JP2008086470A - Passing tube for medical device and catheter with the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a passing tube for medical device capable of excellently retaining lumen lubricating properties without impairing the operability of a medical device after the tube is repeatedly used, for example, in the endovascular treatment; and also to provide a catheter equipped with the tube. <P>SOLUTION: The passing tube for medical device has a layered structure consisting of a lubricating layer 4 and a flexible layer 5 disposed around the lubricating layer 4. The passing tube for medical device is characterized by the lubricating layer 4 which is made of a fluorine-containing ethylenic polymer to improve the reversibility as well as the lubricating property when the medical device passes through the tube. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to a medical device passing tube and a percutaneous angioplasty catheter provided with the tube. More specifically, the present invention is used in percutaneous angioplasty (PTA: Percutaneous Transluminal Angioplasty, PTCA: Percutaneous Transluminal Coronary Angioplasty, etc.) when performing peripheral angioplasty, coronary angioplasty, valvuloplasty, etc. A medical device passing tube suitable for transcutaneous and transluminal use, such as a balloon catheter, a suction catheter as described in JP-A-2004-65326, and a penetration catheter as described in JP-A-2004-154195, and the like It is related with the provided catheter. The medical device passage tube of the present invention is particularly useful for structurally determining the lumen of a catheter, such as a rapid-exchange catheter or an over-the-wire catheter. Useful.

Conventionally, in order to reduce physical and time burdens on patients, minimally invasive endovascular surgery in which a catheter is inserted into a blood vessel percutaneously to treat a vascular lesion has become the mainstream in recent years. For example, percutaneous angioplasty such as expanding the stenosis of a blood vessel with a balloon or removing the thrombus outside the body by applying negative pressure to the catheter in a blood vessel occluded by a thrombus, and as a special example, coronary artery Extended treatment for chronic total occlusion (CTO) lesions in blood vessels. For example, the following properties are required for a catheter used in the above-mentioned percutaneous angioplasty or endovascular surgery.
(1) Maintenance of lumen diameter and lubricity on the lumen surface: Through a tube lumen formed by the inner resin of the catheter, other medical devices such as a guide wire are passed through a bent blood vessel without difficulty, or suction, etc. The ability to smoothly remove intravascular substances such as blood clots and debris (foreign substances) from within the blood vessel, or to obtain a backup in order to pass a guide wire through a completely occluded lesion in the blood vessel (lumen lubricity) It is. Specifically, it is necessary to have trackability to a bent blood vessel so that the bent blood vessel can be smoothly inserted and pulled out several times without damaging the inner wall of the blood vessel. In addition, the tip of the catheter reaches the target position, and kink resistance is required so that the catheter does not bend at the curved and bent portions of the blood vessel. Moreover, the flexibility which maintains the shape according to the blood vessel shape without damaging the blood vessel wall is required.
(2) Repeated operability: For example, once the balloon is dilated at a diffuse intravascular stenosis, the guide wire is smoothed to adjust the position of the balloon when dilatation is performed again at the other stenosis. Need to be pulled back or propelled. Also, current catheter balloons are expanded at higher pressures than the prior art. For example, until recently, the balloon expansion pressure was about 10 atmospheres. However, the current tidal current performs balloon expansion under a high pressure of about 20 atmospheres or more. Therefore, after balloon expansion treatment at a high expansion pressure, a medical device such as a guide wire needs to smoothly pass through the tube lumen even after the balloon is deflated.

  In order to satisfy such required characteristics, various catheters using, for example, a multilayer tube including an outer layer excellent in flexibility and an inner layer excellent in lubricity have been developed.

  In patent document 1, it is an expansion | swelling catheter using an elongate guide wire, Comprising: It comprises the outer tube member which has an expansion | swelling balloon in the distal part, and the inner tube member arrange | positioned in an outer tube member, The said inner side The tube member is composed of an outer layer made of a thin polyimide and an inner layer made of polytetrafluoroethylene, and the inner diameter of the inner tube member is about 0.003 inches (0.076 mm) at maximum than the outer diameter of the guide wire. An inflatable tube is disclosed in which an inner lumen having a diameter of up to and including a balloon end and a distal end of the inner tube member are sealed. However, this configuration provides pushability and lubricity, but is inferior in elongation resistance due to the placement of polyimide in the outer layer, and plastic deformation of the inner tube member outer layer when expanded and contracted many times. Can cause lumen changes and clog the guidewire.

  Patent Document 2 discloses an interventional catheter including a catheter tube composed of two layers, an inner layer and an outer layer, which are fixed to each other and have different mechanical properties, and a balloon having a proximal end portion and a distal end portion. Thus, an interventional catheter is disclosed in which the inner layer is made of polyethylene, the outer layer is made of polyamide, and the distal end of the balloon is welded to the outer layer. However, although this structure provides followability and lubricity to bent blood vessels, it is easy to cause plastic deformation because it is made of a highly crystalline resin such as polyamide for the outer layer and polyethylene for the inner layer. When contracted, the lumen may change due to plastic deformation of the catheter tube, and the guide wire may also become clogged.

  In Patent Document 3, an inner tubular member made of a crosslinked polyolefin and a reinforcing tube disposed around the inner tubular wall and made of a material selected from the group of nylon, polyethylene, polyolefin, polyvinyl chloride, and polyurethane are provided. A vasodilator catheter is disclosed. However, although this structure provides followability and lubricity to bent blood vessels, since a highly crystalline resin such as crosslinked polyethylene is selected for the inner layer, plastic deformation may occur under high expansion pressure. When expanded and contracted, the lumen of the catheter tube may change, and the guide wire may also become clogged.

Patent Document 4 discloses a coextruded, flexible tube comprising an outer layer comprising a directly adherent polymer, an inner layer comprising a lubricious polymer, an intermediate joining layer comprising a functionalized polymer, and the same A medical device is disclosed. However, although this structure provides followability to the bent blood vessel and lubricity, the outer layer and the inner layer are insoluble, so an intermediate bonding layer is always required, so performance such as adhesion is obtained when thinning. It may not be possible. Moreover, it is not economical because the introduction of coextrusion equipment is essential.
European Patent No. 0351687 Patent No. 2918459 US Pat. No. 5,041,089 Japanese Patent Laid-Open No. 10-305093

  In view of the above-mentioned present situation, the subject of the present invention is, for example, a tube for passing a medical device that is excellent in maintaining lumen lubricity without causing deterioration in operability of the medical device even during repeated use during endovascular treatment. Is provided.

In order to solve the above problems, the present invention has one or more of the following features.
[1] One feature of the present invention is a medical device passage tube having a laminated structure of a lubricating layer (1) and a flexible layer (2) disposed around the lubricating layer (1), In the medical device passing tube, the lubricating layer (1) is formed of a fluorine-containing ethylenic polymer in order to enhance reversibility in addition to lubricity during passage of the medical device.
[2] In a preferred embodiment, the Shore hardness of the lubricating layer (1) is 40D or more and 75D or less.
[3] In a preferred embodiment, the Shore hardness of the flexible layer (2) is 25D or more and 90D or less.
[4] In a preferred embodiment, the lubricating layer (1) is formed of a fluorine-containing ethylenic polymer having a reactive functional group on the surface in order to enhance adhesion to the flexible layer (2).
[5] In a preferred embodiment, the lubricating layer (1) comprises polytetrafluoroethylene (PTFE), tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA), vinylidene fluoride-hexafluoropropylene copolymer. (FKM), a fluorine-containing ethylenic polymer of vinylidene fluoride-tetrafluoroethylene-hexafluoropropylene copolymer (THV), or a combination thereof.
[6] In a preferred embodiment, the flexible layer (2) is made of polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyester elastomer, polystyrene elastomer, polyolefin elastomer, vinyl chloride elastomer, or silicon elastomer. It consists of any resin material or a combination thereof.
[7] In a preferred embodiment, the flexible layer (2) has a hardness gradient.
[8] In a preferred embodiment, the tensile elastic modulus of the medical device passage tube is 0.1 N / mm ² or more and 5.0 N / mm ² or less.
[9] In a preferred embodiment, the ratio (A2 /) of the stress (A1) (N / mm ² ) at the time of 10 mm elongation and the stress (A2) (N / mm ² ) at the time of 100 mm elongation of the medical device passage tube. A1) is 0.8 or more and less than 2.0.
[10] In a preferred embodiment, the medical device passage tube has a tensile elastic modulus of 0.1 N / mm ² or more and 2.0 N / mm ² or less, and a stress (A1) (N / Mm ² ) and the stress (A2) (N / mm ² ) at 100 mm elongation (A2 / A1) is 1.0 or more and less than 1.8.
[11] In a preferred embodiment, the thickness of the lubricating layer (1) is 0.1 mm or less.
[12] In a preferred embodiment, the flexible layer (2) has a thickness of 0.1 mm or less.
[13] In a preferred embodiment, the medical device passage tube has an inner diameter of 0.2 mm to 1.0 mm.
[14] In a preferred embodiment, the cross-sectional shape of the medical device passage tube is a circle or an ellipse.
[15] In a preferred embodiment, the medical device passage tube has a major axis (D1) and a minor axis at the inner diameter of the cross section of the tube in order to increase a contact area with a member disposed outside the tube. The ratio (D1 / D2) of (D2) is 1.0 or more and 4.0 or less.
[16] In a preferred embodiment, the medical device is a guide wire.
[17] Another feature of the present invention is a catheter including the medical device passage tube.
[18] Another feature of the present invention is a balloon catheter comprising the medical device passage tube and a balloon disposed outside the medical device passage tube.
[19] In a preferred embodiment, the catheter is a thrombus aspiration catheter or a wire support catheter.

  Other features and effects of the present invention including the above features will become apparent from the following description of embodiments.

  Hereinafter, the present invention will be described in detail based on embodiments.

1. Hardness of Tube Lubricant Layer for Passing Medical Device (1) “Hardness” in the present invention indicates Shore hardness according to the measurement standard ASTM D1706 as an example. The “hardness” of the tube lubrication layer for medical device passage (1) in the present invention is 40D or more and 75D or less, preferably 45D or more and 74D or less, more preferably 50D or more and 72D or less. By making the hardness flexible within the above range, for example, the hardness can be adjusted in the range of 40D to 75D even in the softening of the tube, and the curved blood vessel can be maintained while maintaining the lubricity. Reduction in followability can be suppressed.

  However, when the hardness of the lubricating layer (1) is too low, the frictional resistance in the operation of the medical device or the like is increased, and the lubricity of the tube lumen surface is decreased, which is not preferable. On the other hand, if the hardness is too high, the followability to the bent blood vessel is inferior.

2. Hardness of tube flexible layer for medical device passage (2) “Hardness” of tube flexible layer for medical device passage (2) in the present invention is 25D or more and 90D or less, preferably 30D or more and 74D or less, more preferably 40D or more and 72D or less. By making the hardness flexible within the above range, for example, the hardness can be made relatively low even in the softening of the tube, and the reduction in the followability of the curved blood vessel can be suppressed.

  However, if the hardness of the flexible layer (2) is too low, pushability in the operation of a medical device or the like is lowered, which is not preferable. On the other hand, if the hardness is too high, the followability to bent blood vessels is inferior, which is not preferable.

3. Fluorine-containing ethylenic polymer Although it does not specifically limit as a fluorine-containing ethylenic polymer used for the lubricating layer (1) in this invention, For example, polytetrafluoroethylene (PTFE), tetrafluoroethylene perfluoro Alkyl vinyl ether copolymer (PFA), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), ethylene-tetrafluoroethylene copolymer (ETFE), polychlorotrifluoroethylene (PCTFE), ethylene-chlorotrifluoroethylene Copolymer (ECTFE), ethylene-tetrafluoroethylene-hexafluoropropylene copolymer (EFEP), vinylidene fluoride-tetrafluoroethylene-hexafluoropropylene copolymer (THV), polyvinylidene fluoride (P VDF), polyvinyl fluoride (PVF), vinylidene fluoride-hexafluoropropylene copolymer (FKM), and the like, and two or more kinds of blends may be appropriately implemented. Moreover, in order to improve the visibility of the catheter under X-ray fluoroscopy in a surgical technique, a substance having radiopacity to the resin may be included. Any radiopaque material may be used as long as it has sufficient radiopacity, for example, barium sulfate, bismuth trioxide, bismuth subcarbonate, basic bismuth carbonate, bismuth tungstate, powder Examples include tungsten, powdered tantalum, or a combination thereof.

  In addition, the device passage tube can increase the slidability of the lumen by using the material as described above, so that the injection pressure can be easily increased without increasing the injection pressure more than necessary. Injection is possible.

4). Resin material used for the flexible layer (2) The resin material used for the flexible layer (2) in the present invention is not particularly limited. For example, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyester Various elastomers such as elastomers, polystyrene elastomers, polyolefin elastomers, vinyl chloride elastomers, silicon elastomers, fluorine elastomers, latex rubbers, or combinations of two or more thereof can be used.

  Here, the polyamide elastomer is, for example, nylon 6, nylon 64, nylon 66, nylon 610, nylon 612, nylon 46, nylon 9, nylon 11, nylon 12, N-alkoxymethyl modified nylon, hexamethylenediamine-isophthalic acid. Typical block copolymers include polycondensates, various aliphatic or aromatic polyamides such as metaxyloxydiamine-adipic acid polycondensate as hard segments, and polymers such as polyester and polyether as soft segments. In addition, a polymer alloy (polymer blend, graft polymerization, random polymerization, etc.) of the polyamide and a flexible resin, a softened polyamide with a plasticizer or the like, and a concept including a mixture thereof It is.

  The polyester elastomer is typically a block copolymer of a saturated polyester such as polyethylene terephthalate or polybutylene terephthalate and a polyether or polyester. In addition, the polymer alloy or the saturated polyester may be used as a plasticizer. It is a concept that includes a softened material and a mixture thereof.

  As a material suitably used, polyamide elastomer is preferable from the viewpoint of processability and flexibility, and for example, PEBAX manufactured by Arkema is representative.

  The flexible layer as an embodiment employs a resin material of polyamide elastomer, polyurethane elastomer, polyester elastomer or a combination thereof in order to improve adhesion to a member disposed outside the tube for passing a medical device. You can also For example, if a balloon made of the same material is disposed outside the medical device passage tube, the two can be firmly integrated when they are welded together. Moreover, in order to improve the visibility of the catheter under X-ray fluoroscopy in a surgical technique, a substance having radiopacity to the resin may be included. Any radiopaque material may be used as long as it has sufficient radiopacity, for example, barium sulfate, bismuth trioxide, bismuth subcarbonate, basic bismuth carbonate, bismuth tungstate, powder Examples include tungsten, powdered tantalum, or a combination thereof.

5. Reactive Functional Group In order to improve the adhesion to the flexible layer (2), the reactive functional group of the fluorine-containing ethylenic polymer is not particularly limited, but is a hydroxyl group (—OH), an epoxy group (—C ₂ O). ), Carboxyl group (—COOH), carbonyl group (—C═O), carboxylate group (—COOR), carboxylate group (—COONa), amine group (—NH ₂ ), sulfonate group (—SO _3). Na) is preferable because it is easily formed by surface treatment. The step of imparting the reactive functional group to the surface of the fluorine-containing ethylenic polymer by the surface treatment step includes, for example, a sodium etching treatment step using a chemical treatment solution such as a sodium salt-ammonia solution, This can be achieved by a method known per se such as a flame treatment step for melting the surface, a corona discharge step, a plasma treatment step, and an excimer laser treatment step.

6). Tensile Elastic Modulus and Tensile Stress of Medical Device Passing Tube Although the “tensile elastic modulus” of the medical device passing tube of the embodiment is not particularly specified, the upper limit is 5.0 N when displaced in the longitudinal direction by 1.0 mm. / Mm ² or less, preferably 4.0 N / mm ² or less, more preferably 3.0 N / mm ² or less, 2.0 N / mm ² or less.

The lower limit of the tensile elastic modulus is not particularly limited as long as it is within the above range, but is, for example, 0.1 N / mm ² or more, more preferably 0.2 N / mm ² or more, and still more preferably 0. .3 N / mm ² or more. If the tensile elastic modulus is too small, the medical device passage tube may be stretched, which may cause a problem in the position adjustability of the medical device. On the other hand, if the tensile elastic modulus is too large, the followability to the bent blood vessel is inferior.

The ratio of the tensile stress (A1) (N / mm ² ) at the time of 10 mm displacement to the tensile stress (A2) (N / mm ² ) at the time of 100 mm displacement (A2) / ( A1) "is less than 2.0, preferably less than 1.9, more preferably less than 1.8. The lower limit of the tensile stress ratio is not particularly limited as long as it is within the above range, but is 0.8 or more, more preferably 0.9 or more, and still more preferably 1.0 or more. be able to. If the tensile stress ratio is too large, shape recovery due to plastic deformation is not expected, and a medical device clogging may occur when performing balloon expansion treatment a number of times, which is not preferable. If the tensile stress ratio is too low, it is not preferable because the tube may be broken when inserted into the bent blood vessel.

The ratio between the like "," tensile modulus "and / or tensile at" 10mm displacement stress ^{(A1) (N / mm 2} ) and tensile at 100mm displacement stress ^{(A2) (N / mm 2} ) (A2 ) / (A1) ”is achieved by the configuration and material of each layer constituting the medical device passage tube as the embodiment described above. As a result of intensive studies, the present inventor found that polytotrafluoroethylene having a low friction coefficient exhibits rubber-like properties, as will be apparent from examples described later, and is particularly suitable as an embodiment of the lubricating layer. I found. The rubbery property can also be expressed as reversibility, rebound resilience, resilience or shape recovery. Furthermore, in the case of PTFE, since it has a high melting point, there is also an effect that it is not affected by thermal processing (for example, baking treatment) described later.

7). Thickness of lubrication layer (1) and flexible layer (2) The “thickness” of the lubrication layer (1) of the tube for medical device passage in the present invention is 0.10 mm or less, preferably 0.07 mm or less. Preferably it is 0.05 mm or less. The lower limit of the thickness of the lubricating layer (1) is not particularly limited as long as it is within the above range, but is, for example, 0.01 mm or more, more preferably 0.012 mm or more, still more preferably 0.00. It can be set to 015 mm or more. Since the wall thickness can be obtained as thin as in the above range, for example, the inner diameter can be made relatively wide even when the tube is made thinner, and the sliding resistance of the medical device can be suppressed. However, if the thickness of the lubrication layer (1) is too small, it is not preferable because the lubricity of the tube lumen surface is reduced due to frictional resistance in the operation of a medical device or the like. On the other hand, if the wall thickness is too large, the thickness of the flexible layer is limited, so that the welding with the balloon disposed outside the flexible layer (2) may be inferior. The “thickness” of the flexible layer (2) is in the same range as the thickness of the lubricating layer (1). The thicknesses of the lubricating layer (1) and the flexible layer (2) may be different or the same.

8). Inner Diameter of Medical Device Passing Tube The “inner diameter” of the medical device passing tube in the present invention is 0.2 mm or more and 1.0 mm or less, preferably 0.3 mm or more and 0.9 mm or less, more preferably 0. It is 4 mm or more and 0.8 mm or less. By carrying out the inner diameter so as to fall within the above range, a passing tube adapted to the outer diameter size of the medical device can be supplied.

  However, if the inner diameter is too small, insertion of a medical device or the like becomes difficult and the function of the catheter is lowered, which is not preferable. Moreover, since the thickness of a flexible layer will be restrict | limited if an internal diameter is too large, welding with the balloon arrange | positioned on the outer side of a flexible layer (2) may be inferior, and it is unpreferable.

9. The cross-sectional shape of the tube for passing medical devices The “cross-sectional shape” of the tube for passing medical devices in the present invention is not particularly limited, but a circular or elliptical shape is preferable from the viewpoint of device passability. That is, the ratio (D1 / D2) of the major axis (D1) to the minor axis (D2) in the cross section of the medical device passage tube is 1.0 or more and 4.0 or less, preferably 1.0 or more and 3.5 or less, Preferably they are 1.0 or more and 3.0 or less. With this cross-sectional shape, it is possible to secure an increase in the contact area with the catheter component while maintaining the device passability, and it is possible to improve the welding performance. If the ratio of the major axis to the minor axis is too large, the device passability may be deteriorated due to an increase in the sliding area, which is not preferable.

10. Manufacturing method of tube for medical device passage Here, the manufacturing method of the tube for medical device passage in this invention is shown. In the embodiment, a guide wire will be described as an example of the “medical device” in the “medical device passage tube”.

  First, a metal core wire 1 is prepared as shown in FIG. This metal core wire is wound around a reel 2 and its outer diameter is substantially the same as the inner diameter of the guide wire passing tube to be manufactured. The material is preferably a metal-plated copper wire such as silver or a stainless steel wire.

  Subsequently, as shown in FIG. 2, the lubricating layer 4 is formed by extrusion coating on the metal core wire by the extruder 3.

  When polytetrafluoroethylene is used as the lubricating layer, a baking treatment is performed after the processing aid is dried.

  Further, in the step of coating the subsequent flexible layer, the surface treatment step can be performed for the purpose of increasing the adhesive force between the lubricating layer and the flexible layer. Subsequently, as shown in FIG. 3, the lubricating layer 4 is covered with the flexible layer 5. The flexible layer 5 is a resin material tube having an inner diameter slightly larger than the outer diameter of the lubricating layer 4.

  The flexible layer 5 may have the same hardness as that of the lubricating layer 4, and the position corresponding to the distal portion of the medical device passage tube may be more flexible.

  The step of coating the flexible layer 5 is not particularly limited, but a shrink coating method, an extrusion coating method (wire coating), a switching extrusion coating method (one of extrusion methods for imparting a hardness gradient) or the like is appropriately selected. .

  For example, as shown in FIG. 3, as a shrink coating method, the lubrication layer 4 and the flexible layer 5 are integrated by carrying out heating with a heater or heating with high-frequency electromagnetic waves using a shrink tube 6 made of fluororesin or polyolefin. be able to. After the integration, the medical device passage tube can be obtained by peeling the shrink tube and removing the metal core wire. Further, an X-ray opaque marker, which is an X-ray opaque member for identifying a position under X-ray fluoroscopy, may be provided on the outside of the medical device passage tube. One or more radiopaque markers can be provided. For example, during endovascular treatment, position adjustment with an intravascular stenosis can be facilitated under fluoroscopy.

  In another preferred embodiment, the rigidity of the distal end portion of the medical device passage tube is lower than the rigidity of the tube proximal end portion, and / or the outer diameter of the distal end portion of the medical device passage tube is equal to the tube proximal end portion. And / or the medical device passage tube can be designed with a core wire.

11. The material of the “balloon” disposed outside the medical device passage tube in the balloon embodiment (for example, by welding to the outside of the tube) is not particularly limited. For example, polyesters such as polyamide, polyamide elastomer, polyethylene terephthalate and polybutylene terephthalate, polyester elastomer, polyurethane, polyurethane elastomer, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer Polymers, polyolefins such as ionomers, polyolefin elastomers, and their cross-linked products, polystyrene elastomers, polyvinyl chloride, fluororesins, fluororubbers and other resin materials In addition to those obtained by combining these mixtures, silicone rubber, latex rubber and the like can be used. A multilayer balloon in which these polymer materials are appropriately laminated can also be used.

  Further, as a method for producing a balloon, there are dipping molding, blow molding and the like, and an appropriate method can be selected according to the use application of the balloon catheter provided with the medical device passage tube in the present invention.

12 Catheter The catheter or balloon catheter provided with the medical device passage tube of the embodiment can be used as, for example, a thrombus suction catheter, a wire support catheter, a penetration catheter, or a microcatheter.

13. Evaluation Method The evaluation value referred to in this specification means a value measured by the following method.

(Tube outer diameter / inner diameter for guide wire passage)
The outer diameter of the obtained guide wire passing tube was measured using a laser diameter measuring machine LS-3100 manufactured by Keyence Corporation. The inner diameter of the tube was measured using a pin gauge manufactured by Eisen Co., Ltd. The wall thickness was calculated by the following formula.

(Thickness / mm) = (tube outer diameter / mm−tube inner diameter / mm) / 2
(Tensile test)
Using Strograph EII manufactured by Toyo Seiki Seisakusho Co., Ltd., a tensile test was performed at a load cell of 50 N, a distance between chucks of 50 mm, and a chuck speed of 100 mm / min. The tensile modulus (N / mm 2) at 1.0 mm displacement and the stress after the yield region were measured as the stress value (N / mm ² ) at 10 mm displacement and the stress value (N / mm ² ) at 100 mm displacement. .

  As an index for repeated use, stress ratios at 10 mm and 100 mm displacement were adopted. The stress ratio was calculated by the following formula.

Stress ratio (N / mm ² ) = [Stress value at 100 mm displacement (N / mm ² )] / [Stress value at 10 mm displacement (N / mm ² )]
As the stress ratio is closer to 1.0, rubber elasticity is exhibited, so that it is determined that the member can be used repeatedly.

(Guide wire capture test under expanded pressure)
An evaluation sample was prepared by covering the guide wire passing tube with a balloon and welding the distal end portion and the proximal end portion while providing a transition portion. An evaluation sample was put into a constant temperature water bath having a water temperature of 37 ° C., and Crescent Design Inc. The presence / absence of capture of the guide wire at each expansion pressure and the presence / absence of capture after release of pressure were determined using a Hydraulic Burst / Leak Tester Model 2000 manufactured by the company. The expansion pressure conditions were 10 atm 30 sec, 15 atm 30 sec, and 20 atm 30 sec, respectively. As a judgment, the case where the guide wire was not captured at the expansion pressure was evaluated as “◯”, the case where the guide wire was captured as “×”, the case where there was no capture after releasing the pressure as “◯”, and the case where there was capture as “X”. The tube without the capture of the guide wire after the pressure release is determined as a reusable catheter member.

  Specific examples and comparative examples according to the present invention will be described in detail below, but the present invention is not limited to these examples.

(Example 1)
A PTFE coating layer FA (Daikin Industries, Ltd., Polyflon PTFE F207) was applied to a thickness of 0.03 mm on a silver-plated annealed copper wire having an outer diameter of 0.42 mm. Furthermore, a polyamide elastomer layer PA-A (Arkema, Pebax 7233) having a thickness of 0.04 mm is coated thereon, and the anodized copper wire is drawn out to form an inner layer PTFE and an outer layer polyamide elastomer having an outer diameter of 0.56 mm / inner diameter of 0.42 mm. A guide wire passing tube was prepared.

The obtained guide was stress measured at a stress and 100mm displacement in tensile modulus and 10mm displacement of the wire passing tube, a respective ^{1.0N / mm 2, 30N / mm} 2, 31N / mm 2, the stress The ratio was 1.1. Further, the capture of the guide wire under the expansion pressure occurred only under 20 atm, and no capture occurred after the pressure release.

(Example 2)
A guide wire passing tube was produced in the same manner as in Example 1 except that PTFE coating layer FB (Asahi Glass Co., Ltd., Full-on PTFE AD-1) was used. The obtained guide was stress measured at a stress and 100mm displacement in tensile modulus and 10mm displacement of the wire passing tube, respectively 1.1 N / mm ^2, a ^{32N / mm 2, 34N / mm} 2, the stress The ratio was 1.1. Further, the capture of the guide wire under the expansion pressure occurred only at 20 atm, and no capture occurred after the release of the pressure.

(Example 3)
A guide wire passing tube was prepared in the same manner as in Example 1 except that the polyamide elastomer layer PA-B (Arkema, Pebax5533) was coated. The obtained guide was stress measured at a stress and 100mm displacement in tensile modulus and 10mm displacement of the wire passing tube, respectively 0.4 N / mm ^2, a ^{13N / mm 2, 16N / mm} 2, the stress The ratio was 1.2. Further, the capture of the guide wire under the expansion pressure occurred at 15 atm and 20 atm, and no capture occurred after the pressure was released.

Example 4
A guide wire passing tube was prepared in the same manner as in Example 1 except that the polyamide elastomer layer PA-C (Arkema, Pebax 4033) was coated. The tensile modulus of the obtained tube for passing the guide wire and the stress at 10 mm displacement and the stress at 100 mm displacement were measured and found to be 0.3 N / mm ² , 9 N / mm ² and 13 N / mm ² , respectively. The ratio was 1.4. Further, guide wire capture under expansion pressure (up to 20 atm) occurred at 10 atm, 15 atm, and 20 atm, and no capture occurred after release of pressure.

(Comparative Example 1)
Using a three-layer, three-layer tube extrusion device, the outer layer is a polyamide elastomer layer PA-A, the adhesive layer is a modified polyethylene layer AD (Lyondell Chemical Co. Plexar 2000), and the inner layer is a high-density polyethylene layer HD-A (Nippon Polyethylene Corporation) A guide wire passing tube having an outer diameter of 0.56 mm and an inner diameter of 0.42 mm was prepared so as to be a high-density polyethylene, Novatec HB530). The obtained guide to measure the stress in the stress and 100mm displacement wire passing tube of the tensile modulus and 10mm displacement, respectively ^{0.9N / mm 2, 20N / mm} 2, a 41N / mm ^2, the stress The ratio was 2.1. In addition, guide wire capture under expansion pressure occurred at 15 atm and 20 atm, and there was wire capture after release of expansion pressure at 15 atm and 20 atm.

(Comparative Example 2)
A guide wire passing tube was produced in the same manner as Comparative Example 1 except that the polyamide elastomer layer PA-B was used as the outer layer. The tensile modulus of the obtained guide wire passing tube and the stress at 10 mm displacement and the stress at 100 mm displacement were measured and found to be 0.5 N / mm ² , 10 N / mm ² and 22 N / mm ² , respectively. The ratio was 2.2. Further, guide wire capture under expansion pressure occurred at any expansion pressure of 10 atm, 15 atm, and 20 atm, and there was wire capture after the expansion pressure was released at 15 atm and 20 atm.

(Comparative Example 3)
A guide wire passing tube having an outer diameter of 0.56 mm and an inner diameter of 0.42 mm was produced using high-density polyethylene HD-A (Nippon Polyethylene Corporation, high-density polyethylene, Novatec HB530). The obtained guide was stress measured at a stress and 100mm displacement in tensile modulus and 10mm displacement of the wire passing tube, respectively 1.5 N / mm ^2, a ^{22N / mm 2, 45N / mm} 2, the stress The ratio was 2.0. In addition, guide wire capture under expansion pressure occurred at any expansion pressure of 15 atm or 20 atm, and there was wire capture after the expansion pressure was released at 15 atm or 20 atm.

(Comparative Example 4)
A guide wire passing tube was prepared in the same manner as Comparative Example 2 except that the outer diameter was 0.58 mm / the inner diameter was 0.44 mm. The obtained guide was stress measured at a stress and 100mm displacement in tensile modulus and 10mm displacement of the wire passing tube, respectively 1.5 N / mm ^2, a ^{21N / mm 2, 44N / mm} 2, the stress The ratio was 2.1. Guide wire capture under expansion pressure occurred at any expansion pressure of 15 atm or 20 atm, and there was wire capture after release of expansion pressure at 15 atm or 20 atm.

(Comparative Example 5)
A PTFE coating layer FA (Daikin Industries, Ltd., Polyflon PTFE F207) is applied at a thickness of 0.03 mm on a silver-plated annealed copper wire having an outer diameter of 0.42 mm, and a 0.04 mm-thick polyimide layer PI is further coated thereon. Then, a guide wire passing tube having an outer diameter of 0.56 mm and an inner diameter of 0.42 mm made of inner layer PTFE and outer layer polyimide was produced. The tensile modulus of the obtained guide wire passing tube and the stress at 10 mm displacement and the stress at 100 mm displacement were measured and found to be 3.0 N / mm ² , 31 N / mm ² and 72 N / mm ² , respectively. The ratio was 2.3. Further, guide wire capture under expansion pressure occurred at any expansion pressure of 15 atm or 20 atm, and there was wire capture after the expansion pressure was released at 15 atm or 20 atm.

The measurement results of the tubes obtained in Example 1-4 and Comparative Example 1-5 are shown in Table 1.
(Measurement results for each tube)

表１における各実施例と比較例の結果から、１０ｍｍ変位時の応力と１００ｍｍ変位時の応力比が２．０未満であれば、拡張圧下開放下におけるガイドワイヤーの捕捉を抑えること（表１の「ガイドワイヤー捕捉有無（拡張圧下および圧開放下）」参照）につながっていることが分かる。即ち、ＰＴＦＥ層及びポリアミドエラストマー層のいずれもが、本来のゴム的性質を持ち、バルーン拡張圧開放下において、ガイドワイヤー通過チューブが圧縮に対する形状回復性を示すようになる。その結果、バルーン拡張、収縮が繰り返されても、ワイヤーの捕捉がないことから操作性の低下を抑えることにつながっていることが分かる。

From the results of the examples and comparative examples in Table 1, if the stress ratio at 10 mm displacement and the stress ratio at 100 mm displacement is less than 2.0, the capture of the guide wire under the expansion pressure release is suppressed (in Table 1). It can be seen that it is connected to the presence or absence of guide wire capture (expansion pressure reduction and pressure release)). That is, both of the PTFE layer and the polyamide elastomer layer have an original rubber property, and the guide wire passage tube exhibits shape recovery property against compression under release of the balloon expansion pressure. As a result, it can be seen that even if balloon expansion and contraction are repeated, the wire is not captured, which leads to a reduction in operability.

Drawing 1 is a schematic diagram showing the manufacturing method of the tube for medical device passage of an embodiment. Drawing 2 is a schematic diagram showing the manufacturing method of the tube for medical device passage of an embodiment. Drawing 2 is a schematic diagram showing the manufacturing method of the tube for medical device passage of an embodiment.

Explanation of symbols

4 ... Lubrication layer 5 ... Flexible layer 6 ... Shrink tube

Claims (19)

A medical device passing tube having a laminated structure of a lubricating layer (1) and a flexible layer (2) disposed around the lubricating layer (1),
The medical device passage tube, wherein the lubricating layer (1) is formed of a fluorine-containing ethylenic polymer in order to enhance reversibility in addition to lubricity during passage of the medical device. The tube for medical device passage according to claim 1, wherein a Shore hardness of the lubricating layer (1) is 40D or more and 75D or less. The tube for medical device passage according to claim 1 or 2, wherein a Shore hardness of the flexible layer (2) is 25D or more and 90D or less.   The said lubricating layer (1) is formed with the fluorine-containing ethylenic polymer which has a reactive functional group on the surface in order to improve the adhesiveness with respect to the said soft layer (2). The medical device passage tube according to any one of the above.   The lubricating layer (1) is made of polytetrafluoroethylene (PTFE), tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA), vinylidene fluoride-hexafluoropropylene copolymer (FKM), vinylidene fluoride-tetra The medical device passage tube according to any one of claims 1 to 4, wherein the tube comprises a fluoroethylenic polymer of any one of fluoroethylene-hexafluoropropylene copolymer (THV) or a combination thereof. .   The flexible layer (2) is a resin material of polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyester elastomer, polystyrene elastomer, polyolefin elastomer, vinyl chloride elastomer, silicon elastomer, or a combination thereof. The medical device passage tube according to any one of claims 1 to 5, wherein the medical device passage tube is formed of a combination.   The medical device passage tube according to any one of claims 1 to 6, wherein the flexible layer (2) has a hardness gradient. The medical device passage tube according to any one of claims 1 to 7, wherein the medical device passage tube has a tensile elastic modulus of 0.1 N / mm ² or more and 5.0 N / mm ² or less. The ratio (A2 / A1) of the stress (A1) (N / mm ² ) at the time of 10 mm elongation and the stress (A2) (N / mm ² ) at the time of 100 mm elongation of the medical device passage tube is 0.8 or more, It is less than 2.0, The medical device passage tube in any one of Claims 1-8 characterized by the above-mentioned. The medical device passage tube has a tensile elastic modulus of 0.1 N / mm ² or more and 2.0 N / mm ² or less, and a stress (A1) (N / mm ² ) when stretched by 10 mm and a stretch of 100 mm stress ^{(A2) (N / mm 2} ) ratio (A2 / A1) is 1.0 or more, any medical devices passing tube of claim 1, wherein the less than 1.8.   The medical device passing tube according to any one of 1 to 10, wherein the lubricating layer (1) has a thickness of 0.1 mm or less.   The medical device passage tube according to any one of claims 1 to 11, wherein the flexible layer (2) has a thickness of 0.1 mm or less.   The medical device passage tube according to any one of claims 1 to 12, wherein an inner diameter of the medical device passage tube is 0.2 mm to 1.0 mm.   The medical device passage tube according to any one of claims 1 to 13, wherein a cross-sectional shape of the medical device passage tube is a circle or an ellipse.   In order to increase the contact area between the medical device passing tube and a member disposed outside the tube, the ratio of the major axis (D1) to the minor axis (D2) (D1 / D2) in the inner diameter of the cross section of the tube ) Is 1.0 or more and 4.0 or less, The medical device passage tube according to any one of claims 1 to 14.   The medical device passage tube according to any one of claims 1 to 15, wherein the medical device is a guide wire.   A catheter comprising the medical device passage tube according to claim 1.   A balloon catheter comprising: the medical device passage tube according to any one of claims 1 to 16; and a balloon disposed outside the medical device passage tube.   The catheter according to claim 17 or 18, wherein the catheter is a thrombus aspiration catheter or a wire support catheter.

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