JP2014230710A - Therapeutic method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To easily deliver a catheter to a treatment object in the treatment of lower extremities.SOLUTION: In a treatment method, an operator introduces a catheter assembly 12 inside a blood vessel of an arm 106, and delivers a leading end 12a of the catheter assembly 12 to a predetermined position of lower extremities 104 through a blood vessel 102 in the body. Furthermore, in this treatment method, an inner catheter 16 is drawn out of an outer catheter 14, and a treatment device 18 is advanced to the treatment object through the inside of the outer catheter 14 so that the treatment of the treatment object is performed by the treatment device 18.

Description

  The present invention relates to a treatment method for treating a lower limb by an intervention technique.

  Conventionally, interventional techniques have often been performed by introducing a catheter from the patient's thigh to the femoral artery and delivering the distal end of the catheter to the treatment target in the lumen. In recent years, there has been an increase in procedures (TRI: Trans Radial Intervention) for introducing a catheter from the artery of the arm, particularly the radial artery (or brachial artery), for reasons such as less physical burden on the patient and faster discharge. ing.

  For example, Non-Patent Document 1 discloses a treatment method for performing percutaneous coronary intervention (PCI) by introducing a catheter from an arm. Further, Non-Patent Document 1 describes, as an application example of catheter treatment, delivering a catheter to a lesion occurring in a blood vessel of a lower limb, for example, peripheral arterial disease (PAD) and performing treatment. Has been.

Catheterization and Cardiovascular Interventions Volume 78, Issue 6, pages 823-839, 15 November 2011 [Transradial arterial access for coronary and peripheral procedures: Executive summary by the transradial committee of the SCAI]

  By the way, in the treatment of the lower limbs, when performing an interventional procedure for introducing a catheter from an arm artery (radial artery or brachial artery), it is necessary to use a sufficiently long catheter. However, a catheter whose length is simply increased will deteriorate the delivery characteristics (kink resistance, torque transmission, operability, etc.), and advanced techniques are required when treating the lower limbs. It will be.

  The present invention has been made in connection with an interventional procedure for introducing a catheter from the arm in the treatment of the lower limbs, and can easily deliver the catheter to the treatment target in the lumen of the lower limbs for good treatment. It aims at providing the treatment method which can be performed.

  In order to achieve the above object, the present invention provides a treatment method for treating at least one lower limb treatment target, which is configured by arranging a second catheter in the lumen of the first catheter. A providing step, an introducing step for introducing the catheter assembly into a blood vessel of an arm, and manipulating an exposed portion of the catheter assembly from outside the body so that the distal end of the catheter assembly is positioned at a predetermined position of the lower limb via the aorta. A delivery step of delivering to the device, a device advancement step of causing a treatment device for treating the treatment subject after the delivery step to advance to the treatment subject through the inside of the first catheter, and treatment to the treatment subject by the treatment device And a treatment step for performing.

  Based on the above, the surgeon can smoothly deliver the catheter assembly to a predetermined position of the lower limb in the delivery step by using the catheter assembly that is doubled by the first catheter and the second catheter. That is, the catheter assembly has improved delivery characteristics (kink resistance, torque transmission, operability, etc.) due to the double structure of the first catheter and the second catheter. Therefore, even if the catheter assembly is formed to have a length that reaches the lower limb from the arm, the operator can easily deliver the distal end portion of the catheter assembly. Therefore, in this treatment method, the first catheter can be efficiently arranged at a predetermined position, and the treatment device can be quickly and accurately delivered to the treatment target via the inside of the first catheter for treatment.

  In this case, in the treatment method, before the device advancement step, the distal end of the second catheter or the distal end of the third catheter introduced by pulling out the second catheter is passed through the inside of the first catheter, The device may further include a catheter advance step for making the device advance close to the device, and in the device advance step, the treatment device may be advanced through the lumen of the second catheter or the third catheter.

  Thus, in the treatment method, the treatment device can be delivered to various blood vessels existing in the lower limbs by advancing the second catheter or the third catheter from the first catheter. That is, since the second catheter or the third catheter formed with a diameter smaller than that of the first catheter is delivered, even when the treatment target exists in a narrower blood vessel, the second catheter or the third catheter is brought close to the treatment target. You can advance and then guide the treatment device.

  Here, when the treatment target exists in both the first lower limb and the second lower limb constituting the left and right lower limbs of the patient, in the treatment step, the treatment of the treatment target of the first lower limb is performed. The treatment method includes a step of returning the distal end of the first catheter to the connection position of the blood vessel of the first lower limb and the blood vessel of the second lower limb after the treatment step, and the second lower limb from the connection position after the retraction step. Another part delivery step for delivering the first catheter to a predetermined position, and another part treatment device for treating the treatment target of the second lower limb after the another part delivery step through the inside of the first catheter. 2 advancement step by device to advance to the treatment target of the lower limb, and separate treatment step to treat the treatment target of the second lower limb by the separate treatment device It is preferred to have and.

  Thereby, the surgeon can continuously perform the intervention technique on the treatment target of each of the two lower limbs (the first lower limb and the second lower limb). That is, after the first lower limb treatment target is treated, the first catheter is moved backward to the connection position, and then the second lower limb treatment target is advanced to perform the treatment. Thereby, the some treatment object which exists in a different location by one treatment can be treated efficiently.

  In this case, before the separate site treatment step, the distal end of the second catheter and the distal end of the third catheter introduced by pulling out the second catheter are passed through the inside of the first catheter to be treated of the second lower limb. It may be configured to further include a catheter-specific location advancement step that advances to the vicinity, and in the device-specific location advancement step, the separate location treatment device is advanced through the lumen of the second catheter or the third catheter.

  As described above, even when the treatment target exists in the two lower limbs, the treatment device can be guided to the vicinity of the treatment target using the third catheter.

  In the introducing step, a sheath having an outer diameter of 2.8 mm or less may be introduced into the blood vessel of the arm first, and the catheter assembly may be introduced through the lumen of the sheath.

  Thus, by using a sheath having an outer diameter of 2.8 mm, a sufficiently thick first catheter (for example, an outer diameter of around 2.4 mm) can be applied. Thereby, since a catheter assembly becomes thick, the characteristic at the time of delivery can be improved more.

  Further, when the treatment target is present in a blood vessel on the peripheral side of the popliteal artery of the lower limb, in the delivery step, the tip of the catheter assembly is positioned in the femoral artery or the iliac artery, In the device advancement step, the treatment device may be delivered from the catheter assembly to the femoral artery, and the treatment device may be advanced to the popliteal artery. Further, when a long catheter assembly is inserted, damage due to abrasion at the puncture site of the blood vessel can be prevented.

  Thus, in the treatment method, the distal end portion of the catheter assembly is positioned in the femoral artery or the iliac artery in the delivery step, so that the advancement of the treatment device can be supported by the first catheter in the device advancement step. In addition, since the treatment device is formed with a smaller diameter than the first catheter, it can advance well to the popliteal artery having a relatively large meander.

  Alternatively, when the treatment target is present in a blood vessel on the distal side of the popliteal artery of the lower limb, in the delivery step, the distal end of the catheter assembly is positioned in the popliteal artery or the peripheral blood vessel. May be.

  In this way, by positioning the distal end of the catheter assembly in the popliteal artery or the peripheral blood vessel, a treatment target generated near the knee, below the knee, or the ankle can be better treated by a treatment device that is delivered later. .

  In this case, it is preferable that the treatment target exists near the knee, the calf, or the ankle.

  In this way, even when the treatment target is near the knee, calf, or ankle, the characteristics during delivery of the dual structure catheter assembly can be maintained, so that the treatment device can be delivered smoothly. .

  The treatment device may be a delivery device for delivering and placing an endoluminal prosthesis to the treatment target, a balloon catheter for expanding the treatment target, or a drug application device for applying a drug to the treatment target. Examples of the endoluminal prosthesis include a stent. Examples of the drug application device include a drug eluting balloon catheter and a drug eluting stent.

  Thus, by applying a delivery device, a balloon catheter, or a drug application device, it is possible to satisfactorily treat a stenosis or an occlusion that has occurred in a blood vessel of the lower limb.

  Furthermore, in the construction state of the catheter assembly, it is preferable that the first catheter and the second catheter can be fixed to each other by a lock mechanism provided at each proximal end portion.

  Thus, by fixing the first catheter and the second catheter by the locking mechanism, the first catheter and the second catheter can be integrally operated when the catheter assembly is operated. Therefore, the characteristics at the time of delivery of the catheter assembly inserted in the blood vessel can be further enhanced.

  ADVANTAGE OF THE INVENTION According to this invention, when treating a leg by the intervention technique which introduce | transduces a catheter from an arm, a catheter can be delivered to a treatment object easily and treatment can be performed favorably.

It is the schematic explaining the treatment method which concerns on 1st Embodiment of this invention. It is a partial side sectional view showing the catheter assembly and sheath introducer used for the treatment method concerning a 1st embodiment. It is 1st explanatory drawing which shows the introduction state of the catheter assembly in the treatment method which concerns on 1st Embodiment. 4A is a second explanatory view showing the operation of the distal end portion of the catheter assembly of the treatment method according to the first embodiment, and FIG. 4B is a second view showing the operation of the distal end portion of the catheter assembly of the treatment method following FIG. 4A. FIG. 3 is an explanatory diagram. 5A is a fourth explanatory diagram of the treatment method following FIG. 4B, FIG. 5B is a fifth explanatory diagram of the treatment method following FIG. 5A, and FIG. 5C is a sixth explanation of the treatment method following FIG. 5B. FIG. 5D is a seventh explanatory diagram of the treatment method following FIG. 5C. 6A is an eighth explanatory diagram of the treatment method following FIG. 5D, FIG. 6B is a ninth explanatory diagram of the treatment method following FIG. 6A, and FIG. 6C is a tenth explanatory diagram of the treatment method following FIG. 6B. FIG. FIG. 7A is a schematic view showing a treatment device of the treatment method according to the first modification, FIG. 7B is a schematic view showing a treatment device of the treatment method according to the second modification, and FIG. FIG. 7D is a schematic diagram illustrating a treatment device for a treatment method according to a fourth modification, and FIG. 7D is a schematic diagram illustrating the treatment device for the treatment method according to a fourth modification. 8A is a first explanatory view showing a treatment method according to a fifth modification, FIG. 8B is a second explanatory view of the treatment method following FIG. 8A, and FIG. 8C is a view of the treatment method following FIG. 8B. It is 3rd explanatory drawing. FIG. 9A is a first explanatory view showing a treatment method according to the second embodiment, and FIG. 9B is a second explanatory view of the treatment method following FIG. 9A. 10A is a third explanatory diagram of the treatment method following FIG. 9B, and FIG. 10B is a fourth explanatory diagram of the treatment method following FIG. 10A. 11A is a first explanatory view showing a treatment method according to a sixth modification, FIG. 11B is a second explanatory view of the treatment method following FIG. 11A, and FIG. 11C is a view of the treatment method following FIG. 11B. It is 3rd explanatory drawing.

  Hereinafter, preferred embodiments (first and second embodiments) of the treatment method according to the present invention will be described and described in detail with reference to the accompanying drawings.

  As shown in FIG. 1, the treatment method according to the first embodiment is related to an intervention technique in which treatment is performed via the blood vessel 102 of the patient 100, and treats a lesion that occurs in the blood vessel 102 of the lower limb 104. . As a treatment target, for example, a stenosis portion X generated by accumulation of a thrombus or the like in the popliteal artery can be mentioned. In the following description, the treatment of the stenosis X occurring in the left foot 104b of the pair of lower limbs 104 (left foot 104b: first lower limb, right foot 104a: second lower limb) of the patient 100 will be described.

  Further, in this treatment method, the intervention device 10 is introduced from the blood vessel 102 of the arm 106 (upper limb), and the distal end portion of the intervention device 10 is delivered to the stenosis portion X for treatment. Therefore, the entire length of the intervention device 10 is sufficiently longer than a device used for, for example, percutaneous coronary angioplasty.

  The intervention device 10 used in this treatment method includes a catheter assembly 12 in which two catheters (an outer catheter 14 and an inner catheter 16) are doubled, and a treatment device 18 for treating the stenosis X. The catheter assembly 12 (hereinafter simply referred to as the assembly 12) is a so-called guiding catheter that guides a treatment device 18 that is introduced earlier into the blood vessel 102 of the patient 100 and later introduced. The treatment device 18 includes a treatment portion 20 that performs treatment at the distal end portion, and the treatment portion 20 advances into the constriction portion X via the assembly 12.

  Here, in order to facilitate understanding of the treatment method according to the first embodiment, first, the flow of the procedure will be schematically described. In this treatment method, an introduction step is first performed to introduce the assembly 12 into the blood vessel 102 of the arm 106 of the patient 100. In the introducing step, for example, the sheath introducer 22 (see FIGS. 2 and 3) is inserted into the right radial artery 200 present on the wrist 108 of the right arm 106a, and the assembly 12 is introduced through the sheath introducer 22.

  Next, a delivery step is performed to deliver the distal end portion 12a of the assembly 12 to a predetermined position of the lower limb 104 via the blood vessel 102 in the body by manipulating the proximal end side of the assembly 12 (a portion exposed outside the body). When the distal end 12a of the assembly 12 is introduced into the right radial artery 200 of the right arm 106a, the delivery step includes the distal end 12a along the right radial artery 200, the right upper arm artery 202, the right subclavian artery 204, and the brachiocephalic artery 206. Advance. Thereafter, the distal end portion 12a is delivered in the order of the aortic arch 208, the thoracic aorta 210, the abdominal aorta 212, the left common iliac artery 214, the left external iliac artery 216, and the left femoral artery 218.

  After the delivery step, a withdrawal step is performed to withdraw the inner catheter 16 from the outer catheter 14. That is, the outer catheter 14 is fixed and the inner catheter 16 is retracted to be pulled out, and the outer catheter 14 is left in the body of the patient 100.

  After the inner catheter 16 is pulled out, a device advancement step is performed in which the treatment portion 20 of the treatment device 18 is advanced through the inside of the outer catheter 14. The surgeon delivers the treatment portion 20 of the treatment device 18 from the distal opening 28 a of the outer catheter 14 and delivers the treatment portion 20 from the left femoral artery 218 toward the stenosis portion X of the left popliteal artery 220.

  Thereafter, a treatment step of treating the stenosis portion X by the treatment portion 20 of the treatment device 18 is performed. After the treatment step, the interventional procedure is completed by withdrawing the outer catheter 14 and the treatment device 18 from the body of the patient 100.

  Next, the assembly 12 used in this treatment method and the sheath introducer 22 used in the introduction step will be specifically described with reference to FIG.

  As described above, the assembly 12 is configured by overlapping the outer catheter 14 (first catheter) and the inner catheter 16 (second catheter) in a double manner. The outer catheter 14 includes an outer shaft 24 formed in a long tube having flexibility, and an outer catheter hub 26 provided on the proximal end side of the outer shaft 24.

  An insertion lumen 28 (lumen) is formed through the inside of the outer shaft 24 and the outer catheter hub 26 along the axial direction. The insertion lumen 28 is continuous with a distal end opening 28 a formed at the distal end of the outer shaft 24, and is continued with a proximal end opening 28 b formed at the proximal end of the outer catheter hub 26. The inner catheter 16 is inserted into this insertion lumen 28.

  The outer shaft 24 is set so that the insertion lumen 28 has a relatively large inner diameter. The outer diameter of the outer shaft 24 is set to be approximately the same as the outer diameter of the conventional guiding catheter introduced from the right radial artery 200, for example, 2.33 to 2.4 mm (7 Fr: 1 Fr is 1/3 mm). Set to degree. On the other hand, although the inner diameter of the insertion lumen 28 depends on the outer diameter of the inner catheter 16 and the treatment device 18, it is set to 2.2 mm or less, for example. That is, the outer shaft 24 is formed with a thin wall portion 24 a surrounding the insertion lumen 28.

  And in order to improve the kink resistance of the outer side shaft 24, torque transmission property, and operativity inside the wall part 24a, the reinforcement wire 30 is embedded. The reinforcing wire 30 is composed of a braided body (blade) or a coil. The reinforcing wire 30 is formed in a thin strip shape, and is wound in a coil shape (or mesh shape) along the circumferential direction of the wall portion 24a. Further, the reinforcing wire 30 is provided from a position spaced apart from the tip of the outer shaft 24 by a predetermined distance to a connecting portion of the outer catheter hub 26, and reinforces the entire outer shaft 24. Examples of the material constituting the reinforcing wire 30 include metals such as Ni—Ti alloys, stainless steel (all types of SUS), hard polymers such as polyolefin, and liquid crystal polymers.

  The total length of the outer shaft 24 is preferably set to, for example, 150 cm or more so that the distal end of the outer shaft 24 reaches the left femoral artery 218, although it depends on the physical size of the patient 100 and the like. The outer catheter hub 26 is firmly connected to the proximal end portion of the outer shaft 24 so that the operator can reliably operate the outer shaft 24.

  The outer catheter hub 26 has a larger diameter than the outer shaft 24 so that the operator can easily grasp it. A strain relief 26a for reducing the load applied to the connection portion with the outer shaft 24 is provided at the distal end portion of the outer catheter hub 26. The outer peripheral surface of the outer catheter hub 26 is provided to improve the operability for the operator. A pair of wings 26b are provided.

  A convex portion 32 a constituting one of the locking mechanisms 32 of the assembly 12 is formed at the proximal end portion of the outer catheter hub 26. The convex portion 32a is formed so as to protrude in the circumferential direction of the outer peripheral surface of the outer catheter hub 26, and is screwed into a threaded concave portion 32b of the inner catheter hub 36 described later.

  On the other hand, like the outer catheter 14, the inner catheter 16 has an inner shaft 34 formed in a flexible long tube body, and an inner catheter hub 36 provided on the proximal end side of the inner shaft 34. . A guide wire lumen 38 is formed through the inside of the inner shaft 34 and the inner catheter hub 36 along the axial direction. A guide wire 40 (see FIG. 3 and the like) is inserted into the guide wire lumen 38. The guide wire lumen 38 constitutes the lumen of the assembly 12 in the assembled state of the assembly 12. Therefore, it is preferable that the guide wire lumen 38 is set to a dimension that allows the guide wire 40 to slide and does not perfuse blood (biological fluid) flowing in the blood vessel.

  The inner shaft 34 is set to have a longer overall length than the outer shaft 24. For this reason, the inner shaft 34 can be exposed from the distal end opening 28 a of the outer shaft 24 in a state where the assembly 12 is assembled and the proximal end portion is exposed from the proximal end opening 28 b of the outer catheter hub 26.

  The tip of the inner shaft 34 is formed with a tip inclined portion 34b that is inclined obliquely so as to easily guide the direction of the assembly 12 during the delivery step. In order to obtain good slidability in the blood vessel 102, it is preferable that a hydrophilic polymer coating is applied to the outer peripheral surface of the tip inclined portion 34b. Furthermore, a reinforcing wire (blade) 42 that reinforces the inner shaft 34 may be embedded in a wall portion 34 a of the inner shaft 34 that is spaced apart from the tip inclined portion 34 b of the inner shaft 34.

  The outer diameter of the inner shaft 34 depends on the inner diameter of the insertion lumen 28 of the outer shaft 24. For example, when the inner diameter of the insertion lumen 28 is about 2.2 m, it is set to about 2.1 mm (6 Fr). Good. For example, when the inner diameter of the insertion lumen 28 is about 1.7 mm, it may be set to about 1.5 to 1.6 mm (5 Fr).

  It is preferable that the outer shaft 24 or the inner shaft 34 has rigidity and flexibility capable of moving forward and backward in the blood vessel 102 meandering in the delivery step. Examples of the material constituting the outer shaft 24 or the inner shaft 34 include resin and metal. Examples of the resin include polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyvinyl chloride, polyamide, polyamide. Examples thereof include polymer materials such as elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, polyimides, fluororesins, mixtures thereof, and the above two or more polymer materials. Examples of the metal include pseudo-elastic alloys (including superelastic alloys) such as Ni-Ti alloys, shape memory alloys, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS430F, SUS302, etc.), cobalt-based alloys, noble metals such as gold and platinum, tungsten-based alloys, carbon-based materials (including piano wires), and the like. A composite of these resins and metals (for example, a laminated multilayer tube) can also be applied. Furthermore, an X-ray impermeable marker that can be recognized under X-ray imaging may be provided near the tip of the outer shaft 24 or the inner shaft 34.

  The inner catheter hub 36 connected to the inner shaft 34 is formed in a cylindrical shape having the same outer diameter as the outer catheter hub 26. A connector tube portion 44 is provided at the distal end portion of the inner catheter hub 36 so as to surround the connection protrusion 36 a that connects the inner shaft 34. The connector tube portion 44 constitutes the other side of the lock mechanism 32, and a screw-like recess 32b capable of screwing the projection 32a of the outer catheter hub 26 is formed on the inner peripheral surface thereof.

  That is, in the assembly 12, the proximal end portion of the outer catheter hub 26 and the distal end portion of the inner catheter hub 36 are connected and fixed (locked) by the locking mechanism 32 to form one operation portion that can operate the double catheter. The surgeon grasps the outer catheter hub 26 and the inner catheter hub 36 and arbitrarily performs the advancement / retraction operation and the rotation operation, thereby integrally moving the outer shaft 24 and the inner shaft 34 forward and backward. Can do. The locking mechanism 32 can be separated (released) relatively easily by the relative rotation of the inner catheter hub 36 with respect to the outer catheter hub 26.

  The assembly 12 is constructed in a state in which the inner catheter 16 is inserted into the insertion lumen 28 of the outer catheter 14 and the axial movement thereof is restricted by the lock mechanism 32 before the introduction step is performed. Then, in the introduction step, the assembly 12 is inserted into the wrist 108 of the patient 100 via the sheath introducer 22.

  The sheath introducer 22 includes a tubular sheath 46 having flexibility and an introducer hub 48 connected to the proximal end portion of the sheath 46. A guide lumen 50 is formed through the sheath 46 and the introducer hub 48 along the axial direction. The guide lumen 50 is continuous with a distal end opening 50 a (see FIG. 3) formed at the distal end of the sheath 46, and is continued with a proximal end opening 50 b formed at the proximal end of the introducer hub 48. A dilator (not shown) that punctures the wrist 108 of the patient 100 is first inserted into the guide lumen 50, and the assembly 12 is inserted after the dilator is removed.

  The sheath 46 is inserted and placed into the right radial artery 200 to facilitate introduction of the assembly 12 during the introduction step. The overall length of the sheath 46 is shorter than the outer shaft 24 and the inner shaft 34, and is set to about 10 to 30 cm, for example. The outer diameter of the sheath 46 is set to, for example, about 2.7 mm (8 Fr), that is, 2.8 mm or less, for insertion into the right radial artery 200 having a blood vessel diameter of about 2.9 mm ± 0.6 mm. Yes.

  Although the material which comprises the sheath 46 is not specifically limited, For example, PEEK (polyetheretherketone), PEK (polyetherketone), PEKK (polyetherketoneketone), PEEKK (polyetheretherketoneketone) , PPS (polyphenylene sulfide), PES (polyethersulfone), PSF (polysulfone), PI (polyimide), PEI (polyetherimide), PAR (amorphous polyarylate), etc. Can be applied. Other resin materials may be applied. For example, ethylene tetrafluoroethylene copolymer (ETFE) has excellent properties such as strength and ease of processing, and the sheath 46 is thin. Is suitable.

  Therefore, the wall part 46a of the sheath 46 which comprises the guide lumen 50 is formed in thin thickness about 0.1-0.15 mm, for example. Therefore, the inner diameter of the guide lumen 50 is increased, and the outer catheter 14 (assembly 12) can be sufficiently thick (7Fr) depending on the guide lumen 50. Further, the distal end portion of the sheath 46 is tapered to reduce a step generated between the assembly 12 and the dilator delivered from the distal end opening 50a.

  The introducer hub 48 has a larger diameter than the sheath 46 so that the operator can easily grasp the introducer hub 48 and can easily introduce the assembly 12. A port 48a communicating with the guide lumen 50 is formed on the side peripheral surface of the introducer hub 48, and a tube 51 having a general-purpose connector 51a (three-way cock) is connected to the port 48a. The sheath introducer 22 can guide a liquid such as physiological saline to the guide lumen 50 via the connector 51a. Moreover, it is preferable that the guide lumen 50 of the introducer hub 48 is provided with a valve portion (not shown) that prevents blood from flowing out to the outside.

  The assembly 12 and the sheath introducer 22 of the intervention device 10 are basically configured as described above. Returning to FIG. 1, the treatment device 18 of the intervention device 10 may be generally known except that the entire length of the treatment device side shaft 52 inserted into the outer shaft 24 is long. For example, the treatment portion 20 provided at the distal end portion of the treatment device side shaft 52 of the treatment device 18 includes a stent 54 placed in the stenosis portion X and a balloon 56 that is expandable inside the stent 54 (FIG. 5C). reference). That is, the treatment device 18 is configured as a stent delivery device capable of expanding and placing the stent 54 with respect to the stenosis portion X.

  The intervention device 10 is basically configured as described above, and the treatment method according to the first embodiment will be specifically described below.

  In the following description, a treatment method for treating the stenosis portion X of the left popliteal artery 220 of the left foot 104b described above will be described in detail, but the treatment target of this treatment method is not particularly limited. For example, the treatment site may be an artery such as the left femoral artery 218, the left anterior tibial artery 222, the left posterior tibial artery 224, or a peripheral blood vessel 226 connected to the artery, or a vein may be treated in addition to the artery. Naturally, it may be a blood vessel of the right foot 104a (right femoral artery 230, right popliteal artery 232, right anterior tibial artery 234, right posterior tibial artery 236, etc.). In short, the treatment site can cover any lumen within the lower limb 104. In addition to the stenosis part X, various lesions that can be treated by the treatment device 18 in an interventional procedure, such as an occlusion part, blood vessel damage or aneurysm, can be targeted as a lesion part to be treated.

  Prior to the implementation of the treatment method, the operator presets the introduction portion Y of the blood vessel 102 of the arm 106, and the intervention device 10 (assembly 12, treatment device 18, guide) having a length corresponding to the introduction portion Y. A wire 40) is prepared.

  Here, the case where the wrist 108 (the right radial artery 200) of the right arm 106a is selected as the introduction part Y will be described, but the introduction part Y is not limited to this. For example, instead of the right radial artery 200, the right ulnar artery 201 extending in the wrist 108 of the right arm 106a may be selected. When the introduction part Y is the wrist 108 (the right radial artery 200 or the right ulnar artery 201), there are advantages such that the elbow can be bent after treatment, hemostasis is easy, and the rest period is short.

  Further, as shown in FIG. 1, the assembly 12 may be directly introduced into the right upper arm artery 202 by using the vicinity of the elbow of the right arm 106 a as an introduction portion Y ′. Since the right radial artery 200 and the right ulnar artery 201 are connected to the right upper arm artery 202, the blood vessel diameter is larger than that of the right radial artery 200 and the like, and the larger diameter assembly 12 and the sheath introducer 22 can be inserted. it can. Further, in consideration of the dominant arm of the patient 100, the introduction portion Y ′ may be set at the wrist 108 (left radial artery or left ulnar artery) or near the elbow (left brachial artery) of the left arm 106b. In short, the introduction portions Y and Y ′ of the intervention device 10 arbitrarily set appropriate positions of both arms in consideration of the deliverability of the assembly 12 up to the stenosis X, the postoperative care of the patient 100, and the like. It's okay.

  After selecting an appropriate assembly 12 according to the setting of the introduction portion Y, the operator inserts the inner catheter 16 into the insertion lumen 28 of the outer catheter 14, and the distal inclined portion 34 b of the inner catheter 16 is opened to the distal end of the outer catheter 14. Assemble in a state protruding from 28a. In other words, the assembly 12 is configured as a double catheter in which the axis of the insertion lumen 28 and the axis of the guide wire lumen 38 are positioned substantially coaxially (providing step). At this time, the threaded recess 32b of the inner catheter hub 36 and the protrusion 32a of the outer catheter hub 26 are screwed together (locked), so that the assembled state of the assembly 12 is maintained. The assembly 12 may be assembled in advance in the product provision state.

  In the introduction step, the surgeon specifies the right radial artery 200 on the wrist 108 of the right arm 106a, punctures or incises the right radial artery 200 by a known technique such as the Seldinger method, and inserts the guide wire 40. That is, as shown in FIG. 3, the guide wire 40 is inserted with the palm facing upward, and the dilator of the sheath introducer 22 is inserted into the right radial artery 200 along the guide wire 40. The outer peripheral surface of the dilator is covered with the sheath 46 of the sheath introducer 22, and the sheath 46 is inserted into the right radial artery 200 as the dilator is inserted. As described above, since the sheath 46 is thinner than the blood vessel diameter of the right radial artery 200, the sheath 46 can be advanced into the right radial artery 200 relatively easily.

  After the distal end of the sheath 46 has advanced a predetermined amount toward the central side of the right radial artery 200, the operator pulls out the dilator and inserts the assembly 12 from the proximal opening 50 b of the introducer hub 48. At this time, the guide wire 40 inserted in advance with respect to the guide wire lumen 38 of the inner catheter 16 is inserted, and the assembly 12 is advanced along the guide wire 40. Here, because the wall 46a of the sheath 46 is formed thin, the guide lumen 50 has an inner diameter that can easily assist the advancement (sliding) of the assembly 12 (outer catheter 14). That is, the assembly 12 is smoothly delivered from the distal opening 50 a of the sheath 46 and advances in the right radial artery 200.

  Returning to FIG. 1, the surgeon performs the advancement movement of the assembly 12 along the preceding guidewire 40 in the delivery step. At this time, the surgeon grasps the proximal end side of the assembly 12 exposed from the introducer hub 48 while confirming the state of the distal end portion 12a of the assembly 12 based on the X-ray image acquired by X-ray imaging. . As a result, the distal end portion 12a of the assembly 12 moves from the right radial artery 200 into the right upper arm artery 202, and further advances around the right subclavian artery 204, passes through the brachiocephalic artery 206, and passes through the aorta (aorta). Enter the bow 208).

  When the distal end portion 12a of the assembly 12 is advanced to the aortic arch 208, the proximal end side of the assembly 12 is rotated under X-ray imaging to move the distal end portion 12a of the assembly 12 to the thoracic aorta 210 side. Since the distal end inclined portion 34b of the inner catheter 16 is inclined with respect to the axial direction of the assembly 12, the distal end portion 12a of the assembly 12 advanced from the brachiocephalic artery 206 can be relatively easily thoracic aorta as shown in FIG. 4A. It can face 210 side.

  When the distal end portion 12a of the assembly 12 moves toward the thoracic aorta 210, the surgeon further pushes the proximal end side of the assembly 12. Thus, the distal end portion 12a of the assembly 12 moves from the central side to the distal side along the aorta (the thoracic aorta 210 and the abdominal aorta 212), and the right common iliac artery 228 and the left common intestine on the distal side of the abdominal aorta 212. The connection position Z of the bone artery 214 is reached. As shown in FIG. 4B, even at this connection position Z, the distal end inclined portion 34b can face the desired direction (the left common iliac artery 214) by rotating the proximal end side of the assembly 12. Then, the surgeon pushes the proximal end side of the assembly 12 to advance and move the distal end portion 12a of the assembly 12 from the left common iliac artery 214 to the left external iliac artery 216 and the left femoral artery 218.

  Here, at the stage where the catheter whose length is simply increased is inserted from the arm 106 and advanced to the blood vessel 102 of the lower limb 104, most of the catheter is inserted into the body, and the operability of the catheter is lowered. That is, even if the proximal end of the catheter exposed outside the body is operated, the outer peripheral surface of the catheter is in contact with the blood vessel 102 or the like, so that the operating force is difficult to be transmitted to the distal end side, and delivery to the lower limb 104 is possible. It will get worse.

  On the other hand, by using the assembly 12 that is a double catheter as in the treatment method according to the first embodiment, the distal end portion 12a of the assembly 12 can be easily delivered to the blood vessel 102 of the lower limb 104. . That is, in the assembly 12, the inner catheter 16 housed in the insertion lumen 28 of the outer catheter 14 reinforces the entire assembly 12. Therefore, for example, even when the outer catheter 14 is compressed from the blood vessel 102, the inner catheter 16 can support the outer catheter 14 well.

  In particular, in this assembly 12, even when the outer catheter 14 receives a relatively large frictional force from the blood vessel 102, the outer peripheral surface of the inner catheter 16 is subjected to a large frictional force against the wall 34a of the outer catheter 14 during the rotation operation. Contact. Therefore, since the rotational force of the inner catheter 16 is transmitted in addition to the rotational force of the outer catheter 14, rotation of the entire assembly 12 is promoted. Thereby, as for the assembly 12, the torque transmission property with respect to the front-end | tip part 12a improves.

  Alternatively, if it is desired to change the course of the assembly 12, only the inner catheter 16 may be rotated without rotating the outer catheter 14. As a result, the outer catheter 14 is fixed, and the distal inclined portion 34b of the inner catheter 16 that is relatively rotated faces in a desired direction. As a result, the delivery characteristics of the assembly 12 are further enhanced.

  As shown in FIG. 5A, in the delivery step, the tip 12a of the assembly 12 is delivered to a predetermined position of the left femoral artery 218 (a position near the upper part of the left popliteal artery 220), and the delivery of the assembly 12 is stopped. Since the left popliteal artery 220 has a smaller blood vessel diameter and larger meandering than the left femoral artery 218, stopping in the left femoral artery 218 prevents a large load from the blood vessel 102 from being applied to the outer catheter 14. Can do.

  Note that the end of the delivery step (the stop position of the distal end portion 12a of the assembly 12) is not particularly limited, and may be arbitrarily changed by the operator during the procedure depending on the treatment status and the treatment target. For example, in the delivery step, the distal end portion 12a of the assembly 12 is delivered to the vicinity of the knee (eg, popliteal artery) of the patient 100, below the knee (eg, anterior tibial artery or posterior tibial artery), or an ankle (eg, radial artery or dorsal artery). May be. As a result, the treatment target generated near the knee, below the knee, or the ankle can be better treated by the treatment device 18 to be delivered later. Depending on the treatment target, for example, the distal end portion 12a of the assembly 12 may be stopped at the iliac artery (the left common iliac artery 214 or the left external iliac artery 216). That is, “lower limb blood vessels” in this specification includes blood vessels (eg, iliac arteries) on the peripheral side of the abdominal aorta 212.

  In the pulling-out step after the delivery step, the lock of the inner catheter hub 36 connected to the outer catheter hub 26 by the lock mechanism 32 is released. That is, the assembled state of the double catheter of the assembly 12 is eliminated. Then, as shown in FIG. 5B, the axial position of the outer catheter 14 and the guide wire 40 with respect to the left femoral artery 218 is fixed, and only the inner catheter 16 is moved backward, so that the outer catheter is placed inside the patient 100. Only 14 are left. As described above, the outer catheter 14 is reinforced by embedding the reinforcing wire 30 in the wall portion 24a of the outer shaft 24. Therefore, the outer catheter 14 can maintain the insertion lumen 28 well even after the extraction step.

  In the device advancement step after the extraction step, the operator inserts the treatment device 18 (stent delivery device) from the proximal end opening 28 b of the outer catheter 14. At this time, the guide wire 40 is inserted into the treatment device 18, and the treatment device 18 is advanced and moved along the insertion lumen 28 of the outer catheter 14 and the guide wire 40. Thereby, the treatment part 20 of the therapeutic device 18 is delivered to the distal end side of the outer catheter 14 as shown in FIG. 5C.

  As shown in FIG. 5D, the surgeon advances the treatment portion 20 even after the treatment portion 20 is delivered from the distal end opening 28 a of the outer catheter 14 to the left femoral artery 218. The treatment device 18 moves with the treatment device side shaft 52 guided by the outer shaft 24 and enters the left popliteal artery 220 relatively easily. When the surgeon recognizes that the treatment unit 20 has been delivered to a position overlapping the stenosis X under X-ray imaging, the device delivery step is terminated.

  Thereafter, in the treatment step, the surgeon performs a treatment to push the stenosis portion X of the left popliteal artery 220. Specifically, as shown in FIG. 6A, the treatment portion 20 is positioned so as to overlap with the axial position of the constriction portion X. Then, as shown in FIG. 6B, the balloon 56 is expanded by the operator's expansion operation, and the stent 54 around the balloon 56 is expanded in the radial direction of the left popliteal artery 220. As a result, the stent 54 acts to expand and expand the blood vessel wall 102a of the left popliteal artery 220 and maintain the expanded state. After expansion of the stent 54, the balloon 56 is again deflated and the treatment device 18 is retracted as shown in FIG. 6C.

  That is, the left popliteal artery 220 (stenosis part X) is supported by the expansion of the expanded stent 54 in the radial direction, so that the blood flows well inside the stent 54. Note that the stent 54 may be configured to elute a drug upon placement. For example, the stent 54 can continuously maintain the expanded state of the blood vessel 102 by eluting a drug that suppresses restenosis.

  In the treatment method according to the first embodiment, the treatment device 18 for treating the treatment target is not limited to the stent delivery device, and various modifications and application examples can be taken. Hereinafter, some other treatment devices 18 will be described by way of example.

  In the treatment method according to the first modification shown in FIG. 7A, the treatment portion 20A of the treatment device 18A is constituted by the balloon 60. The balloon 60 is delivered to the treatment target (for example, the stenosis part X) by the treatment device advancement step, and then is expanded in the radial direction based on an expansion operation by the operator. Thereby, the blood vessel 102 of the stenosis part X is expanded and blood circulation is facilitated.

  In the treatment method according to the second modified example shown in FIG. 7B, the treatment device 18B is configured by a drug application device 18B (drug elution balloon catheter: DEB) that applies a drug. The drug application device 18B may be used, for example, when a damage Xα such as a crack occurs in the blood vessel wall 102a of the blood vessel 102 as a treatment target due to PTA (percutaneous angioplasty) or the like. The treatment section 20B of the drug application device 18B is configured by a balloon 58 that expands to the same diameter as or slightly smaller than the inner diameter of the blood vessel 102 in which the damage Xα has occurred, and the side surface of the balloon 58 treats the damage Xα. The medicine 58a for coating is coated. The drug application device 18B can apply the drug 58a to the damaged Xα by the expanded balloon 58.

  In the treatment method according to the third modification shown in FIG. 7C, the treatment unit 20C of the treatment device 18C is configured by a cutter unit 62 (atherectomy device) that scrapes off atheroma (plaque). For example, after the cutter unit 62 is delivered to the treatment target in the treatment device advancement step, the cutter unit 62 rotates around the axis of the treatment device side shaft 52 based on the operation of the operator to remove the atheroma around the cutter unit 62. I do.

  In the treatment method according to the fourth modification shown in FIG. 7D, the treatment device 18D treats the aneurysm Xβ (treatment target) generated in the blood vessel 102, and an indwelling object 64 (for example, a coil) is used as the treatment unit 20D. The indwelling object delivery part 66 packed in the aneurysm Xβ is provided. The indwelling object delivery unit 66 is delivered into the aneurysm Xβ (or the opening of the aneurysm Xβ) by the treatment device advancement step, and then the indwelling object 64 is packed into the aneurysm Xβ based on the operation of the surgeon. Close treatment is performed.

  As another treatment device 18 applicable to the treatment target, for example, a suction mechanism for sucking a thrombus or the like constituting the stenosis portion X can be applied.

  The treatment method according to the fifth modification shown in FIGS. 8A to 8C is configured to send a guiding catheter 70 (third catheter) from the outer catheter 14. The guiding catheter 70 accommodates the treatment device 18 in an internal accommodation space 72 (lumen), and can deliver the treatment device 18 when it has advanced to some extent in the blood vessel 102. The treatment device 18 may apply the various configurations described above, such as a stent delivery device.

  This treatment method is particularly effective when the treatment target X is in the peripheral blood vessel 226 that is thinner than the artery. Hereinafter, an example of a specific treatment method will be described. In this case, the same method as described above can be used until the extraction step of extracting the inner catheter 16 from the outer catheter 14 of the assembly 12 delivered to the left femoral artery 218. After the extraction step, as shown in FIG. 8A, the operator performs a catheter advancement step in which the guiding catheter 70 is advanced along the insertion lumen 28 of the outer catheter 14.

  In the catheter advancement step, the guiding catheter 70 is delivered from the distal end opening 28 a of the outer catheter 14, and further, as shown in FIG. 7B, the guiding catheter 70 is advanced and the distal end thereof reaches the vicinity of the opening of the peripheral blood vessel 226. Deliver. Thereafter, similarly to the above-described treatment device advancement step, the treatment device 18 previously accommodated in the accommodation space 72 of the guiding catheter 70 is delivered from the distal end of the guiding catheter 70 to the treatment target X of the peripheral blood vessel 226. Deliver. Then, a treatment step of treating the treatment target X by the treatment unit 20 of the treatment device 18 is performed.

  In this manner, by delivering the guiding catheter 70 from the outer catheter 14, the treatment device 18 can be delivered to various blood vessels 102 existing in the lower limb 104. In particular, the blood vessel 102 on the peripheral side with respect to the left popliteal artery 220 has a larger meander, but the guiding catheter 70 formed with a diameter smaller than that of the outer catheter 14 advances well to the treatment target of the peripheral blood vessel 226. . Thereby, the treatment device 18 can be easily delivered to the treatment subject.

  In addition, the 3rd catheter delivered to the treatment object X through the outer catheter 14 is not limited to the guiding catheter 70, and can take various configurations. For example, as the third catheter, a contrast catheter for performing intravascular contrast, a microcatheter for treating thinner blood vessels, and the like can be applied. In the treatment method, the inner catheter 16 that is the second catheter may not be pulled out (the pulling step is not performed), and the inner catheter 16 may be advanced to guide the treatment device 18 through the inner catheter 16. . Even in such a case, it can be said that the treatment device 18 passes through the lumen (inside) of the outer catheter 14.

  As described above, the treatment method according to the first embodiment can satisfactorily deliver the distal end portion 12 a of the assembly 12 to the blood vessel 102 of the lower limb 104 by using the double-structured assembly 12. That is, the assembly 12 has improved delivery characteristics (kink resistance, torque transmission, operability, etc.) due to the double structure of the outer catheter 14 and the inner catheter 16. Therefore, even if the assembly 12 is formed to have a length that reaches the lower limb 104 from the arm 106, the operator can easily operate the distal end portion 12a of the assembly 12 to advance in the blood vessel. As a result, the outer catheter 14 can be efficiently disposed at a predetermined position, and the treatment device 18 can be delivered to the treatment target smoothly and accurately via the outer catheter 14 for treatment.

  Further, by using the sheath 46 having an outer diameter of 2.8 mm, a sufficiently thick outer catheter 14 (for example, an outer diameter of around 2.4 mm) can be applied, thereby further improving the characteristics during delivery. be able to.

  Further, in the delivery step, the distal end portion 12a of the assembly 12 is positioned in the left femoral artery 218, so that the advancement of the treatment device 18 can be supported (guided) by the outer catheter 14 in the device advancement step. Since the treatment device 18 is formed to have a smaller diameter than the outer catheter 14, the treatment device 18 can be advanced with respect to the left popliteal artery 220 having a relatively large meander. And even if the treatment object exists near the knee, the calf, or the ankle, the characteristics at the time of delivery of the dual-structure catheter assembly 12 can be maintained, so that the treatment device 18 can be delivered smoothly. .

  Furthermore, by fixing (locking) the outer catheter 14 and the inner catheter 16 by the locking mechanism 32, the outer catheter 14 and the inner catheter 16 can be integrally operated when the assembly 12 is operated. Thereby, the delivery characteristics of the assembly 12 inserted into the blood vessel 102 can be further enhanced.

  Next, a treatment method according to the second embodiment will be described with reference to FIGS. 9A to 10B. The treatment method according to the second embodiment is a technique for treating a treatment target (hereinafter, referred to as a right stenosis part X1 and a left stenosis part X2) generated in both of the two lower limbs (the right foot 104a and the left foot 104b) of the patient 100. It is. As the intervention device 10 used in this treatment method, basically the same intervention device 10 as in the first embodiment can be applied.

  Further, in the following description, a procedure for first treating the left stenosis part X2 and then treating the right stenosis part X1 as in the first embodiment will be described. In this case, in the treatment of the left stenosis X2, the procedure from the introduction step to the treatment step described above can be performed. Needless to say, the treatment order of the right foot 104a and the left foot 104b can be arbitrarily selected by the operator.

  In the treatment method according to the second embodiment, after the treatment step of the left stenosis part X2 is completed, as shown in FIG. 9A, a device retraction step of retreating the treatment device 18 that has treated the left stenosis part X2 from the outer catheter 14 is performed. Do. Thereby, the treatment device 18 is pulled out from the outer catheter 14, and the outer catheter 14 and the guide wire 40 are left in the body of the patient 100.

  Next, as shown in FIG. 9B, the operator performs a retraction step of retreating the distal end portion of the outer catheter 14 to the connection position Z between the right common iliac artery 228 and the left common iliac artery 214. As a result, the distal end portion of the outer catheter 14 located in the left femoral artery 218 is retracted to the distal side of the abdominal aorta 212 (connection position Z) via the left external iliac artery 216 and the left common iliac artery 214. Moving. At this time, the guide wire 40 is also moved backward together.

  After the retraction step, the surgeon performs another part delivery step of delivering the outer catheter 14 from the distal side of the abdominal aorta 212 to a predetermined position of the right femoral artery 230 of the right foot 104a as shown in FIG. 10A. At this time, the guide catheter 40 is advanced to advance the outer catheter 14, and the right common iliac artery 228, right external iliac artery 229, and right femoral artery 230 are delivered. In this separate delivery step, the assembly 12 is reconstructed by reinserting the inner catheter 16 into the outer catheter 14 depending on the condition of the blood vessel 102 of the patient 100 (eg, large meandering, thin blood vessels, etc.). Also good. Thereby, the distal end portion 12 a of the assembly 12 can be delivered to the right femoral artery 230 in the same manner as when delivered to the left femoral artery 218.

  After this separate part delivery step, as shown in FIG. 10B, the surgeon performs a treatment device specific part advancement step for advancing the treatment device 80 (different part treatment device) for treating the right stenosis part X1 of the right foot 104a. . As the treatment device 80, a device in which a stent 54 placed in the right stenosis portion X1 is arranged in the treatment portion 80a is used. The treatment device 80 advances through the insertion lumen 28 of the outer catheter 14 and is delivered from the distal opening 28 a of the outer catheter 14 to the right femoral artery 230. After being delivered to the right femoral artery 230, the treatment portion 80a is delivered to the location (the right popliteal artery 232) where the right stenosis portion X1 exists.

  Then, another part treatment step for treating the right stenosis part X1 by the treatment device 80 in the right stenosis part X1 is performed. In the different part treatment step, the stent 56 is expanded by expanding the balloon 56 of the treatment portion 80a of the treatment device 80, and the right stenosis portion X1 is expanded. Thereby, the stent 54 is indwelled so that the expansion state of the right stenosis part X1 may be maintained, and the treatment of the right stenosis part X1 is completed.

  As described above, according to the treatment method according to the second embodiment, when the treatment target exists in the two lower limbs 104, the intervention technique can be continuously performed. That is, after the treatment of the treatment target of one lower limb 104, the outer catheter 14 is moved backward to the distal side of the abdominal aorta 212 and advanced to the treatment target of the other lower limb 104, so that different points are obtained in one treatment. A plurality of treatment subjects existing in can be treated.

  Further, as a modified example (sixth modified example) of the treatment method according to the second embodiment, a catheter-specific location advancement step for advancing the distal end of the guiding catheter 82 (third catheter) is further performed before the separate location treatment step. You may go. For example, as shown in FIGS. 11A to 11C, when the right stenosis part X1 exists in the peripheral blood vessel 226 connected to the right popliteal artery 232 of the right foot 104a, it is close to the right stenosis part X1 through the insertion lumen 28 of the outer catheter 14. Until the distal end of the guiding catheter 82 is delivered. Then, by sending the treatment device 18 from the distal end portion of the guiding catheter 82, the treatment portion 80a of the treatment device 80 can be successfully delivered to the right stenosis portion X1.

  In the above description, the present invention has been described with reference to preferred embodiments. However, the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the present invention. Yes.

DESCRIPTION OF SYMBOLS 10 ... Intervention device 12 ... Catheter assembly 14 ... Outer catheter 16 ... Inner catheter 18, 18A-18D, 80 ... Treatment device 22 ... Sheath introducer 28 ... Insertion lumen 32 ... Locking mechanism 70, 82 ... Guiding catheter 100 ... Patient 104 ... lower limb 106 ... arm 218 ... left femoral artery 220 ... left popliteal artery 230 ... right femoral artery 232 ... right popliteal artery X, X1, X2 ... stenosis (treatment target)

Claims (10)

A treatment method for treating a treatment target of at least one lower limb, comprising:
Providing a catheter assembly configured by placing a second catheter in the lumen of the first catheter;
Introducing the catheter assembly into the blood vessel of the arm;
A delivery step of manipulating an exposed portion of the catheter assembly from outside the body to deliver the tip of the catheter assembly through the aorta to a predetermined location on the lower limb;
A device advancement step of causing a treatment device for treating the treatment subject after the delivery step to advance into the treatment subject through the inside of the first catheter;
A treatment step of treating the treatment target with the treatment device. The treatment method according to claim 1, wherein
Prior to the device advancement step, the catheter advancement step of causing the distal end of the second catheter or the distal end of the third catheter introduced by pulling out the second catheter to advance near the treatment target through the inside of the first catheter. Further comprising
In the device advancement step, the treatment device is advanced through the lumen of the second catheter or the third catheter. The treatment method according to claim 1, wherein
When the treatment target exists in both the first lower limb and the second lower limb constituting the left and right lower limbs of the patient, in the treatment step, the treatment of the treatment target of the first lower limb is performed,
Further, in the treatment method, after the treatment step, a step of returning the tip of the first catheter to a connection position of the blood vessel of the first lower limb and the blood vessel of the second lower limb,
A separate part delivery step of delivering the first catheter from the coupling position to a predetermined position of the second leg after the retracting step;
A device-specific location advancement step of advancing another location treatment device for treating the treatment subject of the second lower limb after the delivery location of the second location through the inside of the first catheter to the treatment subject of the second lower limb;
A treatment method comprising: another treatment step of treating the treatment target of the second lower limb with the separate treatment device. The treatment method according to claim 3,
Prior to the treatment at the different site, the distal end of the second catheter and the distal end of the third catheter introduced by pulling out the second catheter are advanced through the inside of the first catheter to the vicinity of the treatment target of the second lower limb. And further having a catheter advancement step.
In the device-specific location advancement step, the different location treatment device is advanced through the lumen of the second catheter or the third catheter. The treatment method according to claim 1, wherein
In the introducing step, a sheath having an outer diameter of 2.8 mm or less is first introduced into the blood vessel of the arm, and the catheter assembly is introduced through the lumen of the sheath. The treatment method according to claim 1, wherein
When the treatment target is present in a blood vessel on the peripheral side of the popliteal artery of the lower limb,
In the delivery step, the tip of the catheter assembly is positioned in the femoral artery or iliac artery;
In the device advancement step, the treatment device is delivered from the catheter assembly to the femoral artery, and the treatment device is further advanced to the popliteal artery. The treatment method according to claim 1, wherein
When the treatment target is present in a blood vessel on the peripheral side of the popliteal artery of the lower limb,
In the delivery step, the distal end of the catheter assembly is positioned in the popliteal artery or the peripheral blood vessel. The treatment method according to claim 1, wherein
The treatment target is present near the knee, calf or ankle. The treatment method according to claim 1, wherein
The treatment device is a delivery device for delivering and placing an endoluminal prosthesis to the treatment object, a balloon catheter for expanding the treatment object, or a drug application device for applying a drug to the treatment object. Method of treatment. The treatment method according to claim 1, wherein
In the construction state of the catheter assembly, the first catheter and the second catheter can be fixed to each other by a lock mechanism provided at each proximal end portion.

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