JP2018050734A - Medical system, medical device, and treatment method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical system, a medical device, and a treatment method that allow a puncturing position to be grasped easily, and enhance safety by suppressing erroneous puncturing.SOLUTION: A medical system 10 inserted into a living body lumen for puncturing the oval fossa O and holding a formed hole in a spread state includes a dilator 40 whose outer diameter of the distal side end part gradually decreases toward the distal side, an outer sheath 50 into which the dilator 40 can be inserted, a positioning part 20 disposed in the dilator 40 so as to be movable in the axis direction, which can protrude to the distal side with respect to the dilator 40, and a puncture device 60 that can be inserted into a first lumen 45 of the dilator 40. The positioning part 20 protrudes in a direction different from the protrusion direction of the puncture device 60 from the dilator 40.SELECTED DRAWING: Figure 3

Description

  The present invention relates to a medical system, a medical device, and a treatment method for puncturing a living tissue.

  The heart circulates blood by repeating contraction and expansion at an appropriate timing by the flow of current through myocardial tissue called a stimulation conduction system. When the generation and transmission of electrical signals flowing through the stimulation conduction system become abnormal, contraction and expansion cannot be performed at appropriate timing, and arrhythmia occurs.

  As a method for treating arrhythmia, a method is known in which a conduction path of a signal causing arrhythmia is blocked by ablation by heating or cooling. As a device for performing this treatment method, a device that can be percutaneously inserted up to the left atrium and capable of ablating a signal conduction path located at a pulmonary vein opening is known. Such ablation devices are actively used because they are minimally invasive and provide high effects.

  When ablation is performed in the left atrium, a needle is inserted into the thin septum called the oval fossa of the atrial septum from the right atrium to open a hole that leads from the right atrium to the left atrium. A procedure is required (see, for example, Patent Document 1). This procedure can be accompanied by serious complications such as cardiac tamponade (a state where blood accumulates between the pericardium and the myocardium, resulting in cardiac failure) if it is accidentally punctured at a site different from the target position. For this reason, it is necessary to insert a catheter called an intracardiac echo catheter (ICE) into the right atrium and specify the position of the foveal fossa in advance during the puncture procedure.

International Publication No. 2007/147060

  In the device described in Patent Document 1, the state where the puncture needle protrudes from the dilator is maintained after puncturing. For this reason, there is a possibility of erroneous puncture by a sharp puncture needle. Further, when an intracardiac echocardiography catheter is required, it takes time and effort for the operator, and the physical and economic burden on the patient is great.

  The present invention has been made to solve the above-described problems, and provides a medical system, a medical device, and a treatment method that can easily grasp a puncture position, suppress erroneous puncture, and improve safety. The purpose is to do.

  A medical system that achieves the above object is a medical system that is inserted into a living body lumen to puncture a living tissue, and holds a hole formed by puncturing in an expanded state, and is provided with at least one lumen. A dilator in which the outer diameter of the distal end gradually decreases toward the distal side, an outer sheath having a lumen into which the dilator can be inserted, and the dilator, between the dilator and the outer sheath, or A positioning part that is arranged on the outer sheath so as to be movable in the axial direction, and is capable of projecting more distally than the dilator; and a long puncture device that can be inserted into the lumen of the dilator, The part protrudes in a direction different from the protruding direction of the puncture device from the dilator.

  A medical device that achieves the above-described object is a medical device that is inserted into a biological lumen to widen a hole in a biological tissue, and a first lumen penetrating in the axial direction is formed at a distal end. A dilator having a reduced diameter portion whose outer diameter decreases toward the distal side, and a dilator disposed in the dilator so as to be movable in the axial direction of the dilator, and capable of projecting from the reduced diameter portion further to the distal side than the dilator Positioning part, and protrudes in a different direction from the positioning part and the first lumen.

  A treatment method for achieving the above object is a treatment method for puncturing a living tissue in a living body using the medical system and holding the formed hole in an expanded state, wherein the dilator and the outer sheath are Inserting into the body lumen, bringing the positioning portion into contact with the edge of the concave portion of the biological tissue, and projecting the puncture device distally from the lumen of the dilator to puncture the biological tissue Forming a hole, inserting the dilator and the outer sheath into a hole formed in the living tissue, and removing the dilator from the outer sheath.

  In the medical system, medical device, and treatment method configured as described above, the positioning portion protruding from the dilator can be brought into contact with the edge of the concave portion of the living tissue by pushing the dilator. Thereby, the puncture position can be easily grasped, and the dilator can be positioned at an appropriate position appropriately separated from the edge of the concave portion of the living tissue. For this reason, an appropriate position can be punctured, and erroneous puncture can be suppressed to increase safety.

It is a top view which shows the medical system which concerns on embodiment. It is sectional drawing which shows the medical system which concerns on embodiment. It is sectional drawing which shows the state which combined each device of the medical system which concerns on embodiment. It is sectional drawing which follows the AA line of FIG. It is a perspective view which shows the distal part of a medical system. It is a side view which shows the distal part of a medical system, (A) is an accommodation state, (B) is a protrusion state, (C) shows a bending state. It is a top view which shows the distal part of a medical system, (A) is an accommodation state, (B) is a protrusion state, (C) shows a bending state. It is a fragmentary sectional view showing the inside of the heart. It is sectional drawing for demonstrating the procedure by the medical system which concerns on embodiment, (A) is the state which inserted the sheath assembly into the right atrium along the guide wire, (B) is the state which protruded the positioning part, (C) shows a state in which the dilator is positioned, and (D) shows a state in which the dilator is punctured. It is a top view for demonstrating the procedure by the medical system which concerns on embodiment, (A) is the state which inserted the sheath assembly into the right atrium along the guide wire, (B) is the state which protruded the positioning part, (C) is sectional drawing which shows the state which punctured the oval fossa with the puncture device. It is sectional drawing for demonstrating the procedure by the medical system which concerns on embodiment, (A) is the state which retracted the positioning part, (B) is inserting a dilator and a sheath in the hole of an ovule along a puncture device (C) shows a state in which the dilator and the puncture device are pulled out from the outer sheath. It is sectional drawing which shows the 1st modification of a medical system. It is sectional drawing which shows the modification of a medical system, (A) shows a 2nd modification, (B) shows a 3rd modification, (C) shows a 4th modification. It is sectional drawing which shows the modification of a medical system, (A) shows a 5th modification, (B) shows a 6th modification. It is a side view which shows the 7th modification of a medical system. It is a top view which shows the 8th modification of a medical system, (A) shows the state which the support part protruded, (B) shows the state which the support part bent. It is a side view which shows the 8th modification of a medical system, (A) shows the state which the support part protruded, (B) shows the state which the support part bent. It is a side view which shows the 9th modification of a medical system, (A) shows the state which the support part protruded, (B) shows the state which the support part bent. It is a perspective view which shows the 10th modification of a medical system.

  Embodiments of the present invention will be described below with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio. In this specification, the side of the device that is inserted into the blood vessel is referred to as the “distal side”, and the proximal side that is operated is referred to as the “proximal side”.

  In the medical system 10 according to the embodiment of the present invention, a hole is formed from the right atrium R to the oval fossa O of the atrial septum (see FIG. 8), and the hole leading from the right atrium R to the left atrium L is widened. Used to hold. If there is a hole in the oval fossa O, the ablation catheter inserted percutaneously into the vena cava is guided to the right atrium R and then inserted into the left atrium via the hole, for example, ablation around the pulmonary vein mouth Can do. In other words, the medical system 10 is a device for forming an access route of an ablation catheter in the fossa ovum O.

  As shown in FIGS. 1 to 5, the medical system 10 according to the first embodiment includes a puncture device 60, a dilator 40, an outer sheath 50, and a positioning unit 20. The dilator 40 and the positioning unit 20 are connected to form one medical device.

  The puncture device 60 is a device for forming a hole in the foveal fossa O. The puncture device 60 includes a long wire portion 62 and a sharp puncture needle 61 provided at a distal end portion of the wire portion 62. Note that the puncture device 60 may not have the sharp puncture needle 61. The puncture device may be a device that denatures and punctures a living tissue using, for example, high-frequency current, electromagnetic waves, laser, cooling, or the like.

  The dilator 40 is used to widen the hole of the oval fossa O opened by the puncture device 60. The dilator 40 includes a dilator central portion 41 having a substantially constant outer diameter, a taper portion 42 (a reduced diameter portion) located on the distal side of the dilator central portion 41, and a dilator vicinity located on the proximal side of the dilator central portion 41. And a positioning portion 43. The dilator central portion 41 is a tubular body having a substantially constant outer diameter. The tapered portion 42 has an outer diameter that decreases in a tapered shape toward the distal side. The inclination angle α1 with respect to the central axis of the tapered portion 42 is set as appropriate, and is, for example, 1 to 80 degrees, more preferably 1 to 30 degrees, and still more preferably 1 to 10 degrees. The dilator proximal portion 43 has a male connector 44 that can be connected to the Y connector on the outer peripheral surface.

  Further, the dilator 40 includes a first lumen 45 that movably accommodates the puncture device 60 and two second lumens 46 that movably accommodate the positioning unit 20. The first lumen 45 is located at the center of the dilator 40 in a cross section perpendicular to the central axis of the dilator 40. The first lumen 45 penetrates the dilator 40 in the axial direction. The first lumen 45 opens at the distal end of the taper portion 42 having the most reduced diameter. The second lumen 46 is located radially outward from the first lumen 45 in a cross section perpendicular to the central axis of the dilator 40. The distance of each second lumen 46 from the first lumen 45 is equal. The two second lumens 46 are parallel to the central axis of the dilator 40 except near the proximal opening. Note that the two second lumens 46 may not be parallel to the central axis of the dilator 40. A plane P passing through both central axes of the second lumen 46 parallel to the central axis of the dilator 40 is separated from the central axis of the first lumen 45. The proximal portion of the second lumen 46 is inclined in the direction away from the central axis of the dilator 40 toward the proximal side, and is open at the outer peripheral surface of the dilator 40.

  The two second lumens 46 open at the tapered surface 42 </ b> A where the tapered portion 42 is inclined. The dilator 40 has a receiving portion 47 in which the second lumen 46 is opened in the tapered portion 42. The accommodating portion 47 is a concave portion that connects both openings of the two second lumens 46 along the tapered surface 42 </ b> A of the tapered portion 42. The accommodating portion 47 can accommodate the distal end portion of the positioning portion 20. The accommodating portion 47 forms a space that is large enough to accommodate the positioning portion 20 to be accommodated inside the tapered surface 42A. The inner side of the tapered surface 42A means the inner side of the outer peripheral surface of the cone of which the tapered surface 42A constitutes a part. The accommodating portion 47 may not be able to accommodate the positioning portion 20 to be accommodated inside the tapered surface 42A. The accommodating portion 47 is cut out so as to open toward the distal side and radially outward in a range shorter than the entire length in the axial direction of the tapered portion 42 and in a range less than 180 degrees in the circumferential direction. The accommodating portion 47 has a first surface 47A that faces the distal side and a second surface 47B that faces the radially outer side. The second lumen 46 opens at the first surface 47A. The accommodating portion 47 has a space extending from the second lumen 46. Since the accommodating portion 47 is open toward the distal side and radially outward, the positioning portion 20 accommodated in the accommodating portion 47 is distant from the tapered portion 42 toward the distal side and radially outward of the dilator 40. Can protrude easily.

  The first lumen 45 has a distal lumen 45A on the distal side, a proximal lumen 45B having a larger inner diameter than the distal lumen 45A, and an inner diameter between the distal lumen 45A and the proximal lumen 45B. Is provided with a central lumen 45C. The inner diameter of the proximal lumen 45 </ b> B is sufficiently larger than the outer diameter of the puncture device 60. For this reason, the puncture device 60 inserted into the proximal lumen 45B can move smoothly along the inner peripheral surface of the dilator 40. The central lumen 45C smoothly guides the puncture device 60 through the distal lumen 45A to the proximal lumen 45B. The inner diameter of the distal lumen 45A is an inner diameter that allows the puncture device 60 to be slid while contacting with a small clearance. Thereby, the dilator 40 can accurately define the position of the puncture device 60 that moves to the outside by moving the distal lumen 45A.

  The dilator 40 has a bent portion 48 bent at a predetermined angle at a distal portion in a natural state where no external force acts. The bending portion 48 plays a role of directing the puncture needle 61 of the puncture device 60 inserted into the right atrium R toward the oval fossa O. Although angle (beta) 1 of the bending part 48 with respect to the proximal part of the dilator 40 is not specifically limited, For example, it is 10-90 degree | times, More preferably, it is 30-80 degree | times, More preferably, it is 40-70 degree | times. Although the length from the distal end part of the dilator 40 to the bending part 48 is set suitably, it is 10-150 mm, More preferably, it is 15-90 mm, More preferably, it is 20-70 mm.

  The axial length of the dilator 40 is set as appropriate, and is, for example, 500 to 800 mm. Although the outer diameter of the dilator 40 is set suitably, it is 1.0-10.0 mm, for example. The inner diameter of the distal lumen 45A is appropriately set, and is, for example, 0.3 to 5.0 mm. The clearance between the inner peripheral surface of the distal lumen 45A and the outer peripheral surface of the puncture device 60 is set as appropriate, and is, for example, 0.01 to 1.00 mm. The inner diameter of the second lumen 46 is appropriately set according to the outer diameter of the positioning portion 20 to be accommodated, but is, for example, 0.1 to 2.0 mm, more preferably 0.2 to 1.0 mm, and still more preferably 0. .3 to 0.7 mm.

  The constituent material of the dilator 40 is preferably flexible. For example, polyolefins such as polyethylene and polypropylene, polyesters such as polyamide and polyethylene terephthalate, fluorine-based polymers such as ETFE, PEEK (polyether ether ketone), polyimide, Metals such as shape memory alloy, stainless steel, tantalum, titanium, platinum, gold, and tungsten can be suitably used. In addition, the dilator 40 may include an X-ray contrast material or an ultrasound contrast material.

  The positioning unit 20 protrudes distally from the dilator 40 and can contact the living tissue. Thereby, the positioning part 20 positions the dilator 40 from which the puncture device 60 protrudes in an appropriate position. The positioning unit 20 includes a long body 21 that penetrates the dilator 40 and an operation unit 30 that is provided at a proximal portion of the long body 21. The long body 21 is configured by folding one elastically deformable wire at the distal portion. The long body 21 has a contact portion 22 located at a portion where the wire is folded and two support portions 23 extending from the contact portion 22 to the proximal side. The two support portions 23 pass through the second lumen 46. The contact portion 22 can be accommodated in the accommodation portion 47 of the dilator 40. The long body 21 of the positioning unit 20 is curved and shaped. The elongated body 21 is linear (the shape of the second lumen 46) in the second lumen 20, but is curved by projecting from the opening of the second lumen 46, and the dilator 40 of the puncture device 60. Projects in a direction different from the projecting direction from

  The operation unit 30 includes a casing 31 fixed to the proximal portion of the dilator 40 and a slide unit 32. The slide part 32 is arranged in the casing 31 so as to be slidable along the axial direction of the dilator 40. The support portion 23 led out from the second lumen 46 to the proximal side is fixed to the slide portion 32. For this reason, when the slide part 32 is moved proximally with respect to the casing 31, the support part 23 moves in the second lumen 46 to the proximal side. Thereby, the contact part 22 located in the distal side of the support part 23 is accommodated in the accommodating part 47 (refer FIG. 6 (A) and FIG. 7 (A)). When the slide portion 32 is moved distally with respect to the casing 31, the support portion 23 moves distally within the second lumen 46. Thereby, the contact part 22 protrudes in the distal side from the accommodating part 47 (refer FIG. 6 (B) and FIG. 7 (B)). As shown in FIG. 1, a first display portion 33 such as a scale is provided on the outer surface of the casing 31 along a movable range of the slide portion 32. In addition, a second display unit 34 that is paired with the first display unit 33 is provided on the outer surface of the slide unit 32. Thereby, the position of the slide part 32 with respect to the casing 31 can be easily grasped. For this reason, from the position of the slide part 32 with respect to the casing 31, the protrusion amount from the dilator 40 of the positioning part 20 can be grasped | ascertained. In addition, the 1st display part 33 and the 2nd display part 34 which are provided in the casing 31 and the slide part 32 may not be a scale, for example, may be a symbol, a figure, a character, etc. Further, the first display unit 33 may be provided not on the casing 31 but on the outer peripheral surface of the dilator 40.

  The distal part of the support part 23 and the contact part 22 can be accommodated in the dilator 40 as shown in FIGS. 6 (A) and 7 (A). At this time, the contact portion 22 is located in the accommodating portion 47 of the dilator 40. In this accommodated state, the support part 23 and the contact part 22 are elastically deformed and accommodated in the dilator 40.

  As shown in FIGS. 6B and 7B, the support portion 23 has a support bending portion 24 that bends in a direction away from the plane P in the protruding state protruding from the dilator 40. The direction in which the support bending portion 24 is bent with respect to the plane P is opposite to the direction in which the dilator 40 is bent (see FIG. 1). The two support portions 23 have an angle θ (relative to the plane P) with respect to the central axis of the distal portion of the dilator 40 in the protruding state. The central axis of the distal portion of the dilator 40 coincides with the protruding direction of the puncture device 60 protruding from the dilator 40. Therefore, the support part 23 in the protruding state extends in a direction different from the protruding direction of the puncture device 60 from the dilator 40. Note that the support portion 23 may be curved in a direction away from the plane P as a whole, instead of being bent in the direction away from the plane P only by the support bending portion 24. The two support portions 23 protrude from the second lumen 46 and thereby spread away from each other by their own elastic force (restoring force). Thereby, the support part 23 and the contact part 22 which protruded from the dilator 40 become a substantially U shape. The contact portion 22 in the protruding state is located on the distal side of the distal end portion of the dilator 40. Further, the abutting portion 22 in the protruding state is positioned away from the central axis of the distal portion of the dilator 40 to the outside in the radial direction of the dilator 40.

  When the contact part 22 hits the contact object, as shown in FIGS. 6C and 7C, a force toward the proximal side acts on the contact part 22 and the support part 23 bends. The direction of bending is different from the protruding direction of the puncture device 60 from the dilator 40 and the extending direction of the support portion 23 in the protruding state. For example, the direction of bending is perpendicular to the central axis of the dilator 40 and the extending direction of the support portion 22 (the direction in which the two support portions 23 are separated). In the protruding state, the two support portions 23 spread away as shown in FIG. For this reason, as shown in FIG. 7C, the two support portions 23 are further deformed as the contact portion 22 hits the contact target. Thereby, the contact part 22 and the support part 23 can deform | transform along the shape of a contact symmetry thing. Moreover, the two support parts 23 have an angle θ with respect to the central axis of the distal part of the dilator 40 in the protruding state, as shown in FIG. For this reason, when the contact portion 22 hits the contact object, the two support portions 23 further bend in a direction away from the plane P as shown in FIG. Thereby, the distal end of the dilator 40 can be positioned at a position away from the contact portion 22.

  Although angle (theta) of the elongate body 21 is set suitably, it is more than 0 degree and below 80 degree, for example, More preferably, it is 0-70 degree, More preferably, it is 0-60 degree.

  The constituent material of the long body 21 is preferably flexible. For example, a shape memory alloy, stainless steel, tantalum, titanium, platinum, gold, tungsten, or the like, to which a shape memory effect or superelasticity is imparted by heat treatment. Polyolefins such as polyethylene and polypropylene, polyesters such as polyamide and polyethylene terephthalate, fluoropolymers such as ETFE, PEEK (polyetheretherketone), and polyimide can be preferably used. As the shape memory alloy, a Ni-Ti system, a Cu-Al-Ni system, a Cu-Zn-Al system, or the like can be suitably used. Further, the elongated body 21 may include an X-ray contrast material. The X-ray contrast material is preferably made of, for example, at least one metal or two or more alloys selected from the group consisting of gold, platinum, iridium, tungsten, alloys thereof, and silver-palladium alloys. is there. Further, the long body 21 may include an ultrasonic contrast material. As the ultrasonic contrast material, stainless steel or the like can be used in addition to the X-ray contrast material described above.

  The outer sheath 50 provides an access route for the ablation catheter, as shown in FIGS. The outer sheath 50 includes a sheath body 51, a hub 54 connected to the proximal portion of the sheath body 51, a port portion 56 communicating with the hub 54, and a valve body 55 inside the hub 54.

  The sheath body 51 is a long tube body that accommodates the dilator 40 so as to be movable in the axial direction. The sheath body 51 has an inner peripheral surface that slides smoothly with the dilator 40. The sheath body 51 has a sheath bent portion 52 bent at a predetermined angle at the distal portion in a natural state. The angle β2 of the sheath bending portion 52 with respect to the proximal portion of the sheath body 51 is not particularly limited, but is, for example, 0 to 90 degrees, more preferably 20 to 70 degrees, and further preferably 30 to 60 degrees. The sheath bending part 52 plays a role of directing the puncture needle 61 of the puncture device 60 inserted into the right atrium R toward the oval fossa O.

  The sheath body 51 has a sheath taper portion 53 whose diameter decreases in a tapered shape toward the distal side at the distal end portion. The lumen of the sheath body 51 is open at the end of the sheath taper portion 53 that has the smallest diameter. The inclination angle α2 with respect to the central axis of the sheath taper portion 53 is appropriately set, and is, for example, 1 to 15 degrees, more preferably 2 to 10 degrees, and further preferably 3 to 7 degrees. In the sheath assembly 80 in which the dilator 40 is inserted into the outer sheath 50, the sheath taper portion 53 can be positioned on the proximal side of the taper portion 42 of the dilator 40 and can be continuous with the taper portion 42. It is preferable that the inner peripheral surface of the sheath main body 51 has an appropriate clearance between the outer peripheral surface of the dilator 40 and the outer peripheral surface of the dilator 40 so as to be slidable.

  The dilator 40 can pass through the entire length of the sheath body 51. Therefore, the axial length of the sheath body 51 is shorter than that of the dilator 40.

  The axial length of the sheath body 51 is set as appropriate, and is, for example, 400 to 790 mm. The outer diameter of the sheath body 51 is set as appropriate, and is, for example, 1.1 to 11.0 mm. The inner diameter of the sheath body 51 is set as appropriate, and is, for example, 1.05 to 10.95 mm. The clearance between the inner peripheral surface of the sheath body 51 and the outer peripheral surface of the dilator 40 is set as appropriate, and is, for example, 0.01 to 1.00 mm.

  The constituent material of the sheath body 51 is preferably a flexible material. For example, polyolefin such as polyethylene or polypropylene, polyester such as polyamide or polyethylene terephthalate, fluorine-based polymer such as ETFE, PEEK (polyetheretherketone). ), Polyimide and the like can be suitably used.

  The hub 54 is provided in the proximal portion of the sheath body 51 and communicates with the lumen of the sheath body 51. The dilator 40 passes through the hub 54. The port portion 56 is connected to the hub 54 and communicates with the lumen of the sheath body 51 through the lumen of the hub 54. The port portion 56 has a three-way cock 57 at the end. By connecting a syringe or the like to the three-way cock 57, the lumen of the sheath body 51 can be primed, or a contrast agent, a drug, or the like can be injected into the sheath body 51.

  The valve body 55 is a member for sealing the hub 54 and the lumen of the sheath body 51. The valve body 55 can be flexibly deformed and is disposed on the inner peripheral surface of the hub 54. The valve body 55 is slidably in contact with the outer peripheral surface of the dilator 40. Further, the valve body 55 can press the dilator 40 with elastic force in a state where the dilator 40 is inserted, and can fix the dilator 40 and the outer sheath 50. Even if the valve body 55 is fixed, it can be relatively moved in the axial direction by gripping the dilator 40 and the outer sheath 50 and applying a force. Further, by pulling out the dilator 40 from the hub 54, the hole portion of the valve body 55 in which the dilator 40 is inserted is closed, and the lumen of the hub 54 is sealed from the proximal side. The valve body 55 is a member having a cut in the center of a disk-like elastic body, for example. Examples of the elastic body include natural rubber, silicone rubber, and various elastomers. The valve body 55 suppresses blood from leaking through the outer sheath 50 while allowing the dilator 40 to be inserted and removed, and suppresses air from entering the body.

  In a state in which the dilator 40 and the outer sheath 50 are combined, it is preferable that the positions, bending directions, and bending angles of the bending portion 48 and the sheath bending portion 52 coincide or substantially coincide. Thereby, the puncture needle 61 and the positioning part 20 can be protruded in a desired direction.

  Next, a method for providing an access route for an ablation catheter by opening a hole in the fossa fossa O using the medical system 10 according to the embodiment will be described.

  First, a catheter introducer is percutaneously punctured into a blood vessel by the Seldinger method or the like. Next, a sheath assembly 80 in which the dilator 40 is inserted into the outer sheath 50 is prepared. The support part 23 and the contact part 22 are accommodated in the dilator 40. The contact portion 22 is located in the accommodating portion 47. Next, the guide wire 90 is inserted into the first lumen 45 of the dilator 40. Next, the sheath assembly 80 is inserted into the catheter introducer and inserted into the blood vessel. Subsequently, the distal portion of the sheath assembly 80 is gradually pushed to the right atrium R while the guide wire 90 is advanced. Next, the dilator 40 is temporarily inserted from the right atrium R into the superior vena cava along the guide wire 90. Subsequently, when the dilator 40 is retracted and retracted into the right atrium R, as shown in FIGS. 8, 9A, and 10A, the distal end of the dilator 40 is moved into the oval fossa O. Naturally guided to the vicinity of Thereafter, the guide wire 90 is removed from the sheath assembly 80.

  Next, the slide part 32 of the operation part 30 is moved to the distal side while confirming the positions of the support part 23 and the contact part 22 on the X-ray fluoroscopic image. Thereby, the support part 23 and the contact part 22 protrude from the dilator 40, as shown to FIG. 9 (B) and FIG. 10 (B). At this time, by adjusting the amount of movement of the slide portion 32 relative to the casing 31 while grasping with the first display portion 33 and the second display portion 34 (see FIG. 1), the support portion 23 and the contact portion 22 are adjusted. The amount of protrusion can be adjusted. When the support part 23 and the contact part 22 are protruded from the dilator 40, the support part 23 is bent in a direction away from the plane P. Further, the two support portions 23 spread away from each other.

  Next, the dilator 40 is pushed distally. Thereby, as shown in FIG. 9C and FIG. 10C, the contact portion 22 contacts the edge portion of the oval fossa O. The marginal portion of the oval fossa O is located at the boundary between the thin oval fossa O of the atrial septum and the thick part, and the thickness greatly changes in steps. When the contact part 22 hits the edge of the oval fossa O, a force in the proximal direction acts on the contact part 22 and the support part 23 bends. The two support portions 23 are deformed so as to be separated when the contact portion 22 abuts on the edge of the oval fossa O. Thereby, the contact part 22 and the support part 23 deform | transform along the edge part of the oval fossa O. As shown in FIG. Furthermore, when the contact part 22 hits the edge part of the oval fossa O, the two support parts 23 further bend in the direction away from the plane P, that is, toward the proximal side. The contact portion 22 moves in a direction away from the central axis of the dilator 40 while moving toward the proximal side. As a result, the distal end portion of the dilator 40 can be abutted to an optimal position away from the marginal portion of the oval fossa O by a predetermined distance. And the shape of the support part 23 and the contact part 22 is confirmed with an X-ray contrast image. The support part 23 and the contact part 22 are deformed along the edge of the oval fossa O. For this reason, the shape of the edge part of the oval fossa O can be grasped | ascertained by confirming the shape of the support part 23 and the contact part 22 under X-ray fluoroscopy. Moreover, since the support part 23 and the contact part 22 contact the marginal part of the oval fossa O in a wide range, the burden on the living body can be reduced. And it can recognize that the dilator 40 has been arrange | positioned in the desired position by confirming the shape which the support part 23 and the contact part 22 deform | transformed and expanded with a X-ray fluoroscopic image. Therefore, it is not necessary to use an intracardiac echocardiography catheter (ICE). In order to further increase safety, an intracardiac echocardiographic catheter may be used in combination.

  The appropriate position of the dilator 40 relative to the oval fossa O varies depending on the procedure. In the procedure described here, it is preferable to puncture the lower part of the foveal fossa O so that the ablation catheter can be easily guided to the pulmonary vein of the left atrium L. Further, for example, in a procedure for treating a mitral valve, it is preferable to puncture the upper part of the foveal fossa O so that the catheter can be easily guided to the mitral valve. The medical system 10 adjusts the dilator 40 according to the procedure by adjusting the protrusion amount of the support part 23 and the contact part 22, the angle with respect to the foveal fossa, the shape, the position in the right atrium R, and the like. Can be positioned.

  Subsequently, when the dilator 40 is pushed in to the distal side, the fossa fossa O is pushed to the left atrium L side and protrudes. At this time, since the outer sheath 50 and the distal portion of the dilator 40 are bent, the distal end portion of the dilator 40 tends to face toward the foveal fossa O. Note that the oval fossa O does not have to protrude to the left atrium L side.

  Next, as shown in FIGS. 9D and 10C, the puncture device 60 is inserted into the first lumen 45 from the proximal side of the dilator 40 and protrudes from the distal end of the dilator 40. Let Thereby, the puncture needle 61 punctures the oval fossa O. At this time, the distal end of the dilator 40 is positioned at an appropriate position. For this reason, it is possible to suppress the puncture needle 61 from erroneously puncturing an unintended position. Moreover, since the support part 23 and the contact part 22 correspond to the shape of the oval fossa O, the position shift of the support part 23 and the contact part 22 from the oval fossa O is suppressed. Thereby, the position of the dilator 40 becomes difficult to shift, and erroneous puncture can be suppressed.

  When the puncture needle 61 penetrates the foveal fossa O, a part of the distal end of the dilator 40 that has pressed the foveal fossa O to the left atrium L side enters a hole opened in the foveal fossa O. . Note that a part of the dilator 40 may not enter the hole of the oval fossa O.

  Next, as shown in FIG. 11A, the slide part 32 located outside the body is moved to the proximal side. Thereby, the support part 23 and the contact part 22 are elastically deformed and accommodated in the dilator 40.

  Next, the dilator 40 is pushed distally along the puncture device 60. As a result, as shown in FIG. 11B, the taper portion 42 of the dilator 40 and the sheath taper portion 53 of the outer sheath 50 pass through the foveal fossa O while expanding the hole of the foveal fossa O, and the left atrium L To reach. At this time, since the tapered portion 42 and the sheath tapered portion 53 are reduced in diameter toward the distal side, the hole of the oval fossa O can be smoothly expanded. In addition, when the oval fossa O is punctured by the puncture needle 61, a part of the tapered portion 42 of the dilator 40 enters the hole of the oval fossa O. For this reason, it is easy to push the dilator 40 and the outer sheath 50 into the hole of the oval fossa O. Further, the abutting portion 22 is accommodated in the accommodating portion 47 and is located on the inner side than the tapered surface 42A. For this reason, the contact part 22 does not become a hindrance when pushing the dilator 40 into the hole.

  Next, the puncture device 60 is removed from the dilator 40. Subsequently, as shown in FIG. 11D, the dilator 40 is removed from the body while leaving the outer sheath 50. The hole of the oval fossa O expanded by the dilator 40 is maintained by the outer sheath 50. When the dilator 40 is removed from the outer sheath 50, the valve body 55 is closed, and leakage of blood and mixing of air or the like into the blood vessel can be suppressed. Thereafter, an ablation catheter is inserted from the proximal side of the outer sheath 50 through the valve body 55. Accordingly, the ablation catheter can be inserted into the left atrium L using the outer sheath 50 penetrating the oval fossa O. After ablation is performed in the left atrium L with the ablation catheter, when the ablation catheter and the outer sheath 50 are removed from the body, the hole of the fossa fossa O contracts. This completes the procedure.

  As described above, the medical system 10 according to the first embodiment is inserted into a biological lumen (blood vessel, vessel, etc.), punctures the atrial septum (biological tissue), and widens the hole formed by puncturing. System 10 for holding in a closed state, wherein at least one lumen is provided, and a dilator 40 in which the outer diameter of the distal end gradually decreases toward the distal side, and the dilator 40 can be inserted An outer sheath 50 having an inner lumen, a positioning portion 20 that is disposed on the dilator 40 so as to be movable in the axial direction, and that can project more distally than the dilator 40, and a first lumen 45 of the dilator 40. The positioning unit 20 protrudes in a direction different from the direction in which the puncture device 60 protrudes from the dilator 40.

  The medical system 10 configured as described above can cause the positioning unit 20 to protrude more distally than the dilator 40 and abut on the edge of the oval fossa O (concave) of the atrial septum. At this time, since the positioning portion 20 protrudes in a direction different from the protruding direction of the puncture device 60, the positioning portion 20 comes into contact with the edge of the foveal fossa O by pushing the dilator 40, and the positioning portion 20 is in contact with the dilator. Located away from 40. For this reason, the dilator 40 can be positioned at an appropriate position appropriately separated from the edge of the fossa ovum O by pushing the dilator 40. For this reason, an appropriate position can be punctured by the puncture device 60, and erroneous puncture can be suppressed and safety can be improved. Moreover, the dilator 40 can be accurately positioned with respect to the fossa ovum O by grasping the position of the positioning unit 20 based on an X-ray fluoroscopic image or a hand feeling. For this reason, erroneous puncture can be suppressed without using an intracardiac echocardiography catheter (ICE). As a result, the procedure is simplified, the necessary devices are reduced, and the physical burden and the economical burden on the patient can be reduced.

  The positioning unit 20 includes a long support portion 23 that can protrude from the dilator 40 and can be elastically deformed, and an abutment portion 22 supported by a distal portion of the support portion 23. Thereby, the positioning part 20 protrudes further to the distal side than the dilator 40, and the abutting part 22 can be aligned along the edge of the oval fossa O of the atrial septum while elastically deforming the support part 23. it can. At this time, since the support portion 23 protrudes in a direction different from the protruding direction of the puncture device 60, by pushing the dilator 40, the abutment portion 22 abuts on the edge of the oval fossa O, and the support portion 23 is Deflection away from the dilator 40. For this reason, the dilator 40 can be positioned at an appropriate position appropriately separated from the edge of the fossa ovum O by pushing the dilator 40. For this reason, an appropriate position can be punctured by the puncture device 60, and erroneous puncture can be suppressed and safety can be improved. Further, the dilator 40 can be accurately positioned with respect to the fossa ovum O by grasping the shape change of the support portion 23 or the contact portion 22 based on a fluoroscopic image or a hand feeling. For this reason, erroneous puncture can be suppressed without using an intracardiac echocardiography catheter (ICE). As a result, the procedure is simplified, the necessary devices are reduced, and the physical burden and the economical burden on the patient can be reduced.

  Further, the dilator 40 has a bent portion 48 that bends toward one side toward the distal side, and the direction in which the extending direction of the support portion 23 is inclined with respect to the protruding direction of the puncture device 60 is such that the bent portion 48 is distal. The direction is opposite to the direction of bending toward the side. Thereby, when the contact part 22 is made to follow the marginal part of the oval fossa O, the dilator 40 strikes the oval fossa O at an appropriate angle. For this reason, the puncture device 60 can puncture an appropriate position of the oval fossa O in an appropriate direction.

  Further, the positioning portion 20 is formed by a long body 21 folded back at the distal portion, and a portion of the long body 21 that is folded back forms a contact portion 22, and from the portion of the long body 21 that is folded back. Two elongated portions extending proximally form a support portion 23. Thereby, both the support part 23 and the contact part 22 bend as one long body 21 by pushing the positioning part 20 into the distal side in a protruding state, and the margin of the oval fossa O It deforms along the part. For this reason, the positioning part 20 contacts naturally so that it may correspond to the edge part of the oval fossa O, and can position the dilator 40 in an appropriate position.

  Further, the dilator 40 is formed with a second lumen 46 that accommodates the positioning portion 20 so as to be movable. Thereby, the positioning part 20 is accommodated in the second lumen 46, and the positioning part 20 can be prevented from interfering with other devices such as the puncture device 60.

  In addition, a concave accommodating portion 47 capable of accommodating the abutting portion 22 is formed on the outer peripheral surface of the distal portion of the dilator 40, and the second lumen 46 is opened by the accommodating portion 47. Thereby, when the dilator 40 is inserted into the hole formed in the oval fossa O by the puncture device 60, the abutting portion 22 can be accommodated in the accommodating portion 47. For this reason, it can suppress that the contact part 22 prevents insertion to the hole of the dilator 40. FIG. Therefore, the dilator 40 can be smoothly inserted into the hole formed in the oval fossa O.

  The medical device included in the present embodiment is a medical device that is inserted into a living body lumen (blood vessel, vessel, etc.) to widen the hole of the oval fossa O (living tissue) in the axial direction. A first lumen 45 is formed therethrough, and a dilator 40 having a tapered portion 42 (reduced diameter portion) whose outer diameter decreases toward the distal side at the distal end, and the axis of the dilator 40 on the dilator 40. The positioning portion 20 is disposed so as to be movable in a direction and can be protruded from the tapered portion 42 to the distal side of the dilator 40, and the positioning portion 20 extends in a direction different from that of the first lumen 45. To do.

  In the medical device configured as described above, the positioning unit 20 can be protruded more distally than the dilator 40 and can be brought into contact with the edge of the oval fossa O (concave) of the atrial septum. At this time, since the positioning portion 20 protrudes in a direction different from that of the first lumen 45, the positioning portion 20 comes into contact with the edge of the foveal fossa O by pushing the dilator 40, and the positioning portion 20 is in contact with the dilator 40. Located away from. For this reason, the dilator 40 can be positioned at an appropriate position appropriately separated from the edge of the fossa ovum O by pushing the dilator 40. For this reason, by projecting the puncture device 60 from the first lumen 45, an appropriate position can be punctured by the puncture device 60, and erroneous puncture can be suppressed to increase safety. Moreover, the dilator 40 can be accurately positioned with respect to the fossa ovum O by grasping the position of the positioning unit 20 based on an X-ray fluoroscopic image or a hand feeling. For this reason, erroneous puncture can be suppressed without using an intracardiac echocardiography catheter (ICE). As a result, the procedure is simplified, the necessary devices are reduced, and the physical burden and the economical burden on the patient can be reduced. Moreover, since the positioning part 20 can protrude from the taper part 42, the site | part which is located in the distal part of the taper part 42 and contacts with the oval fossa O can be positioned with high precision. Further, since the positioning portion 20 can protrude from the taper portion 42, the positioning portion 20 tends to protrude in a direction different from the first lumen 45 while moving toward the distal side. Further, since the positioning portion 20 can protrude from the tapered portion 42, it can be prevented from interfering with the outer sheath 50 that houses the dilator 40.

  Further, the dilator 40 has a second lumen 46 formed along the central axis. Thereby, the 2nd lumen 46 is accommodated in the positioning part 20, and it can suppress that the positioning part 20 interferes with other devices, such as the puncture device 60. FIG.

  In addition, a concave accommodating portion 47 capable of accommodating the abutting portion 22 is formed in the tapered portion 42 (reduced diameter portion), and the second lumen 46 is opened by the accommodating portion 47. Thereby, when inserting the dilator 40 into the hole formed in the oval fossa O, the contact part 22 of the positioning part 20 can be accommodated in the accommodating part 47. For this reason, it can suppress that the positioning part 20 becomes obstructive of insertion. Therefore, the dilator 40 can be smoothly inserted into the hole formed in the oval fossa O.

  Further, the dilator 40 of the medical device has a bent portion 48 that bends to one side toward the distal side, and the extending direction of the support portion 23 protruding from the dilator 40 is relative to the extending direction of the first lumen 45. The direction in which the bent portion 48 tilts is opposite to the direction in which the bent portion 48 bends toward the distal side. As a result, when the abutting portion 22 protrudes from the dilator 40 and extends along the edge of the oval fossa O, the dilator 40 abuts the oval fossa O at an appropriate angle. For this reason, the puncture device 60 protruding from the first lumen 45 can puncture an appropriate position of the oval fossa O in an appropriate direction.

  In addition, the dilator 40 included in the present embodiment is a dilator 40 in which a first lumen 45 penetrating in the axial direction is formed to widen a hole formed in the oval fossa O (living tissue). A second lumen 46 is formed along the central axis of the first and second concave portions 47 in which the second lumen 46 is opened on the outer peripheral surface of the distal portion of the dilator 40.

  In the dilator 40 configured as described above, the puncture device 60 can be movably accommodated in the first lumen 45, and the positioning portion 20 can be movably accommodated in the second lumen 46. For this reason, an appropriate position can be punctured by the puncture device 60, and erroneous puncture can be suppressed and safety can be improved. Further, since the second lumen 46 is opened in the accommodating portion 47, when the dilator 40 is inserted into the hole formed in the oval fossa O by the puncture device 60, the distal portion of the positioning portion 20 ( The abutting part 22) can be accommodated in the accommodating part 47. For this reason, it can suppress that the positioning part 20 becomes obstructive of insertion. Therefore, the dilator 40 can be smoothly inserted into the hole formed in the oval fossa O.

  Further, the dilator 40 has a bent portion 48 that bends to one side toward the distal side, and the direction in which the accommodating portion 47 is located with respect to the central axis of the dilator 40 is such that the bent portion 48 is directed toward the distal side. The direction is the opposite of the direction of the turn. Thereby, when the contact part 22 protrudes from the accommodating part 47 and is made to follow the edge part of the oval fossa O, the dilator 40 abuts on the oval fossa O at an appropriate angle. For this reason, the puncture device 60 can puncture an appropriate position of the oval fossa O in an appropriate direction.

  The present invention also provides a treatment method (therapeutic method) for puncturing the oval fossa O (living tissue) in vivo using the above-described medical system 10 and holding the formed hole in an expanded state. Including. In the treatment method, the step of inserting the dilator 40 and the outer sheath 50 into the living body lumen, the step of bringing the positioning unit 20 into contact with the marginal portion of the oval fossa O, and the puncture device 60 in the first of the dilator 40. Piercing the oval fossa O to project distally from the lumen 45 of the tube, forming a hole, inserting the dilator 40 and the outer sheath 50 into the hole formed in the oval fossa O, and the outer sheath 50 Removing the dilator 40 from.

  In the treatment method configured as described above, the positioning unit 20 can be protruded further to the distal side than the dilator 40 and can be along the marginal portion of the oval fossa O. At this time, since the positioning portion 20 protrudes in a direction different from the protruding direction of the puncture device 60, the dilator 40 is positioned at an appropriate position appropriately separated from the edge of the fossa ovum O by pushing the dilator 40. it can. For this reason, an appropriate position of the oval fossa O can be punctured by the puncture device 60, and erroneous puncture can be suppressed to improve safety. Moreover, since the dilator 40 can be accurately positioned with respect to the foveal fossa O by an X-ray fluoroscopic image or a hand feeling, erroneous puncture can be suppressed without using an intracardiac echocardiography (ICE). For this reason, the procedure is simplified, the number of devices is reduced, and the physical burden and economical burden on the patient can be reduced.

  Note that the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, the medical system 10 described above may be used to puncture living tissue other than the foveal fossa O.

  Moreover, the support part 23 of the positioning part 20 does not need to bend so that it may leave | separate from the plane P in the natural state where an external force does not act. That is, the support part 23 may be linear in a natural state. In this case, as in the first modification shown in FIG. 12, the second lumen 46A of the dilator 40 may be bent in the direction away from the central axis of the dilator 40 in the vicinity of the opening on the distal side. . Accordingly, the support portion 23 can protrude in a direction away from the central axis of the dilator 40 while being forcibly bent by the inner peripheral surface of the dilator 40 inside the second lumen 46A. That is, even if the support portion 23 is linear in the natural state, the support portion 23 is separated from the central axis of the dilator 40 by a portion (non-linear second lumen 46A) that prevents the support portion 23 from protruding linearly. Can protrude in the direction.

  Moreover, the support part 23 may be accommodated in the groove | channel 49 of the outer peripheral surface of the dilator 40 like the 2nd modification shown to FIG. 13 (A). Further, as in the third modification shown in FIG. 13B, the second lumen 46B in which the two support portions 23 are accommodated is one lumen that can accommodate the two support portions 23 together. Also good. In this case, the contact portion 22 can be accommodated inside the second lumen 46B. Further, as in the fourth modification shown in FIG. 13C, the support portion 23 may be accommodated in the groove 46 </ b> C on the inner peripheral surface of the dilator 40.

  Moreover, the support part 23 may be accommodated in the 2nd lumen | rumen 58 formed in the outer sheath 50 like the 5th modification shown in FIG. 14 (A). Moreover, the support part 23 may be accommodated in the groove | channel 59 formed in the internal peripheral surface of the outer sheath 50 like the 6th modification shown in FIG.14 (B). The positioning unit 20 may be accommodated in both the groove on the outer peripheral surface of the dilator 40 and the groove on the inner peripheral surface of the outer sheath 50.

  Further, as in the seventh modification shown in FIG. 15, the position where the positioning portion 20 protrudes from the dilator 40 may not be the tapered portion 42. And the contact part 22 in the protrusion state may have angle (theta) with respect to the central axis of the distal part of the dilator 40 because the dilator 40 bends.

  Further, the contact portion 22 may be a member different from the support portion 23 as in the eighth modification shown in FIGS. 16 (A) and 17 (A). The contact portion 22A has higher bending rigidity than the support portion 23. The marginal part of the oval fossa O varies from individual to individual and may be formed deep into the tissue of the atrial septum. In this case, since the rigidity of the contact portion 22A is high, it is difficult for the contact portion 22A to be deformed, and the contact portion 22 can be prevented from entering too far. Since the contact portion 22A does not enter too far, the support portion 23 is appropriately bent and the dilator 40 can be appropriately positioned as shown in FIGS. 16 (B) and 17 (B). In addition, although the support part 23 and contact part 22A from which a shape differs may be another members, it is good also as a different shape by processing one wire.

  Further, as in the ninth modification shown in FIG. 18A, the contact portion 22B is provided with the contact portion 22B provided at the distal portion of the two support portions 23, and the two support portions 23 are positioned. The surface to be inclined may be inclined at an angle γ. In this case, the direction in which the contact portion 22B extends may have an angle of more than 90 degrees with respect to the axial direction of the distal portion of the dilator 40. In this case, the contact portion 22B can be prevented from coming into contact with the edge of the oval fossa O on a wide surface and entering too deep into the edge. Thereby, as shown to FIG. 18 (B), the support part 23 bends appropriately and the dilator 40 can be positioned appropriately. The contact portion 22 may be a separate member from the support portion 23, but may be formed of the same member (wire).

  Further, as in the tenth modification shown in FIG. 19, the accommodating portion 70 may have a shape that follows the curved shape of the support portion 23 and the contact portion 22. The accommodating portion 70 forms a substantially U-shaped space that is folded back on the distal side on the outer surface of the tapered portion 42. Thereby, the support part 23 and the contact part 22 accommodated in the accommodating part 70 can reduce the recessed part and convex part in 42 A of taper surfaces as much as possible. For this reason, when inserting the dilator 40 in the hole formed in the oval fossa O, it can suppress that the positioning part 20 obstructs insertion. Therefore, the dilator 40 can be smoothly inserted into the hole formed in the oval fossa O.

  Moreover, the accommodating part of a dilator may be a part of 2nd lumen or groove | channel formed in a dilator. In other words, the accommodating portion in which the second lumen or groove opens may not have a space that is wider than the second lumen or groove.

  Further, the number of support portions is not limited to two, and may be one or three or more. Further, the support portion and the contact portion may be a single wire that is linear or curved in a natural state.

10 Medical system,
20 positioning part,
21 long body,
22 contact part,
23 support part,
24 support bending part,
40 Dilator,
42 Tapered part (reduced diameter part),
42A taper surface,
45 The first lumen,
46, 46A, 46B, 58 second lumen,
46C, 49, 59 groove,
47, 70 accommodating part,
48 bending part,
50 outer sheath,
60 Puncture device,
O Fovea (concave),
L left atrium,
R right atrium,
θ angle.

Claims (12)

A medical system for inserting into a living body lumen to puncture a living tissue and holding the formed hole in an expanded state,
A dilator provided with at least one lumen, wherein the outer diameter of the distal end decreases towards the distal side;
An outer sheath having a lumen into which the dilator can be inserted;
A positioning portion that is disposed between the dilator and the outer sheath or in the outer sheath so as to be movable in the axial direction, and is capable of projecting more distally than the dilator;
An elongate puncture device that is insertable into the lumen of the dilator,
The medical system according to claim 1, wherein the positioning portion protrudes in a direction different from a protruding direction of the puncture device from the dilator.   The positioning portion includes a long support portion that can protrude from the dilator or an outer sheath and is elastically deformable, and a contact portion that is supported by a distal portion of the support portion. Medical system as described in. The dilator has a bent portion that bends to one side toward the distal side,
The medical system according to claim 2, wherein a direction in which a protruding direction of the support portion protruding from the dilator is inclined with respect to a protruding direction of the puncture device is opposite to a direction in which the bent portion is bent toward the distal side. . The positioning portion is formed of a wire rod folded at a distal portion,
The portion of the wire that is folded back forms the contact portion,
The medical system according to claim 2 or 3, wherein two long portions extending proximally from the folded portion of the wire form the support portion.   The medical system according to any one of claims 2 to 4, wherein the dilator is formed with a second lumen or groove that movably accommodates the positioning portion. On the outer peripheral surface of the distal portion of the dilator, a concave housing portion that can accommodate the contact portion is formed,
The medical system according to claim 5, wherein the second lumen or groove is opened in the housing portion. A medical device that is inserted into a biological lumen to widen a hole in biological tissue,
A dilator having a reduced diameter portion formed with a first lumen penetrating in an axial direction and having an outer diameter decreasing distally at a distal end;
A positioning part that is arranged in the dilator so as to be movable in the axial direction of the dilator, and that can project from the reduced diameter part to the distal side of the dilator,
The positioning device is a medical device that protrudes in a direction different from that of the first lumen.   The said positioning part has the elongate support part which can protrude from the said dilator and is elastically deformable, and the contact part supported by the distal part of the said support part. Medical device.   The medical device according to claim 9, wherein the dilator is formed with a second lumen or groove along a central axis. The reduced diameter portion is formed with a concave accommodating portion capable of accommodating the contact portion,
The medical device according to claim 8 or 9, wherein the second lumen or groove is opened in the housing portion. The dilator has a bent portion that bends to one side toward the distal side,
The direction in which the extending direction of the support portion protruding from the dilator is inclined with respect to the extending direction of the first lumen is opposite to the direction in which the bent portion is bent toward the distal side. The medical device according to any one of 10. A treatment method for puncturing a living tissue in vivo using the medical system according to claim 1 and holding the formed hole in an expanded state,
Inserting the dilator and outer sheath into a biological lumen;
Bringing the positioning part into contact with the edge of the concave part of the biological tissue;
Projecting the puncture device distally from the lumen of the dilator to puncture biological tissue to form a hole;
Inserting the dilator and outer sheath into a hole formed in the living tissue;
Removing the dilator from the outer sheath.

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