JP2018164761A - Catheter and balloon catheter - Google Patents

Abstract

Provided is a catheter capable of suppressing an increase in outer diameter at an end portion of a reinforcing body while suppressing the lifting of the reinforcing body.
A catheter 11A includes a tubular inner layer 100, a coil body 110 as a reinforcing body wound around the outer periphery of the inner layer 100, a protective layer 120 covering the outer periphery of the end of the coil body 110, and at least An outer layer 130 covering the outer periphery of the protective layer 120, the protective layer 120 covering at least the outer periphery of the tip of the coil body 110, and the coil body 110 covered by the protective layer 120. The strand 110a is buried on the inner layer 100 side with respect to the strand 110a of the coil body 110 that is not covered with the protective layer 120.
[Selection] Figure 2

Description

  The present invention relates to a medical catheter and a balloon catheter.

  As a conventional catheter, for example, as disclosed in Patent Document 1, an inner layer, a coil layer (reinforcing body) formed by winding a wire material around the inner layer, and an outer layer covering the coil layer, A configuration including a long tubular body including the above has already been proposed.

  Patent Document 2 discloses an inner layer, a reinforcing layer composed of a coil layer composed of an inner layer, a first coil deposited on the outer side of the inner layer, and a second coil, and an outer layer deposited on the outer side of the reinforcing layer. A medical tube having the following is disclosed.

  However, in the catheter of the above-mentioned patent document 1 and the medical tube of the above-mentioned patent document 2, there is a problem that the end of the coil is lifted because the coil as a reinforcing body tends to spread by the springback when it is bent. is there.

  In addition, as a configuration that can solve such a problem, Patent Document 3 includes an inner layer, an outer layer, and an intermediate layer (reinforcing body) that is provided so as to be sandwiched between the inner layer and the outer layer, and is formed using a linear body. And an outer catheter in which the tip of the intermediate layer is covered with a contrast ring (protective layer).

JP 2012-1000082 A Japanese Patent No. 3659664 JP 2012-249812 A

  However, the outer catheter of Patent Document 3 has a problem that the outer diameter of the catheter becomes thick at the end of the intermediate layer because the contrast ring becomes thick.

  Then, an object of this invention is to provide the catheter and balloon catheter which can suppress that an outer diameter becomes large at the edge part of a reinforcement body, suppressing the lifting of a reinforcement body.

  The present invention includes a tubular inner layer, a reinforcing body wound around the outer periphery of the inner layer, a protective layer partially covering the outer periphery of the reinforcing body, and an outer layer covering at least the outer periphery of the protective layer, The protective layer covers at least the outer periphery of one end of the reinforcing body, and the one end of the reinforcing body covered with the protective layer is not covered with the protective layer. The catheter is buried on the inner layer side of the portion.

  In such a configuration, since the end portion of the reinforcing body is covered with the protective layer, the end portion of the reinforcing body is suppressed from being lifted during bending. In addition, since the end of the reinforcing body covered with the protective layer is buried and restrained in the inner layer, the relative movement with respect to the inner layer is less than the portion of the reinforcing body that is not buried. It is suppressed, and the floating at the time of bending is suppressed more reliably. Furthermore, since the end portion of the reinforcing body is buried in the inner layer, the outer diameter of the entire catheter is suppressed from being thicker than the other portions in the portion.

  The protective layer is preferably made of a resin.

  In such a configuration, the catheter can be easily manufactured and processed. Further, by adopting a resin having generally low rigidity for the protective layer, breakage of the catheter can be suppressed.

  Furthermore, the protective layer is preferably composed of a heat-shrinkable resin tube.

  If the protective layer is formed of a so-called heat-shrinkable resin tube as in this configuration, the manufacturing process can be simplified.

  The outer layer is preferably made of a resin, and the resin constituting the protective layer preferably has a higher melting point than the resin constituting the outer layer.

  In such a configuration, when the outer layer is melted into the inner layer, the protective layer can be prevented from being thinned when melted. For this reason, it becomes possible to ensure the strength of the protective layer, and it is possible to more reliably prevent the end of the reinforcing body from rising.

  The protective layer preferably covers both one end and the other end of the reinforcing body.

  In this configuration, the reinforcing body can be further reliably prevented from floating from the inner layer due to the spring back, and the outer diameter is also prevented from becoming thick at one end and the other end of the reinforcing body. can do.

  Furthermore, the balloon catheter of the present invention includes the catheter and a balloon joined to the outer periphery of the outer layer of the catheter.

  In such a configuration, it is possible to provide a balloon catheter having a structure in which lifting of the end portion of the reinforcing body is suppressed.

  ADVANTAGE OF THE INVENTION This invention can provide the catheter which can suppress that an outer diameter becomes thick at the edge part of a reinforcement body, suppressing the lifting of the edge part of a reinforcement body.

  Moreover, this invention can provide a balloon catheter provided with the structure which can suppress that an outer diameter becomes large at the edge part of a reinforcement body, suppressing the lifting of the edge part of a reinforcement body.

1 is a plan view of a catheter according to Example 1. FIG. 1 is a partially enlarged cross-sectional view of a catheter according to Example 1. FIG. FIG. 6 is an explanatory diagram illustrating a manufacturing process of a catheter according to Example 1; 6 is a partially enlarged cross-sectional view of a catheter according to Example 2. FIG. 10 is a partial enlarged cross-sectional view of a catheter according to Example 3. FIG. 6 is a partial cross-sectional plan view of a balloon catheter according to Example 4. FIG. FIG. 6 is a partially enlarged cross-sectional view of a balloon catheter according to Example 4. FIG. 10 is a partial enlarged cross-sectional view of a balloon catheter according to Example 5.

  Hereinafter, the embodiment which actualized the catheter of the present invention is described in detail. However, the present invention is not limited to the examples shown below, and the design can be changed as appropriate. 1 to 8, the left side is the distal end side (distal side) to be inserted into the body, and the right side is the rear end side (proximal side, proximal end side) operated by an operator such as a doctor.

[Example 1]
As shown in FIG. 1, the catheter device 1A includes a catheter 11A. The catheter 11A includes an operation unit 10 operated by an operator, a main body unit 15 extending from the operation unit 10, and a main body unit 15. And a distal end portion 16 located on the distal end side.

  More specifically, as shown in FIG. 2, the catheter 11 </ b> A has a tubular inner layer 100. The inner layer 100 constitutes an inner lumen 101 through which a guide wire or the like is inserted.

  In addition, a coil body 110 as a reinforcing body formed by spirally winding an element wire 110 a is disposed on the outer periphery of the inner layer 100.

  Further, a protective layer 120 is formed on the outer periphery of the tip portion that is one end portion of the coil body 110, and the tip portion of the coil body 110 is covered with the protective layer 120. An unprotected portion 122 that is not covered with the protective layer 120 is formed on the proximal end side of the distal end portion of the coil body 110. Therefore, the protective layer 120 partially covers the outer periphery of the coil body 110.

  Further, the portion of the coil body 110 covered by the protective layer 120 is in a state where the strand 110a of the coil body 110 is buried in the inner layer 100 on the inner layer 100 side. On the other hand, the strand 110a of the coil body 110 in the non-protected portion 122 is not buried in the inner layer 100.

  An outer layer 130 is formed on the outer periphery of the inner layer 100, the coil body 110, and the protective layer 120. The outer layer 130 covers the inner layer 100, the coil body 110, and the protective layer 120. ing.

  Furthermore, a coating layer that covers the outer layer 130 may be provided on the outer periphery of the outer layer 130.

  The distal end portion 16 of the catheter 11 </ b> A is configured by a portion from the distal end of the inner layer 100 to the distal end of the coil body 110.

  The inner layer 100 is preferably made of a resin such as polyethylene, polyurethane, polyamide, polyamide elastomer, polyolefin, polyester, or polyester elastomer. In consideration of slidability with a guide wire or the like inserted into the inner lumen 101, the inner peripheral surface of the inner layer 100 may be covered with a fluorine resin such as PEFE.

  The coil body 110 is preferably composed of a superelastic alloy such as stainless steel (SUS304), tungsten, or a Ni—Ti alloy. Note that the cross-sectional shape of the wire 110a of the coil body 110 is not limited to a rectangle, and may be a circle, an ellipse, a polygon, or the like.

  The protective layer 120 is preferably formed of a heat-shrinkable resin tube having a melting point higher than that of the outer layer 130. For example, a polyethylene terephthalate resin (PET resin), a polyimide resin, a polyether ether ketone resin ( The tube etc. which were comprised with PEEK resin) are preferable. Therefore, when the outer layer 130 is melted into the inner layer 100, the protective layer 120 can be prevented from being thinned at the time of melting, and as a result, the strength of the protective layer 120 can be ensured. Thus, it is possible to reliably prevent the end of the coil body 110 from being lifted. In addition, although the said protective layer 120 may be comprised with a metal material, when the manufacture and process of the catheter 11A become easy, it is preferable that the said protective layer 120 is comprised with resin. Further, by adopting a resin having generally low rigidity for the protective layer 120, breakage of the catheter 11A can be suppressed.

  The outer layer 130 is preferably made of a resin such as polyethylene, polyurethane, polyamide, polyamide elastomer, polyolefin, polyester, or polyester elastomer.

  In the catheter 11A, when the catheter 11A is bent, the protective layer 120 prevents the coil body 110 from being lifted from the inner layer 100 by springback. Further, the tip of the coil body 110 covered with the protective layer 120 is buried in the inner layer 100, and the periphery of the wire 110a of the coil body 110 of the portion is covered with the inner layer 100. The distal end portion of the coil body 110 is constrained by the inner layer 100, and the distal end portion of the coil body 110 is further less likely to float during bending. Furthermore, since the distal end portion of the coil body 110 is buried in the inner layer 100, the outer diameter of the catheter 11A is suppressed from being increased.

  Moreover, since the strand 110a of the coil body 110 in the unprotected portion 122 is not buried in the inner layer 100, flexibility as an elastic body is not impaired. Compared to the case where the entire length of the coil body 110 is buried in the inner layer 100 without providing the non-protection portion 122, the catheter 11A is likely to bend along the blood vessels and digestive organs. As a result, when the catheter 11A is inserted into a blood vessel or digestive organ, the catheter 11A is unlikely to break during the process.

  Note that the wire 110a of the coil body 110 may be completely buried in the inner layer 100, or the wire 110a may be partially buried in the inner layer 100 and embedded. Good.

Hereinafter, a method for manufacturing the catheter 11A will be briefly described.
First, as shown in FIG. 3A, the coil body 110 is wound around the outer periphery of the inner layer 100, and a heat-shrinkable resin tube 120 a is disposed on the outer periphery of the distal end portion of the coil body 110.

  Next, the heat-shrinkable resin tube 120a is heated and shrunk to form the protective layer 120, and the wire 110a at the tip of the coil body 110 is pressed against the inner layer 100 as shown in FIG. Then, only the depth d is buried.

  And as shown in FIG.3 (c), the said outer layer 130 is welded to the outer periphery of the said inner layer 100, the said coil body 110, and the said protective layer 120. FIG. The outer layer 130 may be formed after the heat-shrinkable resin tube for forming the protective layer 120 is heat-shrinked or may be formed when heat-shrinking.

  As described above, by using the heat-shrinkable resin tube 120a for the protective layer 120, when the outer layer 130 is welded to the inner layer 100, the protective layer 120 can be formed at one time. It can be simplified.

  In addition, the said manufacturing method is an example, Comprising: Of course, another manufacturing method may be employ | adopted. For example, the protective layer 120 may be formed around the coil body 110 after the coil body 110 is fitted into the inner layer 100 side by so-called caulking. In addition, without using the heat-shrinkable resin tube 120a as the protective layer 120, a tube made of a resin material or a metal material is disposed on the outer periphery of the tip portion of the coil body 110, and then the element of the coil body 110 is subjected to caulking. The wire 110a may be buried on the inner layer 100 side.

[Example 2]
A catheter 11B according to Example 2 will be described with reference to FIG. In addition, what has the structure similar to Example 1 attaches | subjects the same code | symbol, and abbreviate | omits description.

  The catheter 11B in the catheter device 1B uses a blade 111 in which a plurality of strands 111a are knitted in a mesh shape (mesh shape) instead of the coil body 110 of the first embodiment. The blade 111 corresponds to a reinforcing body. In addition, it is preferable that the some strand 111a which comprises the said blade 111 is comprised with superelastic alloys, such as stainless steel (SUS304), tungsten, and a Ni-Ti alloy. The cross-sectional shape of the plurality of strands 111a constituting the blade 111 is not limited to a rectangle, and may be a circle, an ellipse, a polygon, or the like.

  The tip of the blade 111 is covered with a protective layer 120, and the strand 111 a of the blade 111 covered with the protective layer 120 is buried in the inner layer 100.

Even in such a configuration, when the catheter 11B is curved, the protective layer 120 prevents the blade 111 from being lifted up from the inner layer 100 by the spring back. Also, since the tip of the blade 111 covered with the protective layer 120 is buried in the inner layer 100, the tip of the blade 111 is constrained by the tip of the blade 111 being covered with the inner layer 100, The lifting of the blade 111 when bent is further suppressed. Furthermore, since the blade 111 is buried in the inner layer 100, the outer diameter of the catheter 11B is prevented from being increased. Moreover, since the strand 111a of the blade 111 in the non-protected portion 122 is not buried in the inner layer 100, flexibility as an elastic body is not impaired. Compared to the case where the entire length of the blade 111 is buried in the inner layer 100 without providing the non-protection portion 122, the catheter 11B is likely to bend along the blood vessels and digestive organs. As a result, when the catheter 11B is inserted into a blood vessel or digestive organ, the catheter 11B is less likely to break along the way.

Example 3
A catheter 11C according to Example 3 will be described with reference to FIG. In addition, what has the structure similar to Example 1, 2 attaches | subjects the same code | symbol, and abbreviate | omits description.

  In the catheter 11C used in the catheter device 1C, a protective layer 121 is provided on the rear end, which is the other end, in addition to the front end of the coil body 110. The protective layer 121 embeds the rear end of the coil body 110 on the inner layer 100 side by a depth d.

  By adopting such a configuration, it is possible to prevent the coil body 110 from floating at the front end portion and the rear end portion of the coil body 110. Furthermore, it can suppress that an outer diameter becomes large in the front-end | tip part and rear-end part of the coil body 110. FIG.

Example 4
A balloon catheter 1D according to Example 4 will be described with reference to FIG. In addition, what has the structure similar to Examples 1-3 attaches | subjects the same code | symbol, and abbreviate | omits description.

  For example, a balloon catheter 1D used for treatment of a stenosis in a blood vessel of the heart includes a balloon 20. Moreover, the outer shaft 30, the connector 40, the inner shaft 50 corresponding to the said catheter 11A, the chip | tip 60, and the core wire 90 are comprised.

  The balloon 20 has a function of expanding the narrowed portion and is made of a resin member. And it has the front-end | tip attachment part 22 in the front end side, and has the rear-end attachment part 23 in the rear end side. The front end attachment portion 22 is joined to the front end of the inner shaft 50 via a tip 60, and the rear end attachment portion 23 is joined to the front end of the outer shaft 30.

  The outer shaft 30 has a function of supplying a fluid, and is composed of a tubular member constituting an expansion lumen 36 for supplying the fluid. Further, the outer shaft 30 has a front outer shaft portion 31, a guide wire port portion 33, an intermediate outer shaft portion 35, and a rear end outer shaft portion 37 in order from the front end side. The guide wire port portion 33 is a portion where the distal end outer shaft portion 31, the intermediate outer shaft portion 35, and the inner shaft 50 are joined.

  As shown in FIG. 7, the balloon catheter 1 </ b> D having such a configuration has an inner shaft 50 as the catheter 11 </ b> A in which the lifting of the end of the coil body 110 is suppressed. Therefore, when the balloon 20 is expanded, it is pressurized in the outer circumferential direction by a contrast medium, physiological saline, or the like, so that the end of the coil body 110 tends to float, but this state is effective. Can be suppressed.

Example 5
A balloon catheter 1E according to Example 5 will be described with reference to FIG. In addition, what has the structure similar to Examples 1-4 attaches | subjects the same code | symbol, and abbreviate | omits description.

  As shown in FIG. 8, the balloon catheter 1E is obtained by applying the catheter 11A of Example 1 to the distal outer shaft portion 31. Even when such a structure is adopted, the balloon catheter 1E in which the lifting of the end of the coil body 110 is suppressed can be obtained.

  In addition, this invention is not limited to embodiment of Examples 1-5, For example, the dimension shape of each part can be freely changed suitably.

  Moreover, in Example 4 and 5, although the catheter 11A of Example 1 was applied to the said inner shaft 50 and the said front-end | tip outer shaft part 31, it is not limited to this. For example, the catheter 11B of Example 2 may be applied to the inner shaft 50 and the distal outer shaft part 31, or the catheter 11C of Example 3 may be applied to the inner shaft 50 and distal outer shaft part 31. Also good.

  Further, in Examples 1 to 5 above, the coil body 110 and the blade 111 that are the reinforcing bodies are not buried at all in the inner layer 100 in the non-protected portion 122 that is not covered with the protective layer 120. It is not limited. In the non-protected portion 122, the coil body 110 and the blade 111, which are reinforcing bodies, may be somewhat buried in the inner layer 100 so as not to lose flexibility as an elastic body.

1A, 1B, 1C Catheter apparatus 1D, 1E Balloon catheter 11A, 11B, 11C Catheter 20 Balloon 100 Inner layer 110 Coil body (reinforcing body)
111 Blade (Reinforcing body)
120 Protective layer 122 Non-protected part 130 Outer layer

Claims (6)

A tubular body;
A reinforcing body wound around the tubular body;
A first resin layer formed of a first resin and covering an outer periphery of the first portion of the reinforcing body;
A second resin layer formed of a second resin and covering the outer periphery of the second portion of the reinforcing body and the outer periphery of the first resin layer;
With
The first portion of the reinforcing body is disposed so as to be positioned in the center direction of the tubular body with respect to the second portion of the reinforcing body in a cross-sectional view of the tubular body.
A long medical member characterized by the above.   The long medical member according to claim 1, wherein the resin forming the first resin layer has a higher melting point than the resin forming the second resin layer. In the reinforcing body, the strand is wound spirally,
The long medical member according to claim 1 or 2, wherein the medical member is long. The strands forming the reinforcing body have a long direction and a short direction,
The longitudinal direction of the reinforcing body is disposed along the long axis direction of the tubular body.
The long medical member according to claim 3. The tip of the first resin layer is disposed so as to be located on the tip side of the tip of the reinforcing layer.
The long medical member according to any one of claims 1 to 4, wherein the medical member is long. The long medical member further has an expansion body,
Circulating a fluid for inflating the expansion body through the inside of the tubular body;
The long medical member according to any one of claims 1 to 5, wherein the medical member is long.

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