WO2018079508A1

WO2018079508A1 - Medical device and treatment method

Info

Publication number: WO2018079508A1
Application number: PCT/JP2017/038246
Authority: WO
Inventors: 高橋侑右
Original assignee: テルモ株式会社
Priority date: 2016-10-28
Filing date: 2017-10-24
Publication date: 2018-05-03
Also published as: JP2020000264A

Abstract

Provided are a medical device and a treatment method, which are capable of improving safety by inhibiting erroneous puncturing and enable efficient expansion of a formed hole. A medical device (1) for forming a hole in the fossa ovalis (O) inside a living body and expanding said hole, said device comprising a needle part (30) to which a sharp puncture part (31) is provided at the distal end thereof, a protective tube (60) that slidably houses the puncture part (31), and a first biasing part (90) that moves the protective tube (60) in the distal direction with respect to the puncture part (31), wherein when the puncture part (31) forms a hole in the fossa ovalis (O), the protective tube (60) can move toward the distal side by the biasing force from the first biasing part (90) so as to expand the hole formed in the fossa ovalis (O) by the puncture part (31) and house the puncture part (31).

Description

Medical device and treatment method

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 when current flows 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 the 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. The transseptal needle, which is a device for performing this atrial septal puncture, includes a mechanical puncture needle (Mechanical Needle) and a high-frequency energy puncture needle (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 that can improve safety by suppressing erroneous puncture and can efficiently expand a formed hole. With the goal.

A 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. An elongated body, a long protective tube that slidably accommodates the puncture portion, and a first urging portion that moves the protective tube in a distal direction with respect to the puncture portion. When the puncture unit forms a hole in the biological tissue, the protective tube expands the hole formed in the biological tissue by the puncture unit and accommodates the puncture unit. It can move to the distal side by the urging force from.

A 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 tubular protection member that slidably accommodates the puncture portion, and a first elastic member that moves the protection member in a distal direction with respect to the puncture portion. When the puncture unit forms a hole in the biological tissue, the protective member expands the hole formed in the biological tissue by the puncture unit and accommodates the puncture unit. It is possible to move to the distal side by elasticity.

A treatment method according to the present invention that achieves the above-described object is a treatment method for forming a hole in a living tissue in vivo using the medical device described above and expanding the hole, wherein the treatment device is in the accommodated state. A step of inserting the protective tube and the puncture portion into the living body, and moving the protective tube to the distal side and pressing it against the living tissue, thereby moving the protective tube to the proximal side with respect to the puncture portion. A step of projecting the puncture portion relatively to the distal side from the protective tube, a step of forming a hole in the biological tissue by the puncture portion, and a step of pushing the protective tube into the hole formed in the biological tissue And moving the protective tube distally with respect to the puncture portion by the urging force of the first urging portion to house the puncture portion in the protective 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 against the puncture unit against the urging force of the first urging unit. It moves to the proximal side, and the puncture part protrudes from the protective tube. For this reason, a puncture part can be conveyed to the target position, maintaining safety, and a puncture part can be protruded and a hole can be formed in a biological tissue by pressing on a biological tissue. Moreover, the hole can be efficiently expanded by pushing the protective tube into the hole formed in the living tissue. Furthermore, when a hole is formed in the living tissue, the urging force of the first urging portion moves the protective tube to the distal side with respect to the puncture portion, and the puncture portion is automatically accommodated in the protective tube. For this reason, the erroneous puncture to the non-target site | part by the puncture part is suppressed, and safety can be improved.

It is a top view which shows the medical device which concerns on 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 site | part of the medical device which concerns on embodiment. It is a perspective view which shows a cancellation | release part and a movement part. It is sectional drawing which shows the proximal part and distal part of a medical device. FIG. 6 is a cross-sectional view taken along line AA in FIG. 5. It is a top view which shows a moving part and a convex 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 a medical device, (A) is the 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 in which the puncture device is inserted into the sheath assembly. It is sectional drawing which shows the state at the time of puncturing with a medical device, (A) is the state which inserted the puncture device in the sheath assembly, (B) is the state which cancel | released the safety mechanism, (C) is an egg by a puncture part The state which punctures the fossa is shown. It is sectional drawing which shows the state at the time of puncturing with a medical device, (A) is the state which the protection tube penetrated the hole of the fossa fossa, (B) is the state in which the puncture part was accommodated in the protection tube, (C ) Shows a state where the sheath assembly is inserted into the hole of the foveal fossa. It is sectional drawing which shows the state at the time of puncturing with a medical device, (A) is the state which pulled out the puncture device from the sheath assembly, (B) is the state which pulled the dilator from the outer sheath, (C) is the outer sheath Shows a state where a guide wire is inserted. It is a flowchart for demonstrating the procedure using a medical device. It is sectional drawing which shows the 1st modification of a medical device, (A) is the state in which the safety mechanism is operating, (B) shows the state by which the safety mechanism was cancelled | released. 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, an embodiment of the present invention will be described 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”.

The medical device 1 according to the embodiment of the present invention is used to form a hole from the right atrium R to the left atrium L (see FIG. 8) by inserting a needle from the right atrium into the fossa of the atrial septum. It is done. 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 around the pulmonary vein opening. That is, the medical device 1 is a device for forming an access route for an ablation catheter in the foveal fossa.

The medical device 1 according to the present embodiment includes a puncture device 10 that performs puncture and a sheath assembly 20 that accommodates the puncture device 10 as shown in FIGS. The puncture device 10 includes a long needle part 30 (long body), a protective tube 60 (protective member) that accommodates the needle part 30, an operation part 70, a moving part 80, and a first biasing part 90. (First elastic member) and a second urging portion 91 (second elastic member). The sheath assembly 20 includes 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-like member. The needle part 30 has a sharp puncture part 31 at the distal end. The proximal end of the needle part 30 is connected to the operation part 70.

The needle part 30 includes a needle bending part 35 bent at a predetermined angle on the proximal side of the puncture part 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 portion 31 of the needle portion 30 inserted into the right atrium toward the foveal fossa O. The needle part 30 may not include the needle bending part 35.

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

The part proximal to the puncture part 31 of the needle part 30 is a long cylindrical wire. In addition, the cross-sectional shape of the needle part 30 may not be circular.

The length of the needle portion 30 is set as appropriate, and is, for example, 500 to 1100 mm. The outer diameter of the needle part 30 is appropriately set, and is, for example, 0.5 to 1.0 mm. The inclination angle α1 with respect to the central axis of the sharp end of the puncture portion 31 is appropriately set, and 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 PTFE (polytetrafluoroethylene) and ETFE (tetrafluoroethylene / ethylene copolymer), PEEK (poly Ether ether ketone), polyimide and the like can be preferably used. As the shape memory alloy, Ni—Ti, Cu—Al—Ni, Cu—Zn—Al, and the like can be preferably 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 protective tube 60 is a tubular body and accommodates the needle portion 30 so as to be slidable. The protective tube 60 accommodates the puncture part 31 of the needle part 30 inside and protects the living tissue. When the protective tube 60 slides proximally along the needle portion 30, the puncture portion 31 protrudes from the inside of the protective tube 60 to the distal side. When the protective tube 60 slides distally along the needle portion 30, the puncture portion 31 is accommodated inside the protective tube 60. The proximal portion of the protective tube 60 is connected to a moving portion 80 that can move inside the operation portion 70. The protective 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 contact the living tissue with low friction. Examples of the low friction material include fluorine polymers such as PTFE (polytetrafluoroethylene) and ETFE (tetrafluoroethylene / ethylene copolymer). Further, the outer surface of the protective tube 60 may be formed with a plurality of grooves extending along the axial direction so as to be able to contact the living tissue with low friction. Further, the inner surface of the protective 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 is preferably thin in the radial direction so that the resistance received from the living tissue when inserted into the hole of the living tissue is reduced. The thickness of the protective tube 60 is, for example, equal to or less than the diameter of the needle part 30. The clearance at the radius between the inner peripheral surface of the protective tube 60 and the outer peripheral surface of the needle portion 30 is set as appropriate, and is, for example, 0.025 to 0.1 mm.

The protective tube 60 has a protective tube bending portion 62 bent at a predetermined angle at the distal portion in a natural state. The angle β2 of the protective tube bending portion 62 with respect to the proximal portion of the protective tube 60 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 protective tube bending portion 62 plays a role of directing the puncture portion 31 of the needle portion 30 inserted into the right atrium toward the foveal fossa. The outer peripheral edge of the distal end of the protective tube 60 is preferably processed into a curved surface so that it can be smoothly inserted into the dilator 40.

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

The constituent material of the protective tube 60 is preferably a flexible material, for example, a shape memory alloy, stainless steel, tantalum, titanium, platinum, gold, tungsten, etc. to which a shape memory effect or superelasticity is imparted by heat treatment. Metals, polyolefins such as polyethylene and polypropylene, polyesters such as polyamide and polyethylene terephthalate, fluoropolymers such as PTFE (polytetrafluoroethylene) and ETFE (tetrafluoroethylene / ethylene copolymer), PEEK (polyetheretherketone) Polyimide and the like can be preferably used. The protective tube 60 may include an X-ray contrast material or an ultrasound contrast material. The protective tube 60 may have the same strength as the constituent material of the needle part 30 so as not to be damaged by the needle part 30.

The proximal portion of the needle portion 30 is connected to the operation portion 70. In addition, the needle part 30 may be indirectly connected with the operation part 70 through another member. The operation unit 70 includes an operation main body unit 71, a release unit 100, a port unit 72, and a support tube 36.

The operation main body 71 is a cylindrical member, and includes a lead-out hole 79, a first accommodation portion 76, a second accommodation portion 77, and a third accommodation portion 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 protective tube 60 so as to be movable from the inside of the operation main body 71 to the outside. The first accommodating portion 76 accommodates the moving portion 80 and the first urging portion 90. The second accommodating portion 77 accommodates the release portion 100 and the second urging portion 91. The third accommodating portion 78 accommodates a part of the port portion 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 passes through the operation main body 71 and enters the third accommodating portion 78 and is connected to the moving portion 80. The tube 74 communicates with the lumen of the protective tube 60 inside the moving unit 80. The other end of the tube 74 is located outside the operation main body 71, and a three-way stopcock 75 is fixed thereto. By connecting a syringe or the like to the three-way stopcock 75, the lumen of the protective tube 60 can be primed, or a contrast agent, a drug, or the like can be injected into the protective tube 60.

The 1st accommodating part 76 accommodates the moving part 80 so that sliding to the axial direction of the needle part 30 is possible. The first accommodating portion 76 accommodates the first biasing portion 90 on the proximal side of the moving portion 80. Therefore, the moving unit 80 is urged distally by the first urging unit 90 inside the first accommodating unit 76. The proximal end face 76 A inside the first accommodating portion 76 is in contact with the proximal end portion of the first urging portion 90, and the needle portion 30 penetrating the first urging portion 90. The proximal parts of the two are connected. A support tube 36 through which the needle portion 30 passes is connected to the proximal end surface 76 A inside the first accommodating portion 76. The support tube 36 prevents the needle portion 30 from being bent inside the first housing portion 76.

The second accommodating portion 77 accommodates the release portion 100 so as to be slidable in a direction orthogonal to the axial direction of the needle portion 30. The second housing part 77 communicates with the first housing part 76. The second accommodating portion 77 has an inlet portion 77 A that opens to the outer peripheral surface of the operation main body portion 71. The release portion 100 penetrates the entrance portion 77A so as to be movable. The second accommodating portion 77 accommodates the second urging portion 91 on the side opposite to the inlet portion 77A. The release portion 100 is urged toward the inlet portion 77 A by the second urging portion 91 inside the second housing portion 77.

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

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

The moving part 80 is a substantially rectangular parallelepiped member capable of sliding the first accommodating part 76 along the axial direction of the needle part 30 as shown in FIGS. The moving part 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 to the proximal end of the protective tube 60 that enters the operation main body 71 from the lead-out hole 79 of the operation main body 71. The needle part 30 led out from the protective tube 60 to the proximal side passes through the through hole 81 and is connected to the proximal end face of the first accommodating part 76. The support tube 36 that covers the needle portion 30 enters the through hole 81 from the proximal side. The through hole 81 is provided with a seal portion 73 slidable with the support tube 36. The moving unit 80 includes a first facing portion 82 that faces the second facing portion 105. The first facing portion 82 is provided on a plane parallel to the moving direction of the moving portion 80 and the moving direction of the release portion 100.

The seal part 73 is a member for sealing the lumen of the protective tube 60. The seal portion 73 is disposed on the inner peripheral surface of the through hole 81 continuing from the protective tube 60. The seal portion 73 is slidably in contact with the outer peripheral surface of the support tube 36. The seal part 73 is, for example, an O-ring. The O-ring suppresses blood from leaking from the gap between the protective tube 60 and the support tube 36 and 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 portion 83 is formed linearly along the axial direction of the needle portion 30. A distal end portion 83 A is provided at the distal end of the first groove portion 83. 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 is inside the operation portion 70 along the axial direction of the needle portion 30. It becomes possible to move. Therefore, the protective tube 60 connected to the moving unit 80 can move with respect to the needle unit 30 connected to the operation unit 70.

The second groove portion 84 communicates with the 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 84 A of the second groove portion 84 is located on the opposite side to the pushing direction of the release portion 100 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 portion 83. The vicinity of the proximal end portion 84 A has an angle of 90 degrees or more than 90 degrees with respect to the first groove portion 83. For this reason, when the convex part 106 of the operation part 70 is located at the proximal end part 84A of the second groove part 84, when the moving part 80 attempts to move proximally with respect to the operation part 70, the convex part 106 is obtained. Contacts the distal edge 84C of the proximal end portion 84A. As a result, the moving unit 80 cannot move along the axial direction of the needle unit 30 inside the operation unit 70. Therefore, the protective 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 part 31 is accommodated 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 84 A of the second groove portion 84. For this reason, the protrusion which the puncture part 31 does not intend is suppressed, and safety | security is ensured. That is, the second groove portion 84 and the convex portion 106 constitute a safety mechanism that suppresses unintentional protrusion of the puncture portion 31.

The third groove 85 communicates with the proximal portion of the first groove 83 and changes the direction from the first groove 83 toward the proximal side. The proximal end portion 85 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 85 includes a third inclined groove 85B that changes its direction from the first groove 83 toward the proximal side, and a proximal terminal end 85A. The third inclined groove 85B is inclined at an angle of less than 90 degrees with respect to the first groove portion 83. The vicinity of the proximal end portion 85 A 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 85 A is parallel to the first groove portion 83. Note that the third groove 85 may be formed linearly continuously from the first groove 83. For this reason, when the convex part 106 of the release part 100 is located at the proximal end part 85A of the third groove part 85, the convex part 106 moves toward the first groove part 83 along the third groove part 85. it can. For this reason, the moving part 80 can move to the proximal side with respect to the operation part 70. Therefore, the protective tube 60 connected to the moving unit 80 is movable 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 in which the puncture portion 31 is accommodated to the puncture portion. 31 is exposed to the outside.

Between the second groove portion 84 and the third groove portion 85, a movement restricting portion 86 protruding to the distal side is formed. The movement restricting portion 86 is formed by the second inclined groove 84 B and the groove edge of the proximal end portion 85 A of the third groove 85. Therefore, the edge of the movement restricting portion 86 on the second groove portion 84 side is inclined with respect to the moving direction of the moving portion 80, but the edge of the movement restricting portion 86 on the third groove portion 85 side is the moving portion 80. It is parallel to the moving direction. For this reason, the movement restricting portion 86 allows the convex portion 106 to move from the second groove portion 84 to the third groove portion 85, but the convex portion 106 returns from the third groove portion 85 to the second groove portion 84. Limit 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 that is inclined with respect to the moving direction of the moving portion 80. As a result, the movement restricting portion 86 receives force from the convex portion 106 and moves the moving portion 80 to the proximal side while contracting the first urging portion 90. For this reason, the movement restricting portion 86 can move to the third groove portion 85 beyond the movement restricting portion 86. However, when the convex portion 106 tries 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 toward the moving direction. For this reason, the convex part 106 cannot move the moving part 80, and is restricted from moving beyond the movement restricting part 86 to the second groove part 84.

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 capable of protruding from the protective tube 60. The length L2 along the axial direction of the needle portion 30 from the distal end portion 83A of the first groove 83 to the proximal end portion 84A of the second groove portion 84 is a puncture projecting from the protective tube 60 The portion 31 has a length that 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, and 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. For example, polycarbonate, polyethylene, polypropylene, ABS resin (a general term for acrylonitrile, butadiene, styrene copolymer synthetic resin), and the like. A hard resin, a metal such as stainless steel, and the like can be suitably used.

The first urging portion 90 is a coil spring (elastic body) located in the first housing portion 76 and surrounding the needle portion 30 and the support tube 36. The distal end of the first urging unit 90 contacts the moving unit 80. The proximal end portion of the first urging portion 90 is in contact with the proximal end surface 76 A of the first accommodating portion 76. In a state where the moving unit 80 is located on the most distal side of the first accommodating portion 76, that is, in a state where the first urging unit 90 is most expanded, the first urging unit 90 is a natural part where no external force acts. It is the same as the natural length in the state or somewhat shorter than the natural length. Thereby, the 1st biasing part 90 can urge the moving part 80 to a distal side with expansion force.

The second urging portion 91 is a coil spring (elastic body) located in the second accommodating portion 77. One end of the second urging portion 91 is in contact with 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 inlet portion 77A. In a state where the internal structure 102 is located closest to the inlet portion 77A of the second accommodating portion 77, that is, in a state where the second urging portion 91 is most expanded, the second urging portion 91 is subjected to an external force. Not the same as the natural length in the natural state or somewhat shorter than the natural length. Thereby, the 2nd urging | biasing part 91 can urge the cancellation | release part 100 to the opposite side to the pushing direction of the cancellation | release part 100 with expansion force. The pushing direction means a direction in which the pushing portion 101 of the release portion 100 is pushed toward the operation main body portion 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 may not be coil springs as long as they generate an urging force. Therefore, the first urging portion 90 and the second urging portion 91 are, for example, an elastic body, a bellows structure member made of an elastically deformable material, a cylinder or a balloon containing a compressive fluid, and the like. May be. 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 formed by the needle portion 30 as shown in FIGS. The dilator 40 includes a dilator body 41, a hub 47 connected to the proximal portion of the dilator body 41, a port portion 48 communicating with the hub 47, and a valve body 49 inside the hub 47. A three-way cock 48 A is provided at the end of the port portion 48.

The dilator body 41 is a long tube body that accommodates the needle portion 30 and the protective tube 60. The dilator main body 41 has a tapered 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.

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

The dilator body 41 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 body 41 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 part 46 plays a role of directing the puncture part 31 of the needle part 30 inserted into the right atrium and the taper part 42 of the dilator 40 toward the fossa.

The length of the dilator body 41 is set as appropriate, and is, for example, 400 to 1500 mm. The outer diameter of the dilator body 41 is set as appropriate, 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, and is, for example, 1 to 15 mm, more preferably 2 to 12 mm, and further preferably 3 to 10 mm. The radius clearance between the inner peripheral surface of the dilator distal portion 43 and the outer peripheral surface of the protective tube 60 is set as appropriate, and is, for example, 0.03 to 0.1 mm.

The constituent material of the dilator body 41 is preferably flexible. For example, polyolefins such as polyethylene and polypropylene, polyesters such as polyamide and polyethylene terephthalate, PTFE (polytetrafluoroethylene), ETFE (ethylene / tetrafluoroethylene) Fluoropolymers such as copolymers), PEEK (polyetheretherketone), polyimide, shape memory alloy, stainless steel, tantalum, titanium, platinum, gold, tungsten, and other metals can be suitably used. The dilator body 41 may include an X-ray contrast material or an ultrasound contrast material.

The hub 47 is provided at the 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 the end. By connecting a syringe or the like to the three-way stopcock 48 A, the lumen of the dilator main body 41 can be primed, or a contrast agent or a drug can be injected into the dilator main body 41.

The valve body 49 is a member for sealing the lumens of the hub 47 and the dilator main body 41. The valve body 49 can be deformed flexibly and is disposed on the inner peripheral surface of the hub 47. The valve body 49 is slidably in contact with the outer peripheral surface of the protective tube 60. Further, the valve body 49 can press the protective tube 60 with an elastic force in a state where the protective tube 60 is inserted, and can fix the protective tube 60 and the dilator 40. Even if the valve body 49 is fixed, it can be relatively moved in the axial direction by gripping the protective tube 60 and the dilator 40 and applying a force. Further, by pulling out the protective tube 60 from the hub 47, the hole portion of the valve body 49 in which the protective tube 60 is inserted is closed, and the lumen of the hub 47 is sealed from the proximal side. The valve body 49 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 49 suppresses blood from leaking through the dilator 40 and allows air to be mixed into the body while allowing the protective tube 60 to be inserted and removed.

The outer sheath 50 provides an 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 part 31 of the needle part 30 inserted into the right atrium and the distal part of the sheath body 51 toward the foveal fossa.

The sheath main 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 20 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 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 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, 2.5 to 7.0 mm. The inner diameter of the sheath body 51 is set as appropriate, 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 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 and polypropylene, polyester such as polyamide and polyethylene terephthalate, PTFE (polytetrafluoroethylene), ETFE (ethylene tetra Fluoropolymers such as (fluorinated ethylene copolymer), 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 at 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 lumens of the hub 54 and 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 the state where the needle part 30, the protective 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 protective tube bending part 62, the dilator bending part 46 and the sheath bending part 52 are as follows: It is preferable to match or approximately match. Thereby, the puncture part 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 1 according to this embodiment will be described with reference to the flowchart of FIG.

First, a needle is punctured into the femoral vein, and a short guide wire is inserted into the needle. Next, the needle is removed and a catheter introducer is inserted into the blood vessel along the short guide wire. Next, the sheath assembly 20 in which the dilator 40 is inserted into the outer sheath 50 is prepared. Subsequently, the short guide wire is removed, and the guide wire 110 is inserted into the catheter introducer. Next, with the guide wire 60 left in the blood vessel, the catheter introducer is removed, and the proximal end of the guide wire 60 is inserted into the lumen 41A from the distal end of the dilator 40 of the sheath assembly 20. Then, it is inserted into the blood vessel (step S10). Subsequently, the distal portion of the sheath assembly 20 is gradually pushed up to the right atrium R while the guide wire 110 is advanced. Next, the sheath assembly 20 is temporarily inserted along the guide wire 110 from the right atrium R into the superior vena cava. Subsequently, when the sheath assembly 20 is retracted and drawn into the right atrium R, as shown in FIGS. 8 and 9A, the distal end of the sheath assembly 20 is located in the vicinity of the foveal fossa O. Naturally guided to. Thereafter, the guide wire 110 is removed from the sheath assembly 20.

Subsequently, the sheath assembly 20 is pushed to the distal side while observing the left atrium L and the right atrium R with an intracardiac echo catheter (ICE: Intra cardiac echo catheter). As a result, as shown in FIG. 9B, the ovarian fossa O is pushed to the left atrium L side by the dilator 40 and protrudes (step S11). At this time, since the distal portions of the outer sheath 50 and the dilator 40 are bent, the distal end portion of the sheath assembly 20 is likely to face the egg fossa O. Note that the oval fossa O does not have to protrude to the left atrium L side.

Next, as shown in FIG. 9C, the puncture device 10 is inserted into the lumen 41A from the proximal side of the dilator 40 (step S12). 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 is activated and the moving portion 80 is operated. The movement with respect to the operation unit 70 is restricted. Therefore, the puncture part 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. 10 (B), the pushing portion 101 of the releasing portion 100 is pushed in to release the safety mechanism (step S13). When the push-in part 101 is pushed in, the internal structure 102 moves in the push-in direction inside the second housing part 77 and the second urging part 91 contracts. At this time, the convex portion 106 is located at the proximal end portion 84 A of the second groove portion 84 extending in a 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 contacts the movement restricting portion 86, the first urging portion 90 contracts, and the moving portion 80 moves to the operation portion 70. Move to the proximal side. Thereby, the convex portion 106 reaches the proximal end portion 85 A 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 exceeding the movement restricting portion 86 expands to return 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 convex portion 106 that has reached the third groove portion 85 can move to the first groove portion 83 along the third groove portion 85. Thereby, the moving part 80 can move to the proximal side with respect to the operation part 70, and the puncture part 31 can protrude from the protective tube 60. When the convex portion 106 reaches the third groove portion 85, the second urging portion 91 contracts, and the urging force in the direction opposite to the pushing direction acts on the release portion 100. However, since the movement restricting portion 86 is positioned on the opposite side 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, a direction orthogonal to the pushing direction. For this reason, even if the convex part 106 contacts the movement restriction part 86, the moving part 80 does not move relative to the operation part 70. For this reason, the convex portion 106 cannot return to the second groove portion 84 beyond the movement restriction portion 86. For this reason, the state which released the safety mechanism is maintained. 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 part 80 is urged by the first urging part 90, it is possible to restrict the convex part 106 from returning to the second groove part 84 beyond the movement restricting part.

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 portion 71 and the moving portion 80. At this time, the protective tube 60 strikes the oval fossa O, and movement to the distal side is restricted. For this reason, the protective tube 60 moves to the proximal side with respect to the puncture part 31, and the puncture part 31 protrudes relatively from the protective tube 60, and pierces into the oval fossa O (step S14). When the protective tube 60 moves proximally with respect to the puncture unit 31, the moving unit 80 to which the protective tube 60 is connected is proximal to the operation unit 70 while contracting the first urging unit 90. Move to the side. When the moving unit 80 moves to the proximal side with respect to the operation unit 70, the convex portion 106 of the operation unit 70 moves from the third groove 85 to the first groove 83 of the moving unit 80. When the convex portion 106 reaches the distal end portion 83 A of the first groove portion 83, the movement portion 80 is restricted from further movement toward the proximal side with respect to the operation portion 70. For this reason, the protective tube 60 cannot move proximally with respect to the puncture portion 31. Therefore, when the puncture unit 31 connected to the operation unit 70 is moved to the distal side, the protective tube 60 is also moved 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 oval fossa O formed by the puncture part 31, and reaches the left atrium L (step S15). When the protective tube 60 reaches the left atrium L, the resistance force that the protective tube 60 receives from the ovarian fossa O decreases. As a result, as shown in FIG. 11B, the first urging portion 90 expands, and the moving portion 80 moves distally with respect to the operating portion 70. When the moving unit 80 moves to the distal side with respect to the operation unit 70, the protective tube 60 moves to the distal side with respect to the puncture unit 31, and the puncture unit 31 is accommodated in the protective tube 60 (step S16). For this reason, when the puncture unit 31 and the protective tube 60 penetrate the ovule fossa O, the puncture unit 31 is automatically accommodated in the protective tube 60 by the urging force of the first urging unit 90. Therefore, it is possible to prevent the puncture unit 31 from erroneously puncturing an unintended position, and high safety can be obtained.

When the moving part 80 moves to the distal side with respect to the operation part 70, the convex part 106 of the releasing part 100 moves to the proximal side of the first groove part 83, and the second groove part 84 and the third groove part 85. To reach the confluence. At this time, the convex part 106 is urged | biased by the 2nd urging | biasing part 91 to the opposite direction side of the pushing direction. For this reason, the convex part 106 does not enter the third groove part 85 located on the push direction side with respect to the first groove part 83, and does not enter the third groove part 85 located on the opposite side of the push direction with respect to the first groove part 83. The second groove portion 84 is entered, and the proximal end portion 84A of the second groove portion 84 is reached. If the convex part 106 is located in the proximal end part 84A of the 2nd groove part 84, a safety mechanism will act | operate and the movement with respect to the operation part 70 of the moving part 80 will be restrict | limited (step S17). Therefore, the puncture part 31 does not protrude from the protective tube 60, and high safety is ensured.

When the puncture unit 31 and the protective tube 60 penetrate 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.

Next, the sheath assembly 20 is pushed distally along the puncture device 10. As a result, as shown in FIG. 11C, 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 (Step S18). 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 ovum puncture O is punctured by the puncture portion 31, a part of the tapered portion 42 of the dilator 40 enters the hole of the ovum fossa O. For this reason, it is easy to push the dilator 40 and the outer sheath 50 into the hole of the oval fossa O.

Next, as shown in FIG. 12A, the puncture device 10 is removed from the dilator 40 (step S19). Subsequently, as shown in FIG. 12B, the dilator 40 is removed from the body leaving the outer sheath 50 (step S20). The hole of the oval fossa O expanded 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 is closed, and leakage of blood and mixing of air or the like into the blood vessel can be suppressed. Thereafter, as shown in FIG. 12C, the guide wire 110 is inserted from the proximal side of the outer sheath 50 through the valve body 55 to reach the left atrium L. Thereafter, a second medical device such as an ablation catheter is inserted along the guide wire 110 from the proximal side of the outer sheath 50 via the valve body 55 (step S21). Thereby, the second medical device can be inserted into the left atrium L using the outer sheath 50 penetrating the oval fossa O. Note that the second medical device may be inserted without being along the guide wire 110. After performing treatment such as ablation in the left atrium L with the second medical device (step S22), when the second medical device and the outer sheath 50 are removed from the body, the hole of the fossa fossa O contracts (step) S23). This completes the procedure. Note that the second medical device inserted into the living body via the outer sheath 50 is not limited to the ablation catheter. The position (target site) for inserting the second medical device via the outer sheath 50 is not limited to the pulmonary vein or the left atrium L, and may be, for example, the right atrium R, the left atrial appendage, and the mitral valve. .

As described above, the medical device 1 according to the present embodiment is a medical device 1 for forming a hole in an oval fossa O (living tissue) in a living body and expanding the hole, A long needle part 30 (long body) provided with a sharp puncture part 31 at an end, a long protective tube 60 (protective member) that slidably accommodates the needle part 30, and a protective tube 60 A first urging portion 90 (first elastic member) that moves in the distal direction with respect to the needle portion 30, and when the puncture portion 31 forms a hole in the fossa ovum O, a protective tube 60 is movable to the distal side by the urging force from the first urging portion 90 so as to expand the hole formed by the puncture portion 31 in the oval fossa O and accommodate the puncture portion 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 against the needle portion 30. Then, the puncture portion 31 protrudes from the protective tube 60. For this reason, the needle part 30 can be conveyed to the target position, maintaining safety. Then, by pressing the protective tube 60 against the foveal fossa O, the puncture portion 31 can be projected to form a hole in the foveal fossa O. Moreover, the hole can be efficiently expanded by pushing the protective tube 60 into the hole formed in the oval fossa O. Furthermore, when a hole is formed in the oval fossa O, the urging force of the first urging unit 90 moves the protective tube 60 to the distal side with respect to the puncture unit 31, and the puncture unit 31 is automatically protected. Housed in a tube 60. For this reason, it can suppress that the puncture part 31 punctures the site | part which is not the purpose, and can improve safety | security.

In addition, the medical device 1 can be in an accommodated state in which the puncture unit 31 is accommodated in the protective tube 60 and in a projecting state in which the puncture unit 31 projects from the protective tube 60 to the distal side. The protective tube 60 receives the urging force from the first urging unit 90 and accommodates the puncture unit 31. In the protruding state, the protective tube 60 receives an external force in the proximal direction, so that the first urging unit 90 It moves to the proximal side relative to the puncture portion 31 against the urging force, and the puncture portion 31 protrudes relatively from the protective tube 60 to the distal side. Thereby, when the protection tube 60 in the accommodated state is pressed against the oval fossa O, the first urging portion 90 is deformed, and the protection tube 60 moves to the proximal side with respect to the needle portion 30, and is in the protruding state. Become. For this reason, the needle part 30 can be conveyed to the target position, maintaining safety. Then, the protective tube 60 is pressed against the oval fossa O so as to project, and the puncture portion 31 can puncture the oval fossa O. In the protruding state, the protective tube 60 enters the hole formed in the foveal fossa O, and can efficiently expand the hole. Further, when a hole is formed in the oval fossa O, the protective tube 60 moves to the distal side with respect to the puncture portion 31 by the urging force of the first urging portion 90 and automatically enters a housed state. For this reason, it can suppress that the puncture part 31 punctures the site | part which is not the purpose, and can improve safety | security.

Further, 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 0.025 to 0.1 mm. Thereby, the protective tube 60 can slide while being in close contact with the needle portion 30. For this reason, the protective tube 60 enters the hole of the oval fossa O formed by the puncture part 31 along the needle part 30, and the hole can be smoothly expanded.

Further, the medical device 1 has a safety mechanism that controls the movement of the protective tube 60 toward the proximal side with respect to the needle part 30. Thereby, the medical device 1 can suppress the protrusion which the puncture part 31 does not intend, and safety improves.

The medical device 1 further includes an operation unit 70 to which the proximal portion of the needle unit 30 is coupled, and a moving unit 80 to which the proximal portion of the protective tube 60 is coupled. 80 includes a first opposing portion 82 and a second opposing portion 105 that are opposed to each other, and the first opposing portion 82 extends in the axial direction of the needle portion 30. The second facing 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, and the medical device 1 is in a protruding state. As a result, the convex portion 106 hits the end portion of the extending direction of the first groove portion 83, and the movement of the moving portion 80 toward the proximal side with respect to the operation portion 70 is restricted. Accordingly, since the medical device 1 is in the protruding state, movement of the moving unit 80 toward the proximal side with respect to the operation unit 70 is limited, and thus the protective tube 60 is in a state of protruding from the protective tube 60. The proximal movement relative to the needle portion 30 is limited. For this reason, while forming a hole in the oval fossa 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 oval fossa O to expand the hole.

Further, the first facing portion 82 has a second groove portion 84 that communicates with the first groove portion 83, and in the accommodated state, the second groove portion 84 can accommodate the convex portion 106, and the second The groove portion 84 restricts the convex portion 106 from moving to the first groove portion 83 along the axial direction of the needle portion 30. Thereby, in the accommodation state in which the convex part 106 was accommodated in the 2nd groove part 84, it can restrict | limit that the puncture part 31 protrudes from the protective tube 60, and can improve safety | security.

Further, the first facing portion 82 has a third groove portion 85 communicating with the first groove portion 83 and the second groove portion 84, and the third groove portion 85 can accommodate the convex portion 106 in the accommodated state. The third groove portion 85 allows the convex portion 106 to move to the first groove portion 83 along the axial direction of the needle portion 30. Thereby, the convex part 106 accommodated in the 3rd groove part 85 becomes movable to the 1st groove part 83 by moving the convex part 106 from the 2nd groove part 84 to the 3rd groove part 85. FIG. For this reason, the protection tube 60 and the needle part 30 connected to the first facing part 82 and the second facing part 105 can be relatively moved. Thereby, the external force in the proximal direction acts on the protective tube 60, and the protective tube 60 moves to the proximal side with respect to the puncture unit 31 while resisting 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 does not act on the protective tube 60, the protective tube 60 moves to the distal side with respect to the needle portion 30 by the biasing force of the first biasing portion 90, and the protective tube 60 is The puncture part 31 can be accommodated automatically.

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. A movement restriction unit 86 is provided. Accordingly, the movement restricting portion 86 restricts the convex portion 106 from returning to the second groove portion 84 by moving the convex portion 106 from the second groove portion 84 to the third groove portion 85. For this reason, the convex part 106 is located in the 3rd groove part 85, and the state (state in which the safety mechanism was cancelled | released) which can protrude the puncture part 31 from the protective tube 60 can be maintained favorable.

The operation unit 70 is connected to the needle unit 30 and includes an operation main body 71 that accommodates the moving unit 80 movably along the axial direction of the needle unit 30, and the second facing unit 105 includes the needle unit 30. And a release portion 100 that moves the convex portion 106 accommodated in the second groove portion 84 from the second groove portion 84 in a direction that intersects the axial direction of the first groove portion 84. Thereby, the convex part 106 located in the 2nd groove part 84 can be moved from the 2nd groove part 84 by moving the cancellation | release part 100. FIG. For this reason, the state in which the puncture portion 31 is restricted from protruding from the protective tube 60 can be easily released by operating the release portion 100, and the operability is improved.

The operation unit 70 further includes a second urging unit 91 that urges the release unit 100. Thereby, it is possible to prevent the release unit 100 from being urged by the second urging unit 91 and the state where the puncture unit 31 is restricted from protruding from the protective tube 60 from being inadvertently released. For this reason, high safety can be secured.

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

The present invention also includes a treatment method (therapeutic method) for forming a hole in the oval fossa O (living tissue) in vivo using the medical device 1 described above and expanding the hole. In this treatment method, the protective tube 60 and the puncture portion 31 in the accommodated state are inserted into the living body, and the protective tube 60 is moved to the distal side and pressed against the fossa O to puncture the protective tube 60. A step of moving the puncture part 31 relatively to the distal side from the protective tube 60, a step of forming a hole in the oval fossa O by the puncture part 31, The step of pushing the protective tube 60 into the hole formed in the circle O and the urging force of the first urging unit 90 move the protective tube 60 to the distal side with respect to the puncture unit 31, Accommodating the puncture unit 31.

In the treatment method configured as described above, the protective tube 60 in the accommodated state is pressed against the oval fossa O, the first urging portion 90 is deformed, and the protective tube 60 is proximal to the puncture portion 31. The puncture part 31 is protruded from the protective tube 60. For this reason, the needle part 30 can be conveyed to the target position, maintaining safety. Then, by pressing the protective tube 60 against the foveal fossa O, the puncture portion 31 can be projected to form a hole in the foveal fossa O. Further, when a hole is formed in the oval fossa O, the urging force of the first urging portion 90 moves the protective tube 60 to the proximal side with respect to the puncture portion 31, and the puncture portion 31 is automatically protected. It can be accommodated in the tube 60. For this reason, it can suppress that the puncture part 31 punctures the site | part which is not the purpose, and can improve safety | security. Moreover, the hole can be efficiently expanded by pushing the protective tube 60 slidably holding the needle part 30 into the hole formed in the oval fossa O.

Note that the present invention is not limited to 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 foveal fossa.

Further, the needle portion may be hollow. 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.

Further, as in the first modification shown in FIG. 14A, the third groove portion is not formed in the first facing portion 121 of the moving portion 120, and the first groove portion 83 and the second groove portion 84 are not formed. Only may be formed. In addition, the same code | symbol is attached | subjected to the site | part which has a function similar to the above-mentioned embodiment, and description is abbreviate | omitted. Accordingly, by pressing the release portion 100 from the state in which the convex portion 106 is positioned in the second groove portion 84 and the safety mechanism is activated, the convex portion 106 is moved to the first groove portion as shown in FIG. The safety mechanism can be released at the position 83. Then, the puncture part 31 can be protruded 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.

Further, as in the second modification shown in FIG. 15, the second groove portion and the third groove portion are not formed in the first facing portion 131 of the moving portion 130, and only the first groove portion 83 is formed. May be. The operation unit 140 does not include a release unit that releases the safety mechanism. The first groove portion 83 accommodates a convex portion 142 provided on the operation main body portion 141 facing the first facing portion 131. As a result, the third modification does not include a safety mechanism, but the convex portion 142 moves within the range of the first groove portion 83. Thereby, the movement range with respect to the puncture part 31 of the protective tube 60 can be restrict | limited. For this reason, after the puncture part 31 punctures a biological tissue, the protective tube 60 which is located proximal to the puncture part 31 and whose movement is restricted can be easily pushed into a hole formed in the biological tissue. .

Further, as in the third modification shown in FIG. 16, the first groove portion, the second groove portion, and the third groove portion are not formed in the moving portion 150, and the release portion is not provided in the operation portion 160. Good. Even with such a structure, the first urging portion 90 contracts by abutting the protective tube 60 against the living tissue, and the puncture portion 31 can be protruded from the protective tube 60. Further, the protective tube 60 can be pushed into a hole formed in the living tissue, and the puncture portion 31 can be accommodated in the protective tube 60 by the urging force of the first urging portion 90.

Further, as in the fourth modification example shown in FIG. 17, the inner diameter of the protective tube 170 may be larger than the distal portion 171 on the proximal side of the distal portion 171 that accommodates the puncture portion 31. Thereby, the sliding resistance between the protective tube 170 and the needle portion 30 is reduced, and the needle portion 30 can be smoothly moved inside the protective tube 170. In addition, the outer diameter of the distal end 172 of the protective tube 170 decreases in a tapered manner 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 with respect to the central axis of the distal end 172 is set as appropriate, but is preferably smaller than the inclination angle α1 with respect to the central axis of the puncture portion 31. As a result, the distal end 172 is less likely to damage the living tissue.

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

Furthermore, this application is based on Japanese Patent Application No. 2016-2111316 filed on Oct. 28, 2016, the disclosures of which are referenced and incorporated as a whole.

1 medical device,
10 Puncture device,
20 sheath assembly;
30 Needle part (long body),
31 Puncture part,
40 Dilator,
41A lumen (lumen),
60, 170 protective tube (protective member),
70, 140, 160 operation unit,
71, 141 operation main body,
80, 120, 130, 150 moving part,
82, 121, 131 first opposing portion,
83 first groove,
83A distal end,
84 second groove,
85 third groove,
86 Movement restriction part,
90 a first urging portion (first elastic member),
91 second urging portion (second elastic member),
100 release part,
105 second facing portion,
106, 142 convex part,
O oval fossa (living tissue),
L left atrium,
R Right atrium.

Claims

A medical device for forming a hole in a living tissue in a living body and expanding the hole,
An elongated body provided with a sharp puncture at the distal end;
A long protective tube that slidably accommodates the puncture portion;
A first urging portion that moves the protective tube in a distal direction with respect to the puncture portion,
When the puncture portion forms a hole in the biological tissue, the protective tube extends from the first biasing portion so that the puncture portion expands the hole formed in the biological tissue and accommodates the puncture portion. A medical device that can be moved to the distal side by the biasing force.
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 elongated body is 0.025 to 0.1 mm.
The medical device according to claim 1 or 2, wherein the outer diameter of the distal end portion of the protective tube decreases toward the distal side.
The medical device according to any one of claims 1 to 3, further comprising a safety mechanism that controls movement of the protective tube to the proximal side with respect to the elongated body.
An operation unit to which a proximal portion of the elongated body is coupled;
A moving part to which a proximal part of the protective tube is connected,
The operation unit and the moving unit have a first opposed unit and a second opposed unit that move relatively to each other,
The first facing portion has a first groove extending along the axial direction of the elongated body,
The second facing portion has a convex portion that is accommodated in the first groove portion and is movable along the first groove portion,
2. The protrusion of the medical device in a protruding state causes the projecting portion to abut an end portion in the extending direction of the first groove portion to restrict movement of the moving portion to the proximal side with respect to the operation portion. The medical device according to any one of 1 to 4.
The first facing portion has a second groove portion communicating with the first groove portion,
In the accommodation state, the second groove portion can accommodate the convex portion, and the second groove portion moves to the first groove portion along the axial direction of the elongated body. The medical device according to claim 5, wherein the medical device is restricted.
The first facing portion has a third groove portion communicating with the first groove portion and the second groove portion,
In the accommodation state, the third groove part can accommodate the convex part, and the third groove part moves to the first groove part along the axial direction of the elongated body. The medical device according to claim 6, wherein the medical device is allowed.
The first facing portion includes a movement limiting portion that protrudes between the second groove portion and the third groove portion so as 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.
The operation unit is
The long body is connected, and an operation main body that accommodates the moving part movably along the axial direction of the long body;
The first opposing part or the second opposing part is moved in a direction intersecting the axial direction of the elongated body, and the convex part accommodated in the second groove part is moved from the second groove part. The medical device according to any one of claims 6 to 8, further comprising a release unit.
The medical device according to claim 9, wherein the operation unit further includes a second urging unit that urges the release unit.
A medical device for forming a hole in a living tissue in a living body and expanding the hole,
An elongated body provided with a sharp puncture at the distal end;
A long tubular protective member that slidably accommodates the puncture portion;
A first elastic member that moves the protective member in a distal direction with respect to the puncture portion,
When the puncture unit forms a hole in the biological tissue, the protective member extends from the first elastic member so that the puncture unit expands the hole formed in the biological tissue and accommodates the puncture unit. A medical device that can move distally by elasticity.
A treatment method for forming a hole in a living tissue in vivo using the medical device according to claim 1 and expanding the hole,
Inserting the protective tube and the puncture portion in the housed state into a living body;
By moving the protective tube to the distal side and pressing it against the living tissue, the protective tube is moved proximally with respect to the puncture portion, and the puncture portion is moved relative to the distal side from the protective tube. Projecting step,
Forming a hole in a living tissue by the puncture unit;
Pushing the protective tube into the hole formed in the biological tissue;
A treatment method comprising: moving the protective tube distally with respect to the puncture portion by an urging force of the first urging portion to house the puncture portion in the protective tube.