Catheter set and guide pipe member replacement method

Abstract

To provide a catheter set capable of easily replacing a guide pipe member and to provide a guide pipe member replacement method.SOLUTION: A catheter set comprises: a first guide pipe member and a second guide pipe member to be inserted in a living body; a shaft member to be inserted into each of the first guide pipe member and the second guide pipe member; and a hub member detachably attached to a proximal end of the shaft member. Out of the first guide pipe member and the second guide pipe member, one guide pipe member in a state that the shaft member is inserted can be replaced with the other guide pipe member from the proximal side of the shaft member by the removal of the hub member from the proximal end.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure relates to a catheter set and a method for replacing a guide tube member.

Background Art

[0002] Conventionally, as a treatment for lesions such as stenotic portions of blood vessels, a technique using a treatment catheter such as a balloon catheter is known. In this type of technique, a guiding catheter is inserted into a living body in advance, and a treatment catheter such as a balloon catheter is delivered to the lesion through the guiding catheter, and the lesion is treated with this treatment catheter. Patent Document 1 discloses an angioplasty device as a treatment catheter used in this type of technique.

[0003] The angioplasty device described in Patent Document 1 is formed of a superelastic material, has a proximal end portion and a distal end portion, a hollow tube that defines a lumen inside, and is attached to the distal end portion of this hollow tube, and defines a balloon recess inside, and a balloon that is in fluid communication with the lumen, and a detachable hub connected to the proximal end portion of the hollow tube.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] Procedures performed using a treatment catheter such as a balloon catheter include, for example, procedures for stenotic portions of coronary arteries, etc., where positioning of the guiding catheter in the living body is particularly important. In such procedures, in order to improve the positioning accuracy of the guiding catheter, the guiding catheter may be exchanged during the procedure. Further, not limited to positioning accuracy, for various other purposes, it may be necessary to exchange the guide tube member such as the guiding catheter during the procedure.

[0006] In the exchange of the guide tube member, it is necessary to remove the treatment catheter inserted into the living body through the guide tube member together with the guide tube member outside the living body. That is, for the exchange of the guide tube member, removal and reinsertion of the treatment catheter are required. Therefore, there is a risk that the burden on the patient will increase due to an increase in the procedure time.

[0007] An object of the present disclosure is to provide a catheter set and a guide tube member exchange method in which the guide tube member can be easily exchanged.

Means for Solving the Problems

[0008] A catheter set according to a first aspect of the present disclosure includes (1) a first guide tube member and a second guide tube member that can be inserted into the living body, a shaft member that can be inserted through each of the first guide tube member and the second guide tube member, and a hub member that is detachable from the proximal end portion of the shaft member, and among the first guide tube member and the second guide tube member, one guide tube member in a state where the shaft member is inserted therethrough can be exchanged for the other guide tube member from the proximal side of the shaft member by removing the hub member from the proximal end portion of the shaft member.

[0009] A catheter set according to one embodiment of the present disclosure includes (2) The maximum width of the hub member in the radial direction of the shaft member is greater than the maximum inner diameter of the first guide tube member and the maximum inner diameter of the second guide tube member, the catheter set according to (1) above.

[0010] A catheter set as one embodiment of the present disclosure is (3) The proximal end portion of the shaft member and the hub member are engageable, the catheter set according to (1) or (2) above.

[0011] A catheter set as one embodiment of the present disclosure is (4) The proximal end portion of the shaft member includes a male thread portion, The hub member includes a female thread portion that can be screwed with the male thread portion, the catheter set according to (3) above.

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

[0013] A catheter set as one embodiment of the present disclosure is (6) The shaft member A long shaft body and An expansion body that is attached to the distal end portion of the shaft body and can expand and contract in the radial direction of the shaft body, the catheter set according to any one of (1) to (5) above.

[0014] A catheter set as one embodiment of the present disclosure is (7) The catheter set according to any one of (1) to (6) above, wherein each of the first guide tube member and the second guide tube member is a guiding catheter or a guide extension catheter.

[0015] As a second aspect of the present disclosure, a method for replacing a guide tube member is (8) a first guide tube member insertion step of inserting a first guide tube member into a living body; a shaft member insertion step of inserting a shaft member through the first guide tube member; a hub member removal step of removing a hub member attached to a proximal end portion of the shaft member from the proximal end portion of the shaft member; a first guide tube member removal step of leaving the shaft member in the living body and removing the first guide tube member from the living body; a second guide tube member insertion step of inserting a second guide tube member into the living body along the shaft member from a proximal side of the shaft member, the method for replacing a guide tube member including the steps.

[0016] As one embodiment of the present disclosure, a method for replacing a guide tube member is (9) including a wire insertion step of inserting a guide wire through the first guide tube member after the first guide tube member insertion step; In the first guide tube member removal step, the guide wire and the shaft member are left in the living body, and the first guide tube member is removed from the living body, the method for replacing a guide tube member according to (8) above.

[0017] As one embodiment of the present disclosure, a method for replacing a guide tube member is (10) including a wire locking step of locking the guide wire to the proximal end portion of the shaft member after the hub member removal step; In the step of removing the first guide tube member, the first guide tube member is removed outside the body with the guide wire locked to the proximal end portion of the shaft member, which is the guide tube member replacement method according to (9) above.

[0018] A guide tube member replacement method as one embodiment of the present disclosure is (11) After the step of removing the hub member, the method includes a step of attaching an extension shaft member to the proximal end portion of the shaft member, which is the guide tube member replacement method according to (9) above.

Effect of the Invention

[0019] According to the present disclosure, it is possible to provide a catheter set and a guide tube member replacement method capable of easily replacing the guide tube member.

Brief Description of the Drawings

[0020]

Figure 1

Figure 2

Figure 3

Figure 4A

Figure 4B

Figure 4C

Figure 4D

Figure 4E

Figure 4F

Figure 4G

Figure 4H

Figure 5

Figure 6

MODE FOR CARRYING OUT THE INVENTION

[0021] Hereinafter, embodiments of the catheter set and the guide pipe member replacement method according to the present disclosure will be exemplarily described with reference to the drawings. In each figure, the same code | symbol is attached | subjected to the same structure.

[0022] FIG. 1 is a diagram showing a catheter set 100 as an embodiment of a catheter set according to the present disclosure. The catheter set 100 includes a first guide pipe member 1, a second guide pipe member 2, a shaft member 3, and a hub member 4. The shaft member 3 and the hub member 4 of the present embodiment are part of the treatment catheter 5. In other words, the catheter set 100 of the present embodiment includes a treatment catheter 5 including a shaft member 3 and a hub member 4. In FIG. 1, for convenience of explanation, the guide wire 60 inserted through the shaft member 3 is shown by a one-dot chain line.

[0023] Hereinafter, in the present embodiment, in the longitudinal direction A of the shaft member 3, the tip side inserted into the living body is described as the "distal side", and the opposite proximal side is described as the "proximal side". Further, the direction orthogonal to the longitudinal direction A of the shaft member 3 is referred to as the radial direction B of the shaft member 3.

[0024] The first guide tube member 1 and the second guide tube member 2 are configured to be insertable into the living body. More specifically, the first guide tube member 1 and the second guide tube member 2 of the present embodiment are insertable from outside the living body into a living body lumen such as a blood vessel in the living body. The first guide tube member 1 and the second guide tube member 2 may be, for example, a guiding catheter, a guide extension catheter, etc. that can guide the shaft member 3 to a target site such as a stenosis of a blood vessel.

[0025] The shaft member 3 is configured to be insertable into each of the first guide tube member 1 and the second guide tube member 2. The shaft member 3 of the present embodiment is selectively inserted into each of the first guide tube member 1 and the second guide tube member 2 and used. The hub member 4 is detachable from the proximal end portion 3a of the shaft member 3. Further, the maximum width W1 in the radial direction B of the hub member 4 is larger than the maximum inner diameter W2 of the first guide tube member 1 and the maximum inner diameter W3 of the second guide tube member 2. The maximum inner diameter W2 of the first guide tube member 1 means the maximum value of the width of the guide lumen 1a in a cross section orthogonal to the central axis direction of the first guide tube member 1. Further, the maximum inner diameter W3 of the second guide tube member 2 means the maximum value of the width of the guide lumen 2a in a cross section orthogonal to the central axis direction of the second guide tube member 2. Therefore, each of the first guide tube member 1 and the second guide tube member 2 is configured to be non-insertable through the hub member 4.

[0026] The shaft member 3 of the present embodiment includes a long shaft body 11 and an expander 12. That is, the treatment catheter 5 including the shaft member 3 and the hub member 4 of the present embodiment is a balloon catheter. The expander 12 is attached to the distal end of the shaft body 11 as the distal end portion 3b of the shaft member 3. Further, the expander 12 is expandable and contractible in the radial direction of the shaft body 11 (the same direction as the radial direction B of the shaft member 3), which is orthogonal to the longitudinal direction of the shaft body 11 (the same direction as the longitudinal direction A of the shaft member 3). The above-described hub member 4 is detachable from the proximal end of the shaft body 11 as the proximal end portion 3a of the shaft member 3.

[0027] The shaft member 3 only needs to be insertable into each of the first guide tube member 1 and the second guide tube member 2, and its configuration is not particularly limited. Therefore, in addition to the shaft body 11 and the expander 12 described above, the shaft member 3 may further include another element, for example, a stent disposed around the expander 12.

[0028] Further, the shaft member 3 may be configured without the expander 12. That is, the treatment catheter 5 including the shaft member 3 and the hub member 4 is not limited to a balloon catheter. Therefore, the treatment catheter 5 may be, for example, an ablation catheter having an ablation portion at the distal end of the shaft body 11 instead of the expander 12. Also, the treatment catheter 5 may be, for example, a DCA (Directional Coronary Atherectomy) catheter having a cutting portion at the distal end of the shaft body 11 instead of the expander 12.

[0029] Furthermore, the shaft member 3 and the hub member 4 do not have to be part of the treatment catheter 5. The shaft member 3 and the hub member 4 may be part of a diagnostic catheter that is inserted into a blood vessel, for example, to diagnose a lesion such as a stenosis in the blood vessel. Examples of the diagnostic catheter include an intravascular optical coherence tomography (OCT) catheter having a head portion in which a sensor is disposed instead of the dilator 12 at the distal end of the shaft body 11. Examples of the diagnostic catheter also include an intravascular ultrasound (IVUS) catheter having a head portion in which an ultrasonic vibrator is disposed instead of the dilator 12 at the distal end of the shaft body 11.

[0030] Although details will be described later, according to the catheter set 100 shown in FIG. 1, one of the first guide tube member 1 and the second guide tube member 2 through which the shaft member 3 is inserted can be replaced with the other guide tube member from the proximal side of the shaft member 3 by removing the hub member 4 from the proximal end 3a of the shaft member 3. Details of this guide tube member replacement method will be described later (see FIGS. 4A to 4H).

[0031] Hereinafter, with reference to FIGS. 1 to 3, further details of the first guide tube member 1, the second guide tube member 2, the shaft member 3, and the hub member 4 of the present embodiment will be described. FIG. 2 is an enlarged view showing the proximal end 3a of the shaft member 3 and the hub member 4 of the present embodiment. FIG. 3 is a view showing a modified example of the hub member 4 of the present embodiment.

[0032] First, a balloon catheter as the treatment catheter 5 including the shaft member 3 and the hub member 4 of the present embodiment will be described.

[0033] The balloon catheter as the treatment catheter 5 of the present embodiment is used for procedures such as the treatment of sites where surgical operations are difficult, treatments aimed at minimally invasive access to the human body, and examinations such as cardiovascular angiography. Examples of the treatment of sites where surgical operations are difficult include percutaneous transluminal coronary angioplasty (PTCA) performed for myocardial infarction or angina pectoris. When the shaft member 3 of the treatment catheter 5 of the present embodiment is inserted near the stenosis of the coronary artery, which is the target site, the guide wire 60 protruding from the distal end of the shaft member 3 passes through the stenosis and expands the stenosis while guiding the expander 12 of the subsequent shaft member 3 to the stenosis.

[0034] As shown in FIG. 1, the hub member 4 of the present embodiment includes a hub body 41 and a kink protector 42 connected to the distal side of the hub body 41. A connector portion 41a connectable to an auxiliary device is provided at the proximal end portion of the hub body 41. Further, as shown in FIG. 2, a hub through hole 43 is defined in the hub member 4, which extends from the proximal opening 43a formed in the connector portion 41a of the hub body 41 to the distal opening 43b formed at the distal end of the kink protector 42.

[0035] The auxiliary device connected to the connector portion 41a of the hub body 41 may be, for example, an inflator capable of supplying an expansion fluid for expanding the expander 12 of the shaft member 3. The expansion fluid may be, for example, a liquid such as water, physiological saline, or an electrolyte solution.

[0036] The constituent materials of the hub body 41 and the kink protector 42 of the hub member 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 41 and the kink protector 42 may be, for example, metals such as stainless steel. However, when the kink protector 42 is made of a metal such as stainless steel, a plurality of slits 42a may be formed in the kink protector 42 as shown in FIG. 3 in order to ensure a predetermined flexibility.

[0037] As described above, the hub member 4 is detachable from the proximal end portion 3a of the shaft member 3. Specifically, the hub member 4 of the present embodiment can be attached to the proximal end portion 3a of the shaft member 3 such that the hub through-hole 43 communicates with the flow path 36 of the shaft member 3 in a liquid-tight manner. As shown in FIG. 2, the proximal end portion 3a of the shaft member 3 and the hub member 4 are configured to be fitted to each other. More specifically, the proximal end portion 3a of the shaft member 3 of the present embodiment is provided with a male screw portion 38. The male screw portion 38 is provided on the outer surface of the proximal end portion 3a. Further, the hub member 4 of the present embodiment is provided with a female screw portion 48 that can be screwed with the male screw portion 38 of the proximal end portion 3a of the shaft member 3. The female screw portion 48 is provided on the inner surface of the hub through-hole 43. And the hub member 4 of the present embodiment can be attached to the proximal end portion 3a of the shaft member 3 by fitting the proximal end portion 3a of the shaft member 3 into the hub through-hole 43 of the hub member 4 through the distal opening 43b, and screwing the above-described male screw portion 38 and female screw portion 48 together.

[0038] Also, it is preferable that the tensile strength in the longitudinal direction A of the shaft member 3 at the proximal end portion 3a of the shaft member 3 and the mounting portion of the hub member 4 is 5 N or more. By doing so, when the hub member 4 is gripped and the shaft member 3 is inserted into the first guide tube member 1 or the second guide tube member 2, it is possible to more reliably prevent the hub member 4 from falling off the shaft member 3. Note that the shaft member 3 has such a strength that it does not deform in the radial direction B even when the internal pressure of the flow path 36 inside it reaches the rated burst pressure of the expandable body 12.

[0039] As described above, the shaft member 3 of the present embodiment includes a shaft body 11 and an expandable body 12.

[0040] The shaft body 11 of the present embodiment includes a proximal shaft 31, an intermediate shaft 32, a distal shaft 33, an inner tube shaft 34, and a reinforcing body 35.

[0041] The proximal shaft 31 is tubular. The proximal end of the proximal shaft 31 of the present embodiment is the proximal end of the shaft body 11 and constitutes the proximal end 3a of the shaft member 3. That is, in the shaft member 3 of the present embodiment, the proximal end of the proximal shaft 31 is detachably configured with respect to the hub member 4. The proximal shaft 31 demarcates a proximal lumen 36a inside.

[0042] The intermediate shaft 32 is tubular. The intermediate shaft 32 demarcates an intermediate lumen 36b inside. The proximal end of the intermediate shaft 32 is joined to the distal end of the proximal shaft 31 while maintaining a liquid-tight state. The distal end of the intermediate shaft 32 is joined to the proximal end of the distal shaft 33 while maintaining a liquid-tight state. That is, the intermediate lumen 36b of the intermediate shaft 32 is in liquid-tight communication with the proximal lumen 36a of the proximal shaft 31 and the distal lumen 36c (described later) of the distal shaft 33.

[0043] The distal shaft 33 is tubular. The distal shaft 33 demarcates a distal lumen 36c inside. The distal lumen 36c opens at the distal end of the distal shaft 33 and communicates with the accommodation space 12a of the expansion fluid of the expander 12.

[0044] The shaft member 3 of the present embodiment demarcates a flow path 36 through which an expansion fluid capable of expanding the expander 12 flows. The flow path 36 of the present embodiment is composed of the proximal lumen 36a, the intermediate lumen 36b, and the distal lumen 36c described above. The expansion fluid supplied from an inflator as an auxiliary device connected to the hub member 4 passes through the hub through-hole 43, the proximal lumen 36a, the intermediate lumen 36b, and the distal lumen 36c in this order and is supplied to the accommodation space 12a of the expander 12.

[0045] The inner tube shaft 34 is tubular. The inner tube shaft 34 defines a wire insertion lumen 37 through which a guide wire 60 can be inserted. The proximal end of the inner tube shaft 34 is joined at the position of the boundary between the intermediate shaft 32 and the distal shaft 33. The inner tube shaft 34 extends from its proximal end into the interior of the distal shaft 33 and protrudes further distally than the distal end of the distal shaft 33. That is, the distal end of the inner tube shaft 34 is located further distally than the distal end of the distal shaft 33. The wire insertion lumen 37 extends continuously from a proximal opening 37a that opens to the outside at the proximal end of the inner tube shaft 34 to a distal opening 37b that opens to the outside at the distal end of the inner tube shaft 34. A contrast marker 39 having, for example, X-ray impermeability may be disposed around the inner tube shaft 34.

[0046] The reinforcement 35 is a solid body and is disposed in the flow path 36 so as to straddle the boundary between the intermediate shaft 32 and the distal shaft 33. By providing the reinforcement 35, kinking of the shaft body 11 can be suppressed at the position of the boundary between the intermediate shaft 32 and the distal shaft 33, that is, at the position of the proximal end of the inner tube shaft 34.

[0047] The constituent material of the proximal shaft 31 is preferably a metal material having relatively high rigidity, and examples thereof include stainless steel, stainless steel drawn alloy, Ni-Ti alloy, brass, and aluminum. However, the constituent material of the proximal shaft 31 may be a resin material having relatively high rigidity. Examples of such resin materials include polyimide, vinyl chloride, and polycarbonate.

[0048] The constituent materials of the intermediate shaft 32 and the distal shaft 33 may be, for example, polymer materials such as polyolefin, cross-linked polyolefin, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluororesin, polyimide, or mixtures thereof.

[0049] The constituent material of the inner tube shaft 34 preferably has flexibility, and for example, may be 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.

[0050] The constituent material of the reinforcing body 35 is preferably a metal material having good rigidity and workability, and for example, may be stainless steel, stainless steel drawn alloy, or Ni-Ti alloy.

[0051] The expander 12 is attached to the shaft body 11 and is configured to be expandable and contractible in the radial direction of the shaft body 11 (the same direction as the radial direction B of the shaft member 3). Specifically, the expander 12 of the present embodiment is constituted by an annular film body. The proximal end portion of the annular film body constituting the expander 12 is fixed on the outer surface of the distal shaft 33. The distal end portion of the annular film body constituting the expander 12 is fixed on the outer surface of the inner tube shaft 34. As described above, the accommodation space 12a for the expansion fluid of the expander 12 communicates with the distal lumen 36c of the distal shaft 33. Therefore, the expansion fluid introduced from the hub member 4 can be supplied to the accommodation space 12a through the flow path 36 of the shaft member 3. Conversely, the expansion fluid in the accommodation space 12a can be discharged to the outside through the flow path 36 of the shaft member 3.

[0052] The constituent material of the expander 12 preferably has flexibility, and for example, may be a polymer material such as polyolefin, crosslinked 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 expander 12 is not limited to the form of using the above polymer material alone. The expander 12 may be, for example, a laminate in which films made of the above polymer material are appropriately laminated.

[0053] The first guide tube member 1 of the present embodiment is a guiding catheter that guides the shaft member 3 to a target site such as a stenosis in a blood vessel. The first guide tube member 1 defines a guide lumen 1a inside that penetrates from the proximal end to the distal end to guide the shaft member 3.

[0054] The guiding catheter as the first guide tube member 1 is inserted in advance to the vicinity of the target site in vivo before the guide wire 60 for treatment and the shaft member 3 of the treatment catheter 5 are inserted. The guide wire 60 and the shaft member 3 are inserted to the target site through the guide lumen 1a of the first guide tube member 1. More specifically, first, the guide wire 60 for treatment is inserted to the target site through the guide lumen 1a of the first guide tube member 1. Next, the shaft member 3 is inserted to the target site along the guide wire 60 inserted into the wire insertion lumen 37.

[0055] As shown in FIG. 1, the first guide tube member 1 of the present embodiment includes a long and flexible guide tube body 21, a guide tube hub 22 attached to the proximal end of the guide tube body 21, and a flexible tip 23 attached to the distal end of the guide tube body 21.

[0056] The above-described guide lumen 1a extends from the proximal opening 1a1 formed in the guide tube hub 22 to the distal opening 1a2 formed in the tip 23 across the guide tube body 21, the guide tube hub 22, and the tip 23.

[0057] The longitudinal length of the guide tube body 21 may be appropriately set according to the length of a body lumen or the like that serves as an insertion path from outside the body to the target site, and may be, for example, 800 to 3000 mm. The inner diameter of the guide tube body 21 may be appropriately set according to the outer diameter of the shaft member 3 inserted into the guide lumen 1a, and may be, for example, 1 to 3 mm. The outer diameter D1 of the guide tube body 21 may be appropriately set according to the inner diameter of a body lumen or the like that serves as an insertion path from outside the body to the target site, and may be, for example, 2 to 4 mm.

[0058] The guide tube body 21 may be at least partially curved in a no-load state where no external force is applied. The curved shape, the position where it curves, etc. of the guide tube body 21 may be appropriately set according to the use of the first guide tube member 1.

[0059] Examples of the constituent material of the guide tube body 21 include styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polybutadiene-based, trans-polyisoprene-based, fluorine-based resin materials such as polytetrafluoroethylene (PTFE) and tetrafluoroethylene-ethylene copolymer (ETFE), and various thermoplastic elastomers such as chlorinated polyethylene-based, etc. It may be a combination of one or more of these (polymer alloy, polymer blend, laminate, etc.).

[0060] The guide tube hub 22 is fixed to the proximal end portion of the guide tube body 21. Various guide wires and the shaft member 3 can be inserted into and removed from the guide lumen 1a through the proximal opening 1a1 formed in the guide tube hub 22. Further, the guide tube hub 22 may be configured to be connectable to other instruments, such as a Y-shaped branch connector, etc. A valve body for sealing the guide lumen 1a may be disposed at the proximal opening 1a1 of the guide lumen 1a formed in the guide tube hub 22 while allowing the insertion of various guide wires and the shaft member 3 into the guide lumen 1a.

[0061] As shown in FIG. 1, the tip chip 23 is preferably made of a highly flexible material and has a rounded tip. By providing such a tip chip 23, the first guide tube member 1 can smoothly and safely advance even in a curved, bent, or branched blood vessel. Examples of the constituent material of the tip chip 23 include various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, chloroprene rubber, silicone rubber, fluororubber, styrene-butadiene rubber, and various thermoplastic elastomers such as styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polybutadiene-based, trans-polyisoprene-based, fluororubber-based, and chlorinated polyethylene-based.

[0062] The second guide tube member 2 of the present embodiment is a guiding catheter, similar to the above-described first guide tube member 1. However, the guiding catheter as the second guide tube member 2 of the present embodiment has a different thickness from the guiding catheter as the first guide tube member 1 described above.

[0063] Specifically, the second guide tube member 2 of the present embodiment includes a guide tube main body 51, a guide tube hub 52 attached to the proximal end of the guide tube main body 51, and a flexible tip chip 53 attached to the distal end of the guide tube main body 51. The second guide tube member 2 defines a guide lumen 2a inside that extends from a proximal opening 2a1 located at the proximal end to a distal opening 2a2 located at the distal end for guiding the shaft member 3. The configuration of the guide tube main body 51 is the same as that of the guide tube main body 21 described above, but its outer diameter D2 is larger than the outer diameter D1 of the guide tube main body 21. The configuration of the guide tube hub 52 is the same as that of the guide tube hub 22 described above, but has a size corresponding to the outer diameter D2 of the guide tube main body 51 described above. Also, the configuration of the tip chip 53 is the same as that of the tip chip 23 described above, but has a size corresponding to the outer diameter D2 of the guide tube main body 51 described above.

[0064] As described above, the first guide tube member 1 and the second guide tube member 2 of the present embodiment are guiding catheters with different sizes. The first guide tube member 1 and the second guide tube member 2 can be selectively used in consideration of the efficiency of the procedure according to the patient's individual biological information such as the thickness of the patient's blood vessel. Note that the guiding catheter as the first guide tube member 1 and the guiding catheter as the second guide tube member 2 are not limited to the difference in outer diameter shown in the present embodiment. For example, the overall length, the length of the distal tip 23, etc. may be different configurations. Further, the guiding catheter as the first guide tube member 1 and the guiding catheter as the second guide tube member 2 are not limited to the difference in size such as the above-described outer diameter and length. For example, physical properties and shapes other than size such as hardness and the curved shape of the distal end portion may be different configurations.

[0065] Further, the second guide tube member 2 may be exactly the same guiding catheter as the first guide tube member 1. That is, the second guide tube member 2 may be a replacement guide tube member for replacing the first guide tube member 1, for example, when the distal tip 23 of the first guide tube member 1 is damaged.

[0066] Note that as described above, the first guide tube member 1 of the present embodiment is a guiding catheter, but is not limited to this configuration. The first guide tube member 1 may be, for example, a guide extension catheter used together with the guiding catheter. In such a case, the second guide tube member 2 may be a guide extension catheter of the same size or a different size from the first guide tube member 1. Specifically, the guide extension catheter as the first guide tube member 1 and the guide extension catheter as the second guide tube member 2 may have different configurations in terms of size such as outer diameter, overall length, and length of the distal tip. Further, the guide extension catheter as the first guide tube member 1 and the guide extension catheter as the second guide tube member 2 are not limited to the difference in size such as the above-described outer diameter and length. For example, physical properties and shapes other than size such as hardness and the curved shape of the distal end portion may be different configurations.

[0067] Further, the first guide tube member 1 and the second guide tube member 2 are not limited to either the guiding catheter or the guide extension catheter described above, and may be guide tube members used for other purposes and applications.

[0068] Furthermore, the first guide tube member 1 and the second guide tube member 2 may be alternatively used, and may be a combination of the same type of guide tube members used for the same purpose or application as described above, or may be a combination of different types of guide tube members used for different purposes or applications.

[0069] Hereinafter, with reference to FIGS. 4A to 4H, an example of a guide tube member replacement method according to the present disclosure performed using the catheter set 100 of the present embodiment will be described. In FIGS. 4A to 4H, as an example of the guide tube member replacement method, a method for replacing the first guide tube member 1 and the second guide tube member 2, which is executed during a procedure for expanding a stenosis X of the coronary artery CA using the treatment catheter 5, is shown. As shown in FIGS. 4A to 4H, the guide tube member replacement method shown here includes a first guide tube member insertion step S1, a wire insertion step S2, a shaft member insertion step S3, a hub member removal step S4, a wire locking step S5, a first guide tube member removal step S6, and a second guide tube member insertion step S7.

[0070] FIG. 4A is a diagram showing an overview of the first guide tube member insertion step S1. In the first guide tube member insertion step S1, the first guide tube member 1 is inserted into a living body. In FIG. 4A, a state where the distal end portion of the guiding catheter as the first guide tube member 1 is inserted from outside the living body through the femoral artery, radial artery, etc. to the inlet Y of the coronary artery CA on the wall surface of the aorta AO is shown. As shown in FIG. 4A, the first guide tube member 1 is inserted into the living body along the preceding guide wire 80. Further, the first guide tube member 1 is retained such that its distal end portion is fitted into the inlet Y of the coronary artery CA and pressed against the wall surface of the aorta AO on the opposite side of the inlet Y of the coronary artery CA. The guide wire 80 is withdrawn outside the living body through the first guide tube member 1 after the first guide tube member 1 is retained.

[0071] FIG. 4B is a diagram showing an overview of the wire insertion step S2 and the shaft member insertion step S3. In FIG. 4B, for convenience of explanation, the guide tube hub 22 of the first guide tube member 1 is omitted. In the wire insertion step S2, a treatment guide wire 60 is inserted through the first guide tube member 1. At this time, the guide wire 60 is inserted into the guide lumen 1a of the first guide tube member 1 from the proximal side to the distal side of the first guide tube member 1. Further, in the shaft member insertion step S3, the shaft member 3 is inserted through the first guide tube member 1. At this time, the shaft member 3 is inserted into the guide lumen 1a of the first guide tube member 1 from the proximal side to the distal side of the first guide tube member 1. More specifically, in the shaft member insertion step S3 of the present embodiment, the guide wire 60 is inserted through the wire insertion lumen 37 (see FIG. 1), and the shaft member 3 is inserted into the guide lumen 1a of the first guide tube member 1 along the guide wire 60.

[0072] In FIG. 4B, while advancing the treatment guide wire 60 through the first guide tube member 1 placed in FIG. 4A, both the guide wire 60 and the shaft member 3 of the treatment catheter 5 are inserted into the coronary artery CA from the inlet Y of the coronary artery CA. Further, in FIG. 4B, a state is shown in which the guide wire 60 is inserted until its distal end passes through the stenosis X. From the state shown in FIG. 4B, by advancing the shaft member 3 along the guide wire 60, the expandable body 12 of the shaft member 3 can be guided to the position of the stenosis X. However, for example, when the adhesion force between the distal end of the first guide tube member 1 and the inlet Y of the coronary artery CA is weak, when the reaction force (backup support) obtained from the wall surface of the aorta AO on the opposite side of the inlet Y of the coronary artery CA is small, or when the distal end of the first guide tube member 1 cannot maintain a curved shape due to an increase in the number of devices inserted through the first guide tube member 1, when inserting the shaft member 3 toward the stenosis X, the distal end of the first guide tube member 1 may fall out from the inlet Y of the coronary artery CA, and it may become impossible to insert the shaft member 3. In addition to this, for example, the diameter of the device inserted through the first guide tube member 1 may not be compatible with the first guide tube member 1.

[0073] In such a case, it is necessary to replace it with another guiding catheter of an appropriate size and hardness. Conventionally, however, in order to replace the first guide tube member 1, in addition to the first guide tube member 1, it was necessary to once remove the shaft member 3 and the guide wire 60 outside the body. That is, it was necessary to remove all of the first guide tube member 1, the shaft member 3, and the guide wire 60 and start the procedure again.

[0074] On the other hand, according to the catheter set 100, the first guide tube member 1 can be replaced with the second guide tube member 2 without removing the shaft member 3 and the guide wire 60 in the state shown in FIG. 4B outside the body. Hereinafter, a specific method for replacing the first guide tube member 1 with the second guide tube member 2 will be described.

[0075] FIG. 4C is a diagram showing an overview of the hub member removal step S4. In FIG. 4C, for convenience of explanation, the guide tube hub 22 of the first guide tube member 1 is omitted. In the hub member removal step S4, the hub member 4 located outside the body and attached to the proximal end portion 3a of the shaft member 3 is removed from the proximal end portion 3a of the shaft member 3.

[0076] FIG. 4D is a diagram showing an overview of the wire locking step S5. In the wire locking step S5, the guide wire 60 is locked to the proximal end portion 3a of the shaft member 3. FIG. 4D shows an example in which the guide wire 60 is locked to the proximal end portion 3a of the shaft member 3 by winding it around a male screw portion 38 formed on the outer peripheral surface of the proximal end portion 3a of the shaft member 3. By locking the guide wire 60 to the proximal end portion 3a of the shaft member 3, relative displacement between the shaft member 3 and the guide wire 60 in the longitudinal direction A is suppressed. Therefore, in the first guide tube member removal step S6 described later, the first guide tube member 1 can be removed outside the body with the guide wire 60 locked to the proximal end portion 3a of the shaft member 3. That is, the operator can maintain the position of the shaft member 3 in the body around which the guide wire 60 is wound by gripping the guide wire 60 extending sufficiently long outside the body. That is, by performing the wire locking step S5, in the first guide tube member removal step S6 described later, it becomes easier to remove only the first guide tube member 1 while maintaining the positions of the guide wire 60 and the shaft member 3 in the body.

[0077] Note that, as shown in FIG. 5, the guide wire 60 may be engaged with the proximal end portion 3a of the shaft member 3 by being hooked on a slit 70 formed in the proximal end portion 3a of the shaft member 3 and opening to the proximal end of the shaft member 3. As shown in FIG. 5, the guide wire 60 may be hooked on the slit 70 and wound around the male screw portion 38. In this way, by hooking and fixing the guide wire 60 on the slit 70, the guide wire 60 can be more firmly engaged with the shaft member 3. Further, although the shaft member 3 of the present embodiment is of a rapid exchange type in which a wire insertion lumen 37 (see FIG. 1) is formed only on the distal end side, the shaft member 3 may be of an over-the-wire type in which a wire insertion lumen is formed over the entire length in the longitudinal direction A.

[0078] Alternatively, instead of the wire locking step S5 shown in FIGS. 4D and 5, the extension shaft member mounting step shown in FIG. 6 may be executed. In the extension shaft member mounting step, an extension shaft member 90 is mounted on the proximal end portion 3a of the shaft member 3. The extension shaft member 90 is provided with a female screw portion 91 that can be screwed with the male screw portion 38 of the shaft member 3. Therefore, the extension shaft member 90 can be mounted on the proximal end portion 3a of the shaft member 3 by screwing the female screw portion 91 with the male screw portion 38. The total length of the extension shaft member 90 and the length of the portion of the shaft member 3 extending outside the living body is set so that the sum is longer than the total length of the first guide tube member 1. By doing so, in the first guide tube member removal step S6 described later, when the first guide tube member 1 is removed outside the living body, the operator can always hold at least one of the shaft member 3 and the extension shaft member 90 until the first guide tube member 1 is completely removed outside the living body. That is, in the first guide tube member removal step S6 described later, the operator can hold the shaft member 3 or the extension shaft member 90 mounted on the shaft member 3 in addition to the guide wire 60. Therefore, by executing the extension shaft member mounting step shown in FIG. 6, in the first guide tube member removal step S6 described later, while maintaining the positions of the guide wire 60 and the shaft member 3 in the living body, only the first guide tube member 1 can be more easily removed. Note that in FIG. 6, a so-called over-the-wire type shaft member 3 is illustrated, but a rapid exchange type may also be used.

[0079] FIG. 4E is a diagram showing an overview of the first guide tube member removal step S6. In the first guide tube member removal step S6, the guide wire 60 and the shaft member 3 are left in the living body, and the first guide tube member 1 is removed outside the living body. In this way, by removing the hub member 4 from the proximal end portion 3a of the shaft member 3, the first guide tube member 1 can be removed from the proximal side of the shaft member 3.

[0080] FIG. 4F and FIG. 4G are diagrams showing an overview of the second guide tube member insertion step S7. In FIG. 4G, for convenience of explanation, the guide tube hub 52 of the second guide tube member 2 is omitted. In the second guide tube member insertion step S7, instead of the removed first guide tube member 1, the second guide tube member 2 is inserted into the living body along the shaft member 3 from the proximal side of the shaft member 3. That is, while maintaining the positions of the guide wire 60 and the shaft member 3 in the living body, the second guide tube member 2 can be inserted into the living body along the shaft member 3. And, as shown in FIG. 4G, the second guide tube member 2 is inserted into the living body until its distal end is fitted into the inlet Y of the coronary artery CA. Thus, according to the catheter set 100, the first guide tube member 1 can be replaced with the second guide tube member 2 without removing the shaft member 3 and the guide wire 60 in the state shown in FIG. 4B from the living body.

[0081] FIG. 4H shows a state in which the locking state of the guide wire 60 to the proximal end portion 3a of the shaft member 3 is released from the state shown in FIG. 4G, and the hub member 4 is reattached to the proximal end portion 3a of the shaft member 3. Further, FIG. 4H shows a state in which the shaft member 3 is advanced along the guide wire 60 toward the stenosis X, and the stenosis X is expanded by the expander 12. In FIG. 4H, for convenience of explanation, the guide tube hub 52 of the second guide tube member 2 is omitted. Thus, according to the catheter set 100, the first guide tube member 1 can be replaced with the second guide tube member 2 without removing the shaft member 3 and the guide wire 60 in the state shown in FIG. 4B from the living body, and the procedure can be resumed from the state shown in FIG. 4B. Thereby, the working efficiency of the procedure is improved, the time required for the procedure can be shortened, and the burden on the patient can also be reduced.

[0082] And the second guide tube member 2, the shaft member 3, and the guide wire 60 are removed from the living body after the treatment of the stenosis X is completed.

[0083] In FIGS. 4A to 4H, an example of exchanging the first guide tube member 1 and the second guide tube member 2 before performing the dilation treatment of the stenosis X with the treatment catheter 5 is shown. However, the timing of exchanging the first guide tube member 1 and the second guide tube member 2 is not limited to this example. The first guide tube member 1 may be exchanged for the second guide tube member 2, for example, during the dilation treatment of the stenosis X with the treatment catheter 5. That is, during the dilation of the stenosis X by the dilator 12 of the treatment catheter 5, this treatment may be interrupted once, and the first guide tube member 1 may be exchanged for the second guide tube member 2. In such a case, after exchanging the first guide tube member 1 for the second guide tube member 2, the treatment of dilating the stenosis X may be performed again. Further, the first guide tube member 1 may be exchanged for the second guide tube member 2, for example, after the dilation treatment of the stenosis X with the treatment catheter 5 is completed and before continuing to perform the treatment of another lesion. Thus, the timing of exchanging the first guide tube member 1 and the second guide tube member 2 is not particularly limited.

[0084] The catheter set and the guide tube member exchange method according to the present disclosure are not limited to the specific configurations and steps shown in the above-described embodiments and modified examples, and various modifications, changes, combinations, substitutions, etc. are possible without departing from the scope of the claims.

Industrial Applicability

[0085] The present disclosure relates to a catheter set and a guide tube member exchange method.

Explanation of Reference Numerals

[0086] 1: First guide tube member 1a: Guide lumen 1a1: Proximal opening 1a2: Distal opening 2: Second guide tube member 2a: Guide lumen 2a1: Proximal opening 2a2: Distal opening 3: Shaft member 3a: Proximal end portion of the shaft member 3b: Distal end of the shaft member 4: Hub member 5: Treatment catheter 11: Shaft body 12: Expander 12a: Accommodation space 21: Guide tube body 22: Guide tube hub 23: Tip 31: Proximal shaft 32: Intermediate shaft 33: Distal shaft 34: Inner tube shaft 35: Reinforcement 36: Flow path 36a: Proximal lumen 36b: Intermediate lumen 36c: Distal lumen 37: Wire insertion lumen 37a: Proximal opening 37b: Distal opening 38: Male thread portion 39: Contrast marker 41: Hub body 41a: Connector portion 42: Kink-resistant protector 42a: Slit 43: Hub through-hole 43a: Proximal opening 43b: Distal opening 48: Female thread portion 51: Guide tube body 52: Guide tube hub 53: Tip 60: Guide wire 70: Slit 80: Guide wire 90: Extension shaft member 91: Female thread portion 100: Catheter set A: Longitudinal direction of the shaft member B: Radial direction of the shaft member AO: Aorta CA: Coronary artery D1: Outer diameter of the guide tube body of the first guide tube member D2: Outer diameter of the guide tube body of the second guide tube member X: Stenosis Y: Entrance of the coronary artery W1: Maximum width of the hub member W2: Maximum inner diameter of the first guide tube member W3: Maximum inner diameter of the second guide tube member

Claims

1. A first guide tube member and a second guide tube member that can be inserted into a living body, a shaft member that can be inserted into each of the first guide tube member and the second guide tube member, and a hub member that is detachable from the proximal end portion of the shaft member, wherein, among the first guide tube member and the second guide tube member, one guide tube member in a state where the shaft member is inserted therein can be exchanged from the proximal side of the shaft member to the other guide tube member by removing the hub member from the proximal end portion of the shaft member. A catheter set.

2. The catheter set according to claim 1, wherein a maximum width of the hub member in a radial direction of the shaft member is larger than a maximum inner diameter of the first guide tube member and a maximum inner diameter of the second guide tube member.

3. The catheter set according to claim 1 or 2, wherein the proximal end portion of the shaft member and the hub member are engageable.

4. The proximal end portion of the shaft member includes a male thread portion, and the hub member includes a female thread portion that can be screwed with the male thread portion. The catheter set according to claim 3.

5. The catheter set according to claim 1 or 2, wherein a tensile strength in a longitudinal direction of the shaft member at the proximal end portion of the shaft member and a mounting portion of the hub member is 5 N or more.

6. The shaft member includes a long shaft body, and an expandable body that is attached to a distal end portion of the shaft body and can expand and contract in a radial direction of the shaft body. The catheter set according to claim 1 or 2.

7. The catheter set according to claim 1 or 2, wherein each of the first guide tube member and the second guide tube member is a guiding catheter or a guide extension catheter.

8. A first guide tube member insertion step of inserting a first guide tube member into a living body, a shaft member insertion step of inserting a shaft member into the first guide tube member, a hub member removal step of removing a hub member attached to a proximal end portion of the shaft member from the proximal end portion of the shaft member, a first guide tube member removal step of leaving the shaft member in the living body and removing the first guide tube member from the living body, A guide tube member replacement method, comprising: a second guide tube member insertion step of inserting the second guide tube member into the living body along the shaft member from the proximal side of the shaft member.

9. After the first guide tube member insertion step, it includes a wire insertion step of inserting a guide wire through the first guide tube member. In the first guide tube member removal step, the guide wire and the shaft member are left in the living body, and the first guide tube member is removed outside the living body. The guide tube member replacement method according to claim 8.

10. After the hub member removal step, it includes a wire locking step of locking the guide wire to the proximal end portion of the shaft member. In the first guide tube member removal step, with the guide wire locked to the proximal end portion of the shaft member, the first guide tube member is removed outside the living body. The guide tube member replacement method according to claim 9.

11. After the hub member removal step, it includes an extension shaft member mounting step of mounting an extension shaft member to the proximal end portion of the shaft member. The guide tube member replacement method according to claim 9.

Images