JP2022185719A - Medical film delivery tool and medical device manufacturing method - Google Patents

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 x, and a first lumen 13 and a second lumen 14; a second shaft 20 disposed in the first lumen 13, which can be moved in the longitudinal direction x with respect to the first shaft 10; a balloon 42 disposed at a distal part of the first shaft 10, whose inner part is communicated with the second lumen 14; and a first element 61 and a second element 62 disposed at a distal part of the second shaft 20.SELECTED DRAWING: Figure 1

Description

TECHNICAL FIELD The present invention relates to a surgical tool for delivering a medical film into the body using an endoscope and a method of manufacturing a medical device.

In endoscopic surgery, for the purpose of promoting healing of the affected area, alleviating bleeding, suppressing adhesion of organs, and the like, a technique of placing and attaching a film to a portion of the body where a lesion has been excised is sometimes performed. As an example of an instrument for performing such a procedure, Patent Literature 1 discloses an endoscopic surgical device having a pressing portion for pressing a sheet against a surgical site. Patent Literature 1 also discloses that the compressing portion is a balloon provided at a portion on the distal end side of the inner shaft. It is also disclosed that the sheet is wound or wrapped around the outer peripheral surface of the balloon mounted on the distal end portion of the inner shaft in a single roll or multiple rolls.

Patent Literature 2 discloses a sheet insertion device. Patent Document 2 discloses that an extrusion member for pushing out a sheet has a bifurcated sheet winding portion provided at the tip of a shaft, and that the sheet winding portion is separated from each other with a gap large enough to insert the sheet. It is disclosed to have two plates arranged facing each other.

Patent Document 3 discloses a sheet inserter having a sheet holding member and an outer cylinder member. The sheet holding member has at least a front end side formed by four bar-shaped members bundled together, and holds the sheet by sandwiching the sheet between the bar-shaped members.

US Pat. No. 5,400,003 discloses a system for delivering sheet-like implants to a surgical site having first and second deployment arms having distal and proximal ends, respectively.

JP 2011-147567 A JP 2013-116337 A Japanese Patent Application Laid-Open No. 2020-36670 Japanese Patent Publication No. 2020-505183

In the devices described in Patent Documents 1 to 4, the degree of adhesion of the film to body tissue is sometimes insufficient, and there is room for improvement in this respect. SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide a medical film delivery device and a method for manufacturing a medical device that facilitates the adhesion of a film to a treatment site in the body.

One embodiment of the medical film delivery device of the present invention, which has achieved the above object, is a medical film delivery device for delivering a medical film into the body, comprising a distal end and a proximal end in the longitudinal direction. a first shaft having an end and having a first lumen and a second lumen; and a second shaft disposed in the first lumen of the first shaft and longitudinally movable relative to the first shaft. a balloon disposed distally of the first shaft and internally communicating with the second lumen; and first and second elements disposed distally of the second shaft. has an gist. According to the medical film delivery device according to the present invention, after the film is spread in the treatment area using the first element and the second element, the film is pressed using the balloon, thereby making it easier to adhere the film to the treatment area. .

In the medical film delivery device, at least one of the first element and the second element may have a contact portion that contacts the film. Further, the medical film delivery device further has a third shaft having a third lumen and the first shaft is arranged in the third lumen, and the inner surface of the third shaft in the third lumen is: You may have a contact part which contacts a film.

In the above medical film delivery device, when the first element and the second element protrude from the first shaft, at least part of the first element is arranged away from the second element in the radial direction of the second shaft. may be Also, the first element and the second element may be positioned distally of the balloon when the second shaft is positioned most distally with respect to the first shaft.

In the above medical film delivery device, when the first element and the second element are housed in the first lumen of the first shaft, at least one of the first element and the second element contacts the inner surface of the first shaft. may The first element and the second element may contact each other when the first element and the second element are housed in the first lumen of the first shaft.

In the above medical film delivery device, when the first element and the second element are accommodated in the first lumen of the first shaft, at least one of the first element and the second element and the balloon in the longitudinal direction of the first shaft. may overlap.

When the medical film delivery device further comprises a third shaft having a third lumen and the first shaft being disposed in the third lumen, the first shaft is disposed in the third lumen of the third shaft. When the element, the second element, and the balloon are housed, the first element and the second element may be positioned distally from the balloon in the longitudinal direction of the third shaft.

In the above medical film delivery device, the first element and the second element may each have an elongated portion. The first element and the second element may each have a first section extending along the longitudinal direction of the second shaft when the first element and the second element protrude from the first shaft. good. At least one of the first element and the second element extends radially inward from the proximal end side toward the distal end side of the second shaft when the first element and the second element protrude from the first shaft. may have a second section extending outwardly from the .

In the medical film delivery device, the proximal end of the first element and the proximal end of the second element are fixed to each other, and the distal end of the first element and the distal end of the second element are They do not have to be fixed to each other.

The medical film delivery device may further comprise a handle connected to the proximal portion of the second shaft, wherein manipulation of the handle causes the second shaft to rotate about its central longitudinal axis.

In the above medical film delivery device, the second shaft may further have a third element disposed on its distal portion.

The present invention also provides a method of manufacturing a medical device. One embodiment of the method for manufacturing a medical device of the present invention includes a medical film, a first shaft having a distal end and a proximal end in the longitudinal direction and having a first lumen and a second lumen; a second shaft disposed in the first lumen of the first shaft and longitudinally movable relative to the first shaft; a third shaft having a third lumen and wherein said first shaft is disposed in said third lumen; A medical application having three shafts, a balloon disposed distally of a first shaft and internally communicating with a second lumen, a first element and a second element disposed distally of the second shaft providing a film delivery device; attaching the film to the first and second elements; and placing the first and second elements with the attached films in the third lumen of the third shaft. and Since the method of manufacturing the medical device according to the present invention includes the step of placing the first element and the second element with the film attached in the third lumen of the third shaft, the film is attached to the first element, the second element and the third element. 3 It becomes easy to be held by the shaft. As a result, it is possible to prevent the film from falling off from the third shaft during film delivery.

According to the medical film delivery device according to the present invention, after the film is spread in the treatment area using the first element and the second element, the film is pressed using the balloon, thereby making it easier to adhere the film to the treatment area. . Moreover, according to the manufacturing method of the medical device according to the present invention, the film is easily held by the first element, the second element and the third shaft. can be prevented.

1 is a side view (partial cross-sectional view) of a medical film delivery device according to one embodiment of the present invention. FIG. FIG. 2 is a cut end view of the medical film delivery device shown in FIG. 1 taken along line II-II. 3 is a cut end view showing a modified example of the medical film delivery device shown in FIG. 2. FIG. 2 is a side view (partial cross-sectional view) showing a state in which the first element and the second element are accommodated in the third shaft of the medical film delivery device shown in FIG. 1. FIG. 2 is a side view (partial cross-sectional view) showing a state in which the first element and the second element are housed in the first shaft of the medical film delivery device shown in FIG. 1, and the balloon is protruded from the third shaft. FIG. FIG. 3 is a side view (partial cross-sectional view) showing a state in which the first element and the second element are accommodated in the third shaft and the first shaft of the medical film delivery device shown in FIG. 1; 2 is an enlarged side view of the distal portion of the medical film delivery device shown in FIG. 1; FIG. FIG. 8 is a side view showing a modification of the distal portion of the medical film delivery device shown in FIG. 7; FIG. 8 is a side view showing another modification of the distal portion of the medical film delivery device shown in FIG. 7; BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic diagram showing an example of a delivery method for a medical film. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic diagram showing an example of a delivery method for a medical film. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic diagram showing an example of a delivery method for a medical film.

Hereinafter, the present invention will be described in more detail based on the following embodiments, but the present invention is not limited by the following embodiments, and can be modified appropriately within the scope of the above and later descriptions. It is of course possible to carry out in addition, and all of them are included in the technical scope of the present invention. In each drawing, for the sake of convenience, hatching, member numbers, etc. may be omitted. In such cases, the specification and other drawings shall be referred to. In addition, the dimensions of various members in the drawings may differ from the actual dimensions, since priority is given to helping to understand the features of the present invention.

One embodiment of the medical film delivery device of the present invention is a medical film delivery device for delivering a medical film into the body, the device having a longitudinal distal end and a proximal end, and a second end. a first shaft having one lumen and a second lumen; a second shaft disposed in the first lumen of the first shaft and longitudinally movable relative to the first shaft; The gist of the present invention is that it has a balloon disposed in a portion and internally communicating with a second lumen, and a first element and a second element disposed in a distal portion of the second shaft. According to the medical film delivery device according to the present invention, after the film is spread in the treatment area using the first element and the second element, the film is pressed using the balloon, thereby making it easier to adhere the film to the treatment area. .

A medical film delivery device is introduced into a body cavity via a treatment device insertion channel of an endoscope, and is used to deliver and retain a medical film inside the body. Hereinafter, the medical film delivery device may be simply referred to as a delivery device.

BACKGROUND ART Medical films are left in treatment sites such as resected lesions in the body for the purpose of promoting healing of affected areas, alleviating bleeding, suppressing adhesion of organs, and the like. Medical films also include what are referred to as sheets or films. The medical film may be simply referred to as a film below. Although the shape of the film is not particularly limited, it 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.

As used herein, medical devices include medical films and medical film delivery devices.

Configuration examples of the delivery device and the medical device will be described with reference to FIGS. 1 to 12. FIG. FIG. 1 is a side view (partial cross-sectional view) of a medical film delivery device according to one embodiment of the present invention. FIG. 2 is an end view of the medical film delivery device shown in FIG. 1 taken along line II-II. FIG. 3 is a cut end view showing a modified example of the medical film delivery device shown in FIG. 4 is a side view (partially cross-sectional view) showing a state in which the first element and the second element are accommodated in the third shaft of the medical film delivery device shown in FIG. 1. FIG. 5 is a side view (partial cross-sectional view) showing a state in which the first element and the second element are housed in the first shaft of the medical film delivery device shown in FIG. 1, and the balloon is projected from the third shaft. is. 6 is a side view (partial cross-sectional view) showing a state in which the first element and the second element are accommodated in the third shaft and the first shaft of the medical film delivery device shown in FIG. 1. FIG. 7 is an enlarged side view of the distal portion of the medical film delivery device shown in FIG. 1. FIG. 8 and 9 are side views showing modifications of the distal portion of the medical film delivery device shown in FIG. 10 to 12 are schematic diagrams showing an example of a delivery method for a medical film. The delivery device 5 has a first shaft 10 , a second shaft 20 , a balloon 42 , a first element 61 and a second element 62 . 7 to 9 show the shapes of the first element 61 and the second element 62 when projected from the first shaft 10. FIG.

The distal side of the delivery device 5 refers to the side of the first shaft 10 on the side of the distal end 11 in the longitudinal direction x and the side to be treated. The proximal side of the delivery device 5 refers to the proximal end 12 side of the first shaft 10 in the longitudinal direction x and the user's hand side. When each member is divided into two halves in its longitudinal direction, the proximal side may be called the proximal portion, and the distal side may be called the distal portion. The inner and outer sides of the delivery device 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 can also be rephrased as a central axis extending in the longitudinal direction. The same applies to the following description.

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, the balloon 42 is housed in the third lumen 33 as shown in FIG. Also, the second shaft 20 is inserted into the first shaft 10 , but the first element 61 and the second element 62 protrude from the first shaft 10 . A first element 61 and a second element 62 with a film 70 attached thereto as shown in FIG. In the state shown in FIG. 10, the delivery tool 5 is inserted through the endoscope to the vicinity of the treatment section 80 in the body. By an operation such as moving the third shaft 30 to the proximal side, as shown in FIG. Temporarily placed in the treatment section 80 . At this time, at least a portion of the film 70 may spontaneously unfold due to the stiffness and tension of the film 70 . After the film 70 is temporarily placed on the treatment section 80, the first element 61 and the second element 62 are positioned distally of the balloon 42 as shown in FIG. 12 or FIG. Balloon 42 is inflated as shown in FIG. The expanded balloon 42 is used to press the film 70 against the treatment area 80 . 12 or 1, the expanded balloon 42 is displaced with the first element 61 and the second element 62 housed in the first lumen 13 of the first shaft 10 as shown in FIG. may be used to press the film 70 against the treatment portion 80 . Next, as shown in FIG. 6, the first shaft 10 is housed in the third lumen 33 of the third shaft 30, and the entire delivery device 5 is moved proximally. This completes the delivery and placement of the film 70 to the treatment section 80 .

Next, each member constituting the delivery device 5 will be described. As shown in FIGS. 1 and 2, the first shaft 10 is an elongated 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 longitudinal direction x. Since the second shaft 20 is arranged inside the first shaft 10, the first shaft 10 preferably has, for example, a tubular shape, and more preferably has a tubular shape with both ends opened. First shaft 10 has a first lumen 13 and a second lumen 14 . A second shaft 20 is arranged in the first lumen 13 . The second lumen 14 functions as a fluid flow path for expanding and contracting the balloon 42 . The first lumen 13 may extend distally beyond the second lumen 14 .

1 and 2 show an example in which the first shaft 10 has a multi-lumen structure having a plurality of lumens, but it is not limited to this aspect. As shown in FIG. 3 , the first shaft 10 may have an outer shaft 101 having a longitudinal direction and an inner shaft 102 arranged in the lumen of the outer shaft 101 . Inner shaft 102 may extend from the distal end of outer shaft 101 . In that 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 multi-tube structure in this manner, the second shaft 20 accommodated in the first lumen 13 can be easily arranged at a position close to the central axis of the first shaft 10 in the longitudinal direction x. As a result, the first element 61 and the second element 62 also tend to be arranged at positions close to the central axis in the longitudinal direction x.

The first shaft 10 has one or more openings through which the first element 61 and the second element 62 protrude. In FIG. 1, the first shaft 10 has a distal opening 15 in its distal end face. First lumen 13 communicates with the outside of first shaft 10 through distal opening 15 .

The first shaft 10 preferably has flexibility. Thereby, the first shaft 10 can be deformed along the shape of the body cavity. For shape retention, the first shaft 10 preferably has elasticity. The first shaft 10 is preferably made of resin, metal, or a combination of resin and metal. The first shaft 10 may be a resin tube; a metal tube; a hollow body formed by arranging wires in a predetermined pattern; , such as those connected in the longitudinal direction x. A resin tube can be manufactured, for example, by extrusion molding. Hollow bodies in which wires are arranged in a predetermined pattern include tubular bodies having a mesh structure simply by crossing or weaving wires, and coils 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 circular, oval, polygonal, or a combination thereof, for example. The oval shape includes an elliptical shape, an oval shape, and a rounded rectangular shape, and the same applies to the following description. The type of network structure is not particularly limited, nor is the number of coil turns or density. The mesh structure or coils may be formed with a constant density over the entire lengthwise direction x of the first shaft 10, or may be formed with different densities depending on the positions in the lengthwise direction x of the first shaft 10. . In order to increase the flexibility of the metal tube, the outer surface of the metal tube may be cut or grooved. The shape of the incision or groove can be linear, arcuate, annular, spiral, or a combination thereof. When the first shaft 10 is a cylindrical resin tube, the first shaft 10 can be composed of a single layer or multiple layers, and part of the longitudinal direction x or the circumferential direction p is composed of a single layer, The other portion may be composed of multiple layers.

The balloon 42 is arranged at the distal portion of the first shaft 10 and the second lumen 14 of the first shaft 10 communicates with the inside of the balloon 42 . The introduction of fluid into the interior of the balloon 42 through the second lumen 14 expands the balloon 42 radially outwardly of the first shaft 10 . Also, removing the fluid from the interior of the balloon 42 causes the balloon 42 to deflate. By pressing the film with the expanded balloon 42, the film can be brought into close contact with the treatment site. It is preferable that the balloon 42 is inserted into the gap of the film delivered to the vicinity of the treatment area to expand the diameter thereof, thereby spreading the film at once and pressing the film against the treatment area. A fluid port 18 may be arranged in the proximal portion of the first shaft 10 for the introduction and removal of fluids.

1 and 4-6, the distal and proximal ends of balloon 42 are each secured to the outer surface of first shaft 10. In FIGS. Specifically, 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 first lumen 13 and the second lumen 14 of the first shaft 10 A proximal end of balloon 42 is secured to a section having a .

The balloon 42 can be manufactured by molding resin. Examples of the resin forming the balloon 42 include polyamide-based resins, polyester-based resins, polyurethane-based resins, polyolefin-based resins, polyphenylene sulfide-based resins, fluorine-based resins, vinyl chloride-based resins, silicone-based resins, and natural rubber. These may use only 1 type and may use 2 or more types together.

The balloon 42 may be provided with reinforcing material in order to improve its expansion performance and dimensional stability against expansion pressure. 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 fibrous materials may be monofilaments or multifilaments.

The balloon 42 may be of a compliant type in which the outer diameter changes according to the expansion pressure, or may be 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 predetermined expansion pressure. There may be. The compliant type makes it easier to press the film flexibly against uneven or hard treatment sites. With the non-compliant type, it is possible to assist dilation of the constricted part, and the film can be crimped more firmly than with the compliant type.

The shape of the balloon 42 is not particularly limited, but it may have a straight tube portion 43 as shown in FIG. In the straight tube portion 43, the balloon 42 preferably has a cylindrical shape. Since the balloon 42 has a cylindrical shape, it becomes easy to press a wide area of the film at once, so that the operation time can be shortened. In FIG. 1, straight tube section 43 is disposed between proximal taper section 44 and distal taper section 45 . Proximal taper 44 and distal taper 45 may be frusto-conical, for example. The straight tube portion 43 may be inclined according to the shape of the lesion as long as the angle of inclination is smaller than that of the proximal tapered portion 44 and the distal tapered portion 45 .

Balloon 42 may have a spherical or oblong spherical shape. Even if the treatment site has undulations or isthmus, the rounded shape of the balloon 42 makes it easier to press the film against the undulations or isthmus.

It is preferable that the balloon 42 can be accommodated within the third shaft 30, which will be described later. By housing in the third shaft 30, the balloon 42 can be prevented from coming into contact with places other than the treatment site. The maximum outer diameter of the balloon 42 when fully deflated is preferably less than the minimum inner diameter of the third lumen 33 of the third shaft 30 .

The second shaft 20 is an elongate 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 longitudinally. A second shaft 20 is arranged in the first lumen 13 of the first shaft 10 . The second shaft 20 functions as a pushing member for moving the first element 61 and the second element 62 forward and backward with respect to the first shaft 10 . The second shaft 20 can be constructed from 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 .

The second shaft 20 preferably has a solid shape. Since it becomes easy to impart rigidity to the second shaft 20, the first element 61 and the second element 62 can be easily protruded and retracted. FIGS. 1 and 2 show an example in which the second shaft 20 has a straight solid bar shape.

The second shaft 20 may have a hollow shape. The second shaft 20 is a resin tube; a metal tube; a hollow body formed by arranging wires in a predetermined pattern; It may be a combination. The description of the first shaft 10 can be referred to for these configurations.

The second shaft 20 is movable relative to the first shaft 10 in the longitudinal direction x. This allows the first element 61 and the second element 62 to protrude from the distal opening 15 of the first shaft 10 . Specifically, moving the second shaft 20 distally with respect to the first shaft 10 allows the first element 61 and the second element 62 to protrude from the distal side of the first shaft 10 . For example, when the second shaft 20 is positioned most distally with respect to the first shaft 10 , the proximal end of the first element 61 and the proximal end of the second element 62 are aligned with the distal end of the first shaft 10 . It is preferably positioned more distal than the . Also, when the second shaft 20 is moved proximally with respect to the first shaft 10 , the first element 61 and the second element 62 can be housed in the first lumen 13 . For example, when the second shaft 20 is positioned most proximally with respect to the first shaft 10 , the distal end of the first element 61 and the distal end of the second element 62 are aligned with the distal end of the first shaft 10 . It is preferably positioned more proximal than the .

The second shaft 20 may be rotatable with respect to the first shaft 10 . By rotating the second shaft 20, the directions of the first element 61 and the second element 62 can be changed, so that the film can be easily developed, or the first element 61 and the second element 62 can reach the treatment site. You can press the film. For example, the delivery device 5 preferably further comprises a handle connected to the proximal portion of the second shaft 20 such that manipulation of the handle causes the second shaft 20 to rotate about its central longitudinal axis. .

The configuration for changing the positions of the first element 61 and the second element 62 in the longitudinal direction x with respect to the first shaft 10 is not particularly limited. For example, in FIG. 1 a first handle 71 is connected to the proximal portion of the second shaft 20 . The first handle 71 has a tubular portion 72 in which a connecting portion 73 is arranged. A proximal portion of the first shaft 10 is connected to a second handle 74 having a tubular 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 tubular portion 75 of the second handle 74 . A 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 . By moving the first handle 71 distally with respect to the second handle 74 , the first element 61 and the second element 62 can be protruded from the first shaft 10 . By moving the first handle 71 proximally with respect to the second handle 74 , the first element 61 and the second element 62 can be retracted within the first shaft 10 .

The first handle 71 and the second handle 74 can each be constructed from one or more members. Synthetic resins such as polyolefin resins, polyester resins, polycarbonate resins, ABS resins, polyurethane resins, and the like can be used as materials for forming the first handle 71 and the second handle 74, for example.

As shown in FIG. 1, the first element 61 and the second element 62 are arranged on the distal portion of the second shaft 20 . The first element 61 and the second element 62 are used as triggers for expanding the film near the treatment area. According to the delivery device 5 , after the film is spread at the treatment site using the first element 61 and the second element 62 , the film is pressed using the balloon 42 , making it easier to adhere the film to the treatment site. Note that the first element 61 and the second element 62 may be used for pressing the film.

A first element 61 and a second element 62 can be connected to the distal end of the second shaft 20 . Specifically, the first element 61 and the second element 62 are preferably arranged to extend distally from the distal end 21 of the second shaft 20 .

The first element 61 and the second element 62 may be integrally molded with the second shaft 20, or may be formed from separate members and connected to each other. The first element 61, the second element 62, and the second shaft 20 may be directly connected, or may be connected via another member. The first element 61 and the second element 62 may be fixed to the distal end of the second shaft 20 by welding, welding, gluing, or the like. The proximal end of the first element 61, the proximal end of the second element 62, and the distal end of the second shaft 20 are connected to each other by crimping them with fasteners such as ring members. may

Preferably, the first element 61 and the second element 62 each have an elongated portion. This makes it easier to wind the 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, band-like, plate-like, arm-like, or a combination of these shapes. The shapes of the first element 61 and the second element 62 may be the same or different.

When the first element 61 and the second element 62 protrude from the first shaft 10, the first element 61 and the second element 62 preferably have portions arranged parallel to each other. Since it is easy to wind the film around the portions arranged parallel to each other, the operation of attaching the film is facilitated. It can also prevent the film from falling off during delivery.

The first element 61 and the second element 62 can be arranged so as to face each other in the radial direction of the second shaft 20 . It is preferable to sandwich the film between the first element 61 and the second element 62 . It is also preferred that the film is wrapped around the first element 61 and the second element 62 .

The shapes of the first element 61 and the second element 62 may be line-symmetrical with respect to the central axis c in the longitudinal direction of the second shaft 20 as shown in FIG. It may be asymmetric as shown in 7. Here, the side view of the delivery device 5 means the direction in which the radial distance between the first element 61 and the second element 62 is maximized when the first element 61 and the second element 62 protrude from the first shaft 10. It is a side view when the delivery device 5 is directed to the . In addition, when the delivery device 5 has the third shaft 30, the above-described side view is a state in which the first element 61 and the second element 62 are also projected from the third shaft 30 as shown in FIG. is a side view of

As shown in FIG. 1 , when the first element 61 and the second element 62 are projected from the first shaft 10 , at least a portion of the first element 61 extends from the second element 62 in the radial direction of the second shaft 20 . They are preferably spaced apart. By configuring the first element 61 and the second element 62 in this way, it becomes easier to spread the film near the treatment area. In addition, when the first element 61 and the second element 62 are projected from the first shaft 10 , the distal end of the second element 62 and the distal end of the first element 61 are located in the radial direction of the second shaft 20 . They are preferably spaced apart.

As shown in FIGS. 7-9, the proximal end of the first element 61 and the proximal end of the second element 62 are fixed together and the distal end of the first element 61 and the second element 62 are fixed together. The distal ends of the are preferably not fixed to each other. This configuration makes it easier to deploy the film on the distal end sides of the first element 61 and the second element 62 .

As shown in FIG. 10, at least one of the first element 61 and the second element 62 preferably has a contact portion (hereinafter referred to as a first contact portion) that contacts the film 70 . Since the film 70 is pressed by the contact of the first contact portion, it is possible to prevent the film 70 from falling off from the distal side of the third shaft 30 during delivery of the film 70 .

Preferably, the first contact portion holds the film 70 . The specific mode of holding is not particularly limited, and the film 70 may be sandwiched between the first contact portion and a second contact portion described later, the film may be wound around the first contact portion, or both may be used. may be retained. When the first element 61 and the second element 62 each have a first contact portion, the film 70 may be sandwiched between the two first contact portions.

A long portion of the first element 61 and the second element 62 may be the first contact portion. Of the first element 61 and the second element 62, a first section, which will be described later, may be the first contact portion. Also, the portion where the first element 61 and the second element 62 are arranged parallel to each other when the first element 61 and the second element 62 are projected from the first shaft 10 may be the first contact portion. . Of the first element 61 and the second element 62, a first section, which will be described later, may be the first contact portion. FIG. 10 shows an example in which the first element 61 has the first contact portion 64 and the second element 62 has the first contact portion 65 .

The first element 61 and the second element 62 form a first section extending along the longitudinal direction of the second shaft 20 when the first element 61 and the second element 62 are projected from the first shaft 10. It is preferable to have each. Each element having a first section facilitates wrapping the film around each first section. 7-8, the first element 61 has a first section 611 and the second element 62 has a first section 621. In FIGS.

At least one of the first element 61 and the second element 62 projects from the proximal end 22 side of the second shaft 20 to the distal end 21 when the first element 61 and the second element 62 protrude from the first shaft 10 . It preferably has a second section extending radially from the inner side to the outer side. By providing such a second section, when these elements are projected from the first shaft 10, the distal end of the first element 61 and the distal end of the second element 62 are radially separated from each other. Easier to position. As a result, the expansion of the first element 61 and the second element 62 facilitates the expansion of the film. FIG. 7 shows an example in which the second element 62 has a 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 arranged distally relative to the second section, and the first section is adjacent to the second section and distal to the first section. It is more preferable to be arranged on the side. Thereby, when the first element 61 and the second element 62 are protruded from the first shaft 10, the first element 61 and the second element 62 are arranged so as to be separated from each other on the side near the distal end of the delivery device 5. be able to. In addition, in the first element 61 or the second element 62, the first section may be arranged closer to the proximal side than the second section.

In the first element 61 and the second element 62, the shape of the element can be changed by bending or curving the middle of the element, or by performing 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 portion, it becomes easier to smoothly accommodate 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 bent portions. Preferably, each element has only one bend, or no bends, to facilitate insertion into the first lumen 13 .

It is preferable that the first element 61 and the second element 62 have elasticity to the extent that they can be expanded when projected from the first shaft 10 . On the other hand, when the first element 61 and the second element 62 are accommodated in the first lumen 13 of the first shaft 10, at least one of the first element 61 and the second element 62 contacts the inner surface of the first shaft 10. You may Further, when the first element 61 and the second element 62 are accommodated in the first lumen 13 of the first shaft 10, the first element 61 and the second element 62 may contact each other.

As the constituent materials of the first element 61 and the second element 62, those mentioned in the description of the second shaft 20 can be used. The constituent materials of the first element 61 and the second element 62 may be the same or different. The constituent material 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.

As shown in FIG. 1, when the second shaft 20 is positioned most distally with respect to the first shaft 10, the first element 61 and the second element 62 are positioned distally relative to the balloon 42. is preferred. By configuring the delivery device 5 so as to be arranged in this order, it is easy to smoothly perform the procedure of pressing the film against the treatment site with the balloon 42 after the film is expanded by the first element 61 and the second element 62. Become.

As shown in FIGS. 5 and 6, when the first element 61 and the second element 62 are accommodated in the first lumen 13 of the first shaft 10, the first element 61 and the first element 61 are arranged in the longitudinal direction x of the first shaft 10. At least one of the second elements 62 and the balloon 42 preferably overlap. At least one of the first element 61 and the second element 62 is arranged on the side near the distal end 11 of the first shaft 10 to close the distal side of the first lumen 13 of the first shaft 10. can be done. As a result, body fluids and foreign substances are less likely to enter the first shaft 10 through the distal opening 15 of the first shaft 10 . Also, when the film is crimped by the balloon 42, since the first element 61 and the second element 62 are housed in the first shaft 10 when operating the first shaft 10, body tissue may be inadvertently damaged. Risk can be reduced. In particular, it is possible to smoothly remove the delivery device 5 from the body after the film is left in place.

When the first element 61 and the second element 62 are housed in the first lumen 13 of the first shaft 10 , the distal end of the first element 61 and the distal end of the second element 62 are positioned proximally of the balloon 42 . It may be located proximal to the end.

When the first element 61 and the second element 62 protrude from the first shaft 10, the longer side of the first element 61 and the second element 62 than the balloon 42 in the longitudinal direction x of the first shaft 10 longer is preferred. After the film is developed by the first element 61 and the second element 62, the procedure of pressing the film against the treatment site with the balloon 42 can be performed smoothly. Note that when the first element 61 and the second element 62 protrude from the first shaft 10, the length of the balloon 42 in the longitudinal direction x of the first shaft 10 is longer than the length of the first element 61 and the second element 62. can be longer.

In a side view of the delivery device 5 , the maximum outer diameter of the balloon 42 when expanded is preferably larger than the maximum radial distance between the first element 61 and the second element 62 . As a result, the balloon 42 can easily press a wide area of the film all at once, so that the procedure time can be shortened.

In a side view of the delivery device 5 , the maximum outer diameter of the balloon 42 when expanded may be smaller than the maximum radial distance between the first element 61 and the second element 62 . While the first element 61 and the second element 62 widen the film, the small balloons 42 make it easier to selectively press the film for each part.

7 and 8 show examples in which the first element 61 and the second element 62 are provided, one or more elements may be provided. For example, as shown in FIG. 9, delivery device 5 may further include a third element 63 disposed distally of second shaft 20 . By having the third element 63 in this way, it becomes easier to hold the film, so that it becomes easier to expand the film.

When the first element 61 , the second element 62 and the third element 63 protrude from the first shaft 10 , at least part of the first element 61 extends in the radial direction of the second shaft 20 to the second element 62 and the third element 63 . Preferably, they are arranged so as to be separated from the element 63 respectively. For other configurations of the third element 63, the description of the first element 61 and the second element 62 can be referred to.

The delivery device 5 may further have a third shaft 30, as shown in FIG. The third shaft 30 has a third lumen 33 and the first shaft 10 is arranged in the third lumen 33 . The third shaft 30 is a member for housing the first shaft 10, the second shaft 20, the balloon 42, the first element 61 and the second element 62 during delivery of the film into the body. The third shaft 30 makes it difficult for the balloon 42, the first element 61 and the second element 62 to come into contact with places other than the treatment site during delivery of the film.

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 longitudinally. 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 tubular shape, and more preferably has a tubular shape with both ends opened.

As shown in FIG. 10, it is preferable that the third lumen 33 can accommodate the first element 61 and the second element 62 to which the film 70 is attached. The film 70 can be delivered to the treatment site while being held by the first element 61 , the second element 62 and the third shaft 30 .

The third shaft 30 has one or more openings through which the balloon 42, the first element 61 and the second element 62 protrude. For example, in FIG. 1, the third shaft 30 has a distal opening 35 in its distal end face. The third lumen 33 communicates with the outside of the third shaft 30 at least through the distal opening 35 .

The third shaft 30 is a resin tube; a metal tube; a hollow body formed by arranging wires in a predetermined pattern; It may be a combination. The description of the first shaft 10 can be referred to for these configurations.

As shown in FIG. 10 , the inner surface of the third shaft 30 in the third lumen 33 preferably has a contact portion that contacts the film 70 (hereinafter referred to as a second contact portion 38 ). Since the film 70 is pressed by the second contact portion 38 coming into contact with the film, it is possible to prevent the film 70 from falling off from the distal side of the third shaft 30 during delivery of the film 70 .

The film 70 is preferably held between the first contact portion and the second contact portion 38, and more preferably sandwiched. The contact of the film 70 with the first contact portion 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 .

If the delivery device 5 has a third shaft 30 with a third lumen 33 and the first shaft 10 is disposed in the third lumen 33, as shown in FIG. When the first element 61, the second element 62, and the balloon 42 are housed in the third lumen 33 of the third shaft 30, the first element 61 and the second element 62 are positioned distally of the balloon 42 in the longitudinal direction of the third shaft 30. is preferably located in By configuring the delivery device 5 so as to be arranged in this order, the portion of the third lumen 33 on the distal side of the distal end of the balloon 42 is secured widely as a space for storing the film. easier to do. In addition, after the film is expanded by the first element 61 and the second element 62, the procedure of pressing the film against the treatment site with the balloon 42 can be performed smoothly.

The invention also provides a method of manufacturing a medical device. A method for manufacturing a medical device 1 according to an embodiment of the present invention includes a step of preparing a medical film 70 and a medical film delivery device 5, and a step of attaching the film 70 to the first element 61 and the second element 62. and placing the first element 61 and the second element 62 with the film 70 attached thereto as shown in FIG. As shown in FIG. 1, the medical film delivery device 5 includes 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 and a second lumen 14. , a second shaft 20 disposed in the first lumen 13 of the first shaft 10 and movable in the longitudinal direction x with respect to the first shaft 10; A third shaft 30 arranged in a lumen 33, a balloon 42 arranged in a distal portion of the first shaft 10 and internally communicating with the second lumen 14, and a distal portion of the second shaft 20. It has a first element 61 and a second element 62 that are arranged in a row. Since the manufacturing method of the medical device 1 includes a step of arranging the first element 61 and the second element 62 with the film 70 attached thereto in the third lumen 33 of the third shaft 30, the film 70 is Since it is easily held by the second element 62 and the third shaft 30, it is possible to prevent the film 70 from falling off the third shaft 30 while the film 70 is being delivered.

For the medical film 70 and the medical film delivery device 5, the configurations described above can be appropriately combined and employed.

The method of attaching the film 70 to the first element 61 and the second element 62 is not particularly limited. At least one of 62 may be wrapped with film 70 . The film 70 may be rolled or folded.

In the step of disposing the first element 61 and the second element 62 to which the film 70 is attached in the third lumen 33 of the third shaft 30 , the first element 61 and the second element 62 protrude from the first shaft 10 . is preferably located in the third lumen 33 . This makes it easier for the film 70 to be held by the first element 61 , the second element 62 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 42: balloon 61: third 1 element 611: first section 612: second section 62: second element 621: first section 622: second section 63: third element 70: film 80: treatment section

Claims (16)

A medical film delivery device for delivering a medical film into the body,
a first shaft having longitudinal distal and proximal ends and having first and second lumens;
a second shaft disposed in the first lumen of the first shaft and movable in the longitudinal direction relative to the first shaft;
a balloon disposed distally of the first shaft and internally communicating with the second lumen;
A medical film delivery device having a first element and a second element disposed distally of the second shaft. 2. The medical film delivery device according to claim 1, wherein at least one of said first element and said second element has a contact portion that contacts said film. further comprising a third shaft having a third lumen, wherein the first shaft is disposed in the third lumen;
The medical film delivery device according to claim 1 or 2, wherein the inner surface of the third shaft in the third lumen has a contact portion that contacts the film. At least part of the first element is arranged to be separated from the second element in a radial direction of the second shaft when the first element and the second element are projected from the first shaft. The medical film delivery device according to any one of items 1 to 3. 5. The first element and the second element according to any one of claims 1 to 4, wherein the first element and the second element are positioned distally relative to the balloon when the second shaft is positioned most distally with respect to the first shaft. or the medical film delivery device according to claim 1. At least one of the first element and the second element contacts the inner surface of the first shaft when the first element and the second element are accommodated in the first lumen of the first shaft. Item 6. The medical film delivery device according to any one of items 1 to 5. 7. The first element and the second element are in contact with each other when the first element and the second element are accommodated in the first lumen of the first shaft. A medical film delivery device as described. When the first element and the second element are accommodated in the first lumen of the first shaft, at least one of the first element and the second element and the balloon are arranged in the longitudinal direction of the first shaft. The medical film delivery device according to any one of claims 1 to 7, which overlaps with. further comprising a third shaft having a third lumen, wherein the first shaft is disposed in the third lumen;
When the first element, the second element, and the balloon are accommodated in the third lumen of the third shaft, the first element and the second element are arranged in the longitudinal direction of the third shaft from the balloon. 9. The medical film delivery device according to any one of claims 1 to 8, wherein the is also located on the distal side. The medical film delivery device according to any one of claims 1 to 9, wherein each of said first element and said second element has an elongated portion. The first element and the second element have a first section extending along the longitudinal direction of the second shaft when the first element and the second element protrude from the first shaft. The medical film delivery device according to any one of claims 1 to 10, respectively. At least one of the first element and the second element extends from the proximal end side to the distal end side of the second shaft when the first element and the second element protrude from the first shaft. The medical film delivery device according to any one of claims 1 to 11, having a second section extending radially from the inside to the outside. the proximal end of the first element and the proximal end of the second element are fixed together;
The medical film delivery device according to any one of claims 1 to 12, wherein the distal end of the first element and the distal end of the second element are not fixed to each other. further comprising a handle connected to the proximal portion of the second shaft;
The medical film delivery device according to any one of claims 1 to 13, wherein the second shaft rotates about its longitudinal central axis by operating the handle. The medical film delivery device according to any one of claims 1 to 14, wherein said second shaft further comprises a third element arranged at its distal portion. a medical film; a first shaft having longitudinal distal and proximal ends and having a first lumen and a second lumen; a second shaft longitudinally moveable relative to the first shaft, a third shaft having a third lumen and wherein the first shaft is disposed in the third lumen, distal to the first shaft a medical film delivery device having a first element and a second element disposed at a distal portion of the second shaft; and
attaching the film to the first element and the second element;
placing said first element and said second element with said film attached in said third lumen of said third shaft.

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