Medical film delivery device and method for manufacturing medical device

Abstract

To provide a medical film delivery tool that easily causes a film to come in close contact with a treatment part in the body, and to provide a medical device manufacturing method.SOLUTION: A medical film delivery tool 5 for delivering a medical film in the body includes: a first shaft 10 having a distal end 11 and a proximal end 12 in a longitudinal direction, and a first lumen 13; a second shaft 20 disposed in the first lumen 13 of the first shaft 10, which can be moved in the longitudinal direction with respect to the first shaft 10; and a first enlarged diameter part 40 disposed at a distal part of the first shaft 10, whose diameter can be enlarged; and a second enlarged diameter part 50 disposed at a distal part of the second shaft 20 whose diameter can be enlarged. The shapes of the first enlarged diameter part 40 and the second enlarged diameter part 50 when the diameters are enlarged are different from each other.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a surgical tool for delivering a medical film into the body using an endoscope and a method for manufacturing the medical tool. [Background technology]

[0002] In endoscopic surgery, a procedure may be performed in which a film is placed and attached to a part of the body where a diseased part has been removed, for the purpose of promoting healing of the affected part, mitigating bleeding, and inhibiting adhesion of organs. As an example of an instrument for performing such a procedure, Patent Document 1 discloses an endoscopic surgery device having a compression part for compressing a sheet against the operative part. Patent Document 1 also discloses that the compression part is composed of a balloon provided at a part on the tip side of the inner shaft. It also discloses that the sheet is attached by being wound or wrapped around the outer circumferential surface of the balloon attached to the tip part of the inner shaft in a single or multiple winding state.

[0003] Patent Document 2 discloses a sheet insertion device. Patent Document 2 discloses that a pushing member for pushing out a sheet has a bifurcated sheet winding section provided at the tip of a shaft, and that the sheet winding section has two plate sections arranged opposite each other with a gap large enough to insert a sheet.

[0004] Patent Document 3 discloses a sheet inserter having a sheet holding member and an outer tube member. At least the tip side of the sheet holding member is formed by four rod-shaped members bundled together, and the sheet is held by sandwiching the sheet between the rod-shaped members.

[0005] Patent Document 4 discloses a system for delivering a sheet-like implant to a surgical site, the system having a first deployment arm and a second deployment arm, each having a distal end and a proximal end. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] JP 2011-147567 A [Patent Document 2] JP 2013-116337 A [Patent Document 3] JP 2020-36670 A [Patent Document 4] Special Publication No. 2020-505183 Summary of the Invention [Problem to be solved by the invention]

[0007] In the devices described in Patent Documents 1 to 4, the degree of adhesion of the film to the body tissue is sometimes insufficient, and in this respect there is room for improvement. Therefore, an object of the present invention is to provide a medical film delivery tool and a method for manufacturing a medical device that can easily adhere a film to a treatment site inside the body. [Means for solving the problem]

[0008] One embodiment of the medical film delivery tool of the present invention that has achieved the above object is a medical film delivery tool for delivering a medical film into a body, which includes a first shaft having a distal end and a proximal end in the longitudinal direction and a first lumen, a second shaft disposed in the first lumen of the first shaft and movable in the longitudinal direction relative to the first shaft, a first enlarged diameter section disposed in the distal part of the first shaft and capable of expanding, and a second enlarged diameter section disposed in the distal part of the second shaft and capable of expanding, and the gist of the medical film delivery tool is that the first enlarged diameter section and the second enlarged diameter section have different shapes when expanded. According to the medical film delivery tool of the present invention, since the first enlarged diameter section and the second enlarged diameter section have different shapes when expanded, it is possible for one of the first enlarged diameter section and the second enlarged diameter section to have a function of assisting in the deployment of the film, and the other to have a function of pressing the film. For example, the film can be easily attached to the treatment section by using the second enlarged diameter section to deploy the film at the treatment section and then pressing the film using the first enlarged diameter section.

[0009] In the above medical film delivery tool, the second enlarged diameter portion may have a contact portion that contacts the film. The above medical film delivery tool may further have a third shaft having a third lumen and the first shaft disposed in the third lumen, and the inner surface of the third shaft may have a contact portion that contacts the film in the third lumen.

[0010] In the medical film delivery tool, when the second shaft is positioned most distally relative to the first shaft, the second expanded diameter portion may be located distal to the first expanded diameter portion. In the medical film delivery tool, the first expanded diameter portion and the second expanded diameter portion may have different maximum outer diameters when expanded. In the medical film delivery tool, the maximum outer diameter of the first expanded diameter portion when expanded may be larger than the maximum outer diameter of the second expanded diameter portion when expanded.

[0011] In the above medical film delivery tool, when the second enlarged diameter portion is housed in the first lumen of the first shaft, the first enlarged diameter portion and the second enlarged diameter portion may overlap in the longitudinal direction of the first shaft. If the above medical film delivery tool further includes a third shaft having a third lumen and the first shaft is disposed in the third lumen, when the first enlarged diameter portion and the second enlarged diameter portion are housed in the third lumen of the third shaft, the second enlarged diameter portion may be located distal to the first enlarged diameter portion in the longitudinal direction of the third shaft.

[0012] In the above medical film delivery tool, the first expanded diameter portion may be a balloon, the first shaft may have a second lumen, and the second lumen may be connected to the inside of the balloon. The second expanded diameter portion may have a first element and a second element, and the first element and the second element may each have a long portion. When the first element and the second element are protruded from the first shaft, at least a part of the first element may be disposed away from the second element in the radial direction of the second shaft.

[0013] In the above medical film delivery tool, when the first element and the second element are protruded from the first shaft, the first element and the second element may have a portion arranged parallel to each other. The first enlarged diameter portion may be a balloon having a straight tube portion.

[0014] In the medical film delivery tool, the second enlarged diameter portion may be a loop wire, and the first enlarged diameter portion may be a balloon having a spherical or elliptical spherical shape.

[0015] The present invention also provides a method for producing a medical device. One embodiment of the method for producing a medical device of the present invention includes the steps of preparing a medical film, a first shaft having a distal end and a proximal end in the longitudinal direction and a first lumen, a second shaft disposed in the first lumen of the first shaft and movable in the longitudinal direction relative to the first shaft, a third shaft having a third lumen and the first shaft disposed in the third lumen, a first enlarged portion disposed in the distal portion of the first shaft and capable of expanding in diameter, and a second enlarged portion disposed in the distal portion of the second shaft and capable of expanding in diameter, the first enlarged portion and the second enlarged portion having different shapes when enlarged in diameter, a step of attaching a film to the second enlarged portion, and a step of arranging the second enlarged portion to which the film is attached in the third lumen of the third shaft. The method for producing a medical device according to the present invention includes the step of arranging the second enlarged portion to which the film is attached in the third lumen of the third shaft, so that the film is easily held by the second enlarged portion and the third shaft. As a result, it is possible to prevent the film from falling off the third shaft during delivery of the film. Effect of the Invention

[0016] According to the medical film delivery tool of the present invention, one of the first and second enlarged diameter sections can perform the function of assisting in spreading the film, while the other can perform the function of pressing the film. Also, according to the manufacturing method of the medical tool of the present invention, the film is easily held by the second enlarged diameter section and the third shaft, so that the film can be prevented from falling off the third shaft during delivery. [Brief description of the drawings]

[0017] [Figure 1] FIG. 1 is a side view (partial cross-sectional view) of a medical film delivery tool according to one embodiment of the present invention. [Diagram 2] 2 is a cross-sectional end view of the medical film delivery device shown in FIG. 1 taken along line II-II. [Diagram 3] 3 is a cut-away end view showing a modified example of the medical film delivery tool shown in FIG. 2. FIG. [Figure 4] 2 is a side view (partial cross-sectional view) showing a state in which a second enlarged diameter portion is housed in a third shaft of the medical film delivery tool shown in FIG. 1. FIG. [Diagram 5] 2 is a side view (partial cross-sectional view) showing a state in which a second enlarged diameter portion is housed in a first shaft of the medical film delivery tool shown in FIG. 1 and a first enlarged diameter portion protrudes from a third shaft. FIG. [Figure 6] 2 is a side view (partial cross-sectional view) showing a state in which a second enlarged diameter portion is housed in a third shaft and a first shaft of the medical film delivery device shown in FIG. 1. FIG. [Figure 7] 2 is an enlarged side view of a distal portion of the medical film delivery tool shown in FIG. 1. [Figure 8] 8 is a side view showing a modification of the distal part of the medical film delivery tool shown in FIG. 7. [Figure 9] 8 is a side view showing another modified example of the distal part of the medical film delivery tool shown in FIG. 7. [Figure 10] FIG. 13 is a side view (partially cross-sectional view) of a medical film delivery tool according to another embodiment of the present invention. [Figure 11] FIG. 1 is a schematic diagram showing an example of a method for delivering a film for medical use. [Figure 12] FIG. 1 is a schematic diagram showing an example of a method for delivering a film for medical use. [Figure 13] FIG. 1 is a schematic diagram showing an example of a method for delivering a film for medical use. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] The present invention will be described in more detail below based on the following embodiments, but the present invention is not limited to the following embodiments, and can be modified as long as it meets the purpose described above and below, and all of these modifications are included in the technical scope of the present invention. In addition, hatching and component symbols may be omitted in each drawing for convenience, but in such cases, the specification and other drawings should be referred to. In addition, the dimensions of various components in the drawings may differ from the actual dimensions because priority is given to helping understand the features of the present invention.

[0019] One embodiment of the medical film delivery tool of the present invention is a medical film delivery tool for delivering a medical film into a body, comprising a first shaft having a distal end and a proximal end in the longitudinal direction and a first lumen, a second shaft disposed in the first lumen of the first shaft and movable in the longitudinal direction relative to the first shaft, a first enlarged portion disposed in the distal part of the first shaft and capable of expanding, and a second enlarged portion disposed in the distal part of the second shaft and capable of expanding, the gist being that the first enlarged portion and the second enlarged portion have different shapes when expanded. According to the medical film delivery tool of the present invention, since the first enlarged portion and the second enlarged portion have different shapes when expanded, it is possible for one of the first enlarged portion and the second enlarged portion to have a function of assisting in the deployment of the film, and the other to have a function of pressing the film. For example, the film can be easily attached to the treatment portion by using the second enlarged portion to deploy the film at the treatment portion and then pressing the film using the first enlarged portion.

[0020] The medical film delivery tool is introduced into a body cavity via a treatment tool insertion channel of an endoscope and is used to deliver and place a medical film inside the body. Hereinafter, the medical film delivery tool may be simply referred to as a delivery tool.

[0021] The medical film is placed in the treatment area, such as the part where the diseased part in the body has been removed, for the purpose of promoting the healing of the affected part, mitigating bleeding, suppressing adhesion of organs, etc. Medical films also include those called sheets or membranes. Hereinafter, the medical film may be simply called a film. The shape of the film is not particularly limited, but can be, for example, rectangular. The size of the film can be appropriately set according to the size of the treatment part. The film may be biodegradable or bioabsorbable.

[0022] In the present invention, the medical device includes a medical film and a medical film delivery device.

[0023] An example of the configuration of a delivery tool and a medical tool will be described with reference to Figs. 1 to 13. Fig. 1 is a side view (partially cross-sectional) of a medical film delivery tool according to one embodiment of the present invention. Fig. 2 is a cut end view taken along line II-II of the medical film delivery tool shown in Fig. 1. Fig. 3 is a cut end view showing a modified example of the medical film delivery tool shown in Fig. 2. Fig. 4 is a side view (partially cross-sectional) showing a state in which the second enlarged diameter part is housed in the third shaft of the medical film delivery tool shown in Fig. 1. Fig. 5 is a side view (partially cross-sectional) showing a state in which the second enlarged diameter part is housed in the first shaft of the medical film delivery tool shown in Fig. 1 and the first enlarged diameter part protrudes from the third shaft. Fig. 6 is a side view (partially cross-sectional) showing a state in which the second enlarged diameter part is housed in the third shaft and the first shaft of the medical film delivery tool shown in Fig. 1. Fig. 7 is an enlarged side view of the distal part of the medical film delivery tool shown in Fig. 1. Figs. 8 to 9 are side views showing modified examples of the distal part of the medical film delivery tool shown in Fig. 7. Fig. 10 is a side view (partial cross-sectional view) of a medical film delivery tool according to another embodiment of the present invention. Figs. 11 to 13 are schematic diagrams showing an example of a delivery method for a medical film. The delivery tool 5 has a first shaft 10, a second shaft 20, a first enlarged diameter section 40, and a second enlarged diameter section 50. Figs. 7 to 9 show the shape of the second enlarged diameter section 50 when protruding from the first shaft 10.

[0024] The distal side of the delivery tool 5 refers to the distal end 11 side of the first shaft 10 in the longitudinal direction x, which is the side to be treated. The proximal side of the delivery tool 5 refers to the proximal end 12 side of the first shaft 10 in the longitudinal direction x, which is the side closest to the user. When each member is divided into two equal parts in the longitudinal direction, the proximal side may be referred to as the proximal portion, and the distal side may be referred to as the distal portion. The inner and outer sides of the delivery tool 5 refer to the inner and outer sides in the radial direction of the first shaft 10, and the inner side in the radial direction refers to the side closer to the central axis of the first shaft 10 in the longitudinal direction x. Here, the central axis in the longitudinal direction may be rephrased as the central axis extending in the longitudinal direction. The same applies to the following explanation.

[0025] First, an example of a method for placing the film 70 will be described. The first shaft 10 is inserted into the third lumen 33 of the third shaft 30. At this time, as shown in FIG. 11, the first enlarged diameter portion 40 is stored in the third lumen 33. Also, the second shaft 20 is inserted into the first shaft 10, but the second enlarged diameter portion 50 protrudes from the first shaft 10. As shown in FIG. 11, the second enlarged diameter portion 50 to which the film 70 is attached is disposed in the third lumen 33 of the third shaft 30. In the state of FIG. 11, the delivery tool 5 is inserted to the vicinity of the treatment site 80 in the body via the endoscope. By an operation such as moving the third shaft 30 proximally, the second enlarged diameter portion 50 is protruded from the third shaft 30 to expose the film 70 as shown in FIG. 12, and the film 70 is temporarily placed at the treatment site 80. At this time, at least a part of the film 70 may be spontaneously deployed due to the stiffness or tension of the film 70. When the film 70 is temporarily placed in the treatment portion 80, the second enlarged diameter portion 50 is positioned distal to the first enlarged diameter portion 40 as shown in FIG. 13 or FIG. 1. When the first enlarged diameter portion 40 is a balloon 42 as shown in FIG. 13, the balloon 42 is expanded. The expanded first enlarged diameter portion 40 is used to press the film 70 against the treatment portion 80. Instead of the state shown in FIG. 13 or FIG. 1, the film 70 may be pressed against the treatment portion 80 using the expanded first enlarged diameter portion 40 in a state in which the second enlarged diameter portion 50 is stored in the first lumen 13 of the first shaft 10 as shown in FIG. 5. Next, as shown in FIG. 6, the first shaft 10 is stored in the third lumen 33 of the third shaft 30, and the entire delivery tool 5 is moved proximally. This completes the delivery and placement of the film 70 in the treatment portion 80.

[0026] Next, each member constituting the delivery tool 5 will be described. As shown in FIG. 1 and FIG. 2, the first shaft 10 is a long member having a longitudinal direction x, a radial direction, and a circumferential direction p. The first shaft 10 has a distal end 11 and a proximal end 12 in the longitudinal direction x. Since the second shaft 20 is disposed within the first shaft 10, the first shaft 10 preferably has a cylindrical shape, for example, and more preferably has a cylindrical shape with both ends open. The first shaft 10 has at least a first lumen 13. The second shaft 20 is disposed in the first lumen 13. When the first enlarged diameter portion 40 is a balloon 42 as shown in FIG. 1, the first shaft 10 may have a second lumen 14. The second lumen 14 functions as a flow path for a fluid to enlarge and shrink the first enlarged diameter portion 40. The first lumen 13 may extend to a position distal to the second lumen 14.

[0027] In Figs. 1 and 2, an example in which the first shaft 10 has a multi-lumen structure having a plurality of lumens is shown, but the present invention is not limited to this embodiment. As shown in Fig. 3, the first shaft 10 may have an outer shaft 101 having a longitudinal direction and an inner shaft 102 disposed in the lumen of the outer shaft 101. The inner shaft 102 may extend from the distal end of the outer shaft 101. In this case, the lumen of the inner shaft 102 can be used as the first lumen 13, and the space between the outer shaft 101 and the inner shaft 102 can be used as the second lumen 14. By forming the first shaft 10 into a multiple tube structure in this way, the second shaft 20 housed in the first lumen 13 can be easily disposed in a position close to the central axis of the first shaft 10 in the longitudinal direction x. As a result, the second enlarged diameter portion 50 can also be easily disposed in a position close to the central axis in the longitudinal direction x.

[0028] The first shaft 10 has one or more openings for projecting the second enlarged diameter portion 50. In Fig. 1, the first shaft 10 has a distal opening 15 on its distal end surface. The first lumen 13 communicates with the outside of the first shaft 10 through the distal opening 15.

[0029] The first shaft 10 is preferably flexible. This allows the first shaft 10 to be deformed according to the shape of the body cavity. In order to maintain the shape, the first shaft 10 is preferably elastic. The first shaft 10 is preferably made of resin, metal, or a combination of resin and metal. Examples of the first shaft 10 include a resin tube; a metal tube; a hollow body formed by arranging wires in a predetermined pattern; a hollow body in which at least one of the inner surface and the outer surface is coated with resin; or a combination of these, for example, a combination of these, for example, a combination of these in the longitudinal direction x. The resin tube can be manufactured by, for example, extrusion molding. Examples of the hollow body in which wires are arranged in a predetermined pattern include a cylindrical body having a mesh structure in which wires are simply crossed or woven, and a coil in which wires are wound. The wire may be one or more solid wires, or one or more twisted wires. The cross-sectional shape of the wire may be, for example, a circle, an oval, a polygon, or a combination of these. The oval shape includes an ellipse, an egg, and a rounded rectangle, and the same applies in the following description. The type of the mesh structure is not particularly limited, and the number of turns and density of the coil are also not particularly limited. The mesh structure and the coil may be formed with a constant density over the entire longitudinal direction x of the first shaft 10, or may be formed so that the density varies depending on the position in the longitudinal direction x of the first shaft 10. In order to increase the flexibility of the metal tube, a cut or groove may be formed on the outer surface of the metal tube. The shape of the cut or groove may be linear, arc-shaped, annular, spiral, or a combination of these. When the first shaft 10 is a cylindrical resin tube, the first shaft 10 may be composed of a single layer or multiple layers, and a part in the longitudinal direction x or the circumferential direction p may be composed of a single layer, and the other part may be composed of multiple layers.

[0030] The first enlarged diameter section 40 is an expandable section disposed at the distal portion of the first shaft 10. The first enlarged diameter section 40 expands radially outward of the first shaft 10. The film can be pressed against the treatment area by the enlarged first enlarged diameter section 40. It is preferable to expand the film all at once by inserting the first enlarged diameter section 40 into a gap in the film that has been delivered to the vicinity of the treatment area and expanding the diameter of the film, thereby pressing the film against the treatment area.

[0031] The first enlarged diameter section 40 is preferably capable of being stored in the third shaft 30 described later. By storing it in the third shaft 30, it is possible to prevent the first enlarged diameter section 40 from coming into contact with places other than the treatment site. It is preferable that the maximum outer diameter of the first enlarged diameter section 40 when fully contracted is smaller than the minimum inner diameter of the third lumen 33 of the third shaft 30.

[0032] The first enlarged diameter portion 40 may be, for example, a balloon, a basket with multiple elastic wires, a stent, or a snare. Among them, as shown in FIG. 1, the first enlarged diameter portion 40 is preferably a balloon 42. This is because the balloon 42 is unlikely to damage the biological wall even when it comes into contact with it. By pressing the film using the balloon 42, the degree of adhesion of the film to the treatment area can be increased. Note that when a basket, stent, or snare is used, the wires constituting these easily bite into the biological wall, so that the film can be firmly attached.

[0033] When the first expanded diameter portion 40 is a balloon 42, it is preferable that the first shaft 10 has a second lumen 14, and the second lumen 14 communicates with the inside of the balloon 42. As a result, the balloon 42 expands toward the outside in the radial direction of the first shaft 10 by introducing a fluid into the inside of the balloon 42 through the second lumen 14. Also, the balloon 42 contracts by removing the fluid from the inside of the balloon 42. A fluid inlet / outlet 18 may be provided in the proximal portion of the first shaft 10 to introduce and remove the fluid.

[0034] 1 and 4 to 6, the distal end and the proximal end of the balloon 42 are each fixed to the outer surface of the first shaft 10. In detail, the distal end of the balloon 42 is fixed to a section of the first shaft 10 that does not have the second lumen 14, and the proximal end of the balloon 42 is fixed to a section of the first shaft 10 that has the first lumen 13 and the second lumen 14.

[0035] The balloon 42 can be manufactured by molding a resin. Examples of resins constituting the balloon 42 include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, polyphenylene sulfide resins, fluorine resins, vinyl chloride resins, silicone resins, natural rubber, etc. These may be used alone or in combination of two or more.

[0036] In order to improve the expansion performance and dimensional stability against the expansion pressure, a reinforcing material may be disposed in the balloon 42. As the reinforcing material, for example, a fiber material can be used, and specifically, polyarylate fiber, aramid fiber, ultra-high molecular weight polyethylene fiber, PBO fiber, carbon fiber, etc. are preferably used. These fiber materials may be monofilament or multifilament.

[0037] The balloon 42 may be of a compliant type, in which the outer diameter changes according to the expansion pressure, or of a non-compliant type, in which the outer diameter of the balloon 42 hardly increases even if the expansion pressure is increased above a certain expansion pressure. If it is of a compliant type, the film can be easily and flexibly pressed against an undulating or hard treatment area. If it is of a non-compliant type, it is possible to assist the expansion of the stenosis area, and the film can be pressed more firmly than with a compliant type.

[0038] The shape of the balloon 42 is not particularly limited, but as shown in FIG. 1, the balloon 42 preferably has a straight tube section 43. In the straight tube section 43, the balloon 42 preferably has a cylindrical shape. Since the balloon 42 has a cylindrical shape, it is easy to press a wide area of ​​the film at once, so that the procedure time can be shortened. In FIG. 1, the straight tube section 43 is disposed between the proximal taper section 44 and the distal taper section 45. The proximal taper section 44 and the distal taper section 45 may be, for example, a truncated cone shape. The straight tube section 43 may be inclined according to the shape of the lesion as long as the inclination angle is smaller than that of the proximal taper section 44 and the distal taper section 45.

[0039] The balloon 42 may have a spherical or elliptical shape. Even if the treatment site has undulating or isthmus, the roundness of the balloon 42 makes it easier to press the film against the undulating or isthmus.

[0040] When the first enlarged diameter portion 40 is a loop wire, forceps, or a basket with multiple elastic wires, it is preferable that the first enlarged diameter portion 40 is made of an elastically deformable material. This allows the first enlarged diameter portion 40 to expand in diameter when protruding from the third lumen 33 of the third shaft 30. In addition, when the first enlarged diameter portion 40 is retracted relative to the third shaft 30, the first enlarged diameter portion 40 reduces in diameter, allowing the first enlarged diameter portion 40 to be smoothly accommodated in the third lumen 33.

[0041] When the first expanded portion 40 is a loop wire, forceps, or basket, it may be made of, for example, a superelastic alloy such as a Ni-Ti alloy, or stainless steel such as SUS303, SUS304, or SUS316.

[0042] The second shaft 20 is a long member having a longitudinal direction, a radial direction, and a circumferential direction. The second shaft 20 has a distal end 21 and a proximal end 22 in the longitudinal direction. The second shaft 20 is disposed in the first inner cavity 13 of the first shaft 10. The second shaft 20 functions as a pushing member for moving the second enlarged diameter portion 50 forward and backward relative to the first shaft 10. The second shaft 20 can be composed of one or more members.

[0043] The second shaft 20 preferably extends in the longitudinal direction x of the first shaft 10. With this configuration, the second shaft 20 can be disposed along the first shaft 10.

[0044] It is preferable that the second shaft 20 has a solid shape. This makes it easier to impart rigidity to the second shaft 20, and therefore makes it easier to perform the protruding and retracting operations of the second enlarged diameter portion 50. Figures 1 and 2 show an example in which the second shaft 20 has a solid rod shape having a straight line.

[0045] The second shaft 20 may have a hollow shape. The second shaft 20 may be a resin tube, a metal tube, a hollow body formed by arranging wires in a predetermined pattern, the hollow body having at least one of the inner and outer surfaces coated with resin, or a combination of these. For the configuration of these, refer to the description of the first shaft 10.

[0046] The second shaft 20 is movable in the longitudinal direction x relative to the first shaft 10. This allows the second enlarged diameter portion 50 to protrude from the distal opening 15 of the first shaft 10. In particular, when the second shaft 20 is moved distally relative to the first shaft 10, the second enlarged diameter portion 50 can protrude from the distal side of the first shaft 10. For example, when the second shaft 20 is positioned most distally relative to the first shaft 10, it is preferable that the proximal end of the second enlarged diameter portion 50 is positioned more distally than the distal end of the first shaft 10. In addition, when the second shaft 20 is moved proximally relative to the first shaft 10, the second enlarged diameter portion 50 can be stored in the first lumen 13. For example, when the second shaft 20 is positioned most proximally relative to the first shaft 10, it is preferable that the distal end of the second enlarged diameter portion 50 is positioned more proximally than the distal end of the first shaft 10.

[0047] The second shaft 20 may be rotatable relative to the first shaft 10. By rotating the second shaft 20, the orientation of the second enlarged portion 50 can be changed, making it easier to unfold the film, or allowing the second enlarged portion 50 to press the film against the treatment area. If the delivery tool 5 further has a handle (hereinafter referred to as the first handle 71) connected to the proximal portion of the second shaft 20, the second shaft 20 can be rotated about its central axis in the longitudinal direction by operating the first handle 71.

[0048] The configuration for changing the position of the second enlarged diameter portion 50 in the longitudinal direction x relative to the first shaft 10 is not particularly limited. For example, in FIG. 1, the first handle 71 has a cylindrical portion 72, and a connecting portion 73 is arranged inside the cylindrical portion 72. The proximal portion of the first shaft 10 is connected to a second handle 74 having a cylindrical portion 75. The first handle 71 is arranged outside the cylindrical portion 75 of the second handle 74. The first handle 71 is configured to be slidable in the longitudinal direction of the cylindrical portion 75 of the second handle 74. The proximal portion of the second shaft 20 extends proximally from the proximal end 12 of the first shaft 10 and is connected to the connecting portion 73. The second enlarged diameter portion 50 can be protruded from the first shaft 10 by moving the first handle 71 distally relative to the second handle 74. The second enlarged diameter portion 50 can be stored inside the first shaft 10 by moving the first handle 71 proximally relative to the second handle 74.

[0049] The first handle 71 and the second handle 74 can each be made of one or more members. Examples of materials that can be used to make the first handle 71 and the second handle 74 include synthetic resins such as polyolefin resin, polyester resin, polycarbonate resin, ABS resin, and polyurethane resin.

[0050] The second enlarged diameter section 50 is an expandable section disposed at the distal portion of the second shaft 20. The second enlarged diameter section 50 is preferably used as a trigger for deploying the film near the treatment site, but may be used to press the film. The second enlarged diameter section 50 expands radially outwardly of the second shaft 20. The second enlarged diameter section 50 is also preferably capable of being housed within the third shaft 30 described below. For this reason, the second enlarged diameter section 50 is preferably contractible.

[0051] The second expanding portion 50 can be composed of one or more members. The second expanding portion 50 may be, for example, a loop wire, a forceps, a balloon, or a basket equipped with multiple elastic wires. The second expanding portion 50 may also have a first element 61 and a second element 62. The configurations of the first element 61 and the second element 62 will be described later.

[0052] The second enlarged diameter portion 50 is preferably made of an elastically deformable material. This allows the second enlarged diameter portion 50 to expand in diameter when protruding from the first inner cavity 13 of the first shaft 10, and allows the second enlarged diameter portion 50 to be stored in the first inner cavity 13.

[0053] The second expanded diameter portion 50 can be made of, for example, a superelastic alloy such as a Ni-Ti based alloy, or stainless steel such as SUS303, SUS304, or SUS316.

[0054] The second shaft 20 and the second enlarged diameter portion 50 may be integrally molded, or may be formed from separate members and then connected. The second shaft 20 and the second enlarged diameter portion 50 may be directly connected, or may be connected via another member. The second shaft 20 and the second enlarged diameter portion 50 may be connected by a method such as crimping with a fastener such as a ring member, welding, melting, or adhesion.

[0055] 11, the second enlarged diameter section 50 preferably has a contact portion (hereinafter referred to as a first contact portion 51) that contacts the film 70. The contact of the first contact portion 51 holds the film 70, thereby preventing the film 70 from falling off from the distal side of the third shaft 30 during delivery of the film 70.

[0056] It is preferable that the first contact portion 51 holds the film 70. The specific manner of holding is not particularly limited, and the film 70 may be sandwiched between the first contact portion 51 and a second contact portion described below, the film may be wrapped around the first contact portion 51, or it may be held by both. When the second enlarged diameter portion 50 has a first element 61 and a second element 62, each of which has a first contact portion 51, the film 70 may be sandwiched between the two first contact portions 51.

[0057] As shown in Fig. 1, the delivery tool 5 may further have a third shaft 30. The third shaft 30 has a third lumen 33, and the first shaft 10 is disposed in the third lumen 33. The third shaft 30 is a member for storing the first shaft 10, the second shaft 20, the first enlarged portion 40, and the second enlarged portion 50 when the film is delivered into the body. The third shaft 30 makes it difficult for the first enlarged portion 40 and the second enlarged portion 50 to come into contact with places other than the treatment site when the film is delivered.

[0058] The third shaft 30 is an elongated member having a longitudinal direction, a radial direction, and a circumferential direction. The third shaft 30 has a distal end 31 and a proximal end 32 in the longitudinal direction. The longitudinal direction of the third shaft 30 preferably extends in the longitudinal direction x of the first shaft 10. Since at least the first shaft 10 is disposed inside the third shaft 30, the third shaft 30 preferably has, for example, a cylindrical shape, and more preferably has a cylindrical shape with both ends open.

[0059] 11, it is preferable that the third lumen 33 can accommodate the second enlarged portion 50 to which the film 70 is attached. The film 70 can be delivered to the treatment site while being held by the second enlarged portion 50 and the third shaft 30.

[0060] The third shaft 30 has one or more openings for projecting the first enlarged diameter portion 40 and the second enlarged diameter portion 50. For example, in Fig. 1, the third shaft 30 has a distal opening 35 on its distal end surface. The third lumen 33 communicates with the outside of the third shaft 30 through at least the distal opening 35.

[0061] The third shaft 30 may be a resin tube, a metal tube, a hollow body formed by arranging wires in a predetermined pattern, the hollow body having at least one of the inner and outer surfaces coated with resin, or a combination of these. For the configuration of these, refer to the description of the first shaft 10.

[0062] 11, the inner surface of the third shaft 30 in the third lumen 33 preferably has a contact portion (hereinafter referred to as the second contact portion 38) that contacts the film 70. The contact of the second contact portion 38 holds the film 70, thereby preventing the film 70 from falling off from the distal side of the third shaft 30 during delivery of the film 70.

[0063] It is preferable that the film 70 is held, and more preferably, clamped, by the first contact portion 51 and the second contact portion 38. The contact of the film 70 with the first contact portion 51 and the second contact portion 38 can prevent the film 70 from falling off the distal side of the third shaft 30 during delivery of the film 70.

[0064] In the delivery tool 5, the first enlarged diameter section 40 and the second enlarged diameter section 50 have different shapes when enlarged. With this configuration, at least one of the first enlarged diameter section 40 and the second enlarged diameter section 50 can perform the function of assisting in the deployment of the film, and at least the other can perform the function of pressing the film. For example, after the film is deployed at the treatment area using the second enlarged diameter section 50, the film can be pressed using the first enlarged diameter section 40, making it easier to make the film adhere to the treatment area. Note that the first enlarged diameter section 40 may perform the function of assisting in the deployment of the film, and the second enlarged diameter section 50 may perform the function of pressing the film. In addition, both the first enlarged diameter section 40 and the second enlarged diameter section 50 may perform the function of assisting in the deployment of the film.

[0065] The first enlarged diameter section 40 and the second enlarged diameter section 50 have different shapes from each other, which means that the outer shapes (contour shapes) of the first enlarged diameter section 40 and the second enlarged diameter section 50 do not match when viewed from the side of the delivery tool 5, when the delivery tool 5 is oriented in a direction in which the outer diameters of the enlarged diameter sections are maximized with the second enlarged diameter section 50 protruding from the first shaft 10. This also includes cases in which the shapes of the first enlarged diameter section 40 and the second enlarged diameter section 50 are similar to each other (overlapped by enlarging, reducing, translating, or rotating). In addition, when the delivery tool 5 has a third shaft 30, the above-mentioned side view is a side view in a state in which the first enlarged diameter section 40 and the second enlarged diameter section 50 protrude from the third shaft 30 as shown in FIG. 1. In the following description, unless otherwise specified, the term "side view" refers to a side view when the delivery tool 5 is oriented in the above-mentioned direction.

[0066] When the second expanded diameter portion 50 is protruded from the first shaft 10, it is preferable that the length of the second expanded diameter portion 50 is longer than the length of the first expanded diameter portion 40 in the longitudinal direction x of the first shaft 10. This makes it easier to smoothly perform the procedure of pressing the film against the treatment area with the first expanded diameter portion 40 after the film is expanded by the second expanded diameter portion 50. Note that when the second expanded diameter portion 50 is protruded from the first shaft 10, the length of the first expanded diameter portion 40 may be longer than the length of the second expanded diameter portion 50 in the longitudinal direction x of the first shaft 10.

[0067] The diameter expansion mechanisms of the first expansion section 40 and the second expansion section 50 may be the same or different. For example, the first expansion section 40 may be a balloon 42 that expands and contracts by introducing and removing a fluid, and the second expansion section 50 may be made of an elastically deformable material. The second expansion section 50 may expand in diameter by protruding from the first shaft 10 and being released from the restriction of the first shaft 10, and contract in diameter by being stored within the first shaft 10.

[0068] In a side view of the delivery tool 5, the first and second enlarged diameter sections 40 and 50 may have the same maximum outer diameter when expanded, but it is preferable that the first and second enlarged diameter sections 40 and 50 have different maximum outer diameters when expanded, as shown in Fig. 1. This makes it easier for one of the two enlarged diameter sections to perform the function of assisting in spreading the film, and for the other to perform the function of pressing the film.

[0069] 1, in a side view of the delivery tool 5, the maximum outer diameter of the first expanded diameter section 40 when expanded is preferably larger than the maximum outer diameter of the second expanded diameter section 50 when expanded. This makes it easier for the second expanded diameter section 50 to simultaneously press a wide range of the film, thereby shortening the procedure time.

[0070] In a side view of the delivery tool 5, the maximum outer diameter of the first expanded diameter section 40 when expanded may be smaller than the maximum outer diameter of the second expanded diameter section 50 when expanded. This makes it easier to selectively press the film against each site with the small first expanded diameter section 40 while the second expanded diameter section 50 expands the film widely.

[0071] 1, when the second shaft 20 is positioned most distally relative to the first shaft 10, the second expanded diameter section 50 is preferably positioned distal to the first expanded diameter section 40. By configuring the delivery tool 5 so that they are arranged in this order, it becomes easier to smoothly perform the procedure of pressing the film against the treatment area with the first expanded diameter section 40 after the film is expanded with the second expanded diameter section 50.

[0072] As shown in Figs. 5 and 6, when the second enlarged diameter portion 50 is housed in the first lumen 13 of the first shaft 10, the first enlarged diameter portion 40 and the second enlarged diameter portion 50 preferably overlap in the longitudinal direction of the first shaft 10. By disposing the second enlarged diameter portion 50 on the side closer to the distal end 11 of the first shaft 10, the distal side of the first lumen 13 of the first shaft 10 can be blocked. As a result, bodily fluids and foreign matter are less likely to enter the first shaft 10 through the distal opening 15 of the first shaft 10. In addition, when the film is crimped with the first enlarged diameter portion 40, the risk of inadvertently damaging body tissues can be reduced by housing the second enlarged diameter portion 50 in the first shaft 10 when operating the first shaft 10. In particular, the procedure of removing the delivery tool 5 from the body after the film is placed can be performed smoothly.

[0073] When the second enlarged diameter portion 50 is stored in the first inner cavity 13 of the first shaft 10, the distal end of the second enlarged diameter portion 50 may be located proximal to the proximal end of the first enlarged diameter portion 40.

[0074] In the case where the delivery tool 5 has a third shaft 30 having a third lumen 33 and the first shaft 10 disposed in the third lumen 33, as shown in FIG. 4, when the first enlarged portion 40 and the second enlarged portion 50 are housed in the third lumen 33 of the third shaft 30, it is preferable that the second enlarged portion 50 is located distal to the first enlarged portion 40 in the longitudinal direction of the third shaft 30. By configuring the delivery tool 5 so that they are arranged in such an order, it becomes easier to secure a portion of the third lumen 33 distal to the distal end of the first enlarged portion 40 as a space for housing the film. In addition, after the film is deployed by the second enlarged portion 50, the procedure of pressing the film against the treatment area by the first enlarged portion 40 can be performed smoothly.

[0075] An embodiment of the second expanded diameter section 50 will be described. As shown in Figs. 1 and 4 to 9, the second expanded diameter section 50 preferably has a first element 61 and a second element 62. The first element 61 and the second element 62 can be connected to the distal end of the second shaft 20. In detail, the first element 61 and the second element 62 are preferably arranged to extend in the distal direction from the distal end 21 of the second shaft 20.

[0076] As shown in Figures 7 to 9, it is preferable that the first element 61 and the second element 62 each have a long portion. This makes it easier to wind a film around the first element 61 and the second element 62. The first element 61 and the second element 62 may have, for example, a linear, rod-like, strip-like, plate-like, arm-like, or a combination of these shapes. The first element 61 and the second element 62 may have the same shape or different shapes.

[0077] When the first element 61 and the second element 62 are protruded from the first shaft 10, it is preferable that the first element 61 and the second element 62 have portions arranged parallel to each other. The portions arranged parallel to each other make it easy to wrap a film around them, making it easier to attach the film. This also makes it possible to prevent the film from falling off during delivery.

[0078] The first element 61 and the second element 62 can be disposed so as to face each other in the radial direction of the second shaft 20. It is preferable that the first element 61 and the second element 62 sandwich the film. It is also preferable that the film is wound around at least one of the first element 61 and the second element 62.

[0079] The shapes of the first element 61 and the second element 62, when viewed from the side of the delivery device 5, may be linearly symmetrical with respect to the longitudinal central axis c of the second shaft 20 as shown in FIG. 8, or may be asymmetrical as shown in FIG. 7.

[0080] 1, when the first element 61 and the second element 62 are protruded from the first shaft 10, it is preferable that at least a part of the first element 61 is arranged to be separated from the second element 62 in the radial direction of the second shaft 20. By configuring the first element 61 and the second element 62 in this manner, it becomes easier to spread the film in the vicinity of the treatment site. Note that when the first element 61 and the second element 62 are protruded from the first shaft 10, it is preferable that the distal end of the second element 62 is arranged to be separated from the distal end of the first element 61 in the radial direction of the second shaft 20.

[0081] 7 to 9, the proximal end of the first element 61 and the proximal end of the second element 62 are fixed to each other, and the distal end of the first element 61 and the distal end of the second element 62 do not have to be fixed to each other. This configuration makes it easier to spread the film on the distal end side of each of the first element 61 and the second element 62.

[0082] It is preferable that at least one of the first element 61 and the second element 62 has the first contact portion 51. For example, a long portion of the first element 61 and the second element 62 may be the first contact portion 51. Also, a portion where the first element and the second element are arranged parallel to each other when the first element and the second element are protruded from the first shaft may be the first contact portion 51. A first section of the first element 61 and the second element 62, which will be described later, may be the first contact portion 51.

[0083] The first element 61 and the second element 62 may each have a first section extending along the longitudinal direction of the second shaft 20 when the first element 61 and the second element 62 are protruded from the first shaft 10. When each element has a first section, it becomes easier to wind a film around each first section. In Figs. 7 and 8, the first element 61 has a first section 611, and the second element 62 has a first section 621.

[0084] At least one of the first element 61 and the second element 62 may have a second section extending from the inside to the outside in the radial direction from the proximal end 22 side to the distal end 21 side of the second shaft 20 when the first element 61 and the second element 62 are protruded from the first shaft 10. By providing such a second section, when these elements are protruded from the first shaft 10, the distal end of the first element 61 and the distal end of the second element 62 are easily positioned so as to be separated in the radial direction. As a result, the film is easily developed by the expansion of the first element 61 and the second element 62. FIG. 7 shows an example in which the second element 62 has the second section 622. FIG. 8 shows an example in which the first element 61 has the second section 612 and the second element 62 has the second section 622.

[0085] In the first element 61 or the second element 62, the first section is preferably disposed distally of the second section, and more preferably the first section is disposed adjacent to the second section and distally of the first section. This allows the first element 61 and the second element 62 to be disposed so as to be separated from each other on the side closer to the distal end of the delivery tool 5 when the first element 61 and the second element 62 are protruded from the first shaft 10. Note that in the first element 61 or the second element 62, the first section may be disposed proximally of the second section.

[0086] The shape of the first element 61 and the second element 62 can be changed by bending or curving the element midway, or by both. At least one of the first element 61 and the second element 62 may have one or more curved portions. By providing the curved portions, the elements can be more easily stored in the first lumen 13. At least one of the first element 61 and the second element 62 may have one or more curved portions. In order to facilitate storage in the first lumen 13, it is preferable that each element has only one curved portion or no curved portion.

[0087] It is preferable that the first element 61 and the second element 62 have a degree of elasticity that allows them to expand when protruding from the first shaft 10. On the other hand, when the first element 61 and the second element 62 are housed in the first inner cavity 13 of the first shaft 10, at least one of the first element 61 and the second element 62 may contact the inner surface of the first shaft 10. Also, when the first element 61 and the second element 62 are housed in the first inner cavity 13 of the first shaft 10, the first element 61 and the second element 62 may contact each other.

[0088] The constituent materials of the first element 61 and the second element 62 may be the same or different. The constituent materials of the first element 61 and the second element 62 and the constituent material of the second shaft 20 may be the same or different.

[0089] 7 and 8 show an example in which the first element 61 and the second element 62 are provided as the second expanded diameter section 50, but one or more elements may be further provided. For example, as shown in Fig. 9, the second expanded diameter section 50 may have the first element 61, the second element 62, and the third element 63. By having the third element 63 in this way, it becomes easier to hold the film, and therefore the film can be easily expanded.

[0090] When the first element 61, the second element 62, and the third element 63 are protruded from the first shaft 10, it is preferable that at least a portion of the first element 61 is disposed away from the second element 62 and the third element 63 in the radial direction of the second shaft 20. Note that the description of the first element 61 and the second element 62 can be referred to for other configurations of the third element 63.

[0091] 10, the second enlarged diameter portion 50 may be a loop wire 67. The loop wire 67 may be in any shape as long as it is a closed loop, and may be in a circular, elliptical, polygonal, etc. The loop shape can be changed by bending or curving the loop wire 67 midway, or by both.

[0092] The loop wire 67 may have one or more curved portions. Providing a curved portion makes it easier to smoothly store the loop wire 67 in the first lumen 13. Note that the loop wire 67 may have one or more curved portions, but in order to facilitate storage in the first lumen 13, it is preferable that the loop wire 67 has only one curved portion or no curved portion.

[0093] When the loop wire 67 is stored in the first lumen 13 of the first shaft 10, it is preferable that the loop is folded so that one or more points of the loop wire 67 contact the inner surface of the first shaft 10 in the first lumen 13.

[0094] The method of connecting the loop wire 67 and the second shaft 20 can refer to the method of connecting the first element 61, the second element 62, and the second shaft 20. Fig. 10 shows an example in which the proximal end of the loop wire 67 and the distal end of the second shaft 20 are joined by crimping with a fastening ring 69.

[0095] 1, when the first expanded diameter section 40 is a balloon 42 having a straight tube section 43, the second expanded diameter section 50 has a first element 61 and a second element 62, and it is preferable that the first element 61 and the second element 62 have portions arranged parallel to each other when the first element 61 and the second element 62 are protruded from the first shaft 10. In this way, the first expanded diameter section 40 and the second expanded diameter section 50 have linear portions, which makes it easier to place the film on the wall of an organ having a linear shape, such as the esophagus.

[0096] 10, when the first expanding portion 40 is a balloon 42 having a spherical or oval spherical shape, it is preferable that the second expanding portion 50 is a loop wire 67. By having the first expanding portion 40 and the second expanding portion 50 have curved portions in this way, it becomes easier to press the film against the wall of an organ having folds or a curved shape so that it reaches deep inside.

[0097] The present invention also provides a method for manufacturing the medical device 1. The method for manufacturing the medical device 1 according to one embodiment of the present invention includes the steps of preparing a medical film 70 and a medical film delivery device 5, attaching the film 70 to the second expanded diameter section 50, and arranging the second expanded diameter section 50 to which the film 70 is attached, in the third lumen 33 of the third shaft 30, as shown in FIG. As shown in FIG. 1, the medical film delivery device 5 comprises a first shaft 10 having a distal end 11 and a proximal end 12 in the longitudinal direction x and having a first lumen 13, a second shaft 20 disposed in the first lumen 13 of the first shaft 10 and movable in the longitudinal direction x relative to the first shaft 10, a third shaft 30 having a third lumen 33 and in which the first shaft 10 is disposed in the third lumen 33, a first expansion section 40 disposed in a distal portion of the first shaft 10 and expandable in diameter, and a second expansion section 50 disposed in a distal portion of the second shaft 20 and expandable in diameter, the first expansion section 40 and the second expansion section 50 having different shapes when expanded in diameter. Since the manufacturing method of the above-mentioned medical device 1 includes a step of placing the second expansion portion 50 to which the film 70 is attached in the third lumen 33 of the third shaft 30, the film 70 is easily held by the second expansion portion 50 and the third shaft 30, thereby preventing the film 70 from falling off the third shaft 30 during delivery of the film 70.

[0098] For the medical film 70 and the medical film delivery tool 5, the above-mentioned configurations can be appropriately combined and used.

[0099] The method of attaching the film 70 to the second expanded diameter section 50 is not particularly limited, and for example, the film 70 may be clamped by the second expanded diameter section 50, or the film 70 may be wrapped around the second expanded diameter section 50. The film 70 may be rolled or folded.

[0100] In the step of placing the second expanded diameter portion 50 with the film 70 attached thereto in the third lumen 33 of the third shaft 30, it is preferable that the second expanded diameter portion 50 is placed in the third lumen 33 in a state where it protrudes from the first shaft 10. This makes it easier for the film 70 to be held by the second expanded diameter portion 50 and the third shaft 30. [Explanation of symbols]

[0101] 1: Medical equipment 5: Medical film delivery device 10: First shaft 13: 1st lumen 14:Second lumen 20: 2nd shaft 30: 3rd shaft 33: Third lumen 40: 1st enlarged diameter part 42: Balloon 50:Second enlarged diameter part 61: First element 62: Second Element 67: Loop wire 70:Film 80: Treatment department

Claims

1. A medical film delivery device for delivering a medical film into a body, comprising: a first shaft having a distal end and a proximal end longitudinally and having a first lumen; a second shaft disposed in the first lumen of the first shaft and movable in the longitudinal direction relative to the first shaft; A first expanding portion disposed in a distal portion of the first shaft and capable of expanding in diameter; A second expanding portion is disposed in a distal portion of the second shaft and is expandable in diameter, The medical film delivery tool, wherein the first expanded diameter portion and the second expanded diameter portion have different shapes when expanded.

2. The medical film delivery tool according to claim 1 , wherein the second enlarged diameter portion has a contact portion that contacts the film.

3. a third shaft having a third lumen, the first shaft being disposed in the third lumen; The medical film delivery tool according to claim 1 or 2, wherein an inner surface of the third shaft in the third lumen has a contact portion that contacts the film.

4. A medical film delivery device as described in any one of claims 1 to 3, wherein when the second shaft is positioned most distally relative to the first shaft, the second expansion portion is positioned distally of the first expansion portion.

5. The medical film delivery tool according to any one of claims 1 to 4, wherein the first expanded diameter section and the second expanded diameter section have mutually different maximum outer diameters when expanded.

6. The medical film delivery tool according to claim 5 , wherein the maximum outer diameter of the first expanded diameter portion when expanded is larger than the maximum outer diameter of the second expanded diameter portion when expanded.

7. A medical film delivery device as described in any one of claims 1 to 6, wherein when the second expansion portion is stored in the first inner cavity of the first shaft, the first expansion portion and the second expansion portion overlap in the longitudinal direction of the first shaft.

8. a third shaft having a third lumen, the first shaft being disposed in the third lumen; A medical film delivery device as described in any one of claims 1 to 7, wherein when the first expansion portion and the second expansion portion are stored in the third inner cavity of the third shaft, the second expansion portion is located distal to the first expansion portion in the longitudinal direction of the third shaft.

9. the first expanding portion is a balloon, The medical film delivery tool according to any one of claims 1 to 8, wherein the first shaft has a second lumen, and the second lumen communicates with the interior of the balloon.

10. The medical film delivery tool according to any one of claims 1 to 9, wherein the second expanding portion has a first element and a second element, and the first element and the second element each have a long portion.

11. The medical film delivery device according to claim 10, wherein when the first element and the second element are protruded from the first shaft, at least a portion of the first element is arranged away from the second element in the radial direction of the second shaft.

12. The medical film delivery tool according to claim 10 or 11, wherein when the first element and the second element are protruded from the first shaft, the first element and the second element have portions arranged parallel to each other.

13. The medical film delivery tool according to claim 12, wherein the first enlarged diameter section is a balloon having a straight tube section.

14. The medical film delivery tool according to any one of claims 1 to 9, wherein the second enlarged diameter portion is a loop wire.

15. The medical film delivery tool according to claim 14 , wherein the first enlarged diameter portion is a balloon having a spherical or ellipsoidal shape.

16. a medical film delivery device having a first shaft having a distal end and a proximal end in a longitudinal direction and having a first lumen, a second shaft disposed in the first lumen of the first shaft and movable in the longitudinal direction relative to the first shaft, a third shaft having a third lumen and the first shaft disposed in the third lumen, a first expanding portion disposed in a distal portion of the first shaft and expandable in diameter, and a second expanding portion disposed in a distal portion of the second shaft and expandable in diameter, the first expanding portion and the second expanding portion having different shapes when expanded in diameter; attaching the film to the second expanded diameter portion; and placing the second expanded diameter portion with the film attached in the third lumen of the third shaft.

Images