JP2013226178A - Therapeutic device assembly and therapeutic method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a therapeutic device assembly and therapeutic method, capable of forming a bypass for communicating flow paths on front and back sides of an obstructed part with each other in a living lumen, within which the obstructed part is generated, by an intralumen procedure.SOLUTION: A therapeutic device assembly 10 includes: a tubular puncture device 14 that has on a tip portion thereof a puncturing portion 28 capable of puncturing a blood vessel wall; a bypass tube-delivering device 16 that includes a bypass tube 30 capable of being arranged in a blood vessel and a bypass tube-delivering catheter 32 for detachably holding the bypass tube 30; and a fixing member-delivering device 18 that includes a fixing member 50 capable of fixing edges of the bypass tube 30 to the blood vessel and a fixing member-delivering catheter 57 for detachably holding the fixing member 50.

Description

  The present invention relates to a treatment device assembly and a treatment method for forming a bypass with respect to a biological lumen in which an occluded portion is generated by an intraluminal procedure.

  When the coronary arteries that send blood to the heart muscle are narrowed or blocked, the heart muscle from that point becomes deficient in oxygen, causing angina or myocardial infarction. Methods for surgically treating angina pectoris and myocardial infarction include balloon dilatation (percutaneous angioplasty: PCI), which expands the stenosis of blood vessels with a balloon, and blood transplanted with other blood vessels or artificial blood vessels. There is a vascular bypass technique that creates a bypass. The improvement of stenosis formed in living organs such as other blood vessels, bile ducts, trachea, esophagus, urethra, and other organs may be performed in the same manner.

  The conventional cardiovascular bypass technique applied to this kind of treatment has a high degree of invasion because of thoracotomy, blood vessel cutting and suture anastomosis, and a heavy burden on the patient's body. On the other hand, percutaneous angioplasty using a balloon can be performed simply by piercing a thin sheath, so that it is minimally invasive and places little burden on the patient's body.

  However, in the case of PCI for a chronic total occlusion lesion (CTO lesion) in which the blood vessel is 100% constricted, it is difficult to pass the guide wire because the lesion is completely occluded. Since it is difficult to pass the balloon, it takes much more time than the usual treatment of the lesion, and a high degree of difficulty is required. In addition, PCI for CTO lesions also has a problem that the probability of causing restenosis is higher than in the case of normal lesions. On the other hand, according to the vascular bypass surgery, since a new blood bypass is created, there is an advantage that blood flow can be reliably ensured after the treatment. There is a problem that the degree of invasiveness is high because it is necessary to breast.

  Patent Document 1 below discloses a method of treating an occlusion in a coronary artery by forming a perfusion channel in a myocardial tissue by an intravascular technique. However, the method of Patent Document 1 does not form a bypass for communicating blood vessels before and after the occlusion.

  Patent Document 2 below discloses a method of treating a blockage of a coronary artery by placing a conduit on the heart wall. However, the method of Patent Document 2 does not form a bypass for communicating blood vessels before and after the obstruction.

Japanese Unexamined Patent Publication No. 2000-41988 JP 2009-34529 A

  The present invention has been made in consideration of the above-described problems, and a bypass for communicating the flow path before and after the occluded portion with a living lumen in which the occluded portion has occurred by a technique in the living body lumen is less invasive. It is an object to provide a treatment device assembly and a treatment method that can be formed.

  In order to achieve the above object, the present invention provides a treatment device assembly for forming a bypass in a living body lumen having an occlusion portion by a procedure in a living body lumen, in which a linear guide means can be inserted. A tubular puncture device having a cavity and having a puncture portion at the tip thereof that can be pierced through the wall of the biological tube, a bypass tube that can be disposed with respect to the biological lumen, and a guide that holds the bypass tube in a detachable manner A bypass tube delivery device having a bypass tube delivery catheter provided with a lumen through which the means can be inserted, a fixing member capable of fixing at least one end of the bypass tube and the biological lumen, and the fixing member being removable And a fixing member delivery device having a fixing member delivery catheter provided with a lumen through which the guide means can be inserted.

  According to the treatment device assembly configured as described above, the bypass tube is disposed in the living body lumen so as to bypass the occlusion by sequentially using the puncture device, the bypass tube delivery device, and the fixing member delivery device. Can be fixed. As a result, a bypass communicating with the flow path before and after the occlusion is formed, and the flow of the biological fluid in the living body lumen where the occlusion occurs can be recovered. Therefore, according to this invention, obstruction | occlusion of the biological lumen by an obstruction | occlusion part can be treated with minimal invasiveness.

  In the treatment device assembly, the bypass tube delivery catheter has an expandable portion that can be expanded and contracted, and the bypass tube is held by the expanded portion in a state where the expandable portion is expanded in the bypass tube. In the state where the expansion portion is contracted, it is preferable that the expansion portion can come out of the bypass pipe.

  According to the above configuration, since the expansion portion can be expanded and contracted in the bypass tube, the bypass tube is securely held by maintaining the expanded state until the bypass tube is delivered to the target position of the living body lumen. can do. In addition, after delivering the bypass tube to the target position of the biological lumen, the bypass tube is released from the expanded portion by contraction of the expanded portion, and then the bypass tube delivery catheter including the expanded portion is retracted, thereby bypass tube delivery catheter Can be removed from the bypass pipe. Therefore, the bypass pipe can be reliably disposed at the target position of the biological lumen in a state where both ends of the bypass pipe are disposed in the biological lumen and a midway portion of the bypass pipe is disposed outside the biological lumen. .

  In the treatment device assembly, the expansion portion covers a balloon that expands and contracts by inflow and outflow of the expansion fluid, and a distal end portion of the balloon, is configured to be harder than the balloon and has a tapered shape. It is good to have a tip cover.

  According to the above configuration, when the bypass tube delivery catheter is fed from the outside of the living body lumen into the inside, the tip cover constituting the tip of the bypass tube delivery catheter easily passes through the living tube wall. It can be delivered quickly and smoothly to the target site.

  The treatment device assembly may further include a guide device having a guide portion that guides the puncture device toward the living body lumen in the living body lumen.

  According to the above configuration, since the tip of the puncture device is guided toward the biological tube wall by advancing the puncture device along the guide device, the tip of the puncture device is smoothly moved from the inside of the biological tube wall to the outside. Can be pierced.

  In the treatment device assembly, the guide device has an expansion body that is expandable in the biological lumen and provided with the guide portion, and the expansion body is expanded in the biological lumen. In addition, the living body tube wall may be pressed outward.

  According to the above configuration, the puncture portion by the puncture device is pressed by pressing the living body tube wall outward by the expanded body, thereby suitably preventing or suppressing leakage of the biological fluid from the puncture portion. be able to.

  The method invention according to the present invention is a treatment method for forming a bypass in a living body lumen having an occlusion part from a procedure in a living body lumen, and is a tubular puncture having a piercing part at the tip through the living body lumen A puncture device delivery step for delivering the device to the front side of the occlusion portion generated in the living body lumen, and the living body in a form that bypasses the occlusion portion via the outside of the living body lumen. A step of placing a puncture device in a lumen, and advancing linear guide means through the lumen of the puncture device placed in the biological lumen, thereby passing the guide means through the outside of the biological lumen A guide means placement step for placing the guide means around the obstruction, and a puncture device removal for removing the puncture device from the living body lumen while maintaining the position of the guide means. A bypass tube delivery device having a step, a bypass tube and a bypass tube delivery catheter, and being advanced along the guide means with the bypass tube held by the bypass tube delivery catheter. A bypass tube delivery device placement step for placing the bypass tube in a state where the bypass tube is located in the living body lumen and an intermediate portion of the bypass tube is located outside the living body lumen; A bypass tube delivery catheter removal step for removing the bypass tube delivery catheter from the bypass tube by retracting the bypass tube delivery catheter and retracting the bypass tube delivery catheter, and a fixing member and a fixing member delivery catheter A fixation member delivery device, said fixation member delivery A fixing member delivery device arrangement step of advancing along the guide means in a state where the fixing member is held by a taper, and arranging the fixing member delivery device so that the fixing member comes to an end of the bypass pipe; And a fixing step of fixing the end portion of the bypass tube and the living body lumen by the fixing member.

  According to such a treatment method, a bypass flow path for the biological fluid that bypasses the flow path before and after the occlusion portion is formed, and the flow of the biological fluid in the biological lumen portion where the occlusion portion is generated can be recovered. Therefore, according to this invention, obstruction | occlusion of the biological lumen by an obstruction | occlusion part can be treated with minimal invasiveness.

  The treatment method further includes a guide device placement step of placing a guide device having a guide portion capable of guiding the puncture device in the living body lumen on the near side of the occlusion portion, and the puncture device placement step includes: The tip of the puncture device may be sent out of the living body lumen to the outside of the living body lumen by advancing the puncturing device under the guide action of the guide portion of the guide device.

  According to the above method, since the tip of the puncture device is guided toward the biological vessel wall by advancing the puncture device along the guide device, the tip of the puncture device is smoothly moved from the inside of the biological lumen to the outside. Can be pierced.

  In the treatment method, the guide device has an expansion body that can be expanded in the living body lumen. In the guide device arranging step, the living body tube is expanded by expanding the expansion body in the living body lumen. The wall should be pressed from the inside.

  According to the above method, the puncture part by the puncture device is pressed by pressing the living body tube wall from the inside with the expanded body that is expanded, thereby suitably preventing or suppressing leakage of the biological fluid from the puncture part. be able to.

  According to the treatment device assembly and the treatment method of the present invention, a bypass communicating with the front and rear of the obstruction portion can be formed in a minimally invasive manner with respect to the biological lumen in which the obstruction portion has occurred, by a procedure in the living body lumen. .

1 is a partially omitted side view showing a treatment device assembly according to an embodiment of the present invention. 2A is a perspective view showing a distal end portion of the guide device, and FIG. 2B is a longitudinal sectional view taken along line IIB-IIB in FIG. 2A. It is a longitudinal cross-sectional view of the front-end | tip part of a puncture device. It is a partially omitted vertical cross-sectional view of the bypass tube delivery device. It is a partially-omission longitudinal cross-sectional view which shows the front-end | tip part of the bypass pipe delivery device of the state which the expansion part contracted. FIG. 5 is a partially omitted vertical cross-sectional view of a fixing member delivery device. FIG. 7A is a longitudinal sectional view showing a state in which the fixing member is expanded in the fixing member delivery device, and FIG. 7B is a side view showing the distal end portion of the fixing member delivery device according to the modification. FIG. 8A is a diagram illustrating a state in which the distal end portion of the guide device is disposed in front of the occlusion portion in the blood vessel, and FIG. 8B is a state in which the puncture portion of the puncture device is guided toward the blood vessel wall by the guide device. FIG. 8C is a diagram illustrating a state in which the puncture portion of the puncture device is pierced from the inside of the blood vessel wall to the outside. FIG. 9A is a diagram illustrating a state in which the puncture device is advanced along the outer wall of the blood vessel, and FIG. 9B is a diagram illustrating a state in which the puncture portion of the puncture device is pierced from the outside to the inside of the blood vessel wall. FIG. 9C is a diagram illustrating a state in which the puncture device is further advanced. 10A is a diagram showing a state in which the guide wire is advanced along the puncture device, and FIG. 10B is a diagram showing a state in which the guide wire is disposed in the blood vessel so as to bypass the occlusion portion, and FIG. FIG. 5 is a view showing a state in which a bypass tube delivery device is arranged along a guide wire. FIG. 11A is a diagram illustrating a state where the bypass tube delivery catheter is removed from the bypass tube, FIG. 11B is a diagram illustrating a state where the fixing member delivery device is inserted into the bypass tube, and FIG. It is a figure which shows the state which has arrange | positioned the fixing member to both ends.

  Hereinafter, preferred embodiments of a treatment device assembly and a treatment method according to the present invention will be described with reference to the accompanying drawings.

  FIG. 1 is a partially omitted side view showing a configuration of a treatment device assembly 10 according to an embodiment of the present invention. The treatment device assembly 10 is a medical device that is used to form a bypass that communicates the flow path before and after the occlusion portion with respect to the biological lumen having the occlusion portion by an intraluminal procedure.

  As shown in FIG. 1, the treatment device assembly 10 comprises a plurality of devices. In this embodiment, the treatment device assembly 10 comprises a guide device 12, a puncture device 14, a bypass tube delivery device 16, and a fixation member delivery device 18. In use, these devices are sequentially inserted into a living body lumen or the like and delivered to a target site in the living body lumen. Hereinafter, the configuration of each device will be described.

  The guide device 12 includes an expansion body 20 constituted by a balloon that can be expanded and contracted in a biological lumen such as a blood vessel, a long and thin tube 24 having one end connected to the expansion body 20, and the tube. An expansion port 26 is connected to the other end of 24.

  As shown in FIGS. 2A and 2B, the expansion body 20 is configured in a bag shape that can be expanded and contracted by supplying and discharging an expansion fluid (for example, a contrast medium, physiological saline, and the like) to and from the inside. Although the illustrated expansion body 20 has a substantially rectangular parallelepiped shape, other arbitrary shapes (cylindrical shape or the like) can be adopted. A groove-shaped guide portion 22 is provided on the outer peripheral portion of the expanded body 20 in the expanded state. The guide portion 22 has an inclined portion 22 a that extends along the longitudinal direction of the guide device 12 and approaches the outer peripheral surface side of the guide portion 22 from the midway portion to the tip.

  As long as the expansion body 20 is flexible enough to be expanded and contracted by supplying and discharging the expansion fluid to and from the inside thereof, and has a practically appropriate strength, the constituent material is not particularly limited. . The constituent material of the expanded body 20 is, for example, polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyvinyl chloride, and the like. , Polyamides, polyamide elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, polyimides, fluororesins and the like, or mixtures thereof, or the above two or more polymer materials. The expansion body 20 is provided with an X-ray impermeable marker made of a material (for example, gold, platinum, tungsten, etc.) having an X-ray (radiation) non-transmissibility so as to be recognized under X-ray fluoroscopy. May be.

  The tube 24 has a lumen serving as a passage for the expansion fluid, and one end is connected to the proximal end of the expansion body 20. The lumen of the tube 24 communicates with the inside of the expansion body 20. The tube 24 is preferably flexible enough to easily follow the curvature of the living body lumen when inserted into a living body lumen such as a blood vessel and traveling through the living body lumen.

  Examples of the material constituting the tube 24 include metals and resins. 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. 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. As the tube 24, a multilayer tube made of a composite formed of these metals and resins can be applied.

  An expansion port 26 is provided at the other end of the tube 24. By connecting a pressure applying device (not shown) to the expansion port 26 and introducing the expansion fluid into the expansion body 20 via the expansion port 26 and the tube 24, the expansion body as shown in FIGS. 2A and 2B. 20 expands. On the other hand, when the expansion fluid is discharged from the expansion body 20, the expansion body 20 contracts as shown by the phantom line in FIG. 2B.

  The size of the guide device 12 is appropriately selected according to the site to be treated. For example, when used for the treatment of an occlusion (such as a CTO lesion) in the coronary artery, the expansion body 20, the tube 24, and the dilation are used. The total length including the port 26 is 500 to 2000 mm, the total length of the expansion body 20 is about 5 to 100 mm, the thickness or width of the expansion body 20 (outer diameter in the case of a cylindrical shape) is about 0.5 to 20 mm, and the tube 24 The outer diameter is set to about 0.5 to 10 mm.

  Since the guide device 12 is configured in this way, the puncture device 14 is advanced by moving the puncture device 14 along the guide portion 22 in a state where the expansion body 20 is expanded in the blood vessel, as will be described later. Can be guided toward the blood vessel wall. Further, the guide device 12 has a function of pressing the blood vessel wall outward when it is expanded in the blood vessel.

  As shown in FIG. 1, the puncture device 14 is a tubular body in which a puncture portion 28 that can penetrate a biological lumen such as a blood vessel is formed at the distal end portion. The puncture device 14 preferably has flexibility (flexibility) that can easily follow the curvature of a living body lumen such as a meandering blood vessel and has rigidity capable of piercing and penetrating the living body lumen. In this case, as the constituent material of the puncture device 14, any one or more materials exemplified as the constituent material of the tube 24 that constitutes the guide device 12 described above can be adopted.

  In the vicinity of the tip of the puncture device 14, an X-ray non-transmission made of a material having an X-ray (radiation) non-transmissibility (for example, gold, platinum, tungsten, etc.) so that it can be recognized under fluoroscopy. A marker may be installed.

  As shown in FIG. 3, the puncture portion 28 provided at the distal end of the puncture device 14 is formed at an acute angle by projecting a part of the tubular body constituting the puncture portion 28 in the circumferential direction from the other portion. That is, the distal end surface of the puncture portion 28 forms an inclined surface 29, and the distal end opening 29 a is formed obliquely along the inclined surface 29. Needless to say, the shape of the puncture portion 28 is not limited to this.

  In a natural state that is not elastically deformed, the puncture portion 28 is directed in a tilt direction with respect to a portion on the proximal end side of the puncture portion 28 (hereinafter referred to as the body portion 15). In the puncture device 14, the inclination angle of the axis of the puncture part 28 with respect to the axis of the body part 15 is set to, for example, about 1 to 45 °, and preferably about 5 to 20 °. In this way, the puncture portion 28 is formed obliquely with respect to the body portion 15, so that, as will be described later, in the procedure of arranging the puncture device 14 in the body lumen so as to bypass the occlusion portion, the puncture portion The operation of puncturing the living body tube wall from the outside of the living body tube wall and feeding the puncture portion 28 into the living body lumen can be easily performed.

  The dimensions of the puncture device 14 are appropriately selected according to the site to be treated. For example, when used for the treatment of an obstruction such as a CTO lesion occurring in the coronary artery, the overall length is about 600 to 2500 mm and the outer diameter is 0. It is set to about 3 to 10 mm.

  As shown in FIGS. 1 and 4, the bypass tube delivery device 16 includes a bypass tube 30 that can be disposed with respect to a living body lumen, a releasable holding of the bypass tube 30, and a guide wire (guide means) that can be inserted therethrough. And a bypass tube delivery catheter 32 provided with a lumen 42a. The bypass tube delivery device 16 is a device for delivering the bypass tube 30 to a target site in a living body lumen and placing the bypass tube 30 at the target site.

  The bypass tube 30 is an artificial blood vessel made of a material that has flexibility and can be applied as a substitute for a living body. As such a material, for example, artificial materials such as polyester fiber, ePTFE (expanded polytetrafluoroethylene), and polyurethane can be used. In this case, the bypass tube 30 may use a hybrid material (hybrid artificial blood vessel) whose inner peripheral surface is coated with a biological material such as endothelial cells or proteins. Furthermore, an artificial blood vessel formed by tissue engineering or genetic engineering can be applied.

  The size and shape of the bypass tube 30 are set so that the bypass tube 30 functions appropriately as a bypass suitable for a biological lumen such as a blood vessel in which an obstructed portion has occurred. When the bypass tube 30 is applied to a coronary artery, the bypass tube 30 is set to have a total length of about 10 mm to 200 mm, an outer diameter of about 1 mm to 10 mm, and a wall thickness of about 1 mm to 3 mm, for example.

  As shown in FIG. 4, the bypass tube delivery catheter 32 includes a thin and long tubular shaft 34, an inner tube 42 disposed inside the shaft 34, and an outer tube 44 disposed outside the shaft 34. And an extended portion 36 provided at the distal end portion of the shaft 34 and a hub 46 provided at the proximal end portion of the shaft 34.

  The shaft 34 is a flexible tubular member that constitutes most of the long bypass tube delivery catheter 32, and extends so as to connect the rear end of the balloon 38 and the front end of the hub 46. Inside the shaft 34, an inner tube 42 having a wire lumen 42a into which a guide wire 74 (see FIG. 8A) is inserted is disposed. The inner tube 42 and the shaft 34 disposed so as to surround the inner tube 42 constitute a concentric double tube.

  An expansion lumen 43 for supplying an expansion fluid for the balloon 38 is formed between the inner tube 42 and the shaft 34 so as to extend in the axial direction. The expansion lumen 43 communicates with the inside of the balloon 38. The shaft 34 is, for example, a tube 24 having an outer diameter of about 1 to 3 mm, a thickness of about 100 to 500 μm, and a length of about 500 to 2000 mm.

  The inner tube 42 is a flexible tubular member that extends in the axial direction inside the balloon 38, the shaft 34, and the hub 46. The distal end of the inner tube 42 opens at the distal end surface of the expansion portion 36, and the proximal end thereof is the hub. Open at the base end of 46. The inner tube 42 is, for example, the tube 24 having an outer diameter of about 0.5 to 2 mm, a wall thickness of about 100 to 500 μm, and a length of about 700 to 2200 mm.

  In the bypass tube delivery catheter 32, a guide wire 74 inserted with the distal end opening of the inner tube 42 as an entrance is inserted through the lumen 42 a of the inner tube 42 from the distal end side to the proximal end side, and from the proximal end of the hub 46. It is configured as a derived “over the wire type” catheter.

  The outer tube 44 is a flexible tubular member extending in the axial direction outside the balloon 38 and the shaft 34, and the inner peripheral portion of the distal end thereof is supported by the outer peripheral portion on the proximal end side of the expanded balloon 38. . The outer tube 44 is, for example, the tube 24 having an outer diameter of about 2 to 10 mm, a wall thickness of about 100 to 1000 μm, and a length of about 500 to 2000 mm.

  The bypass tube delivery catheter 32 may be configured as a so-called “rapid exchange type” catheter in which an opening through which the guide wire 74 is led out is provided in the middle portion of the shaft 34 in the longitudinal direction. In this case, the outer tube 44 is provided with a long hole (slit) for leading the guide wire 74 along the axis of the outer tube 44.

  The shaft 34, the inner tube 42, and the outer tube 44 allow the operator to smoothly insert the long shaft 34 into a living body lumen such as a blood vessel while grasping and operating the proximal end side. A structure having moderate flexibility and moderate rigidity is preferable. Therefore, the shaft 34, the inner tube 42 and the outer tube 44 are made of, for example, polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of these. Etc.), a polymer material such as polyvinyl chloride, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, or a mixture thereof, or a multilayer tube of the above two or more polymer materials.

  The expansion part 36 provided at the tip of the shaft 34 can be expanded and contracted. In a state where the expansion part 36 is expanded inside the bypass pipe 30, the bypass pipe 30 is held by the expansion part 36. The expanded portion 36 can be pulled out from the bypass pipe 30 in a state where the expanded portion 36 is contracted. In the present embodiment, the expansion portion 36 includes a balloon 38 that expands and contracts by the inflow and outflow of the expansion fluid, and a distal end cover 40 that covers the distal end portion of the balloon 38.

  The balloon 38 can be expanded and contracted by a change in internal pressure. FIG. 4 shows the balloon 38 in an expanded state inside the bypass pipe 30. The balloon 38 is expanded into a cylindrical shape (cylindrical shape) by the expansion fluid injected into the inside through the expansion lumen 43. The balloon 38 has a tip inner peripheral portion that is liquid-tightly joined to the outer peripheral surface of the inner tube 42, and a base end that is liquid-tightly joined to the tip portion of the shaft 34. The balloon 38 and the inner tube 42 and the balloon 38 and the shaft 34 may be fixed in a liquid-tight manner, and are joined by, for example, adhesion or heat fusion. The constituent material of the balloon 38 can be selected from, for example, those exemplified as the constituent material of the expansion body 20 described above.

  As shown in FIG. 4, the overall length of the balloon 38 is preferably longer than the entire length of the bypass tube 30, and the balloon 38 is held by the expanded balloon 38 with both ends of the balloon 38 protruding from both ends of the bypass tube 30. It is good to be done. Thereby, since the bypass pipe 30 is supported over the entire length on the outer peripheral surface of the balloon 38, the balloon 38 can be stably held until the bypass pipe 30 is delivered to the target site.

  As shown in FIG. 5, the outer diameter of the expansion portion 36 including the balloon 38 is smaller than the inner diameter of the bypass pipe 30 when the balloon 38 is deflated. Therefore, as will be described later, after the bypass tube 30 is disposed at the target site of the blood vessel, the expansion portion 36 including the balloon 38 is contracted to release the holding of the bypass tube 30 by the expansion portion 36. The bypass tube delivery catheter 32 can be removed from the bypass tube 30 by retracting the bypass tube delivery catheter 32 including the expansion portion 36 in a state where the holding of the bypass tube 30 is released.

  The balloon 38 is required to have appropriate flexibility in the same manner as the shaft 34, and needs to be strong enough to hold the bypass pipe 30 securely. The material of the balloon 38 is, for example, the shaft 34 exemplified above. It may be the same as the constituent material, or may be another material.

  A portion of the inner tube 42 located in the balloon 38 may be provided with an X-ray non-transparent marker. The X-ray non-transparent marker is made of an X-ray (radiation) non-transparent material (for example, gold, platinum, tungsten, etc.) and is used for visually recognizing the position of the balloon 38 in the living body under X-ray contrast. It is. Note that the number of X-ray non-transparent markers is not limited to one, and a plurality of X-ray non-transmissive markers may be provided, or may be arranged on the proximal end side of the inner tube 42 where the balloon 38 is provided.

  The tip cover 40 that covers the tip of the balloon 38 is a hollow cylindrical member that is configured to be harder than the balloon 38 and has a tapered portion that decreases in diameter toward the tip. The tip cover 40 is harder than the balloon 38, but has a flexibility to extend and contract following the expansion / contraction operation of the balloon 38. Therefore, as shown in FIG. 4, in a state where the balloon 38 is expanded and the bypass pipe 30 is held at the outer peripheral portion thereof, the inner diameter of the tip cover 40 and the inner diameter of the bypass pipe 30 substantially coincide with each other. On the other hand, as shown in FIG. 5, when the balloon 38 is deflated, the distal end cover 40 is also contracted (reduced diameter) as the balloon 38 is contracted, so that the outer diameter of the distal end cover 40 becomes the inner diameter of the bypass pipe 30. Smaller than.

  Examples of the constituent material of the tip cover 40 include polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polychlorinated salt, and the like. Examples thereof include polymer materials such as vinyl, polyamide, polyester, polyurethane, polyimide, and fluorine resin, or a mixture thereof, or the above two or more polymer materials.

  As shown in FIG. 4, the hub 46 provided at the proximal end of the shaft 34 is provided with a balloon expansion port 46b branched from the hub body 46a, and the lumen 38 and the balloon 38 provided in the balloon expansion port 46b. Is communicated with the inside through an expansion lumen 43.

  The constituent material of the hub 46 is not particularly limited, but a relatively hard resin material such as polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, Examples thereof include acrylonitrile-butadiene-styrene copolymers, polyesters such as polyethylene terephthalate and polyethylene naphthalate, butadiene-styrene copolymers, and polyamides (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12).

  The balloon expansion port 46b can be connected to an expansion fluid supply means such as an indeflator (not shown). By connecting the expansion fluid supply means to the balloon expansion port 46b and operating the expansion fluid supply means, the expansion fluid (for example, contrast medium) is supplied from the expansion fluid supply means to the hub 46 and the expansion lumen 43. The liquid can be sent to the balloon 38 via the.

  As shown in FIG. 6, the fixing member delivery device 18 includes a fixing member 50 that can fix at least one end of the bypass tube 30 and the living body lumen, a long shaft 52 on which the fixing member 50 is placed, A tubular sheath 54 slidable in the axial direction with respect to the shaft 52 and capable of accommodating the fixing member 50, and a sheath driving handle 56 provided at the proximal end of the sheath 54 are provided. The shaft 34, the sheath 54, and the sheath driving handle 56 constitute a fixing member delivery catheter 57 provided with a lumen 52a through which the fixing member 50 is detachably held and the guide wire 74 can be inserted.

  In the present embodiment, the fixing member 50 has a self-expanding function and is configured in a hollow cylindrical shape. The fixing member 50 is formed of a structure in which a plurality of skeletons formed of a superelastic alloy such as a Ti-Ni alloy are formed in a ring shape or a Z shape to form a hollow cylinder as a whole, or a superelastic alloy or the like. A configuration in which the wire is knitted into a mesh and formed into a hollow cylinder as a whole may be used.

  In FIG. 6, the fixing member 50 is accommodated in a space formed by a mount portion 53 and a sheath 54 provided on the shaft 34, and is in a state of being expanded with its expansion restricted (contracted state). When the sheath 54 moves backward with respect to the shaft 34 and the fixing member 50 housed therein is released from the restriction by the sheath 54, the fixing member 50 expands / deploys by a self-expanding function as shown in FIG. 7A. .

  The shaft 52 is a flexible tube-like member having flexibility in which a lumen 52a through which the guide wire 74 is inserted is formed through the entire length. A tapered nose portion 52 b (nose cone) is provided at the tip of the shaft 52. A mount portion 53 for mounting the fixing member 50 is provided in the vicinity of the distal end portion of the shaft 52, that is, on the proximal end side of the nose portion 52b. The mount portion 53 positions and holds the fixing member 50 in a reduced diameter state by the sheath 54 by the front wall 53a that forms a step on the distal end side and the rear wall 53b that forms a step on the proximal end side. be able to.

  The sheath 54 is a flexible and thin-walled tubular member that is slidably disposed in the axial direction on the outer surface side of the shaft 52. The sheath driving handle 56 is a portion that is gripped by the user when the sheath 54 is moved in the proximal direction, is connected to the proximal end portion of the sheath 54 and has a larger diameter than the sheath 54. Thus, it can be displaced in the axial direction integrally with the sheath 54.

  The constituent materials of the shaft 52 and the sheath 54 are not particularly limited, but have an appropriate flexibility and an appropriate rigidity so that the long shaft 52 and the sheath 54 can be smoothly inserted into the blood vessel of the living body. Is preferred. Therefore, as the constituent material of the shaft 52 and the sheath 54, one or more materials exemplified as the constituent material of the shaft 34 of the bypass tube delivery device 16 described above can be adopted.

  The sheath 54 is movable in the proximal direction (proximal direction) from the initial position (pre-use position) shown in FIG. 6 with reference to the position of the sheath driving handle 56. In the initial position, the sheath 54 is disposed on the most distal side of the movable range with respect to the shaft 52. In the fixing member delivery catheter 57, at this initial position, the sheath 54 completely covers the mount portion 53 of the shaft 52, and stores the fixing member 50 disposed on the mount portion 53 by compression over the entire length.

  As shown in FIG. 7A, the sheath 54 can be retracted to the proximal end side from the rear wall 53 b of the mount portion 53 provided on the shaft 52 at the most distal end portion of the sheath 54. When the sheath 54 is retracted to the proximal end side with respect to the rear wall 53b, the fixing member 50 is completely released from the sheath 54.

  Instead of the fixing member delivery device 18 configured as described above, a fixing member delivery device 60 according to a modification shown in FIG. 7B may be employed. The fixing member delivery device 60 is provided with a fixing member 62 that can fix at least one end of the bypass tube 30 and the living body lumen, and a lumen that removably holds the fixing member 62 and through which a guide wire can be inserted. And a fixed member delivery catheter 64.

  The fixing member 62 is a hollow cylindrical member configured to be expandable by being pushed and expanded from the inside by the balloon 66 of the fixing member delivery catheter 64, and is mounted on the outer periphery of the balloon 66. The material constituting the fixing member 62 is preferably a biocompatible metal, for example, an iron base alloy such as stainless steel, tantalum (tantalum alloy), platinum (platinum alloy), gold (gold alloy), or cobalt base alloy. , Cobalt chromium alloy, titanium alloy, niobium alloy and the like.

  The fixed member delivery catheter 64 includes a long and flexible shaft 68 and a balloon 66 provided at the distal end of the shaft 68 and capable of expanding and contracting. The balloon 66 expands and contracts by the inflow and outflow of the expansion fluid. As shown in FIG. 7B, the balloon 66 is deflated in the initial state, and holds the fixed member 62 in the deflated state from the inside. When the balloon 66 is expanded by introducing an expansion fluid into the balloon 66, the fixing member 50 is expanded from the inside and expanded (expanded diameter). In FIG. 7B, the fixed member 62 in the expanded state is indicated by a virtual line. Since the deformation of the fixing member 62 at this time is plastic deformation, even if the balloon 66 is contracted after that, the fixing member 62 hardly contracts and substantially maintains the shape when expanded.

  The treatment device assembly 10 according to the present embodiment is basically configured as described above. Hereinafter, the treatment device assembly 10 will be described in relation to the method of using the treatment device assembly 10 (treatment method). The operation and effect of the solid 10 will be described. The treatment method using the treatment device assembly 10 includes the following steps.

(1) Guide Device Arrangement Step In the guide device arrangement step, as shown in FIG. 8A, the guide device 12 is arranged in the living body lumen on the near side (central side) of the occlusion portion 72. The obstruction | occlusion part 72 is a site | part which inhibits the flow of the liquid in a biological lumen. Examples of the biological lumen in which the occluded portion 72 is generated include a blood vessel, a digestive tract, a trachea, a bile duct, a lymphatic vessel, an otonasal cavity, and a lacrimal gland. Since the occlusion portion 72 shown in FIG. 8A etc. completely occludes the living body lumen at the site, no liquid flows to the distal side (right side in FIG. 8A etc.) from the occlusion portion 72. It has become. Hereinafter, the case where the living body lumen is the blood vessel 70 (particularly the coronary artery) will be described.

  Specifically, in the guide device placement step, first, the catheter 69 having the guide wire 74 inserted therein is run in the blood vessel 70, and the distal end of the catheter 69 reaches the position before the obstruction portion 72. Thereafter, the guide device 12 in a state in which the expansion body 20 is contracted is inserted into the catheter 69 and sent out from the distal end of the catheter 69 into the blood vessel 70. And the position of the guide device 12 is adjusted so that the expansion body 20 which comprises the front-end | tip part of the guide device 12 may come slightly before the obstruction | occlusion part 72 (central side). When the position of the guide device 12 with respect to the blood vessel 70 is adjusted, the expansion body 20 is expanded by supplying the expansion fluid to the expansion body 20 as shown in FIG. 8A. The expansion of the expansion body 20 forms a guide portion 22 including an inclined portion 22a that is inclined outward toward the distal end side, and the wall of the blood vessel 70 (hereinafter referred to as a blood vessel wall) by the outer peripheral portion of the expansion body 20. ) Is pressed outward.

(2) Puncture device delivery step In the puncture device delivery step, the puncture device 14 is delivered to the front side of the occlusion 72 through the catheter 69 and the blood vessel 70 as shown in FIG. 8B. Specifically, the guide wire 74 is advanced, and the distal end portion of the guide wire 74 enters the guide portion 22 of the guide device 12. Next, in a state where the guide wire 74 is inserted into the lumen of the puncture device 14, the puncture device 14 is advanced along the guide wire 74 so that the puncture portion 28 of the puncture device 14 enters the guide portion 22. .

(3) Puncture device placement step In the puncture device placement step, the puncture device 14 is placed in the blood vessel 70 so as to bypass the blockage 72 via the outside of the blood vessel 70. Specifically, by further advancing the puncture device 14 from the state of FIG. 8B, the puncture portion 28 is brought close to the blood vessel wall under the guide action of the inclined portion 22a provided in the guide portion 22, and the puncture device 14 Is fed out from the blood vessel 70 to the outside of the blood vessel 70 (see FIG. 8C). As described above, the tip of the puncture device 14 is guided toward the blood vessel wall by the action of the guide portion 22, so that the tip of the puncture device 14 can be smoothly pierced from the inside of the blood vessel wall to the outside. Moreover, the puncture part by the puncture device 14 is pressed by pressing the blood vessel wall from the inside with the expanded body 20 expanded, and thereby, bleeding from the puncture part can be suitably prevented or suppressed.

  Next, the puncture part 28 that has come out of the blood vessel 70 is advanced along the blood vessel 70 (see FIG. 9A). Next, the puncture portion 28 of the puncture device 14 is sent from the outside of the blood vessel 70 into the blood vessel 70 on the distal side of the blocking portion 72 (see FIG. 9B). In this case, the puncture device 14 is advanced by rotating the puncture device 14 in the circumferential direction on the hand side so that the puncture portion 28 inclined with respect to the body portion 15 faces the blood vessel 70 side. As described above, in the puncture device 14, the puncture portion 28 is inclined with respect to the body portion 15, so that the puncture portion 28 is punctured from the outside of the blood vessel wall into the blood vessel wall and the puncture portion 28 is fed into the blood vessel 70. Operation can be performed easily. As shown in FIG. 9C, the puncture device 14 is further advanced until the distal end portion of the puncture device 14 is inserted into the blood vessel 70 to some extent.

(4) Guide means placement step In the guide means placement step, the guide wire 74 (guide means) is advanced through the lumen of the puncture device 14 placed in the blood vessel 70 so as to bypass the occlusion portion 72, thereby causing the blood vessel 70 to move forward. A guide wire 74 is disposed so as to bypass the blocking portion 72 via the outside of the guide wire 74 (see FIG. 10A). In this case, since the puncture device 14 is disposed in the blood vessel 70 so as to bypass the occlusion portion 72, the guide wire 74 can be moved along the puncture device 14 only by advancing the guide wire 74 inserted through the puncture device 14. Then, the blood vessel 70 is sent out from the inside of the blood vessel 70, and is advanced from the outside of the blood vessel 70 along the blood vessel 70 to the back side of the blocking portion 72.

(5) Puncture device extraction step In the puncture device extraction step, the puncture device 14 is extracted out of the blood vessel 70 while maintaining the position of the guide wire 74. Specifically, the puncture device 14 is first retracted along the guide wire 74 in a state where the position of the guide wire 74 disposed in the blood vessel 70 is maintained so as to bypass the occlusion portion 72. Is moved from the inside of the blood vessel wall to the outside, and once moved outside the blood vessel 70, the blood vessel wall is moved from the outside to the inside of the blood vessel wall. Then, the puncture device 14 is further retracted to remove the puncture device 14 from the catheter 69 (see FIG. 10B).

(6) Bypass tube delivery device placement step In the bypass tube delivery device placement step, the bypass tube delivery device 16 in a state where the bypass tube 30 is held by the bypass tube delivery catheter 32 is advanced along the guide wire 74, and the bypass tube It is assumed that both ends of the tube 30 are located in the blood vessel 70 and a midway portion of the bypass tube 30 is located outside the blood vessel 70 (see FIG. 10C). Specifically, the guide device 12 with the bypass tube 30 held by the bypass tube delivery catheter 32 is inserted into the catheter 69, and the guide wire 74 is inserted into the lumen 42a of the bypass tube delivery device 16 (see FIG. 4). The bypass tube delivery device 16 is advanced in the catheter 69 while being inserted into the blood vessel 70, and is delivered into the blood vessel 70 from the distal end of the catheter 69.

  Then, by further advancing the bypass tube delivery device 16, the bypass tube delivery device 16 is sent out from the inside of the blood vessel 70 along the guide wire 74, and the occlusion 72 along the blood vessel 70 outside the blood vessel 70. When it is advanced to the back side of the blood vessel 70, it is fed from the outside to the inside of the blood vessel 70. In this case, since the distal end cover 40 constituting the distal end of the bypass tube delivery catheter 32 has a tapered shape, the bypass tube delivery catheter 32 easily passes through the blood vessel wall.

(7) Bypass tube delivery catheter 32 extraction step In the bypass tube delivery catheter 32 extraction step, the bypass tube 30 is detached from the bypass tube delivery catheter 32 while maintaining the position of the bypass tube 30 as shown in FIG. 11A. The bypass tube delivery catheter 32 is removed from the bypass tube 30 by retracting the bypass tube delivery catheter 32. In the present embodiment, when the balloon 38 constituting the expansion portion 36 is deflated, the outer diameter of the balloon 38 becomes smaller than the inner diameter of the bypass tube 30, thereby holding the bypass tube 30 by the expansion portion 36 including the balloon 38. It is released (see FIG. 5). Then, the bypass tube delivery catheter 32 is withdrawn from the bypass tube 30 by retracting the bypass tube delivery catheter 32 in a state where the expansion portion 36 is contracted. Then, the bypass tube delivery catheter 32 is removed from the catheter 69 by further retracting the puncture device 14.

(8) Fixing member delivery device arrangement step In the fixing member delivery device arrangement step, as shown in FIG. 11B, the fixing member delivery device 18 in a state where the fixing member 50 is held by the fixing member delivery catheter 57 is attached to the guide wire 74. The fixation member delivery device 18 is arranged so that the fixation member 50 comes to one end of the bypass pipe 30.

  Specifically, the fixing member delivery device 18 in a state where the fixing member 50 is held by the fixing member delivery catheter 57 is inserted into the catheter 69 and the guide wire 74 is inserted through the lumen of the fixing member delivery device 18. In that state, the fixation member delivery device 18 is advanced within the catheter 69 and delivered from the distal end of the catheter 69 into the blood vessel 70. Then, by further advancing the fixing member delivery device 18, the fixing member delivery device 18 is sent out from the inside of the blood vessel 70 along the guide wire 74, and the occlusion 72 along the blood vessel 70 outside the blood vessel 70. When it is advanced to the back side of the blood vessel 70, it is fed from the outside to the inside of the blood vessel 70. In this case, the position of the fixing member delivery device 18 is adjusted so that a part of the fixing member 50 comes out from one end of the bypass pipe 30. In FIG. 11B, the fixing member 50 is located at one end portion of the bypass pipe 30 on the distal side of the blocking portion 72.

(9) Fixing Step In the fixing step, as shown in FIG. 11C, at least one end of the bypass pipe 30 and the blood vessel 70 are fixed by the fixing member 50. In the following, the fixing member 50 disposed on the distal end side (peripheral side) of the bypass tube 30 is referred to as “fixing member 50a”, and is disposed on the proximal end side (front side / central side) of the bypass tube 30. The fixing member 50 may be referred to as “fixing member 50b” to be distinguished.

  Specifically, in this embodiment, when the sheath 54 is retracted with respect to the shaft 52, the fixing member 50 expands due to elastic restoring force as the sheath 54 retracts, so that the outer peripheral portion of the fixing member 50a is bypassed. One end of the tube 30 and the blood vessel 70 are pressed into contact with each other. Thereby, the front-end | tip part of the bypass pipe 30 and the blood vessel 70 of the peripheral side rather than the obstruction | occlusion part 72 are fixed by the fixing member 50a. When the fixing member 50 a is thus arranged, the fixing member delivery catheter 57 is removed from the bypass tube 30, the blood vessel 70, and the catheter 69. Next, the proximal end portion of the bypass tube 30 and the blood vessel 70 are fixed by the fixing member 50b by the same method. Note that the fixing member 50 a may be disposed on the distal end side of the bypass pipe 30 after the fixing member 50 b is disposed on the proximal end side of the bypass pipe 30. Alternatively, the fixing member 50 may be disposed only at one end of the bypass pipe 30.

  As described above, according to the treatment device assembly 10 and the treatment method using the treatment device assembly 10, the puncture device 14, the bypass tube delivery device 16, and the fixing member delivery device 18 are sequentially used to bypass the occlusion portion 72. In this manner, the bypass tube 30 can be placed and secured in a biological lumen such as the blood vessel 70. As a result, a bypass that connects the near side and the distal side of the occlusion portion 72 is formed, and the flow (blood flow or the like) of the biological fluid in the biological lumen where the occlusion portion 72 is generated can be recovered. Therefore, according to the present invention, the obstruction in the living body lumen due to the obstruction portion 72 can be treated with minimal invasiveness.

  In the case of this embodiment, since the expansion part 36 can be expanded and contracted in the bypass tube 30, the bypass tube 30 is maintained by maintaining the expanded state until the bypass tube 30 is delivered to the target position of the living body lumen. Can be securely held. In addition, after the bypass tube 30 is delivered to the target position of the living body lumen, the bypass tube 30 is released from the expanded portion 36 by contraction of the expanded portion 36, and then the bypass tube delivery catheter 32 including the expanded portion 36 is retracted. Thus, the bypass tube delivery catheter 32 can be removed from the bypass tube 30. Therefore, the bypass tube 30 can be reliably disposed at the target position of the biological lumen in a state where both ends of the bypass tube 30 are disposed in the biological lumen.

  In the case of the present embodiment, since the distal end cover 40 is configured to be harder and tapered than the balloon 38, the distal end of the bypass tube delivery catheter 32 is fed when the bypass tube delivery catheter 32 is fed into the living body lumen from the outside. The tip cover 40 that constitutes is easy to pass through the living body tube wall. Therefore, the bypass pipe delivery device 16 can be delivered quickly and smoothly to the target site.

  In the case of this embodiment, the guide device 12 further includes a guide unit 22 that guides the puncture device 14 toward the living body lumen in the living body lumen. According to this configuration, since the tip of the puncture device 14 is guided toward the living vessel wall by advancing the puncture device 14 along the guide device 12, the tip of the puncture device 14 is removed from the inside of the vessel tube wall. You can pierce smoothly.

  In the case of the present embodiment, the guide device 12 has an expansion body 20 that is expandable in a living body lumen and is configured by a balloon provided with a guide portion 22, and the expansion body 20 is expanded in the living body lumen. When this occurs, the living tube wall is pressed outward. According to this configuration, the puncture portion by the puncture device 14 is pressed by pressing the biological tube wall outward by the expanded body 20 that is expanded, and thus it is preferable to leak biological fluid (blood, etc.) from the puncture portion. Can be prevented or suppressed.

  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 ... Treatment device assembly 12 ... Guide device 14 ... Puncture device 16 ... Bypass tube delivery device 18, 60 ... Fixing member delivery device 20 ... Expansion body 28 ... Puncture part 30 ... Bypass tube 32 ... Bypass tube delivery catheter 38 ... Balloon 40 ... End cover 50, 62 ... Fixing member 57, 64 ... Fixing member delivery catheter

Claims (8)

A treatment device assembly for forming a bypass in a body lumen having an obstruction from a body lumen procedure,
A tubular puncture device having a lumen through which a linear guide means can be inserted, and having a puncture portion at the tip that can be pierced into a biological tube wall;
A bypass tube delivery device comprising: a bypass tube that can be disposed with respect to the living body lumen; and a bypass tube delivery catheter provided with a lumen through which the bypass tube is detachably held and the guide means can be inserted;
A fixing member having a fixing member capable of fixing at least one end of the bypass tube and the living body lumen, and a fixing member delivery catheter provided with a lumen in which the fixing member is detachably held and the guide means can be inserted. A member delivery device,
A treatment device assembly. The treatment device assembly of claim 1, wherein
The bypass tube delivery catheter has an expandable portion that can be expanded and contracted,
In a state where the extension portion is expanded in the bypass pipe, the bypass pipe is held by the extension portion,
With the expansion portion contracted, the expansion portion can come out of the bypass pipe.
A treatment device assembly. The treatment device assembly according to claim 1 or 2,
The extension is
A balloon that expands and contracts by inflow and outflow of the expansion fluid;
Covering the tip of the balloon, the tip cover is configured to be harder than the balloon and tapered.
A treatment device assembly. The treatment device assembly according to any one of claims 1 to 3,
A guide device having a guide portion for guiding the puncture device toward the living body lumen in the living body lumen;
A treatment device assembly. The treatment device assembly of claim 4.
The guide device has an expansion body that is expandable within the living body lumen and is provided with the guide portion;
When the expansion body expands in the living body lumen, it presses the living body wall outward.
A treatment device assembly. A treatment method for forming a bypass in a body lumen having an obstruction from a procedure in a body lumen,
A puncture device delivery step for delivering a tubular puncture device having a puncture portion at the tip to the front side of the occlusion portion formed in the biological lumen through the living body lumen;
A puncture device placement step of placing the puncture device in the biological lumen in a form that bypasses the obstruction via the outside of the biological lumen;
The guide means is arranged to bypass the occluded portion via the outside of the biological lumen by advancing linear guide means through the lumen of the puncture device arranged in the biological lumen. A guide means arranging step to perform,
A puncture device removal step of removing the puncture device out of the living body lumen while maintaining the position of the guide means;
A bypass tube delivery device having a bypass tube and a bypass tube delivery catheter is advanced along the guide means in a state where the bypass tube is held by the bypass tube delivery catheter, and both ends of the bypass tube are the biological tubes. A bypass tube delivery device placement step that is located in the cavity and in which the intermediate portion of the bypass tube is located outside the living body lumen; and
Bypass tube delivery in which the bypass tube is removed from the bypass tube delivery catheter and the bypass tube delivery catheter is withdrawn from the bypass tube by retracting the bypass tube delivery catheter while maintaining the position of the bypass tube A catheter removal step;
A fixing member delivery device having a fixing member and a fixing member delivery catheter is advanced along the guide means in a state where the fixing member is held by the fixing member delivery catheter, and the fixing member delivery device is fixed to the end of the bypass pipe. A securing member delivery device positioning step for positioning the securing member delivery device so that the member is coming;
A fixing step of fixing the end portion of the bypass tube and the living body lumen by the fixing member;
The treatment method characterized by the above-mentioned. The treatment method according to claim 6, wherein
A guide device placement step of placing a guide device having a guide portion capable of guiding the puncture device in the living body lumen on the near side of the occlusion portion;
In the puncture device placement step, the tip of the puncture device is sent out from the living body lumen to the outside of the living body lumen by advancing the puncturing device under the guide action of the guide portion of the guide device.
The treatment method characterized by the above-mentioned. The treatment method according to claim 7.
The guide device has an expansion body that is expandable in the living body lumen;
In the guide device arranging step, the living body tube wall is pressed from the inside by expansion of the expansion body in the living body lumen.
The treatment method characterized by the above-mentioned.

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