Catheter and catheter performance adjustment method

Abstract

The present invention provides a catheter with adjustable pushability and trackability. [Solution] The catheter according to the present disclosure comprises a long catheter body and a long reinforcing body that is movable in the longitudinal direction of the catheter body inside the catheter body, wherein the catheter body has a communication hole that connects the inside and outside of the catheter body, allowing the base end of the reinforcing body to be exposed to the outside of the catheter body, so that the position of the tip of the reinforcing body in the longitudinal direction inside the catheter body can be adjusted.

Description

Technical Field

[0001] The present disclosure relates to a catheter and a method for adjusting catheter performance.

Background Art

[0002] Conventionally, catheters with a reinforcement fixed inside have been known. Patent Document 1 describes a balloon catheter as this type of catheter. The balloon catheter described in Patent Document 1 includes a shaft and a reinforcement disposed in a lumen penetrating the shaft and having a fixed position. In the balloon catheter described in Patent Document 1, kinking is suppressed by disposing the reinforcement in the lumen.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] In a catheter as described in Patent Document 1, the required rigidity of the reinforcement varies depending on the state of the lesion to be treated, the position of the lesion to be treated, and the like. For example, in the treatment of a lesion with advanced calcification, in order to pass through the calcified lesion, it is preferable to increase the rigidity of the reinforcement and enhance the pushability of the catheter. On the other hand, when the rigidity of the reinforcement increases, the flexibility of the catheter decreases, and it may become difficult to pass through a bent blood vessel or the like. That is, when inserting the catheter to the lesion, in order to facilitate passing through a bent blood vessel or the like, it is preferable to reduce the rigidity of the reinforcement and enhance the trackability of the catheter.

[0005] In the catheter described in Patent Document 1, the reinforcing body is fixed inside, making it impossible to adjust the pushability and trackability of the catheter according to the condition and location of the lesion being treated. Therefore, users such as surgeons need to use different catheters depending on the condition and location of the lesion being treated.

[0006] This disclosure aims to provide a catheter with adjustable pushability and trackability. [Means for solving the problem]

[0007] A catheter as a first aspect of this disclosure is (1) A long catheter body, The catheter body comprises an elongated reinforcing body that is movable in the longitudinal direction of the catheter body within the catheter body, The catheter body is a catheter having a communication hole that connects the inside and outside of the catheter body, which allows the base end of the reinforcing body to be exposed to the outside of the catheter body, so that the longitudinal position of the tip of the reinforcing body can be adjusted inside the catheter body.

[0008] A catheter as one embodiment of the present disclosure is (2) The catheter body is A flexible tubular body, The tubular body comprises a hub attached to the base end side, The communication hole is the catheter described in (1) above, which is partitioned by the tubular body or the hub.

[0009] A catheter as one embodiment of the present disclosure is (3) The tubular body is The tip shaft and The system comprises a base shaft connected to the longitudinal base end of the tip shaft, and having greater bending rigidity than the tip shaft, The communication hole is partitioned by the base end shaft or the hub of the tubular body, The reinforcing member is the catheter described in (2) above, and is longer than the longitudinal distance between the communication hole and the connection portion between the tip-side shaft and the proximal-side shaft.

[0010] A catheter as one embodiment of the present disclosure is (4) The catheter body is attached to the tip shaft and includes an expandable body that can expand and contract in the radial direction of the catheter body. The reinforcing member is the catheter described in (3) above, and is longer than the longitudinal distance between the communication hole and the expandable body.

[0011] A catheter as one embodiment of the present disclosure is (5) The reinforcing member is the catheter described in (4) above, and is longer than the longitudinal distance between the communication hole and the position of the longitudinal tip of the expanded body.

[0012] A catheter as one embodiment of the present disclosure is (6) The catheter according to (4) or (5) above, wherein the reinforcing body is provided inside the tip-side shaft and the proximal-side shaft, respectively, a first lumen through which the reinforcing body is movable and a second lumen through which the fluid supplied to the expander is movable.

[0013] A catheter as one embodiment of the present disclosure is (7) The reinforcing body is movable, and a common lumen through which the fluid supplied to the expansion body is movable is provided inside the tip-side shaft and the base-side shaft. The catheter according to (4) or (5) above, comprising a lid body that can be attached to the catheter body so as to block the communication hole.

[0014] A catheter as one embodiment of the present disclosure is (8) The catheter according to (7) above, wherein the lid body is attached to the reinforcing body.

[0015] A catheter as one embodiment of the present disclosure is (9) The catheter according to (8) above, wherein the lid body is attached to the reinforcing body so as to be movable along the reinforcing body.

[0016] A catheter as one embodiment of the present disclosure is (10) The catheter according to any one of (3) to (9) above, comprising an inner tube disposed inside the distal shaft of the tubular body and through which a guide wire can be inserted.

[0017] A method for adjusting catheter performance as a second aspect of the present disclosure is (11) A step of preparing the catheter according to (1) above, and An adjustment step of operating the base end portion of the reinforcing body exposed to the outside of the catheter body through the communication hole to adjust the longitudinal position of the tip end portion of the reinforcing body inside the catheter body. A method for adjusting catheter performance, which includes

Advantages of the Invention

[0018] According to the present disclosure, a catheter capable of adjusting pushability and trackability can be provided. ​​​​​​​​​Figure 1 shows a detailed view of the catheter. [Figure 3] This figure shows the state after the reinforcing body has been advanced towards the longitudinal end, compared to the state shown in Figure 2. [Figure 4] This figure shows a modified example of the first lumen shown in Figure 2. [Figure 5] This figure shows details of a catheter as a second embodiment of the present disclosure. [Figure 6] This figure shows the state after the reinforcing body has been advanced towards the longitudinal end, compared to the state shown in Figure 5. [Figure 7A] Figure 5 shows an example of a lid. [Figure 7B] Figure 5 shows an example of a lid. [Figure 8] Figure 5 shows a detailed view of a catheter equipped with a catheter body containing a communication hole, which is one modified example of the communication hole shown in Figure 5. [Figure 9] This figure shows the state after the reinforcing body has been advanced towards the longitudinal end from the state shown in Figure 8. [Figure 10] Figure 5 shows a detailed view of a catheter equipped with a catheter body containing a communication hole, which is one modified example of the communication hole shown in Figure 5. [Figure 11] This figure shows the state after the reinforcing body has been advanced towards the longitudinal end from the state shown in Figure 10. [Figure 12] This figure shows details of a catheter including a cover, as one variation of the cover shown in Figure 10. [Figure 13] This figure shows the state after the reinforcing body has been advanced towards the longitudinal end, compared to the state shown in Figure 12. [Figure 14] This figure shows details of a catheter including a reinforcing element, as one modified example of the reinforcing element shown in Figure 12. [Figure 15] This figure shows the state after the reinforcing body has been advanced towards the longitudinal end, from the state shown in Figure 14. [Figure 16] This flowchart shows an example of a treatment method using a catheter, which includes a catheter performance adjustment method as one embodiment of the present disclosure. [Figure 17]This figure shows a catheter equipped with a stent as one embodiment of the present disclosure. [Figure 18A] This figure shows a catheter without an expander, as one embodiment of the present disclosure. [Figure 18B] This figure shows the expanded state after the expanded body has been pushed out from the state shown in Figure 18A. [Figure 19A] This figure shows an example of the shape of a reinforcing body. [Figure 19B] This figure shows an example of the shape of a reinforcing body. [Figure 19C] This figure shows an example of the shape of a reinforcing body. [Modes for carrying out the invention]

[0020] Hereinafter, embodiments of the catheter and catheter performance adjustment method relating to this disclosure will be illustrated with reference to the drawings. In each figure, identical components are denoted by the same reference numerals.

[0021] <First Embodiment> Figure 1 shows a catheter 100 as one embodiment of the catheter according to this disclosure. Figures 2 and 3 show details of the catheter 100 shown in Figure 1.

[0022] As shown in Figures 1 to 3, the catheter 100 comprises a long catheter body 1 and a long reinforcing body 2. The long reinforcing body 2 is movable inside the catheter body 1. Figures 2 and 3 show different positions of the tip 2a of the reinforcing body 2 inside the catheter body 1. Also, in Figures 2 and 3, the catheter body 1 is shown in a cross-sectional view, and the reinforcing body 2 is shown in a side view.

[0023] Hereinafter, in the catheter 100, the longitudinal direction of the catheter body 1 will be simply referred to as "longitudinal direction A". In addition, in the catheter 100, the side inserted into the body in longitudinal direction A will be referred to as "proximal side A1", and the proximal side manipulated by the operator outside the body in longitudinal direction A will be referred to as "proximal side A2". Furthermore, in the catheter 100, the radial direction of a virtual circle centered on the catheter body 1 in a cross-sectional view perpendicular to longitudinal direction A will be simply referred to as "radial direction B".

[0024] The catheter 100 is used by being inserted into a living lumen such as a blood vessel. Specifically, the catheter 100 is inserted percutaneously into the patient's body and delivered to a lesion in the living lumen, such as a narrowed or blocked area of ​​a blood vessel, and is used to treat the lesion, such as dilating a narrowed area of ​​a blood vessel.

[0025] As will be described in detail later, in the catheter 100 of this embodiment, the catheter body 1 is equipped with a balloon as an expander 50. However, the catheter according to this disclosure is not limited to a configuration in which the catheter body is equipped with a balloon. The catheter body may be configured without a balloon. Details of such a catheter will be described later (see Figures 18A and 18B). Also, in the catheter 100 of this embodiment, the catheter body 1 is not equipped with a stent. However, the catheter according to this disclosure may be configured in which the catheter body is equipped with a stent. Details of such a catheter will also be described later (see Figure 17).

[0026] As shown in Figures 2 and 3, the reinforcing body 2 is movable in the longitudinal direction A inside the catheter body 1. Specifically, the catheter body 1 partitions a communication hole 14a2. The communication hole 14a2 connects the inside and outside of the catheter body 1. As shown in Figures 1 to 3, the reinforcing body 2 is inserted into the inside of the catheter body 1 through the communication hole 14a2. As shown in Figures 1 to 3, the proximal end 2b of the reinforcing body 2 is exposed to the outside of the catheter body 1 through the communication hole 14a2. The position of the tip 2a of the reinforcing body 2 in the longitudinal direction A inside the catheter body 1 can be adjusted by manipulating the proximal end 2b of the reinforcing body 2 that is exposed to the outside of the catheter body 1 through the communication hole 14a2.

[0027] The reinforcing body 2 may be removable from the inside to the outside of the catheter body 1 through the communication hole 14a2. In other words, the reinforcing body 2 may be removable from the catheter body 1 through the communication hole 14a2. Also, the reinforcing body 2 may be insertable from the outside to the inside of the catheter body 1 through the communication hole 14a2. However, the reinforcing body 2 is not limited to being removable from the catheter body 1 as long as it is movable in the longitudinal direction A inside the catheter body 1. For example, the reinforcing body 2 may be movable inside the catheter body 1 such that its tip portion 2a is always located inside the catheter body 1.

[0028] Since the catheter body 1 is provided with a communication hole 14a2, the proximal end 2b of the reinforcing body 2 can be exposed to the outside of the catheter body 1 through the communication hole 14a2 while the tip 2a of the reinforcing body 2 is located inside the catheter body 1. By manipulating the proximal end 2b of the reinforcing body 2 that is exposed outside the catheter body 1, the position of the tip 2a of the reinforcing body 2 in the longitudinal direction A inside the catheter body 1 can be easily adjusted. In this way, the catheter 100 allows for easy adjustment of pushability and trackability.

[0029] Further details of the catheter 100 of this embodiment will be described below.

[0030] As described above, the catheter 100 comprises a long catheter body 1 and a long reinforcing body 2.

[0031] [Catheter body 1] As shown in Figures 2 and 3, the catheter body 1 of this embodiment comprises a flexible tubular body 10, a hub 20 attached to the proximal end A2 of the tubular body 10, a first inner tube 30 and a second inner tube 40 arranged inside the tubular body 10, and an expander 50.

[0032] As shown in Figures 2 and 3, the tubular body 10 of this embodiment comprises a tip shaft 11 and a base shaft 12. The base shaft 12 is connected to the base side A2 of the longitudinal direction A of the tip shaft 11. The base shaft 12 has greater bending rigidity than the tip shaft 11. The hub 20 is attached to the base side A2 of the base shaft 12.

[0033] The tip shaft 11 is preferably flexible. The material used to form the tip shaft 11 is not particularly limited, but examples include thermoplastic resins such as polyamide, polyester, polyamide elastomer, polyester elastomer, polyolefin (e.g., polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, and crosslinked or partially crosslinked products thereof), polyvinyl chloride, and polyurethane.

[0034] The base shaft 12 is not limited in its forming material, as long as its bending rigidity is greater than that of the tip shaft 11. Examples of materials for forming the base shaft 12 include metals such as Ni-Ti, brass, SUS, and aluminum.

[0035] In this embodiment, the tip shaft 11 comprises a main shaft portion 11a and a connecting shaft portion 11b that connects the main shaft portion 11a and the base shaft 12. The bending rigidity of the connecting shaft portion 11b is greater than that of the main shaft portion 11a. However, the tip shaft 11 is not limited to a configuration comprising a main shaft portion 11a and a connecting shaft portion 11b.

[0036] As shown in Figures 2 and 3, the tubular body 10 of this embodiment has a first lumen 14a, a second lumen 14b, and a third lumen 14c inside the tip shaft 11 and the base shaft 12. The first lumen 14a, the second lumen 14b, and the third lumen 14c are separate spaces that are not connected to each other. The first lumen 14a is a space through which the reinforcing body 2 can move. The second lumen 14b is a space through which the fluid supplied to the expansion body 50 can move. The third lumen 14c is a space through which the guide wire 60 can be inserted.

[0037] More specifically, the catheter body 1 of this embodiment includes a first inner tube 30 positioned inside the tubular body 10, which partitions the first lumen 14a internally. The first inner tube 30 of this embodiment extends in the longitudinal direction A across the tip-side shaft 11 and the proximal-side shaft 12 of the tubular body 10. Furthermore, the first inner tube 30 of this embodiment protrudes from the tubular body 10 toward the tip side A1. As shown in Figures 2 and 3, the tip side A1 of the first lumen 14a of this embodiment is not open, but is closed in the region where the expansion body 50 is located in the longitudinal direction A. Furthermore, the proximal-side A2 of the first lumen 14a of this embodiment opens to the outside of the catheter body 1 through a communication hole 14a2, which serves as the proximal opening of the first lumen 14a. More specifically, the communication hole 14a2 of this embodiment is formed at the proximal end of the first inner tube 30, which penetrates the peripheral wall of the proximal-side shaft 12 of the tubular body 10.

[0038] The catheter body 1 of this embodiment includes a second inner tube 40 located inside the tubular body 10, which partitions the third lumen 14c internally. The second inner tube 40 of this embodiment is located inside the tip-side shaft 11 of the tubular body 10, and is not located inside the proximal-side shaft 12 of the tubular body 10. In other words, the second inner tube 40 of this embodiment extends in the longitudinal direction A inside the tip-side shaft 11 of the tubular body 10. Furthermore, the second inner tube 40 of this embodiment protrudes from the tip-side A1 of the tubular body 10. In other words, the second inner tube 40 of this embodiment protrudes from the tip-side shaft 11 of the tubular body 10 in a tip-side A1. As shown in Figures 2 and 3, the tip-side A1 of the third lumen 14c of this embodiment opens to the outside of the catheter body 1 at the tip opening 14c1 formed at the tip of the second inner tube 40. Furthermore, the proximal end A2 of the third lumen 14c in this embodiment opens to the outside of the catheter body 1 at a proximal end opening 14c2 formed at the proximal end of the second inner tube 40, which penetrates the peripheral wall of the tip-side shaft 11 of the tubular body 10. In other words, the catheter body 1 in this embodiment is a so-called rapid exchange type. The proximal end of the second inner tube 40 in this embodiment penetrates the peripheral wall of the tip-side shaft 11 between the main shaft portion 11a and the connecting shaft portion 11b of the tip-side shaft 11.

[0039] In this embodiment, the second lumen 14b is partitioned within the tubular body 10 and the hub 20 by the tubular body 10 and the hub 20. The first inner tube 30 and the second inner tube 40 described above extend in the longitudinal direction A in the second lumen 14b. The tip side A1 of the second lumen 14b communicates with the fluid containment space 50a of the expansion body 50 through a tip opening 14b1 formed at the tip of the tip shaft 11, which is the tip of the tubular body 10. The base side A2 of the second lumen 14b opens to the outside of the catheter body 1 through a base opening 14b2 formed at the base end of the hub 20. However, a valve body 17 may be provided at the base opening 14b2. A fluid supply and discharge device such as an indeflerator may be connectable to the hub 20 so as to communicate liquid-tightly with the second lumen 14b through the valve body 17. However, the base opening 14b2 does not necessarily have to be provided with a valve body 17.

[0040] The first inner tube 30 and the second inner tube 40 may each be formed from a single resin material. However, in order to improve the sliding properties of the reinforcing body 2 and the guide wire 60, it is preferable that the first inner tube 30 and the second inner tube 40 each have an inner layer formed from a low-friction material, such as polyethylene or fluororesin.

[0041] As shown in Figures 1 to 3, the expander 50 is attached to the tubular body 10. More specifically, the base end A2 of the balloon as the expander 50 is joined to the outer surface of the tip shaft 11 of the tubular body 10. The balloon as the expander 50 extends from the position where it is joined to the outer surface of the tip shaft 11 of the tubular body 10 to the tip side A1. The tip side A1 end of the balloon as the expander 50 is joined to the outer surface of the tip side A1 end of the second inner tube 40 which protrudes from the tubular body 10. Thus, the expander 50 of this embodiment is positioned so as to straddle the tip of the tubular body 10 in the longitudinal direction A, and is joined to the outer surface of the tubular body 10 and to the second inner tube 40.

[0042] As shown in Figures 2 and 3, the expander 50 surrounds the outer circumference of the second inner tube 40 in the radial direction B. As described above, the second lumen 14b communicates with the fluid-containing space 50a inside the expander 50. The expander 50 can expand outward in the radial direction B by supplying fluid to the fluid-containing space 50a. Figures 1 to 3 show the expander 50 in the contracted state. However, in Figure 1, the expander 50 in the expanded state is also shown by a dashed line. As shown in Figure 1, the expander 50 has an expandable main body 51 in the center of its longitudinal direction A, which has a substantially cylindrical outer shape in the expanded state. The presence of the expandable main body 51 in the expander 50 makes it easier to spread out lesions such as stenoses and occlusions in blood vessels. The expandable main body 51 of the expander 50 does not have to be perfectly cylindrical, and may be, for example, polygonal prism-shaped. In the contracted state, the expander 50 is contracted inward in the radial direction B compared to the expanded state. In this contracted state, the expanded body 50 may be folded in such a way that it wraps around the outer surface of the second inner tube 40.

[0043] As described above, the expandable body 50 expands when fluid is supplied to the fluid-containing space 50a through the second lumen 14b. More specifically, the expandable body 50 expands radially outward in the direction B due to the pressure of the fluid supplied to the fluid-containing space 50a through the second lumen 14b. The expandable body 50 also contracts when the fluid is removed from the fluid-containing space 50a through the second lumen 14b.

[0044] The fluid used for expanding the expander 50 is not particularly limited. The fluid used for expanding the expander 50 may be either a liquid or a gas. However, it is preferable to use a liquid that is radiopaque. Specifically, the fluid used for expanding the expander 50 may be, for example, a liquid obtained by diluting an X-ray contrast agent, such as an arterial contrast agent, with physiological saline.

[0045] The expanded body 50 is preferably flexible. The material used to form the expanded body 50 is not particularly limited, but examples include thermoplastic resins such as polyolefins, polyvinyl chloride, polyamides, polyamide elastomers, polyester elastomers, polyurethanes, polyesters, and polyarylene sulfides, as well as silicone rubber and latex rubber.

[0046] Next, the position of the communication hole 14a2 will be described. As shown in Figures 2 and 3, the communication hole 14a2 in this embodiment is partitioned by the tubular body 10. More specifically, the communication hole 14a2 in this embodiment is partitioned by the proximal shaft 12 of the tubular body 10. However, the communication hole 14a2 is not limited to a configuration partitioned by the tubular body 10. The communication hole 14a2 may be partitioned by, for example, the hub 20. In other words, the proximal side A2 of the first lumen 14a is not limited to a configuration in which it opens to the outside of the catheter body 1 at the position of the circumferential wall of the proximal shaft 12 of the tubular body 10, but may also be configured to open to the outside of the catheter body 1 at the position of the hub 20.

[0047] Furthermore, as shown in Figures 2 and 3, the tip side A1 of the first lumen 14a in this embodiment terminates at a position covered by the extended body portion 51 of the extended body 50 in the longitudinal direction A, but the configuration is not limited to this. Figure 4 shows one modified example of the first lumen 14a. As shown in Figure 4, the first lumen 14a may extend, for example, from the tip portion in the longitudinal direction A of the extended body 50 to the tip side A1. As shown in Figures 2 to 4, it is preferable that the first lumen 14a extends in the longitudinal direction A from the position of the communication hole 14a2 to at least the position of the tip side A1 beyond the connection portion 15 of the tip-side shaft 11 and the base-side shaft 12. In this way, the position of the connection portion 15, which is the boundary between the tip-side shaft 11 and the base-side shaft 12, which have different bending rigidities, can be reinforced by the reinforcing body 2.

[0048] Furthermore, as shown in Figures 2 to 4, it is more preferable that the first lumen 14a extends in the longitudinal direction A from the position of the communication hole 14a2 to the position covered by the expander 50. This allows the reinforcing body 2 to be inserted to a position A1 on the tip side of the connection part 15 and covered by the expander 50. In other words, the position in the longitudinal direction A of the tip 2a of the reinforcing body 2 can be adjusted to any position in the longitudinal direction A within the tip-side shaft 11. This allows for finer adjustment of the pushability and trackability of the catheter 100.

[0049] From this viewpoint, as shown in Figure 4, it is particularly preferable that the first lumen 14a extends longitudinally A from the position of the communication hole 14a2 to the position A1 on the tip side of the expander 50. In this way, the reinforcing body 2 can reinforce the catheter body 1 even at the position A1 on the tip side of the expander 50. In other words, the pushability and trackability of the catheter 100 can be adjusted more precisely. However, from the viewpoint of reducing the diameter of the tip of the catheter body 1, it is preferable that the first lumen 14a terminates at the proximal end A2 of the tip of the expander 50, as shown in Figures 2 and 3.

[0050] [Reinforcement 2] As shown in Figures 1 to 3, the reinforcing body 2 of this embodiment comprises a reinforcing body main body 70 and an operating section 71.

[0051] As shown in Figures 2 and 3, the reinforcing body 70 of the reinforcing body 2 is inserted into the catheter body 1 through a communication hole 14a2, which serves as the proximal opening of the first lumen 14a. A portion of the reinforcing body 70 also extends outside the catheter body 1 through the communication hole 14a2. The operating section 71, which is connected to the reinforcing body 70, is located outside the catheter body 1. The user, such as an operator, can adjust the amount (insertion length) of the reinforcing body 70 inserted into the catheter body 1 by grasping and operating the operating section 71.

[0052] As shown in Figures 2 and 3, it is preferable that the reinforcing body 2 in this embodiment is longer than the longitudinal distance A L1 between the communication hole 14a2 and the connection portion 15 between the tip shaft 11 and the proximal shaft 12. In this way, the reinforcing body 2 can be inserted into the catheter body 1 such that the tip portion 2a of the reinforcing body 2 is located at a position A1 further to the tip than the connection portion 15. This allows the connection portion 15 to be reinforced by the reinforcing body 2. The connection portion 15 is the boundary between the tip shaft 11 and the proximal shaft 12, which have different bending rigidities, and is therefore prone to kinking. However, by reinforcing the connection portion 15 with the reinforcing body 2, the occurrence of the aforementioned kinking can be suppressed. Note that the distance L1 is the distance from the distal end A1 of the communication hole 14a2 to the distal end A1 of the connection portion 15.

[0053] Furthermore, as shown in Figures 2 and 3, the reinforcing body 2 of this embodiment is longer than the longitudinal distance A L2 between the communication hole 14a2 and the expandable body 50. This allows the position of the tip portion 2a of the reinforcing body 2 in the longitudinal direction A to be adjusted to any position in the longitudinal direction A within the tip-side shaft 11, as described above. This allows for finer adjustment of the pushability and trackability of the catheter 100. Note that distance L2 is the distance from the distal end A1 of the communication hole 14a2 to the proximal end A2 of the expandable portion of the expandable body 50 (in this embodiment, the expandable portion including the expandable main body portion 51).

[0054] Furthermore, as shown in Figure 4, it is preferable that the reinforcing body 2 is longer than the distance L3 in the longitudinal direction A between the communication hole 14a2 and the position of the tip of the expandable body 50 in the longitudinal direction A. By doing so, as described above, the pushability and trackability of the catheter 100 can be adjusted more precisely. Note that the distance L3 is the distance from the distal end A1 of the communication hole 14a2 to the distal end A1 of the expandable portion of the expandable body 50 (in this embodiment, the expandable portion including the expandable main body 51).

[0055] In this embodiment, the first lumen 14a, through which the reinforcing body 2 can move, and the second lumen 14b, through which the fluid supplied to the expander 50 can move, are provided inside the tip-side shaft 11 and the base-side shaft 12, respectively, but the configuration is not limited to this. Below, a configuration in which the lumen through which the reinforcing body 2 can move and the lumen through which the fluid supplied to the expander 50 can move are common will be described.

[0056] <Second Embodiment> Figures 5 and 6 show a catheter 200 as another embodiment of the catheter according to the present disclosure. The catheter 200 shown in Figures 5 and 6 comprises a catheter body 101, a reinforcing body 2, and a lid 3. Figures 5 and 6 show different positions of the tip 2a of the reinforcing body 2 inside the catheter body 101.

[0057] The catheter 200 of this embodiment differs from the catheter 100 described above (see Figures 1 to 3) in that the structure of the catheter body 101 is different. Specifically, the catheter body 101 of the catheter 200 of this embodiment differs from the catheter body 1 of the catheter 100 described above (see Figures 1 to 3) in that it does not have a first inner tube 30 (see Figures 2 and 3). Furthermore, the catheter 200 of this embodiment differs from the catheter 100 described above (see Figures 1 to 3) in that it has a lid 3. Aside from the differences described above, the catheter 200 of this embodiment is the same as the catheter 100 in structure. Therefore, here we will mainly explain only the differences of the catheter 200 described above, and the explanation of other components will be omitted.

[0058] As shown in Figures 5 and 6, in the catheter body 101 of this embodiment, the reinforcing body 2 is movable, and a common lumen 114b through which the fluid supplied to the expander 50 can move is provided inside the tip-side shaft 11 and the proximal-side shaft 12. In other words, in the catheter 200 of this embodiment, the reinforcing body 2 is movable in the longitudinal direction A through the lumen through which the fluid supplied to the expander 50 can move.

[0059] Thus, the catheter body 101 may have a common lumen 114b through which the reinforcing body 2 can move, and through which the fluid supplied to the expander 50 can move.

[0060] However, if the catheter body 101 partitions the common lumen 114b, there is a possibility that the fluid for the expander 50 may leak out of the catheter body 101 through the communication hole 14a2. For this reason, the catheter 200 of this embodiment is equipped with a cover 3 that can be attached to the catheter body 101 to close the communication hole 14a2. By providing such a cover 3, leakage of fluid from the communication hole 14a2 can be suppressed.

[0061] Figures 7A and 7B show specific examples of the cover 3. As shown in Figure 7A, the cover 3 may be configured to fit onto the inner surface that partitions the communication hole 14a2, thereby closing the communication hole 14a2. Alternatively, as shown in Figure 7B, the cover 3 may be configured to have a male threaded portion 3a that can be screwed into a female threaded portion 116 formed on the inner surface that partitions the communication hole 14a2.

[0062] Furthermore, as shown in Figures 5 and 6, it is preferable that the cover 3 is attached to the reinforcing body 2. In particular, it is preferable that the cover 3 is attached to the reinforcing body 2 so as to be movable along the reinforcing body 2. Specifically, the cover 3 may, for example, partition a through hole 3b through which the reinforcing body 2 can be inserted. The cover 3 may be attached to the reinforcing body 2 by inserting the reinforcing body 2 through the through hole 3b. In this way, even if the position of the tip 2a of the reinforcing body 2 in the longitudinal direction A in the common lumen 114b is changed, the communication hole 14a2 can be closed by the cover 3 by moving the cover 3 along the reinforcing body 2. In other words, the communication hole 14a2 can be closed by the cover 3 regardless of the amount (insertion length) of the reinforcing body 2 inserted into the catheter body 101. It is preferable that the gap between the inner surface of the cover 3 partitioning the through hole 3b and the reinforcing body 2 is sealed by, for example, an O-ring. In this way, leakage of fluid for the expansion body 50 can be further suppressed.

[0063] As shown in Figures 5 and 6, the communication hole 14a2 in this embodiment is provided on the proximal shaft 12 of the tubular body 10, but the configuration is not limited to this. Figures 8 and 9 show a modified example of the communication hole 14a2 shown in Figures 5 and 6. Figures 8 and 9 show a state in which the position of the tip portion 2a of the reinforcing body 2 inside the catheter body 101 is different. As shown in Figures 8 and 9, the communication hole 14a2 may be partitioned by a hub 20. In the hub 20 shown in Figures 8 and 9, the communication hole 14a2 is provided separately from the proximal opening 14b2 formed at the proximal end of the hub 20, which is used for supplying fluid to the expandable body 50. Also, as shown in Figures 8 and 9, the lid 3 may be configured to be able to close the communication hole 14a2 partitioned by the hub 20.

[0064] In the hub 20 shown in Figures 8 and 9, a communication hole 14a2 is provided in addition to the base end opening 14b2 formed at the base end of the hub 20, but the configuration is not limited to this. Figures 10 and 11 show another modified example of the communication hole 14a2. Also, Figures 10 and 11 show a state in which the position of the tip portion 2a of the reinforcing body 2 inside the catheter body 101 is different. As shown in Figures 10 and 11, the communication hole 14a2 may be used interchangeably with the base end opening 14b2 formed at the base end of the hub 20. However, as shown in Figures 10 and 11, it is preferable that the lid 3 capable of closing the base end opening 14b2 is provided with a connection port 3c to which a fluid supply / discharge device such as an indeflerator can be connected.

[0065] Furthermore, Figures 10 and 11 show an example in which the lid 3 is attached to the reinforcing body 2 so as to be movable along the reinforcing body 2, but the configuration is not limited to this. Figures 12 and 13 show a lid 103 as one modified example of the lid 3. Figures 12 and 13 show a state in which the position of the tip 2a of the reinforcing body 2 inside the catheter body 101 is different. The lid 103 shown in Figures 12 and 13 does not partition the through hole through which the reinforcing body 2 is inserted. Therefore, as shown in Figure 13, when the lid 103 closes the base end opening 14b2 as a communication hole 14a2, it is connected to the hub 20 by sandwiching the reinforcing body 2 between itself and the hub 20.

[0066] Furthermore, Figures 14 and 15 show a modified example of the reinforcing body 2. Figures 14 and 15 show a different position of the tip 2a of the reinforcing body 2 inside the catheter body 101. The reinforcing body 2 shown in Figures 14 and 15 does not have an operating section 71 and is composed only of the reinforcing body 70. And, as shown in Figures 14 and 15, the lid 103 may be configured to close the base end opening 14b2 after the base end 2b of the reinforcing body 2 has been pushed into the common lumen 114b through the base end opening 14b2 which serves as the communication hole 14a2 of the hub 20.

[0067] Thus, the catheter body 101 may be configured such that the reinforcing body 2 is movable and a common lumen 114b through which the fluid supplied to the expander 50 is movable is partitioned. The communication hole 14a2 connected to the common lumen 114b may be formed in the proximal shaft 12 of the tubular body 10 (see Figures 5 and 6), or it may be formed in the hub 20 (see Figures 8 to 15). Furthermore, the communication hole 14a2 formed in the hub 20 may be separate from the opening used for fluid supply to the expander 50 (proximal opening 14b2 in Figures 8 to 15), or they may be used for both. Furthermore, various configurations can be adopted for the lid that can close the communication hole 14a2, depending on its relationship with the communication hole 14a2 (see Figures 5 to 15).

[0068] As described above, with the catheter according to this disclosure, the pushability and trackability of the catheter can be easily adjusted by adjusting the amount (insertion length) of the reinforcing body inserted into the catheter body through the communication hole. For example, with the catheter 100 described above, it is possible to perform the steps of preparing the catheter 100 and adjusting the position of the tip 2a of the reinforcing body 2 in the longitudinal direction A inside the catheter body 1 by manipulating the proximal end 2b of the reinforcing body 2 exposed to the outside of the catheter body 1 through the communication hole 14a2. This allows the pushability and trackability of the catheter 100 to be adjusted. The same applies to the catheter 200. With the catheter 200, it is possible to perform the steps of preparing the catheter 200 and adjusting the position of the tip 2a of the reinforcing body 2 in the longitudinal direction A inside the catheter body 101 by manipulating the proximal end 2b of the reinforcing body 2 exposed to the outside of the catheter body 101 through the communication hole 14a2. This allows the pushability and trackability of the catheter 200 to be adjusted.

[0069] Figure 16 is a flowchart illustrating an example of a treatment method using catheter 100 (see Figures 1 to 4), including the catheter performance adjustment method described above. The treatment method shown in Figure 16 includes a catheter insertion step S1 in which catheter 100 is inserted into the body, a catheter delivery step S2 in which the inserted catheter 100 is delivered to the lesion, a treatment step S3 in which the lesion is treated using the catheter 100 delivered to the lesion, and a catheter removal step S4 in which catheter 100 is removed from the body. As shown in Figure 16, the catheter performance adjustment method described above is performed in the catheter delivery step S2. This adjusts the pushability and trackability of catheter 100. Subsequently, catheter 100 with adjusted pushability and trackability is delivered to the lesion. Although a treatment method using catheter 100 is shown here, the same applies to catheter 200 (see Figures 5 to 15).

[0070] The catheter and catheter performance adjustment method relating to this disclosure are not limited to the specific configurations and processes shown in the embodiments and modifications described above, and various modifications, substitutions, and combinations are possible as long as they do not depart from the scope of the claims.

[0071] The catheters 100 and 200 in the embodiments described above are so-called balloon catheters and do not have a stent. However, the catheter according to this disclosure may be a catheter 300 that includes a stent 80 attached to the expander 50 so as to cover the expander 50, as shown in Figure 17. Furthermore, the catheter according to this disclosure may be a catheter 400 that does not have an expander, as shown in Figures 18A and 18B. The catheter 400 shown in Figures 18A and 18B includes an outer tube 401, a stent 402 housed in the outer tube 401, an inner tube 403 located inside the outer tube 401, and a reinforcing body 2. The stent 402 is self-expanding and can expand by its own restorative force by being pressed by the inner tube 403 and popping out of the outer tube 401. Thus, the catheter according to this disclosure may have a configuration that does not include an expander.

[0072] Furthermore, the shape of the reinforcing body 2 is not particularly limited. Figure 19A shows an example of the reinforcing body 70 of the reinforcing body 2. As shown in Figure 19A, the tip portion 2a of the reinforcing body 2 may, for example, have a tapered shape. Figure 19B shows another example of the reinforcing body 70 of the reinforcing body 2. As shown in Figure 19B, the reinforcing body 70 of the reinforcing body 2 may, for example, be composed of a spirally extending coil body. Furthermore, Figure 19C is a partial cross-sectional view of an example of the reinforcing body 2. The cross-sectional shape of the reinforcing body 70 of the reinforcing body 2 is not particularly limited and may, for example, be circular or oval. Also, as shown in Figure 19C, the reinforcing body 70 of the reinforcing body 2 may, for example, have a crescent-shaped cross-section.

[0073] Furthermore, in the first embodiment described above, the first lumen 14a through which the reinforcing body 2 is inserted is partitioned by a first tube 30 separate from the tubular body 10, but the configuration is not limited to this. The first lumen 14a may be partitioned by, for example, the tubular body 10. [Industrial applicability]

[0074] This disclosure relates to catheters and methods for adjusting catheter performance. [Explanation of Symbols]

[0075] 1. 101: Catheter body 2: Reinforcement 2a: Tip of the reinforcing body 2b: Base of the reinforcing body 3, 103: Lid 3a: Male threaded portion 3b: Through hole 3c: Connection port 10: Tubular body 11: Shaft at the tip 11a: Main shaft section 11b: Connecting shaft section 12: Base shaft 14a: First lumen 14a2: Communication hole 14b: Second lumen 14b1: Tip opening 14b2: Proximal opening 14c: Third lumen 14c1: Tip opening 14c2: Proximal opening 15: Connection part 17: Valve body 20: Hub 30: 1st inner tube 40:Second inner tube 50: Extended 50a: Fluid containment space 51: Expansion main unit 60: Guidewire 70: Reinforcement body 71:Operation unit 80: Stent 100, 200, 300, 400: Catheter 114b: Common Lumens 116: Female thread section 401: Outer body 402: Stent 403: Inner tubing A: Long direction A1: Distal side A2: Proximal side B: Radial direction L1: Longitudinal distance between the communication hole and the connection point L2: Longitudinal distance between the communication hole and the expansion body L3: The longitudinal distance between the communication hole and the tip of the expansion body.

Claims

1. A long catheter body, The catheter body comprises an elongated reinforcing body that is movable in the longitudinal direction of the catheter body within the catheter body, A catheter having a communication hole that connects the inside and outside of the catheter body, such that the proximal end of the reinforcing body can be exposed to the outside of the catheter body, so that the longitudinal position of the tip of the reinforcing body can be adjusted inside the catheter body.

2. The catheter body is A flexible tubular body, The tubular body comprises a hub attached to the base end side, The catheter according to claim 1, wherein the communication hole is partitioned by the tubular body or the hub.

3. The tubular body is The tip shaft and The system comprises a base shaft connected to the longitudinal base end of the tip shaft, and having greater bending rigidity than the tip shaft, The communication hole is partitioned by the base end shaft or the hub of the tubular body, The catheter according to claim 2, wherein the reinforcing member is longer than the longitudinal distance between the communication hole and the connection portion between the tip-side shaft and the proximal-side shaft.

4. The catheter body is attached to the tip shaft and includes an expandable body that can expand and contract in the radial direction of the catheter body. The catheter according to claim 3, wherein the reinforcing member is longer than the longitudinal distance between the communication hole and the expandable member.

5. The catheter according to claim 4, wherein the reinforcing member is longer than the longitudinal distance between the communication hole and the position of the longitudinal tip of the expanded member.

6. The catheter according to claim 4 or 5, wherein a first lumen through which the reinforcing body is movable and a second lumen through which the fluid supplied to the expander is movable are provided inside the tip-side shaft and the proximal-side shaft, respectively.

7. The reinforcing body is movable, and a common lumen through which the fluid supplied to the expansion body is movable is provided inside the tip-side shaft and the base-side shaft. The catheter according to claim 4 or 5, further comprising a cover that can be attached to the catheter body so as to close the communication hole.

8. The catheter according to claim 7, wherein the cover is attached to the reinforcing body.

9. The catheter according to claim 8, wherein the cover is attached to the reinforcing body so as to be movable along the reinforcing body.

10. The catheter according to any one of claims 3 to 5, comprising an inner tube disposed inside the tip-side shaft of the tubular body through which a guide wire can be inserted.

11. A step of preparing the catheter according to claim 1, A catheter performance adjustment method comprising: an adjustment step of manipulating the base end of the reinforcing body, which is exposed to the outside of the catheter body through the communication hole, to adjust the longitudinal position of the tip of the reinforcing body inside the catheter body.

Images