JP2020000264A - Medical device and treatment method - Google Patents

Abstract

To provide a medical device capable of enhancing safety property by suppressing erroneous puncture and efficiently expanding a formed hole, and to provide a treatment method.SOLUTION: A medical device 1 for forming a hole in an oval fossa O in an organism and expanding the hole includes: a needle part 30 in which a sharp puncture part 31 is provided in an end part at a distal side; a protective pipe 60 slidably storing the needle part 30; and a first energization part 90 for moving the protective pipe 60 in a distal direction to the needle part 30. When the puncture part 31 forms a hole in the oval fossa O, the protective pipe 60 expands the hole which the puncture part 31 forms in the oval fossa O, and can be moved to a distal side by energization force from the first energization part 90 so as to store the puncture part 31.SELECTED DRAWING: Figure 2

Description

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

  The heart repeatedly circulates and contracts and expands at an appropriate timing by passing an electric current through a myocardial tissue called a stimulation conduction system. If the generation or transmission of the electric signal flowing through the stimulation conduction system becomes abnormal, the contraction and expansion cannot be performed at an appropriate timing, and arrhythmia occurs.

  As a method for treating arrhythmia, there is known a method in which a conduction path of a signal causing arrhythmia is ablated by heating or cooling to cut off. As a device for performing this treatment method, a device that is inserted into the left atrium percutaneously and is capable of ablating the signal transmission path located at the pulmonary vein ostium is known. Such ablation devices are widely used because they are highly invasive with minimal invasiveness.

  When performing ablation in the left atrium, a needle is inserted into a thin septum called the ovarian fossa from the right atrium to the atrial septum, and a hole is opened from the right atrium to the left atrium. Technique is required. Transseptal needles, which are devices for performing atrial septal puncture, include mechanical needles (Mechanical Needle) and high-frequency energy puncture needles (Radio Frequency Needle). Mechanical puncture needles have become mainstream due to their low cost.

  A mechanical puncture needle performs puncture using a sharp needle. When using a mechanical puncture needle, there is a risk of puncture due to excessive pressing of the needle. Accidental puncture with a needle can be associated with the serious complication of cardiac tamponade (a condition in which blood pools between the pericardium and myocardium and causes 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, a high-frequency energy puncture needle is not expensive, and requires a console, although there is no risk of puncture.

  For example, Patent Document 1 describes a device in which a mechanical puncture needle is housed inside a dilator. A hole is made in the fossa ovale with a puncture needle protruding from the dilator of this device, and the hole in the fossa ovale is expanded by inserting the dilator into the bored hole.

US Patent Publication No. 2002/0169377

  In the device described in Patent Literature 1, after puncturing, the state where the puncture needle projects from the dilator is maintained. 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 problem, and provides a medical device and a treatment method that can suppress puncture erroneously, increase safety, and efficiently expand a formed hole. With the goal.

  The medical device according to the present invention that achieves the above object is a medical device for forming a hole in a living tissue in a living body and expanding the hole, and a sharp puncture portion is provided at a distal end. A long needle part to be provided, a long tubular protective tube that slidably accommodates the needle part, and a first biasing part that moves the protective tube in a distal direction with respect to the needle part. When the puncture unit forms a hole in the living tissue, the protective tube expands the hole formed by the puncture unit in the living tissue and accommodates the first puncture unit so as to accommodate the puncture unit. Can be moved to the distal side by the urging force from the urging portion.

  A treatment method according to the present invention for achieving the above object is a treatment method for forming a hole in a living tissue in a living body using the medical device, and expanding the hole, wherein Inserting the protective tube and the puncture unit into the living body, and moving the protective tube to the distal side and pressing against the living tissue to move the protective tube proximally with respect to the puncture unit. Projecting the puncture portion relatively to the distal side from the protection tube, forming a hole in the living tissue by the puncture portion, and pushing the protection tube into a hole formed in the living tissue. And moving the protection tube to the distal side with respect to the puncture portion by the urging force of the first urging portion, and housing the puncture portion in the protection tube.

  In the medical device and the treatment method configured as described above, when the protective tube moves to the distal side and hits the living tissue, the protective tube moves against the puncture unit against the urging force of the first urging unit. It moves proximally and the puncture protrudes from the protective tube. For this reason, the puncture unit can be transported to a target position while maintaining safety, and the puncture unit can be protruded by pressing against the living tissue to form a hole in the living tissue. In addition, by pushing the protective tube into the hole formed in the living tissue, the hole can be efficiently expanded. Further, when a hole is formed in the living tissue, the protection tube moves to the distal side with respect to the puncture portion by the urging force of the first urging portion, and the puncture portion is automatically stored in the protection tube. For this reason, erroneous puncturing to a site other than the purpose by the puncturing unit is suppressed, and safety can be improved.

It is a top view showing the medical device concerning an embodiment. It is sectional drawing which shows the medical device which concerns on embodiment. It is sectional drawing which shows the state which combined each part of the medical device which concerns on embodiment. It is a perspective view which shows a release part and a moving part. FIG. 2 is a cross-sectional view showing a proximal portion and a distal portion of a medical device. FIG. 6 is a sectional view taken along line AA of FIG. 5. It is a top view which shows a moving part and a convex part. It is a partial sectional view showing the inside of the heart. It is sectional drawing which shows the state at the time of performing puncture with a medical device, (A) is a state which inserted the sheath assembly in the right atrium along the guide wire, (B) is the state which pulled out the guide wire, (C) Shows a state where the puncture device is inserted into the sheath assembly. It is sectional drawing which shows the state at the time of performing puncture by a medical device, (A) is the state which inserted the puncture device in the sheath assembly, (B) is the state which released the safety mechanism, (C) is the egg by the puncture part. This shows a state in which the pit is punctured. It is sectional drawing which shows the state at the time of performing puncture by a medical device, (A) is a state where the protective tube has penetrated the hole of the fossa ovale, (B) is a state where the puncture part is accommodated in the protective tube, (C) () Shows a state where the sheath assembly has been inserted into the hole of the fossa ovale. It is sectional drawing which shows the state at the time of performing puncture by a medical device, (A) is the state which pulled out the puncture device from the sheath assembly, (B) is the state which pulled out the dilator from the outer sheath, (C) is the outer sheath. Shows a state where a guide wire is inserted. It is sectional drawing which shows the 1st modification of a medical device, (A) shows the state where the safety mechanism is operating, (B) shows the state where the safety mechanism was cancelled. It is sectional drawing which shows the 2nd modification of a medical device. It is sectional drawing which shows the 3rd modification of a medical device. It is sectional drawing which shows the 4th modification of a medical device.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. The dimensional ratios in the drawings may be exaggerated and different from the actual ratios for convenience of explanation. In this specification, the side of the device that is inserted into the blood vessel will be referred to as the “distal side”, and the proximal side for operation will be referred to as the “proximal side”.

  The medical device 1 according to the embodiment of the present invention is used for inserting a needle from the right atrium into the fossa ovalis of the atrial septum to form a hole leading from the right atrium R to the left atrium L (see FIG. 8). Can be When there is a hole in the fossa ovale, 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 area around the pulmonary vein ostium. That is, the medical device 1 is a device for forming an access route of the ablation catheter in the fossa ovale.

  As shown in FIGS. 1 to 3, the medical device 1 according to the present embodiment includes a puncture device 10 for performing puncture, and a sheath assembly 20 that houses the puncture device 10. The puncture device 10 includes a long needle section 30, a protective tube 60 that accommodates the needle section 30, an operation section 70, a moving section 80, a first urging section 90, and a second urging section 91. And The sheath assembly 20 has a dilator 40 into which the puncture device 10 is inserted, and an outer sheath 50 into which the dilator 40 is inserted.

  The needle part 30 is a long wire-shaped member. The needle part 30 has a sharp puncture part 31 at the distal end. The proximal end of the needle unit 30 is connected to the operation unit 70.

  The needle portion 30 includes a needle bent portion 35 bent at a predetermined angle on the proximal side of the puncture portion 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 still more preferably 40 to 70 degrees. The needle bending part 35 plays a role of directing the puncture part 31 of the needle part 30 inserted into the right atrium toward the fossa ovalis O. Note that the needle section 30 may not include the needle bending section 35.

  The puncture part 31 is a sharp part that pierces the living tissue, and has an end face 34 inclined with respect to the central axis. The shape of the puncturing unit 31 is not particularly limited as long as it can puncture the living tissue, and may be, for example, a conical shape.

  The portion of the needle portion 30 closer to the puncture portion 31 is a long columnar wire. In addition, the cross-sectional shape of the needle part 30 does not need to be circular.

  The length of the needle portion 30 is appropriately set, and is, for example, 500 to 1100 mm. The outer diameter of the needle portion 30 is appropriately set, and is, for example, 0.5 to 1.0 mm. The inclination angle α1 of the sharp end of the puncture portion 31 with respect to the central axis is appropriately set, but is, for example, 3 to 45 degrees, more preferably 5 to 40 degrees, and still more preferably 10 to 35 degrees.

  The constituent material of the needle part 30 preferably has flexibility and is somewhat hard. For example, a shape memory alloy to which a shape memory effect or superelasticity is imparted by heat treatment, stainless steel, tantalum, titanium, platinum, Metals such as gold and tungsten, polyolefins such as polyethylene and polypropylene, polyamides and polyesters such as polyethylene terephthalate, fluorine-based polymers such as PTFE (polytetrafluoroethylene) and ETFE (tetrafluoroethylene-ethylene copolymer), and PEEK (polyethylene) Ether ether ketone), polyimide and the like can be suitably used. As the shape memory alloy, a Ni-Ti-based, Cu-Al-Ni-based, Cu-Zn-Al-based or the like can be suitably used. Further, the needle section 30 may include an X-ray opaque material. The X-ray opaque material is preferably formed of, for example, at least one metal or two or more alloys of the group consisting of gold, platinum, iridium, tungsten or alloys thereof, and silver-palladium alloy. is there. Further, the needle part 30 may include an ultrasonic contrast material. As the ultrasound contrast material, stainless steel or the like can be used in addition to the X-ray contrast material described above.

  The protection tube 60 is a tubular body and slidably accommodates the needle portion 30. The protection tube 60 accommodates the puncture part 31 of the needle part 30 therein to protect the living tissue. When the protective tube 60 slides proximally along the needle part 30, the puncture part 31 protrudes distally from inside the protective tube 60. When the protective tube 60 slides distally along the needle portion 30, the puncture portion 31 is housed inside the protective tube 60. The proximal portion of the protection tube 60 is connected to a movable unit 80 that can move inside the operation unit 70. The protection tube 60 is a member that is more flexible than the needle portion 30. The outer surface of the protective tube 60 may be coated with a low friction material so that the outer surface of the protective tube 60 can be brought into contact with the living tissue with low friction. Examples of the low friction material include fluorine-based polymers such as PTFE (polytetrafluoroethylene) and ETFE (tetrafluoroethylene / ethylene copolymer). In addition, a plurality of grooves extending along the axial direction may be formed on the outer surface of the protection tube 60 so as to be able to contact the living tissue with low friction. Further, the inner surface of the protection tube 60 may be coated with a low friction material so as to be able to contact the needle portion 30 with low friction, or a plurality of grooves may be formed along the axial direction. The protective tube 60 preferably has a small radial thickness so that the resistance received from the living tissue when inserted into the hole of the living tissue is small. The thickness of the protective tube 60 is, for example, equal to or less than the diameter of the needle portion 30. The clearance at the radius between the inner peripheral surface of the protective tube 60 and the outer peripheral surface of the needle part 30 is appropriately set, and is, for example, 0.025 to 0.1 mm.

  The protection tube 60 has a protection tube bending portion 62 bent at a predetermined angle at a distal portion in a natural state. The angle β2 of the protection tube bending portion 62 with respect to the proximal portion of the protection tube 60 is not particularly limited, but is, for example, 20 to 90 degrees, more preferably 30 to 80 degrees, and still more preferably 40 to 70 degrees. The protective tube bending part 62 plays a role in directing the puncture part 31 of the needle part 30 inserted into the right atrium toward the fossa ovalis. The outer peripheral edge of the distal end of the protective tube 60 is preferably formed into a curved surface so that it can be smoothly inserted into the dilator 40.

  The length of the protection tube 60 is appropriately set, and is, for example, 400 to 1100 mm. The outer diameter of the protection tube 60 is appropriately set, and is, for example, 0.5 to 1.5 mm. The inner diameter of the protection tube 60 is appropriately set, and is, for example, 0.3 to 1.3 mm.

  The constituent material of the protection tube 60 is preferably a flexible material, for example, a shape memory alloy to which a shape memory effect or superelasticity is imparted by heat treatment, stainless steel, tantalum, titanium, platinum, gold, tungsten, and the like. Metals, polyolefins such as polyethylene and polypropylene, polyamides such as polyamide and polyethylene terephthalate, fluorine-based polymers such as PTFE (polytetrafluoroethylene) and ETFE (tetrafluoroethylene-ethylene copolymer), and PEEK (polyetheretherketone) , Polyimide and the like can be suitably used. Further, the protection tube 60 may include an X-ray contrast material or an ultrasonic contrast material. The protection tube 60 may 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 proximal portion of the needle unit 30 is connected to the operation unit 70. The needle unit 30 may be indirectly connected to the operation unit 70 via another member. The operation section 70 includes an operation main body section 71, a release section 100, a port section 72, and a support tube 36.

  The operation main body 71 is a cylindrical member, and includes a lead-out hole 79, a first housing 76, a second housing 77, and a third housing 78. The lead-out hole 79 is formed on the distal side of the operation main body 71. The lead-out hole 79 leads the protection tube 60 so as to be movable from the inside of the operation main body 71 to the outside. The first housing section 76 houses the moving section 80 and the first urging section 90. The second housing portion 77 houses the release unit 100 and the second urging unit 91. The third housing section 78 houses a part of the port section 72.

  The port portion 72 has a tube 74 that can be flexibly deformed, and a three-way cock 75 provided at an end of the tube 74. A part of the tube 74 penetrates the operation main body 71, enters the third housing part 78, and is connected to the moving part 80. The tube 74 communicates with the lumen of the protective tube 60 inside the moving section 80. The other end of the tube 74 is located outside the operation main body 71, and the three-way cock 75 is fixed. By connecting a syringe or the like to the three-way cock 75, it is possible to prime the lumen of the protection tube 60 or to inject a contrast agent, a drug, or the like into the protection tube 60.

  The first housing section 76 houses the moving section 80 slidably in the axial direction of the needle section 30. The first housing section 76 houses the first urging section 90 on the proximal side of the moving section 80. Therefore, the moving section 80 is urged to the distal side by the first urging section 90 inside the first accommodating section 76. The proximal end of the first urging portion 90 abuts on the proximal end surface 76A inside the first accommodating portion 76, and the needle portion 30 penetrates the first urging portion 90. Are connected. Further, a support tube 36 through which the needle portion 30 penetrates is connected to an end surface 76A on the proximal side inside the first accommodation portion 76. The support tube 36 suppresses the bending of the needle portion 30 inside the first accommodation portion 76.

  The second housing part 77 houses the release part 100 slidably in a direction orthogonal to the axial direction of the needle part 30. The second housing 77 communicates with the first housing 76. The second housing 77 has an inlet 77A that opens on the outer peripheral surface of the operation main body 71. The release portion 100 movably penetrates the entrance 77A. The second housing portion 77 houses the second urging portion 91 on the side opposite to the entrance 77A. The release unit 100 is urged by the second urging unit 91 toward the inlet 77 </ b> A inside the second storage unit 77.

  The third housing 78 is formed along the first housing 76. The third housing portion 78 allows the tube 74 of the port portion 72 to be deformed as the moving portion 80 moves inside the operation main body 71.

  As shown in FIGS. 4 to 6, the release unit 100 includes a pushing unit 101 located outside the operation main body 71, an internal structure 102 located in the third storage unit 78, a pushing unit 101, and the internal structure. And a transmission unit 103 located between the two. The release unit 100 is a part operated to release a safety mechanism described later. The pushing unit 101 is a part where the operator performs a pushing operation. The transmission unit 103 movably penetrates the entrance 77 </ b> A, and transmits the force transmitted from the pushing unit 101 to the internal structure 102. The internal structure 102 has a size that cannot pass through the entrance 77A. The internal structure 102 is located from the entrance 77A side to the opposite side across the first housing 76. The second urging portion 91 of the internal structure 102 is in contact with a surface opposite to the entrance 77A. Therefore, the release portion 100 is urged toward the entrance 77A by the second urging portion 91 inside the second housing portion 77. The internal structure 102 has a concave portion 104 on a side adjacent to the first housing portion 76 in a cross section orthogonal to the axial direction of the needle portion 30. The concave portion 104 has a size such that the internal structure 102 does not enter the first storage portion 76 when the internal structure 102 moves in the direction perpendicular to the axial direction of the needle portion 30 in the second storage portion 77. . Thus, the internal structure 102 does not hinder the movement of the moving unit 80 in the first storage unit 76. In the concave portion 104 of the internal structure 102, a second facing portion 105 facing the moving portion 80 is provided. On the second facing portion 105, a convex portion 106 protruding toward the moving portion 80 is formed.

  As shown in FIGS. 3 to 6, the moving unit 80 is a substantially rectangular parallelepiped member that can slide the first housing unit 76 along the axial direction of the needle unit 30. The moving section 80 has a through hole 81 that penetrates from the proximal side to the distal side. The distal end of the through hole 81 is fixed at the proximal end of the protective tube 60 that enters the operation main body 71 from the outlet hole 79 of the operation main body 71. The needle portion 30 led out from the protection tube 60 to the proximal side penetrates the through hole 81 and is connected to the proximal end surface of the first accommodation portion 76. The support tube 36 that covers the needle portion 30 enters the through hole 81 from the proximal side. A seal portion 73 slidable with the support tube 36 is disposed in the through hole 81. The moving section 80 includes a first facing section 82 facing the second facing section 105. The first opposing portion 82 is provided on a plane parallel to the moving direction of the moving unit 80 and the moving direction of the release unit 100.

  The seal part 73 is a member for sealing the lumen of the protection tube 60. The seal portion 73 is disposed on the inner peripheral surface of the through hole 81 that continues from the protection tube 60. The seal portion 73 slidably contacts the outer peripheral surface of the support tube 36. The seal portion 73 is, for example, an O-ring. The O-ring suppresses blood from leaking from a gap between the protection tube 60 and the support tube 36, and also suppresses air from entering the body.

  As shown in FIGS. 5 to 7, the first facing portion 82 includes a first groove portion 83, a second groove portion 84, and a third groove portion 85 into which the convex portion 106 of the second facing portion 105 enters. . The first groove 83 is formed linearly along the axial direction of the needle 30. The distal end of the first groove 83 is provided with a distal end portion 83A. When the convex portion 106 is located in the first groove portion 83, the convex portion 106 can move along the first groove portion 83, so that the moving portion 80 moves along the axial direction of the needle portion 30 inside the operation portion 70. It can be moved. Therefore, the protection tube 60 connected to the moving unit 80 can be moved with respect to the needle unit 30 connected to the operation unit 70.

  The second groove portion 84 communicates with a proximal portion of the first groove portion 83, and changes its direction from the first groove portion 83 toward the proximal side. The proximal end portion 84A of the second groove portion 84 is located on the side opposite to the direction in which the release portion 100 is pushed in with respect to the first groove portion 83. The second groove portion 84 includes a second inclined groove 84B that changes its direction from the first groove portion 83 toward the proximal side, and a proximal end portion 84A. The second inclined groove 84B is inclined at an angle of less than 90 degrees with respect to the first groove 83. The vicinity of the proximal end portion 84A has an angle of 90 degrees or more than 90 degrees with respect to the first groove portion 83. Therefore, when the convex portion 106 of the operation section 70 is located at the proximal end portion 84A of the second groove portion 84, when the moving section 80 attempts to move to the proximal side with respect to the operation section 70, the convex section 106 Abuts the distal edge 84C of the proximal end 84A. Accordingly, the moving unit 80 cannot move inside the operation unit 70 along the axial direction of the needle unit 30. Therefore, the protection tube 60 connected to the moving unit 80 cannot move with respect to the needle unit 30 connected to the operation unit 70. At this time, the puncture unit 31 is housed in the protective tube 60, and safety is ensured. The convex portion 106 of the medical device 1 before use is located at the proximal end portion 84A of the second groove portion 84. Therefore, unintended protrusion of the puncture unit 31 is suppressed, and safety is ensured. That is, the second groove portion 84 and the convex portion 106 constitute a safety mechanism for suppressing unintended projection of the puncture portion 31.

  The third groove portion 85 communicates with a proximal portion of the first groove portion 83, and changes the direction from the first groove portion 83 toward the proximal side. The proximal end portion 85 </ b> A of the third groove portion 85 is located on the pushing direction side of the release portion 100 with respect to the second groove portion 84. The third groove portion 85 includes a third inclined groove 85B whose direction changes from the first groove portion 83 toward the proximal side, and a proximal end portion 85A. The third inclined groove 85B is inclined at an angle of less than 90 degrees with respect to the first groove 83. The vicinity of the proximal end portion 85A has an angle of less than 90 degrees with respect to the first groove portion 83. In the present embodiment, the vicinity of the proximal end portion 85A is parallel to the first groove 83. The third groove 85 may be formed linearly continuously from the first groove 83. For this reason, when the convex portion 106 of the release portion 100 is located at the proximal end portion 85A of the third groove portion 85, the convex portion 106 moves toward the first groove portion 83 along the third groove portion 85. it can. Therefore, the moving unit 80 can move to the proximal side with respect to the operation unit 70. Therefore, the protection tube 60 connected to the moving unit 80 can move with respect to the needle unit 30 connected to the operation unit 70. When the convex portion 106 moves from the proximal end portion 85A of the third groove portion 85 to the distal end portion 83A of the first groove portion 83, the protective tube 60 moves from the state where the puncture portion 31 is housed to the puncture portion. 31 is exposed to the outside.

  A movement restricting portion 86 protruding distally is formed between the second groove portion 84 and the third groove portion 85. The movement restricting portion 86 is formed by the second inclined groove 84B and the edge of the groove of the proximal end portion 85A of the third groove portion 85. Therefore, the edge of the movement restricting portion 86 on the side of the second groove 84 is inclined with respect to the moving direction of the moving portion 80, but the edge of the movement restricting portion 86 on the side of the third groove 85 is moved by Is parallel to the moving direction of. For this reason, the movement restricting portion 86 allows the protrusion 106 to move from the second groove 84 to the third groove 85, but the protrusion 106 returns from the third groove 85 to the second groove 84. Restrict that. When the convex portion 106 moves from the second groove portion 84 to the third groove portion 85, the convex portion 106 comes into contact with the edge of the movement restricting portion 86 inclined with respect to the moving direction of the moving portion 80. Thereby, the movement restricting unit 86 receives the force from the convex portion 106 and moves the moving unit 80 to the proximal side while contracting the first urging unit 90. For this reason, the movement restriction unit 86 can move to the third groove 85 beyond the movement restriction unit 86. However, when the convex portion 106 attempts to move from the third groove portion 85 to the second groove portion 84, the convex portion 106 comes into contact with the edge of the movement restricting portion 86 parallel to the moving direction of the moving portion 80. Since the edge of the movement restricting portion 86 against which the convex portion 106 abuts is parallel to the moving direction of the moving portion 80, it cannot receive a force in the moving direction. For this reason, the convex portion 106 cannot move the moving portion 80, and is restricted from moving to the second groove portion 84 beyond the movement restricting portion 86.

  The length L1 along the axial direction of the needle portion 30 from the proximal end portion 85A of the third groove portion 85 to the distal end portion 83A of the first groove portion 83 is the puncture portion accommodated in the protective tube 60. 31 is a length that can protrude from the protection tube 60. The length L2 along the axial direction of the needle portion 30 from the distal end portion 83A of the first groove portion 83 to the proximal end portion 84A of the second groove portion 84 is punctured from the protective tube 60. The length is such that the portion 31 can be accommodated in the protective tube 60. In the present embodiment, the length L1 is substantially the same as the length L2, but may be different. The lengths L1 and L2 are appropriately set, but are, for example, 3 to 15 mm, preferably 3 to 10 mm, and more preferably 3 to 5 mm.

  The constituent materials of the operation main body 71, the moving unit 80, the release unit 100, and the support tube 36 are not particularly limited, but, for example, polycarbonate, polyethylene, polypropylene, ABS resin (general term for acrylonitrile, butadiene, styrene copolymer synthetic resin) and the like. Hard resin, metal such as stainless steel, etc. can be preferably used.

  The first urging section 90 is a coil spring (elastic body) that is located in the first housing section 76 and surrounds the needle section 30 and the support tube 36. The distal end of the first urging section 90 contacts the moving section 80. The proximal end of the first biasing portion 90 is in contact with the proximal end surface 76A of the first housing portion 76. In a state in which the moving section 80 is located at the most distal side of the first housing section 76, that is, in a state in which the first biasing section 90 is expanded most, the first biasing section 90 is in a natural state where no external force acts. It is the same as the natural length in the state, or is somewhat shorter than the natural length. Thereby, the first urging unit 90 can urge the moving unit 80 to the distal side by the expanding force.

  The second urging portion 91 is a coil spring (elastic body) located in the second housing portion 77. One end of the second urging portion 91 contacts the internal structure 102 of the release portion 100. The other end of the second urging portion 91 is in contact with the surface of the second housing portion 77 on the side opposite to the entrance 77A. In a state where the internal structure 102 is located closest to the inlet portion 77A of the second housing portion 77, that is, in a state where the second biasing portion 91 is expanded most, the second biasing portion 91 is acted upon by an external force. Not equal to the natural length in the natural state, or somewhat shorter than the natural length. Thereby, the second urging unit 91 can urge the release unit 100 to the side opposite to the pushing direction of the release unit 100 by the expanding force. The pushing direction refers to a direction in which the pushing section 101 of the release section 100 is pushed toward the operation main body section 71.

  The first urging unit 90 and the second urging unit 91 are coil springs made of a shape memory alloy, stainless steel, or the like, but need not be coil springs as long as they generate an urging force. Therefore, the first urging unit 90 and the second urging unit 91 are, for example, an elastic body, a member having a bellows structure made of an elastically deformable material, a cylinder or a balloon containing a compressible fluid, or the like. You may. The elastic body is, for example, natural rubber, silicone rubber, various elastomers and the like.

  As shown in FIGS. 1 to 3, the dilator 40 is used to widen the hole of the fossa ovale formed by the needle part 30. The dilator 40 has a dilator body 41, a hub 47 connected to a proximal portion of the dilator body 41, a port 48 communicating with the hub 47, and a valve element 49 inside the hub 47. At the end of the port portion 48, a three-way cock 48A is provided.

  The dilator main body 41 is a long tube housing the needle portion 30 and the protection tube 60. The dilator main body 41 has a tapered portion 42 at the distal end, the diameter of which is tapered toward the distal side. The lumen of the dilator 40 is open at the end of the tapered portion 42 where the diameter is reduced most. The inclination angle α2 with respect to the center axis of the tapered portion 42 is appropriately set, but is, for example, 1 to 20 degrees, more preferably 3 to 15 degrees, and further preferably 4 to 10 degrees.

  The dilator main body 41 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, a reduced diameter portion 45 whose inner diameter decreases toward the distal side is provided. The inner diameter of the dilator proximal portion 44 is sufficiently larger than the outer diameter of the protection tube 60. Therefore, the protection tube 60 inserted from the hub 47 into the proximal part 44 of the dilator can move smoothly with low friction along the inner peripheral surface of the proximal part 44 of the dilator. The reduced diameter portion 45 guides the protection tube 60 passing through the dilator proximal portion 44 to the dilator distal portion 43 smoothly. The inner diameter of the dilator distal portion 43 is an inner diameter to which the protection tube 60 can slide while contacting with a small clearance. Thereby, the position of the dilator distal part 43 can be accurately defined with respect to the needle part 30 and the protection tube 60. Therefore, the dilator 40 can be smoothly pushed into the hole formed by the needle part 30. Note that the inner diameter of the dilator body 41 may be constant along the axial direction.

  The dilator main body 41 has a dilator bent portion 46 bent at a predetermined angle at a distal portion in a natural state. The angle β3 of the dilator bent portion 46 with respect to the proximal portion of the dilator main body 41 is not particularly limited, but is, for example, 10 to 70 degrees, more preferably 20 to 60 degrees, and still more preferably 30 to 50 degrees. The dilator bending part 46 plays a role in directing the puncture part 31 of the needle part 30 inserted into the right atrium and the tapered part 42 of the dilator 40 toward the fossa ovale.

  The length of the dilator main body 41 is appropriately set, and is, for example, 400 to 1500 mm. The outer diameter of the dilator body 41 is appropriately set, and is, for example, 2 to 6 mm. The inner diameter of the dilator distal portion 43 is appropriately set, and is, for example, 0.5 to 1.5 mm. The inner diameter of the dilator proximal portion 44 is appropriately set, and is, for example, 1.0 to 2.0 mm. The length of the dilator distal portion 43 is appropriately set, but is, for example, 1 to 15 mm, more preferably 2 to 12 mm, and still more preferably 3 to 10 mm. The clearance at the radius between the inner peripheral surface of the dilator distal portion 43 and the outer peripheral surface of the protection tube 60 is appropriately set, and is, for example, 0.03 to 0.1 mm.

  The constituent material of the dilator main body 41 is preferably flexible, for example, polyolefin such as polyethylene and polypropylene, polyester such as polyamide and polyethylene terephthalate, PTFE (polytetrafluoroethylene), and ETFE (ethylene / tetrafluoroethylene). (Polyether ether ketone), polyimide, shape memory alloy, stainless steel, tantalum, titanium, platinum, gold, tungsten, and other metals. Further, the dilator main body 41 may include an X-ray contrast material or an ultrasonic contrast material.

  The hub 47 is provided at a proximal portion of the sheath body 51 and communicates with the lumen of the dilator body 41. The puncture device 10 passes through the hub 47. The port portion 48 is connected to the hub 47 and communicates with the lumen of the dilator main body 41 via the lumen of the hub 47. The port portion 48 has a three-way cock 48A at an end. By connecting a syringe or the like to the three-way cock 48A, it is possible to prime the inner cavity of the dilator main body 41 or to inject a contrast agent or a drug into the dilator main body 41.

  The valve element 49 is a member for sealing the inner cavity of the hub 47 and the dilator main body 41. The valve element 49 can be flexibly deformed, and is arranged on the inner peripheral surface of the hub 47. The valve element 49 slidably contacts the outer peripheral surface of the protection tube 60. Further, the valve element 49 can press the protection tube 60 by elastic force in a state where the protection tube 60 is inserted, and fix the protection tube 60 and the dilator 40. In addition, even if it is fixed with the valve element 49, it is possible to relatively move in the axial direction by gripping the protective tube 60 and the dilator 40 and applying a force. Further, by pulling out the protection tube 60 from the hub 47, the hole of the valve element 49 in which the protection tube 60 is inserted is closed, and the inner cavity of the hub 47 is sealed from the proximal side. The valve element 49 is, for example, a member formed by cutting a center of a disc-shaped elastic body. The elastic body is, for example, natural rubber, silicone rubber, various elastomers and the like. The valve element 49 suppresses blood from leaking through the dilator 40 while allowing the protection tube 60 to be inserted and removed, and also suppresses air from entering the body.

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

  The sheath main body 51 is a long tubular body that accommodates the dilator 40 movably in the axial direction. The sheath body 51 has an inner peripheral surface that slides smoothly with the dilator 40. The sheath main body 51 has a sheath bent portion 52 bent at a predetermined angle at a 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 part 31 of the needle part 30 inserted into the right atrium and the distal part of the sheath body 51 toward the fossa ovalis.

  The sheath main body 51 has a sheath taper portion 53 at the distal end, the diameter of which decreases in a tapered shape toward the distal side. The lumen of the sheath body 51 is open at the end of the sheath taper portion 53 where the diameter is most reduced. The inclination angle α3 of the sheath taper portion 53 with respect to the central axis is appropriately set, but is, for example, 1 to 15 degrees, more preferably 2 to 10 degrees, and further preferably 3 to 7 degrees. In the sheath assembly 20 in which the dilator 40 is inserted into the outer sheath 50, the sheath taper portion 53 is located on the proximal side of the taper portion 42 of the dilator 40 and can be located so as to be continuous with the taper portion 42. The inner peripheral surface of the sheath body 51 preferably has a clearance between the inner 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 slidably contacts.

  The dilator main body 41 can penetrate the sheath main body 51 over its entire length. Therefore, the axial length of the sheath body 51 is shorter than that of the dilator body 41.

  The length of the sheath body 51 is appropriately set, and is, for example, 400 to 1000 mm. The outer diameter of the sheath body 51 is appropriately set, and is, for example, 2.5 to 7.0 mm. The inner diameter of the sheath body 51 is appropriately set, and is, for example, 2 to 6 mm. The clearance at the radius between the inner peripheral surface of the sheath main body 51 and the outer peripheral surface of the dilator main body 41 is appropriately set, 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 and polypropylene, polyamide such as polyamide and polyethylene terephthalate, PTFE (polytetrafluoroethylene), and ETFE (ethylene / 4. Fluorine-based polymers such as fluorinated ethylene copolymer), PEEK (polyetheretherketone), and polyimide can be suitably used. Further, 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 at a 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 an end. By connecting a syringe or the like to the three-way cock 57, it is possible to prime the lumen of the sheath body 51 or to inject a contrast agent, a medicine, or the like into the sheath body 51.

  The valve body 55 is a member for sealing the lumen of the hub 54 and the sheath body 51. The valve element 55 can be flexibly deformed, and is disposed on the inner peripheral surface of the hub 54. The valve body 55 comes into slidable contact with the outer peripheral surface of the dilator 40. Further, the valve body 55 can press the dilator 40 by elastic force in a state where the dilator 40 is inserted, and fix the dilator 40 and the outer sheath 50. In addition, even if it is fixed with the valve body 55, it is possible to relatively move in the axial direction by gripping the dilator 40 and the outer sheath 50 and applying a force. When the dilator 40 is pulled out from the hub 54, the hole of the valve body 55 in which the dilator 40 is inserted is closed, and the inner cavity of the hub 54 is sealed from the proximal side. The valve body 55 is, for example, a member having a cut in the center of a disc-shaped elastic body. The elastic body is, for example, natural rubber, silicone rubber, various elastomers and the like. The valve element 55 suppresses blood from leaking through the outer sheath 50 while allowing the dilator 40 to be inserted and withdrawn, and also suppresses air from entering the body.

  In a state where the needle part 30, the protection tube 60, the dilator 40 and the outer sheath 50 are combined, the positions, bending directions and bending angles of the needle bending part 35, the protection tube bending part 62, the dilator bending part 46 and the sheath bending part 52 are as follows. It is preferred that they match or substantially match. Thereby, the puncture part 31 can be protruded in a desired direction.

  Next, a method of providing an access route for an ablation catheter by making a hole in the fossa ovalis O using the medical device 1 according to the present embodiment will be described.

  First, a needle is punctured into the femoral vein and a short guidewire is inserted into the needle. Next, the needle is withdrawn and a catheter introducer is inserted into the blood vessel along the short guidewire. Next, the sheath assembly 20 in which the dilator 40 is inserted into the outer sheath 50 is prepared. Subsequently, the short guidewire is removed, and the guidewire 110 is inserted into the catheter introducer. Next, while leaving the guidewire 60 in the blood vessel, the catheter introducer is removed, and the proximal end of the guidewire 60 is inserted into the lumen 41A from the distal end of the dilator 40 of the sheath assembly 20. , Inserted into the blood vessel. Subsequently, the distal portion of the sheath assembly 20 is gradually pushed to the right atrium R while the guide wire 110 is advanced. Next, the sheath assembly 20 is once inserted from the right atrium R into the superior vena cava along the guide wire 110. Subsequently, when the sheath assembly 20 is retracted and pulled into the right atrium R, the distal end of the sheath assembly 20 is positioned near the fossa ovalis O, as shown in FIGS. Guided to nature. Thereafter, the guide wire 110 is removed from the sheath assembly 20.

  Subsequently, the sheath assembly 20 is pushed into the distal side while observing the inside of the left atrium L and the right atrium R with an intracardiac echocardiography catheter (ICE). Thus, as shown in FIG. 9B, the fossa ovalis O is pushed by the dilator 40 toward the left atrium L and protrudes. At this time, since the distal portions of the outer sheath 50 and the dilator 40 are bent, the distal end of the sheath assembly 20 is easily directed to the fossa ovalis O. Note that the fossa ovale O need not be in a state of protruding toward the left atrium L.

  Next, as shown in FIG. 9C, the puncture device 10 is inserted into the lumen 41A from the proximal side of the dilator 40. At this time, as shown in FIG. 10A, since the convex portion 106 of the release portion 100 is located at the proximal end portion 84A of the second groove portion 84, the safety mechanism operates and the moving portion 80 is moved. Is limited with respect to the operation unit 70. Therefore, the puncture portion 31 does not protrude from the protective tube 60, and damage to the inner peripheral surface of the dilator 40 can be suppressed.

  Next, as shown in FIG. 10B, the pushing part 101 of the releasing part 100 is pushed in to release the safety mechanism. When the pushing portion 101 is pushed in, the internal structure 102 moves in the pushing direction inside the second housing portion 77, and the second biasing portion 91 contracts. At this time, the convex portion 106 is located at the proximal end portion 84A of the second groove portion 84 extending in the direction perpendicular to the axial direction of the needle portion 30. Therefore, the convex portion 106 can move in a direction perpendicular to the axial direction of the needle portion 30. When the convex portion 106 moves in a direction perpendicular to the axial direction of the needle portion 30, the convex portion 106 comes into contact with the movement restricting portion 86, the first urging portion 90 contracts, and the moving portion 80 moves to the operating portion 70. Move proximally. Thereby, the convex portion 106 reaches the proximal end portion 85A of the third groove portion 85 beyond the movement restricting portion 86. When the convex portion 106 reaches the proximal end portion 85A of the third groove portion 85, the first biasing portion 90 contracted when it exceeds the movement restricting portion 86 expands and returns to the original shape. Thereby, the moving unit 80 returns to the distal side with respect to the operation unit 70. The third groove 85 is provided at an angle of less than 90 degrees with respect to the first groove 83. For this reason, the protrusion 106 that has reached the third groove 85 can move to the first groove 83 along the third groove 85. Thereby, the moving unit 80 can move to the proximal side with respect to the operation unit 70, and the puncturing unit 31 can protrude from the protection tube 60. When the convex portion 106 reaches the third groove portion 85, the second urging portion 91 contracts, and an urging force acts on the release portion 100 in the direction opposite to the pushing direction. However, since the movement restricting portion 86 is located on the side opposite to the pushing direction with respect to the convex portion 106, the convex portion 106 is restricted from returning to the second groove portion 84. The proximal end portion 85A of the third groove portion 85 extends in a direction parallel to the axial direction of the needle portion 30, that is, in a direction orthogonal to the pushing direction. For this reason, even if the convex portion 106 contacts the movement restricting portion 86, the moving portion 80 does not move with respect to the operation portion 70. For this reason, the convex portion 106 cannot return to the second groove portion 84 beyond the movement restricting portion 86. Therefore, the state in which the safety mechanism is released is maintained. Note that the proximal end portion 85A of the third groove portion 85 may not be parallel to the axial direction of the needle portion 30. Even in this case, since the moving portion 80 is urged by the first urging portion 90, it is possible to restrict the protrusion 106 from returning to the second groove portion 84 beyond the movement restricting portion.

  Next, as shown in FIG. 10C, the operation unit 70 is moved to the distal side. Thereby, the puncture part 31 of the needle part 30 connected to the operation part 70 protrudes from the dilator 40. The tube 74 is deformed inside the third housing portion 78 and absorbs the relative movement between the operation main body 71 and the moving portion 80. At this time, the protective tube 60 collides with the fossa ovalis O and its movement to the distal side is restricted. Therefore, the protective tube 60 moves to the proximal side with respect to the puncture unit 31, and the puncture unit 31 relatively projects from the protective tube 60 and pierces the fossa ovalis O. When the protection tube 60 moves to the proximal side with respect to the puncture unit 31, the moving unit 80 to which the protection tube 60 is connected contracts the first urging unit 90 and moves the protection unit 60 proximally to the operation unit 70. Move to the side. When the moving unit 80 moves to the proximal side with respect to the operating unit 70, the convex portion 106 of the operating unit 70 moves from the third groove 85 of the moving unit 80 to the first groove 83. When the convex portion 106 reaches the distal end portion 83A of the first groove portion 83, further movement of the moving portion 80 to the proximal side with respect to the operation portion 70 is restricted. For this reason, the protection tube 60 cannot move to the proximal side with respect to the puncture unit 31. Therefore, when the puncture unit 31 connected to the operation unit 70 is moved to the distal side, the protection tube 60 moves to the distal side together with the puncture unit 31 as shown in FIG. Thereby, the protective tube 60 penetrates while expanding the hole of the fossa ovalis O formed by the puncture part 31 and reaches the left atrium L. When the protective tube 60 reaches the left atrium L, the resistance that the protective tube 60 receives from the fossa ovale O decreases. Thereby, as shown in FIG. 11B, the first urging portion 90 expands, and the moving portion 80 moves to the distal side with respect to the operation portion 70. When the moving unit 80 moves to the distal side with respect to the operation unit 70, the protection tube 60 moves to the distal side with respect to the puncture unit 31, and the puncture unit 31 is housed in the protection tube 60. Therefore, when the puncture portion 31 and the protection tube 60 penetrate the fossa ovale O, the puncture portion 31 is automatically stored in the protection tube 60 by the urging force of the first urging portion 90. Therefore, it is possible to prevent the puncture section 31 from erroneously puncturing an unintended position, and high safety is obtained.

  When the moving section 80 moves to the distal side with respect to the operation section 70, the convex section 106 of the release section 100 moves to the proximal side of the first groove section 83, and the second groove section 84 and the third groove section 85 move. And reach the junction. At this time, the convex portion 106 is urged by the second urging portion 91 in the direction opposite to the pushing direction. For this reason, the convex portion 106 does not enter the third groove portion 85 located on the pushing direction side with respect to the first groove portion 83, and the convex portion 106 is located on the side opposite to the pushing direction with respect to the first groove portion 83. The second groove 84 enters the proximal end 84A of the second groove 84. When the convex portion 106 is located at the proximal end portion 84A of the second groove portion 84, the safety mechanism operates, and the movement of the moving portion 80 with respect to the operation portion 70 is restricted. Therefore, the puncture portion 31 does not protrude from the protective tube 60, and high safety is ensured.

  When the puncture part 31 and the protective tube 60 penetrate the fossa ovalis O, a part of the distal end of the dilator 40 that has pressed the fossa ovalis O toward the left atrium L is opened in the fossa ovalis O. Into the hole. Note that a part of the dilator 40 does not have to enter the hole of the fossa ovalis O.

  Next, the sheath assembly 20 is pushed distally along the puncture device 10. As a result, as shown in FIG. 11C, the taper portion 42 of the dilator 40 and the sheath taper portion 53 of the outer sheath 50 pass through the fossa ovalis O while expanding the holes of the fossa ovalis O, and the left atrium L To reach. At this time, the diameter of the tapered portion 42 and the sheath tapered portion 53 is reduced toward the distal side, so that the hole of the fossa ovalis O can be smoothly expanded. When the puncture portion 31 punctures the fossa ovalis O, a part of the taper portion 42 of the dilator 40 enters the hole of the fossa ovalis O. Therefore, it is easy to push the dilator 40 and the outer sheath 50 into the hole of the fossa ovalis O.

  Next, as shown in FIG. 12A, the puncture device 10 is removed from the dilator 40. Subsequently, as shown in FIG. 12B, the dilator 40 is pulled out of the body while leaving the outer sheath 50. The hole of the fossa ovalis O, which is widened by the protective tube 60, the dilator 40 and the outer sheath 50, is maintained by the outer sheath 50. When the dilator 40 is removed from the outer sheath 50, the valve body 55 closes, and it is possible to suppress leakage of blood and entry of air and the like into the blood vessel. Thereafter, as shown in FIG. 12C, a guide wire 110 is inserted from the proximal side of the outer sheath 50 via the valve body 55 to reach the left atrium L. Thereafter, the ablation catheter is inserted through the valve body 55 from the proximal side of the outer sheath 50 along the guide wire 110. Thus, the ablation catheter can be inserted into the left atrium L using the outer sheath 50 penetrating the fossa ovalis O. After performing ablation in the left atrium L using the ablation catheter, when the ablation catheter and the outer sheath 50 are removed outside the body, the hole of the fossa ovalis O contracts. Thus, the procedure is completed.

  As described above, the medical device 1 according to the present embodiment is a medical device 1 for forming a hole in the ovarian fossa O (living tissue) in a living body and expanding the hole, A long needle portion 30 provided with a sharp puncture portion 31 at an end portion, a long tubular protective tube 60 that slidably accommodates the needle portion 30, and a protective tube 60 distant from the needle portion 30. When the puncture portion 31 forms a hole in the fossa ovale O, the protective tube 60 forms the puncture portion 31 in the fossa ovale O. The hole can be expanded and moved to the distal side by the urging force from the first urging unit 90 to accommodate the puncture unit 31.

  In the medical device 1 configured as described above, when the protective tube 60 moves to the distal side and hits the oval fossa O, the first urging portion 90 is deformed and the protective tube 60 is moved with respect to the needle portion 30. The puncture portion 31 protrudes from the protective tube 60. For this reason, the needle part 30 can be transported to a target position while maintaining safety. Then, by pressing the protective tube 60 against the fossa ovalis O, the puncture part 31 can be protruded to form a hole in the fossa ovalis O. Further, by pushing the protective tube 60 into the hole formed in the fossa ovalis, the hole can be efficiently expanded. Further, when a hole is formed in the fossa ovalis O, the protective tube 60 is moved to the distal side with respect to the puncture part 31 by the urging force of the first urging part 90, and the puncture part 31 is automatically protected. Housed in tube 60. For this reason, it is possible to prevent the puncturing unit 31 from erroneously puncturing an unintended site, thereby improving safety.

  In addition, the medical device 1 can be in a housed state in which the puncture section 31 is housed in the protective tube 60 and in a protruding state in which the puncture section 31 protrudes from the protective tube 60 to the distal side. The protection tube 60 receives the urging force from the first urging portion 90 and accommodates the puncture portion 31, and in a protruding state, the protection tube 60 receives the external force in the proximal direction to cause the first urging portion 90 to move. The puncture unit 31 moves proximally with respect to the puncture unit 31 against the urging force, and the puncture unit 31 relatively projects from the protective tube 60 to the distal side. Accordingly, when the protection tube 60 in the housed state is pressed against the fossa ovalis O, the first urging portion 90 is deformed, and the protection tube 60 is moved to the proximal side with respect to the needle portion 30 to be in the protruding state. Become. For this reason, the needle part 30 can be transported to a target position while maintaining safety. Then, the protective tube 60 is pressed against the fossa ovalis O to make it protrude, and the puncture unit 31 can puncture the fossa ovalis O. In the protruding state, the protective tube 60 enters the hole formed in the fossa ovale O and can efficiently expand the hole. Further, when a hole is formed in the fossa ovalis O, the protective tube 60 is moved distally with respect to the puncture portion 31 by the urging force of the first urging portion 90, and automatically enters the housed state. For this reason, it is possible to prevent the puncturing unit 31 from erroneously puncturing an unintended site, thereby improving safety.

  The clearance at the radius between the inner peripheral surface of the protection tube 60 and the outer peripheral surface of the needle part 30 is 0.025 to 0.1 mm. Thereby, the protection tube 60 can slide while being in close contact with the needle portion 30. For this reason, the protective tube 60 enters along the needle part 30 into the hole of the oval fossa O formed by the puncture part 31, and the hole can be expanded smoothly.

  In addition, the medical device 1 has a safety mechanism that controls movement of the protective tube 60 to the proximal side with respect to the needle unit 30. Thereby, the medical device 1 can suppress unintended protrusion of the puncture unit 31, and safety is improved.

  The medical device 1 further includes an operation unit 70 to which the proximal part of the needle unit 30 is connected, and a moving unit 80 to which the proximal part of the protective tube 60 is connected. 80 has a first opposing portion 82 and a second opposing portion 105 that are relatively movable, and the first opposing portion 82 extends along the axial direction of the needle portion 30. The second opposing portion 105 has a convex portion 106 that is accommodated in the first groove portion 83 and is movable along the first groove portion 83 so that the medical device 1 is in a protruding state. As a result, the protrusion 106 abuts on the terminal end of the first groove 83 in the direction in which the first groove 83 extends, and the movement of the moving unit 80 to the proximal side with respect to the operation unit 70 is restricted. Accordingly, since the medical device 1 is in a protruding state, the movement of the moving unit 80 to the proximal side with respect to the operation unit 70 is restricted. Is restricted from moving toward the needle portion 30 in the proximal direction. For this reason, while forming a hole in the fossa ovalis O by the needle part 30, the protective tube 60 can be pushed into the hole against the force received from the tissue of the fossa ovalis O to expand the hole.

  Further, the first facing portion 82 has a second groove 84 communicating with the first groove 83, and in the housed state, the second groove 84 can house the projection 106, and the second groove 84 The groove 84 restricts the protrusion 106 from moving to the first groove 83 along the axial direction of the needle 30. Thereby, in the housed state where the convex portion 106 is housed in the second groove portion 84, it is possible to restrict the puncture portion 31 from protruding from the protective tube 60, and it is possible to enhance safety.

  Further, the first facing portion 82 has a third groove 85 communicating with the first groove 83 and the second groove 84, and in the housed state, the third groove 85 can house the projection 106. The third groove 85 allows the protrusion 106 to move to the first groove 83 along the axial direction of the needle 30. Thus, by moving the protrusion 106 from the second groove 84 to the third groove 85, the protrusion 106 housed in the third groove 85 can move to the first groove 83. For this reason, the protection tube 60 and the needle unit 30 connected to the first facing unit 82 and the second facing unit 105 can relatively move. Thereby, the external force acts on the protective tube 60 in the proximal direction, so that the protective tube 60 moves proximally with respect to the puncture unit 31 while opposing the urging force of the first urging unit 90, The puncture part 31 can protrude from the protective tube 60. Further, since the external force in the proximal direction stops acting on the protective tube 60, the protective tube 60 is moved to the distal side with respect to the needle portion 30 by the urging force of the first urging portion 90, and the protective tube 60 is moved. The puncture unit 31 can be automatically accommodated.

  Further, the first facing portion 82 protrudes between the second groove portion 84 and the third groove portion 85 to limit the movement of the convex portion 106 from the third groove portion 85 to the second groove portion 84. It has a movement restriction unit 86. Accordingly, the movement restricting portion 86 restricts the protrusion 106 from returning to the second groove 84 by moving the convex 106 from the second groove 84 to the third groove 85. For this reason, the convex part 106 is located in the 3rd groove part 85, and the state in which the puncture part 31 can protrude from the protective tube 60 (the state in which the safety mechanism was released) can be favorably maintained.

  The operation unit 70 includes an operation main body 71 to which the needle unit 30 is connected and which accommodates the moving unit 80 so as to be movable along the axial direction of the needle unit 30, and a second opposing unit 105 to the needle unit 30. And a release unit 100 that moves the convex portion 106 accommodated in the second groove portion 84 from the second groove portion 84 by moving the convex portion 106 in the direction intersecting the axial direction of the second groove portion 84. Thus, by moving the release unit 100, the protrusion 106 located in the second groove 84 can be moved from the second groove 84. Therefore, the state in which the puncture section 31 is prevented from protruding from the protective tube 60 can be easily released by operating the release section 100, and the operability is improved.

  Further, the operation unit 70 further includes a second urging unit 91 that urges the release unit 100. Accordingly, it is possible to suppress the careless release of the state in which the release section 100 is urged by the second urging section 91 to restrict the puncture section 31 from protruding from the protective tube 60. Therefore, high security can be ensured.

  Further, the medical device 1 further includes a dilator 40 having a lumen into which the protective tube 60 can be inserted, and an outer diameter of a distal end portion decreasing toward the distal side. Thereby, the dilator 40 can be smoothly pushed into the hole along the needle portion 30 and the protective tube 60 that have penetrated the hole formed in the fossa ovale O, and the hole can be effectively expanded.

  The present invention also includes a treatment method (treatment method) for forming a hole in the ovarian fossa O (living tissue) in a living body using the medical device 1 and expanding the hole. The treatment method includes a step of inserting the protection tube 60 and the puncture portion 31 in the housed state into the living body, and moving the protection tube 60 to the distal side and pressing the protection tube 60 against the fossa ovalis, thereby puncturing the protection tube 60. Moving the puncture part 31 relatively to the distal side from the protective tube 60 by moving the puncture part 31 to the proximal side with respect to the part 31; forming a hole in the fossa ovalis O by the puncture part 31; Pushing the protection tube 60 into the hole formed in the fossa O, and moving the protection tube 60 distally with respect to the puncture portion 31 by the urging force of the first urging portion 90, Accommodating the puncture unit 31.

  In the treatment method configured as described above, the housed protection tube 60 is pressed against the fossa ovalis O, the first urging portion 90 is deformed, and the protection tube 60 is moved to the proximal side with respect to the puncture portion 31. The puncture unit 31 is moved to protrude from the protective tube 60. Therefore, the needle portion 30 can be transported to a target position while maintaining safety. Then, by pressing the protective tube 60 against the fossa ovalis O, the puncture part 31 can be protruded to form a hole in the fossa ovalis O. Further, when a hole is formed in the fossa ovalis O, the protective tube 60 is moved to the proximal side with respect to the puncture part 31 by the urging force of the first urging part 90, and the puncture part 31 is automatically protected. It can be housed in a tube 60. For this reason, it is possible to suppress the puncturing section 31 from erroneously puncturing an unintended site, thereby improving safety. Further, by pushing the protective tube 60 that slidably holds the needle portion 30 into the hole formed in the fossa ovalis O, the hole can be efficiently expanded.

  Note that the present invention is not limited to only the above-described embodiment, 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 1 described above may be used to puncture a living tissue in a living body other than the fossa ovalis.

  Further, the needle portion may be hollow. In this case, the blood pressure can be measured by injecting a drug or a contrast medium using the lumen of the needle portion, or by guiding blood inside the heart to the outside. By measuring the blood pressure, it is possible to accurately confirm that the needle reaches the left atrium L.

  Also, as in the first modification shown in FIG. 13A, the third groove is not formed in the first facing portion 121 of the moving portion 120, and the first groove 83 and the second groove 84 are not formed. Only one may be formed. Parts having the same functions as those of the above-described embodiment are denoted by the same reference numerals, and description thereof will be omitted. As a result, by pressing the release portion 100 from the state where the safety mechanism is operated with the convex portion 106 being located in the second groove portion 84, the convex portion 106 is moved to the first groove portion as shown in FIG. 83, the safety mechanism can be released. Thereafter, the puncture unit 31 can be made to protrude from the protective tube 60 by pressing the protective tube 60 against the living tissue while maintaining the state where the release unit 100 is pressed.

  As in the second modification shown in FIG. 14, the second and third grooves are not formed in the first facing part 131 of the moving part 130, and only the first groove 83 is formed. You may. The operation unit 140 does not include a release unit that releases the safety mechanism. The first groove 83 accommodates a projection 142 provided on the operation main body 141 facing the first facing portion 131. As a result, the third modification does not include a safety mechanism, but the protrusion 142 moves within the range of the first groove 83. Thereby, the range of movement of the protection tube 60 with respect to the puncture unit 31 can be limited. Therefore, after the puncture unit 31 punctures the living tissue, the protection tube 60, which is located closer to the puncture unit 31 and whose movement is restricted, can be easily pushed into the hole formed in the living tissue. .

  Also, as in the third modified example shown in FIG. 15, the first groove, the second groove, and the third groove are not formed in the moving unit 150, and the release unit is not provided in the operation unit 160. Good. Even with such a structure, by abutting the protective tube 60 against the living tissue, the first urging portion 90 is contracted, and the puncture portion 31 can be projected from the protective tube 60. Further, the protection tube 60 is pushed into the hole formed in the living tissue, and the puncture portion 31 can be housed in the protection tube 60 by the urging force of the first urging portion 90.

  Also, as in the fourth modification shown in FIG. 16, the inner diameter of the protection tube 170 may be larger on the proximal side than the distal portion 171 that houses the puncture portion 31 and larger than the distal portion 171. Thereby, the sliding resistance between the protection tube 170 and the needle portion 30 is reduced, and the needle portion 30 can be smoothly moved inside the protection tube 170. The outer diameter of the distal end 172 of the protective tube 170 is tapered toward the distal side. Thereby, the protective tube 170 can be smoothly inserted into the hole formed in the living tissue, and the hole can be effectively expanded by the protective tube 170. The inclination angle α4 of the distal end portion 172 with respect to the central axis is appropriately set, but is preferably smaller than the inclination angle α1 of the puncture portion 31 with respect to the central axis. This makes it difficult for the distal end 172 to damage living tissue.

  Further, a second facing portion having a convex portion may be provided in the moving portion, and a first facing portion having at least the first groove portion may be provided in the operation portion.

1 medical device,
10 puncture device,
20 sheath assembly,
30 needle part,
31 puncture part,
40 dilators,
41A lumen (lumen),
60, 170 protection tube,
70, 140, 160 operation unit,
71, 141 operation main body,
80, 120, 130, 150 moving part,
82, 121, 131 first opposing portion,
83 first grooves,
83A distal end,
84 a second groove,
85 third groove,
86 movement restriction unit,
90 a first biasing unit;
91 a second biasing unit,
100 release unit,
105 second opposing portion,
106, 142 convex part,
O fossa ovalis (living tissue),
L left atrium,
R Right atrium.

Claims (11)

A medical device for forming a hole in a biological tissue in a living body and expanding the hole,
A long needle portion provided with a sharp puncture portion at the distal end,
A long tubular protective tube that slidably accommodates the needle portion,
A first urging unit that moves the protective tube in a distal direction with respect to the needle unit,
When the puncture portion forms a hole in the living tissue, the protective tube extends the hole formed in the living tissue by the puncture portion, and receives the first puncturing portion so as to receive the puncture portion. Medical device movable to the distal side by the urging force of the medical device.   The medical device according to claim 1, wherein a clearance at a radius between an inner peripheral surface of the protective tube and an outer peripheral surface of the needle part is 0.025 to 0.1 mm.   The medical device according to claim 1, wherein an outer diameter of a distal end of the protection tube decreases toward a distal side.   The medical device according to any one of claims 1 to 3, further comprising a safety mechanism for controlling movement of the protection tube to a proximal side with respect to the needle portion. An operation unit to which a proximal portion of the needle unit is connected;
A moving part to which a proximal part of the protection tube is connected,
The operation unit and the moving unit include a first opposing unit and a second opposing unit that move relatively to each other,
The first opposing portion has a first groove extending along the axial direction of the needle portion,
The second opposing portion has a projection housed in the first groove and movable along the first groove,
2. The projecting state of the medical device causes the protrusion to abut against a terminal end of the first groove in the extending direction, thereby restricting the movement of the moving unit to a proximal side with respect to the operation unit. The medical device according to any one of claims 1 to 4, wherein The first opposing portion has a second groove communicating with the first groove,
In the accommodation state, the second groove can accommodate the protrusion, and the second groove may move the protrusion to the first groove along the axial direction of the needle. 6. The medical device of claim 5, wherein the medical device is restricted. The first facing portion has a third groove communicating with the first groove and the second groove,
In the accommodation state, the third groove can accommodate the protrusion, and the third groove moves the protrusion to the first groove along the axial direction of the needle. 7. The medical device of claim 6, wherein the medical device is acceptable.   The first opposing portion includes, between the second groove portion and the third groove portion, a movement restricting portion that protrudes to restrict the movement of the convex portion from the third groove portion to the second groove portion. The medical device according to claim 7, comprising: The operation unit includes:
An operation main body that is connected to the needle portion and accommodates the moving portion so as to be movable along an axial direction of the needle portion;
Release in which the first opposing portion or the second opposing portion is moved in a direction intersecting with the axial direction of the needle portion, and the protrusion accommodated in the second groove is moved from the second groove. The medical device according to any one of claims 6 to 8, comprising:   The medical device according to claim 9, wherein the operation unit further includes a second urging unit that urges the release unit. A treatment method for forming a hole in a living tissue in a living body using the medical device according to claim 1 and expanding the hole,
Inserting the protective tube and the puncture unit in the accommodated state into a living body;
By moving the protective tube to the distal side and pressing against the living tissue, the protective tube is moved to the proximal side with respect to the puncture portion, and the puncture portion is moved from the protective tube to the distal side. Projecting the target;
Forming a hole in the living tissue by the puncture unit,
Pushing the protective tube into a hole formed in the living tissue;
Moving the protective tube to the distal side with respect to the puncture unit by the urging force of the first urging unit, and housing the puncture unit in the protective tube.

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