Medical film delivery device and method for manufacturing a medical device

Abstract

To provide a medical film delivery tool that allows a film to be expanded in a treatment part in the body easily and allows a storage operation of a tip of the delivery tool to be executed easily, 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; a second shaft 20 disposed in the first lumen 13 of the first shaft 10, which can be moved in the longitudinal direction x with respect to the first shaft 10; and a first element 61 and a second element 62 disposed at a distal part of the second shaft 20. When the first element 61 and the second element 62 are projected from the first shaft 10, a distal end of the second element 62 is farther from a central axis in the longitudinal direction of the second shaft 20 than a distal end of the first element 61 in a radial direction of the second shaft 20.SELECTED DRAWING: Figure 1

Description

Technical Field

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

Background Art

[0002] In endoscopic surgery, for the purpose of promoting the healing of the affected area, alleviating bleeding, suppressing adhesions of organs, etc., a technique of placing and attaching a film to the part where the lesion in the body has been excised may be performed. As an example of an instrument for performing such a technique, Patent Document 1 discloses a sheet insertion device. Patent Document 1 discloses that an extrusion member for sheet extrusion has a bifurcated sheet winding portion provided at the tip of a shaft, and the sheet winding portion has two plate portions arranged to face each other with a gap large enough to insert the sheet.

[0003] Patent Document 2 discloses a sheet insertion tool having a sheet holding member and an outer cylinder member. The sheet holding member is formed at least at the tip side by four rod-shaped members bundled together, and the sheet is held by sandwiching the sheet between the rod-shaped members.

[0004] Patent Document 3 discloses a system for delivering a sheet-shaped implant to a surgical site, which has a first deployment arm and a second deployment arm each having a distal end portion and a proximal end portion.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Patent Document 2

Patent Document 3

Summary of the Invention

Problems to be Solved by the Invention

[0006] In the devices described in Patent Documents 1 to 3, there was room for improvement from the viewpoint of achieving both ease of film deployment and operational efficiency of the device after deployment. Therefore, an object of the present invention is to provide a medical film delivery device that can easily deploy a film to a treatment site in the body and is easy to perform a storage operation of the distal end of the delivery tool, and a manufacturing method of a medical device.

Means for Solving the Problems

[0007] One embodiment of the medical film delivery device of the present invention that can achieve the above object is a medical film delivery device for delivering a medical film into the body, having a distal end and a proximal end in the longitudinal direction and having a first lumen, a second shaft disposed in the first lumen of the first shaft and movable in the longitudinal direction with respect to the first shaft, and a first element and a second element disposed at the distal portion of the second shaft. When the first element and the second element protrude from the first shaft, in the radial direction of the second shaft, the distal end of the second element is further away from the central axis in the longitudinal direction of the second shaft than the distal end of the first element. In the medical film delivery device according to the present invention, since the first element and the second element are arranged as described above when protruding from the first shaft, it becomes easier to greatly deploy the film by at least the distal ends of the first element and the second element, and it is also possible to suppress the drawing resistance when storing the first element and the second element in the first lumen.

[0008] In the above 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 may further include a third shaft having a third lumen and in which the first shaft is 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.

[0009] In the above-mentioned medical film delivery device, the first element and the second element may each have an elongated 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 protrude from the first shaft.

[0010] In the above-mentioned medical film delivery device, when the first element and the second element protrude from the first shaft, in the radial direction of the second shaft, the first section of the second element may be located farther from the central axis than the first section of the first element.

[0011] In the above-mentioned medical film delivery device, when the first element and the second element protrude from the first shaft, the first section of the first element may extend on the extension line of the central axis.

[0012] In the above-mentioned medical film delivery device, when the first element and the second element protrude from the first shaft, in the radial direction of the second 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.

[0013] 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 from the inner side to the outer side in the radial direction 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.

[0014] In the above-mentioned medical film delivery device, the second element has a second section, and when the first element and the second element protrude from the first shaft, in the longitudinal direction of the second shaft, the first section of the second element may be longer than the second section of the second element.

[0015] In the above-described medical film delivery device, when the first element and the second element are protruded from the first shaft, the first element and the second element may have an asymmetric shape with respect to the central axis.

[0016] In the above-described medical film delivery device, the proximal end portions of the first element and the second element may be fixed to each other, and the distal end portions of the first element and the second element may not be fixed to each other.

[0017] In the above-described 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 may contact the inner surface of the first shaft. In the above-described medical film delivery device, when the first element and the second element are housed in the first lumen of the first shaft, the first element and the second element may contact each other.

[0018] The above-described medical film delivery device may further include a balloon in which the first shaft has a second lumen and is disposed at the distal portion of the first shaft and the interior communicates with the second lumen.

[0019] The present invention also provides a method for manufacturing a medical device. One embodiment of the method for manufacturing a medical device according to the present invention includes a medical film, a first shaft having a distal end and a proximal end in the longitudinal direction and a first lumen, a second shaft disposed in the first lumen of the first shaft and movable longitudinally with respect to the first shaft, a third shaft having a third lumen and the first shaft disposed in the third lumen, and a first element and a second element disposed at the distal portion of the second shaft. When the first element and the second element protrude from the first shaft, in the radial direction of the second shaft, the distal end of the second element is farther from the central axis in the longitudinal direction of the second shaft than the distal end of the first element. The method includes preparing a medical film delivery device, attaching the film to the first element and the second element, and disposing the first element and the second element to which the film is attached in the third lumen of the third shaft. The method for manufacturing a medical device according to the present invention includes disposing the first element and the second element to which the film is attached in the third lumen of the third shaft, so that the film is easily held by the first element, the second element, and the third shaft. As a result, it is possible to prevent the film from falling off the third shaft during the delivery of the film.

Advantages of the Invention

[0020] According to the medical film delivery device of the present invention, it is easy to largely expand the film by at least the distal ends of the first element and the second element, and the drawing resistance when the first element and the second element are stored in the first lumen can also be suppressed. Further, according to the method for manufacturing a medical device of the present invention, since the film is easily held by the first element, the second element, and the third shaft, it is possible to prevent the film from falling off the third shaft during the delivery of the film.

Brief Description of the Drawings

[0021]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

BEST MODE FOR CARRYING OUT THE INVENTION

[0022] Hereinafter, the present invention will be described more specifically based on the following embodiments. However, the present invention is not limited by the following embodiments, and it is of course possible to appropriately modify and implement it within a range that conforms to the gist of the foregoing and following descriptions, and all of them are included in the technical scope of the present invention. In each drawing, for convenience, hatching, reference numerals of members, etc. may be omitted, but in such a case, reference shall be made to the specification and other drawings. Also, the dimensions of various members in the drawings may differ from the actual dimensions because priority is given to facilitating the understanding of the features of the present invention.

[0023] 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, having a distal end and a proximal end in the longitudinal direction and a first shaft having a first lumen, a second shaft disposed in the first lumen of the first shaft and movable longitudinally with respect to the first shaft, and a first element and a second element disposed at the distal portion of the second shaft. When the first element and the second element protrude from the first shaft, in the radial direction of the second shaft, the gist lies in that the distal end of the second element is at a position farther from the central axis in the longitudinal direction of the second shaft than the distal end of the first element. In the medical film delivery device according to the present invention, since the first element and the second element are arranged as described above when protruding from the first shaft, it becomes easier to greatly expand the film by at least the distal ends of the first element and the second element, and the pulling resistance when the first element and the second element are housed in the first lumen can also be suppressed.

[0024] The medical film delivery device is introduced into the body cavity via the treatment instrument insertion channel of the endoscope and is used to deliver and retain a medical film in the body. Hereinafter, the medical film delivery device may be simply referred to as a delivery device.

[0025] Medical films are placed on treatment sites such as parts where lesions in the body have been excised for purposes such as promoting the healing of affected areas, alleviating bleeding, and suppressing adhesions of organs. Medical films include those referred to as sheets or membranes. Hereinafter, medical films may simply be referred to as films. The shape of the film is not particularly limited, but it can be, for example, rectangular. The size of the film can be appropriately set according to the size of the treatment site. The film may have biodegradability or bioabsorbability.

[0026] In this specification, medical devices include medical films and medical film delivery devices.

[0027] With reference to FIGS. 1 to 11, a configuration example of the delivery device and the medical device will be described. FIG. 1 is a side view (partial cross-sectional view) of a medical film delivery device according to an embodiment of the present invention. FIG. 2 is an end face view of a cut portion along line II-II of the medical film delivery device shown in FIG. 1. FIG. 3 is an end face view of a cut portion showing a modified example of the medical film delivery device shown in FIG. 2. FIG. 4 is a side view (partial cross-sectional view) showing the storage state of the first element and the second element on 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 stored in the first shaft of the medical film delivery device shown in FIG. 1 and the balloon is projected from the third shaft. FIG. 6 is a side view (partial cross-sectional view) showing the storage state of the first element and the second element on 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 is a side view showing a modified example of the distal portion of the medical film delivery device shown in FIG. 7. FIGS. 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. Note that FIGS. 7 to 8 show the shapes of the first element 61 and the second element 62 when projected from the first shaft 10.

[0028] The distal side of the delivery device 5 refers to the distal end 11 side in the longitudinal direction x of the first shaft 10, which points to the side of the object to be treated. The proximal side of the delivery device 5 refers to the proximal end 12 side in the longitudinal direction x of the first shaft 10, which points to the side of the user's hand. When each member is bisected in its longitudinal direction, the proximal side may be referred to as the proximal part, and the distal side may be referred to as the distal part. The inside and outside of the delivery device 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 in the longitudinal direction x of the first shaft 10. Here, the central axis in the longitudinal direction can also be rephrased as the central axis extending in the longitudinal direction. The same applies to the following explanations.

[0029] First, an example of the method of placing the film 70 will be described. The first shaft 10 is inserted into the third inner cavity 33 of the third shaft 30. At this time, as shown in FIG. 9, the balloon 42 is housed in the third inner cavity 33. Further, 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. As shown in FIG. 9, the first element 61 and the second element 62 to which the film 70 is attached are arranged in the third inner cavity 33 of the third shaft 30. In the state of FIG. 9, the delivery device 5 is inserted via the endoscope to the vicinity of the treatment portion 80 in the body. By operating such as moving the third shaft 30 proximally, as shown in FIG. 10, the first element 61 and the second element 62 are protruded from the third shaft 30 to expose the film 70, and the film 70 is temporarily placed on the treatment portion 80. At this time, at least a part of the film 70 may be spontaneously deployed due to the firmness and stiffness of the film 70. When the film 70 is temporarily placed on the treatment portion 80, the first element 61 and the second element 62 are positioned more distally than 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. Instead of the state of FIG. 11 or FIG. 1, the film 70 may be pressed against the treatment portion 80 using the expanded balloon 42 in a state where the first element 61 and the second element 62 are housed in the first inner cavity 13 of the first shaft 10 as shown in FIG. 5. Next, as shown in FIG. 6, the first shaft 10 is housed in the third inner cavity 33 of the third shaft 30, and the entire delivery device 5 is moved proximally. Thereby, the delivery and placement of the film 70 on the treatment portion 80 are completed.

[0030] Next, each member constituting the delivery device 5 will be described. As shown in FIGS. 1 to 2, the first shaft 10 is a long member having a longitudinal direction x, a radial direction, and a circumferential direction p. The first shaft 10 has a distal end 11 and a proximal end 12 in the longitudinal direction x. Since the second shaft 20 is disposed within the first shaft 10, the first shaft 10 preferably has, for example, a cylindrical shape, and more preferably has a cylindrical shape with both ends open. The first shaft 10 has at least a first inner cavity 13. The second shaft 20 is disposed in the first inner cavity 13. When the delivery device 5 has a balloon 42 as shown in FIG. 1, the first shaft 10 may have a second inner cavity 14. The second inner cavity 14 functions as a fluid flow path for expanding and contracting the balloon 42. The first inner cavity 13 may extend to a position more distal than the second inner cavity 14.

[0031] In FIGS. 1 to 2, an example in which the first shaft 10 has a multi-lumen structure having a plurality of inner cavities is shown, but the present invention 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 disposed in the inner cavity of the outer shaft 101. The inner shaft 102 may extend from the distal end of the outer shaft 101. In that case, the inner cavity of the inner shaft 102 can be used as the first inner cavity 13, and the space between the outer shaft 101 and the inner shaft 102 can be used as the second inner cavity 14. By forming the first shaft 10 into such a multi-tube structure, the second shaft 20 housed in the first inner cavity 13 is likely to be disposed at a position close to the central axis in the longitudinal direction x of the first shaft 10. As a result, the first element 61 and the second element 62 are also likely to be disposed at positions close to the central axis in the longitudinal direction x.

[0032] The first shaft 10 has one or more openings for protruding the first element 61 and the second element 62. In FIG. 1, the first shaft 10 has a distal-side opening 15 at its distal end face. The first inner cavity 13 communicates with the outside of the first shaft 10 through the distal-side opening 15.

[0033] The first shaft 10 preferably has flexibility. Thereby, the first shaft 10 can be deformed along the body cavity shape. For shape retention, the first shaft 10 preferably has elasticity. The first shaft 10 is preferably composed of resin, metal, or a combination of resin and metal. Examples of the first shaft 10 include a resin tube; a metal pipe; a hollow body formed by arranging wire rods in a predetermined pattern; a hollow body with resin coated on at least one of the inner surface and the outer surface; or a combination thereof, for example, those connected in the longitudinal direction x. The resin tube can be manufactured, for example, by extrusion molding. Examples of the hollow body with wire rods arranged in a predetermined pattern include a cylindrical body having a mesh structure formed by simply crossing or braiding the wire rods, and a coil formed by winding the wire rods. The wire rods may be one or more single wires or one or more stranded wires. The cross-sectional shape of the wire rods may be, for example, circular, oval, polygonal, or a combination thereof. Oval shapes include elliptical, egg-shaped, and rounded rectangular shapes, and the same applies to the following descriptions. The type of the mesh structure is not particularly limited, and the number of turns and density of the coil are also not particularly limited. The mesh structure and the coil may be formed with a constant density throughout the longitudinal direction x of the first shaft 10, or may be formed such that the density varies depending on the position in the longitudinal direction x of the first shaft 10. In order to increase the flexibility of the metal pipe, cuts or grooves may be formed on the outer surface of the metal pipe. The shape of the cuts or grooves can be linear, arc-shaped, annular, helical, 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 a part in the longitudinal direction x or the circumferential direction p may be composed of a single layer, while the other part may be composed of multiple layers.

[0034] The second shaft 20 is an elongated member having a longitudinal direction, a radial direction, and a circumferential direction. The second shaft 20 has a distal end 21 and a proximal end 22 in the longitudinal direction. The second shaft 20 is disposed in the first inner cavity 13 of the first shaft 10. The second shaft 20 functions as a pushing member for advancing and retracting the first element 61 and the second element 62 with respect to the first shaft 10. The second shaft 20 can be composed of one or a plurality of members.

[0035] Preferably, the second shaft 20 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.

[0036] Preferably, the second shaft 20 has a solid shape. This makes it easier to impart rigidity to the second shaft 20 and facilitates the protruding and retracting operations of the first element 61 and the second element 62. FIGS. 1 to 2 show an example in which the second shaft 20 has a solid bar shape that is linear.

[0037] 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 wire rods in a predetermined pattern; a resin-coated one on at least one of the inner surface and the outer surface of the hollow body; or a combination thereof. For these configurations, reference can be made to the description of the first shaft 10.

[0038] The second shaft 20 is movable in the longitudinal direction x with respect to the first shaft 10. Thereby, the first element 61 and the second element 62 can be protruded from the distal opening 15 of the first shaft 10. Specifically, when the second shaft 20 is moved distally with respect to the first shaft 10, the first element 61 and the second element 62 can be protruded 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, it is preferable that the proximal ends of the first element 61 and the second element 62 are positioned distally of the distal end of the first shaft 10. Further, 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, it is preferable that the distal ends of the first element 61 and the second element 62 are positioned proximally of the distal end of the first shaft 10.

[0039] The second shaft 20 may be rotatable with respect to the first shaft 10. By rotating the second shaft 20, the orientations of the first element 61 and the second element 62 can be changed, so that the film can be easily deployed, or the film can be pressed against the treatment portion by the first element 61 and the second element 62. For example, the delivery device 5 further has a handle connected to the proximal portion of the second shaft 20, and it is preferable that the second shaft 20 rotates about the central axis in its longitudinal direction by operating the handle.

[0040] The configuration for changing the longitudinal x positions of the first element 61 and the second element 62 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 cylindrical portion 72, and a connecting portion 73 is arranged within the cylindrical portion 72. The proximal portion of the first shaft 10 is connected to a second handle 74 having a cylindrical portion 75. The first handle 71 is arranged outside the cylindrical portion 75 of the second handle 74. The first handle 71 is configured to be slidable with respect to 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 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 housed within the first shaft 10.

[0041] The first handle 71 and the second handle 74 can each be composed of one or a plurality of members. As the constituent materials of the first handle 71 and the second handle 74, for example, synthetic resins such as polyolefin resin, polyester resin, polycarbonate resin, ABS resin, and polyurethane resin can be used.

[0042] As shown in FIG. 1, the first element 61 and the second element 62 are arranged 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 in the vicinity of the treatment section. When the first element 61 and the second element 62 are projected from the first shaft 10, in the radial direction of the second shaft 20, the distal end of the second element 62 is farther from the central axis c in the longitudinal direction of the second shaft 20, that is, the central axis c extending in the longitudinal direction of the second shaft 20 than the distal end of the first element 61. In the delivery device 5, since the first element 61 and the second element 62 are arranged as described above when projected from the first shaft 10, it becomes easier to largely deploy the film by the first element 61 and the second element 62, and the pulling resistance when the first element 61 and the second element 62 are housed in the first lumen 13 can also be suppressed. Incidentally, the first element 61 and the second element 62 may be used for pressing the film.

[0043] The first element 61 and the second element 62 can be connected to the distal end portion of the second shaft 20. Specifically, the first element 61 and the second element 62 are preferably arranged so as to extend distally from the distal end 21 of the second shaft 20.

[0044] The first element 61 and the second element 62 may be integrally formed with the second shaft 20, or may be formed from separate members and connected thereto. 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 portion of the second shaft 20 by methods such as welding, brazing, and adhesion. Further, the proximal end portions of the first element 61, the proximal end portion of the second element 62, and the distal end portion of the second shaft 20 may be caulked with a fixture such as a ring member to connect them to each other.

[0045] It is preferable that the first element 61 and the second element 62 each have a long 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-shaped, strip-shaped, plate-shaped, arm-shaped, or a shape combining these. The shapes of the first element 61 and the second element 62 may be the same as each other or different from each other.

[0046] When the first element 61 and the second element 62 protrude from the first shaft 10, it is preferable that the first element 61 and the second element 62 have portions arranged parallel to each other. Since it is easy to wind the film around the portions arranged parallel to each other, the film attachment operation becomes easy. Also, it is possible to prevent the film from dropping during delivery.

[0047] The first element 61 and the second element 62 can be arranged to face each other in the radial direction of the second shaft 20. It is preferable to sandwich the film between the first element 61 and the second element 62. Also, it is preferable that the film be wound around the first element 61 and the second element 62.

[0048] As shown in FIGS. 7 to 8, when the first element 61 and the second element 62 protrude from the first shaft 10, it is preferable that the first element 61 and the second element 62 have an asymmetrical shape with respect to the central axis c. By forming the first element 61 and the second element 62 in this way, while facilitating the unfolding of the film, the pulling resistance during storage in the first lumen 13 can be suppressed. Here, the shapes of the first element 61 and the second element 2 are shown in a side view when the delivery tool 5 is directed in a direction in which the radial distance between the first element 61 and the second element 62 is maximized in a state where the first element 61 and the second element 62 protrude from the first shaft 10. When the delivery tool 5 has the third shaft 30, the above side view is a side view in a state where the first element 61 and the second element 62 also protrude from the third shaft 30 as shown in FIG. 1.

[0049] As shown in FIGS. 7 to 8, when the first element 61 and the second element 62 protrude from the first shaft 10, in the radial direction of the second shaft 20 in a side view of the delivery tool 5, the distance between the distal end of the second element 62 and the central axis c may be longer than the distance between the distal end of the first element 61 and the central axis c. By forming the first element 61 and the second element 62 in this way as well, while facilitating the unfolding of the film, the pulling resistance during storage in the first lumen 13 can be suppressed.

[0050] As shown in FIGS. 7 to 8, it is preferable that the proximal end portions of the first element 61 and the second element 62 are fixed to each other, and the distal end portions of the first element 61 and the second element 62 are not fixed to each other. With this configuration, it becomes easier to unfold the film on the distal end side of each of the first element 61 and the second element 62.

[0051] 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. When the first contact portion contacts, the film 70 is pressed, so that it is possible to prevent the film 70 from falling off from the distal side of the third shaft 30 during the delivery of the film 70.

[0052] The first contact portion preferably 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 the second contact portion described later, the film may be wound around the first contact portion, or it may be held by both of them. 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.

[0053] The elongated portion of the first element 61 and the second element 62 may be the first contact portion. Among the first element 61 and the second element 62, the first section described later may be the first contact portion. Also, when the first element 61 and the second element 62 are projected from the first shaft 10, the portion where the first element 61 and the second element 62 are arranged parallel to each other may be the first contact portion. Among the first element 61 and the second element 62, the first section described later may be the first contact portion. FIG. 9 shows an example in which the first element 61 has a first contact portion 64 and the second element 62 has a first contact portion 65.

[0054] The first element 61 and the second element 62 preferably 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 projected from the first shaft 10. By each element having the first section, it becomes easier to wind the film around each first section. In FIGS. 7 to 8, the first element 61 has a first section 611 and the second element 62 has a first section 621.

[0055] As shown in FIGS. 7 to 8, when the first element 61 and the second element 62 protrude from the first shaft 10, in the radial direction of the second shaft 20, it is preferable that the first section 621 of the second element 62 is located farther from the central axis c than the first section 611 of the first element 61. By arranging the first sections 611 and 621 in this way, the film is likely to be greatly expanded by the expansion of the first element 61 and the second element 62.

[0056] As shown in FIG. 7, when the first element 61 and the second element 62 protrude from the first shaft 10, it is preferable that the first section 611 of the first element 61 extends on the extension line of the central axis c. By arranging the first section 611 of the first element 61 in this way, it is easy to suppress the drawing resistance when the first element 61 and the second element 62 are housed in the first inner cavity 13.

[0057] It is preferable that the first section 621 of the second element 62 does not extend on the extension line of the central axis c, but a part of the second element 62 may extend on the extension line of the central axis c. For example, the second section 622 of the second element 62 may extend on the extension line of the central axis c.

[0058] As shown in FIG. 8, when the first element 61 and the second element 62 protrude from the first shaft 10, in the radial direction of the second shaft 20, the first section 611 of the first element 61 and the first section 621 of the second element 62 may be located at positions away from the central axis c, respectively. By arranging the first sections 611 and 621 in this way, while facilitating the deployment of the film, the drawing resistance during storage in the first inner cavity 13 can be suppressed.

[0059] It is preferable that at least one of the first element 61 and the second element 62 has a second section that extends from the inner side to the outer side in the radial direction from the proximal end 22 side to the distal end 21 side of the second shaft 20 when the first element 61 and the second element 62 project from the first shaft 10. By providing such a second section, when the elements project from the first shaft 10, the distal ends of the first element 61 and the second element 62 can be easily positioned so as to be radially separated. As a result, the film can be easily deployed by the expansion of the first element 61 and the second element 62. FIG. 7 shows an example in which the second element 62 has a second section 622. FIG. 8 shows an example in which the first element 61 has a second section 612 and the second element 62 has a second section 622.

[0060] In the first element 61 or the second element 62, it is preferable that the first section is arranged on the distal side of the second section, and it is more preferable that the first section is arranged adjacent to the second section on the distal side of the first section. Thereby, when the first element 61 and the second element 62 project from the first shaft 10, the first element 61 and the second element 62 can be arranged so as to be separated from each other on the side closer to the distal end of the delivery tool 5. Note that in the first element 61 or the second element 62, the first section may be arranged on the proximal side of the second section.

[0061] The second element 62 has a second section, and when the first element 61 and the second element 62 project from the first shaft 10, in the longitudinal direction of the second shaft 20, it is preferable that the first section 621 of the second element 62 is longer than the second section 622 of the second element 62. By forming the second element 62 in this way, it becomes easier to hold the film in the first section 621.

[0062] The first element 61 may have a second section 612, but it preferably has only the first section 611 and does not have a second section. The effect of suppressing the drawing resistance during storage in the first lumen 13 can be enhanced.

[0063] In the first element 61 and the second element 62, the shape of the element can be changed by bending, curving, or both in the middle of the element. 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 inner cavity 13. Note that at least one of the first element 61 and the second element 62 may have one or more bent portions. In order to facilitate the accommodation in the first inner cavity 13, it is preferable that each element has only one bent portion or does not have a bent portion.

[0064] The first element 61 and the second element 62 preferably have an elasticity such that they can expand when protruding from the first shaft 10. On the other hand, when the first element 61 and the second element 62 are accommodated in the first inner cavity 13 of the first shaft 10, at least one of the first element 61 and the second element 62 may contact the inner surface of the first shaft 10. Also, when the first element 61 and the second element 62 are accommodated in the first inner cavity 13 of the first shaft 10, the first element 61 and the second element 62 may contact each other.

[0065] 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 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.

[0066] When the first shaft 10 has a second lumen 14, the delivery device 5 preferably has a balloon 42 disposed at the distal portion of the first shaft 10 and internally communicating with the second lumen 14. By introducing fluid into the balloon 42 through the second lumen 14, the balloon 42 expands radially outward of the first shaft 10. Also, by removing fluid from the inside of the balloon 42, the balloon 42 contracts. The film can be made to adhere to the treatment portion by pressing the film with the balloon 42 having an expanded diameter. It is preferable to insert the balloon 42 into the gap of the film delivered to the vicinity of the treatment portion and expand it, thereby expanding the film all at once and crimping the film to the treatment portion. In order to introduce and remove fluid, a fluid inlet / outlet 18 may be disposed at the proximal portion of the first shaft 10.

[0067] In FIGS. 1, 4 to 6, the distal end portion and the proximal end portion of the balloon 42 are respectively fixed to the outer surface of the first shaft 10. Specifically, the distal end portion 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 portion 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.

[0068] The balloon 42 can be manufactured by molding a resin. Examples of the resin constituting 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, natural rubber, and the like. These may be used alone or in combination of two or more.

[0069] In order to enhance the expansion performance and the dimensional stability with respect to the expansion pressure, a reinforcing material may be disposed on the balloon 42. As the reinforcing material, for example, a fiber material can be used, and specifically, polyarylate fiber, aramid fiber, ultra-high molecular weight polyethylene fiber, PBO fiber, carbon fiber, etc. are preferably used. These fiber materials may be monofilaments or multifilaments.

[0070] The balloon 42 may be a compliant type whose outer diameter changes according to the expansion pressure, or may be a non-compliant type in which the outer diameter of the balloon 42 hardly increases even when the expansion pressure is increased above a predetermined expansion pressure. If it is a compliant type, it becomes easier to press the film softly against an uneven or hard treatment part. If it is a non-compliant type, it becomes possible to assist in expanding a constricted part, and the film can be crimped more firmly than in the compliant type.

[0071] The shape of the balloon 42 is not particularly limited, but as shown in FIG. 1, it may have a straight tube portion 43. In the straight tube portion 43, the balloon 42 preferably has a cylindrical shape. Since the balloon 42 having a cylindrical shape makes it easy to press a wide range of the film at once, the procedure time can be shortened. In FIG. 1, the straight tube portion 43 is arranged between the proximal tapered portion 44 and the distal tapered portion 45. The proximal tapered portion 44 and the distal tapered portion 45 may be, for example, frustum shapes. The straight tube portion 43 may be inclined according to the shape of the lesion as long as it has a smaller inclination angle than the proximal tapered portion 44 and the distal tapered portion 45.

[0072] The balloon 42 may have a spherical shape or an ellipsoidal shape. Even if the treatment part has an uneven part or a constricted part, the rounded shape of the balloon 42 makes it easier to press the film against the uneven part or the constricted part.

[0073] The balloon 42 is preferably capable of being housed in a third shaft 30 described later. By housing it in the third shaft 30, contact of the balloon 42 with places other than the treatment part can be prevented. The maximum outer diameter of the balloon 42 when it is most contracted is preferably smaller than the minimum inner diameter in the third lumen 33 of the third shaft 30.

[0074] As shown in FIG. 1, when the second shaft 20 is positioned most distally with respect to the first shaft 10, it is preferable that the first element 61 and the second element 62 are located distally of the balloon 42. By configuring the delivery device 5 to be arranged in such an order, after the film is deployed by the first element 61 and the second element 62, the procedure of pressing the film against the treatment portion with the balloon 42 can be smoothly performed.

[0075] As shown in FIGS. 5 to 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 overlaps 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, it becomes difficult for body fluid and foreign matter to enter the first shaft 10 from the distal opening 15 of the first shaft 10. Further, when the film is crimped with the balloon 42, since the first element 61 and the second element 62 are housed in the first shaft 10 when the first shaft 10 is operated, the risk of inadvertently damaging body tissue can be reduced. In particular, the procedure of removing the delivery device 5 from the body after the film is retained can be smoothly performed.

[0076] 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 proximally of the proximal end of the balloon 42.

[0077] When the first element 61 and the second element 62 protrude from the first shaft 10, it is preferable that, in the longitudinal direction x of the first shaft 10, the longer side of the first element 61 and the second element 62 is longer than the balloon 42. After the film is deployed by the first element 61 and the second element 62, the procedure of pressing the film against the treatment portion with the balloon 42 can be performed smoothly and easily. Note that when the first element 61 and the second element 62 protrude from the first shaft 10, the length of the balloon 42 may be longer than the lengths of the first element 61 and the second element 62 in the longitudinal direction x of the first shaft 10.

[0078] In a side view of the delivery device 5, it is preferable that the maximum outer diameter of the balloon 42 when it expands is larger than the maximum radial distance between the first element 61 and the second element 62. Thereby, since it becomes easy to press a wide range of the film all at once with the balloon 42, the procedure time can be shortened.

[0079] In a side view of the delivery device 5, the maximum outer diameter of the balloon 42 when it expands may be smaller than the maximum radial distance between the first element 61 and the second element 62. While the film is largely expanded by the first element 61 and the second element 62, it becomes easy to selectively press the film against each part with the small balloon 42.

[0080] In addition to the first element 61 and the second element 62, one or more additional elements can also be provided, but it is preferable that only the first element 61 and the second element 62 are provided at the distal portion of the second shaft 20 and no other elements are provided.

[0081] As shown in FIG. 1, the delivery device 5 may further have a third shaft 30. The third shaft 30 has a third inner cavity 33, and the first shaft 10 is disposed in the third inner cavity 33. The third shaft 30 is a member for accommodating the first shaft 10, the second shaft 20, the balloon 42, the first element 61, and the second element 62 when delivering 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 contact a location other than the treatment site when delivering the film.

[0082] The third shaft 30 is an elongated member having a longitudinal direction, a radial direction, and a circumferential direction. The third shaft 30 has a distal end 31 and a proximal end 32 in the longitudinal direction. The longitudinal direction of the third shaft 30 preferably extends in the longitudinal direction x of the first shaft 10. Since at least the first shaft 10 is disposed in the third shaft 30, the third shaft 30 preferably has, for example, a cylindrical shape, and more preferably has a cylindrical shape with both ends open.

[0083] As shown in FIG. 9, it is preferable that the third inner cavity 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 in a state of being held by the first element 61, the second element 62, and the third shaft 30.

[0084] The third shaft 30 has one or more openings for protruding the balloon 42, the first element 61, and the second element 62. For example, in FIG. 1, the third shaft 30 has a distal opening 35 on its distal end face. The third inner cavity 33 communicates with the outside of the third shaft 30 at least through the distal opening 35.

[0085] The third shaft 30 may be a resin tube; a metal tube; a hollow body formed by arranging wire rods in a predetermined pattern; a coated resin on at least one of the inner surface or the outer surface of the hollow body; or a combination thereof. For these configurations, reference can be made to the description of the first shaft 10.

[0086] As shown in FIG. 9, in the third lumen 33, it is preferable that the inner surface of the third shaft 30 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, the film 70 is pressed, so that the film 70 can be prevented from dropping off from the distal side of the third shaft 30 during the delivery of the film 70.

[0087] It is preferable that the film 70 is held by the first contact portion and the second contact portion 38, and it is more preferable that the film 70 is sandwiched. When the film 70 contacts the first contact portion and the second contact portion 38, the film 70 can be prevented from dropping off from the distal side of the third shaft 30 during the delivery of the film 70.

[0088] When the delivery device 5 has a third lumen 33 and has a third shaft 30 in which the first shaft 10 is 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 are located on the distal side of the balloon 42 in the longitudinal direction of the third shaft 30. By configuring the delivery device 5 to be arranged in such an order, it becomes easier to widely secure a portion of the third lumen 33 on the distal side of the distal end of the balloon 42 as a space for storing the film. In addition, after the film is deployed by the first element 61 and the second element 62, it becomes easier to smoothly perform the procedure of pressing the film against the treatment portion with the balloon 42.

[0089] The present invention also provides a method for 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, a step of attaching the film 70 to a first element 61 and a second element 62, and a step of disposing the first element 61 and the second element 62 to which the film 70 is attached in a third inner cavity 33 of a third shaft 30 as shown in FIG. 9. 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 a longitudinal direction x and a first inner cavity 13, a second shaft 20 disposed in the first inner cavity 13 of the first shaft 10 and movable in the longitudinal direction x with respect to the first shaft 10, a third shaft 30 having a third inner cavity 33 and in which the first shaft 10 is disposed in the third inner cavity 33, a first element 61 and a second element 62 disposed at a distal portion of the second shaft 20. When the first element 61 and the second element 62 protrude from the first shaft 10, in the radial direction of the second shaft 20, the distal end of the second element 62 is located farther from the central axis c in the longitudinal direction of the second shaft than the distal end of the first element 61. Since the method for manufacturing the medical device 1 includes a step of disposing the first element 61 and the second element 62 to which the film 70 is attached in the third inner cavity 33 of the third shaft 30, the film 70 is easily held by the first element 61, the second element 62, and the third shaft 30, and it is possible to prevent the film 70 from falling off from the third shaft 30 during the delivery of the film 70.

[0090] Regarding the medical film 70 and the medical film delivery device 5, the above-described configurations can be appropriately combined and employed.

[0091] The method for 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 wound around at least one of the first element 61 and the second element 62. The film 70 may be rolled or folded.

[0092] In the step of disposing the first element 61 and the second element 62, to which the film 70 is attached, in the third inner cavity 33 of the third shaft 30, it is preferable that the first element 61 and the second element 62 are disposed in the third inner cavity 33 in a state of protruding from the first shaft 10. Thereby, the film 70 is likely to be held by the first element 61, the second element 62, and the third shaft 30.

Explanation of Signs

[0093] 1: Medical device 5: Medical film delivery device 10: First shaft 13: First inner cavity 14: Second inner cavity 20: Second shaft 30: Third shaft 33: Third inner cavity 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

Claim 1 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 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 with respect to the first shaft; a first element and a second element disposed at a distal portion of the second shaft; a balloon disposed at a distal portion of the first shaft and having an interior communicating with the second lumen; and when the first element and the second element protrude from the first shaft, in the radial direction of the second shaft, a distal end of the second element is farther from a central axis in the longitudinal direction of the second shaft than a distal end of the first element; a medical film delivery device, wherein when the second shaft is positioned most distally with respect to the first shaft, the first element and the second element are positioned distally of the balloon. Claim 2 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. Claim 3 further comprising a third shaft having a third lumen and the first shaft disposed in the third lumen; the medical film delivery device according to claim 1 or 2, wherein an inner surface of the third shaft in the third lumen has a contact portion that contacts the film. Claim 4 The medical film delivery device according to any one of claims 1 to 3, wherein the first element and the second element each have an elongate portion. Claim 5 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 protrude from the first shaft. Claim 6 The medical film delivery device according to claim 5, wherein when the first element and the second element protrude from the first shaft, in the radial direction of the second shaft, the first section of the second element is farther from the central axis than the first section of the first element. Claim 7 The medical film delivery device according to claim 5 or 6, wherein when the first element and the second element protrude from the first shaft, the first section of the first element extends on the extension line of the central axis.

8. The medical film delivery device according to any one of claims 5 to 7, wherein when the first element and the second element protrude from the first shaft, in the radial direction of the second shaft, the first section of the first element and the first section of the second element are each located at a position away from the central axis.

9. 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 that extends from the inner side to the outer side in the radial direction 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.

10. 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 protrude from the first shaft, in the longitudinal direction of the second shaft, the first section of the second element is longer than the second section of the second element.

11. The medical film delivery device according to any one of claims 1 to 10, wherein when the first element and the second element protrude from the first shaft, the first element and the second element have an asymmetric shape with respect to the central axis.

12. The proximal end portion of the first element and the proximal end portion of the second element are fixed to each other, The medical film delivery device according to any one of claims 1 to 11, wherein the distal end portion of the first element and the distal end portion of the second element are not fixed to each other.

13. The medical film delivery device according to any one of claims 1 to 12, wherein 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.

14. The medical film delivery device according to any one of claims 1 to 13, wherein when the first element and the second element are housed in the first lumen of the first shaft, the first element and the second element contact each other.

15. 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 movable in the longitudinal direction with respect to the first shaft, a third shaft having a third lumen and the first shaft disposed in the third lumen, a first element and a second element disposed at the distal portion of the second shaft, and a balloon disposed at the distal portion of the first shaft and having an internal communication with the second lumen, wherein when the first element and the second element are protruded from the first shaft, in the radial direction of the second shaft, the distal end of the second element is farther from the central axis in the longitudinal direction of the second shaft than the distal end of the first element, and when the second shaft is positioned most distally with respect to the first shaft, the first element and the second element are positioned distally of the balloon, and a step of preparing a medical film delivery device; a step of attaching the film to the first element and the second element; a step of disposing the first element and the second element to which the film is attached in the third lumen of the third shaft. A method for manufacturing a medical device including the above steps.

Images