Patent Application
20160361517
The present invention relates to a catheter having improved kink resistance.
Different types of catheters, while all generally configured to be inserted into a living body, can take various forms depending on their purposes. One exemplary catheter is a blood vessel indwelling catheter, which can take the form of an introducer sheath or a guiding sheath, for percutaneous introduction of a device such as a treatment catheter into a living body. In general, such a sheath includes, as disclosed, for example, in JP-A-8-71161, a flexible tube-shaped main sheath body (main catheter body), a hub connected to a proximal portion of the main sheath body, and a strain relief that surrounds a predetermined range of a proximal side of the main sheath body to suppress the occurrence of a kink. Note that such strain relief for suppressing the occurrence of a kink at a proximal side of a main catheter body can also be provided in other types of catheters.
Such catheters generally also need to have both a minimized outer diameter to reduce the invasiveness thereof while also maintaining a sufficiently large inner diameter for the catheter to remain usable for its intended purpose. One technique for meeting these requirements is to simply reduce a wall thickness of a main catheter body. However, when the wall thickness of a prior art main catheter body is reduced, the possibility that a kink will occur at the time of operating the catheter may increase.
An object of the disclosure is to provide a catheter capable of providing sufficient kink resistance of a main catheter body even if a wall thickness is reduced.
A catheter includes a flexible tube-shaped main catheter body, a hub connected to a proximal portion of the main catheter body, and a flexible strain relief supported by a distal portion of the hub, the flexible strain relief surrounding a predetermined range of a proximal side of the main catheter body. The flexible strain relief includes a hard portion which is provided in each of regions opposite from each other with respect to an axis in at least a distal-side portion, and which is configured to be harder than another portion in a circumferential direction.
When such a catheter is manipulated into a direction in which the hard portion is at a side with respect to a direction in which the main catheter body is bent at the time of use, a proximal-side portion of the main catheter body surrounded by the strain relief is supported by the hard portion when the main catheter body is bent. The proximal-side portion of the main catheter body supported by the hard portion, rigidity of which is higher than that of the other portion, is inhibited from being deformed in an outside direction (horizontal direction), and thus stress concentration corresponding to a source of a kink is relieved. In this way, the occurrence of a kink in the proximal-side portion of the main catheter body may be effectively prevented or suppressed. Therefore, kink resistance of the main catheter body may be increased while decreasing a wall thickness.
In the above-described catheter, a side port may be provided in an outer circumferential portion of the hub, and a circumferential direction position of one hard portion in the strain relief may correspond to a circumferential direction position of the hub in which the side port is provided. When the catheter is indwelled, the side port is normally laterally arranged. Thus, in normal use, the hard portion is inevitably positioned at a side with respect to a bending direction of the proximal-side portion of the main catheter body. Therefore, kink resistance performance may be effectively exhibited without a user paying attention to a direction of the hard portion. In addition, a kink of the main catheter body may be prevented by the hard portion of the strain relief without adjusting a position of the strain relief. Thus, operation man-hours may be reduced, and a burden on an operator may be lightened.
In the above-described catheter, the hard portion may contain the same material as a material of the other portion, and may be formed to be thicker than the other portion. In this way, the hard portion may be easily configured.
In the above-described catheter, the hard portion may contain a harder material than a material of the other portion. In this way, the hard portion may be easily configured.
In the above-described catheter, the hard portion may be configured by adding a reinforcement body to the strain relief. In this way, the hard portion may be easily configured.
In the above-described catheter, the catheter may be an introducer sheath indwelled in a lumen of a living body to introduce another long medical instrument into the body. In this way, it is possible to provide an introducer sheath excellent in kink resistance.
Hereinafter, a catheter according to the disclosure will be described with reference to exemplary embodiments illustrated in the accompanying drawings.
As illustrated in
A length of the main catheter body 12 varies according to type (intended use) of the catheter 10. For example, in the case of the introducer sheath 11, the length is in a range of about 30 to 800 mm.
Examples of one or more materials included in the main catheter body 12 include a polyvinyl chloride-based resin, a urethane resin such as polyurethane, an olefin-based resin such as polyethylene, polyamide, a synthetic resin such as ethylene-vinyl acetate copolymer, silicone rubber, latex rubber, fluorocarbon resin, aromatic polyether ketone, and stainless steel.
The hub 14 is a member that is connected to a proximal portion 12b of the main catheter body 12 and includes a lumen 15 to communicate with the lumen 13 of the main catheter body 12. A protruding portion 19, a diameter of which is reduced with respect to a body portion 18 of the hub 14, is provided to protrude in a distal end direction at a distal end of the hub 14, and the proximal portion 12b of the main catheter body 12 is inserted into and fixed to an inner peripheral portion of a distal end of the protruding portion 19. Examples of a constituent material of the hub 14 include a rigid resin such as polypropylene, polyethylene, ABS, and polycarbonate.
A valve body 20 for preventing a leakage of a liquid from the inside of the hub 14 is disposed inside the hub 14. A hollow fixing member 21 is screwed with a proximal portion of the hub 14, and the valve body 20 is fixed inside the hub 14 when the valve body 20 is interposed between a distal surface of the fixing member 21 and a step portion 14a formed inside the hub 14. Note that while a threaded engagement is used in the embodiment, other methods of fixing the fixing member 21 to the proximal portion of the hub 14 may be used, and other structure capable of keeping the valve body 20 interposed between the hub 14 and the fixing member 21 may also be used. For example, the fixing member 21 may be bonded or heat-welded to the hub 14 such that the valve body 20 is interposed between the hub 14 and the fixing member 21. In addition, instead of providing the valve body 20 in the hub 14, the valve body 20 may be provided in a connector member connectable to a proximal end of the hub 14.
The valve body 20 in the embodiment is made of an elastic material (for example, silicone rubber), and a slit (not illustrated) into which a dilator or another catheter can be inserted is formed in the valve body 20. The valve body 20 is thus configured to prevent a liquid (blood, or the like) flowing in the lumen 15 of the hub 14 through the main catheter body 12 from leaking out in a state in which the dilator, or the like is inserted into the slit.
A flexible side tube 22 is connected to a side portion of the hub 14. In the illustrated example, one end of the side tube 22 is connected to a side port 23 extruding outward from the side portion of the hub 14. A lumen of the side tube 22 communicates with the lumen 15 of the hub 14 through a side hole 14b provided in the hub 14.
A three-way stopcock 24 is provided at an end portion 22b of the side tube 22 on the opposite side from an end portion 22a connected to the hub 14. For example, the three-way stopcock 24 can include a port 25 for discharging air, a port 26 for chemical injection to which a syringe (not illustrated) is connected, a port 27 connected to the end portion 22b of the side tube 22, and a cock 28 for switching communication states of the ports 25, 26, and 27. Note that the port 25 and the port 26 are not restricted to discharging air and chemical injection, and their use is not particularly restricted.
The strain relief 16 has a function of preventing or suppressing a kink (bending) at a proximal side of the main catheter body 12 (specifically, an interlock portion of the main catheter body 12 and the hub 14 and a region around the interlock portion). As illustrated in
An outer diameter of the strain relief 16 is relatively large at a proximal side thereof and relatively small at a distal side thereof, and the outer diameter gradually decreases toward the distal side. A wall thickness of the strain relief 16 decreases toward the distal side. A proximal portion of the strain relief 16 is fit onto the protruding portion 19 provided at the distal end of the hub 14. In this way, the strain relief 16 is supported by the distal portion of the hub 14.
In
Note that a bulge portion 19a annularly extending in a circumferential direction is formed on an outer peripheral surface of the protruding portion 19 in
Examples of a constituent material of the strain relief 16 include a thermoplastic resin such as styrene resin, olefin resin, and polyester resin, or an elastic material such as silicone rubber.
The other portion 34 in the strain relief 16 is a portion which is present at a circumferential direction position between one and the other hard portions 32, and is present in each of regions opposite from each other with respect to the axis a of the strain relief 16.
In the present embodiment, the hard portion 32 includes the same material as that of the other portion 34. That is, the hard portion 32 and the other portion 34 are integrally formed using the same material. In addition, the hard portion 32 is configured to be harder than the other portion 34 by being formed to be thicker than the other portion 34 in the same axial direction position.
A circumferential direction position of the one hard portion 32 in the strain relief 16 corresponds to a circumferential direction position of the hub 14 at which the side port 23 is provided. A circumferential direction position of the other hard portion 32 in the strain relief 16 corresponds to a circumferential direction position on the opposite side from the circumferential direction position of the hub 14 at which the side port 23 is provided.
The hard portion 32 is provided in a predetermined section from a most distal portion 17 of the strain relief 16. For example, a length L of the hard portion 32 along an extending direction of the main catheter body 12 is 3 to 10 mm, and preferably set to 4 to 7 mm. The hard portion 32 may be provided across a whole length of the support portion 30, or may be provided in a portion of the whole length of the support portion 30 (however, the most distal portion 17 of the support portion 30 should be included). The hard portion 32 may be provided continuously or discontinuously along the extending direction of the main catheter body 12.
Hereinafter, operations and effects of a catheter 10 as described above will be set forth. As described in the foregoing, the catheter 10 is configured as the introducer sheath 11. In the use of the introducer sheath 11, the introducer sheath 11 is combined with a dilator (not illustrated). Specifically, an assembly (introducer) in a state in which the dilator is inserted into the introducer sheath 11 punctures a blood vessel of a patient such that a distal end of the introducer sheath 11 secures the blood vessel. Thereafter, the main catheter body 12 is further inserted into the blood vessel and inserted up to a portion around the most distal portion 17 of the support portion 30, and then the dilator is pulled out of the introducer sheath 11. A length in which the main catheter body 12 is inserted into the blood vessel is set to a predetermined length.
As described above, a direction of the side port 23 at the time of indwelling the introducer sheath 11 is practically determined. Therefore, a direction in which the proximal-side portion of the main catheter body 12 is bent at the time of inserting and removing another device (a treatment catheter, or the like) into and from the introducer sheath 11 is determined. In the case of
After indwelling the introducer sheath 11 as described above, another device such as a treatment catheter (balloon catheter, or the like) or a guiding catheter is introduced through the introducer sheath 11 while being led by a guide wire (not illustrated) inside the blood vessel. Then, the device is advanced up to a predetermined region inside the living body, and angiography or treatment is performed.
Incidentally, since the proximal-side portion of the main catheter body 12 (the interlock portion of the main catheter body 12 and the hub 14) is exposed to the outside of the body during a surgery, the hub 14 may be lifted to insert and remove another device from a proximal end opening of the hub 14. In this case, the proximal-side portion of the main catheter body 12 is bent as in
A conventional strain relief exhibits kink resistance to a certain extent. However, stress may be concentrated on a proximal-side portion of a main catheter body to cause a kink. On the other hand, in the case of the strain relief 16 of the catheter 10 according to the present embodiment, since the hard portion 32 configured to be harder than the other portion 34 is provided, the occurrence of a kink may be suitably prevented or suppressed by preventing stress from being concentrated on the proximal-side portion of the main catheter body 12.
Specifically, when the proximal-side portion of the main catheter body 12 is bent, deformation of the proximal-side portion of the main catheter body 12 in a horizontal direction (X direction) is regulated (suppressed) by being supported by an inner surface 32a of the hard portion 32 of the strain relief 16 from both sides as in
In addition, unlike the hard portion 32, the other portion 34, which is bent together with the proximal-side portion of the main catheter body 12 in response to bending of the proximal-side portion, has moderate flexibility. For this reason, flexibility of the strain relief 16 in a bending direction is properly ensured, and it is possible to prevent stress from being concentrated on one point of a contact portion of the proximal-side portion of the main catheter body 12 and the strain relief 16 to cause a source of a kink. Specifically, when a portion of the strain relief 16 other than the hard portion 32 retains flexibility while the main catheter body 12 is bent, a contact area of the main catheter body 12 and the portion of the proximal-side portion of the strain relief 16 other than the hard portion 32 is widened at a center side (inner side) of bending of the main catheter body 12. For this reason, the strain relief 16 and the proximal-side portion of the main catheter body 12 may be inhibited from coming into contact with each other at one point.
Incidentally, as an angle range 81 in which the hard portion 32 is provided increases, an angle range 82 of the other portion 34 decreases (see
Accordingly, for example, the angle range 81 in which the hard portion 32 is provided is preferably set to 10°≦θ1≦120°, and more preferably set to 40°≦θ1≦80°. In this way, the angle range 82 of the other portion 34 is greater than or equal to 60°, and moderate flexibility is ensured. Thus, it is possible to prevent stress from being concentrated on one point of the main catheter body 12 at the time of bending, and a source of a kink from being caused.
As described in the foregoing, when the main catheter body 12 of the catheter 10 is bent, the proximal-side portion of the main catheter body 12 surrounded by the strain relief 16 is supported by the hard portion 32 from the both sides. The main catheter body 12 supported by the hard portion 32, rigidity of which is higher than that of the other portion 34, is inhibited from being deformed in the horizontal direction. Thus, stress concentration corresponding to a source of a kink is relieved, and the occurrence of a kink in the proximal-side portion of the main catheter body 12 may be effectively prevented or suppressed. Therefore, kink resistance of the main catheter body 12 may be increased while a thickness is reduced.
As described in the foregoing, when the introducer sheath 11 is indwelled inside the blood vessel, the main catheter body 12 is inserted into the blood vessel up to a portion around the most distal portion 17 of the support portion 30. For this reason, in particular, a portion around the support portion 30 of the main catheter body 12 fixedly comes into contact with a skin or a blood vessel wall, and a bending degree locally increases easily in the portion. Thus, a kink easily occurs. For this reason, the configuration capable of suppressing a kink in the proximal-side portion of the main catheter body 12 is suitable for the introducer sheath 11.
In addition, when the introducer sheath 11 is indwelled inside the blood vessel as in
As described in the foregoing, the circumferential direction position of the one hard portion 32 in the strain relief 16 corresponds to the circumferential direction position of the hub 14 at which the side port 23 is provided. The circumferential direction position of the other hard portion 32 in the strain relief 16 corresponds to the circumferential direction position on the opposite side from the circumferential direction position of the hub 14 at which the side port 23 is provided. When the catheter 10 is indwelled, the side port 23 is normally laterally arranged. Thus, in normal use, the hard portion 32 is inevitably positioned at a side with respect to the bending direction of the proximal-side portion of the main catheter body 12 (see
The hubs 14 of certain types of catheters may not include a side port 23. In this case, the catheter 10 can be manipulated into an orientation in which the hard portion 32 is at a side with respect to a direction in which the main catheter body 12 is bent at the time of use, so that the proximal-side portion of the main catheter body 12 surrounded by the strain relief 16 will be supported by the hard portion 32 when the main catheter body 12 is bent. Therefore, the occurrence of a kink in the proximal-side portion of the main catheter body 12 may still be effectively prevented or suppressed.
In addition, a certain mark, or the like can be provided on an outer peripheral surface of the hard portion 32 such that a position of the hard portion 32 can be recognized from appearance, in which case the use can easily see how to manipulate the catheter 10 into the orientation in which the hard portion 32 is at the side with respect to the direction in which the main catheter body 12 is bent at the time of use.
The strain relief 16 may be rotatable with respect to the main catheter body 12. In this case, when the mark, or the like is provided in the hard portion 32, a position of the hard portion 32 may be easily adjusted after indwelling the catheter 10. That is, positioning may be easily performed such that the hard portion 32 is positioned at a side with respect to the bending direction of the proximal-side portion of the main catheter body 12 by rotating the strain relief 16 with respect to the main catheter body 12.
A hard portion 42 containing a harder material than that of another portion 34 may be provided in each of regions opposite from each other with reference to an axis a as in a strain relief 40 according to a first modified example illustrated in
According to a configuration of
A hard portion 48 configured by adding a reinforcement body 46 thereto may be provided in each of regions opposite from each other with respect to an axis a as in a strain relief 44 according to a second modified example illustrated in
The reinforcement body 46 contains a harder material than a base material of the strain relief 44. Examples of the material contained in the reinforcement body 46 include a hard olefin resin such as high molecular weight polyethylene or polypropylene, a resin such as polyimide, polyethylene terephthalate, rigid polyvinyl chloride, acrylic resin, polycarbonate, acrylonitrile-butadiene-styrene resin (ABS resin), polystyrene, or aromatic polyether ketone, and metal such as stainless steel. For example, as illustrated in
According to a configuration of
The detailed description above describes a catheter. The invention is not limited, however, to the precise embodiments and variations described. Various changes, modifications and equivalents can be effected by one skilled in the art without departing from the spirit and scope of the invention as defined in the accompanying claims. It is expressly intended that all such changes, modifications and equivalents which fall within the scope of the claims are embraced by the claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2014-041413 | Mar 2014 | JP | national |
This application is a continuation of International Application No. PCT/JP2015/054514 filed on Feb. 19, 2015, and claims priority to Japanese Patent Application No. 2014-041413 filed on Mar. 4, 2014, the entire content of each of which is incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/JP2015/054514 | Feb 2015 | US |
| Child | 15245755 | US |
