WO2023176864A1

WO2023176864A1 - Chip used at distal end of medical device to be inserted into body, and medical device

Info

Publication number: WO2023176864A1
Application number: PCT/JP2023/009980
Authority: WO
Inventors: 健太郎鈴木; 崇亘 ▲濱▼淵; 絵里奈佐野; 一博佐藤
Original assignee: 株式会社カネカ
Priority date: 2022-03-17
Filing date: 2023-03-15
Publication date: 2023-09-21

Abstract

The purpose of the present invention is to provide a chip which is unlikely to damage a tissue contacted thereby and which is easily inserted into a narrow site. This chip is used at a distal end of a medical device to be inserted into the body. The chip has: a first member that includes the proximal end of the chip; and a second member that is positioned more toward the distal side than the distal end of the first member. The first member has a first opposing surface opposing the second member. The first opposing surface has a first fixed section which is fixed to the second member, and a non-fixed section which is not fixed to the second member.

Description

Chip used at the distal end of a medical device inserted into the body, and a medical device

The present invention relates to a chip used at the distal end of a medical device inserted into the body, and a medical device.

Conventionally, a catheter is sometimes inserted or passed through a narrowed site such as a narrowed gastrointestinal tract or blood vessel, and a tip is provided at the tip of the catheter. As a catheter having a distal tip, for example, Patent Document 1 discloses a tube body having an inner layer, a reinforcing body covering the inner layer, and an outer layer covering the reinforcing body, and a tubular tip made of metal provided at the distal end of the tube body. A catheter is disclosed which includes a tip, a slit is formed in the distal tip, an outer coating is provided on the outer peripheral surface of the distal tip, and the outer coating is inserted into the inside of the slit.

JP2015-208425A

The distal tip of Patent Document 1 is provided with a spiral slit extending in the axial direction in order to make the tip easier to bend as a whole, but since the outer covering is inside the slit, the material of the outer covering is Depending on the situation, there was a possibility that the tip would hardly bend. In addition, in recent years, a stent delivery catheter is often used to place a stent in a stenotic area. There was a need to improve the ease of insertion. The present invention has been made in view of the above-mentioned problems, and its purpose is to provide a tip that is less likely to damage contact tissue and that is easier to insert into a stenotic site. Another object is to provide a medical device that is less likely to damage contact tissues and that is easier to insert into a stenotic site.

The chip used in the distal end of the medical device according to the embodiment of the present invention, which can solve the above problems, is as follows.
[1] A chip used at the distal end of a medical device inserted into the body,
a first member including a proximal end of the tip;
a second member located on the distal side of the distal end of the first member;
The first member has a first opposing surface facing the second member, and the first opposing surface includes a first fixing part fixed to the second member and a first fixing part fixed to the second member. A chip that does not have a non-fixed part.

As mentioned above, since the first opposing surface has the non-fixed part, a gap is formed between the first member and the second member that functions as a buffer part, and the chip becomes partially flexible. , the tip becomes less likely to damage the tissues it comes in contact with in the body. Furthermore, since the first opposing surface has the fixing portion, the first member and the second member are fixed in the distance direction, making it easier to push the tip into the stenosis from the proximal side to the distal side. .

The chip according to the embodiment of the present invention is preferably one of the following [2] to [12].
[2] The first member has a lumen extending from the proximal end to the distal end,
The chip according to [1], wherein the second member has a lumen extending from the proximal end to the distal end and communicating with the lumen.
[3] The chip according to [2], wherein the non-fixed portion is located closer to the lumen than the first fixed portion.
[4] The first opposing surface has a second fixing part fixed to the second member,
The chip according to [2] or [3], wherein the second fixed part is located closer to the lumen than the non-fixed part.
[5] The chip according to [2] or [3], wherein the first opposing surface does not have a fixing part fixed to the second member on the lumen side relative to the non-fixing part.
[6] The chip according to [2], [3], or [5], wherein the non-fixed portion is a groove extending in the circumferential direction of the inner cavity.
[7] The chip according to [6], wherein the groove extends in a part of the circumferential direction and does not extend all the way around the circumferential direction.
[8] The first opposing surface according to any one of [1] to [7] does not have a non-fixed part that is not fixed to the second member on the outside of the first fixed part. Chip.
[9] The chip according to any one of [1] to [8], wherein the first member has an enlarged diameter portion whose outer diameter increases toward the distal end of the first member. .
[10] The first member includes a first resin,
The chip according to any one of [1] to [9], wherein the second member includes a second resin having a melting point that is the same as or lower than the melting point of the first resin.
[11] The chip according to any one of [1] to [10], wherein the first opposing surface is fixed to the second member by welding at the first fixing portion.
[12] The chip according to any one of [1] to [11], wherein the medical device is a medical tubular body transport device that transports a medical tubular body into the body.

A medical device according to an embodiment of the present invention that can solve the above problem is as shown in [13] below, and preferably any one of [14] to [16].
[13] A medical device inserted into the body,
an inner tube;
an outer tube having at least a portion of the inner tube disposed in a lumen;
The chip according to any one of [1] to [12], which is fixed to at least a portion of the distal end of the inner tube;
A medical device having a medical device disposed between an outer surface of the distal end of the inner tube and an inner surface of the outer tube.
[14] The medical device according to [13], wherein the distal end of the medical device is located closer to the non-fixed portion of the first opposing surface.
[15] The medical device according to [13] or [14], wherein the first member is fixed to the inner tube, and the second member is not fixed to the inner tube.
[16] The medical device according to any one of [13] to [15], wherein the medical device is a medical tubular body, and is a medical tubular body transport device that transports the medical tubular body into the body.

According to the present invention, with the above configuration, it is possible to provide a tip that is difficult to damage contact tissue and that is easy to insert into a stenosis site. Further, according to the present invention, it is possible to provide a medical device that does not easily damage contact tissues and is easy to insert into a stenotic site.

FIG. 1 is a side view of a chip according to an embodiment. FIG. 2 is an axial cross-sectional view of FIG. 1. FIG. FIG. 3 is a cross-sectional view taken along the line AA in FIG. FIG. 4 is a sectional view showing a modification of the cross section of FIG. FIG. 5 is a sectional view showing a modification of the cross section of FIG. FIG. 6 is an axial cross-sectional view of a chip according to another embodiment. FIG. 7 is a sectional view showing a modification of the cross section of FIG. FIG. 8 is a sectional view showing a modification of the cross section of FIG. FIG. 9 is a side view showing the first member fixed to the inner tube and the second member before being fixed to the first member. FIG. 10 is a side view of the medical device according to the embodiment. FIG. 11 is an axial cross-sectional view of FIG. 10. FIG. 12 is an axial cross-sectional view of a medical device according to another embodiment.

In the following, the present invention will be explained in more detail based on the following embodiments, but the present invention is not limited by the following embodiments, and may be modified as appropriate within the scope that fits the spirit of the above and below. Of course, it is also possible to implement in addition, and all of them are included in the technical scope of the present invention. In addition, in each drawing, member numbers etc. may be omitted for convenience, but in such a case, the specification and other drawings shall be referred to. Further, the dimensions of various members in the drawings are given priority to help understanding the features of the present invention, and therefore may differ from actual dimensions.

A chip according to an embodiment of the present invention is a chip used at a distal end of a medical device inserted into a body, and includes a first member including a proximal end of the chip, and a distal end of the first member. and a second member located distally from the end, the first member having a first opposing surface facing the second member, and the first opposing surface being fixed to the second member. The first fixed part is fixed to the second member, and the non-fixed part is not fixed to the second member.

Hereinafter, a chip according to an embodiment and a medical device according to an embodiment will be explained in this order with reference to FIGS. 1 to 12. FIG. 1 is a side view of a chip according to an embodiment. FIG. 2 is an axial cross-sectional view of FIG. 1. FIG. FIG. 3 is a cross-sectional view taken along the line AA in FIG. 4, 5, 7, and 8 are cross-sectional views showing modifications of the cross-section of FIG. 3. FIG. 6 is an axial cross-sectional view of a chip according to another embodiment. FIG. 9 is a side view showing the first member fixed to the inner tube and the second member before being fixed to the first member. FIG. 10 is a side view of the medical device according to the embodiment, and FIG. 11 is a cross-sectional view in the axial direction of FIG. 10. FIG. 12 is an axial cross-sectional view of a medical device according to another embodiment.

A chip 1 shown in FIG. 1 is a chip used at the distal end of a medical device inserted into the body. For example, as shown in FIGS. 10 to 12, the tip 1 is preferably a tip used at the distal end portion 10b of the medical device 10 for transporting the medical device 4 into the body.

As shown in FIGS. 1 to 3, the tip 1 includes a first member 11 including a proximal end 1A of the tip 1, and a second member 12 located distal to the distal end 11b of the first member 11. It has The first member 11 has a first opposing surface 11S that faces the second member 12, and the first opposing surface 11S has a first fixing portion 11T fixed to the second member 12 and a first opposing surface 11S that faces the second member 12. It has a non-fixed portion 11Y that is not fixed.

Since the first opposing surface 11S has the non-fixed portion 11Y, a gap is formed between the first member 11 and the second member 12, which functions as a buffer portion. As a result, the tip 1 becomes partially flexible, making it difficult for the tip 1 to damage the tissue it contacts within the body. Furthermore, since the first opposing surface 11S has the first fixing portion 11T, the second member 12 can be easily pushed into the distal side by the first member 11.

As shown in FIGS. 1 and 2, it is preferable that the first member 11 and the second member 12 each extend in the axial direction 1X of the chip 1. This makes it easier to push the chip 1 in the axial direction 1X. Further, it is preferable that the axial direction of the first member 11 and the axial direction of the second member 12 are the same direction.

The first fixing portion 11T of the first opposing surface 11S only needs to be fixed to the second member 12. As a method of fixing the first fixing part 11T to the second member 12, for example, a part of the first opposing surface 11S of the first member 11 is brought into contact with the second opposing surface 12S of the second member 12 and fixed by welding. A method of fixing a part of the first opposing surface 11S of the first member 11 to the second opposing surface 12S of the second member 12 with an adhesive can be cited. The second opposing surface 12S is a surface of the second member 12 that faces the first member 11.

The first opposing surface 11S is preferably fixed to the second member 12 by welding at the first fixing portion 11T. Since welding improves the fixing strength between the first member 11 and the second member 12, it is possible to make it easier to push the second member 12 distally by the first member 11.

The longest straight line distance in the axial direction 1X from the first opposing surface 11S to the second opposing surface 12S is preferably 0.1 times or more, and 0.2 times or more the maximum outer diameter of the first member 11. It is more preferable that there be. This makes it easier for the gap between the first member 11 and the second member 12 to function as a buffer. On the other hand, the longest linear distance is preferably 0.5 times or less, more preferably 0.4 times or less, and even more preferably 0.3 times or less than the maximum outer diameter of the first member 11. preferable. This makes it easier to push the chip 1 in the axial direction 1X.

As shown in FIG. 2, in the cross section of the chip 1 in the axial direction 1X, the angle between the outer edge of the first fixing portion 11T and the axial direction 1X is preferably 80 degrees or more and 100 degrees or less, and 85 degrees or more, It is more preferably 95 degrees or less, and even more preferably 88 degrees or more and 92 degrees or less. When the angle between the outer edge of the first fixing portion 11T and the axial direction 1X is closer to 90 degrees, it is easier to push the second member 12 distally by the first member 11.

As shown in FIG. 2, the first member 11 has a lumen 11L extending from a proximal end 11A to a distal end 11B, and the second member 12 has a lumen 11L extending from a proximal end 12A to a distal end 12B. It is preferable to have a lumen 12L communicating with the lumen 11L. This allows the flexibility of the chip 1 to be improved. Furthermore, a long body such as a guide wire can also be inserted into the

inner cavities

11L and 12L.

As shown in FIGS. 2 and 3, the non-fixed part 11Y is preferably located closer to the inner cavity 11L than the first fixed part 11T. The gap formed by the non-fixed portion 11Y arranged in this way buffers the force applied from the distal end 1B to the proximal end 1A of the tip 1, making it easier to avoid the tip 1 from penetrating the contact tissue. I can do it.

As shown in FIGS. 2 and 3, it is preferable that the first opposing surface 11S does not have a fixed part fixed to the second member 12 on the side closer to the inner cavity 11L than the non-fixed part 11Y. This forms a gap that communicates with the inner cavity 1L, making it easier to buffer the force applied from the distal end 1B to the proximal end 1A of the tip 1.

As shown in FIG. 3, the non-fixed portion 11Y is preferably a groove 11Z extending in the circumferential direction of the inner cavity 11L. The groove 11Z extending in the circumferential direction makes it easier to buffer the force applied from the distal end 1B to the proximal end 1A of the tip 1. In the cross section in the axial direction 1X, the groove 11Z is preferably V-shaped or U-shaped, more preferably U-shaped. It is preferable that the groove 11Z does not extend in the axial direction 1X. Thereby, the ability of the chip 1 to break through the stenosis can be improved.

The maximum depth of the groove 11Z is preferably 0.1 times or more, more preferably 0.2 times or more the maximum outer diameter of the first member 11. This makes it easier for the groove 11Z to function as a buffer. On the other hand, the maximum depth of the groove 11Z is preferably 0.4 times or less, more preferably 0.3 times or less, the maximum outer diameter of the first member 11. This makes it easier to push the chip 1 in the axial direction 1X.

As shown in FIG. 4, it is preferable that the groove 11Z extends in a part of the circumferential direction and does not extend all the way around the circumferential direction. This makes it easier for the second member 12 to bend slightly toward the groove 11Z when a force is applied in the axial direction 1X, making it easier to avoid the tip 1 sticking into the contact tissue.

As shown in FIG. 5, the non-fixed part 11Y has a part located closer to the inner cavity 11L than the first fixed part 11T, and a part not located closer to the inner cavity 11L than the first fixed part 11T. You can leave it there. This makes it easier for the tip 1 to bend in multiple directions, thereby improving the ability to follow the guide wire. Note that the first opposing surface 11S may have a plurality of first fixing portions 11T in the circumferential direction.

As shown in FIG. 5, the non-fixed portion 11Y may communicate with the inner cavity 1L of the chip 1 and the space outside the chip 1. Depending on the affected area, there may be no health problems even if a part of the tip 1 breaks and remains, so when inserting the tip 1 into such an affected area, make sure that the inner cavity 1L of the tip 1 and the outside of the tip 1 are By providing the non-fixed portion 11Y that communicates with the space and making it easier to break a part of the tip 1, it is possible to further prevent the tip 1 from penetrating the contact tissue. Furthermore, since the non-fixed portion 11Y communicates with the space outside the chip 1, the non-fixed portion 11Y can also function as a visual marker.

As shown in FIG. 2, the first opposing surface 11S preferably does not have a non-fixed part that is not fixed to the second member 12 on the outside of the first fixed part 11T. This makes it easier to prevent the opening portion of the chip 1 from being deformed, such as expanding outward, when the chip 1 is inserted.

As shown in FIGS. 6 and 7, the first opposing surface 11S has a second fixed part 11U fixed to the second member 12, and the second fixed part 11U is larger than the non-fixed part 11Y in the inner cavity 11L. It may be located on the side. This makes it easier to avoid the guide wire from getting caught in the inner cavity 1L of the tip 1.

As shown in FIGS. 6 and 7, the non-fixed part 11Y is located closer to the inner cavity 11L than the first fixed part 11T, and the second fixed part 11U is located closer to the inner cavity 11L than the non-fixed part 11Y. You can leave it there. According to such an arrangement, the gap formed by the non-fixed portion 11Y is closed in the radial direction, so that plastic deformation of the chip 1 can be easily prevented. Although not shown, it is preferable that the non-fixed portion 11Y extends in a part of the circumferential direction and does not extend all the way around the circumferential direction. This makes it easier for the second member 12 to bend slightly toward the non-fixed portion 11Y when a force is applied in the axial direction 1X, making it easier to avoid the tip 1 penetrating the contact tissue. Although not shown, the first opposing surface 11S shown in FIGS. 6 and 7 may further include a non-fixed portion closer to the inner cavity 11L than the second fixed portion 11U. It is preferable that the non-fixed portion is a groove extending in the circumferential direction of the inner cavity 11L. Further, it is preferable that the non-fixed portion extends in a part of the circumferential direction and does not extend all the way around the circumferential direction.

As shown in FIG. 6, the angle between the outer edge of the second fixing part 11U and the axial direction 1X is preferably 80 degrees or more and 100 degrees or less, more preferably 85 degrees or more and 95 degrees or less, More preferably, the temperature is 88 degrees or more and 92 degrees or less. When the angle between the outer edge of the second fixing portion 11U and the axial direction 1X is closer to 90 degrees, it is easier to push the second member 12 distally by the first member 11.

As shown in FIG. 8, the first opposing surface 11S includes, in the circumferential direction, a plurality of first fixed portions 11T and a plurality of non-fixed portions 11Y each disposed between the plurality of first fixed portions 11T. You can leave it there. In this way, the first opposing surface 11S may have two or more non-fixed parts. This makes it easier for the tip 1 to bend in multiple directions, thereby improving the ability to follow the guide wire.

As shown in FIG. 1, it is preferable that the first member 11 has an enlarged diameter portion whose outer diameter increases toward the distal end 11B of the first member 11. It is preferable that the outer diameter of the expanded diameter portion continuously increases toward the distal end 11B. As a result, the distal side of the first member 11 becomes thicker, making it easier to push the second member 12 toward the distal side. The outer edge of the enlarged diameter portion in side view is preferably linear and/or curved, more preferably linear. Note that the first member 11 may have two or more enlarged diameter portions.

Although not shown, the first member 11 may have a constant diameter portion having a constant outer diameter on the distal side of the enlarged diameter portion. This allows the first member 11 to easily push the second member 12 toward the distal side.

The length of the first member 11 in the axial direction is preferably longer than the maximum outer diameter of the first member 11. Thereby, the first member 11 can be easily inserted into the narrowed portion.

As shown in FIG. 1, the second member 12 preferably has a reduced diameter portion where the outer diameter decreases toward the distal end 12B of the second member 12. It is preferable that the outer diameter of the reduced diameter portion decreases continuously toward the distal end 12B. As a result, the distal side of the second member 12 has a tapered shape, so that the second member 12 can be easily pushed into the narrowed portion. The outer edge of the reduced diameter portion in side view is preferably linear and/or curved, more preferably linear. Note that the second member 12 may have two or more reduced diameter portions.

As shown in FIG. 1, in a side view of the tip 1, the angle of inclination of the outer edge of the enlarged diameter portion with respect to the axial direction 1X is preferably larger than the angle of inclination of the outer edge of the reduced diameter portion with respect to the axial direction 1X. This makes it easier to push the first member 11 distally by the second member 12, and also makes it easier to insert the second member 12 into the stenosis.

Preferably, the second member 12 includes the distal end 1B of the tip 1. This makes it easier to push the second member 12 into the narrowed portion. Further, it is preferable that the tip 1 does not include any other member distal to the second member 12.

Although not shown, the second member 12 may have a constant diameter portion having a constant outer diameter on the proximal side of the reduced diameter portion. This makes it easier to push the second member 12 toward the distal side.

The length of the second member 12 in the axial direction is preferably longer than the length of the first member 11 in the axial direction. Thereby, the force applied to the entire chip 1 is easily damped by the gap between the first member 11 and the second member 12. The axial length of the first member 11 is the axial length from the proximal end 11A to the distal end 11B of the first member 11, and the axial length of the second member 12 is the axial length of the second member 11. It is the length in the axial direction from the proximal end 12A to the distal end 12B of No. 12.

The length of the second member 12 in the axial direction is preferably longer than the maximum outer diameter of the second member 12. Thereby, the second member 12 can be easily inserted into the narrowed portion.

It is preferable that the first member 11 contains a first resin, and the second member 12 contains a second resin having a melting point that is the same as or lower than the melting point of the first resin. Thereby, when fixing the second member 12 by heating to the first member 11 fixed to the inner tube 2 as described later, it is possible to reduce the heating temperature when fixing the second member 12. Therefore, thermal stress applied to the inner tube 2 can be reduced. More preferably, the first member 11 is made of a first resin. It is more preferable that the second member 12 is made of a second resin having a melting point that is the same as or lower than the melting point of the first resin. Further, the melting point of the second member 12 is preferably the same as or lower than the melting point of the first member 11, and more preferably lower than the melting point of the first member 11. The melting point can be measured, for example, by DSC, and it is preferable that the temperature at which the top of the endothermic peak of the DSC curve appears is determined as the melting point.

The first member 11 is preferably fixed to the second member 12, for example, by the following method. Specifically, as shown in FIG. 9, after inserting the distal end 2b of the inner tube 2 of the medical device into the inner cavity 11L of the first member 11 and fixing the first member 11 to the inner tube 2, the first member 11 is fixed to the inner tube 2. It is preferable to fix the first member 11 to the second member 12 after bringing at least a portion of the first opposing surface 11S of the first member 11 into contact with the second opposing surface 12S of the second member 12. This reduces the thermal stress during manufacturing on the fixed portion of the first member 11 and second member 12, compared to the case where the first member 11 is fixed to the second member 12 and then the first member 11 is fixed to the inner tube 2. etc., it is possible to easily maintain the fixing strength of the fixing portion of the second member 12 of the first member 11.

As a method for fixing the first member 11 and the second member 12, welding is preferable, and thermal welding is more preferable. As the thermal welding, hot air welding is preferred. For example, in the chip 1 shown in FIGS. 1 to 3, a cooled core material is inserted into the inner cavity 1L with the first opposing surface 11S of the first member 11 in contact with the second opposing surface 12S of the second member 12. After the first member 11 and the second member 12 are inserted, the contact portion between the first member 11 and the second member 12 can be formed by welding from the outside with hot air. Further, the chip 1 shown in FIG. 4 can be formed, for example, by inserting a partially cooled core material into the inner cavity 1L and welding it from the outside with hot air in the same manner as described above. Further, the chip 1 shown in FIG. 5 is formed by, for example, inserting a cooled core material into the inner cavity 1L and applying hot air partially to the contact portion between the first member 11 and the second member 12 in the radial direction. be able to. For the chip 1 shown in FIGS. 6 and 7, for example, the core material is heated to a temperature within the melting point of the chip 1 +10°C, and the heating is preferably performed by external hot air at the same temperature for 1 second or more and 5 seconds or less. It can be formed by performing the process for a while. The chip 1 shown in FIG. 8 can be formed by partially applying hot air to the contact portion between the first member 11 and the second member 12 in the radial direction from the outside.

The first member 11 and the second member 12 may be fixed with an adhesive. Examples of the adhesive include hot melt adhesives, moisture curing adhesives, ultraviolet curable adhesives, and two-component curing adhesives. Among these, hot-melt adhesives and moisture-curing adhesives are preferred. Examples of adhesives include acrylic adhesives, polyurethane adhesives, cyanoacrylate adhesives, silicone adhesives, vinyl acetate adhesives, and epoxy adhesives. These may be used alone or in combination of two or more.

The first member 11 and the second member 12 each preferably contain resin, and are more preferably made of resin. Preferably, the resin is a thermoplastic resin. Specifically, the resins include polyolefin resins such as polyethylene and polypropylene, polyamide resins such as polyamide and polyether polyamide, polyester resins such as polyethylene terephthalate and polybutylene terephthalate, polytetrafluoroethylene, and tetrafluoroethylene/hexafluoropropylene copolymers. Fluororesins such as combinations, polyvinyl chloride resins, silicone resins, polyurethane resins, ethylene-vinyl acetate copolymer resins, polyetheretherketone resins, polyetherimide resins, polyolefin elastomers, polyamide elastomers, polyester elastomers, polyurethane elastomers, or these Preferably, it is a mixture of. These may be used alone or in combination of two or more. Further, the first member 11 and the second member 12 may each contain additives such as a hydrolysis inhibitor, a flame retardant, a filler, and a crosslinking agent. The first member 11 and the second member 12 may contain the same resin, but preferably contain different resins. Further, the first member 11 and the second member 12 may each have a multilayer structure, and each layer may contain a different resin or the same resin.

The first member 11 and the second member 12 can be manufactured using the above resins, for example, by injection molding or extrusion molding.

The chip 1 preferably contains the above resin, and is preferably made of the above resin. The chip 1 may have X-ray opaque particles and/or X-ray opaque marker bands kneaded with the resin. Examples of the X-ray opaque particles include particles made of an X-ray opaque substance. Examples of the radiopaque marker band include marker bands made of a radiopaque substance. The radiopaque material can be gold, platinum, silver, tungsten, tantalum, iridium, palladium, rhenium, rhodium, tin, nickel, titanium, alloys thereof, barium sulfate, bismuth compounds, tungsten compounds, or mixtures thereof. It is preferable that there be. Preferably, the alloy is a gold-palladium alloy, a platinum-iridium alloy, a NiTiPd alloy, a NiTiAu alloy, a NiTi alloy or a mixture thereof. These may be used alone or in combination of two or more.

Although the chip according to the embodiment has been described above, the medical device according to the embodiment will be described below. As shown in FIGS. 10 and 11, the medical device 10 according to the embodiment is a medical device for transporting a medical device 4 into the body, and includes an inner tube 2 and at least one portion of the inner tube 2 in the inner cavity 3L. an outer tube 3 in which a part is arranged; a tip 1 fixed to at least a part of the distal end 2b of the inner tube 2; an outer surface 2O of the distal end 2b of the inner tube 2; 3 and an inner surface 3I of the medical device 4.

The inner tube 2 has a lumen 2L, and the lumen 2L is configured so that a guide wire can be inserted therein. Thereby, the medical device 4 and the like can be delivered to the stenosis by moving the inner tube 2 and the like along the guide wire.

Preferably, at least a portion of the distal end 2b of the inner tube 2 is fixed to the inner surface of the tip 1. Therefore, it is preferable that a part of the inner cavity 1L of the tip 1 has a diameter equal to or larger than the outer diameter of the inner tube 2 so that the distal end 2b of the inner tube 2 can be accommodated therein. Furthermore, the other portion of the lumen 1L of the tip 1 may have a diameter equal to or less than the diameter of the lumen 2L of the inner tube 2. The chip 1 and the inner tube 2 may be directly fixed by thermal welding or the like, or may be indirectly fixed using an adhesive or the like.

The distal end of the inner tube 2 is preferably located closer to the proximal side than the distal end 11B of the first member 11 of the tip 1. Thereby, the force applied to the second member 12 can be easily damped by the gap between the first member 11 and the second member 12.

It is preferable that the first member 11 is fixed to the inner tube 2 and the second member 12 is not fixed to the inner tube 2. Thereby, the force applied to the second member 12 can be easily buffered by the gap between the first member 11 and the second member 12.

It is sufficient that at least a portion of the inner tube 2 is disposed in the inner cavity 3L of the outer tube 3. Preferably, the distal end of the inner tube 2 is located more distally than the distal end of the outer tube 3. This can prevent kinks and reduce rigidity differences. Further, it is preferable that the proximal portion of the inner tube 2 is detachably fixed directly or indirectly to the proximal portion of the outer tube 3. As a result, during delivery, the above-mentioned fixation is performed to prevent unintended movement of the medical device 4, while when the medical device 4 is to be operated, the above-mentioned fixation is removed and the outer tube 3 is moved proximally, thereby preventing the medical device 4 from moving unintentionally. 4 can be operated. The operations of the medical device 4 include operations such as expansion, deployment, and detachment. Note that the above-mentioned attachment and detachment can be performed via an outer handle member 7, which will be described later.

When the medical device 4 is a self-expanding type described below, it is placed between the outer surface 2O of the distal end 2b of the inner tube 2 and the inner surface 3I of the outer tube 3, so that the medical device 4 can maintain a contracted state. It can be maintained and expanded by moving distally from the outer tube 3. Furthermore, the tip 1 can avoid malfunctions such as the medical device 4 moving distally from the outer tube 3 and being deployed before the medical device 4 is placed in the stenotic region.

It is preferable that the distal end 4B of the medical device 4 is located closer to the proximal side than the non-fixed portion 11Y of the first opposing surface 11S. Thereby, damage to the distal end 4B of the medical device 4 due to movement of the tip 1 during delivery can be easily avoided. On the other hand, it is preferable that the distal end 4B of the medical device 4 is located more distally than the proximal end 11A of the first member 11. Thereby, the movement of the medical device 4 in the axial direction can be reduced and positional deviation can be prevented. Furthermore, by overlapping the distal end of the medical device 4 and the tip 1, it is possible to reduce the difference in rigidity and make it easier to prevent kinks.

As shown in FIG. 11, the inner tube 2 preferably has an inner handle member 6 at the proximal end 2a. The outer tube 3 also preferably has an outer handle member 7 at the proximal end 3a. As a result, for example, by pulling the outer tube 3 through the outer handle member 7 while holding the inner handle member 6, the medical device 4 can be positioned on the distal side of the outer tube 3. can work.

It is preferable that the pusher member 5 is fixed to the outer surface 2O of the inner tube 2. The pusher member 5 allows the medical device 4 to be pushed out easily. It is preferable that the pusher member 5 is a tubular body.

As shown in FIG. 12, the outer tube 3 may be movable in the axial direction. For example, the medical device 10 includes an outermost tube 3X in which at least a portion of the outer tube 3 is disposed in the inner lumen 3XL, and a line in which the distal end 3Yb is fixed to the proximal end 3a of the outer tube 3. It is preferable to have a shaped member 3Y. Furthermore, it is more preferable that the outermost tube 3X and the inner tube 2 have inner handle members 6 at the proximal end 3Xa and the proximal end 2a. With this configuration, for example, by pulling the linear member 3Y toward the user's hand via the outer handle member 7 while holding the inner handle member 6, the outer tube 3 can be pulled back toward the user's hand within the outermost tube 3X. , and the medical device 4 can be operated. Note that the linear member 3Y may be a rotating body such as a thumbwheel, or may be wound around a rotating body.

As shown in FIG. 11, the outer handle member 7 may have a flush lumen 8. Thereby, a desired liquid can be injected from the flushing lumen 8 into the lumen 3L of the outer tube 3.

The outer tube 3 may have an X-ray opaque region at the distal end 3b. Thereby, the position of the distal end portion 3b of the outer tube 3 can be grasped. The radiopaque region is preferably located more proximally than the distal end 11B of the first member 11 of the chip 1 and more distally than the proximal end 11A. Thereby, the outer tube 3 can increase the rigidity of the distal end portion 3b. The radiopaque region may contain radiopaque particles and/or radiopaque marker bands intermixed with the resin. Examples of the X-ray opaque particles include particles made of an X-ray opaque substance. Examples of the radiopaque marker band include marker bands made of a radiopaque substance. Regarding the X-ray opaque substance, refer to the description of the X-ray opaque substance in the chip 1.

It is preferable that the inner tube 2, outer tube 3, pusher member 5, and outermost tube 3X each contain resin. Preferably, the resin includes polyethylene, polyimide, polyether block amide, polyamide, polyurethane, polyester, silicone, polyamide elastomer, fluororesin such as PTFE, PFA, or a mixture thereof. These may be used alone or in combination of two or more. The resin may also contain additives such as hydrolysis inhibitors, flame retardants, fillers, and crosslinking agents. The inner tube 2, the outer tube 3, and the outermost tube 3X may each have an inner layer and an outer layer. The inner tube 2, the outer tube 3, and the outermost tube 3X may have a tubular reinforcing member. Examples of the reinforcing member include a spiral wire rod, a braided wire rod, and the like. Examples of the wire include stainless steel, titanium, cobalt chromium alloy, Ni-Ti, tungsten, polyarylate fiber, aramid fiber, ultra-high molecular weight polyethylene fiber, PBO fiber, carbon fiber, and mixtures thereof. Furthermore, examples of the material of the linear member 3Y include stainless steel, titanium, cobalt chromium alloy, Ni--Ti, and tungsten. These may be used alone or in combination of two or more.

Preferably, the medical device 4 includes an X-ray opaque substance. Thereby, the position of the medical device 4 can be confirmed under X-ray fluoroscopy. Regarding the X-ray opaque substance, refer to the description of the X-ray opaque substance in the chip 1. The medical device 4 preferably contains resin and/or metal, more preferably contains metal, and still more preferably consists of metal.

Preferably, the medical device 4 is a medical tubular body. Preferably, the medical tubular body is a stent, stent graft, obturator, infusion catheter, or prosthetic valve, more preferably a stent. Stents include, for example, coiled stents made of linear resin and/or metal, stents made by cutting out a tube with a laser, and stents made by cutting out a sheet with a laser and then winding it into a cylindrical shape and laser welding it. , a stent made by welding linear bodies together using a laser, and a stent made by weaving a plurality of linear resins and/or metals. The stent is preferably a balloon-expandable stent that expands using a balloon mounted on the stent, or a self-expanding stent that expands by itself by removing an external member that inhibits the expansion of the stent. More preferred. Further, the medical device 4 may be a stent having a shape other than a tubular shape, a stent graft having a shape other than a tubular shape, an obturator having a shape other than a tubular shape, or the like. Examples of shapes other than tubular include spherical. Further, the medical device 4 may be any device as long as it can be used in conjunction with the inner tube 2, outer tube 3, and tip 1, and may be, for example, a balloon, a basket, a snare, or an obturator.

The medical device 10 is preferably a medical tubular body transport device that transports the medical tubular body 4 into the body. The medical device 10 can be used for strictures occurring in the coronary arteries of the heart, other blood vessels, the trachea, the esophagus, the bile ducts, the urethra, and the like.

This application claims the benefit of priority based on Japanese Patent Application No. 2022-042700 filed on March 17, 2022. The entire contents of the specification of Japanese Patent Application No. 2022-042700 filed on March 17, 2022 are incorporated by reference into this application.

1 Tip 1A Proximal end of the tip 1B Distal end of the tip 1L Internal lumen of the tip 1X Axial direction of the tip 2 Inner tube 2a Proximal end of the inner tube 2b Distal end of the inner tube 2O Outer surface of the inner tube 2L Inner lumen of inner tube 3 Outer tube 3a Proximal end of outer tube 3b Distal end of outer tube 3L Inner lumen of outer tube 3I Inner surface of outer tube 3X Outermost tube 3Xa Proximal end 3XL Inner lumen 3Y Line shaped member 3Yb distal end 4 medical device 4B distal end of medical device 5 pusher member 6 inner handle member 7 outer handle member 8 flush lumen 10 medical device 10b distal end 11 first member 11A proximal end 11B Distal end 11b Distal end 11L Lumen of first member 11S First opposing surface 11T First fixed part 11U Second fixed part 11Y Non-fixed part 11Z Groove 12 Second member

12A Proximal end

12B Distal end 12L Lumen 12S second opposing surface

Claims

A chip used at the distal end of a medical device inserted into the body,
a first member including a proximal end of the tip;
a second member located on the distal side of the distal end of the first member;
The first member has a first opposing surface facing the second member, and the first opposing surface includes a first fixing part fixed to the second member and a first fixing part fixed to the second member. A chip that does not have a non-fixed part.
the first member has a lumen extending from a proximal end to a distal end;
The tip of claim 1, wherein the second member has a lumen extending from a proximal end to a distal end and communicating with the lumen.
The chip according to claim 2, wherein the non-fixed part is located closer to the lumen than the first fixed part.
The first opposing surface has a second fixing part fixed to the second member,
The chip according to claim 2, wherein the second fixed part is located closer to the inner cavity than the non-fixed part.
The chip according to claim 2, wherein the first opposing surface does not have a fixing part fixed to the second member on the lumen side of the non-fixing part.
The chip according to claim 2, wherein the non-fixed portion is a groove extending in the circumferential direction of the inner cavity.
The chip according to claim 6, wherein the groove extends in a part of the circumferential direction and does not extend all the way around the circumferential direction.
The chip according to claim 1, wherein the first opposing surface does not have a non-fixed part that is not fixed to the second member on the outside of the first fixed part.
The tip according to claim 1, wherein the first member has an enlarged diameter portion whose outer diameter increases toward the distal end of the first member.
The first member includes a first resin,
The chip according to claim 1, wherein the second member includes a second resin having a melting point that is the same as or lower than the melting point of the first resin.
The chip according to claim 1, wherein the first opposing surface is fixed to the second member by welding at the first fixing part.
The chip according to claim 1, wherein the medical device is a medical tubular body transport device that transports a medical tubular body into the body.
A medical device inserted into the body,
an inner tube;
an outer tube having at least a portion of the inner tube disposed in a lumen;
The chip according to any one of claims 1 to 12, which is fixed to at least a portion of the distal end of the inner tube;
A medical device having a medical device disposed between an outer surface of the distal end of the inner tube and an inner surface of the outer tube.
The medical device according to claim 13, wherein the distal end of the medical device is located closer to the non-fixed portion of the first opposing surface.
The medical device according to claim 13, wherein the first member is fixed to the inner tube, and the second member is not fixed to the inner tube.
The medical device according to claim 13, wherein the medical tool is a medical tubular body, and is a medical tubular body transport device that transports the medical tubular body into the body.