JP7644660B2 - Medical film delivery device and method for manufacturing medical device - Google Patents

Description

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.

In endoscopic surgery, a procedure is sometimes performed in which a film is placed and attached to an area where a diseased part has been removed from the body, for the purpose of promoting healing of the affected area, easing 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 surgical site. Patent Document 1 also discloses that the compression part is made of a balloon provided at 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 a balloon attached to the tip portion of the inner shaft in a single or multiple wraps.

Patent document 2 discloses a sheet insertion device. It discloses that a push-out 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.

Patent document 3 discloses a sheet insertion tool 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.

Patent document 4 discloses a system for delivering a sheet-like implant to a surgical site having a first deployment arm and a second deployment arm, each having a distal end and a proximal end.

JP 2011-147567 A JP 2013-116337 A JP 2020-36670 A Special Publication No. 2020-505183

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, the present invention aims to provide a medical film delivery tool and a method for manufacturing a medical tool that makes it easy to adhere the film to the treatment area inside the body.

One embodiment of the medical film delivery device of the present invention that has achieved the above object is 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 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 expanding portion disposed in the distal portion of the first shaft and capable of expanding, and a second expanding portion disposed in the distal portion of the second shaft and capable of expanding, the gist being that the first expanding portion and the second expanding portion have different shapes when expanded. According to the medical film delivery device of the present invention, since the first expanding portion and the second expanding portion have different shapes when expanded, it is possible for one of the first expanding portion and the second expanding 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, by deploying the film at the treatment portion using the second expanding portion and then pressing the film using the first expanding portion, it becomes easier to make the film adhere to the treatment portion.

In the medical film delivery tool, the second enlarged diameter portion may have a contact portion that contacts the film. The 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.

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

In the 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 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.

In the above medical film delivery device, 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 portion of the first element may be arranged so as to be separated from the second element in the radial direction of the second shaft.

In the above medical film delivery device, 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.

In the above medical film delivery device, the second enlarged diameter portion may be a loop wire. Also, the first enlarged diameter portion may be a balloon having a spherical or elliptical shape.

The present invention also provides a method for manufacturing a medical device. One embodiment of the method for manufacturing 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 expanded in diameter, and 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 manufacturing 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.

The medical film delivery device according to the present invention allows either the first or second expansion section to assist in spreading the film, while the other section presses the film. In addition, the medical device manufacturing method according to the present invention makes it easier for the film to be held by the second expansion section and the third shaft, preventing the film from falling off the third shaft during delivery.

FIG. 2 is a side view (partial cross-sectional view) of a medical film delivery tool according to one embodiment of the present invention. 2 is a cross-sectional end view of the medical film delivery device shown in FIG. 1 taken along line II-II. FIG. 3 is a cut-away end view showing a modified example of the medical film delivery tool shown in FIG. 2 . 2 is a side view (partially 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. 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 device shown in FIG. 1 and a first enlarged diameter portion protrudes from a third shaft. FIG. 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. 2 is an enlarged side view of a distal portion of the medical film delivery tool shown in FIG. 1. FIG. 8 is a side view showing a modified example of the distal portion of the medical film delivery tool shown in FIG. 7 . FIG. 8 is a side view showing another modified example of the distal portion of the medical film delivery tool shown in FIG. 7 . FIG. 13 is a side view (partially cross-sectional view) of a medical film delivery tool according to another embodiment of the present invention. FIG. 1 is a schematic diagram showing an example of a method for delivering a film for medical use. FIG. 1 is a schematic diagram showing an example of a method for delivering a film for medical use. FIG. 1 is a schematic diagram showing an example of a method for delivering a film for medical use.

The present invention will be described in more detail below based on the following embodiment, but the present invention is not limited to the following embodiment, and can of course be modified appropriately within the scope of the above and below, all of which 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, reference should be made to the specification or other drawings. Furthermore, the dimensions of various components in the drawings may differ from the actual dimensions, as priority is given to contributing to an understanding of the features of the present invention.

One embodiment of the medical film delivery tool of the present invention is a medical film delivery tool for delivering a medical film into the 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 expanding portion disposed in the distal portion of the first shaft and capable of expanding, and a second expanding portion disposed in the distal portion of the second shaft and capable of expanding, the gist being that the first expanding portion and the second expanding portion have different shapes when expanded. According to the medical film delivery tool of the present invention, since the first expanding portion and the second expanding portion have different shapes when expanded, it is possible for one of the first expanding portion and the second expanding 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 expanding portion to deploy the film at the treatment portion and then pressing the film using the first expanding portion.

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

Medical films are placed in treatment areas, such as areas where diseased areas have been removed from the body, for the purposes of promoting healing of affected areas, easing bleeding, and inhibiting adhesion of organs. Medical films also include those called sheets or membranes. Hereinafter, medical films may be simply called films. The shape of the film is not particularly limited, but can be rectangular, for example. The size of the film can be appropriately set according to the size of the treatment area. The film may be biodegradable or bioabsorbable.

In the present invention, medical devices include medical films and medical film delivery devices.

An example of the configuration of the delivery tool and the medical tool will be described with reference to Figures 1 to 13. Figure 1 is a side view (partial cross-sectional view) of a medical film delivery tool according to one embodiment of the present invention. Figure 2 is a cut end view of the medical film delivery tool shown in Figure 1 taken along line II-II. Figure 3 is a cut end view showing a modified example of the medical film delivery tool shown in Figure 2. Figure 4 is a side view (partial cross-sectional view) showing the second enlarged diameter portion stored in the third shaft of the medical film delivery tool shown in Figure 1. Figure 5 is a side view (partial cross-sectional view) showing the second enlarged diameter portion stored in the first shaft of the medical film delivery tool shown in Figure 1 and the first enlarged diameter portion protruding from the third shaft. Figure 6 is a side view (partial cross-sectional view) showing the second enlarged diameter portion stored in the third shaft and the first shaft of the medical film delivery tool shown in Figure 1. Figure 7 is an enlarged side view of the distal portion of the medical film delivery tool shown in Figure 1. Figures 8 to 9 are side views showing modified examples of the distal portion of the medical film delivery tool shown in Figure 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 method for delivering 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. Note that FIGS. 7 to 9 show the shape of the second enlarged diameter section 50 when protruding from the first shaft 10.

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 component 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 inside and outside of the delivery tool 5 refer to the inside and outside in the radial direction of the first shaft 10, and the inside 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 can also be referred to as the central axis extending in the longitudinal direction. The same applies in the following explanations.

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 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 portion 50 protrudes from the first shaft 10. As shown in FIG. 11, the second enlarged 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, as shown in FIG. 12, the second enlarged portion 50 is protruded from the third shaft 30 to expose the film 70, 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 firmness of the film 70. When the film 70 is temporarily placed in the treatment portion 80, the second enlarged portion 50 is positioned distal to the first enlarged portion 40 as shown in FIG. 13 or FIG. 1. If the first enlarged portion 40 is a balloon 42 as shown in FIG. 13, the balloon 42 is expanded. The expanded first enlarged 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 portion 40 in a state in which the second enlarged 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.

Next, each member constituting the delivery device 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 inner cavity 13. The second shaft 20 is disposed in the first inner cavity 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 inner cavity 14. The second inner cavity 14 functions as a flow path for a fluid to enlarge and reduce the first enlarged diameter portion 40. The first inner cavity 13 may extend distally beyond the second inner cavity 14.

1 and 2 show an example in which the first shaft 10 has a multi-lumen structure having multiple lumens, but this 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 making 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 positioned in a position close to the central axis of the longitudinal direction x of the first shaft 10. As a result, the second enlarged diameter portion 50 can also be easily positioned in a position close to the central axis of the longitudinal direction x.

The first shaft 10 has one or more openings for projecting the second enlarged 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.

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 its 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 with at least one of the inner and outer surfaces coated with resin; or a combination of these, for example, a combination of these connected in the longitudinal direction x. The resin tube can be manufactured, for example, by extrusion molding. Examples of hollow bodies in which wires are arranged in a predetermined pattern include a cylindrical body having a mesh structure formed by simply crossing or weaving wires, 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 circular shape, an oval shape, a polygonal shape, or a combination of these. The oblong shape includes an ellipse, an egg shape, and a rounded rectangular shape, and the same applies in the following description. The type of 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.

The first expansion section 40 is an expandable portion disposed at the distal portion of the first shaft 10. The first expansion section 40 expands radially outward of the first shaft 10. The expanded first expansion section 40 presses the film against the treatment area, thereby allowing the film to be tightly attached to the treatment area. It is preferable to expand the film all at once by inserting the first expansion section 40 into the 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.

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

The first expansion section 40 may be, for example, a balloon, a basket with multiple elastic wires, a stent, or a snare. Of these, it is preferable that the first expansion section 40 is a balloon 42 as shown in FIG. 1. This is because the balloon 42 is less likely to damage the biological wall when it comes into contact with it. By using the balloon 42 to press the film, it is possible to increase the adhesion of the film to the treatment area. Note that when a basket, stent, or snare is used, the wires that make up these can easily bite into the biological wall, allowing the film to be firmly attached.

When the first enlarged 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 is connected to 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 fluid into the inside of the balloon 42 through the second lumen 14. Also, the balloon 42 contracts by removing 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 fluid.

In Fig. 1 and Figs. 4 to 6, the distal end and 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.

The balloon 42 can be manufactured by molding a resin. Examples of resins that make up the balloon 42 include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, polyphenylene sulfide resins, fluorine resins, vinyl chloride resins, silicone resins, and natural rubber. These may be used alone or in combination of two or more types.

To improve the expansion performance and dimensional stability against expansion pressure, a reinforcing material may be arranged in the balloon 42. As the reinforcing material, for example, a fiber material may 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.

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 a compliant type, it becomes easier to flexibly press the film against an uneven or hard treatment area. If it is a non-compliant type, it is possible to assist in the expansion of the narrowed area, and the film can be pressed more firmly than with a compliant type.

The shape of the balloon 42 is not particularly limited, but it is preferable that the balloon 42 has a straight tube section 43 as shown in FIG. 1. In the straight tube section 43, the balloon 42 preferably has a cylindrical shape. The cylindrical shape of the balloon 42 makes it easier to press a wide area of the film at once, thereby shortening the procedure time. 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, truncated cone shapes. 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.

The balloon 42 may have a spherical or elliptical shape. Even if the treatment area has undulating or isthmic sections, the rounded shape of the balloon 42 makes it easier to press the film against the undulating or isthmic sections.

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 inner cavity 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 contracts in diameter, allowing the first enlarged diameter portion 40 to be smoothly stored in the third inner cavity 33.

When the first expansion section 40 is a loop wire, forceps, or basket, it can be made of, for example, a superelastic alloy such as a Ni-Ti alloy, or stainless steel such as SUS303, SUS304, or SUS316.

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.

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 arranged along the first shaft 10.

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 extend and retract the second enlarged diameter portion 50. Figures 1 and 2 show an example in which the second shaft 20 has a straight solid rod shape.

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; a hollow body in which at least one of the inner and outer surfaces is coated with resin; or a combination of these. For details on these configurations, please refer to the description of the first shaft 10.

The second shaft 20 is movable in the longitudinal direction x relative to the first shaft 10. This allows the second enlarged 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 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 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 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 portion 50 is positioned more proximally than the distal end of the first shaft 10.

The second shaft 20 may be rotatable relative to the first shaft 10. By rotating the second shaft 20, the orientation of the second expansion section 50 can be changed, making it easier to deploy the film, or allowing the second expansion section 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 around its longitudinal central axis by operating the first handle 71.

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 in 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 on the outside of 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 in the first shaft 10 by moving the first handle 71 proximally relative to the second handle 74.

The first handle 71 and the second handle 74 can each be made of one or more members. The first handle 71 and the second handle 74 can be made of synthetic resins such as polyolefin resin, polyester resin, polycarbonate resin, ABS resin, and polyurethane resin.

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

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 with multiple elastic wires. The second expanding portion 50 may also have a first element 61 and a second element 62. The configuration of the first element 61 and the second element 62 will be described later.

The second enlarged diameter portion 50 is preferably made of an elastically deformable material. This allows the second enlarged diameter portion 50 to expand 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.

The second expansion section 50 can be made of, for example, a superelastic alloy such as a Ni-Ti alloy, or stainless steel such as SUS303, SUS304, or SUS316.

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, for example, by crimping with a fastener such as a ring member, welding, melting, adhesive, or other methods.

As shown in FIG. 11, the second expansion section 50 preferably has a contact portion (hereinafter referred to as the first contact portion 51) that contacts the film 70. The contact of the first contact portion 51 holds the film 70 in place, thereby preventing the film 70 from falling off the distal side of the third shaft 30 during delivery of the film 70.

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 clamped 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 expansion 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 clamped between the two first contact portions 51.

As shown in FIG. 1, the delivery device 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.

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 within 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.

As shown in FIG. 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.

The third shaft 30 has one or more openings for projecting the first enlarged portion 40 and the second enlarged 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.

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

As shown in FIG. 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 in place, thereby preventing the film 70 from falling off the distal side of the third shaft 30 during delivery of the film 70.

It is preferable that the film 70 is held by the first contact portion 51 and the second contact portion 38, and it is more preferable that the film 70 is clamped. 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.

In the delivery tool 5, the first expanding section 40 and the second expanding section 50 have different shapes when expanded. This configuration allows at least one of the first expanding section 40 and the second expanding section 50 to perform the function of assisting in the deployment of the film, and at least the other to perform the function of pressing the film. For example, after the film is deployed at the treatment area using the second expanding section 50, the film can be pressed using the first expanding section 40, making it easier to adhere the film to the treatment area. Note that the first expanding section 40 may perform the function of assisting in the deployment of the film, and the second expanding section 50 may perform the function of pressing the film. Also, both the first expanding section 40 and the second expanding section 50 may perform the function of assisting in the deployment of the film.

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 diameter of each enlarged diameter section is 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 (overlap each other due to enlargement, reduction, translation, or rotation). 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 side view refers to the side view when the delivery tool 5 is oriented in the above-mentioned direction.

When the second expansion section 50 is protruded from the first shaft 10, it is preferable that the length of the second expansion section 50 is longer than the length of the first expansion section 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 expansion section 40 after the film is deployed with the second expansion section 50. Note that when the second expansion section 50 is protruded from the first shaft 10, the length of the first expansion section 40 may be longer than the length of the second expansion section 50 in the longitudinal direction x of the first shaft 10.

The 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 expanded or contracted by the introduction and removal of a fluid, like a balloon 42, and the second expansion section 50 may be made of an elastically deformable material. The second expansion section 50 may expand by protruding from the first shaft 10 and being released from the restriction of the first shaft 10, and contract by being stored within the first shaft 10.

In a side view of the delivery device 5, the maximum outer diameters of the first expansion section 40 and the second expansion section 50 when expanded may be the same, but as shown in FIG. 1, it is preferable that the maximum outer diameters of the first expansion section 40 and the second expansion section 50 when expanded are different from each other. This makes it easier for one of the two expansion sections to perform the function of assisting in expanding the film, and the other to perform the function of pressing the film.

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

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

As shown in FIG. 1, when the second shaft 20 is positioned most distally relative to the first shaft 10, the second enlarged portion 50 is preferably positioned distal to the first enlarged portion 40. By configuring the delivery device 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 enlarged portion 40 after the film is deployed with the second enlarged portion 50.

As shown in Figures 5 and 6, when the second enlarged diameter portion 50 is stored in the first lumen 13 of the first shaft 10, it is preferable that the first enlarged diameter portion 40 and the second enlarged diameter portion 50 overlap in the longitudinal direction of the first shaft 10. By arranging 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 storing 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.

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

When 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 stored 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 the portion of the third lumen 33 distal to the distal end of the first enlarged portion 40 as a space for storing the film. In addition, after the film is deployed in the second enlarged portion 50, the procedure of pressing the film against the treatment area with the first enlarged portion 40 becomes easier to perform smoothly.

The following describes the configuration of the second enlarged diameter section 50. As shown in Figures 1 and 4 to 9, it is preferable that the second enlarged diameter section 50 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 particular, it is preferable that the first element 61 and the second element 62 are arranged to extend distally from the distal end 21 of the second shaft 20.

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 wrap the film around the first element 61 and the second element 62. The first element 61 and the second element 62 may have a shape such as a line, a rod, a strip, a plate, an arm, or a combination of these. The shapes of the first element 61 and the second element 62 may be the same or different from each other.

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 that are arranged parallel to each other. The portions that are arranged parallel to each other make it easier to wrap the film around them, making it easier to attach the film. This also makes it possible to prevent the film from falling off during delivery.

The first element 61 and the second element 62 can be arranged to face each other in the radial direction of the second shaft 20. It is preferable that the film is sandwiched between the first element 61 and the second element 62. It is also preferable that the film is wrapped around at least one of the first element 61 and the second element 62.

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

As shown in FIG. 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 portion of the first element 61 is arranged so as 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 deploy the film near the treatment site. In addition, 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 so as to be separated from the distal end of the first element 61 in the radial direction of the second shaft 20.

As shown in Figures 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 unfold the film on the distal end side of each of the first element 61 and the second element 62.

It is preferable that at least one of the first element 61 and the second element 62 has a first contact portion 51. For example, the long portion of the first element 61 and the second element 62 may be the first contact portion 51. Also, the 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. The first section of the first element 61 and the second element 62, which will be described later, may be the first contact portion 51.

The first element 61 and the second element 62 may each have a first section that extends 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. By having each element have a first section, it becomes easier to wrap a film around each first section. In Figures 7 and 8, the first element 61 has a first section 611, and the second element 62 has a first section 621.

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, it becomes easier to position the distal end of the first element 61 and the distal end of the second element 62 so that they are separated in the radial direction when these elements are protruded from the first shaft 10. As a result, the film becomes easier to unfold 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.

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.

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. Providing a curved portion makes it easier to smoothly store the element 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. To facilitate storage in the first lumen 13, it is preferable that each element has only one bent portion or no bent portion.

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 stored 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 stored in the first inner cavity 13 of the first shaft 10, the first element 61 and the second element 62 may contact each other.

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.

In Figures 7 and 8, an example is shown in which a first element 61 and a second element 62 are provided as the second expansion section 50, but one or more further elements may be provided. For example, as shown in Figure 9, the second expansion section 50 may have a first element 61, a second element 62, and a third element 63. By having the third element 63 in this way, it becomes easier to hold the film, and therefore it becomes easier to expand the film widely.

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. For other configurations of the third element 63, please refer to the explanations of the first element 61 and the second element 62.

As shown in FIG. 10, the second enlarged portion 50 may be a loop wire 67. The loop wire 67 may be in any shape, such as a circle, an oval, or a polygon, as long as it is a closed loop. The loop shape can be changed by bending or curving the loop wire 67 midway, or by both.

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 while the loop wire 67 may have one or more curved portions, in order to facilitate storage in the first lumen 13, it is preferable that the loop wire 67 have only one curved portion or no curved portion.

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.

The method of connecting the loop wire 67 and the second shaft 20 can be seen in the method of connecting the first element 61, the second element 62, and the second shaft 20. Figure 10 shows an example in which the proximal end of the loop wire 67 and the distal end of the second shaft 20 are crimped and joined with a fastening ring 69.

As shown in FIG. 1, when the first enlarged diameter section 40 is a balloon 42 having a straight tube section 43, the second enlarged 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 a portion 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 enlarged diameter section 40 and the second enlarged diameter section 50 have a straight-lined portion, which makes it easier to place the film against the wall of an organ having a straight line shape, such as the esophagus.

As shown in FIG. 10, when the first expansion section 40 is a balloon 42 having a spherical or elliptical shape, it is preferable that the second expansion section 50 is a loop wire 67. By having the first expansion section 40 and the second expansion section 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.

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 enlarged diameter portion 50, and disposing the second enlarged diameter portion 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. The manufacturing method of the medical device 1 includes a step of placing the second enlarged portion 50 with the film 70 attached in the third lumen 33 of the third shaft 30, so that the film 70 is easily held by the second enlarged portion 50 and the third shaft 30, and therefore the film 70 can be prevented from falling off the third shaft 30 during delivery of the film 70.

The medical film 70 and medical film delivery device 5 can be used in any suitable combination of the above-mentioned configurations.

The method of attaching the film 70 to the second enlarged diameter section 50 is not particularly limited. For example, the film 70 may be clamped by the second enlarged diameter section 50, or the film 70 may be wrapped around the second enlarged diameter section 50. The film 70 may be rolled or folded.

In the process of placing the second enlarged 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 enlarged diameter portion 50 be placed in the third lumen 33 while protruding from the first shaft 10. This makes it easier for the film 70 to be held by the second enlarged diameter portion 50 and the third shaft 30.

1: Medical device 5: Medical film delivery device 10: First shaft 13: First lumen 14: Second lumen 20: Second shaft 30: Third shaft 33: Third lumen 40: First enlarged diameter portion 42: Balloon 50: Second enlarged diameter portion 61: First element 62: Second element 67: Loop wire 70: Film 80: Treatment section

Claims (16)

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. The medical film delivery tool according to claim 1, wherein the second expanding portion has a contact portion that contacts the film. 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. The medical film delivery device according to any one of claims 1 to 3, wherein when the second shaft is positioned most distally relative to the first shaft, the second expansion section is positioned distally of the first expansion section. The medical film delivery device according to any one of claims 1 to 4, wherein the first expanding section and the second expanding section have different maximum outer diameters when expanded. The medical film delivery device according to claim 5, wherein the maximum outer diameter of the first expanding portion when expanded is greater than the maximum outer diameter of the second expanding portion when expanded. The medical film delivery device according to any one of claims 1 to 6, wherein when the second enlarged diameter portion is housed in the first inner cavity of the first shaft, the first enlarged diameter portion and the second enlarged diameter portion overlap in the longitudinal direction of the first shaft. 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. 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. The medical film delivery tool according to any one of claims 1 to 9, wherein the second expanding section has a first element and a second element, and the first element and the second element each have a long portion. The medical film delivery tool 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 so as to be separated from the second element in the radial direction of the second shaft. The medical film delivery tool according to claim 10 or 11, wherein the first element and the second element have portions that are arranged parallel to each other when the first element and the second element are protruded from the first shaft. The medical film delivery device according to claim 12, wherein the first expanded diameter section is a balloon having a straight tube section. The medical film delivery device according to any one of claims 1 to 9, wherein the second expanding portion is a loop wire. The medical film delivery device according to claim 14, wherein the first expanding portion is a balloon having a spherical or elliptical shape. 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.

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