the inner member 36 and sheet placement portion 38 to slide toward the base end along 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. Note that in this embodiment, the base end portion of the inner member 36 is inserted through the inner holes 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 is slid toward the base end.

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.

Sixth Embodiment
23 and 24 show a device 140 according to a sixth embodiment of the present disclosure in an unfolded state with the sheet placement portion 38 protruding 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 structure of the first operating portion 144 and the second operating portion 146 provided on the grip portion 142, but the structure 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, 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 in the fourth embodiment will be omitted by assigning the same reference numerals in the drawings to those in the fourth embodiment.

In this embodiment, a rack portion 150 that constitutes a rack-and-pinion with a gear (pinion portion 152, described below) provided in the first operating unit 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 longitudinal driving force is applied. In other words, spur-toothed projections and recesses are provided continuously along the length of the outer tube 34 on the upper side of the base end portion of the internal member 148, and this rack portion 150 is provided over a certain length from the base end of the internal member 148.

The first operating unit 144 is provided in the storage 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 arranged 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 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 storage space 94. The pinion unit 152 and rotation operating unit 154 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.

The rotation operation unit 154 has an uneven portion 158 with multiple continuous uneven portions on its outer circumferential surface, and an engagement protrusion 160 that protrudes upward into the storage 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 on the outer circumferential surface of the rotation operation unit 154, allowing the rotation operation unit 154 to be rotated in stages with a sense of moderation (clicking).

The second operating unit 146 also includes a winding unit 162 to which the operating wire 78 is fixed within the storage space 94 and which rotates to wind up the operating wire 78. The winding unit 162 is generally cylindrical, and the operating wire 78 is fixed to the outer peripheral surface of the winding unit 162. The second operating unit 146 also includes a dial unit 164 that is arranged coaxially with the winding unit 162 and is rotatable together with the winding unit 162. The dial unit 164 is generally disc-shaped and larger than the winding unit 162, with a portion of its circumference protruding upward from the grip unit 142 and the remaining portion of its circumference housed within the storage space 94. The winding unit 162 and the dial unit 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.

The dial portion 164 has an outer peripheral surface 168 with multiple roughened surfaces (or irregularities, etc.), and the bottom of the grip portion 142 is provided with an abutment protrusion 170 that protrudes into the storage space 94 and abuts against the outer peripheral surface 168 of the dial portion 164. The abutment, sliding, and engagement of the abutment protrusion 170 with the dial portion 164 (outer peripheral surface 168) can be used to appropriately adjust, for example, the rotational feel of the dial portion 164. More specifically, for example, the rotational feel of the dial portion 164 can be adjusted by providing a slight, substantially constant rotational resistance to achieve smooth rotation of the dial portion 164, or by providing a predetermined click feeling, particularly in the rotation direction that applies a pulling force, to facilitate fine adjustments when peeling off the sheet placement portion 38, or by maintaining the rotational position of the dial portion 164 to maintain the pulling force on the sheet placement portion 38.

Even in the device 140 of this embodiment, which has the above-described structure, the sheet mounting portion 38 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 in the unfolded state via the operating force transmission mechanism (operating wire 78), thereby achieving the same effect as the device 30 described in the fourth embodiment.

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 structure of the first operating portion 184 and the second operating portion 186 provided on the grip portion 182, as in the sixth embodiment. However, the structure 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 description 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.

In this embodiment, a housing 190 constituting the gripping portion 182 is connected to the base end of the outer tube 34, through which the inner member 188 and protruding member 48 are inserted. Specifically, the outer tube 34 is inserted into and fixed to the insertion hole 96 at the tip of the housing 190, and the base end of the inner member 188 protrudes further proximally within the inner hole of the housing 190 than the base end of the outer tube 34. An input portion 192 is fixedly attached to the base end of the inner member 188, and the operating wire 78, connected to the sheet placement portion 38 at its tip end, extends proximally through the insertion tube 70, penetrates the input portion 192, and reaches further proximally than the input portion 192.

In addition, a slide operation member 194 including a first operating portion 184 and a rotation operation member 196 including a second operating portion 186 are inserted into the inner hole of the housing 190 from the base end side at their respective tip portions. The slide operation member 194 is generally cylindrical overall, with its tip portion forming 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 has a generally rectangular cylindrical shape 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, which the user can grasp and slide axially toward the base end.

The slide operating member 194 is assembled to the housing 190 so as to be non-rotatable around 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 surface of the slide operating member 194 (for example, the inner surface of the large-diameter cylindrical portion).

Furthermore, the rotation operating member 196 is generally cylindrical overall, with its distal end portion being a second small-diameter cylindrical portion 204 sized to fit within the bore of the slide operating member 194, and its proximal end portion being a cylindrical portion with a larger diameter than the second small-diameter cylindrical portion 204 and a non-circular, e.g., polygonal, outer circumferential surface, which protrudes toward the proximal end of the slide operating member 194. A male thread 206 is formed over a predetermined length on the outer circumferential surface of the second small-diameter cylindrical portion 204, which threads into the female thread 202 of the slide operating member 194. When a user grasps the large-diameter cylindrical portion at the proximal end of the rotation operating member 196 and rotates the rotation operating member 196 relative to the slide operating member 194, the screw mechanism of the male thread 206 and female thread 202 moves the rotation operating member 196 relative to the slide operating member 194 in the central axial direction.

A generally annular or disc-shaped connecting portion 208 is attached to the tip of the second small-diameter cylindrical portion 204 so as to be rotatable relative to the second small-diameter cylindrical portion 204 and inseparable in the axial direction. The operating wire 78, which extends further toward the base end than the input portion 192, is connected to the second small-diameter cylindrical portion 204 via the connecting portion 208 within the first small-diameter cylindrical portion 198 of the slide operating member 194.

When using the device 180 of this embodiment, the sheet material 32 is placed on the sheet placement portion 38, optionally via a nylon mesh 77, 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. After that, 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. 25 and 26. 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 proximal end relative to the slide operating member 194. This pulls the operating wire 78 connected to the rotation operating member 196 via the connecting portion 208 toward the proximal end, causing the sheet placement portion 38 to deform so as to peel off from the sheet material 32. The subsequent operating method is the same as that described in the fourth embodiment.

In this embodiment, the rotation operating member 196 is moved proximally relative to the slide operating member 194 to peel the sheet placement portion 38 from the sheet material 32, and then the slide operating member 194 is slid proximally relative to the housing 190 together with the rotation operating member 196, causing the inner member 188 and the sheet placement portion 38 to move proximally together with the slide operating member 194, thereby retracting the sheet placement portion 38 into the outer tube 34. However, as with the previously 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 protruding, without retracting the sheet placement portion 38 into the outer tube 34.

In this embodiment, even when the slide operating member 194 is moved toward the base end to move the inner member 188 toward the base end, the tensile force applied to the sheet placement section 38 via the operating wire 78 remains substantially constant. That is, in this embodiment, when the inner member 188 moves longitudinally relative to the outer tube 34, an operating force retention mechanism 209 retains the operating force applied to the sheet placement section 38 by the operating force transmission mechanism (operating wire 78). The operating wire 78 is connected to the rotation operating member 196, which moves together with the inner member 188, via the slide operating member 194. In other words, in this embodiment, the operating wire 78 is not connected to the outer tube 34 and the housing 190, but is connected to the rotation operating member 196, which is a member on the inner member 188 side. This operating force retention mechanism can also be achieved by connecting the operating wire 15 to the operating unit 14 on the inner member 12 side in the first to third embodiments described above.

By providing such an operating force retention mechanism 209, slack in the operating wire 78 can be avoided, preventing malfunctions such as snagging or tangling of the operating wire 78, for example, when the inner member 188 moves longitudinally relative to the outer tube 34. It can also prevent the tensile force applied to the sheet placement section 38 via the operating wire 78 from being inadvertently released as the inner member 188 moves longitudinally relative to the outer tube 34, which could result in the unintended release of deformation of the sheet placement section 38.

Even in the device 180 of this embodiment, which has the above-described structure, the sheet mounting portion 38 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 in the unfolded state via the operating force transmission mechanism (operating wire 78), thereby achieving the same effect as the device 30 described in the fourth embodiment.

The present disclosure will be described in more detail below using 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.

[Device Fabrication]
Device 2 shown in FIG. 10 was fabricated.
The device 2 includes 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 engage with it. A hole 19 is formed on 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 a discharge port 21 attached to one end (tip side) of the tube 20 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 elastically deformed and curved with the sheet placement surface 13a facing outward.

[Preparation of MSC sheet]
We created a cell sheet (MSC sheet) mimicking a cardiac tissue sheet 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% _CO /95% air at 37°C. To maintain 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 dish with a temperature-responsive culture surface (UpCell®, CellSeed, Inc.) were used to prepare cell sheets (MSC sheets) according to conventional methods. Five to six million cells (TERT-hMSCs) were seeded onto an FBS-coated 10-cm dish (UpCell®, CellSeed, Inc.) in αMEM + 10% FBS and incubated at 37°C in a humidified atmosphere of ₅ % CO /95% air. On day 4, the MSC sheets were harvested from the UpCell® at room temperature.

[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 sheet mounting part 13 of the device. At this time, the nylon mesh and the MSC sheet were set in this order on the sheet mounting part 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 curve the sheet mounting unit 13, thereby attaching the MSC sheet and nylon mesh to the heart model at predetermined positions. 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.

[MSC sheet transplantation using a cardiac model 2]
Before contacting the sheet mounting section 13 with the surface of the heart model, sufficient water was sprayed onto the surface of the heart model to ensure that the surface was wet. As in MSC sheet transplantation 1 using a heart model, the MSC sheet and nylon mesh were placed on the sheet mounting section 13, and then water was supplied through the outlet 21 to moisten the MSC sheet and nylon mesh ( Figure 29(i) ). The sheet mounting section 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 section 14 was then rotated in one direction to pull the operating wire 15 and bend the sheet mounting section 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).

[MSC sheet transplantation into pig heart]
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).

[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, endoscopic transplantation of MSC sheets into the anterior wall and lateral wall regions of the left ventricle (LV) of the heart model was attempted.
As a result, the MSC sheet could be transplanted into the heart model without tearing, distortion, or dislocation of the MSC sheet in both the anterior and lateral LV wall regions.

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

The manner in which the operating wire is connected to the sheet placement portion is not limited to that exemplified in the above embodiment. For example, the deformation of the sheet placement portion due to an external force is not limited to the deformation in which the leading edge is pulled toward the back surface and bent back, as in the above 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 set appropriately depending on the deformation caused by the sheet placement portion, and should not be interpreted as being limited to the above embodiment.

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

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 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. In other words, in the other embodiments described above, when re-storing the deformed sheet placement portion in the outer tube 34, it is necessary to release the deformation 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.

In addition, in the configuration shown in Figure 31, the insertion tube 70 is arranged extending from the base end toward the tip end of the sheet placement section 210 in the approximate middle of the width direction, thereby improving the shape stability of the sheet placement section 210 and improving the support stability of the sheet material. Furthermore, as can be seen from Figure 31B, when peeling from the sheet material, peeling begins from both widthwise edge portions, making peeling from the sheet material more reliable and potentially shortening the time required for peeling.

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

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 the trigger 224 with their index finger, causing the inner member 226 connected to the trigger 224 to move proximally, retracting the sheet placement portion 38 that protruded from the outer tube 34 into the outer tube 34. Alternatively, the trigger 224 may be moved distally and returned to its initial position, causing the sheet placement portion 38 to protrude from the outer tube 34. A second operating unit 228 for winding 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 include a winding unit 230 and a dial unit 232 to which the operating wire 78 is connected at the proximal end of the device 220, as in the fourth embodiment. In addition, the sheet loading section 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 loading section 38 and the inner member 226.

1. Device (First Embodiment)
2. Device (Third Embodiment)
REFERENCE SIGNS LIST 11 Outer tube 12 Inner member 13 Sheet placement section 13a Sheet placement surfaces 13b, 13c Through hole 13d Opposite surface 14 Operation section 15 Operation wire 16 Physiologically active substance 17 Connection member 18 Reinforcing member 19 Hole 20 Tube 21 Discharge port 22 Syringe 23 Connection section 30 Device (fourth embodiment)
32 Sheet-like material 34 Outer cylinder 36 Inner member 38 Sheet placement portion 40 Peripheral wall 42 Inner peripheral surface 44 Coating 46 Inner cavity 48 Protruding member 50 Groove 52 Holding portion 56 Protruding piece 58 Flange-shaped portion 60 Small diameter portion 62 Large diameter portion 64 Input portion 66 Support recess 68 Liquid transfer tube (tube)
70 Insertion tube 72 Discharge port 73 Connection portion 74 Sheet placement surface 76 Inclined side portion 77 Nylon mesh 78 Operation wire (operation force transmission mechanism)
80 Through hole 81 Through hole 82 Seat back surface 84 Grip portion 86 Housing 88 First housing 90 Second housing 92 Fixing pin 94 Storage space 96 Insertion hole 100 Slide operation portion 102 Insertion window 104 Leg portion 105 Engagement protrusion 106 Slide operation surface 108 Coil springs 109 a, 109 b Engagement recess 110 Winding portion 112 Shaft portion 114 Dial portion 116 First operation portion 118 Seat support surface 120 Second operation portion 130 Device (fifth embodiment)
132 Grip portion 134 Second operation portion 136 Dial portion 138 Winding portion 140 Device (sixth embodiment)
142 Grip portion 144 First operation portion 146 Second operation portion 148 Internal member 150 Rack portion (input portion)
152 Pinion portion 154 Rotation operation portion 156 First rotation shaft portion 158 Concave and concave portion 160 Engagement protrusion portion 162 Winding portion 164 Dial portion 166 Second rotation shaft portion 168 Outer circumferential surface 170 Contact protrusion portion 180 Device (seventh embodiment)
182 Grip portion 184 First operation portion 186 Second operation portion 188 Inner member 190 Housing 192 Input portion 194 Slide operation member 196 Rotation operation member 198 First small diameter cylindrical portion 200 Connecting portion 202 Female thread 204 Second small diameter cylindrical portion 206 Male thread 208 Connection portion 209 Operation force retaining mechanism 210 Sheet placement portions 212a, 212b Operation line 220 Device 222 Grip portion 224 Trigger 226 Inner member 228 Second operation portion 230 Winding portion 232 Dial portion L Center line (of outer cylinder) M Width direction center line (of sheet placement portion)

Claims (5)

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. 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. 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. 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. 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.