Catheter for treatment and catheter set for treatment

Abstract

To provide a catheter for treatment that can suppress an increase in medical waste, and a catheter set for treatment.SOLUTION: A catheter for treatment according to the present disclosure includes: a distal side shaft part including a treatment part; and a proximal side shaft part that can be attached to and detached from a proximal side of the distal side shaft part.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure relates to a treatment catheter and a treatment catheter set.

Background Art

[0002] Conventionally, as a treatment for lesions such as stenotic portions in blood vessels, for example, procedures using treatment catheters such as balloon catheters and stent-mounted balloon catheters are known. Patent Document 1 discloses a balloon catheter as a treatment catheter used in this type of procedure.

[0003] The balloon catheter described in Patent Document 1 includes a tubular shaft, an elongated expansion balloon attached near the tip of the tubular shaft, and means fixed to the tubular shaft so as to prevent expansion of the expansion balloon portion.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] In the procedure as described above, a plurality of treatment catheters may be used. In such a case, the plurality of treatment catheters are sequentially inserted and removed into and from the living body, and the treatment of the lesion by the treatment portion of each treatment catheter is sequentially performed. Then, the used treatment catheter is disposed of as medical waste. Therefore, if the number of treatment catheters used increases, the medical waste also increases.

[0006] In the balloon catheter described in Patent Document 1, means fixed to a tubular shaft includes a sleeve for preventing the expansion of the balloon portion. By covering the balloon with this sleeve, the expansion size of the balloon can be reduced. According to the balloon catheter described in Patent Document 1, it is not necessary to use separate balloon catheters for each desired expansion size, so an increase in medical waste can be suppressed. However, the balloon catheter described in Patent Document 1 cannot be used in procedures that do not use a balloon catheter, and there is still room for improvement from the perspective of suppressing an increase in medical waste.

[0007] An object of the present disclosure is to provide a treatment catheter and a treatment catheter set that can suppress an increase in medical waste.

Means for Solving the Problems

[0008] A treatment catheter as a first aspect of the present disclosure is (1) a distal shaft portion having a treatment portion, and a proximal shaft portion that is detachable from the proximal side of the distal shaft portion, and is a treatment catheter.

[0009] A treatment catheter as one embodiment of the present disclosure is (2) One of the distal shaft portion and the proximal shaft portion includes a male screw portion, and the other of the distal shaft portion and the proximal shaft portion includes a female screw portion that can be screwed into the male screw portion, and is the treatment catheter according to (1) above.

[0010] A treatment catheter as one embodiment of the present disclosure is (3) The proximal shaft portion defines an opening inside that can insert the proximal end portion of the distal shaft portion, and the male screw portion is provided on the outer surface of the proximal end portion of the distal shaft portion. The female screw portion is provided on the inner surface of the proximal shaft portion that partitions the opening, and is the treatment catheter according to (2) above.

[0011] The treatment catheter as one embodiment of the present disclosure is (4) The distal shaft portion defines a guide wire insertion lumen through which a guide wire can be inserted. The male screw portion is located proximal to the wire insertion lumen, and is the treatment catheter according to (3) above.

[0012] The treatment catheter as one embodiment of the present disclosure is (5) The tensile strength in the shaft longitudinal direction of the distal shaft at the mounting portions of the distal shaft portion and the proximal shaft portion is 5 N or more, and is the treatment catheter according to any one of (1) to (4) above.

[0013] The treatment catheter set as the second aspect of the present disclosure is (6) When the distal shaft portion is the first distal shaft portion and the treatment portion is the first treatment portion, the treatment catheter according to any one of (1) to (5) above, and a second distal shaft portion that can be alternatively mounted on the proximal shaft portion and the first distal shaft portion and includes a second treatment portion, and is a treatment catheter set.

[0014] The treatment catheter set as one embodiment of the present disclosure is (7) The first treatment portion of the first distal shaft portion includes a first expandable body that can expand and contract in a direction orthogonal to the shaft longitudinal direction of the first distal shaft portion. The second treatment part of the second distal shaft part is expandable and contractible in a direction orthogonal to the shaft longitudinal direction of the second distal shaft part, and includes a second expandable body having a maximum expanded outer diameter larger than that of the first expandable body, the treatment catheter set according to (6) above.

[0015] A treatment catheter set as one embodiment of the present disclosure is (8) When the proximal shaft part is used as the first proximal shaft part, the treatment catheter according to any one of (1) to (5) above, and a second proximal shaft part that can be alternatively attached to the distal shaft part and the first proximal shaft part, a treatment catheter set.

[0016] A treatment catheter set as one embodiment of the present disclosure is (9) The bending rigidity of the first proximal shaft part is different from that of the second proximal shaft part, the treatment catheter set according to (8) above.

[0017] A treatment catheter set as one embodiment of the present disclosure is (10) When the distal shaft part is used as the first distal shaft part, the treatment part is used as the first treatment part, and the proximal shaft part is used as the first proximal shaft part, the treatment catheter according to any one of (1) to (5) above, a second distal shaft part having a second treatment part, and a second proximal shaft part, and each of the first distal shaft part and the second distal shaft part is detachable from each of the first proximal shaft part and the second proximal shaft part, a treatment catheter set.

[0018] A treatment catheter set as one embodiment of the present disclosure is (11) The first treatment portion of the first distal shaft portion includes a first expandable body that can expand and contract in a direction orthogonal to the shaft longitudinal direction of the first distal shaft portion. The treatment catheter set according to (10) above, wherein the second treatment portion of the second distal shaft portion can expand and contract in a direction orthogonal to the shaft longitudinal direction of the second distal shaft portion, and includes a second expandable body having a maximum expanded outer diameter larger than that of the first expandable body.

[0019] A treatment catheter set as one embodiment of the present disclosure is (12) The treatment catheter set according to (10) or (11) above, wherein the bending rigidity of the first proximal shaft portion is different from the bending rigidity of the second proximal shaft portion.

Advantages of the Invention

[0020] According to the present disclosure, it is possible to provide a treatment catheter and a treatment catheter set that can suppress an increase in medical waste.

Brief Description of the Drawings

[0021]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9A

Figure 9B

Figure 9C

Figure 9D

Figure 10

Figure 11A

Figure 11B

Figure 11C

Figure 11D

Embodiments for Carrying Out the Invention

[0022] Hereinafter, embodiments of a treatment catheter and a treatment catheter set according to the present disclosure will be exemplified and described with reference to the drawings. The same reference numerals are given to the same configurations in each figure.

[0023] FIG. 1 and FIG. 2 are diagrams showing a treatment catheter 1 as an embodiment of a treatment catheter according to the present disclosure. The treatment catheter 1 includes a distal shaft portion 2 having a treatment portion 2a, and a proximal shaft portion 3 that is detachably attached to the proximal side of the distal shaft portion 2. FIG. 1 shows a mounted state in which the proximal shaft portion 3 is mounted on the distal shaft portion 2. FIG. 2 shows a separated state in which the proximal shaft portion 3 is removed from the distal shaft portion 2 and the distal shaft portion 2 and the proximal shaft portion 3 are separated. In the mounted state shown in FIG. 1, the distal shaft portion 2 and the proximal shaft portion 3 can be percutaneously inserted into a living body. The distal shaft portion 2 and the proximal shaft portion 3 are inserted into the living body so that the treatment portion 2a of the distal shaft portion 2 reaches a target site in the living body, such as a stenosis in a blood vessel. By doing so, the treatment portion 2a of the distal shaft portion 2 can treat the target site in the living body. In FIGS. 1 and 2, for convenience of explanation, a guide wire 60 inserted through the distal shaft portion 2 is shown by a dashed line.

[0024] The treatment portion 2a of the present embodiment includes an expandable body 7 that can expand and contract in the shaft radial direction B1, which is a direction orthogonal to the shaft longitudinal direction A1 of the distal shaft portion 2. In other words, the treatment catheter 1 of the present embodiment is a balloon catheter including the expandable body 7. The balloon catheter as the treatment catheter 1 of the present embodiment is used by being percutaneously inserted into a blood vessel so that the expandable body 7 of the treatment portion 2a reaches a target site, such as a stenosis in a blood vessel.

[0025] The expander 7 of the present embodiment can expand a stenosis in a blood vessel, for example, by expanding outward in the shaft diameter direction B1 at the stenosis in the blood vessel. The expander 7 may be, for example, a balloon without a drug coated on its outer surface, or may be a drug coated balloon (DCB) or a drug eluting balloon (DEB) with a drug coated on its outer surface.

[0026] Further, the treatment portion 2a of the distal shaft portion 2 of the present embodiment includes the expander 7 used for expanding a stenosis in a blood vessel, but is not limited to this configuration. The treatment portion 2a of the distal shaft portion 2 may be, for example, configured not to include the expander 7. Further, the treatment portion 2a of the distal shaft portion 2 may be, for example, configured to include an expander used for another purpose, such as for expanding and implanting a stent, rather than for expanding a stenosis in a blood vessel (see FIGS. 5 and 6). Thus, the treatment portion 2a of the distal shaft portion 2 may be any site used for a predetermined treatment of a target site in a living body, and its configuration and use are not particularly limited.

[0027] The proximal shaft portion 3 is attached to and used on the proximal side of the distal shaft portion 2. FIG. 3 is a diagram showing the details of the proximal end portion of the distal shaft portion 2 and the distal end portion of the proximal shaft portion 3. As shown in FIG. 3, the proximal shaft portion 3 of the present embodiment can be attached to the distal shaft portion 2 by screwing into the distal shaft portion 2. More specifically, the distal shaft portion 2 of the present embodiment is provided with a male screw portion 5. The male screw portion 5 is provided on the outer surface of the proximal end portion of the distal shaft portion 2. Further, the proximal shaft portion 3 of the present embodiment is provided with a female screw portion 6 that can be screwed with the male screw portion 5 of the distal shaft portion 2. More specifically, the proximal shaft portion 3 of the present embodiment defines an opening 3a inside which the proximal end portion of the distal shaft portion 2 can be inserted. The female screw portion 6 is provided on the inner surface of the proximal shaft portion 3 that defines the opening 3a. Then, the proximal shaft portion 3 of the present embodiment can be attached to the proximal end portion of the distal shaft portion 2 when the proximal end portion of the distal shaft portion 2 is inserted into and fitted into the opening 3a, and the above-described male screw portion 5 and female screw portion 6 are screwed together. Conversely, by loosening the screwing of the above-described male screw portion 5 and female screw portion 6 and pulling out the proximal end portion of the distal shaft portion 2 from the opening 3a of the proximal shaft portion 3, the attached state (see FIG. 1) of the distal shaft portion 2 and the proximal shaft portion 3 can be released to a separated state (see FIG. 2). However, the proximal shaft portion 3 only needs to be detachable from the proximal side of the distal shaft portion 2, and is not limited to the joining by screwing described above. The distal shaft portion 2 and the proximal shaft portion 3 may be joined by a joining structure different from the joining by screwing described above.

[0028] As described above, the treatment catheter 1 includes a distal shaft portion 2 having a treatment portion 2a, and a proximal shaft portion 3 that is detachably attached to the proximal side of the distal shaft portion 2. Therefore, the proximal shaft portion 3 can be attached to a distal shaft portion different from the distal shaft portion 2 shown in FIGS. 1 and 2 and used. Further, the distal shaft portion 2 can be attached to a proximal shaft portion different from the proximal shaft portion 3 shown in FIGS. 1 and 2 and used. That is, according to the treatment catheter 1, since the distal shaft portion 2 and the proximal shaft portion 3 are detachably configured, only one of the distal shaft portion 2 and the proximal shaft portion 3 can be changed, and the other can be used in common, so that an increase in medical waste can be suppressed.

[0029] Hereinafter, with reference to FIGS. 1 to 3, further details of the treatment catheter 1 of the present embodiment will be described.

[0030] The balloon catheter as the treatment catheter 1 of the present embodiment may be used, for example, for procedures such as treatment of a site where surgical operation is difficult, treatment aimed at minimally invasive to the human body, and examinations such as cardiovascular angiography. Examples of the treatment of a site where surgical operation is difficult include percutaneous transluminal coronary angioplasty (PTCA) performed for myocardial infarction or angina pectoris (see FIGS. 9A to 9D). When the treatment portion 2a of the distal shaft portion 2 of the treatment catheter 1 of the present embodiment is inserted to the vicinity of the stenosis in the blood vessel that is the target site, it protrudes from the distal end of the distal shaft portion 2, and the treatment portion 2a of the subsequent distal shaft portion 2 is guided to the stenosis by the guide wire 60 that has passed through the stenosis in advance.

[0031] As shown in FIGS. 1 and 2, the treatment catheter 1 of the present embodiment includes a hub 4 in addition to the distal shaft portion 2 and the proximal shaft portion 3.

[0032] As shown in FIGS. 1 and 2, the hub 4 of the present embodiment includes a hub body 11 and a kink protector 12 connected to the distal side of the hub body 11. A connector portion 11a that can be connected to an auxiliary device is provided at the proximal end of the hub body 11. Further, as shown in FIGS. 1 and 2, a hub through-hole 13 is defined in the hub 4, which extends from a proximal opening 13a formed in the connector portion 11a of the hub body 11 to a distal opening 13b formed at the distal end of the kink protector 12.

[0033] The auxiliary device connected to the connector portion 11a of the hub body 11 may be, for example, an inflator capable of supplying an expansion fluid for expanding the expansion body 7 of the treatment portion 2a of the distal shaft portion 2. The expansion fluid may be a liquid such as water, physiological saline, or an electrolyte solution.

[0034] The constituent materials of the hub body 11 and the kink protector 12 of the hub 4 are not particularly limited, and may be, for example, thermoplastic resins such as polypropylene, polycarbonate, polyamide, polysulfone, and polyarylate. Further, the constituent materials of the hub body 11 and the kink protector 12 may be metals such as stainless steel. However, when the kink protector 12 is made of a metal such as stainless steel, a plurality of slits may be formed in the kink protector 12 to ensure a predetermined flexibility.

[0035] The hub 4 is fixed to the proximal end of the proximal shaft portion 3. The proximal shaft portion 3 and the hub 4 may be fixedly attached in a non-detachable manner, for example, by adhesion or welding. Specifically, the hub 4 of the present embodiment is fixed to the proximal end of the proximal shaft portion 3 such that the hub through-hole 13 communicates with the flow path 8 defined by the distal shaft portion 2 and the proximal shaft portion 3 in the mounted state shown in FIG. 1 in a liquid-tight manner.

[0036] The distal shaft portion 2 of the present embodiment includes an outer tube 21, an inner tube 22, and a reinforcing body 23.

[0037] The proximal end portion of the distal shaft portion 2 of the present embodiment is constituted by the proximal end portion of the outer tube 21. Accordingly, a male screw portion 5 that can be screwed with the female screw portion 6 of the proximal shaft portion 3 is formed on the outer surface of the outer tube 21. The male screw portion 5 of the present embodiment is located proximal to a wire insertion lumen 25, which will be described later. More specifically, the outer tube 21 of the present embodiment includes a high-rigidity portion that is more rigid in the shaft longitudinal direction A1 than the portion where the wire insertion lumen 25 is located, proximal to the proximal opening 25a of the wire insertion lumen 25. And the male screw portion 5 of the present embodiment is provided on the above-described high-rigidity portion. An increase in rigidity caused by screwing the male screw 5 and the female screw portion 6 results in a rigidity step in the bending rigidity of the treatment catheter 1, and this rigidity step leads to a loss of push force when advancing the treatment catheter 1. Therefore, since the location where the male screw portion 5 and the female screw portion 6 are screwed together is located in the high-rigidity portion proximal to the proximal opening 25a of the wire insertion lumen 25, the above-described rigidity step is less likely to occur, and a loss of push force can be prevented.

[0038] The distal opening 24a of the distal flow path 24 partitioned inside the outer tube 21 communicates with the accommodation space 7a of the expansion fluid of the expander 7. In the mounted state of the distal shaft portion 2 and the proximal shaft portion 3 shown in FIG. 1, the proximal opening 24b of the distal flow path 24 of the distal shaft portion 2 communicates liquid-tightly with the proximal flow path 27 partitioned inside the proximal shaft portion 3.

[0039] In the mounted state of the distal shaft portion 2 and the proximal shaft portion 3 shown in FIG. 1, the distal shaft portion 2 and the proximal shaft portion 3 of the present embodiment partition a flow path 8 through which an expansion fluid capable of expanding the expander 7 flows. The flow path 8 of the present embodiment is constituted by the distal flow path 24 inside the distal shaft portion 2 described above and the proximal flow path 27 inside the proximal shaft portion 3. The expansion fluid supplied from an inflator as an auxiliary device connected to the hub 4 passes through the hub through-hole 13, the proximal flow path 27 inside the proximal shaft portion 3, and the distal flow path 24 inside the distal shaft portion 2 in sequence, and is supplied to the accommodation space 7a of the expander 7.

[0040] The inner tube 22 defines a wire insertion lumen 25 through which a guide wire 60 can be inserted. The proximal end of the inner tube 22 is joined to the peripheral wall of the outer tube 21. The inner tube 22 extends from its proximal end into the interior of the outer tube 21 and protrudes further distally than the distal end of the outer tube 21. That is, the distal end of the inner tube 22 is located further distally than the distal end of the outer tube 21. The wire insertion lumen 25 extends continuously from a proximal opening 25a that opens to the outside of the outer tube 21 at the proximal end of the inner tube 22 to a distal opening 25b that opens to the outside at the distal end of the inner tube 22. A contrast marker 26 having, for example, X-ray impermeability may be disposed around the inner tube 22.

[0041] The reinforcing body 23 is a solid body and is disposed in the distal flow path 24 so as to straddle the proximal end of the inner tube 22. By providing the reinforcing body 23, it is possible to suppress kinking of the outer tube 21 at the position of the proximal end of the inner tube 22.

[0042] The constituent material of the outer tube 21 is not particularly limited, and may be, for example, a polymer material such as polyolefin, crosslinked polyolefin, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluororesin, polyimide, or a mixture thereof.

[0043] The constituent material of the inner tube 22 is not particularly limited, but preferably has flexibility, and may be, for example, a polymer material such as polyolefin, crosslinked polyolefin, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, or a mixture thereof.

[0044] The constituent material of the reinforcing body 23 is not particularly limited, but a metal material having good rigidity and workability is preferred, and may be, for example, stainless steel, stainless steel drawn alloy, or Ni-Ti alloy.

[0045] The expandable body 7 is attached to the outer tube 21 and the inner tube 22, and is configured to be expandable and contractible in the shaft radial direction B1 orthogonal to the shaft longitudinal direction A1 of the distal shaft portion 2. Specifically, the expandable body 7 of the present embodiment is constituted by an annular film body. The proximal end portion of the annular film body constituting the expandable body 7 is fixed on the outer surface of the outer tube 21. The distal end portion of the annular film body constituting the expandable body 7 is fixed on the outer surface of the inner tube 22. As described above, the accommodation space 7a for the expansion fluid of the expandable body 7 communicates with the distal flow path 24 of the outer tube 21 of the distal shaft portion 2. Therefore, the expansion fluid introduced from the hub 4 can be supplied to the accommodation space 7a through the flow path 8 partitioned by the distal shaft portion 2 and the proximal shaft portion 3. Conversely, the expansion fluid in the accommodation space 7a can be discharged to the outside through the flow path 8.

[0046] The constituent material of the expandable body 7 is preferably flexible, and for example, may be a polymer material such as polyolefin, a cross-linked product of polyolefin, polyester, polyester elastomer, polyvinyl chloride, polyurethane, polyurethane elastomer, polyphenylene sulfide, polyamide, polyamide elastomer, fluororesin, silicone rubber, or latex rubber. The constituent material of the expandable body 7 is not limited to the form of using the above polymer material alone. The expandable body 7 may be, for example, a laminate in which films made of the above polymer material are appropriately laminated.

[0047] The proximal shaft portion 3 is tubular and defines a proximal flow path 27 therein. The proximal flow path 27 extends from a distal opening 27a located at the distal end of the proximal shaft portion 3 to a proximal opening 27b located at the proximal end of the proximal shaft portion 3. In the mounted state of the distal shaft portion 2 and the proximal shaft portion 3 shown in FIG. 1, the proximal flow path 27 defined by the proximal shaft portion 3 communicates with the distal flow path 24 defined by the distal shaft portion 2. Further, the proximal flow path 27 defined by the proximal shaft portion 3 communicates with the hub through-hole 13 defined by the hub 4.

[0048] In this embodiment, a female thread portion 6 that can be screwed into the male thread portion 5 of the distal shaft portion 2 is formed on the inner surface of the proximal shaft portion 3 that defines the proximal flow path 27. That is, in this embodiment, the distal end portion of the proximal flow path 27 defined by the proximal shaft portion 3 forms an opening portion 3a into which the proximal end portion of the distal shaft portion 2 is inserted.

[0049] In this embodiment, the male thread portion 5 is provided on the outer surface of the proximal end of the distal shaft portion 2, and the female thread portion 6 is provided on the inner surface of the proximal shaft portion 3 that defines the opening 3a, but this configuration is not limited to this. The distal shaft portion 2 may have a female thread portion, and the proximal shaft portion 3 may have a male thread portion. In other words, one of the distal shaft portion 2 and the proximal shaft portion 3 may have a male thread portion, and the other may have a female thread portion that can be screwed into the male thread portion. However, by configuring the distal shaft portion 2 to have the male thread portion 5 and the proximal shaft portion 3 to have the female thread portion 6 as in this embodiment, when the treatment catheter 1 is a balloon catheter, it is easy to ensure a large cross-sectional area of ​​the proximal flow path 27, so that the time required to discharge the expansion fluid from the accommodation space 7a of the expansion body 7 (deflation time) can be shortened.

[0050] In addition, the tensile strength in the shaft longitudinal direction A1 at the attachment portion of the distal shaft portion 2 and the proximal shaft portion 3 is preferably 5 N or more. This makes it possible to more reliably prevent the proximal shaft portion 3 from being unintentionally detached from the distal shaft portion 2 when the proximal shaft portion 3 is pulled proximally inside the guiding catheter placed in the living body. Furthermore, the distal shaft portion 2 and the proximal shaft portion 3 have a strength sufficient to prevent deformation in the shaft radial direction B1 even when the internal pressure of the flow passage 8 therein reaches the rated burst pressure of the expansion body 7.

[0051] The constituent material of the proximal shaft portion 3 is not particularly limited, but is preferably a metal material having relatively high rigidity. Examples thereof include stainless steel, stainless steel drawn alloy, Ni-Ti alloy, brass, aluminum, etc. However, the constituent material of the proximal shaft portion 3 may be a resin material having relatively high rigidity. Examples of such resin materials include polyimide, vinyl chloride, polycarbonate, etc.

[0052] Next, with reference to FIG. 4, a treatment catheter set 100 as an embodiment of the treatment catheter set according to the present disclosure will be described. As shown in FIG. 4, the treatment catheter set 100 of the present embodiment includes the above-described treatment catheter 1 and a distal shaft portion 102 different from the distal shaft portion 2. The distal shaft portion 102 is detachable from the proximal shaft portion 3, similarly to the distal shaft portion 2. Further, the distal shaft portion 2 and the distal shaft portion 102 can be alternatively attached to the proximal shaft portion 3.

[0053] Hereinafter, for the sake of convenience of explanation, in the treatment catheter set 100 shown in FIG. 4, in order to distinguish between the distal shaft portion 2 and the distal shaft portion 102, the distal shaft portion 2 of the above-described treatment catheter 1 is described as the "first distal shaft portion 2", and the distal shaft portion 102 is described as the "second distal shaft portion 102".

[0054] The second distal shaft portion 102 is different in configuration from the first distal shaft portion 2 in that the maximum expanded outer diameter D2 of the expandable body 107 of the treatment portion 102a is larger than the maximum expanded outer diameter D1 of the expandable body 7 of the treatment portion 2a, and the other configurations are the same. Hereinafter, for the sake of convenience of explanation, in the treatment catheter set 100 shown in FIG. 4, in order to distinguish between the treatment portion 2a and the treatment portion 102a, the treatment portion 2a of the first distal shaft portion 2 is described as the "first treatment portion 2a", and the treatment portion 102a of the second distal shaft portion 102 is described as the "second treatment portion 102a". Further, the expandable body 7 of the first treatment portion 2a is described as the "first expandable body 7", and the expandable body 107 of the second treatment portion 102a is described as the "second expandable body 107".

[0055] According to the treatment catheter set 100 shown in FIG. 4, for example, a procedure can be performed to gradually expand a stenosis in a blood vessel by sequentially using the first expandable body 7 and the second expandable body 107 having different maximum expanded outer diameters. Details of this will be described later (see FIGS. 9A to 9D).

[0056] The second distal shaft portion 102 includes an outer tube 121, an inner tube 122, and a reinforcing body 123. The outer tube 121 of the second distal shaft portion 102 is the same as the outer tube 21 of the first distal shaft portion 2 described above. Also, the inner tube 122 of the second distal shaft portion 102 is the same as the inner tube 22 of the first distal shaft portion 2 described above. Furthermore, the reinforcing body 123 of the second distal shaft portion 102 is the same as the reinforcing body 23 of the first distal shaft portion 2 described above.

[0057] The proximal end portion of the second distal shaft portion 102 of the present embodiment is constituted by the proximal end portion of the outer tube 121. Therefore, a male screw portion 105 that can be screwed with the female screw portion 6 of the proximal shaft portion 3 is formed on the outer surface of the outer tube 121. The male screw portion 105 of the present embodiment is located proximal to the proximal opening 125a of the wire insertion lumen 125 described later.

[0058] The distal opening 124a of the distal flow path 124 partitioned inside the outer tube 121 communicates with the accommodation space 107a of the expansion fluid of the second expandable body 107. In the mounted state of the second distal shaft portion 102 and the proximal shaft portion 3, the proximal opening 124b of the distal flow path 124 of the second distal shaft portion 102 communicates in a liquid-tight manner with the proximal flow path 27 partitioned inside the proximal shaft portion 3.

[0059] In the mounted state of the second distal shaft portion 102 and the proximal shaft portion 3, the second distal shaft portion 102 and the proximal shaft portion 3 define a flow path 108 through which the expansion fluid capable of expanding the second expander 107 flows. The flow path 108 of the present embodiment is composed of the distal flow path 124 in the second distal shaft portion 102 described above and the proximal flow path 27 in the proximal shaft portion 3. The expansion fluid supplied from the inflator as an auxiliary device connected to the hub 4 passes through the hub through-hole 13 (see FIG. 1), the proximal flow path 27 in the proximal shaft portion 3, and the distal flow path 124 in the second distal shaft portion 102 in sequence, and is supplied to the accommodation space 107a of the second expander 107.

[0060] The inner tube 122 defines a wire insertion lumen 125 through which the guide wire 60 can be inserted therein. The proximal end portion of the inner tube 122 is joined to the peripheral wall of the outer tube 121. The inner tube 122 extends from its proximal end portion into the outer tube 121 and protrudes further distally than the distal end of the outer tube 121. That is, the distal end portion of the inner tube 122 is located further distally than the distal end of the outer tube 121. The wire insertion lumen 125 extends from the proximal opening 125a that opens to the outside of the outer tube 121 at the proximal end portion of the inner tube 122 to the distal opening 125b that opens to the outside at the distal end portion of the inner tube 122. A contrast marker 126 having, for example, X-ray impermeability may be disposed around the inner tube 122.

[0061] The reinforcing member 123 is a solid body and is disposed in the distal flow path 124 so as to straddle the proximal end portion of the inner tube 122. By providing the reinforcing member 123, it is possible to suppress the outer tube 121 from kinking at the position of the proximal end portion of the inner tube 122.

[0062] The constituent material of the outer tube 121 may be the same as, for example, the constituent material of the outer tube 21. Further, the constituent material of the inner tube 122 may be the same as, for example, the constituent material of the inner tube 22. Furthermore, the constituent material of the reinforcing member 123 may be the same as, for example, the constituent material of the reinforcing member 23.

[0063] The second expandable body 107 is attached to the outer tube 121 and the inner tube 122, and is configured to be expandable and contractible in the shaft radial direction B2, which is a direction orthogonal to the shaft longitudinal direction A2 of the second distal shaft portion 102. The second expandable body 107 of the present embodiment may be configured by an annular film body, and may be fixed to the outer tube 121 and the inner tube 122 in the same manner as the first expandable body 7 described above.

[0064] As shown in FIG. 4, the maximum expanded outer diameter D2 in the shaft radial direction B2 of the second expandable body 107 is larger than the maximum expanded outer diameter D1 in the shaft radial direction B1 of the first expandable body 7.

[0065] The constituent material of the second expandable body 107 may be the same as, for example, the constituent material of the first expandable body 7.

[0066] Thus, the treatment catheter set 100 of the present embodiment includes only one proximal shaft portion 3 and a plurality of distal shaft portions (the first distal shaft portion 2 and the second distal shaft portion 102 in the present embodiment). The first distal shaft portion 2 and the second distal shaft portion 102 can be selectively attached to the proximal shaft portion 3 and used. That is, in the treatment catheter set 100 of the present embodiment, the two first distal shaft portions 2 and the second distal shaft portion 102 can share one proximal shaft portion 3. Thereby, according to the treatment catheter set 100 of the present embodiment, an increase in medical waste after use can be suppressed as compared with a configuration in which each of the two first distal shaft portions 2 and the second distal shaft portion 102 is provided with a separate dedicated proximal shaft portion.

[0067] Next, with reference to FIG. 5, a treatment catheter set 200 as another embodiment of the treatment catheter set according to the present disclosure will be described. As shown in FIG. 5, the treatment catheter set 200 of this embodiment includes the above-described treatment catheter 1 and a distal shaft portion 202 different from the distal shaft portion 2. The distal shaft portion 202 is detachable from the proximal shaft portion 3, similar to the distal shaft portion 2. Further, the distal shaft portion 2 and the distal shaft portion 202 can be alternatively attached to the proximal shaft portion 3.

[0068] Hereinafter, for convenience of explanation, in the treatment catheter set 200 shown in FIG. 5, in order to distinguish between the distal shaft portion 2 and the distal shaft portion 202, the distal shaft portion 2 of the above-described treatment catheter 1 is described as the "first distal shaft portion 2", and the distal shaft portion 202 is described as the "second distal shaft portion 202".

[0069] The second distal shaft portion 202 is different in configuration from the first distal shaft portion 2 in that a stent 209 is mounted on the outer surface of the expansion body 207 of the treatment portion 202a, and the other configurations are the same. Hereinafter, for convenience of explanation, in the treatment catheter set 200 shown in FIG. 5, in order to distinguish between the treatment portion 2a and the treatment portion 202a, the treatment portion 2a of the first distal shaft portion 2 is described as the "first treatment portion 2a", and the treatment portion 202a of the second distal shaft portion 202 is described as the "second treatment portion 202a". Also, the expansion body 7 of the first treatment portion 2a is described as the "first expansion body 7", and the expansion body 207 of the second treatment portion 202a is described as the "second expansion body 207".

[0070] According to the treatment catheter set 200 shown in FIG. 5, for example, after expanding a stenosis in a blood vessel using the first expansion body 7 of the first distal shaft portion 2, a procedure of implanting the stent 209 using the second distal shaft portion 202 can be performed. Details of this will be described later (see FIG. 10).

[0071] The second distal shaft portion 202 includes an outer tube 221, an inner tube 222, and a reinforcing member 223. The outer tube 221 of the second distal shaft portion 202 is the same as the outer tube 21 of the first distal shaft portion 2 described above. Also, the inner tube 222 of the second distal shaft portion 202 is the same as the inner tube 22 of the first distal shaft portion 2 described above. Furthermore, the reinforcing member 223 of the second distal shaft portion 202 is the same as the reinforcing member 23 of the first distal shaft portion 2 described above.

[0072] The proximal end portion of the second distal shaft portion 202 of the present embodiment is constituted by the proximal end portion of the outer tube 221. Therefore, a male screw portion 205 that can be screwed with the female screw portion 6 of the proximal shaft portion 3 is formed on the outer surface of the outer tube 221. The male screw portion 205 of the present embodiment is located proximal to the proximal opening 225a of the wire insertion lumen 225 described later.

[0073] The distal opening 224a of the distal flow path 224 partitioned inside the outer tube 221 communicates with the accommodation space 207a of the expansion fluid of the second expansion body 207. In the mounted state of the second distal shaft portion 202 and the proximal shaft portion 3, the proximal opening 224b of the distal flow path 224 of the second distal shaft portion 202 communicates with the proximal flow path 27 partitioned inside the proximal shaft portion 3 in a liquid-tight manner.

[0074] In the mounted state of the second distal shaft portion 202 and the proximal shaft portion 3, the second distal shaft portion 202 and the proximal shaft portion 3 partition a flow path 208 through which an expansion fluid capable of expanding the second expansion body 207 flows. The flow path 208 of the present embodiment is constituted by the distal flow path 224 inside the second distal shaft portion 202 described above and the proximal flow path 27 inside the proximal shaft portion 3. The expansion fluid supplied from an inflator as an auxiliary device connected to the hub 4 passes through the hub through-hole 13 (see FIG. 1), the proximal flow path 27 inside the proximal shaft portion 3, and the distal flow path 224 inside the second distal shaft portion 202 in this order, and is supplied to the accommodation space 207a of the second expansion body 207.

[0075] The inner tube 222 defines a wire insertion lumen 225 through which a guide wire 60 can be inserted. The proximal end of the inner tube 222 is joined to the peripheral wall of the outer tube 221. The inner tube 222 extends from its proximal end into the interior of the outer tube 221 and protrudes further distally than the distal end of the outer tube 221. That is, the distal end of the inner tube 222 is located further distally than the distal end of the outer tube 221. The wire insertion lumen 225 extends continuously from a proximal opening 225a that opens to the outside of the outer tube 221 at the proximal end of the inner tube 222 to a distal opening 225b that opens to the outside at the distal end of the inner tube 222. A contrast marker 226 having, for example, X-ray impermeability may be disposed around the inner tube 222.

[0076] The reinforcing member 223 is a solid body and is disposed in the distal flow path 224 so as to straddle the proximal end of the inner tube 222. By providing the reinforcing member 223, it is possible to suppress kinking of the outer tube 221 at the position of the proximal end of the inner tube 222.

[0077] The constituent material of the outer tube 221 may be the same as, for example, the constituent material of the outer tube 21. Also, the constituent material of the inner tube 222 may be the same as, for example, the constituent material of the inner tube 22. Further, the constituent material of the reinforcing member 223 may be the same as, for example, the constituent material of the reinforcing member 23.

[0078] The second expander 207 is attached to the outer tube 221 and the inner tube 222 and is configured to be expandable and contractible in a shaft radial direction B3, which is a direction orthogonal to the shaft longitudinal direction A3 of the second distal shaft portion 202. The second expander 207 of the present embodiment may be constituted by an annular membrane body and may be fixed to the outer tube 221 and the inner tube 222 in the same manner as the first expander 7 described above.

[0079] As shown in FIG. 5, a stent 209 is mounted on the outer surface of the second expander 207. The stent 209 can expand outward in the shaft radial direction B3 as the second expander 207 expands outward in the shaft radial direction B3.

[0080] The constituent material of the second expander 207 may be the same as, for example, the constituent material of the first expander 7.

[0081] The stent 209 includes a linear member that forms a predetermined pattern such as a spiral shape, a lattice shape, or a knitted shape, and forms an annular outer shape as a whole. The constituent material of the linear member of the stent 209 may be, for example, a synthetic resin such as a polyolefin, a polyester, a fluororesin, or a metal such as stainless steel, tantalum, titanium, or the like.

[0082] In addition, in this embodiment, the stent 209 is mounted on the outer surface of the second expander 207, but the configuration is not limited to this. The stent 209 may be, for example, a self-expanding type. In such a case, the second distal shaft portion 202 may be configured not to include the second expander 207.

[0083] As described above, the treatment catheter set 200 of this embodiment includes only one proximal shaft portion 3 and a plurality of distal shaft portions (the first distal shaft portion 2 and the second distal shaft portion 202 in this embodiment). The first distal shaft portion 2 and the second distal shaft portion 202 can be selectively mounted on the proximal shaft portion 3 and used. That is, in the treatment catheter set 200 of this embodiment, the two first distal shaft portions 2 and the second distal shaft portion 202 can also serve as one proximal shaft portion 3. Thereby, according to the treatment catheter set 200 of this embodiment, an increase in medical waste after use can be suppressed as compared with a configuration in which each of the two first distal shaft portions 2 and the second distal shaft portion 202 is provided with a separate dedicated proximal shaft portion.

[0084] Furthermore, in the treatment catheter set 200 of the present embodiment, one proximal shaft portion 3 can be used for two different treatments. That is, in the state where the first distal shaft portion 2 and the proximal shaft portion 3 are attached, it becomes a balloon catheter as the treatment catheter 1, while in the state where the second distal shaft portion 202 and the proximal shaft portion 3 are attached, it becomes a stent-mounted balloon catheter. Therefore, after performing a treatment of expanding a stenosis in a blood vessel with a balloon catheter, by replacing the first distal shaft portion 2 with the second distal shaft portion 202, a treatment of implanting the stent 209 can be performed as a stent-mounted balloon catheter. Details of this will be described later (see FIG. 10).

[0085] Next, with reference to FIG. 6, a treatment catheter set 300 as another embodiment of the treatment catheter set according to the present disclosure will be described. As shown in FIG. 6, the treatment catheter set 300 of the present embodiment includes the above-described treatment catheter 1 and a distal shaft portion 302 different from the distal shaft portion 2. The distal shaft portion 302 is detachable from the proximal shaft portion 3 in the same manner as the distal shaft portion 2. Further, the distal shaft portion 2 and the distal shaft portion 302 can be alternatively attached to the proximal shaft portion 3.

[0086] Hereinafter, for convenience of explanation, in the treatment catheter set 300 shown in FIG. 6, in order to distinguish between the distal shaft portion 2 and the distal shaft portion 302, the distal shaft portion 2 of the above-described treatment catheter 1 is described as the "first distal shaft portion 2", and the distal shaft portion 302 is described as the "second distal shaft portion 302".

[0087] The second distal shaft portion 302 is different in configuration from the first distal shaft portion 2 in that it includes a cutting portion 309 that protrudes on the outer surface of the expansion body 207 of the treatment portion 302a, and the other configurations are the same. Hereinafter, for convenience of explanation, in the treatment catheter set 300 shown in FIG. 6, in order to distinguish between the treatment portion 2a and the treatment portion 302a, the treatment portion 2a of the first distal shaft portion 2 is described as the "first treatment portion 2a", and the treatment portion 302a of the second distal shaft portion 302 is described as the "second treatment portion 302a". Further, the expansion body 7 of the first treatment portion 2a is described as the "first expansion body 7", and the expansion body 307 of the second treatment portion 302a is described as the "second expansion body 307".

[0088] According to the treatment catheter set 300 shown in FIG. 6, for example, after crushing a hardened portion due to calcification or the like of a stenosis in a blood vessel using the second expansion body 307 and the cutting portion 309 of the second distal shaft portion 302, a procedure of expanding the stenosis using the first distal shaft portion 2 can be performed. The details will be described later (see FIG. 10).

[0089] The second distal shaft portion 302 includes an outer tube 321, an inner tube 322, and a reinforcing body 323. The outer tube 321 of the second distal shaft portion 302 is the same as the outer tube 21 of the first distal shaft portion 2 described above. Also, the inner tube 322 of the second distal shaft portion 302 is the same as the inner tube 22 of the first distal shaft portion 2 described above. Further, the reinforcing body 323 of the second distal shaft portion 302 is the same as the reinforcing body 23 of the first distal shaft portion 2 described above.

[0090] The proximal end portion of the second distal shaft portion 302 of the present embodiment is constituted by the proximal end portion of the outer tube 321. Therefore, a male screw portion 305 that can be screwed with the female screw portion 6 of the proximal shaft portion 3 is formed on the outer surface of the outer tube 321. The male screw portion 305 of the present embodiment is located proximal to the proximal opening 325a of the wire insertion lumen 325 described later.

[0091] The distal opening 324a of the distal flow path 324 partitioned inside the outer tube 321 communicates with the accommodation space 307a of the expansion fluid of the second expander 307. In the mounted state of the second distal shaft portion 302 and the proximal shaft portion 3, the proximal opening 324b of the distal flow path 324 of the second distal shaft portion 302 communicates in a liquid-tight manner with the proximal flow path 27 partitioned inside the proximal shaft portion 3.

[0092] In the mounted state of the second distal shaft portion 302 and the proximal shaft portion 3, the second distal shaft portion 302 and the proximal shaft portion 3 partition a flow path 308 through which the expansion fluid capable of expanding the second expander 307 flows. The flow path 308 of the present embodiment is composed of the distal flow path 324 in the second distal shaft portion 302 and the proximal flow path 27 in the proximal shaft portion 3 described above. The expansion fluid supplied from the inflator as an auxiliary device connected to the hub 4 passes through the hub through-hole 13 (see FIG. 1), the proximal flow path 27 in the proximal shaft portion 3, and the distal flow path 324 in the second distal shaft portion 302 in sequence, and is supplied to the accommodation space 307a of the second expander 307.

[0093] The inner tube 322 partitions a wire insertion lumen 325 through which the guide wire 60 can be inserted. The proximal end portion of the inner tube 322 is joined to the peripheral wall of the outer tube 321. The inner tube 322 extends from its proximal end portion into the outer tube 321 and protrudes further distally than the distal end of the outer tube 321. That is, the distal end portion of the inner tube 322 is located further distally than the distal end of the outer tube 321. The wire insertion lumen 325 continues from the proximal opening 325a that opens to the outside of the outer tube 321 at the proximal end portion of the inner tube 322 to the distal opening 325b that opens to the outside at the distal end portion of the inner tube 322. A contrast marker 326 having, for example, X-ray impermeability may be arranged around the inner tube 322.

[0094] The reinforcing body 323 is a solid body and is arranged in the distal flow path 324 so as to straddle the proximal end portion of the inner tube 322. By providing the reinforcing body 323, it is possible to suppress the outer tube 321 from kinking at the position of the proximal end portion of the inner tube 322.

[0095] The constituent material of the outer tube 321 may be the same as, for example, the constituent material of the outer tube 21. Also, the constituent material of the inner tube 322 may be the same as, for example, the constituent material of the inner tube 22. Furthermore, the constituent material of the reinforcing body 323 may be the same as, for example, the constituent material of the reinforcing body 23.

[0096] The second expander 307 is attached to the outer tube 321 and the inner tube 322, and is configured to be expandable and contractible in the shaft radial direction B4, which is a direction orthogonal to the shaft longitudinal direction A4 of the second distal shaft portion 302. The second expander 307 of the present embodiment may be constituted by an annular film body, and may be fixed to the outer tube 321 and the inner tube 322 in the same manner as the first expander 7 described above.

[0097] As shown in FIG. 6, a cutting portion 309 that protrudes outward in the shaft radial direction B4 is provided on the outer surface of the second expander 307. As the second expander 307 expands outward in the shaft radial direction B4, the cutting portion 309 moves outward in the shaft radial direction B4 and can crush a diseased portion hardened by calcification or the like.

[0098] The constituent material of the second expander 307 may be the same as, for example, the constituent material of the first expander 7.

[0099] The constituent material of the cutting portion 309 may be a metal such as stainless steel, tantalum, titanium, or the like.

[0100] In the present embodiment, the cutting portion 309 protrudes from the outer surface of the second expander 307, but the configuration is not limited to this. The second distal shaft portion 302 may be configured to include another mechanism that moves the cutting portion 309 in the shaft radial direction B4 without including the second expander 307.

[0101] As described above, the treatment catheter set 300 of the present embodiment includes only one proximal shaft portion 3 and a plurality of distal shaft portions (in the present embodiment, the first distal shaft portion 2 and the second distal shaft portion 302). The first distal shaft portion 2 and the second distal shaft portion 302 can be selectively attached to the proximal shaft portion 3 and used. That is, in the treatment catheter set 300 of the present embodiment, the two first distal shaft portions 2 and the second distal shaft portion 302 can share one proximal shaft portion 3. Thus, according to the treatment catheter set 300 of the present embodiment, an increase in medical waste after use can be suppressed as compared with a configuration in which each of the two first distal shaft portions 2 and the second distal shaft portion 302 is provided with a separate dedicated proximal shaft portion.

[0102] Furthermore, in the treatment catheter set 300 of the present embodiment, two different treatments can be performed by sharing one proximal shaft portion 3. That is, in a state where the first distal shaft portion 2 and the proximal shaft portion 3 are attached, it becomes a balloon catheter as the treatment catheter 1, while in a state where the second distal shaft portion 302 and the proximal shaft portion 3 are attached, it becomes a DCA catheter used in directional coronary atherectomy (DCA). Therefore, after performing a treatment of crushing a hardened portion of a stenosis in a blood vessel with the DCA catheter, by replacing the second distal shaft portion 302 with the first distal shaft portion 2, a treatment of expanding the stenosis can be performed as a balloon catheter. Details thereof will be described later (see FIG. 10).

[0103] In addition, in FIGS. 4 to 6, the first distal shaft portion and the second distal shaft portion having treatment portions with different configurations or functions are illustrated, but the present invention is not limited to this configuration. The first distal shaft portion and the second distal shaft portion may have treatment portions with the same configuration and function. That is, the second distal shaft portion may be for replacement when the first distal shaft portion is damaged.

[0104] Next, with reference to FIG. 7, a treatment catheter set 400 as another embodiment of the treatment catheter set according to the present disclosure will be described. As shown in FIG. 7, the treatment catheter set 300 of the present embodiment includes the above-described treatment catheter 1 and a proximal shaft portion 403 different from the proximal shaft portion 3. Similar to the proximal shaft portion 3, the proximal shaft portion 403 is detachable from the distal shaft portion 2. Further, the proximal shaft portion 3 and the proximal shaft portion 403 can be alternatively attached to the distal shaft portion 2.

[0105] Hereinafter, for convenience of explanation, in the treatment catheter set 400 shown in FIG. 7, in order to distinguish between the proximal shaft portion 3 and the proximal shaft portion 403, the proximal shaft portion 3 of the above-described treatment catheter 1 is described as the "first proximal shaft portion 3", and the proximal shaft portion 403 is described as the "second proximal shaft portion 403".

[0106] The wall thickness T2 of the second proximal shaft portion 403 is thicker than the wall thickness T1 of the first proximal shaft portion 3. In this regard, the configuration of the second proximal shaft portion 403 is different from that of the first proximal shaft portion 3, and the other configurations are the same. More specifically, in the present embodiment, the inner diameter of the second proximal shaft portion 403 is the same as the inner diameter of the first proximal shaft portion 3, and the outer diameter of the second proximal shaft portion 403 is different from the outer diameter of the first proximal shaft portion 3. By doing so, the bending rigidity of the second proximal shaft portion 403 can be made larger than the bending rigidity of the first proximal shaft portion 3, and the pushability performance can be improved.

[0107] When the treatment catheter 1 is inserted, for example, up to a stenotic portion in a blood vessel, the blood vessel permeability of the treatment catheter 1 may deteriorate depending on the degree of bending of the blood vessel and the inner diameter of the blood vessel in the insertion path up to the stenotic portion. Even in such a case, according to the treatment catheter set 400 shown in FIG. 7, by replacing the first proximal shaft portion 3 with the second proximal shaft portion 403, the pushability performance can be improved and the blood vessel permeability can be enhanced. Details thereof will be described later (see FIGS. 11A to 11D).

[0108] The second proximal shaft portion 403 is tubular and defines a proximal flow path 427 therein. The proximal flow path 427 extends from a distal opening 427a located at the distal end of the second proximal shaft portion 403 to a proximal opening 427b located at the proximal end of the second proximal shaft portion 403. In a state where the distal shaft portion 2 and the second proximal shaft portion 403 are mounted, the proximal flow path 427 defined by the second proximal shaft portion 403 communicates with the distal flow path 24 defined by the distal shaft portion 2. Further, the proximal flow path 427 defined by the second proximal shaft portion 403 communicates with a hub through hole 413 defined by the hub 404. Note that the hub 404 has a different size according to the outer diameter of the second proximal shaft portion 403 as compared with the above-described hub 4, but since other configurations are the same as those of the hub 4, the description thereof is omitted here.

[0109] On the inner surface of the second proximal shaft portion 403 that defines the proximal flow path 427 of the present embodiment, a female screw portion 406 that can be screwed with the male screw portion 5 of the distal shaft portion 2 is formed. That is, in the present embodiment, the distal end portion of the proximal flow path 427 defined by the second proximal shaft portion 403 constitutes an opening 403a into which the proximal end portion of the distal shaft portion 2 is inserted.

[0110] As the constituent material of the second proximal shaft portion 403, for example, it may be the same constituent material as that of the first proximal shaft portion 3.

[0111] Further, in the present embodiment, the pushability performance is enhanced by making the wall thickness T2 of the second proximal shaft portion 403 thicker than the wall thickness T1 of the first proximal shaft portion 3, but the present invention is not limited to this configuration. For example, the first proximal shaft portion 3 and the second proximal shaft portion 403 may have the same wall thickness and different constituent materials to make the pushability performance different.

[0112] As described above, the treatment catheter set 400 of the present embodiment includes only one distal shaft portion 2 and a plurality of proximal shaft portions (in the present embodiment, the first proximal shaft portion 3 and the second proximal shaft portion 403). The first proximal shaft portion 3 and the second proximal shaft portion 403 can be alternatively attached to the distal shaft portion 2 and used. That is, in the treatment catheter set 400 of the present embodiment, the two first proximal shaft portions 3 and the second proximal shaft portion 403 can share one distal shaft portion 2. Accordingly, according to the treatment catheter set 400 of the present embodiment, an increase in medical waste after use can be suppressed as compared with a configuration in which each of the two first proximal shaft portions 3 and the second proximal shaft portion 403 includes a separate dedicated distal shaft portion.

[0113] Furthermore, in the treatment catheter set 400 of the present embodiment, while sharing one distal shaft portion 2, the pushability when inserting the distal shaft portion 2 into the living body can be changed. That is, in a state where the distal shaft portion 2 and the first proximal shaft portion 3 are attached, it becomes a balloon catheter having relatively low pushability performance, while in a state where the distal shaft portion 2 and the second proximal shaft portion 403 are attached, it becomes a balloon catheter having relatively high pushability performance. Therefore, the first proximal shaft portion 3 and the second proximal shaft portion 403 can be selected and used, or replaced and used, according to the desired pushability performance. Details thereof will be described later (see FIGS. 11A to 11D).

[0114] In the present embodiment, an example of changing the pushability performance by exchanging the first proximal shaft portion 3 and the second proximal shaft portion 403 has been shown. However, the first proximal shaft portion 3 and the second proximal shaft portion 403 may be exchanged for purposes different from the pushability performance. For example, the first proximal shaft portion 3 and the second proximal shaft portion 403 may have exactly the same configuration, and the second proximal shaft portion 403 may be for replacement when the first proximal shaft portion 3 is damaged.

[0115] Next, with reference to FIG. 8, a treatment catheter set 500 as another embodiment of the treatment catheter set according to the present disclosure will be described. As shown in FIG. 8, the treatment catheter set 500 of this embodiment includes the above-described treatment catheter 1, a distal shaft portion 102 different from the distal shaft portion 2, and a proximal shaft portion 403 different from the proximal shaft portion 3.

[0116] Hereinafter, for convenience of explanation, in the treatment catheter set 500 shown in FIG. 8, in order to distinguish between the distal shaft portion 2 and the distal shaft portion 102, the distal shaft portion 2 of the above-described treatment catheter 1 is described as the "first distal shaft portion 2", and the distal shaft portion 102 is described as the "second distal shaft portion 102". Since the configuration of the second distal shaft portion 102 of this embodiment is the same as the configuration of the second distal shaft portion 102 shown in FIG. 4 described above, the description thereof will be omitted here.

[0117] Also, hereinafter, for convenience of explanation, in the treatment catheter set 500 shown in FIG. 8, in order to distinguish between the proximal shaft portion 3 and the proximal shaft portion 403, the proximal shaft portion 3 of the above-described treatment catheter 1 is described as the "first proximal shaft portion 3", and the proximal shaft portion 403 is described as the "second proximal shaft portion 403". Since the configuration of the second proximal shaft portion 403 of this embodiment is the same as the configuration of the second proximal shaft portion 403 shown in FIG. 7 described above, the description thereof will be omitted here.

[0118] As described above, the treatment catheter set 500 includes a plurality of distal shaft portions (the first distal shaft portion 2 and the second distal shaft portion 102 in this embodiment), and a plurality of proximal shaft portions (the first proximal shaft portion 3 and the second proximal shaft portion 403 in this embodiment). Each of the first distal shaft portion 2 and the second distal shaft portion 102 is detachable from each of the first proximal shaft portion 3 and the second proximal shaft portion 403. Therefore, according to the treatment catheter set 500, any one of the first distal shaft portion 2 and the second distal shaft portion 102 can be combined with any one of the first proximal shaft portion 3 and the second proximal shaft portion 403 to realize a total of four combinations. That is, according to the treatment catheter set 500, four combinations with different maximum expansion outer diameters or pusherability performances of the expandable body can be realized without preparing four separate treatment catheters. Therefore, an increase in medical waste after use can be suppressed as compared with the case of preparing four separate treatment catheters.

[0119] In FIGS. 4 to 8, a treatment catheter set including two or less distal shaft portions is shown, but the treatment catheter set may include three or more distal shaft portions. Also, in FIGS. 4 to 8, a treatment catheter set including two or less proximal shaft portions is shown, but the treatment catheter set may include three or more proximal shaft portions.

[0120] Further, in FIGS. 4 to 8, four types of distal shaft portions (the first distal shaft portion 2, the second distal shaft portion 102, the second distal shaft portion 202, and the second distal shaft portion 302) with different treatment portions are exemplified, but the distal shaft portion according to the present disclosure is not limited to the four types of distal shaft portions exemplified in FIGS. 4 to 8. That is, the distal shaft portion according to the present disclosure may have a configuration different from the above-described first distal shaft portion 2 (see FIGS. 4 to 8), second distal shaft portion 102 (see FIGS. 4 and 8), second distal shaft portion 202 (see FIG. 5), and second distal shaft portion 302 (see FIG. 6).

[0121] Furthermore, in FIGS. 4 to 8, two types of proximal shaft portions (the first proximal shaft portion 3 and the second proximal shaft portion 403) with different pushability performance due to different bending rigidities are exemplified. However, the proximal shaft portion according to the present disclosure is not limited to the two types of proximal shaft portions exemplified in FIGS. 4 to 8. That is, the proximal shaft portion according to the present disclosure may have a configuration different from the above-described first proximal shaft portion 3 (see FIGS. 4 to 8) and second proximal shaft portion 403 (see FIGS. 7 and 8).

[0122] Moreover, the combination of a plurality of distal shaft portions included in the treatment catheter set according to the present disclosure is not limited to the combinations exemplified in FIGS. 4 to 6 and FIG. 8 respectively. The treatment catheter set according to the present disclosure may include, for example, the second distal shaft portion 102 shown in FIG. 4 and the second distal shaft portion 202 shown in FIG. 5. Further, the treatment catheter set according to the present disclosure may include, for example, the second distal shaft portion 102 shown in FIG. 4 and the second distal shaft portion 302 shown in FIG. 6. Thus, the types of a plurality of distal shaft portions included in the treatment catheter set according to the present disclosure are not particularly limited. Note that the combination of a plurality of proximal shaft portions included in the treatment catheter set according to the present disclosure is also not particularly limited. It may be a combination of a plurality of proximal shaft portions with different pushability performance shown in FIGS. 7 and 8, or a combination of a plurality of proximal shaft portions with different other performances.

[0123] Next, with reference to FIGS. 9A to 9D, an example of a procedure performed using the treatment catheter set 100 shown in FIG. 4 will be described. FIGS. 9A to 9D show a procedure for expanding a stenotic portion X of the coronary artery CA performed using the treatment catheter set 100. The procedure shown in FIGS. 9A to 9D includes a step of exchanging the first distal shaft portion 2 and the second distal shaft portion 102 during the procedure.

[0124] FIG. 9A is a diagram showing a state in which the treatment catheter 1 including the first distal shaft portion 2 and the proximal shaft portion 3 in the mounted state is inserted into a living body through a guiding catheter 90 that has been previously inserted and retained in the living body, and the stenosis X is expanded by the first expander 7. As shown in FIG. 9A, the guiding catheter 90 is previously retained in a state where its distal end is fitted to the inlet Y of the coronary artery CA and abuts against the wall surface of the aorta AO on the opposite side of the inlet Y of the coronary artery CA. The insertion of the treatment catheter 1 into the living body is performed while preceding the guide wire 60 inserted through the wire insertion lumen 25 (see FIG. 4) and following along the guide wire 60.

[0125] FIG. 9B shows a state in which the treatment catheter 1 has been removed from the living body after the first expander 7 is contracted from the state shown in FIG. 9A.

[0126] FIG. 9C is a diagram showing a step of replacing the first distal shaft portion 2 of the treatment catheter 1 removed from the living body in FIG. 9B with the second distal shaft portion 102. Specifically, after the treatment catheter 1 is removed from the living body, the first distal shaft portion 2 is removed from the proximal shaft portion 3 (see the white arrow in FIG. 9C). Then, the second distal shaft portion 102 is attached to the proximal shaft portion 3 (see the thick arrow in FIG. 9C).

[0127] FIG. 9D is a diagram showing a state in which the second distal shaft portion 102 and the proximal shaft portion 3 attached in FIG. 9C are inserted into the living body through the guiding catheter 90, and the stenosis X is further expanded by the second expander 107. The insertion of the second distal shaft portion 102 and the proximal shaft portion 3 attached in FIG. 9C into the living body is performed while inserting the guide wire 60 through the wire insertion lumen 125 (see FIG. 4) and following along the guide wire 60.

[0128] In this way, by using the treatment catheter set 100, the treatment for expanding the stenosis X shown in Fig. 9A and the treatment for further expanding the stenosis X shown in Fig. 9D can be executed by sharing one proximal shaft portion 3 and exchanging the first distal shaft portion 2 and the second distal shaft portion 102. That is, without preparing separate different treatment catheters, the above two treatments can be executed by exchanging a part of the treatment catheter. Therefore, an increase in medical waste after use can be suppressed as compared with the case of preparing separate different treatment catheters.

[0129] In Figs. 9A to 9D, an example of exchanging the first distal shaft portion 2 and the second distal shaft portion 102 used for expanding the stenosis X in two stages during the procedure is shown, but the example is not limited to this. As shown in Fig. 10, for example, for a procedure of sequentially performing fragmentation of the stenosis X, expansion of the stenosis X, and stenting at the position of the stenosis X, the second distal shaft portion 302 shown in Fig. 6, the second distal shaft portion 102 shown in Fig. 4, and the second distal shaft portion 202 shown in Fig. 5 may be sequentially exchanged. That is, the type and order of the distal shaft portions exchanged during the procedure may be appropriately determined according to the procedure.

[0130] Next, with reference to Figs. 11A to 11D, an example of a procedure performed using the treatment catheter set 400 shown in Fig. 7 will be described. The procedure shown in Figs. 11A to 11D includes a step of exchanging the first proximal shaft portion 3 and the second proximal shaft portion 403 during the procedure.

[0131] Fig. 11A is a diagram showing a state in which the treatment catheter 1 including the distal shaft portion 2 and the first proximal shaft portion 3 in the mounted state, which is inserted into the living body through the guiding catheter 90, is withdrawn proximally and the mounting portions of the distal shaft portion 2 and the first proximal shaft portion 3 are exposed outside the living body.

[0132] FIG. 11B is a view showing a state in which the first proximal shaft portion 3 is removed from the distal shaft portion 2 from the state shown in FIG. 11A. FIG. 11C is a view showing a state in which the second proximal shaft portion 403 is attached to the distal shaft portion 2 from the state shown in FIG. 11B. FIG. 11D is a view showing a state in which the attached distal shaft portion 2 and the second proximal shaft portion 403 in FIG. 11C are inserted into a living body through the guiding catheter 90. As shown in FIGS. 11B to 11D, the replacement of the first proximal shaft portion 3 and the second proximal shaft portion 403 during the procedure can be performed without completely removing the distal shaft portion 2 outside the living body. Therefore, the time required for replacing the first proximal shaft portion 3 and the second proximal shaft portion 403 during the procedure can be shortened.

[0133] Thus, by using the treatment catheter set 400, for example, adjustment of pushability performance can be executed by using one distal shaft portion 2 and replacing the first proximal shaft portion 3 and the second proximal shaft portion 403. That is, without preparing separate different treatment catheters, by replacing a part of the treatment catheter, desired adjustments such as adjustment of pushability performance can be executed. Therefore, an increase in medical waste after use can be suppressed as compared with the case of preparing separate different treatment catheters.

[0134] The treatment catheter and the treatment catheter set according to the present disclosure are not limited to the specific configurations described in the above-described embodiments and modifications, and various modifications, combinations, etc. are possible without departing from the scope of the claims. The above-described treatment catheter 1 is a balloon catheter including a distal shaft portion 2, but is not limited to this configuration. The treatment catheter 1 may be a balloon catheter including a distal shaft portion 102 shown in FIG. 4, for example, instead of the distal shaft portion 2. Further, the treatment catheter 1 may be a stent-mounted balloon catheter including a distal shaft portion 202 shown in FIG. 5, for example, instead of the distal shaft portion 2. Furthermore, the treatment catheter 1 may be a DCA catheter including a distal shaft portion 302 shown in FIG. 6, for example, instead of the distal shaft portion 2. Also, the treatment catheter 1 may be an ablation catheter including a distal shaft portion including a treatment portion including a cautery portion, instead of the distal shaft portion 2. That is, the distal shaft portion of the treatment catheter according to the present disclosure is not limited to the above-described distal shaft portion 2.

[0135] Further, the above-described treatment catheter 1 has a configuration including a proximal shaft portion 3, but is not limited to this configuration. The treatment catheter 1 may have a configuration including a proximal shaft portion 403 shown in FIG. 7, for example, instead of the proximal shaft portion 3. That is, the proximal shaft portion of the treatment catheter according to the present disclosure is not limited to the above-described proximal shaft portion 3.

Industrial Applicability

[0136] The present disclosure relates to a treatment catheter and a treatment catheter set.

Explanation of Signs

[0137] 1: Treatment catheter 2: Distal shaft portion (an example of the first distal shaft portion) 2a: Treatment portion (an example of the first treatment portion) 3: Proximal shaft portion (an example of the first proximal shaft portion) 3a: Opening 4, 404: Hub 5: Male thread portion 6: Female thread portion 7: Expander (an example of the first expander) 7a: Accommodation space 8, 108, 208, 308: Flow path 11: Hub body 11a: Connector portion 12: Kink protector 13, 413: Hub through-hole 13a: Proximal opening 13b: Distal opening 21, 121, 221, 321: Outer tube 22, 122, 222, 322: Inner tube 23, 123, 223, 323: Reinforcer 24, 124, 224, 324: Distal-side flow path 24a, 124a, 224a, 324a: Distal opening 24b, 124b, 224b, 324b: Proximal opening 25, 125, 225, 325: Wire insertion lumen 25a, 125a, 225a, 325a: Proximal opening 25b, 125b, 225b, 325b: Distal opening 26, 126, 226, 326: Contrast marker 27: Proximal-side flow path 27a: Distal opening 27b: Proximal opening 60: Guide wire 90: Guiding catheter 100, 200, 300, 400, 500: Treatment catheter set 102, 202, 302: Distal-side shaft portion (an example of the second distal-side shaft portion) 102a, 202a, 302a: Treatment portion (an example of the second treatment portion) 105, 205, 305: Male thread portion 107, 207, 307: Expander (an example of the second expander) 107a, 207a, 307a: Accommodation space 209: Stent 309: Cutting portion 403: Proximal shaft portion (an example of the second proximal shaft portion) 403a: Opening 406: Female thread portion 427: Proximal flow path 427a: Distal opening 427b: Proximal opening A1, A2, A3, A4: Shaft longitudinal direction of the distal shaft portion B1, B2, B3, B4: Shaft diameter direction of the distal shaft portion (direction orthogonal to the shaft longitudinal direction of the distal shaft portion) D1: Maximum expanded outer diameter of the first expandable body D2: Maximum expanded outer diameter of the second expandable body T1: Wall thickness of the first proximal shaft portion T2: Wall thickness of the second proximal shaft portion Y: Inlet portion of the coronary artery AO: Aorta CA: Coronary artery

Claims

1. A distal shaft portion provided with a treatment portion, and a proximal shaft portion that is detachable from the proximal side of the distal shaft portion, a treatment catheter.

2. One of the distal shaft portion and the proximal shaft portion is provided with a male screw portion, The treatment catheter according to claim 1, wherein the other of the distal shaft portion and the proximal shaft portion is provided with a female screw portion that can be screwed into the male screw portion.

3. The proximal shaft portion defines an opening inside which the proximal end portion of the distal shaft portion can be inserted, The male screw portion is provided on the outer surface of the proximal end portion of the distal shaft portion, The treatment catheter according to claim 2, wherein the female screw portion is provided on the inner surface of the proximal shaft portion that defines the opening.

4. The distal shaft portion defines a guide wire insertion lumen through which a guide wire can be inserted, The treatment catheter according to claim 3, wherein the male screw portion is located proximal to the wire insertion lumen.

5. The treatment catheter according to any one of claims 1 to 4, wherein the tensile strength in the shaft longitudinal direction of the distal shaft at the mounting portion of the distal shaft portion and the proximal shaft portion is 5 N or more.

6. When the distal shaft portion is a first distal shaft portion and the treatment portion is a first treatment portion, The treatment catheter according to any one of claims 1 to 4, and A treatment catheter set including a second distal shaft portion that can be alternatively attached to the proximal shaft portion and is provided with a second treatment portion, and can be used when attached to the first distal shaft portion.

7. The first treatment portion of the first distal shaft portion includes a first expandable body that can expand and contract in a direction orthogonal to the shaft longitudinal direction of the first distal shaft portion, The treatment catheter set according to claim 6, wherein the second treatment portion of the second distal shaft portion can expand and contract in a direction orthogonal to the shaft longitudinal direction of the second distal shaft portion, and includes a second expandable body having a maximum expanded outer diameter larger than that of the first expandable body.

8. When the proximal shaft portion is a first proximal shaft portion, The treatment catheter according to any one of claims 1 to 4, and A treatment catheter set including a second proximal shaft portion that can be alternatively attached to the distal shaft portion and can be used when attached to the first proximal shaft portion.

9. The treatment catheter set according to claim 8, wherein the bending rigidity of the first proximal shaft portion is different from the bending rigidity of the second proximal shaft portion.

10. When the distal shaft portion is the first distal shaft portion, the treatment portion is the first treatment portion, and the proximal shaft portion is the first proximal shaft portion, a treatment catheter according to any one of claims 1 to 4; a second distal shaft portion provided with a second treatment portion; and a second proximal shaft portion, The treatment catheter set, wherein each of the first distal shaft portion and the second distal shaft portion is detachable from each of the first proximal shaft portion and the second proximal shaft portion.

11. The first treatment portion of the first distal shaft portion includes a first expandable body that can expand and contract in a direction orthogonal to the shaft longitudinal direction of the first distal shaft portion, The second treatment portion of the second distal shaft portion can expand and contract in a direction orthogonal to the shaft longitudinal direction of the second distal shaft portion, and includes a second expandable body having a maximum expanded outer diameter larger than that of the first expandable body. The treatment catheter set according to claim 10.

12. The treatment catheter set according to claim 10, wherein the bending rigidity of the first proximal shaft portion is different from the bending rigidity of the second proximal shaft portion.

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