JP7715537B2 - 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 of the body where a lesion has been removed, with the aim of promoting healing of the affected area, mitigating bleeding, and preventing organ adhesions. As an example of an instrument for performing such a procedure, Patent Document 1 discloses a sheet insertion device. Patent Document 1 discloses that an extrusion member for pushing out the sheet has a bifurcated sheet winding section attached to the tip of the shaft, and that the sheet winding section has two plate sections arranged opposite each other with a gap large enough to insert the sheet.

Patent Document 2 discloses a sheet inserter having a sheet holding member and an outer tube member. The sheet holding member is formed at least at its tip end by four rod-shaped members bundled together, and holds the sheet by sandwiching it between the rod-shaped members.

Patent document 3 discloses a system for delivering a sheet-like implant to a surgical site, which includes a first deployment arm and a second deployment arm, each having a distal end and a proximal end.

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

The devices described in Patent Documents 1 to 3 leave room for improvement in terms of achieving both ease of film deployment and operational efficiency of the device after deployment. Therefore, the present invention aims to provide a medical film delivery device and a method for manufacturing the medical device that facilitates deployment of the film at the treatment site inside the body and facilitates retraction of the tip of the delivery device.

One embodiment of the medical film delivery device of the present invention that achieves the above-mentioned object is a medical film delivery device 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 longitudinally relative to the first shaft; and a first element and a second element disposed in the distal portion of the second shaft, wherein when the first element and the second element are protruded from the first shaft, the distal end of the second element is located farther from the longitudinal central axis of the second shaft in the radial direction of the second shaft than the distal end of the first element. In the medical film delivery device of the present invention, the first element and the second element are positioned as described above when protruded from the first shaft, making it easier to significantly deploy the film by at least the distal ends of the first and second elements, and also reducing retraction resistance when the first element and the second element are retracted into the first lumen.

In the above-mentioned medical film delivery device, at least one of the first element and the second element may have a contact portion that contacts the film. The above-mentioned medical film delivery device may also 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 in the third lumen may have a contact portion that contacts the film.

In the above-mentioned medical film delivery device, the first element and the second element may each have a long portion. In the above-mentioned medical film delivery device, the first element and the second element may each have a first section that extends along the longitudinal direction of the second shaft when the first element and the second element are protruded from the first shaft.

In the above-mentioned medical film delivery device, when the first element and the second element are protruded from the first shaft, the first section of the second element may be located farther from the central axis in the radial direction of the second shaft than the first section of the first element.

In the above-mentioned medical film delivery device, when the first element and the second element are protruded from the first shaft, the first section of the first element may extend on an extension of the central axis.

In the above-mentioned medical film delivery device, when the first element and the second element are protruded from the first shaft, the first section of the first element and the first section of the second element may each be located away from the central axis in the radial direction of the second shaft.

In the above-mentioned medical film delivery device, at least one of the first element and the second element may have a second section that extends radially from the inner side to the outer side from the proximal end to the distal end of the second shaft when the first element and the second element are protruded from the first shaft.

In the above-mentioned medical film delivery device, the second element may have a second section, and when the first element and the second element are protruded from the first shaft, the first section of the second element may be longer than the second section of the second element in the longitudinal direction of the second shaft.

In the above-mentioned medical film delivery device, when the first element and the second element protrude from the first shaft, the first element and the second element may have an asymmetric shape with respect to the central axis.

In the above-mentioned medical film delivery device, the proximal end of the first element and the proximal end of the second element may be fixed to each other, and the distal end of the first element and the distal end of the second element may not be fixed to each other.

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

The medical film delivery device may further include a first shaft having a second lumen and a balloon disposed at the distal portion of the first shaft, the interior of which is in communication with the second lumen.

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 is characterized by the steps of preparing a medical film and a medical film delivery device having: a first shaft having distal and proximal ends in the longitudinal direction and a first lumen; a second shaft disposed in the first lumen of the first shaft and movable longitudinally relative to the first shaft; a third shaft having a third lumen, the first shaft disposed in the third lumen; and a first element and a second element disposed in a distal portion of the second shaft, wherein, when the first element and the second element are protruded from the first shaft, the distal end of the second element is located farther from the longitudinal central axis of the second shaft than the distal end of the first element in the radial direction of the second shaft; attaching the film to the first element and the second element; and placing the first element and the second element with the attached film in the third lumen of the third shaft. The method for manufacturing a medical device according to the present invention includes a step of placing the first and second elements, each having a film attached thereto, in the third lumen of the third shaft, which makes it easier for the film to be held by the first and second elements 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 of the present invention makes it easier to deploy the film widely using at least the distal ends of the first and second elements, and also reduces retraction resistance when the first and second elements are retracted into the first lumen. Furthermore, the medical device manufacturing method of the present invention makes it easier for the film to be held by the first and second elements and the third shaft, preventing the film from falling off the third shaft during delivery.

1 is a side view (partial cross-sectional view) of a medical film delivery tool according to one embodiment of the present invention. FIG. 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 cross-sectional end view showing a modified example of the medical film delivery device shown in FIG. 2. 1. FIG. 4 is a side view (partial cross-sectional view) showing a state in which a first element and a second element are housed in a third shaft of the medical film delivery device shown in FIG. 2 is a side view (partial cross-sectional view) showing the 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 protruding from the third shaft. FIG. 1. FIG. 4 is a side view (partial cross-sectional view) showing a state in which the first element and the second element are housed in the third shaft and the first shaft of the medical film delivery device shown in FIG. FIG. 2 is an enlarged side view of the distal portion of the medical film delivery device 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. 1 is a schematic diagram showing an example of a method for delivering a medical film. FIG. 1 is a schematic diagram showing an example of a method for delivering a medical film. FIG. 1 is a schematic diagram showing an example of a method for delivering a medical film.

The present invention will be described in more detail below based on the following embodiments. However, the present invention is not limited to the following embodiments, and can of course be implemented with appropriate modifications within the scope of the spirit described above and below, all of which are within the technical scope of the present invention. For convenience, hatching and component symbols may be omitted in the drawings. In such cases, please refer to the specification or other drawings. The dimensions of various components in the drawings may differ from their actual dimensions, as priority is given to aiding understanding of 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, 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 longitudinally relative to the first shaft; and a first element and a second element disposed in the distal portion of the second shaft. When the first element and the second element are protruded from the first shaft, the distal end of the second element is located farther from the longitudinal central axis of the second shaft in the radial direction of the second shaft than the distal end of the first element. In the medical film delivery device of the present invention, the first element and the second element are positioned as described above when protruded from the first shaft, making it easier to significantly deploy the film by at least the distal ends of the first and second elements, and also reducing retraction resistance when the first element and the second element are retracted into the first lumen.

A medical film delivery device 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 device may be simply referred to as the delivery device.

Medical films are placed in treatment areas, such as areas where a lesion has been removed from the body, for purposes such as promoting healing of the affected area, easing bleeding, and preventing organ adhesions. Medical films also include those known as sheets or membranes. Hereinafter, medical films may be simply referred to as 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 to match the size of the treatment area. The film may be biodegradable or bioabsorbable.

In this specification, medical devices include medical films and medical film delivery devices.

Examples of the configuration of delivery instruments and medical instruments will be described with reference to Figures 1 to 11. Figure 1 is a side view (partially cross-sectional) of a medical film delivery instrument according to one embodiment of the present invention. Figure 2 is a cross-sectional end view of the medical film delivery instrument shown in Figure 1 taken along line II-II. Figure 3 is a cross-sectional end view showing a modified example of the medical film delivery instrument shown in Figure 2. Figure 4 is a side view (partially cross-sectional) showing the first and second elements housed in the third shaft of the medical film delivery instrument shown in Figure 1. Figure 5 is a side view (partially cross-sectional) showing the first and second elements housed in the first shaft of the medical film delivery instrument shown in Figure 1, with a balloon protruding from the third shaft. Figure 6 is a side view (partially cross-sectional) showing the first and second elements housed in the third and first shafts of the medical film delivery instrument shown in Figure 1. Figure 7 is an enlarged side view of the distal portion of the medical film delivery instrument shown in Figure 1. Figure 8 is a side view showing a modified example of the distal portion of the medical film delivery instrument shown in Figure 7. Figures 9 to 11 are schematic diagrams showing an example of a method for delivering 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. Figures 7 and 8 show the shapes of the first element 61 and the second element 62 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's hand. When each component is divided into two equal halves in the longitudinal direction, the proximal side is sometimes referred to as the proximal portion, and the distal side is sometimes 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. 9, the balloon 42 is housed in the third lumen 33. The second shaft 20 is inserted into the first shaft 10, with the first element 61 and the second element 62 protruding from the first shaft 10. As shown in FIG. 9, the first element 61 and the second element 62, to which the film 70 is attached, are disposed in the third lumen 33 of the third shaft 30. In the state shown in FIG. 9, the delivery device 5 is inserted via the endoscope to the vicinity of the treatment site 80 inside the body. By moving the third shaft 30 proximally, the first element 61 and the second element 62 protrude from the third shaft 30, exposing the film 70 as shown in FIG. 10, and the film 70 is temporarily placed at the treatment site 80. At this time, at least a portion of the film 70 may unfold spontaneously due to the stiffness and tautness of the film 70. Once the film 70 is temporarily placed in the treatment portion 80, the first element 61 and the second element 62 are positioned distal to the balloon 42, as shown in FIG. 11 or FIG. 1. The balloon 42 is expanded as shown in FIG. 11. The expanded balloon 42 is used to press the film 70 against the treatment portion 80. Alternatively, instead of the state shown in FIG. 11 or FIG. 1, the first element 61 and the second element 62 may be housed in the first lumen 13 of the first shaft 10, as shown in FIG. 5, and the expanded balloon 42 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 tool 5 is moved proximally. This completes the delivery and placement of the film 70 in the treatment portion 80.

Next, the components that make up the delivery device 5 will be described. As shown in Figures 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 the longitudinal direction x. Because the second shaft 20 is disposed within the first shaft 10, the first shaft 10 preferably has a cylindrical shape, more preferably a cylindrical shape with both ends open. The first shaft 10 has at least a first lumen 13. The second shaft 20 is disposed in the first lumen 13. When the delivery device 5 has a balloon 42 as shown in Figure 1, the first shaft 10 may have a second lumen 14. 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 multiple lumens, but this is not limited to this. 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 providing the first shaft 10 with this multi-tube structure, the second shaft 20 housed in the first lumen 13 can be more easily positioned 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 can also be more easily positioned 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 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, allowing it to deform to conform to the shape of the body cavity. 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 a resin coating on at least one of the inner and outer surfaces; and a combination of these, such as a combination of these connected in the longitudinal direction x. Resin tubes can be manufactured, for example, by extrusion molding. Examples of hollow bodies with wires arranged in a predetermined pattern include a cylindrical body with a mesh structure formed by simply crossing or weaving wires, and a coil formed by winding wires. The wire may be one or more solid wires, or one or more twisted wires. The cross-sectional shape of the wire may be, for example, a circle, an oval, a polygon, or a combination of these. The term "oval shape" includes elliptical, oval, and rounded rectangular shapes, and the same applies in the following description. The type of mesh structure, the number of turns of the coil, and the density are not particularly limited. The mesh structure or coil may be formed with a constant density throughout 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. To increase the flexibility of the metal tube, cuts or grooves may be formed on the outer surface of the metal tube. The shapes of the cuts or grooves may be linear, arc-shaped, annular, spiral, or a combination thereof. When the first shaft 10 is a cylindrical resin tube, the first shaft 10 may be composed of a single layer or multiple layers. A portion in the longitudinal direction x or circumferential direction p may be composed of a single layer, and the other portion may be composed of multiple layers.

The second shaft 20 is an elongated member having longitudinal, radial, and circumferential directions. 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 lumen 13 of the first shaft 10. The second shaft 20 functions as a push-out member for moving the first element 61 and the second element 62 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. This configuration allows the second shaft 20 to 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, facilitating the extension and retraction of the first element 61 and the second element 62. 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 with a resin coating on at least one of the inner and outer surfaces; 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 first element 61 and the second element 62 to protrude from the distal opening 15 of the first shaft 10. Specifically, when the second shaft 20 is moved distally relative to the first shaft 10, the first element 61 and the second element 62 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 ends of the first element 61 and the second element 62 are located distally of the distal end of the first shaft 10. Furthermore, when the second shaft 20 is moved proximally relative to the first shaft 10, the first element 61 and the second element 62 can be stored in the first lumen 13. For example, when the second shaft 20 is positioned most proximal relative to the first shaft 10, it is preferable that the distal ends of the first element 61 and the second element 62 be positioned more proximal 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 first element 61 and the second element 62 can be changed, making it easier to deploy the film or to press the film against the treatment area with the first element 61 and the second element 62. For example, it is preferable that the delivery device 5 further has a handle connected to the proximal portion of the second shaft 20, and that the second shaft 20 rotates around its longitudinal central axis by operating the handle.

The configuration for changing the longitudinal position x of the first element 61 and the second element 62 relative 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 cylindrical portion 72, within which a connecting portion 73 is disposed. 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 disposed 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. By moving the first handle 71 distally relative to the second handle 74, the first element 61 and the second element 62 can be protruded from the first shaft 10. The first element 61 and the second element 62 can be stored within 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 up of one or more components. The first handle 71 and the second handle 74 can be made from synthetic resins such as polyolefin resin, polyester resin, polycarbonate resin, ABS resin, and polyurethane resin.

As shown in FIG. 1 , the first element 61 and the second element 62 are disposed at the distal portion of the second shaft 20. The first element 61 and the second element 62 are used as triggers for deploying the film near the treatment site. When the first element 61 and the second element 62 are protruded from the first shaft 10, the distal end of the second element 62 is located farther from the longitudinal central axis c of the second shaft 20 than the distal end of the first element 61 in the radial direction of the second shaft 20, i.e., the central axis c extending in the longitudinal direction of the second shaft 20. In the delivery device 5, the first element 61 and the second element 62 are disposed as described above when protruded from the first shaft 10. This makes it easier to deploy the film widely by the first element 61 and the second element 62, and also reduces retraction resistance when the first element 61 and the second element 62 are retracted into the first lumen 13. The first element 61 and the second element 62 may also be used to press the film.

The first element 61 and the 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 then connected. The first element 61, the second element 62, and the second shaft 20 may be connected directly, 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, fusion, adhesive, or other methods. Alternatively, 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 may be connected to each other by crimping them together with a fastener such as a ring member.

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, for example, a linear, rod-like, strip-like, plate-like, arm-like shape, or a combination of these shapes. 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. This makes it easier to wrap a film around the parallel portions, making the film attachment operation easier. It also prevents 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 that the film be sandwiched between the first element 61 and the second element 62. It is also preferable that the film be wrapped around the first element 61 and the second element 62.

As shown in Figures 7 and 8, 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 an asymmetric shape with respect to the central axis c. Forming the first element 61 and the second element 62 in this manner facilitates film deployment while reducing retraction resistance when stored in the first lumen 13. Here, the shapes of the first element 61 and the second element 62 are shown in a side view when the delivery device 5 is oriented in a direction that maximizes the radial distance between the first element 61 and the second element 62 with the first element 61 and the second element 62 protruding from the first shaft 10. Note that if the delivery device 5 has a third shaft 30, the above side view is a side view when the first element 61 and the second element 62 also protrude from the third shaft 30, as shown in Figure 1.

As shown in Figures 7 and 8, when the first element 61 and the second element 62 protrude from the first shaft 10, the distance between the distal end of the second element 62 and the central axis c in the radial direction of the second shaft 20 in a side view of the delivery device 5 may be longer than the distance between the distal end of the first element 61 and the central axis c. Forming the first element 61 and the second element 62 in this manner also makes it possible to easily deploy the film while reducing retraction resistance when it is stored in the first lumen 13.

As shown in Figures 7 and 8, it is preferable that 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 are not 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.

As shown in FIG. 9, it is preferable that at least one of the first element 61 and the second element 62 has a contact portion (hereinafter referred to as the first contact portion) that contacts the film 70. The contact of the first contact portion holds the film 70 in place, thereby preventing the film 70 from falling off the distal side of the third shaft 30 during delivery.

The first contact portion preferably holds the film 70. The specific manner of holding is not particularly limited, and the film 70 may be sandwiched between the first contact portion and the second contact portion described below, or the film may be wrapped around the first contact portion, or it may be held by both. If 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.

The long portions of the first element 61 and the second element 62 may be the first contact portion. The first section of the first element 61 and the second element 62, which will be described later, may be the first contact portion. Furthermore, the first contact portion may be 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 protruded from the first shaft 10. The first contact portion may be the first section of the first element 61 and the second element 62, which will be described later. Figure 9 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.

It is preferable that the first element 61 and the second element 62 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. Having each element have a first section makes it 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.

As shown in Figures 7 and 8, when the first element 61 and the second element 62 are protruded from the first shaft 10, it is preferable that the first section 621 of the second element 62 be located farther from the central axis c in the radial direction of the second shaft 20 than the first section 611 of the first element 61. By arranging the first sections 611, 621 in this manner, the film is more likely to be unfolded widely as the first element 61 and the second element 62 expand.

As shown in Figure 7, when the first element 61 and the second element 62 are protruded from the first shaft 10, it is preferable that the first section 611 of the first element 61 extend on an extension of the central axis c. By arranging the first section 611 of the first element 61 in this manner, it becomes easier to reduce retraction resistance when the first element 61 and the second element 62 are stored in the first lumen 13.

It is preferable that the first section 621 of the second element 62 does not extend on an extension of the central axis c, but a portion of the second element 62 may extend on an extension of the central axis c. For example, the second section 622 of the second element 62 may extend on an extension of the central axis c.

As shown in FIG. 8, when the first element 61 and the second element 62 are protruded from the first shaft 10, the first section 611 of the first element 61 and the first section 621 of the second element 62 may each be located away from the central axis c in the radial direction of the second shaft 20. By arranging the first sections 611, 621 in this manner, it is possible to easily deploy the film while reducing retraction resistance when storing it in the first lumen 13.

It is preferable that at least one of the first element 61 and the second element 62 has a second section extending radially from the inside to the outside from the proximal end 22 to the distal end 21 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 spaced apart radially when these elements are protruded from the first shaft 10. As a result, the film is more easily unfolded by the expansion of the first element 61 and the second element 62. Figure 7 shows an example in which the second element 62 has the second section 622. Figure 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 of the second section, and more preferably the first section is arranged adjacent to the second section and distally of the first section. This allows the first element 61 and the second element 62 to be arranged so that they are separated from each other on the side closer to the distal end of the delivery device 5 when the first element 61 and the second element 62 are protruded from the first shaft 10. Note that the first section in the first element 61 or the second element 62 may also be arranged proximal to the second section.

The second element 62 has a second section, and when the first element 61 and the second element 62 protrude from the first shaft 10, it is preferable that the first section 621 of the second element 62 be longer than the second section 622 of the second element 62 in the longitudinal direction of the second shaft 20. By forming the second element 62 in this manner, it becomes easier to hold the film in the first section 621.

The first element 61 may have a second section 612, but preferably has only the first section 611 and no second section. This can enhance the effect of reducing retraction resistance when storing into the first lumen 13.

The shape of the first element 61 and the second element 62 can be changed by bending and/or curving the element midway. At least one of the first element 61 and the second element 62 may have one or more curved portions. Providing curved portions 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 easier storage in the first lumen 13, it is preferable that each element have only one curved portion or no curved portions.

It is preferable that the first element 61 and the second element 62 have enough elasticity to expand when protruding from the first shaft 10. On the other hand, when the first element 61 and the second element 62 are housed in the first inner cavity 13 of the first shaft 10, at least one of the first element 61 and the second element 62 may come into contact with the inner surface of the first shaft 10. Furthermore, when the first element 61 and the second element 62 are housed in the first inner cavity 13 of the first shaft 10, the first element 61 and the second element 62 may come into contact with each other.

The constituent materials of the first element 61 and the second element 62 can be the same as those described for the second shaft 20. 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.

When the first shaft 10 has the second lumen 14, the delivery device 5 preferably has a balloon 42 disposed in the distal portion of the first shaft 10 and internally communicating with the second lumen 14. When fluid is introduced into the balloon 42 through the second lumen 14, the balloon 42 expands radially outward of the first shaft 10. Furthermore, when fluid is removed from the balloon 42, the balloon 42 contracts. The expanded balloon 42 can be used to press the film against the treatment site, thereby adhering the film to the treatment area. It is preferable to expand the film by inserting the balloon 42 into the gaps in the film delivered to the vicinity of the treatment site and expanding the diameter, thereby rapidly expanding the film and crimping it to the treatment site. A fluid inlet/outlet port 18 may be disposed in the proximal portion of the first shaft 10 to allow for the introduction and removal of fluid.

In Figures 1 and 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. 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 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 can be used to make 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.

The balloon 42 may be provided with a reinforcing material to improve its expansion performance and dimensional stability against expansion pressure. Examples of reinforcing materials include fiber materials, such as polyarylate fiber, aramid fiber, ultra-high molecular weight polyethylene fiber, PBO fiber, and carbon fiber. These fiber materials may be monofilament or multifilament.

The balloon 42 may be a compliant type, whose outer diameter changes depending on the inflation pressure, or a non-compliant type, whose outer diameter barely increases even when the inflation pressure is increased above a certain inflation pressure. A compliant type makes it easier to flexibly press the film against uneven or hard treatment areas. A non-compliant type can assist in the expansion of strictures and allows the film to be more firmly pressed against the treatment area than a compliant type.

The shape of the balloon 42 is not particularly limited, but it may have a straight tube section 43 as shown in Figure 1. It is preferable that the balloon 42 has a cylindrical shape in the straight tube section 43. The cylindrical shape of the balloon 42 makes it easier to press the film over a wide area at once, thereby shortening the procedure time. In Figure 1, the straight tube section 43 is disposed between the proximal tapered section 44 and the distal tapered section 45. The proximal tapered section 44 and the distal tapered section 45 may be, for example, frustum-shaped. The straight tube section 43 may be inclined depending on the shape of the lesion, as long as the inclination angle is smaller than that of the proximal tapered section 44 and the distal tapered 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.

The balloon 42 is preferably storable within the third shaft 30, which will be described later. Storing it within the third shaft 30 prevents the balloon 42 from coming into contact with areas other than the treatment site. It is preferable that the maximum outer diameter of the balloon 42 when fully deflated be smaller than the minimum inner diameter of the third lumen 33 of the third shaft 30.

As shown in Figure 1, when the second shaft 20 is positioned most distally relative to the first shaft 10, the first element 61 and the second element 62 are preferably positioned distal to the balloon 42. By configuring the delivery device 5 so that they are arranged in this order, it becomes easier to smoothly perform the procedure of deploying the film with the first element 61 and the second element 62 and then pressing the film against the treatment area with the balloon 42.

As shown in Figures 5 and 6, when the first element 61 and the second element 62 are housed in the first lumen 13 of the first shaft 10, it is preferable that at least one of the first element 61 and the second element 62 overlap with the balloon 42 in the longitudinal direction x of the first shaft 10. By arranging at least one of the first element 61 and the second element 62 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. Furthermore, when crimping the film with the balloon 42, having the first element 61 and the second element 62 housed in the first shaft 10 during manipulation of the first shaft 10 reduces the risk of inadvertent damage to body tissue. In particular, the procedure of removing the delivery device 5 from the body after the film has been placed can be performed smoothly.

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 may each be located proximal to the proximal end of the balloon 42.

When the first element 61 and the second element 62 are protruded from the first shaft 10, it is preferable that the longer of the first element 61 and the second element 62 is longer than the balloon 42 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 balloon 42 after the film is deployed with the first element 61 and the second element 62. Note that when the first element 61 and the second element 62 are protruded from the first shaft 10, the length of the balloon 42 may be longer than the length of the first element 61 and the second element 62 in the longitudinal direction x of the first shaft 10.

When viewed from the side of the delivery device 5, the maximum outer diameter of the balloon 42 when expanded is preferably greater than the maximum radial distance between the first element 61 and the second element 62. This makes it easier for the balloon 42 to press a wide area of the film simultaneously, thereby shortening the procedure time.

When viewed from the side 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. This makes it easier to selectively press the film against individual areas using the small balloon 42, while the first element 61 and the second element 62 widely expand the film.

In addition to the first element 61 and the second element 62, one or more further elements may be provided, but it is preferable that only the first element 61 and the second element 62 are provided in the distal portion of the second shaft 20, and no other elements are provided.

As shown in FIG. 1, the delivery device 5 may further include 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 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 less likely that the balloon 42, the first element 61, and the second element 62 will come into contact with areas 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 in the longitudinal direction. The longitudinal direction of the third shaft 30 preferably extends in the longitudinal direction x of the first shaft 10. Because at least the first shaft 10 is disposed within the third shaft 30, the third shaft 30 preferably has a cylindrical shape, for example, and more preferably has a cylindrical shape with both ends open.

As shown in Figure 9, the third lumen 33 is preferably capable of housing a first element 61 and a second element 62 to which a 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 for projecting the balloon 42, first element 61, and second element 62. 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 with a resin coating on at least one of the inner and outer surfaces; or a combination of these. For details on these configurations, please refer to the description of the first shaft 10.

As shown in FIG. 9, 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. When the second contact portion 38 contacts the film, it holds the film 70 in place, preventing the film 70 from falling off the distal side of the third shaft 30 during delivery.

It is preferable that the film 70 be held by the first contact portion and the second contact portion 38, and more preferably, the film 70 be clamped. Contact of the film 70 with the first contact portion and the second contact portion 38 prevents the film 70 from falling off the distal side of the third shaft 30 during delivery.

When the delivery device 5 has a third shaft 30 having a third lumen 33 and a first shaft 10 disposed in the third lumen 33, as shown in FIG. 4, 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, it is preferable that the first element 61 and the second element 62 be located distal to the balloon 42 in the longitudinal direction of the third shaft 30. By configuring the delivery device 5 so that they are arranged in this order, it becomes easier to ensure that the portion of the third lumen 33 distal to the distal end of the balloon 42 is a wide space for housing the film. Furthermore, after the film is deployed by the first element 61 and the second element 62, the procedure of pressing the film against the treatment area with the balloon 42 can be performed more smoothly.

The present invention also provides a method for manufacturing a medical device. The method for manufacturing a 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 a first element 61 and a second element 62, and placing the first element 61 and the second element 62 with the film 70 attached in the third lumen 33 of the third shaft 30, as shown in FIG. 9. 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 the first shaft 10 disposed in the third lumen 33, and a first element 61 and a second element 62 disposed in the distal portion of the second shaft 20, and when the first element 61 and the second element 62 are protruded from the first shaft 10, the distal end of the second element 62 is located farther from the longitudinal central axis c of the second shaft than the distal end of the first element 61 in the radial direction of the second shaft 20. The manufacturing method for the medical device 1 described above includes a step of placing 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. 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, preventing the film 70 from falling off the third shaft 30 during delivery.

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

The method of attaching the film 70 to the first element 61 and the second element 62 is not particularly limited; for example, the film 70 may be sandwiched between the first element 61 and the second element 62, or the film 70 may be wrapped around at least one of the first element 61 and the second element 62. The film 70 may be rolled or folded.

In the process of placing the first element 61 and second element 62 with the film 70 attached in the third lumen 33 of the third shaft 30, it is preferable that the first element 61 and second element 62 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 first element 61, second element 62, and 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: First element 611: First section 612: Second section 62: Second element 621: First section 622: Second section 70: Film 80: Treatment section

Claims (15)

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 a longitudinal direction and having a first lumen and a second 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 element and a second element disposed at a distal portion of the second shaft;
a balloon disposed in a distal portion of the first shaft and having an interior in communication with the second lumen ;
when the first element and the second element are protruded from the first shaft, a distal end of the second element is located farther from a central axis of the second shaft in a longitudinal direction than a distal end of the first element in a radial direction of the second shaft,
A medical film delivery device in which, when the second shaft is positioned most distally relative to the first shaft, the first element and the second element are positioned distally of the balloon . The medical film delivery device according to claim 1, wherein at least one of the first element and the second element 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 the 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 the first element and the second element each have a long portion. The medical film delivery device according to any one of claims 1 to 4, wherein the first element and the second element each have a first section that extends along the longitudinal direction of the second shaft when the first element and the second element are protruded from the first shaft. The medical film delivery device according to claim 5, wherein when the first element and the second element are protruded from the first shaft, the first section of the second element is located farther from the central axis in the radial direction of the second shaft than the first section of the first element. The medical film delivery device according to claim 5 or 6, wherein when the first element and the second element are protruded from the first shaft, the first section of the first element extends on an extension of the central axis. The medical film delivery device according to any one of claims 5 to 7, wherein when the first element and the second element are protruded from the first shaft, the first section of the first element and the first section of the second element are each positioned away from the central axis in the radial direction of the second shaft. The medical film delivery device according to any one of claims 5 to 8, wherein at least one of the first element and the second element has a second section extending radially from the inner side to the outer side from the proximal end to the distal end of the second shaft when the first element and the second element are protruded from the first shaft. the second element has the second section,
The medical film delivery device according to claim 9, wherein when the first element and the second element are protruded from the first shaft, the first section of the second element is longer than the second section of the second element in the longitudinal direction of the second shaft. The medical film delivery device according to any one of claims 1 to 10, wherein when the first element and the second element are protruded from the first shaft, the first element and the second element have asymmetric shapes with respect to the central axis. a proximal end of the first element and a proximal end of the second element are fixed to each other;
The medical film delivery tool according to any one of claims 1 to 11, wherein the distal end of the first element and the distal end of the second element are not fixed to each other. The medical film delivery device according to any one of claims 1 to 12, wherein 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 housed in the first lumen of the first shaft. The medical film delivery device according to any one of claims 1 to 13, wherein the first element and the second element come into contact with each other when housed in the first lumen of the first shaft. a medical film delivery device comprising: a first shaft having a distal end and a proximal end in a longitudinal direction and having a first lumen and a second 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, the first shaft disposed in the third lumen; a first element and a second element disposed in a distal portion of the second shaft; and a balloon disposed in the distal portion of the first shaft, the interior of which is in communication with the second lumen, wherein when the first element and the second element are protruded from the first shaft, the distal end of the second element is located farther from the central axis of the second shaft in the longitudinal direction than the distal end of the first element in the radial direction of the second shaft, and when the second shaft is positioned most distally relative to the first shaft, the first element and the second element are located distal to the balloon ;
attaching the film to the first element and the second element;
and placing the first element with the film attached and the second element in the third lumen of the third shaft.