JP2019193681A - Medical device and treatment method - Google Patents

Abstract

To provide a medical device and a treatment method capable of preventing the needle part from projecting more than needed and inhibiting miss-puncture, thereby increasing safety.SOLUTION: A medical device 10 is inserted into a lumen of a living body to puncture living tissue and keeps the formed puncture open, comprising: a flexible elongated needle part 30; a flexible tubular dilator 40 for receiving the needle part 30 in such a manner that the needle part can project to a distal side; and a force generation part 74 provided on a proximal side of the dilator 40 to cause a force directed toward a proximal side to be exerted to the needle part 30 from a state in which the needle part 30 is projected from an elongated body.SELECTED DRAWING: Figure 1

Description

  The present invention relates to 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 ovary 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. Transseptal needles that are devices for performing this atrial septal puncture include mechanical puncture needles and high-frequency energy puncture needles (Radio Frequency Needle). Mechanical puncture needles are mainstream because they are inexpensive.

  The mechanical puncture needle performs puncture using a sharp needle. When using a mechanical puncture needle, there is a risk of false puncture due to excessive pressing of the needle. Accidental puncture with a needle can be accompanied by serious complications such as cardiac tamponade (a condition in which blood accumulates between the pericardium and myocardium causing heart failure). On the other hand, the high frequency energy puncture needle is a method of penetrating the atrial septum by outputting high frequency energy supplied from a console which is a separately provided device. For this reason, the high frequency energy puncture needle has no risk of erroneous puncture, but is expensive and requires a console.

  For example, Patent Document 1 describes a device in which a mechanical puncture needle is accommodated in a dilator. A hole is made in the foveal fossa with a puncture needle protruding from the dilator of the device, and the dilator is inserted into the opened hole to widen the hole in the foveal fossa.

US Patent Publication No. 2002/0169377

  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.

  The present invention has been made in order to solve the above-described problems, and provides a medical device and a treatment method in which a needle portion does not protrude more than necessary, and erroneous puncture can be suppressed to improve safety. With the goal.

  A medical device according to the present invention that achieves the above object is a medical device that is inserted into a living body lumen, punctures a living tissue, and holds the hole that has been punctured to open the hole, and is flexible. Provided with a long needle part having the property, a tubular long body having flexibility for accommodating the needle part so as to protrude to the distal side, and a proximal side of the long body, A force generation unit that applies a force toward the proximal side of the needle part from a state in which the needle part protrudes from the elongated body.

  A treatment method according to the present invention that achieves the above object is a treatment method for puncturing a living tissue in a living body using the above-described medical device and holding the punctured hole in an expanded state. A step of inserting the elongate body and the needle part into a living body lumen, a step of projecting the needle part from the elongate body and puncturing a living tissue, and the needle part projecting from the elongate body A force generating part that applies a force toward the proximal side to the proximal part of the needle part by being in a state, a step of applying a force toward the proximal side to the proximal part of the protruding needle part; and Accommodating a needle portion in the elongated body.

  In the medical device and the treatment method configured as described above, a force acts in a direction in which the needle part is housed in the elongated body by the needle part protruding. For this reason, the needle portion does not protrude more than necessary, and erroneous puncture can be suppressed and safety can be improved.

It is a top view which shows the medical device which concerns on 1st Embodiment. It is sectional drawing which shows the medical device which concerns on 1st Embodiment. It is sectional drawing which shows the state which combined each site | part of the medical device which concerns on 1st Embodiment. It is a top view which shows the modification of a needle part. It is a fragmentary sectional view showing the inside of the heart. It is sectional drawing which shows the state at the time of puncturing with the medical device which concerns on 1st Embodiment, (A) is the state which inserted the sheath assembly into the right atrium along the guide wire, (B) is drawing out a guide wire (C) shows a state in which the outer tube and the needle portion are inserted into the sheath assembly, and (D) shows a state in which the operation portion is moved proximally. It is sectional drawing which shows the state at the time of puncturing with the medical device which concerns on 1st Embodiment, (A) is the state which punctured the fossa fossa with the needle part, (B) is the punctured needle part returning in an outer tube | pipe (C) shows a state in which the dilator and the sheath are inserted into the hole of the foveal fossa, and (D) shows a state in which the dilator is pulled out from the outer sheath. It is sectional drawing which shows the medical device which concerns on 2nd Embodiment. It is sectional drawing which shows the state at the time of puncturing with the medical device which concerns on 2nd Embodiment, (A) is the state which inserted the outer tube | pipe and the needle part in the sheath assembly, (B) is the operation part to the proximal side. (C) is the state in which the follicular fossa is punctured by the needle part, (D) is the state in which the punctured needle part has returned to the outer tube, and (E) is the dilator and the outside in the follicular hole. The state which inserted the sheath is shown. It is sectional drawing which shows the medical device which concerns on 3rd Embodiment. It is sectional drawing which shows the state at the time of performing puncture with the medical device which concerns on 3rd Embodiment, (A) is the state which inserted the outer tube | pipe and the needle part in the sheath assembly, (B) is the operation part on the proximal side. (C) is the state in which the follicular fossa is punctured by the needle part, (D) is the state in which the punctured needle part has been returned to the outer tube, and (E) is the dilator and the outside in the follicular hole. The state which inserted the sheath is shown. It is sectional drawing which shows the medical device which concerns on 4th Embodiment. It is sectional drawing which shows the state at the time of performing puncture with the medical device which concerns on 4th Embodiment, (A) is the state which inserted the outer tube | pipe and the needle part in the sheath assembly, (B) is the operation part to the proximal side. (C) shows a state in which the foveal fossa is punctured by the needle portion, and (D) shows a state in which a dilator and an outer sheath are inserted into the hole of the foveal fossa. It is sectional drawing which shows the medical device which concerns on 5th Embodiment. It is sectional drawing which shows the state at the time of puncturing with the medical device which concerns on 5th Embodiment, (A) is the state which inserted the outer tube | pipe and the needle part in the sheath assembly, (B) is the operation part to the proximal side. (C) is the state where the follicular fossa is punctured by the needle part, (D) is the state where the dilator and the outer sheath are inserted into the hole of the follicular fossa, (E) is the state where the punctured needle part is outside The state returned to the inside of the pipe is shown. It is a top view which shows the proximal part of the medical device which concerns on 6th Embodiment. It is sectional drawing which shows the proximal part of the medical device which concerns on 6th Embodiment, (A) is an initial state, (B) is the state which pulled the holding part, (C) shows the state which protruded the needle part. . It is a perspective view which shows the puncture adjustment part of the medical device which concerns on 6th Embodiment. It is a top view which shows the modification of the medical device which concerns on 3rd Embodiment, (A) is the state in which the hook part was accommodated in the outer tube, (B) is the state in which the hook part protruded from the outer tube, (C) Indicates a state in which the hook portion is accommodated in the outer tube.

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”.
<First Embodiment>

  The medical device 10 according to the first embodiment of the present invention has a state in which a hole leading from the right atrium R to the left atrium L (see FIG. 5) is widened by inserting a needle from the right atrium into the fossa of the atrial septum Used to hold in. When there is a hole in the foveal fossa, an ablation catheter inserted percutaneously into the vena cava can be guided to the right atrium and then inserted into the left atrium through the hole to ablate the periphery of the pulmonary vein mouth. That is, the medical device 10 is a device for forming an ablation catheter access route in the foveal fossa.

  As shown in FIGS. 1 to 3, the medical device 10 according to the first embodiment includes a needle assembly 20 having a long needle portion 30 and a sheath assembly 80 that houses the needle assembly 20. Yes.

  The needle assembly 20 can be inserted into and removed from the dilator 40. The needle assembly 20 includes a needle part 30, an outer tube 60 (long body) in which the needle part 30 is accommodated, and an operation unit 70 located at a proximal part of the outer tube 60. The sheath assembly 80 includes a dilator 40 (elongate body) and an outer sheath 50 that accommodates the dilator 40.

  The needle 30 includes a conical sharp puncture needle 31 at the distal end, a grip 32 provided at the proximal end, and a wire extending between the puncture needle 31 and the grip 32. A portion 33 is provided.

  The needle part 30 has a needle bending part 35 bent at a predetermined angle on the proximal side of the puncture needle 31. The angle β1 of the needle bending portion 35 with respect to the proximal portion is not particularly limited, but is, for example, 20 to 90 degrees, more preferably 30 to 80 degrees, and further preferably 40 to 70 degrees. The needle bending portion 35 plays a role of directing the puncture needle 31 of the needle portion 30 inserted into the right atrium toward the foveal fossa. The needle part 30 may be bent in advance or not. By bending in advance to an appropriate angle, sliding resistance with the bent outer tube 60 can be reduced, and puncture can be performed smoothly.

  Since the puncture needle 31 is conical, it is difficult to contact the inner peripheral surface of the outer tube 60 or the dilator 40 even in the bent outer tube 60 or the dilator 40. For this reason, damage to the outer tube 60 and the dilator 40 can be suppressed. The puncture needle 31 may have an end face 34 that is inclined with respect to the central axis, as in the modification shown in FIG. In this case, it is preferable that the sharp end portion is located on a side (lower side in FIG. 4) that is bent with respect to the proximal portion of the outer tube 60 or the dilator 40. Thereby, even if the sharp end part of the puncture needle 31 is the inside of the bent outer tube 60 or the dilator 40, it is hard to contact the inner peripheral surface of the outer tube 60 or the dilator 40. When the needle part 30 is moved to the distal side, the needle part 30 comes into strong contact with the side opposite to the side bent with respect to the proximal part of the outer tube 60 and the dilator 40, but the puncture needle 31 is placed on this side. The edge is not located. For this reason, the sharp end of the puncture needle 31 is unlikely to contact the inner peripheral surface of the outer tube 60 or the dilator 40, and damage to the outer tube 60 or the dilator 40 can be suppressed.

  The wire portion 33 is a long cylindrical wire extending to the proximal side of the puncture needle 31. In addition, the cross-sectional shape of the wire part 33 may not be circular.

  The grip portion 32 is a portion that is gripped by an operator and operates the needle portion 30 for puncturing. The grip portion 32 is fixed to the proximal side of the wire portion 33 and has an outer diameter larger than that of the wire portion 33. Since the grip part 32 has a larger outer diameter than the wire part 33, the operator can easily grip and operate it. The grip portion 32 may be a member integrated with the puncture needle 31 and the wire portion 33, but may be a different member.

  Although the length of the wire part 33 is set suitably, it is 500-1100 mm, for example. Although the outer diameter of the wire part 33 is set suitably, it is 0.5-1.0 mm, for example. Although the inclination angle α1 with respect to the central axis of the sharp end of the puncture needle 31 is appropriately set, it is, for example, 3 to 45 degrees, more preferably 5 to 40 degrees, and further preferably 10 to 35 degrees.

  The constituent material of the needle part 30 is preferably flexible and hard to some extent. For example, a shape memory alloy, stainless steel, tantalum, titanium, platinum, to which a shape memory effect or superelasticity is imparted by heat treatment, Metals such as gold and tungsten, polyolefins such as polyethylene and polypropylene, polyesters such as polyamide and polyethylene terephthalate, fluorine-based polymers such as ETFE, PEEK (polyether ether ketone), 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. The needle unit 30 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 needle part 30 may include an ultrasound 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 tube 60 accommodates the needle part 30 in a projectable manner. The outer tube 60 supports the needle portion 30 and prevents the needle portion 30 from bending when the long needle portion 30 protrudes, and suppresses a reduction in the pushing force of the needle portion 30. The outer tube 60 includes an outer tube shaft 61 that accommodates the needle unit 30, and an operation unit 70 that is connected to a proximal portion of the outer tube shaft 61. The outer tube 60 protects the living body from damage by protecting the tip of the needle part 30.

  The outer tube shaft 61 is a long tube body that accommodates the needle portion 30. The outer tube shaft 61 has an appropriate rigidity in order to apply a pushing force to the needle portion 30. The outer tube shaft 61 has an inner peripheral surface that slides smoothly with the needle portion 30. The outer tube shaft 61 accommodates the distal end portion of the puncture needle 31 so as not to protrude in a natural state where a force from a force generating portion 74 described later is not applied. The outer tube shaft 61 has an outer tube bending portion 62 bent at a predetermined angle at a distal portion in a natural state. The angle β2 of the outer tube bending portion 62 with respect to the proximal portion of the outer tube shaft 61 is not particularly limited, but is, for example, 20 to 90 degrees, more preferably 30 to 80 degrees, and further preferably 40 to 70 degrees. The outer tube bending part 62 plays a role of directing the puncture needle 31 of the needle part 30 inserted into the right atrium toward the foveal fossa. The outer peripheral edge of the distal end of the outer tube 60 is preferably machined into a curved surface so that it can be smoothly inserted into the dilator 40.

  The operation unit 70 is a portion on the proximal side of the outer tube 60. The operation unit 70 includes a first connection part 71 to which the dilator 40 is coupled, a port part 72 communicating with the inside of the first connection part 71, a seal part 73 disposed inside the first connection part 71, a needle And a force generation unit 74 that applies a force to the unit 30.

  The first connection portion 71 is a female connector that can be coupled to the second connection portion 41 (male connector) provided in the proximal portion of the dilator 40. By connecting the first connecting portion 71 to the dilator 40, the protruding length of the puncture needle 31 from the dilator 40 can be defined. The inner peripheral surface of the first connection portion 71 is continuous with the inner peripheral surface of the outer tube shaft 61. The port portion 72 communicates with the lumen of the outer tube shaft 61 inside the first connection portion 71. The port portion 72 has a three-way cock 75 at the end. By connecting a syringe or the like to the three-way cock 75, the lumen of the outer tube shaft 61 can be primed, or a contrast agent, a drug, or the like can be injected into the outer tube shaft 61. The first connecting portion 71 may be a member that is integral with the outer tube shaft 61, but may be a different member.

  The seal portion 73 is a member for sealing the lumen of the outer tube shaft 61. The seal portion 73 is disposed on the inner peripheral surface of the first connection portion 71 that continues from the outer tube shaft 61. The outer peripheral surface of the needle part 30 is slidably contacted. The seal part 73 is, for example, an O-ring. The O-ring suppresses blood from leaking from the gap between the outer tube 60 and the needle portion 30, and suppresses air from entering the body.

  The length of the outer tube shaft 61 is appropriately set, and is, for example, 400 to 1100 mm. The outer diameter of the outer tube shaft 61 is appropriately set, and is, for example, 1.0 to 1.5 mm. The inner diameter of the outer tube shaft 61 is appropriately set, and is, for example, 0.4 to 1.3 mm.

  The constituent material of the outer tube shaft 61 and the first connection portion 71 is preferably a flexible material, for example, a shape memory alloy, stainless steel, tantalum, titanium, to which a shape memory effect or superelasticity is imparted by heat treatment. Metals such as platinum, gold and tungsten, polyolefins such as polyethylene and polypropylene, polyesters such as polyamide and polyethylene terephthalate, fluorine polymers such as ETFE, PEEK (polyetheretherketone), and polyimide can be preferably used. Further, the outer tube shaft 61 may include an X-ray contrast material or an ultrasound contrast material. The outer tube shaft 61 and the first connecting portion 71 preferably have the same strength as the constituent material of the needle portion 30 so as not to be damaged by the needle portion 30.

  The force generation unit 74 is a coil spring (elastic body) that surrounds the wire portion 33 located between the grip portion 32 and the first connection portion 71. A distal end portion of the force generation portion 74 is fixed to the first connection portion 71. A proximal side end portion of the force generation portion 74 is fixed to the grip portion 32. The force generation part 74 has a reference length L0 along the axial direction of the needle part 30 in a natural state where no external force acts. The force generator 74 generates a contraction force that attempts to return to the reference length L0 by extending to a length longer than the reference length L0 (for example, the maximum length L1 in FIG. 6D). Further, the force generation unit 74 contracts to a length shorter than the reference length L0 (for example, the minimum length L2 in FIG. 7A), thereby generating an expansion force that attempts to return to the reference length L0. . The force generator 74 can be expanded and contracted within a predetermined range. Therefore, the force generation unit 74 has a maximum length L1 that can be expanded and a minimum length L2 that can be contracted. When the force generator 74 has the reference length L0, the puncture needle 31 at the distal portion of the needle portion 30 is positioned in the vicinity of the distal end portion of the outer tube shaft 61 in the outer tube shaft 61. When the force generating portion 74 reaches the maximum length L1, the needle portion 30 moves relative to the outer tube 60 toward the proximal side. As a result, the puncture needle 31 at the distal portion of the needle portion 30 moves proximally within the outer tube shaft 61. When the force generating portion 74 reaches the minimum length L1, the needle portion 30 moves relative to the outer tube 60 to the distal side. As a result, the puncture needle 31 protrudes more distally than the outer tube shaft 61.

  The force generator 74 may not be a coil spring as long as it generates a force to return to the original shape (or a shape close to the original shape) by extending or contracting from the reference length L0. . Therefore, the force generation unit 74 may be, for example, an elastic body, a member having a bellows structure made of an elastically deformable material, a cylinder or a balloon containing a compressive fluid, and the like. Examples of the elastic body include natural rubber, silicone rubber, and various elastomers.

  The dilator 40 is used to widen the hole in the foveal fossa opened by the needle part 30. The dilator 40 is a long tube body that accommodates the needle portion 30 and the distal portion of the outer tube 60. The dilator 40 has a taper portion 42 whose diameter decreases in a tapered shape toward the distal side at the distal end portion. The lumen of the dilator 40 opens at the end of the tapered portion 42 with the smallest diameter. The inclination angle α2 with respect to the central axis of the taper portion 42 is appropriately set, and is, for example, 1 to 20 degrees, more preferably 3 to 15 degrees, and further preferably 4 to 10 degrees. A second connection portion 41 that can be coupled to the first connection portion 71 of the outer tube 60 is provided on the outer peripheral surface of the proximal portion of the dilator 40. The 2nd connection part 41 is a male connector.

  The dilator 40 has a dilator distal portion 43 having a small inner diameter on the distal side and a dilator proximal portion 44 having a larger inner diameter than the dilator distal portion 43 on the proximal side. Between the dilator distal portion 43 and the dilator proximal portion 44, an inner diameter reduced diameter portion 45 whose inner diameter is reduced toward the distal side is provided. The inner peripheral surface of the dilator proximal portion 44 can be slidably in close contact with the outer peripheral surface of the outer tube shaft 61. In addition, the length of the dilator proximal portion 44 matches the length of the outer tube shaft 61. Therefore, when the outer tube shaft 61 is inserted into the dilator proximal portion 44, the outer tube shaft 61 is fixed at an accurate position with respect to the dilator 40. At this time, the distal end portion of the outer tube shaft 61 comes into contact with the inner diameter reduced diameter portion 45. The inner diameter reduced portion 45 is reduced in diameter toward the distal side. For this reason, when the outer tube shaft 61 abuts against the inner diameter reduced portion 45, the axis of the distal end of the outer tube shaft 61 and the axis of the inner diameter reduced portion 45 are exactly aligned. Therefore, the puncture needle 31 protruding from the outer tube shaft 61 can be smoothly guided to the dilator distal portion 43. The inner diameter of the dilator distal portion 43 is smaller than the inner diameter of the outer tube shaft 61 and larger than the outer diameter of the long portion of the needle portion 30. Accordingly, the position of the wire portion 33 and the puncture needle 31 is maintained inside the dilator distal portion 43 where the clearance is small while maintaining the slidability of the wire portion 33 well inside the outer tube shaft 61 where clearance is secured to some extent. Can be accurately defined. The length of the dilator distal portion 43 is set so that the needle portion 30 protruding from the outer tube shaft 61 can pass and protrude further to the distal side than the dilator 40. The dilator 40 has a dilator bending portion 46 bent at a predetermined angle at a distal portion in a natural state. The angle β3 of the dilator bending portion 46 with respect to the proximal portion of the dilator 40 is not particularly limited, but is, for example, 10 to 70 degrees, more preferably 20 to 60 degrees, and further preferably 30 to 50 degrees. The dilator bending portion 46 plays a role of directing the puncture needle 31 of the needle portion 30 inserted into the right atrium toward the foveal fossa. The position, angle and bending direction of the dilator bending portion 46 preferably coincide with the position, angle and bending direction of the outer tube bending portion 62 in a state where the dilator 40 and the outer tube 60 are connected.

  Although the length of the dilator 40 is set suitably, it is 400-1500 mm, for example. The outer diameter of the dilator 40 is set as appropriate, and is, for example, 2 to 6 mm. Although the internal diameter of the dilator distal part 43 is set suitably, it is 0.5-1.3 mm, for example. Although the internal diameter of the dilator proximal part 44 is set suitably, it is 1.0-2.0 mm, for example. The length of the dilator distal portion 43 is appropriately set, and is, for example, 1 to 15 mm, more preferably 5 to 13 mm, and still more preferably 8 to 12 mm. The clearance at the radius between the inner peripheral surface of the dilator distal portion 43 and the outer peripheral surface of the needle portion 30 is appropriately set, and is, for example, 0.03 to 0.1 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 outer sheath 50 provides the access route for the ablation catheter. 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 β4 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, 10 to 180 degrees, more preferably 30 to 150 degrees, and further preferably 45 to 135 degrees. The sheath bending part 52 plays a role of directing the puncture needle 31 of the needle part 30 inserted into the right atrium toward the foveal fossa.

  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 α3 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. The inner peripheral surface of the sheath body 51 preferably has a clearance between the outer peripheral surface of the dilator 40 and the outer peripheral surface of the dilator 40 so that the outer peripheral surface of the dilator 40 is slidably contacted.

  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 length of the sheath body 51 is set as appropriate, and is, for example, 400 to 1000 mm. The outer diameter of the sheath body 51 is set as appropriate, and is, for example, 2 to 5 mm. The inner diameter of the sheath body 51 is set as appropriate, and is, for example, 1.5 to 4 mm. The clearance at the radius 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, 0.1 to 0.5 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. In addition, the constituent material of the sheath body 51 may include an X-ray contrast material, an ultrasonic contrast material, a metal blade, and a coil.

  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 where the needle portion 30, the outer tube 60, the dilator 40, and the outer sheath 50 are combined, the positions, bending directions, and bending angles of the needle bending portion 35, the outer tube bending portion 62, the dilator bending portion 46, and the sheath bending portion 52 are as follows. It is preferable to match or approximately match. Thereby, the puncture needle 31 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 foveal fossa O using the medical device 10 according to the first 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, and the guide wire 90 is inserted into the lumen 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 up to the right atrium R as shown in FIG. 5 and FIG. Thereafter, the guide wire 90 is removed from the sheath assembly 80 as shown in FIG.

  Next, as shown in FIG. 6C, the needle assembly 20 is inserted into the lumen of the dilator 40 from the proximal side of the dilator 40. At this time, since the puncture needle 31 is completely accommodated inside the outer tube shaft 61, damage to the dilator 40 can be suppressed. Next, the needle assembly 20 is pushed forward, the distal end portion of the outer tube shaft 61 is abutted against the inner diameter reduced portion 45 of the dilator 40, and the first connection portion 71 and the second connection portion 41 are connected. Thereby, the needle assembly 20 is accurately positioned with respect to the dilator 40. Thereafter, the distal end of the dilator 40 is abutted against the fossa ovum O while confirming the position of the dilator 40 under X-ray or ultrasonic fluoroscopy. Thereby, the oval fossa O will be in the state protruded by being pushed to the left atrium L side. At this time, since the distal portions of the outer sheath 50, the dilator 40, and the outer tube 60 are bent, the distal end portion of the dilator 40 can be easily directed to the foveal fossa O.

  Next, as illustrated in FIG. 6D, the operation unit 70 located outside the body is held, and the grasping unit 32 is moved to the proximal side. As a result, the force generation unit 74 extends, and the puncture needle 31 moves to the proximal side in the outer tube shaft 61. Next, when the gripping portion 32 is released, the force generating portion 74 contracts beyond the reference length L0 by its own contracting force, as shown in FIG. As a result, the puncture needle 31 moves from the outer tube shaft 61 to the inside of the dilator distal portion 43 and further protrudes from the dilator 40 to the distal side. Thereby, the puncture needle 31 punctures the oval fossa O. At this time, the outer tube 60 supports the needle portion 30 and suppresses the bending of the needle portion 30, and suppresses the reduction of the pushing force of the puncture needle 31. Moreover, since the inner diameter of the dilator distal portion 43 is smaller than the inner diameter of the outer tube shaft 61, the puncture needle 31 that passes through the dilator distal portion 43 protrudes while maintaining an accurate position. The puncture needle 31 is supported by the inner peripheral surface of the dilator distal portion 43 even if it receives a reaction force during puncturing, and therefore the position is not easily displaced, and an accurate position can be punctured. In addition, since the force generating portion 74 has a minimum length L2 that can be contracted, the puncture needle 31 has a maximum protrusion length that can be protruded. For this reason, it is possible to prevent the puncture needle 31 from being erroneously punctured to an unintended position.

  When the puncture needle 31 penetrates the foveal fossa O, a part of the distal end portion of the dilator 40 that has pressed the foveal fossa O to the left atrium L side enters the 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. Thereafter, the force generating unit 74 that has once contracted beyond the reference length L0 extends to return to the reference length L0. Accordingly, as shown in FIG. 7B, the puncture needle 31 automatically returns to the inside of the outer tube shaft 61, and the state where the puncture needle 31 protrudes from the dilator 40 is not maintained. For this reason, safety is ensured. In addition, when returning from the contracted state, the force generation unit 74 may extend beyond the reference length L0 and contract again beyond the reference length L0. That is, the force generator 74 may repeat reciprocating motion by vibrating depending on design conditions. However, even in that case, since the energy of the force generating unit 74 is consumed by the resistance that the needle unit 30 receives from the seal unit 73, the outer tube 60, the dilator 40, the oval fossa O, blood, and the like, the puncture needle 31 does not protrude distally from the dilator 40. In other words, the medical device 10 is designed such that the puncture needle 31 does not protrude from the dilator 40 again due to the reciprocating motion of the force generation unit 74.

  Next, the operation part 70 outside the body is pushed in, and the medical device 10 is moved to the distal side. As a result, as shown in FIG. 7C, the tapered portion 42 of the dilator 40 and the sheath tapered portion 53 of the outer sheath 50 pass through the ovary fossa O while expanding the hole of the ovary 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. Further, when the oval fossa O is punctured by the puncture needle 31, a part of the tapered portion 42 of the dilator 40 has entered the hole of the oval fossa O, so that the dilator 40 and the outer sheath 50 are connected to the oval fossa. It is easy to push into the O hole.

  Next, as shown in FIG. 7D, the needle assembly 20 and the dilator 40 are removed from the body, 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, an electrode catheter, a diagnostic catheter or the like 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 an ablation catheter, when the ablation catheter and the outer sheath 50 are removed from the body, the hole of the oval fossa O contracts. This completes the procedure.

  As described above, the medical device 10 according to the first embodiment is a medical device 10 that is inserted into a living body lumen, punctures a living tissue, and holds the punctured hole that is opened. A long needle portion 30 having flexibility, and a tubular long body (outer tube 60 or dilator 40) having flexibility, which accommodates the needle portion 30 so as to be able to protrude to the distal side, A force generating portion 74 provided on the proximal side of the elongated body, and acting on the needle portion 30 toward the proximal side from a state in which the needle portion 30 protrudes from the elongated body; In the medical device 10 configured as described above, a force acts in a direction in which the needle part 30 is accommodated in the elongated body by the needle part 30 protruding. For this reason, the needle part 30 does not protrude more than necessary, and erroneous puncture can be suppressed and safety can be improved. Moreover, since the force generation part 74 is provided in the proximal side of a long body, it can arrange | position outside a living body, compared with the case where it arrange | positions in a living body, a structure is rational and easy to implement | achieve.

  Moreover, the force generation part 74 can make the force which makes the needle part 30 in the state accommodated in the elongate body protrude from the outer tube 60 to the distal side. Thereby, the force generation part 74 can make the needle part 30 protrude to the distal side from the state accommodated in the elongate body. For this reason, the force generation part 74 can make force act so that the needle part 30 may protrude from a long body, and the needle part 30 which protruded from the long body may be accommodated in a long body. Therefore, the force generating part 74 can realize the puncture of the oval fossa O and the accommodation of the needle part 30 by the needle part 30 by a continuous series of operations, and the operability is improved.

  The elongate body may be a dilator 40 in which the outer diameter of the distal end portion gradually decreases toward the distal side. Thereby, the dilator 40 can be smoothly inserted into the hole of the oval fossa O vacated by the needle part 30, and the hole of the oval fossa O can be easily expanded.

  The long body may be an outer tube 60 that can be detachably accommodated in the dilator 40 and that slidably accommodates the needle portion 30. Thereby, the needle part 30 and the outer pipe 60 can be attached to and detached from the dilator 40 while the needle part 30 is accommodated in the outer pipe 60 to ensure safety. For this reason, after guiding the dilator 40 to a predetermined position using the guide wire 90 or the like, the outer tube 60 and the needle portion 30 can be attached to the dilator 40. Can be removed. For this reason, various operations are possible, and the operability is improved.

  Further, the force generation part 74 is an elastic body that can be elastically deformed along the axial direction of the needle part 30. Thereby, the needle part 30 can be easily moved along an axial direction using the elastic force of an elastic body.

  Further, the force generation unit 74 has a reference length L0 in a natural state where no external force acts, and the force generation unit 74 has a reference length L0 that is longer than the reference length L0 by its own elastic force. By contracting to a shorter length, a force projecting distally is applied to the needle portion 30. Thereby, the needle part 30 can be protruded to the distal side by the elastic contraction force of the force generation part 74 by opening the force generation part 74 after extending it longer than the reference length L0.

  Moreover, the force generation part 74 makes the force toward the proximal side act on the needle part 30 by approaching a natural state by its own elastic force from a state shorter than the reference length L0. Thus, after causing the needle portion 30 to protrude distally by the contraction force of the force generating portion 74, the needle portion 30 is automatically moved to the outer tube 60 using the elastic restoring force of the force generating portion 74. Can be accommodated.

  Further, the proximal end of the elastic body, which is the force generating portion 74, is connected to the needle part 30, and the distal end of the elastic body is connected to the outer tube 60 (long body). . For this reason, when the needle part 30 moves to the proximal side with respect to the outer tube | pipe 60, an elastic body expand | extends and contractile force generate | occur | produces in an elastic body. Thereafter, the needle 30 can be protruded from the outer tube 60 to the distal side by opening the elastic body. Note that the distance between the proximal end of the elastic body and the distal end of the needle 30 is constant (substantially constant) even if the elastic body is deformed. On the other hand, the distance between the distal end portion of the elastic body and the distal end portion of the needle portion 30 changes when the elastic body is deformed.

The present invention also includes a treatment method for puncturing the oval fossa O (biological tissue) in vivo using the above-described medical device 10 and holding the punctured hole in an expanded state. . The treatment method includes a step of inserting a long body (the outer tube 60 or the dilator 40) and the needle part 30 into the ovary fossa O, and a needle part 30 protruding from the long body to puncture the ovary fossa O. And a step of applying a force toward the proximal side to the proximal portion of the protruding needle portion 30 by the force generating portion 74 and a step of accommodating the needle portion 30 in the elongated body. In the treatment method configured as described above, a force toward the proximal side is applied to the proximal portion of the needle portion 30 that protrudes and punctures the oval fossa O, so that the needle portion 30 does not protrude more than necessary. For this reason, the erroneous puncture by the needle part 30 can be suppressed and safety can be improved.
Second Embodiment

  The medical device 100 according to the second embodiment is different from the first embodiment only in that the inner tube 120 is provided between the outer tube 60 and the needle part 30. In addition, the same code | symbol is attached | subjected to the site | part which has a function similar to 1st Embodiment, and description is abbreviate | omitted.

  As shown in FIG. 8, the needle assembly 110 of the medical device 100 according to the second embodiment is positioned between the needle unit 30, the outer tube 60, the operation unit 70, and the outer tube shaft 61 and the needle unit 30. And an inner tube 120 that is a tubular body. The inner peripheral surface of the inner tube 120 is slidable with the outer peripheral surface of the needle part 30. The outer peripheral surface of the inner tube 120 is slidable with the inner peripheral surface of the outer tube shaft 61. The proximal portion of the inner tube 120 is located between the grip portion 32 and the first connection portion 71 through the seal portion 73. The proximal portion of the inner tube 120 has a large diameter portion 121 having a large outer diameter. The large-diameter portion 121 has a size that cannot be accommodated in the lumen of the first connecting portion 71. The term “unaccommodable” means that at least a part of the large diameter portion 121 exceeds the shape of the first connecting portion 71, and in order to accommodate the entire large diameter portion 121, the large diameter portion 121 is deformed. Or it means a condition that needs to be destroyed. In the present embodiment, the outer diameter of the large diameter portion 121 is larger than the inner diameter of the first connection portion 71. The proximal end portion of the inner tube 120 can contact the movement restricting portion 130 that is the distal surface of the grip portion 32. When the needle part 30 and the grip part 32 move relatively distally with respect to the outer tube 60, the movement restricting part 130 contacts the proximal end of the inner tube 120, and the needle of the inner tube 120. Limiting proximal movement relative to portion 30. In addition, when the needle part 30 and the grip part 32 move relative to the outer tube 60 relative to the outer tube 60, the movement restricting unit 130 moves to the distal side relative to the needle unit 30 of the inner tube 120. Allow unrestricted movement.

  The inner tube 120 has an inner tube taper portion 122 whose diameter is tapered toward the distal side at the distal end. The lumen of the inner tube 120 is open at the end of the inner tube taper portion 122 with the smallest diameter. The inclination angle α4 with respect to the central axis of the inner tube taper portion 122 is appropriately set, and is, for example, 5 to 90 degrees, more preferably 10 to 60 degrees, and further preferably 15 to 45 degrees. In a state where the proximal end portion of the inner tube 120 is in contact with the movement restricting portion 130 of the grasping portion 32, the inner tube taper portion 122 is located on the proximal side of the puncture needle 31 and the inclined surface of the puncture needle 31. And can be positioned to be continuous.

  The constituent material of the inner tube 120 is preferably a flexible material, for example, polyolefins such as polyethylene and polypropylene, polyesters such as polyamide and polyethylene terephthalate, fluorine-based polymers such as ETFE, PEEK (polyetheretherketone). ), Polyimide, shape memory alloy, stainless steel, tantalum, titanium, platinum, gold, tungsten, and other metals can be suitably used.

  Next, a method for providing an access route for an ablation catheter by opening a hole in the foveal fossa O using the medical device 100 according to the second embodiment will be described.

  First, similarly to the method described in the first embodiment, the distal portion of the sheath assembly 80 is gradually pushed up to the right atrium R, and the guide wire 90 is removed from the sheath assembly 80 (FIGS. 6A and 6B). See B)).

  Next, the needle assembly 110 is inserted into the lumen of the dilator 40 from the proximal side of the dilator 40. Thereafter, the distal end of the dilator 40 is abutted against the fossa fossa O. As a result, as shown in FIG. 9A, the foveal fossa O is pushed to the left atrium L side and protrudes.

  Next, as illustrated in FIG. 9B, the operation unit 70 located outside the body is held, and the grasping unit 32 is moved to the proximal side. As a result, the force generation unit 74 extends, and the puncture needle 31 and the inner tube 120 move proximally in the outer tube shaft 61. The proximal end portion of the inner tube 120 is in contact with the movement restricting portion 130 of the grip portion 32. Next, when the gripping portion 32 is released, the force generating portion 74 contracts beyond the reference length L0 by its own contracting force as shown in FIG. 9C. At this time, the movement restricting portion 130 of the grip portion 32 contacts the proximal end portion of the inner tube 120 and restricts the movement of the inner tube 120 relative to the needle portion 30 to the proximal side. 120 is moved distally. As a result, the puncture needle 31 and the inner tube 120 move from the outer tube shaft 61 to the inside of the dilator distal portion 43 and further protrude from the dilator 40 to the distal side. Thereby, the puncture needle 31 and the inner tube 120 puncture the oval fossa O. At this time, since the inner tube 120 has the inner tube taper portion 122, it can be smoothly inserted into the foveal fossa O together with the puncture needle 31. Further, since the inner diameter of the dilator distal portion 43 is smaller than the inner diameter of the outer tube shaft 61, the puncture needle 31 and the inner tube 120 that pass through the dilator distal portion 43 protrude while maintaining an accurate position. Since the puncture needle 31 and the inner tube 120 are supported by the inner peripheral surface of the dilator distal portion 43 even when a reaction force is applied during puncturing, the puncture needle 31 and the inner tube 120 can puncture an accurate position without being displaced.

  When the puncture needle 31 penetrates the foveal fossa O, a part of the distal end portion of the dilator 40 that has pressed the foveal fossa O to the left atrium L side enters the 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. Thereafter, the force generating unit 74 that has once contracted beyond the reference length L0 extends to return to the reference length L0. 9D, the puncture needle 31 automatically returns to the inside of the outer tube shaft 61, and the state where the puncture needle 31 protrudes from the dilator 40 is not maintained. For this reason, safety is ensured. At this time, the movement restricting portion 130 allows the movement of the inner tube 120 relative to the needle portion 30 relative to the distal side without restricting. Furthermore, the movement of the inner tube 120 is restricted by friction with the penetrating oval fossa O. For this reason, the inner tube 120 does not move proximally together with the needle part 30. For this reason, the inner tube 120 is maintained in a state of penetrating the oval fossa O to the left atrium L side. Since the inner tube 120 has the large-diameter portion 121 that cannot be inserted into the lumen of the first connection portion 71, the inner tube 120 does not fall out into the body, and safety can be ensured.

  Next, the operation unit 70 outside the body is pushed in, and the medical device 100 is moved to the distal side. As a result, as shown in FIG. 9E, the taper portion 42 of the dilator 40 and the sheath taper portion 53 of the outer sheath 50 pass through the ovary fossa O while expanding the hole of the ovary fossa O, and the left atrium L To reach. At this time, since a part of the taper portion 42 of the dilator 40 has entered the hole of the oval fossa O, it is easy to push the dilator 40 and the outer sheath 50 into the hole of the oval fossa O. Further, since the inner tube 120 penetrates the oval fossa O, the dilator 40 and the outer sheath 50 can be accurately and quickly pushed into the hole of the oval fossa O along the inner tube 120. Further, the use of a wire or the like can prevent the inner tube from coming off.

  Next, leaving the outer sheath 50, the needle assembly 110 and the dilator 40 are removed from the body. The hole of the oval fossa O expanded by the dilator 40 and the outer sheath 50 is maintained by the outer sheath 50 as in the first embodiment (see FIG. 7D). 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 an ablation catheter, when the ablation catheter and the outer sheath 50 are removed from the body, the hole of the oval fossa O contracts. This completes the procedure.

As described above, the medical device 100 according to the second embodiment is a tubular body that is located on the radially inner side of the outer tube 60 and on the radially outer side of the needle portion 30, with respect to the outer tube 60 and the needle portion 30. The inner tube 120 is relatively movable in the axial direction, and when the needle portion 30 protrudes distally from the outer tube 60, the inner tube 120 moves proximally relative to the needle portion 30. And a movement restricting portion 130 that allows the inner tube 120 to move relative to the needle portion 30 when the needle portion 30 moves distally with respect to the outer tube 60. . Thereby, when the needle part 30 protrudes from the dilator 40, the movement to the proximal side of the inner tube 120 with respect to the needle part 30 is restricted, and the inner tube 120 penetrates the foveal fossa O together with the needle part 30. When the needle portion 30 returns to the dilator 40, the inner tube 120 is allowed to move distally together with the needle portion 30 because the distal movement of the inner tube 120 relative to the needle portion 30 is allowed. In other words, the state where the inner tube 120 has penetrated the oval fossa O is maintained. For this reason, after the puncture by the needle part 30 is completed, even if the needle part 30 is accommodated in the outer tube 60 for safety, the state where the inner tube 120 penetrates the foveal fossa O can be maintained. Therefore, the access route of the ablation catheter can be secured quickly and reliably by inserting the dilator 40 and the outer sheath 50 along the inner tube 120 into the hole of the oval fossa O.
<Third Embodiment>

  The medical device 200 according to the third embodiment is different from the first embodiment only in that the needle portion 220 has a through hole 221 and the holding wire 230 is inserted into the through hole 221. In addition, the same code | symbol is attached | subjected to the site | part which has a function similar to 1st Embodiment, and description is abbreviate | omitted.

  As illustrated in FIG. 10, the needle assembly 210 of the medical device 200 according to the third embodiment is inserted into the outer tube 60, the operation unit 70, the needle unit 220 having a through hole, and the through hole 221. A wire 230 is included.

  The needle part 220 has a puncture needle 222 cut at an angle with respect to the central axis at the distal end. The needle part 220 has a through hole 221 that penetrates from the distal side to the proximal side. The inclination angle α5 with respect to the central axis of the puncture needle 222 is appropriately set, and is, for example, 5 to 90 degrees, more preferably 10 to 60 degrees, and further preferably 15 to 45 degrees.

  The holding wire 230 has a wire part 231 slidably received in the through hole 221 of the needle part 220 and a holding part 232 fixed to the distal side of the wire part 231. The holding part 232 is located on the distal side of the inclined end face of the puncture needle 222. When puncturing with the puncture needle 222, the position of the most distal side of the holding portion 232 is located more proximal than the position of the most distal side of the puncture needle 222. The holding part 232 has a size that cannot be accommodated in the through hole 221 of the needle part 220. Note that “cannot be accommodated” means that the shape of the holding portion 232 exceeds the shape of the through hole 221 of the needle portion 220, and in order to accommodate the entire holding portion 232 in the through hole 221 of the needle portion 220, It means a state where 232 needs to be deformed or destroyed. Further, the holding portion 232 can be accommodated in the inner cavity of the outer tube shaft 61. As a result, the holding portion 232 can be positioned more distally than the puncture needle 222 in the lumen of the outer tube shaft 61. The holding portion 232 has a size that can pass through the lumen of the dilator distal portion 43. Thereby, when the puncture needle 222 protrudes, the holding portion 232 can pass through the lumen of the dilator distal portion 43 together with the puncture needle 222.

  The constituent material of the holding wire 230 is preferably a flexible material. For example, polyolefin such as polyethylene and polypropylene, polyester such as polyamide and polyethylene terephthalate, fluorine-based polymer such as ETFE, PEEK (polyether ether ketone) ), Polyimide, shape memory alloy, stainless steel, tantalum, titanium, platinum, gold, tungsten, and other metals can be suitably used.

  Next, a method for providing an access route for an ablation catheter by opening a hole in the foveal fossa O using the medical device 200 according to the third embodiment will be described.

  First, similarly to the method described in the first embodiment, the distal portion of the sheath assembly 80 is gradually pushed up to the right atrium R, and the guide wire 90 is removed from the sheath assembly 80 (FIGS. 6A and 6B). See B)).

  Next, the needle assembly 210 is inserted into the lumen of the dilator 40 from the proximal side of the dilator 40. Thereafter, the distal end of the dilator 40 is abutted against the fossa fossa O. Thereby, as shown in FIG. 11A, the foveal fossa O is pushed to the left atrium L side and protrudes.

  Next, as illustrated in FIG. 11B, the operation unit 70 located outside the body is held, and the gripping unit 32 is moved to the proximal side. As a result, the force generation unit 74 extends, and the puncture needle 222 and the holding wire 230 move proximally in the outer tube shaft 61. Next, when the gripping portion 32 is released, the force generating portion 74 contracts beyond the reference length L0 by its own contracting force as shown in FIG. 9C. At this time, the inclined end surface of the puncture needle 222 contacts the holding portion 232 of the holding wire 230 and moves the holding wire 230 to the distal side. As a result, the puncture needle 222 and the holding wire 230 move from the outer tube shaft 61 to the inside of the dilator distal portion 43 and further protrude from the dilator 40 to the distal side. Thereby, the puncture needle 222 punctures the oval fossa O. At this time, since the outer diameter of the holding portion 232 is smaller than the inner diameter of the dilator distal portion 43, the holding portion 232 can pass through the dilator distal portion 43. Further, since the puncture needle 222 has an inclined end surface, even if the holding portion 232 is located on the distal side of the puncture needle 222, the most distal portion of the puncture needle 222 is located on the distal side of the holding portion 232. can do. For this reason, the puncture with the puncture needle 222 is not hindered by the holding part 232.

  When the puncture needle 222 and the holding portion 232 pass through the foveal fossa O, a part of the distal end of the dilator 40 that has pressed the foveal fossa O toward the left atrium L is opened in the foveal fossa O. Get into the hole. Note that a part of the dilator 40 may not enter the hole of the oval fossa O. Thereafter, the force generating unit 74 that has once contracted beyond the reference length L0 extends to return to the reference length L0. Accordingly, as shown in FIG. 11D, the puncture needle 222 automatically returns to the inside of the outer tube shaft 61, and the state where the puncture needle 222 protrudes from the dilator 40 is not maintained. For this reason, safety is ensured. At this time, the holding portion 232 having an outer diameter larger than that of the wire portion 231 is allowed to move proximally relative to the needle portion 220. For this reason, the holding | maintenance part 232 is hooked by the oval fossa O, and is maintained in the state which penetrated the oval fossa O to the left atrium L side.

  Next, the operation unit 70 outside the body is pushed in, and the medical device 200 is moved to the distal side. Accordingly, as shown in FIG. 11E, the tapered portion 42 of the dilator 40 and the sheath tapered portion 53 of the outer sheath 50 pass through the ovary fossa O while expanding the hole of the ovary fossa O, and the left atrium L To reach. At this time, since a part of the taper portion 42 of the dilator 40 has entered the hole of the oval fossa O, it is easy to push the dilator 40 and the outer sheath 50 into the hole of the oval fossa O. Further, since the holding wire 230 passes through the foveal fossa O, the dilator 40 and the outer sheath 50 can be accurately and quickly pushed into the hole of the foveal fossa O along the holding wire 230.

  Next, leaving the outer sheath 50, the needle assembly 210 and the dilator 40 are removed from the body. The hole of the oval fossa O expanded by the dilator 40 is maintained by the outer sheath 50 as in the first embodiment (see FIG. 7D). 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 an ablation catheter, when the ablation catheter and the outer sheath 50 are removed from the body, the hole of the oval fossa O contracts. This completes the procedure.

As described above, in the medical device 200 according to the third embodiment, the needle part 220 is a tubular body, the medical device 200 has the holding wire 230 inserted into the lumen of the needle part 220, and the holding wire 230 is The wire portion 231 is slidably inserted into the lumen of the needle portion 220, and the holding portion 232 is fixed to the distal side of the wire portion 231, and the holding portion 232 is more than the needle portion 220. It is located on the distal side and has a size that cannot be accommodated in the lumen of the needle portion 220. Thereby, when the needle part 220 protrudes from the outer tube 60, the holding part 232 cannot be accommodated in the lumen of the needle part 220. The oval fossa O is penetrated together with the portion 220. Thereafter, when the needle part 220 returns to the inside of the outer tube 60, the holding part 232 is hooked and held in the ovary fossa O, and the wire part 231 penetrates the ovary fossa O to the left atrium L side. Maintained. For this reason, even after the puncture by the needle portion 220 is completed, even if the needle portion 220 is accommodated in the outer tube 60 for safety, the state in which the holding wire 230 penetrates the foveal fossa O can be maintained. For this reason, the access route of the ablation catheter can be secured quickly and reliably by inserting the dilator 40 and the outer sheath 50 along the holding wire 230 into the hole of the oval fossa O.
<Fourth embodiment>

  The medical device 300 according to the fourth embodiment is different from the first embodiment only in that a hook portion 321 is provided on the needle portion 320. In addition, the same code | symbol is attached | subjected to the site | part which has a function similar to 1st Embodiment, and description is abbreviate | omitted.

  The needle assembly 310 of the medical device 300 according to the fourth embodiment includes a needle part 320, an outer tube 60, and an operation part 70, as shown in FIG. The needle part 320 has a small-diameter part 323 whose outer diameter is partially reduced at the distal part. The needle part 320 has a small diameter part 323 whose outer diameter is small at a position where it can protrude from the dilator 40. The small diameter part 323 has a hook part 321 whose outer diameter decreases toward the proximal side and an inclined part 322 whose outer diameter decreases toward the distal side. The hook portion 321 is located on the distal side of the inclined portion 322. The hook portion 321 has a short length toward the proximal side, and the outer diameter decreases. On the other hand, the inclined portion 322 has a longer length than the hooking portion 321 and the outer diameter decreases toward the distal side. Therefore, when the needle part 320 moves distally and penetrates the puncture object, the inclined part 322 having a small inclination has a small contact resistance received from the puncture object and can easily pass through the puncture object. is there. On the other hand, when the needle part 320 penetrating the puncture target moves to the proximal side, the hook part 321 having a large inclination has a large contact resistance received from the puncture target, and thus it is difficult to pass through the puncture target. is there. The inclination angle θ1 of the hook portion 321 with respect to the central axis of the needle portion 320 can be set as appropriate, and is, for example, 45 to 135 degrees, more preferably 60 to 120 degrees, and further preferably 75 to 105 degrees. Although the inclination angle θ2 of the inclined part 322 with respect to the central axis of the needle part 320 can be set as appropriate, it is, for example, 40 to 130 degrees, more preferably 60 to 120 degrees, and further preferably 75 to 115 degrees.

  Next, a method for providing an access route for an ablation catheter by opening a hole in the foveal fossa O using the medical device 300 according to the fourth embodiment will be described.

  First, similarly to the method described in the first embodiment, the distal portion of the sheath assembly 80 is gradually pushed up to the right atrium R, and the guide wire 90 is removed from the sheath assembly 80 (FIGS. 6A and 6B). See B)).

  Next, the needle assembly 310 is inserted into the lumen of the dilator 40 from the proximal side of the dilator 40. Thereafter, the distal end of the dilator 40 is abutted against the fossa fossa O. Thereby, as shown to FIG. 13 (A), the oval fossa O will be in the state protruded by being pushed to the left atrium L side.

  Next, as shown in FIG. 13B, the operation unit 70 located outside the body is held, and the gripping unit 32 is moved to the proximal side. As a result, the force generation unit 74 extends, and the puncture needle 31 moves to the proximal side in the outer tube shaft 61. Next, when the gripping portion 32 is released, the force generating portion 74 contracts beyond the reference length L0 by its own contracting force, as shown in FIG. As a result, the puncture needle 31 moves from the outer tube shaft 61 to the inside of the dilator distal portion 43 and further protrudes from the dilator 40 to the distal side. Thereby, the puncture needle 31 punctures the oval fossa O. At this time, since the inclined portion 322 of the needle portion 320 has a small inclination, it can pass through the puncture target.

  When the puncture needle 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 the 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. After that, the force generating unit 74 that has once contracted beyond the reference length L0 tries to expand so as to return to the reference length L0. Thereby, the puncture needle 31 automatically moves to the proximal side. At this time, the hook portion 321 having a large inclination is caught in the foveal fossa O and cannot pass through the foveal fossa O. However, since the puncture needle 31 is in a state of being pulled proximally by the force generation unit 74, erroneous puncture is suppressed.

  Next, the operation unit 70 outside the body is pushed in, and the medical device 300 is moved to the distal side. As a result, as shown in FIG. 13D, the tapered portion 42 of the dilator 40 and the sheath tapered portion 53 of the outer sheath 50 pass through the ovary fossa O while expanding the hole of the ovary fossa O, and the left atrium L To reach. At this time, since the puncture needle is in a state of being pulled proximally by the force generation unit 74, the puncture needle is gradually housed inside the dilator 40 as the dilator 40 approaches the left atrium L. For this reason, even if the medical device 300 is moved to the distal side, the puncture needle does not protrude more than necessary, and erroneous puncture by the puncture needle can be suppressed.

  When the distal portion of the dilator 40 reaches the inside of the left atrium L, the hooked portion 321 is released from being caught on the fossa ovum O. Thereby, as shown in FIG. 13D, the puncture needle 31 automatically returns to the inside of the outer tube shaft 61, and the state where the puncture needle 31 protrudes from the dilator 40 is not maintained. For this reason, safety is ensured. At this time, since a part of the taper portion 42 of the dilator 40 has entered the hole of the oval fossa O, it is easy to push the dilator 40 and the outer sheath 50 into the hole of the oval fossa O. Further, since the puncture needle penetrates the oval fossa O, the dilator 40 and the outer sheath 50 can be accurately and quickly pushed into the hole of the oval fossa O along the puncture needle.

  Next, the needle assembly 310 and the dilator 40 are 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 as in the first embodiment (see FIG. 7D). 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 an ablation catheter, when the ablation catheter and the outer sheath 50 are removed from the body, the hole of the oval fossa O contracts. This completes the procedure.

As described above, in the medical device 300 according to the fourth embodiment, the needle part 320 has the hook part 321 whose outer diameter decreases toward the proximal side at a position where it can protrude from the dilator 40. Thereby, after the needle part 320 protrudes from the dilator 40 and stabs into the oval fossa O, the hook part 321 is hooked on the oval fossa O by returning to the proximal side. For this reason, the needle part 320 is prevented from coming out of the ovary fossa O after the needle part 320 is pierced into the ovary fossa O. For this reason, the access route of the ablation catheter can be secured quickly and reliably by inserting the dilator 40 and the outer sheath 50 into the hole of the oval fossa O along the needle portion 320.
<Fifth Embodiment>

  The medical device 400 according to the fifth embodiment is different from the first embodiment only in that the hook portion 421 is provided on the needle portion 420. In addition, the same code | symbol is attached | subjected to the site | part which has a function similar to 1st Embodiment, and description is abbreviate | omitted.

  As shown in FIG. 14, the needle assembly 410 of the medical device 400 according to the fifth embodiment includes a needle part 420, an outer tube 60, and an operation part 70. The needle portion 420 has a hook portion 421 that is bent in a natural state where the outer diameter is smaller than the proximal portion and no external force acts at a position where the needle portion 420 can protrude from the dilator 40. The hook portion 421 is housed inside the outer tube shaft 61 in a state of being elastically deformed and extended. When the hook portion 421 protrudes from the dilator 40, it elastically returns to its original shape and bends. Then, the hooking portion 421 that protrudes and bends is housed in the dilator 40 or the outer tube 60 to be elastically deformed and extended. In the natural state, the inclination angle of the hook portion 421 with respect to the proximal portion of the needle portion 420 can be set as appropriate, but is, for example, 30 to 135 degrees, more preferably 45 to 105 degrees, and further preferably 60 to 90 degrees. .

  Next, a method for providing an access route for an ablation catheter by opening a hole in the foveal fossa O using the medical device 400 according to the fifth embodiment will be described.

  First, similarly to the method described in the first embodiment, the distal portion of the sheath assembly 80 is gradually pushed up to the right atrium R, and the guide wire 90 is removed from the sheath assembly 80 (FIGS. 6A and 6B). See B)).

  Next, the needle assembly 410 is inserted into the lumen of the dilator 40 from the proximal side of the dilator 40. Thereafter, the distal end of the dilator 40 is abutted against the fossa fossa O. Thereby, as shown to FIG. 15 (A), the oval fossa O will be in the state protruded by being pushed to the left atrium L side.

  Next, as shown in FIG. 15B, the operation unit 70 located outside the body is held, and the gripping unit 32 is moved to the proximal side. As a result, the force generation unit 74 extends, and the puncture needle 31 moves to the proximal side in the outer tube shaft 61. Next, when the gripping portion 32 is released, the force generating portion 74 contracts beyond the reference length L0 by its own contracting force, as shown in FIG. As a result, the puncture needle 31 moves from the outer tube shaft 61 to the inside of the dilator distal portion 43 and further protrudes from the dilator 40 to the distal side. Thereby, the puncture needle 31 is pierced into the oval fossa O, returning to the original bent shape.

  When the puncture needle 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 the 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. After that, the force generating unit 74 that has once contracted beyond the reference length L0 tries to expand so as to return to the reference length L0. Thereby, the puncture needle 31 automatically moves to the proximal side. At this time, the bent hook portion 421 is caught in the foveal fossa O and cannot pass through the foveal fossa O. However, since the puncture needle 31 is in a state of being pulled proximally by the force generation unit 74, erroneous puncture is suppressed.

  Next, the operation unit 70 outside the body is pushed in, and the medical device 400 is moved to the distal side. As a result, as shown in FIG. 15D, 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 puncture needle 31 is in a state of being pulled proximally by the force generation unit 74, the puncture needle 31 is gradually housed inside the dilator 40 as the dilator 40 approaches the left atrium L. For this reason, even if the medical device 400 is moved to the distal side, the puncture needle 31 does not protrude more than necessary, and erroneous puncture by the puncture needle 31 can be suppressed. In addition, since a part of the tapered portion 42 of the dilator 40 enters the hole of the oval fossa O, it is easy to push the dilator 40 and the outer sheath 50 into the hole of the oval fossa O. Further, since the puncture needle penetrates the oval fossa O, the dilator 40 and the outer sheath 50 can be accurately and quickly pushed into the hole of the oval fossa O along the puncture needle.

  When the distal portion of the dilator 40 reaches the inside of the left atrium L, the hooking portion 421 comes into contact with the dilator 40 and the hooking portion 421 is released from being caught on the fossa ovum O. Thereafter, the operation unit 70 located outside the body is held, and the grasping unit 32 is moved to the proximal side. As a result, as shown in FIG. 15E, the force generating portion 74 is extended, and the hook portion 421 is accommodated in the dilator 40 and the outer tube 60 while being linearly extended. Instead of holding the operating unit 70 and moving the grasping unit 32 to the proximal side, the force generating unit 74 is elastically extended, so that the puncture needle 31 is placed inside the dilator 40 and the outer tube shaft 61. You may return automatically.

  Next, the needle assembly 410 and the dilator 40 are 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 as in the first embodiment (see FIG. 7D). 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 an ablation catheter, when the ablation catheter and the outer sheath 50 are removed from the body, the hole of the oval fossa O contracts. This completes the procedure.

As described above, in the medical device 400 according to the fifth embodiment, the needle part 420 has the hook part 421 whose outer diameter decreases toward the proximal side at a position where it can protrude from the dilator 40. Thereby, after the needle part 420 protrudes from the dilator 40 and pierces the ovule O, the hook part 421 is hooked on the ovule O by returning to the proximal side. For this reason, the needle 420 is prevented from coming out of the fovea O after the needle 420 is stuck in the fovea O. For this reason, the access route of the ablation catheter can be secured quickly and reliably by inserting the dilator 40 and the outer sheath 50 into the hole of the oval fossa O along the needle portion 420.
<Sixth Embodiment>

  The medical device 500 according to the sixth embodiment is different from the first embodiment only in that an operation unit 520 that discharges the needle unit 30 by a switch operation is provided in the proximal portion of the needle assembly 510. In addition, the same code | symbol is attached | subjected to the site | part which has a function similar to 1st Embodiment, and description is abbreviate | omitted.

  As shown in FIGS. 16 and 17A, the needle assembly 510 of the medical device according to the sixth embodiment has an operation unit 520 that discharges the needle unit 30 to the distal part of the needle assembly 510 by a switch operation. Have The operation part 520 includes an extension cylinder 530 located on the proximal side of the first connection part 71, an engagement part 540 extending proximally from the grip part 32, a pressing part 550 disposed on the extension cylinder 530, and an extension A puncture adjusting portion 560 disposed inside the tube 530.

  The extension cylinder 530 extends from the first connection portion 71 to the proximal side. The extension cylinder 530 accommodates the force generation part 74, the wire part 33, and the puncture adjusting part 560 therein.

  The engaging portion 540 extends distally from the grip portion 32. In a state where the force generation unit 74 extends beyond the reference length L0, the distal end surface 541 of the engagement portion 540 can abut against the proximal end surface 531 of the extension cylinder 530 and engage with it. The engaging portion 540 restricts the grip portion 32 from approaching the first connecting portion 71 by engaging with the proximal end surface 531 of the extension cylinder 530. The engaging portion 540 can be bent toward the inside of the extension cylinder 530. When the engaging portion 540 is bent from the state of being engaged with the proximal end surface 531, it does not come into contact with the proximal end surface 531 and the engagement is released. The engagement portion 540 is maintained in a state of being bent toward the inside of the extension cylinder 530 as shown in FIG. 17A in a state where the force generation portion 74 is the reference length L0.

  The pressing portion 550 is disposed on the extension cylinder 530 and is located outside the engaging portion 540 in a state where the distal end surface 541 is in contact with the proximal end surface 531. The pressing portion 550 is supported by the beam portion 551 with respect to the extension cylinder 530. The pressing portion 550 can move toward the inside of the extension cylinder 530 by the bending of the beam portion 551, and can press the engaging portion 540 to release the engagement.

  As shown in FIGS. 17 and 18, the puncture adjusting portion 560 is a member for adjusting the protruding length of the beam portion 551, and is disposed on the distal side inside the extension cylinder 530. Puncture adjusting portion 560 is a disk-shaped member that can rotate inside extension cylinder 530. Puncture adjusting portion 560 has a plurality of step portions 561 arranged in the circumferential direction on the proximal surface. The plurality of stepped portions 561 differ in the amount of protrusion toward the proximal side. The stepped portion 561 can come into contact with the distal end surface 541 of the engaging portion 540 that is disengaged and moves in the extension cylinder 530 to the distal side. In addition, puncture adjusting portion 560 has an operation convex portion 562 for an operator to operate on the outer peripheral surface. The operation convex portion 562 protrudes to the outside from a side hole 532 provided in the extension cylinder 530. The side hole 532 has a size capable of rotating the operation convex portion 562 in the circumferential direction. When the operation convex portion 562 protruding from the side hole 532 is operated to rotate the puncture adjusting portion 560, the step portion 561 with which the distal end surface 541 of the engaging portion 540 contacts can be selected.

  Next, the operation of the operation unit 520 of the medical device 500 according to the sixth embodiment will be described. As shown in FIG. 17 (A), the position of the extension cylinder 530 is held while the force generating portion 74 is at the reference length L0, and the grip portion 32 is moved to the proximal side. As a result, the force generating portion 74 extends, and the needle portion 30 moves proximally in the outer tube shaft 61. Moreover, the engaging part 540 moves to the proximal side along the inner peripheral surface of the extension cylinder 530 in a bent state. When the distal end surface 541 of the engaging portion 540 reaches the proximal end surface 531 of the extension tube 530, the engaging portion 540 returns to its original shape as shown in FIG. 541 engages the proximal end face 531. Thereby, the force generation part 74 is hold | maintained by length longer than the reference length L0.

  Next, the operation convex portion 562 is operated to select the stepped portion 561 with which the distal end surface 541 of the engaging portion 540 comes into contact. In addition, a scale, a character, a symbol, a figure, a color, etc. may be provided on the outer peripheral surface of the extension cylinder 530 so that the selected step portion 561 can be understood.

  Next, when puncturing with the needle part 30, as shown in FIG. 17C, the pressing part 550 is pushed. As a result, the engaging portion 540 that receives the force from the pressing portion 550 is bent and moves to the inside of the extension cylinder 530, and the distal end surface 541 moves to a position where it does not come into contact with the proximal end surface 531. Thereby, the engagement of the engaging portion 540 is released. When the engagement portion 540 is disengaged, the gripping portion 32 comes close to the first connection portion 71 due to the contraction force of the force generation portion 74, and the needle portion 30 can protrude from the dilator 40. When the engagement is released, the distal end surface 541 of the engagement portion 540 moves to the distal side inside the extension cylinder 530 and abuts against the selected stepped portion 561. For this reason, the moving length of the needle part 30 can be limited by the height of the selected step part 561. Therefore, the protrusion length of the needle part 30 from the dilator 40 can be adjusted by the puncture adjusting part 560.

  As described above, in the medical device 500 according to the sixth embodiment, the force generator 74 holds the force that causes the needle 30 to protrude from the long body (dilator 40 or the outer tube 60) in the distal direction. , An engaging portion 540 that engages with another portion to maintain the state of the force generating portion 74, and a pressing portion 550 that can release the engagement of the engaging portion 540 by pressing. Thereby, the needle part 30 can be protruded from an elongate body only by pushing the press part 550, and the oval fossa O can be punctured, and operativity improves. Moreover, the needle part 30 can be always protruded with the optimal protrusion length and protrusion output for puncture, and the operability and safety are improved. In addition, the puncture operation becomes less dependent on the skill of the operator, improving operability and safety.

  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 device described above may be used to puncture living tissue in a living body other than the foveal fossa.

  Moreover, the needle part of the medical device according to the first, second, and fourth to sixth embodiments may be hollow as in the second embodiment. In this case, a blood pressure can be measured by injecting a medicine or a contrast medium using the lumen of the needle part or guiding blood inside the heart to the outside. By measuring the blood pressure, it is possible to accurately confirm the arrival of the needle portion at the left atrium L.

  Moreover, the usage method of the medical device which concerns on embodiment mentioned above is not limited to the method mentioned above. For example, the medical device according to the first to fifth embodiments extends the force generation unit 74 and punctures the needle by protruding the contraction force of the force generation unit 74, but extends the force generation unit 74. Instead, puncture may be performed by pushing the grip portion 32 to the distal side by hand. Even in this case, the needle part can be accommodated in the outer tube 60 or the dilator 40 by the expansion force of the force generation part 74 by releasing the hand from the grip part 32 after puncturing.

  In addition, the dilator 40 and the outer sheath 50 are fixed by the contraction force of the valve body 55, but may have a separate fixing means. Moreover, although the dilator 40 and the outer tube 60 are separate bodies, they may be integrated.

  Moreover, the hook part of 3rd Embodiment may be comprised by another shape with the wire material which can be elastically deformed. For example, as in the modification shown in FIG. 19, the needle portion 610 may be an umbrella-shaped hook portion 611 made of an elastically deformable wire. As shown in FIG. 19B, the hook portion 611 includes a ring-shaped base portion 612 that is fixed to the proximal side of the puncture needle 31 and an intermediate wire 613 that extends from the base portion 612 in a natural state where no external force acts. A tip ring 614. A plurality of intermediate wires 613 are arranged in the circumferential direction. Each intermediate wire 613 gradually spreads from the base 612 toward the proximal side. The tip ring 614 connects the proximal ends of the plurality of intermediate wires 613. Therefore, in the natural state, the outer diameter of the hook portion 611 gradually increases toward the proximal side. When the hook portion 611 exceeds the tip ring 614, the outer diameter decreases stepwise. The constituent material of the hook portion 611 is a shape memory alloy.

  The needle portion 610 is elastically deformed and accommodated in the outer tube 60 as shown in FIG. When the needle portion 610 protrudes distally from the outer tube 60, the hook portion 611 returns to its original shape and expands as shown in FIG. Thereby, the hook part 611 can be hooked on the oval fossa O. Thereafter, when the outer tube 60 is moved to the distal side, the hook portion 611 that receives the force is deformed toward the distal side so as to turn over. Thereby, the hook part 611 can be accommodated in the outer tube 60.

10, 100, 200, 300, 400, 500 medical devices,
20, 110, 210, 310, 410, 510 needle assembly,
30, 220, 320, 420, 610 needle part,
31, 222 Puncture needle,
40 Dilator,
42 taper part,
43 distal part of the dilator,
50 outer sheath,
51 sheath body,
60 outer tube,
70, 520 operation unit,
74 force generator,
80 sheath assembly,
90 guide wire,
120 inner pipe,
121 large diameter part,
130 movement restriction unit,
221 through-hole,
230 retaining wire,
231 wire part,
232 holding part,
321, 421, 611 hook part,
540 engaging portion,
550 pressing part,
560 puncture control unit,
O foveal fossa,
L left atrium,
R Right atrium.

Claims (11)

A medical device for inserting into a living body lumen to puncture a living tissue and puncture and hold a hole that has been opened,
A long needle with flexibility;
A tubular long body having flexibility for accommodating the needle portion so as to protrude to the distal side; and
A medical device, comprising: a force generation unit that is provided on a proximal side of the elongated body, and that applies a force toward the proximal side of the needle portion from a state in which the needle portion protrudes from the elongated body.   The medical device according to claim 1, wherein the force generation unit is capable of applying a force that causes the needle portion in a state of being accommodated in the long body to protrude distally from the long body. .   The medical device according to claim 1, wherein the elongated body has a dilator in which an outer diameter of a distal end portion gradually decreases toward a distal side.   The medical device according to any one of claims 1 to 3, wherein the elongate body has an outer tube that can be detachably accommodated in the dilator and slidably accommodate the needle portion.   The medical device according to claim 2, wherein the force generation unit is an elastic body that is elastically deformable along an axial direction of the needle unit. The force generation part is a reference length in a natural state where no external force acts,
The force generation portion contracts from a length longer than the reference length to a length shorter than the reference length by its own elastic force, thereby applying a force protruding distally to the needle portion. Item 6. The medical device according to Item 5.   The medical device according to claim 6, wherein the force generation unit applies a force toward the proximal side to the needle unit by approaching a natural state by its own elastic force from a state shorter than the reference length.   The proximal end portion of the elastic body is connected to the needle portion, and the distal end portion of the elastic body is connected to the elongated body. Medical device as described in. An inner tube that is radially inward of the outer tube and positioned radially outward of the needle portion, and is movable relative to the outer tube and the needle portion in the axial direction;
When the needle portion protrudes distally from the elongated body, the movement of the inner tube relative to the needle portion is limited, and the needle portion is moved relative to the elongated body. 9. A medical device according to claim 1, further comprising a movement restriction portion that allows movement of the inner tube relative to the needle portion relative to the needle portion when moving to the proximal side. device. The needle portion is a tubular body,
Having a holding wire inserted into the lumen of the needle,
The holding wire has a wire part slidably received in the lumen of the needle part, and a holding part fixed to the distal side of the wire part, and the holding part is the needle part The medical device according to any one of claims 1 to 9, wherein the medical device is located on a more distal side than the needle portion and cannot be received in the lumen of the needle portion. A treatment method for puncturing a living tissue in vivo using the medical device according to claim 1, and holding the punctured hole opened in an expanded state,
Inserting the elongate body and the needle part into the body lumen;
Projecting the needle portion from the elongated body and puncturing a living tissue;
Applying a force toward the proximal side to the proximal portion of the protruding needle portion by the force generating portion;
Accommodating the needle part in the elongated body.

Images