JP5952562B2 - Catheter and method for manufacturing catheter - Google Patents

Description

  The present invention relates to a catheter and a manufacturing method thereof.

  As a method for introducing a catheter into the body, a method using a guide wire is known. In this method, first, a guide wire is inserted into the inside of the catheter tube constituting the catheter, the inserted guide wire is inserted into the body, and then the catheter is introduced into the body along the guide wire inserted into the body. .

  Also, a so-called RX type catheter is known in which the guide wire is introduced into the tube from an intermediate position in the axial direction of the tube so that the guide wire can be inserted inside the catheter tube. In this RX type catheter, a guide wire port is formed in the middle of the catheter tube in the axial direction so as to penetrate the peripheral wall portion of the tube, and the guide wire is introduced into the catheter tube through the guide wire port. Is done.

  By the way, in order to reduce the sliding resistance when the catheter is introduced into the body, a hydrophilic coating may be applied to the outer surface of the catheter tube (see, for example, Patent Document 1). Here, when such a hydrophilic coating is applied to the RX type catheter, for example, it is conceivable to coat the distal end side of the catheter tube with respect to the guide wire port.

  When applying such a coating, for example, a hydrophilic coating liquid is applied to the distal end side of the guide wire port on the outer surface of the catheter tube in a state where the catheter tube is suspended so that the axial direction is directed upward and downward. Then, the applied coating solution is fixed by heating or the like. Thereby, a hydrophilic coating layer is formed on the outer surface of the catheter tube.

JP 2000-107294 A

  By the way, in order to further reduce the sliding resistance of the catheter, it is desirable to apply the above hydrophilic coating to the proximal end side of the guide wire port in the catheter tube. However, when the coating liquid is applied from the distal end side to the proximal end side of the guide wire port, the applied coating liquid may enter the guide wire port due to dripping. In this case, the coating liquid that has entered may not be fixed by the fixing process and may remain in the guide wire port as it is, and there is a concern that the guide wire may be lowered.

  The present invention has been made in view of the above circumstances, and a catheter capable of preventing the coating liquid from entering the guide wire port when applying the coating liquid to the catheter having the guide wire port, and a manufacturing method thereof. The main purpose is to provide

  In order to solve the above-mentioned problem, the catheter of the first invention is provided with a tube having a lumen therein, and a guide wire is guided into the tube in the axial direction on the peripheral wall portion surrounding the lumen in the tube. The guide wire port is formed, and the tube is provided with coating regions each having a hydrophilic coating on the outer surface on both sides of the guide wire port in the axial direction. One of the regions is disposed in an axially spaced relationship with respect to the guide wire port, and a region between the one coating region and the guide wire port in the tube is formed on the outer surface of the coating. It is characterized by being an uncoated region that has not been subjected to.

  According to the present invention, since a hydrophilic coating is applied to both sides of the tube having a guide wire port in the axial direction on both sides of the port, the coating is applied only to the tip side of the guide wire port. Compared with the case where it is, the sliding resistance at the time of inserting a catheter in a body can be reduced.

  In the tube, an uncoated region is provided between one of the coated regions and the guide wire port. Therefore, when applying the coating liquid to the tube, even if liquid dripping occurs when the coating liquid is applied to the range to be one coating area, the liquid can be retained in the uncoated area. As a result, it is possible to prevent the coating liquid from entering the guide wire port, so that it is possible to prevent inconveniences such as deterioration of the guide wire insertion property.

  The catheter of the second invention is the catheter of the first invention, wherein the guide wire port is opened to the outside of the tube toward the proximal end side, and the uncoated region is proximal to the guide wire port. It is provided in.

  The guide wire introduced into the catheter is led out from the tube from the distal end side to the proximal end side through the guide wire port. Therefore, in order to make the guide wire led out from the guide wire port easily follow the catheter, it is desirable that the guide wire port is opened toward the proximal end side. Here, when the coating liquid is applied to the tube having such a configuration, when the coating liquid is applied to a region closer to the base end side than the guide wire port, the liquid easily enters the guide wire port. It is assumed that In this regard, in the present invention, since the uncoated region is provided on the proximal end side with respect to the guide wire port, the coating liquid can be prevented from entering the guide wire port even in such a configuration.

  The catheter of the third invention is the catheter according to the second invention, wherein the other coating region of the coating regions is a distance between the guide wire port and the one coating region in the axial direction with respect to the guide wire port. It is characterized by being arranged at a smaller interval than the guide wire port.

  When the coating liquid is applied to the tip side of the guide wire port (ie, the other coating area), even if the liquid dripping, the coating liquid in the base end side of the guide wire port drips. Compared to the case, the liquid is less likely to enter the guide wire port. Therefore, in the present invention, in view of this point, the other coating region is provided to a position closer to the guide wire port than one coating region. In this case, in the configuration in which the uncoated region is provided between the one coated region and the guide wire port, it is possible to secure a wide range in which the tube is coated, thereby reducing the sliding resistance of the catheter. This is a preferable configuration.

  The catheter of the fourth invention is the catheter of the second or third invention, wherein the coating applied to the one coating region in the tube is smaller in thickness than the coating applied to the other coating region. Features.

  According to the present invention, since the thickness of the coating applied to one of the coating regions on both sides sandwiching the guide wire port is relatively small, the range of the one coating region (hereinafter referred to as the following coating region) When the coating liquid is applied to the thin coating range, it is applied thinly. In this case, since it is possible to suppress dripping when applying the coating liquid to the thin coating range, it is possible to more reliably prevent the coating liquid from entering the guide wire port.

  The catheter of the fifth invention is characterized in that, in the fourth invention, the one coating region is arranged on the proximal end side with respect to the guide wire port.

  When a catheter is introduced into the body, it is assumed that a greater resistance is generated on the distal end side as an introduction destination. Therefore, in the present invention, the thickness of the coating applied to the coating region on the tip side of the guide wire port among the coating regions on both sides sandwiching the guide wire port is increased. Thereby, since the sliding resistance on the tube tip side can be reduced, the insertion of the catheter into the body can be improved.

  In addition, it is considered that the peeling of the coating, wear, and the like are more likely to occur on the distal end side of the tube, where a large resistance is generated when the catheter is inserted into the body, compared to the proximal end side, and there is concern about the durability of the coating. In this respect, according to the above configuration in which the coating thickness on the tube tip side is increased, there is also an advantage that the durability of the coating can be improved.

  According to a sixth aspect of the present invention, there is provided a catheter manufacturing method comprising: a tube having a lumen therein; and a guide wire port for guiding a guide wire into the tube in the axial direction on a peripheral wall portion surrounding the lumen in the tube. The catheter is a method for manufacturing the catheter, wherein the tube is suspended below the guide wire port on the outer surface of the tube in a state where the tube is suspended so that the axial direction thereof is vertically directed. A first application step of applying a hydrophilic coating liquid in a predetermined range on the side, and in the suspended state of the tube, above the guide wire port on the outer surface of the tube and the guide wire A second application step of applying the coating liquid to a predetermined range spaced from the port; By fixing the coating solution was applied by cloth process, characterized in that it comprises a fixing step of forming a coating layer on the outer surface of the tube.

  According to the present invention, the tube is first suspended with its axial direction facing up and down, and a hydrophilic coating solution is applied to both sides of the tube on the outer surface of the tube sandwiching the guide wire port. . Thereafter, the applied coating solution is fixed to form a hydrophilic coating layer on the outer surface of the tube. In this case, since the hydrophilic coating layer is formed on both sides of the guide wire port, the sliding resistance when the catheter is inserted into the body can be suitably reduced.

  Further, when the coating liquid is applied to a predetermined range above the guide wire port in the tube, the application is performed for a predetermined range upward from a predetermined distance above the guide wire port. That is, the coating liquid is not applied in a range from the guide wire port to a position a predetermined distance above the port in the tube. Therefore, even if dripping occurs during application of the coating liquid, the dripping liquid can be kept in the above-described region where the application is not performed. This can prevent the coating liquid from entering the guide wire port when the coating liquid is applied.

  According to a seventh aspect of the present invention, there is provided the method for producing a catheter according to the sixth aspect, wherein the coating liquid is applied thinner to the outer surface of the tube in the second application step than in the first application step. And

  According to the present invention, when the range above the guide wire port is applied to the tube, the coating liquid is applied to the lower side because the range is applied thinner than when the range below the guide wire port is applied. Can be prevented from dripping. This can more reliably prevent the coating liquid from entering the guide wire port.

The whole side view which shows the structure of a balloon catheter. The longitudinal cross-sectional view which shows the structure around a guide wire port. Explanatory drawing for demonstrating the work procedure at the time of giving a hydrophilic coating to an outer side shaft and a balloon.

  Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In the present embodiment, a balloon catheter including a balloon that can be inflated and deflated at the distal end is embodied. FIG. 1 is an overall side view showing the configuration of a balloon catheter.

  As shown in FIG. 1, the balloon catheter 10 includes a catheter shaft 11, a hub 12 attached to a proximal end portion (proximal end portion) of the catheter shaft 11, and a distal end side (distal end side) of the catheter shaft 11. ) Attached to the balloon 13.

  The catheter shaft 11 is composed of a plurality of tubular shafts (tubes), and has an inner / outer multiple tube structure at least from the midway position in the axial direction (longitudinal direction) to the position of the balloon 13. Specifically, the catheter shaft 11 includes an outer shaft 15 and an inner shaft 16 having an inner diameter and an outer diameter smaller than the outer shaft 15, and the inner shaft 16 is inserted into the outer shaft 15. Thus, it has an inner and outer double pipe structure.

  The outer shaft 15 is formed in a tubular shape having outer tube holes 15a (see FIG. 2) that are continuous over the entire axial direction and open at both ends. Here, the outer shaft 15 corresponds to a “tube”, and the outer tube hole 15a corresponds to a “lumen”. The outer shaft 15 is configured by joining a plurality of shafts 17 to 19 aligned in the axial direction to each other by welding (thermal welding) or the like. However, each shaft 17-19 does not necessarily need to be joined by welding, and may be joined by other joining methods such as adhesion.

  Each of these shafts 17 to 19 is a proxy shaft 17, a mid shaft 18, and a distal shaft 19 in order from the base end side. The proxy shaft 17 is made of a metal such as a Ni—Ti alloy or stainless steel, and its base end is joined to the hub 12. The mid shaft 18 is formed of a thermoplastic polyamide elastomer and has a lower rigidity than the proxy shaft 17. The distal shaft 19 is formed of a thermoplastic polyamide elastomer and has a lower rigidity than the midshaft 18.

Note that the proxy shaft 17 is not necessarily made of metal, and may be formed of a synthetic resin. Further, the mid shaft 18 and the distal shaft 19 are not necessarily formed of a polyamide elastomer, and may be formed of other synthetic resins. In this specification, the term “rigidity” refers to the magnitude of the moment that acts when the catheter is bent in a direction perpendicular to the axial direction. The inner shaft 16 is continuous over the entire axial direction. In addition, it is formed in a tubular shape having inner tube holes 16a (see FIG. 2) opened at both ends. The inner tube hole 16a functions as a guide wire lumen through which the guide wire G is inserted. The inner shaft 16 is inserted into a distal shaft 19 of the outer shaft 15, and a base end portion of the inner shaft 16 is located at an intermediate position in the axial direction of the outer shaft 15, specifically, a boundary portion between the mid shaft 18 and the distal shaft 19. It is joined to.

  A guide wire port 21 is formed at a joint portion between the outer shaft 15 and the distal shaft 19. The inner tube hole 16 a of the inner shaft 16 is opened to the outside through the guide wire port 21. That is, the catheter 10 is configured as a so-called RX-type catheter having a guide wire port 21 at an intermediate position in the axial direction.

  Here, the configuration around the guide wire port 21 will be described with reference to FIG. FIG. 2 is a longitudinal sectional view showing the configuration around the guide wire port 21. FIG. 2 shows a region C1 in FIG. Reference numeral 29 in FIG. 2 denotes a core wire for adjusting rigidity.

  As shown in FIG. 2, the distal shaft 19 has an inner tube hole 19 a therein, and the inner tube hole 19 a constitutes a part of the outer tube hole 15 a of the outer shaft 15. A guide wire port 21 is formed at the proximal end of the distal shaft 19. The guide wire port 21 is formed so as to penetrate the peripheral wall portion 23 surrounding the inner tube hole 19 a in the distal shaft 19.

  The configuration of the guide wire port 21 will be described in more detail. At the proximal end portion of the distal shaft 19, a step portion 24 is provided on the side where the guide wire port 21 is formed in the circumferential direction. In the stepped portion 24, the peripheral wall portion 23 of the distal shaft 19 is inclined radially inward from the distal end side toward the proximal end side, and a guide wire port 21 is formed in the inclined portion. Thereby, the guide wire port 21 is opened to the outer side of the distal shaft 19 toward the base end side.

  The proximal end portion of the inner shaft 16 is joined to the peripheral portion of the guide wire port 21 in the distal shaft 19 (the peripheral wall portion 23). In this case, the inner tube hole 16a of the inner shaft 16 is opened to the outside of the catheter 10 via the guide wire port 21 at the base end thereof. Thereby, the guide wire G introduced into the inner tube hole 16 a from the opening on the front end side of the inner shaft 16 can be led out from the inner tube hole 16 a through the guide wire port 21.

  Returning to the description of FIG. 1, a part of the inner shaft 16 extends to the tip side from the outer shaft 15, and the balloon 13 is provided so as to cover the extended region from the outside. Yes. The balloon 13 is made of a thermoplastic polyamide elastomer. However, the balloon 13 may be formed of other thermoplastic resins such as polyethylene and polypropylene.

  The base end portion of the balloon 13 is joined to the distal end portion of the outer shaft 15. The inside of the balloon 13 communicates with the hub 12 through the outer tube hole 15a of the outer shaft 15, so that the compressed fluid supplied through the hub 12 can be supplied to the balloon 13 through the outer tube hole 15a. Yes. Specifically, when compressed fluid is supplied to the balloon 13 through the outer tube hole 15a, the balloon 13 is in an inflated state, and when the negative pressure is applied to the outer tube hole 15a and the compressed fluid is discharged, the balloon 13 is It becomes a contracted state.

  The balloon 13 is formed with a plurality of wings in the circumferential direction. In the contracted state, the balloon 13 is folded so that a plurality of wings are formed. Will be wrapped around the shaft. When the catheter 10 is introduced into the body, the balloon 13 is introduced in such a contracted state.

  Here, in the present catheter 10, a hydrophilic coating is applied to the outer surface (outer peripheral surface) of the outer shaft 15 in order to reduce sliding resistance when the catheter 10 is introduced into the body. Hereinafter, the contents of the hydrophilic coating will be described.

  As shown in FIGS. 1 and 2, the outer shaft 15 includes coating regions 25 and 26 each having a hydrophilic coating on the outer surface on both sides of the guide wire port 21 in the axial direction. In this case, hydrophilic coating layers 31 and 32 are formed on the outer surfaces of these coating regions 25 and 26. Each of the coating layers 31 and 32 is made of a hydrophilic material such as polyethylene oxide (PEO), alkyl vinyl ether-maleic anhydride copolymer (VEMA), or polyvinyl pyrrolidone (PVP). In FIG. 2, for convenience, the ratio of the thickness of the coating layers 31 and 32 to the thickness of the outer shaft 15 is shown larger than the actual one.

  Among the coating regions 25, 26, the first coating region 25 is provided on the distal end side of the guide wire port 21 in the outer shaft 15, and the shaft 15 extends from the distal end portion of the guide wire port 21 in the outer shaft 15. It constitutes the range to the tip. A first coating layer 31 is formed on the outer surface of the first coating region 25.

  The second coating region 26 is provided on the outer shaft 15 on the proximal end side with respect to the guide wire port 21. The second coating region 26 forms a range from a position on the outer shaft 15 on the proximal end side with respect to the guide wire port 21 to the vicinity of the proximal end portion of the mid shaft 18. A second coating layer 32 is formed on the outer surface of the second coating region 26. The coating thickness of the second coating layer 32 is thinner than that of the first coating layer 31.

  In the outer shaft 15, a region between the guide wire port 21 and the second coating region 26 is an uncoated region 27 where the outer surface is not coated with a hydrophilic coating. In other words, in the uncoated region 27, the hydrophilic coating layer is not formed on the outer surface, and therefore the outer surface is exposed. In the present embodiment, the length in the axial direction in the uncoated region 27 is set to about 30 mm. That is, the second coating region 26 and the guide wire port 21 are separated from each other by about 30 mm in the axial direction.

  The length in the axial direction of the uncoated region 27 may be longer or shorter than 30 mm. Further, the length in the axial direction in the uncoated region 27 may be constant in the outer peripheral direction of the outer shaft 15 or may be changed.

  Further, the hydrophilic coating is not applied to the region between the first coated region 25 and the uncoated region 27 in the outer shaft 15, that is, the region corresponding to the length of the guide wire port 21 in the axial direction. Therefore, the hydrophilic coating is not applied in the whole area between the first coating region 25 and the second coating region 26 in the outer shaft 15.

  In the present catheter 10, a hydrophilic coating is applied to the outer surface of the balloon 13 in addition to the outer surface of the outer shaft 15. A coating layer (not shown) having the same thickness as the first coating layer 31 in the outer shaft 15 is formed on the outer surface of the balloon 13. Therefore, a hydrophilic coating layer is formed over almost the entire area of the outer surface of the catheter 10 on the distal end side of the guide wire port 21.

  Next, an operation procedure when a hydrophilic coating is applied to the outer surfaces of the outer shaft 15 and the balloon 13 will be described with reference to FIG. FIG. 3 is an explanatory diagram for explaining an operation procedure when a hydrophilic coating is applied to the outer shaft 15 and the balloon 13. This coating operation is performed after the catheter body 30 is manufactured by joining the catheter shaft 11 and the balloon 13.

  In the coating operation, first, as shown in FIG. 3A, a suspending process is performed in which the catheter body 30 is suspended so that the axial direction is vertically directed. In this step, the catheter body 30 is suspended with the balloon 13 facing downward (in other words, with the tip of the outer shaft 15 facing downward). In this case, the catheter body 30 is suspended by, for example, attaching the proximal end side of the outer shaft 15 to a suspension jig (not shown).

  Next, as shown in FIG. 3 (b), the outer surface of the first coating region 25 (specifically, the region that becomes the first coating region 25 by being coated) and the outer surface of the balloon 13 on the outer shaft 15. And a first coating step of applying a hydrophilic coating liquid. In this step, a sponge is immersed in the coating solution and the coating solution is soaked in the sponge, and then the coating solution is applied to the outer surface of the outer shaft 15 and the outer surface of the balloon 13 using the sponge.

  Next, as shown in FIG. 3C, a coating liquid is applied to the outer surface of the second coating region 26 (specifically, the region that becomes the second coating region 26 by being coated) on the outer shaft 15. A 2nd application | coating process is performed. In this step, the coating liquid is thinly applied compared to the application in the first application step. Specifically, after application is performed in the first application process, the amount of the coating liquid soaked into the sponge is reduced by squeezing the sponge, and then application is performed using the sponge. Apply thinner.

  As described above, in the second application process, the coating liquid is applied thinner than in the first application process, so that the coating liquid is prevented from dripping down along the outer surface of the outer shaft 15 during application. Can do. In addition, since an uncoated region 27 is provided between the second coating region 26 and the guide wire port 21, even if the coating solution dripping occurs during application, the dripping coating solution is not removed. It can be fastened at the coating area 27. Thereby, it is possible to prevent the coating liquid from reaching the guide wire port 21, and thus to prevent the coating liquid from entering the guide wire port 21.

  In addition, the first application step and the second application step are not necessarily performed according to the above procedure. For example, before performing each application process, the sponge may be immersed in the coating liquid and the coating liquid may be soaked in the sponge before application. Even in this case, the coating liquid may be applied thinner in the second application step than in the first application step. In each application process, it is not always necessary to apply the coating liquid using a sponge, and application may be performed using another application tool such as a brush. In addition to application using an applicator, other application methods such as application by spraying a coating liquid using a spray or the like may be employed.

  Next, as shown in FIG. 3D, a fixing process for fixing the coating liquid applied in each application process is performed. In this step, the coating solution is fixed by irradiating the region where the coating solution is applied in the catheter body 30 with ultraviolet rays (UV) using the ultraviolet irradiation device 35. However, the method of fixing the coating liquid is not necessarily limited to this method, and may be arbitrary, for example, fixing by heating with a heater or the like. Thereby, the first coating layer 31 and the second coating layer 32 are formed on the outer surface of the outer shaft 15, and the coating layer is formed on the outer surface of the balloon 13.

  After the coating operation is completed, the manufacturing operation of the balloon catheter 10 is completed by performing operations such as joining the hub 12 to the catheter body 30 as a post process.

  Next, a method for using the balloon catheter 10 will be briefly described.

  First, a guiding catheter is inserted into a sheath introducer inserted into a blood vessel, and the distal end opening of the guiding catheter is introduced to the coronary artery entrance. Next, the guide wire G is inserted into the guiding catheter, and the inserted guide wire G is introduced from the coronary artery entrance to a peripheral site through a treatment site such as a stenosis site.

  Subsequently, the balloon catheter 10 is introduced into the guiding catheter along the guide wire G, and the balloon 13 is placed at the treatment site while performing a push-pull operation. Here, in a state where the balloon catheter 10 is introduced into the body via the guiding catheter, the second coating layer 32 is disposed in the guiding catheter, and at least a part of the first coating layer 31 is the tip of the guiding catheter. It arrange | positions in the state extended from the opening part to the front end side.

  Thereafter, the compressed fluid is supplied to the balloon 13 from the hub 12 side through the outer tube hole 15a of the outer shaft 15 using the pressurizer, and the balloon 13 is inflated. As a result, the narrowed portion is expanded by the balloon 13.

  As mentioned above, according to the structure of this embodiment explained in full detail, the following outstanding effects are acquired.

  The outer shaft 15 is provided with coating regions 25 and 26 each having a hydrophilic coating on the outer surface on both sides of the guide wire port 21, and the second coating region 26 and the guide wire port 21 are separated in the axial direction. Thus, an uncoated region 27 where no hydrophilic coating is applied is provided between the second coated region 26 and the guide wire port 21. In this case, compared with the case where the outer shaft 15 having the guide wire port 21 is coated only on the distal end side of the port 21, sliding resistance when the catheter 10 is inserted into the body can be reduced.

Further, when the catheter body 30 (outer shaft 15) is suspended during the coating operation, it is suspended such that the range that becomes the second coating region 26 (in other words, the uncoated region 27) is on the upper side with respect to the guide wire port 21. By lowering, even if liquid dripping occurs when the coating liquid is applied to the range, the liquid can be retained in the uncoated region 27. Accordingly, when the coating liquid is applied to the outer shaft 15, the coating liquid can be prevented from entering the guide wire port 21, so that it is possible to prevent the inconvenience of the guide wire G from being lowered. Moreover, since the guide wire port 21 is opened to the outer side of the shaft toward the proximal end side, when the catheter body 30 is suspended in the above-described direction, the guide wire port 21 is opened to the upper side. Become. Therefore, when liquid dripping occurs when the coating liquid is applied to the area above the guide wire port 21 in the outer shaft 15, that is, the area to be the second coating area 26, the liquid easily enters the guide wire port 21. It can be considered. In this respect, since the uncoated region 27 is provided on the base end side of the guide wire port 21, the coating liquid can be prevented from entering the guide wire port 21 even in such a configuration.

  Since the first coating region 25 is provided continuously with the guide wire port 21 in the outer shaft 15, the outer shaft 15 is configured in a configuration in which the uncoated region 27 is provided between the second coating region 26 and the guide wire port 21. In contrast, a hydrophilic coating can be applied over a wide range. In this case, it can be said that this is a preferable configuration for reducing the sliding resistance of the catheter 10.

  The thickness of the second coating layer 32 formed in the second coating region 26 was made smaller than that of the first coating layer 31 formed in the first coating region 25. In this case, when the coating liquid is applied to a range (hereinafter referred to as a thin coating range) to be the second coating region 26, the coating solution is applied relatively thinly. Therefore, in the state where the catheter body 30 is suspended so that the thin coating range (in other words, the uncoated region 27) is on the upper side with respect to the guide wire port 21, liquid dripping occurs when the coating liquid is applied to the thin coating range. It can be suppressed from occurring. Thereby, it is possible to more reliably prevent the coating liquid from entering the guide wire port 21.

  Since the thickness of the first coating layer 31 disposed on the distal end side with respect to the guide wire port 21 is made larger than the thickness of the second coating layer 32, the outer shaft 15 is more resistant to resistance when the catheter 10 is introduced into the body. The sliding resistance can be reduced on the tip side. Thereby, the penetration property of the catheter 10 into the body can be enhanced. Further, in this case, since a greater resistance is generated when the catheter 10 is introduced into the body, durability of the coating on the tube tip side where the coating is likely to be peeled off or worn can be increased.

  The present invention is not limited to the above embodiment, and may be implemented as follows, for example.

  (1) In the above-described embodiment, each application process is performed in a state where the catheter body 30 is suspended so that the axial direction is vertically directed. However, the application process is not necessarily performed in such a suspended state. For example, the coating liquid may be applied in a state in which the catheter body 30 is laid on a dedicated support base (that is, in a state where the axial direction is in the lateral direction). Even in this case, when the coating liquid is applied to the outer shaft 15 in the range closer to the base end side than the guide wire port 21 (that is, the range serving as the second coating region 26), dripping occurs or the liquid is applied to the outer shaft. Even if it flows along the outer surface of 15 to the front end side, the liquid can be retained in the uncoated region 27, so that the coating liquid can be prevented from entering the guide wire port 21.

  Further, the fixing step may be performed with the catheter body 30 laid down.

  (2) In the above-described embodiment, each application process is performed in a state where the catheter body 30 is suspended with the balloon 13 facing downward. However, even if each application process is performed with the balloon 13 suspended in an upward direction, Good. In that case, an uncoated region where no hydrophilic coating is applied may be provided between the guide wire port 21 and the first coating region 25 in the outer shaft 15. Then, when the coating liquid is applied to the range above the guide wire port 21 in the outer shaft 15 (that is, the range to be the first coating area 25) in the suspended state, the dripping coating liquid is guided to the guide wire. Intrusion into the port 21 can be prevented.

  Moreover, you may provide an uncoated area | region in the both sides which pinched | interposed the guide wire port 21 in the outer side shaft 15, respectively. That is, in the outer shaft 15, an uncoated region (hereinafter referred to as a tip-side uncoated region) is provided between the guide wire port 21 and the first coated region 25, and between the guide wire port 21 and the second coated region 26. An uncoated region 27 (hereinafter referred to as a proximal end uncoated region) may be provided. Then, even if the catheter body 30 is suspended so that the balloon 13 faces upward or downward, when the coating liquid is applied to the range above the guide wire port 21 in the outer shaft 15, the dripping coating liquid is guided. Intrusion into the wire port 21 can be prevented. Therefore, when the catheter body 30 is suspended during the coating operation, it is not necessary to pay attention to which direction the catheter body 30 is suspended.

  Note that the length in the axial direction of the distal-side uncoated region may be shorter or longer than the length of the proximal-side uncoated region 27 in the axial direction. Further, the length in the axial direction of each uncoated region may be the same.

  (3) In the above embodiment, the second coating layer 32 is formed thinner than the first coating layer 31. However, the second coating layer 32 is thicker than the first coating layer 31. It may be formed. Moreover, you may make the thickness of each coating layer 31 and 32 the same.

  (4) In the above embodiment, the case where the present invention is applied to a balloon catheter has been described. However, the present invention is applied to other Rx type catheters in which a guide wire port 21 is provided at an intermediate position in the axial direction. Also good.

  DESCRIPTION OF SYMBOLS 10 ... Balloon catheter as a catheter, 13 ... Balloon, 15 ... Outer shaft as a tube, 15a ... Outer lumen as a lumen, 21 ... Guide wire port, 25 ... First coating region, 26 ... Second coating region, 27 ... uncoated region, 31 ... first coating layer, 32 ... second coating layer.

Claims (7)

It has a tube with a lumen inside,
A guide wire port for guiding a guide wire into the tube is formed in the axial direction on the peripheral wall portion surrounding the lumen in the tube,
The tube is provided with a coating region in which a hydrophilic coating is applied to each outer surface on both sides of the guide wire port in the axial direction,
One of the coating regions is disposed in an axial direction away from the guide wire port,
In the tube, a region between the one coated region and the guide wire port is an uncoated region where an outer surface is not coated with the coating. The guide wire port is opened to the outside of the tube toward the proximal end side,
The catheter according to claim 1, wherein the uncoated region is provided on a proximal side with respect to the guide wire port.   Of the coating regions, the other coating region is disposed at an interval smaller than the interval between the guide wire port and the one coating region in the axial direction with respect to the guide wire port. The catheter according to claim 2, wherein the catheter is arranged continuously with the wire port.   The catheter according to claim 2 or 3, wherein the coating applied to the one coating region of the tube has a smaller thickness than the coating applied to the other coating region.   The catheter according to claim 4, wherein the one coating region is disposed on a proximal end side with respect to the guide wire port. It has a tube with a lumen inside,
In the tube, the peripheral wall portion surrounding the lumen is applied to a catheter in which a guide wire port for guiding a guide wire into the tube is formed in the middle of the axial direction, and a method for manufacturing the catheter,
A first application step of applying a hydrophilic coating liquid to a predetermined range below the guide wire port on the outer surface of the tube in a state where the tube is suspended so that the axial direction thereof is directed vertically. ,
Similarly, in the suspended state of the tube, a second application step of applying the coating liquid to a predetermined range on the outer surface of the tube above the guide wire port and spaced from the guide wire port;
A fixing step of forming a coating layer on the outer surface of the tube by fixing the coating liquid applied in each of the application steps;
A method for producing a catheter, comprising:   The method for manufacturing a catheter according to claim 6, wherein in the second application step, the coating liquid is applied thinner to the outer surface of the tube than in the first application step.

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