JP2018068901A - Medical device and treatment method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical device capable of retaining a state where a needle part is punctured in a living tissue and enhancing safety by suppressing erroneous puncture, and a treatment method.SOLUTION: A medical device 1 for forming a hole at an oval fossa O in a living body, includes: a long needle part 30 provided with a puncture part 31; a tubular outer tube 60 for storing the needle part 30; an operating part 70 to which a proximal portion of the outer tube 60 is connected; a move part 80 to which a proximal portion of the needle part 30 is connected and that is movable along the axial direction of the needle part 30; and a force generation part 90 applying force to the move part 80 in a direction of projecting of the puncture part 31 from the outer tube 60. The force generation part 90 can move the move part 80 to a distal side, where a distance between a proximal-side action part 121 and a distal-side action part 86 is longer than a natural length L0 of the force generation part 90.SELECTED DRAWING: Figure 2

Description

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

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

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

  When ablation is performed in the left atrium, a needle is inserted into the thin septum called the ovary fossa of the atrial septum from the right atrium to open a hole that leads from the right atrium to the left atrium. A procedure is required. Transseptal needles that are devices for performing this atrial septal puncture include mechanical puncture needles and high-frequency energy puncture needles (Radio Frequency Needle). Mechanical puncture needles are mainstream because they are inexpensive.

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

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

US Patent Publication No. 2002/0169377

  In the device described in Patent Document 1, the state where the puncture needle protrudes from the dilator is maintained after puncturing. For this reason, there is a possibility of erroneous puncture by a sharp puncture needle.

  The present invention has been made to solve the above-described problems, and can maintain a state in which a needle portion is punctured into a living tissue, and can improve safety by suppressing erroneous puncture by the needle portion. And to provide a method of treatment.

  A medical device according to the present invention that achieves the above-described object is a medical device for forming a hole in a living tissue in a living body, and is a long needle portion provided with a puncture portion at a distal end, A tubular elongated body that accommodates the needle portion so as to protrude distally, an operation portion to which a proximal portion of the elongated body is coupled, a proximal portion of the needle portion is coupled, and the needle portion A moving portion that is movable along the axial direction of the piercing portion, and a force generating portion that applies a force to the moving portion in a direction in which the puncture portion protrudes from the elongated body. A first action part that receives a force from the generation part, and the moving part has a second action part that receives a force from the force generation part, and the first action part and the second action part At least one is separable from the force generating portion, and the force generating portion expands from the contracted state to expand the first action. And the force can be applied to the second action part to move the moving part to the distal side, and the distance between the first action part and the second action part is the natural distance of the force generation part. Longer than long.

  A treatment method according to the present invention that achieves the above object is a treatment method for forming a hole in a living tissue in a living body using the medical device described above, wherein the force generating part contracts and the puncture part Preparing the medical device in a state of being accommodated in the elongated body, inserting the elongated body and the puncture portion of the medical device into a living body, and projecting the puncture portion from the elongated body The living tissue is punctured, and the puncture part is projected from the elongated body, and at least one of the first action part and the second action part is separated from the force generation part. Maintaining.

  In the medical device and the treatment method configured as described above, the distance between the first action part and the second action part is longer than the natural length of the force generation part, and the first action part and the second action part. At least one of the two can be separated from the force generation unit. Thereby, after the force generation part expands and the puncture part protrudes from the elongated body and punctures the living tissue, at least one of the first action part and the second action part is separated from the force generation part. For this reason, a puncture part does not return in a long body, but the state which the puncture part punctured the biological tissue can be maintained. Further, in a state where the puncture portion protrudes from the elongated body, at least one of the first action portion and the second action portion is separated from the force generation portion, so that the needle portion is biased by the force generation portion. Not. For this reason, when it contacts the site | part which should not contact a puncture part and receives the force which goes to a proximal side, it can return to the inside of an outer tube | pipe easily. Therefore, it is possible to improve safety by suppressing erroneous puncture by the puncture unit. In addition, since the living tissue can be punctured with the force and puncture stroke set in advance by the force of the force generation unit, erroneous puncture can be suppressed and safety can be improved.

It is a top view which shows the medical device which concerns on 1st Embodiment. It is sectional drawing which shows the medical device which concerns on 1st Embodiment. It is sectional drawing which shows the state which combined each site | part of the medical device which concerns on 1st Embodiment. It is sectional drawing which shows operation | movement of a puncture device, (A) is an initial state, (B) is the state which engaged the engaging part with the movement part, (C) is the state which protruded the puncture part, (D) Indicates a state where the puncture portion is accommodated in the outer tube. 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 engaged the engaging part with the moving part, (C ) Shows a state where the fossa is punctured by the puncture part. 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 hole of an oval fossa, (B) is the state which accommodated the puncture part in the outer tube, (C ) Shows a state where the puncture portion is housed in the dilator. It is sectional drawing which shows the state at the time of puncturing with a medical device, (A) shows the state which pulled out the dilator and the puncture device from the outer sheath, and (B) shows the state which inserted the guide wire into the outer sheath. It is sectional drawing which shows the puncture device of 2nd Embodiment, (A) is an initial state, (B) is the state which engaged the engaging part with the movement part, (C) is the state which protruded the puncture part, (D) shows a state where the puncture portion is housed in the outer tube. It is a top view which shows the puncture device of 3rd Embodiment. It is sectional drawing which shows the puncture device of 3rd Embodiment. It is a perspective view which shows the puncture adjustment part of the puncture device of 3rd Embodiment. It is sectional drawing which shows the puncture device of 4th Embodiment, (A) is an initial state, (B) is the state which engaged the engaging part with the movement part, (C) is the state which protruded the puncture part, (D) shows a state where the puncture portion is housed in the outer tube. It is a figure which shows the modification of a medical device, (A) is sectional drawing which shows the distal part of the puncture device of a 1st modification, (B) shows the distal part of the puncture device of a 2nd modification. It is a top view.

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

  The medical device 1 according to the first embodiment of the present invention pierces a needle from the right atrium to the oval fossa O of the atrial septum to form a hole that leads from the right atrium R to the left atrium L (see FIG. 5). Used for. If there is a hole in the oval fossa O, ablation catheter inserted percutaneously into the vena cava is guided to the right atrium R and then inserted into the left atrium L through the hole to ablate around the pulmonary vein mouth Can do. That is, the medical device 1 is a device for forming an access route for an ablation catheter in the foveal fossa.

  As shown in FIGS. 1 to 3, the medical device 1 includes a puncture device 10 that performs puncture and a sheath assembly 20 that houses the puncture device 10. The puncture device 10 includes a long needle part 30, an outer tube 60 that houses the needle part 30, and an operation part 70. The puncture device 10 further includes a moving unit 80, a force generating unit 90, a biasing unit 100, and a gripping unit 110 inside the operation unit 70. 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 and hollow wire-shaped member. The needle part 30 has a sharp puncture part 31 at the distal end. The proximal end portion of the needle unit 30 is connected to a moving unit 80 disposed inside the operation unit 70. The needle part 30 includes a through hole 32 that penetrates from the distal side to the proximal side. A side hole 33 that opens to the side surface is formed in the proximal portion of the needle portion 30. The side hole 33 is disposed inside the operation unit 70. The needle portion may be solid rather than hollow. Further, the needle part 30 may be hollow on the distal side and have a side hole, and the proximal side may be solid.

  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 the 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 circular tube. In addition, the cross-sectional shape of the needle part 30 may not be circular.

  Although the length of the needle part 30 is set suitably, it is 500-1100 mm, for example. Although the outer diameter of the needle part 30 is set suitably, it is 0.5-1.0 mm, for example. Although the internal diameter of the needle part 30 is set suitably, it is 0.3-0.8 mm, for example. The inclination angle α1 with respect to the central axis of the end face 34 of the puncture unit 31 is set as appropriate, and 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 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 (ethylene-tetrafluoroethylene copolymer), PEEK ( (Polyetheretherketone), polyimide and the like can be preferably used. As the shape memory alloy, a Ni-Ti system, a Cu-Al-Ni system, a Cu-Zn-Al system, or the like can be suitably used. The needle unit 30 may include an X-ray contrast material. The X-ray contrast material is preferably made of, for example, at least one metal or two or more alloys selected from the group consisting of gold, platinum, iridium, tungsten, alloys thereof, and silver-palladium alloys. is there. Further, the needle part 30 may include an ultrasound contrast material. As the ultrasonic contrast material, stainless steel or the like can be used in addition to the X-ray contrast material described above.

  The outer tube 60 is a tubular body and accommodates the needle portion 30 in a slidable manner. The outer tube 60 has an inner peripheral surface that slides smoothly with the needle portion 30. The outer tube 60 accommodates the puncture part 31 of the needle part 30 inside and protects the dilator 40 and the living tissue. When the needle part 30 moves to the distal side in the outer tube 60, the puncture part 31 protrudes from the inside of the outer tube 60 to the distal side. When the needle part 30 moves proximally inside the outer tube 60, the puncture part 31 is accommodated from the inside of the outer tube 60. The outer tube 60 is more flexible than the needle part 30. The outer surface of the outer tube 60 may be coated with a low friction material so that it can contact the dilator 40 with low friction. Examples of the low friction material include fluorine-based polymers such as PTFE (polytetrafluoroethylene) and ETFE (ethylene / tetrafluoroethylene copolymer). Further, the inner surface of the outer tube 60 may be coated with a low friction material so that the inner surface of the outer tube 60 can contact the needle portion 30 with low friction.

  The outer tube 60 has an outer tube bent portion 62 bent at a predetermined angle at a distal portion in a natural state. The angle β2 of the outer tube bending portion 62 with respect to the proximal portion of the outer tube 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 outer 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 O. The outer peripheral edge of the distal end of the outer tube 60 is preferably machined into a curved surface so that it can be smoothly inserted into the dilator 40.

  Although the length of the outer tube | pipe 60 is set suitably, it is 400-1100 mm, for example. The outer diameter of the outer tube 60 is appropriately set, and is, for example, 0.5 to 1.5 mm. The inner diameter of the outer tube 60 is appropriately set, and is, for example, 0.3 to 1.3 mm. The clearance at the radius between the inner peripheral surface of the outer tube 60 and the outer peripheral surface of the needle portion 30 is set as appropriate, and is, for example, 0.025 to 0.2 mm.

  The constituent material of the outer 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, fluorine-based polymers such as PTFE (polytetrafluoroethylene) and ETFE (ethylene / tetrafluoroethylene copolymer), PEEK (polyether ether ketone) ), Polyimide and the like can be suitably used. Further, the outer tube 60 may include an X-ray contrast material or an ultrasound contrast material. The outer 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 distal part of the operation part 70 has a cylinder part 71 connected to the proximal part of the outer tube 60, a first connection part 72 connected to the dilator 40, and a port part 73. The cylindrical portion 71 is located at the end on the distal side of the operation portion 70. The cylinder portion 71 allows the lumen of the outer tube 60 to be connected to communicate with the inside of the port portion 73. The first connecting portion 72 is a cylindrical member that is rotatably provided on the outer peripheral surface of the cylindrical portion 71. On the inner peripheral surface of the first connection portion 72, a female connector that can be screwed with the second connection portion 41 provided in the proximal portion of the dilator 40 is formed.

  The port portion 73 includes a seal portion 74, a first accommodating portion 77 provided between the seal portion 74 and the cylindrical portion 71, a flexible deformable tube 75, and a three-way cock 76 provided at an end portion of the tube 75. have. The needle portion 30 penetrates the seal portion 74 so as to be slidable. The seal portion 74 seals the first housing portion 77 from the second housing portion 120 on the proximal side. The seal portion 74 is slidably in contact with the outer peripheral surface of the needle portion 30. The seal part 74 is, for example, an O-ring. The O-ring suppresses blood from leaking from the outer tube 60 and the needle portion 30 and suppresses air from entering the body. The tube 75 communicates with the first housing part 77. A side hole 33 of the needle part 30 is located inside the first housing part 77. The needle portion 30 can move in the axial direction in the first housing portion 77, but the side hole 33 is always located in the first housing portion 77. By connecting a syringe or the like to the three-way cock 76, the lumen of the outer tube 60 can be primed or a contrast agent, a drug, or the like can be injected into the outer tube 60 via the first housing 77. . Further, by connecting a syringe or the like to the three-way stopcock 76, the through hole 32 of the needle portion 30 is primed from the side hole 33 through the first housing portion 77, or a contrast agent, a drug, or the like is added to the through hole 32. Or can be injected. In addition, blood pressure can be measured by using the through-hole 32 of the needle portion 30 to guide blood in the living body to the outside. By measuring the blood pressure, it can be accurately confirmed that the puncture unit 31 has reached the target position.

  The operation unit 70 further includes a second storage unit 120 that stores the moving unit 80 and the force generation unit 90, and a third storage unit 130 that stores the biasing unit 100 and the gripping unit 110.

  The 2nd accommodating part 120 accommodates the distal part of the moving part 80, and the force generation part 90 so that a movement is possible. A proximal side action part 121 (first action part) that comes into contact with the proximal end of the force generation part 90 is formed inside the second housing part 120. The proximal side action part 121 is a part where the force of the force generation part 90 acts. The proximal side action part 121 restrict | limits that the force generation part 90 which contact | abuts moves to a proximal side. A first opening portion 122 penetrating into the internal space is formed on the side surface of the second housing portion 120. A release portion 123 that extends distally and can be elastically bent toward the first opening 122 is provided on the outer surface of the second accommodating portion 120. The release unit 123 includes a pressing unit 124 that can enter the first opening 122. The pressing part 124 can push in the receiving part 82 provided in the moving part 80. The second accommodating portion 120 has an engaging portion 125 that can engage with the moving portion 80 on the distal side of the first opening portion 122. The engaging part 125 protrudes to the inner surface side of the second housing part 120. The proximal engaging surface 126 on the proximal side of the engaging portion 125 is perpendicular to the moving direction of the moving portion 80. The distal inclined surface 127 on the distal side of the engaging portion 125 is inclined with respect to the moving direction of the moving portion 80.

  The 3rd accommodating part 130 accommodates the urging | biasing part 100, the holding | grip part 110, and the ring part 131 located between the urging | biasing part 100 and the moving part 80 so that a movement is possible. Two second openings 132 penetrating into the internal space are formed on the side surface of the third housing portion 130. The two second openings 132 lead the grip 110 to the side. A wall part 133 through which the moving part 80 passes is formed between the second accommodating part 120 and the third accommodating part 130. The wall 133 divides the internal space of the second storage part 120 and the third storage part 130. The wall 133 abuts on the distal portion of the grip 110 and restricts the grip 110 from moving distally.

  The moving unit 80 can move inside the second storage unit 120 and the third storage unit 130 along the axial direction of the needle unit 30. The moving part 80 penetrates the force generating part 90 and the urging part 100 which are coil springs. The proximal part of the needle part 30 is fixed to the distal part of the moving part 80. The moving portion 80 includes a bending portion 81 extending to the distal side, a distal side action portion 86 (second action portion) that contacts the distal end portion of the force generation portion 90, and a hook portion 87. Is formed. The bending part 81 can bend elastically. The bending portion 81 includes a receiving portion 82 that is pushed in by the pressing portion 124 and a moving engagement portion 83 that is located on the distal side of the receiving portion 82. The moving engagement portion 83 and the receiving portion 82 protrude toward the first opening 122. The distal engagement surface 84 on the distal side of the moving engagement portion 83 is perpendicular to the moving direction of the moving portion 80. The proximal inclined surface 85 on the proximal side of the moving engagement portion 83 is inclined with respect to the moving direction of the moving portion 80. The distal side action part 86 is a part where the force of the force generation part 90 acts. The distal action portion 86 abuts on the distal end of the force generation portion 90. When the distal side action part 86 receives the action force from the force generation part 90, the moving part 80 can move to the distal side. The hook part 87 is located at the proximal end of the moving part 80. The hook portion 87 penetrates the urging portion 100 and the ring portion 131 from the distal side to the proximal side, and abuts on the proximal side surface of the ring portion 131. The ring portion 131 is a ring-shaped member for favorably connecting the urging portion 100 and the hook portion 87.

  The force generation unit 90 is a coil spring (elastic body) that surrounds the moving unit 80 inside the second housing unit 120. The distal end portion of the force generation unit 90 can abut on the distal action portion 86 of the moving unit 80. Further, the distal end portion of the force generation unit 90 can be separated from the distal action portion 86. The proximal end portion of the force generation unit 90 can abut on the proximal action unit 121 of the operation unit 70. Further, the proximal end portion of the force generation unit 90 can be separated from the proximal action unit 121. Therefore, the force generation unit 90 is not fixed to either the moving unit 80 or the operation unit 70. The force generation unit 90 may be fixed to one of the distal side action unit 86 and the proximal side action unit 121. The natural length L0 of the force generator 90 along the moving direction of the moving part 80 is shorter than the distance L1 when the proximal side action part 121 and the distal side action part 86 are farthest away (see FIG. 4C). ). The natural length L0 of the force generation unit 90 is a length from a portion that can contact the distal action portion 86 to a portion that can contact the proximal action portion 121 in a natural state where no external force is applied. It is.

  The urging unit 100 is a coil spring (elastic body) that is located in the third storage unit 130 and surrounds the moving unit 80. The distal end of the urging unit 100 can abut on the gripping unit 110. The proximal end portion of the urging unit 100 abuts on the proximal action unit 121 of the operation unit 70. The proximal end portion of the urging portion 100 abuts on the ring portion 131 located on the distal side of the hook portion 87. The spring constant of the urging unit 100 is smaller than the spring constant of the force generating unit 90. The urging force of the urging unit 100 generated when the puncture unit 31 protrudes most from the outer tube 60 and stops is equal to or less than the minimum force necessary for the needle unit 30 to start moving from this state to the proximal side. It is. Therefore, when the needle part 30 protrudes and stops, the needle part 30 receives a biasing force from the biasing part 100, but the needle part 30 does not move from the stopped state. The minimum force required to start moving the proximal portion from the state where the needle portion 30 protrudes most distally from the outer tube 60 and stops is the bending load from the outside, the thrombus, etc. It is preferable to measure the maximum static frictional force when the needle portion 30 with respect to the outer tube 60 in the natural state that is not given resistance starts to move proximally.

  The urging portion 100 is not fixed to either the grip portion 110 or the ring portion 131. Note that the biasing portion 100 may be fixed to at least one of the grip portion 110 and the ring portion 131. The natural length of the urging unit 100 along the moving direction of the moving unit 80 is longer than the length L2 when the gripping unit 110 and the ring unit 131 are closest to each other (see FIG. 4C). As a result, the urging unit 100 applies a force toward the proximal side to the needle unit 30 in a state where the gripping unit 110 and the ring unit 131 are closest to each other, that is, in a state where the puncture unit 31 protrudes from the outer tube 60. be able to.

  The force generation unit 90 and the urging unit 100 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 expansion force. Therefore, the force generation unit 90 and the urging unit 100 may be, for example, an elastic body, a member having a bellows structure made of an elastically deformable material, a cylinder or a balloon containing a compressive fluid, and the like. Examples of the elastic body include natural rubber, silicone rubber, and various elastomers. The force generation unit 90 and the urging unit 100 have a natural length in a state where no external force is applied, and can contract shorter than the natural length when the external force is applied, regardless of the above configuration. And the force generation part 90 and the urging | biasing part 100 are expandable so that it may return to natural length with the self-expansion force from the contracted state.

  The gripping part 110 is located in the third housing part 130 and is movable along the moving direction of the moving part 80. The grip 110 has a recess 111 that opens to the proximal side and a protrusion 112 that protrudes laterally from the second opening 132 of the operation unit 70. The urging portion 100 and the ring portion 131 are movably accommodated in the recess 111. The bottom surface 113 of the recess 111 is in contact with the distal end of the urging unit 100. The moving part 80 passes through the bottom surface 113 of the recess 111. The grip part 110 receives a biasing force toward the distal side from the biasing part 100 in contact with the bottom surface 113. As a result, the distal end surface of the grip 110 is pressed against the wall 133. The protruding part 112 is a part for the operator to grasp and move the grasping part 110 to the proximal side with respect to the operation part 70. When the surgeon moves the grip portion 110 to the proximal side with respect to the operation portion 70, the distal end surface of the grip portion 110 is separated from the wall portion 133. As a result, the urging unit 100 contracts.

  The constituent materials of the operation unit 70, the moving unit 80, the gripping unit 110, and the ring unit 131 are not particularly limited. For example, polycarbonate, polyethylene, polypropylene, ABS resin (a general term for acrylonitrile, butadiene, styrene copolymer synthetic resins), and the like. Hard resin, metal such as stainless steel, etc. can be suitably used. The member including the first accommodating portion 77, the second accommodating portion 120, and the second accommodating portion 120 of the operation unit 70 has been described as one member for easy understanding, but a plurality of members are connected. Can be configured.

  The dilator 40 is used to widen the hole in the foveal fossa formed by the needle part 30 as shown in FIGS. The dilator 40 has a taper portion 42 whose diameter decreases in a tapered shape toward the distal side at the distal end portion. The lumen of the dilator 40 opens at the end of the tapered portion 42 with the smallest diameter. The inclination angle α2 with respect to the central axis of the taper portion 42 is appropriately set, and is, for example, 1 to 20 degrees, more preferably 3 to 15 degrees, and further preferably 4 to 10 degrees. A second connection portion 41 that can be connected to the first connection portion 72 of the operation portion 70 is provided on the outer peripheral surface of the proximal portion of the dilator 40. The second connection part 41 is a male connector.

  The dilator 40 has a dilator distal portion 43 having a small inner diameter on the distal side and a dilator proximal portion 44 having a larger inner diameter than the dilator distal portion 43 on the proximal side. Between the dilator distal portion 43 and the dilator proximal portion 44, an inner diameter reduced diameter portion 45 whose inner diameter is reduced toward the distal side is provided. The inner peripheral surface of the dilator proximal portion 44 can be slidably in close contact with the outer peripheral surface of the outer tube 60. In addition, the length of the dilator proximal portion 44 matches the length of the outer tube 60. Therefore, when the outer tube 60 is inserted into the dilator proximal portion 44, the outer tube 60 is fixed at an accurate position with respect to the dilator 40. At this time, the distal end portion of the outer tube 60 contacts the inner diameter reduced diameter portion 45. The inner diameter reduced portion 45 is reduced in diameter toward the distal side. For this reason, when the outer tube 60 abuts against the inner diameter reduced diameter portion 45, the axis of the distal end of the outer tube 60 and the axis of the inner diameter reduced diameter portion 45 exactly coincide. Therefore, the puncture portion 31 protruding from the outer tube 60 can be smoothly guided to the dilator distal portion 43. The inner diameter of the dilator distal portion 43 is smaller than the inner diameter of the outer tube 60 and larger than the outer diameter of the long portion of the needle portion 30. Thereby, the position of the needle part 30 is accurately defined inside the dilator distal part 43 having a small clearance while maintaining the slidability of the needle part 30 inside the outer tube 60 where a clearance is secured to some extent. be able to. The length of the dilator distal portion 43 is set so that the needle portion 30 protruding from the outer tube 60 can pass and protrude further to the distal side than the dilator 40. Note that the inner diameter of the dilator 40 may be constant along the axial direction.

  The dilator 40 has a dilator bending portion 46 bent at a predetermined angle at a distal portion in a natural state. The angle β3 of the dilator bending portion 46 with respect to the proximal portion of the dilator 40 is not particularly limited, but is, for example, 10 to 70 degrees, more preferably 20 to 60 degrees, and further preferably 30 to 50 degrees. The dilator bending 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.

  Although the length of the dilator 40 is set suitably, it is 400-1500 mm, for example. The outer diameter of the dilator 40 is set as appropriate, and is, for example, 2 to 6 mm. Although the internal diameter of the dilator distal part 43 is set suitably, it is 0.5-1.5 mm, for example. Although the internal diameter of the dilator proximal part 44 is set suitably, it is 1.0-2.0 mm, for example. The length of the dilator distal portion 43 is appropriately set, and is, for example, 1 to 15 mm, more preferably 2 to 12 mm, and further 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 outer tube 60 is appropriately set, and is, for example, 0.03 to 0.1 mm.

  The constituent material of the dilator 40 is preferably flexible. For example, polyolefins such as polyethylene and polypropylene, polyamides, polyesters such as polyethylene terephthalate, PTFE (polytetrafluoroethylene), and ETFE (ethylene / tetrafluoroethylene co-polymer). Polymers), PEEK (polyether ether ketone), polyimide, shape memory alloy, stainless steel, tantalum, titanium, platinum, gold, tungsten, and other metals can be suitably used. In addition, the dilator 40 may include an X-ray contrast material or an ultrasound contrast material.

  The outer sheath 50 provides the access route for the ablation catheter. The outer sheath 50 has a sheath body 51, a hub 54 connected to the proximal portion of the sheath body 51, a sheath 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 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 40 can pass through the entire length of the sheath body 51. Therefore, the axial length of the sheath body 51 is shorter than that of the dilator 40.

  The length of the sheath body 51 is set as appropriate, and is, for example, 400 to 1000 mm. The outer diameter of the sheath body 51 is set as appropriate, and is, for example, 2.5 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 body 51 and the outer peripheral surface of the dilator 40 is set as appropriate, and is, for example, 0.1 to 0.5 mm.

  The constituent material of the sheath body 51 is preferably a flexible material. For example, polyolefin such as polyethylene 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 in the proximal portion of the sheath body 51 and communicates with the lumen of the sheath body 51. The dilator 40 passes through the hub 54. The sheath port portion 56 is connected to the hub 54 and communicates with the lumen of the sheath main body 51 via the lumen of the hub 54. The sheath port portion 56 has a three-way cock 57 at the end. By connecting a syringe or the like to the three-way cock 57, the lumen of the sheath body 51 can be primed, or a contrast agent, a drug, or the like can be injected into the sheath body 51.

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

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

  Next, the operation of the puncture device 10 will be described. In the initial state, as shown in FIG. 4A, the puncture portion 31 is accommodated in the outer tube 60. The moving unit 80 is urged proximally by the urging unit 100. For this reason, the puncture part 31 does not protrude from the outer tube 60, and safety can be ensured. In order to urge the moving unit 80 by the urging unit 100, the natural length of the urging unit 100 is longer than the distance between the bottom surface 113 of the gripping unit 110 and the ring unit 131 in the initial state. Therefore, the urging unit 100 contracts between the bottom surface 113 and the ring unit 131 to generate an urging force. In the initial state, the moving unit 80 may not be urged by the urging unit 100. The distal inclined surface 127 of the engaging portion 125 is in contact with the proximal inclined surface 85 of the moving engaging portion 83. The distal end portion of the force generation unit 90 is in contact with the distal action portion 86, and the proximal end portion of the force generation portion 90 is in contact with the proximal action portion 121. At this time, the force generation unit 90 has a substantially natural length.

  Next, the grip part 110 is moved to the proximal side with respect to the operation part 70 as indicated by a two-dot chain line shown in FIG. Thereby, after the urging portion 100 having a smaller spring constant than the force generating portion 90 contracts, the force acting on the grip portion 110 is transmitted to the hook portion 87 via the ring portion 131. Thereby, the movement part 80 moves to the proximal side, the distal side action part 86 and the proximal side action part 121 approach, and the force generation part 90 contracts. When the moving part 80 moves to the proximal side, the distal inclined surface 127 presses the proximal inclined surface 85 to the proximal side, and the releasing part 123 and the bending part 81 are bent. For this reason, the movement engagement part 83 moves to the proximal side from the engagement part 125. As a result, the bending of the release portion 123 and the bending portion 81 returns, and the proximal engagement surface 126 of the engagement portion 125 engages with the distal engagement surface 84 of the movement engagement portion 83. When the proximal engagement surface 126 engages with the distal engagement surface 84, the moving unit 80 cannot move to the distal side with respect to the operation unit 70 in a state where the force generation unit 90 contracts. In a state where the engaging part 125 is engaged with the moving part 80, the receiving part 82 of the bending part 81 is positioned in the pressing direction of the pressing part 124 of the releasing part 123. After the engaging portion 125 engages with the moving portion 80, when the operator releases the grasping portion 110, the grasping portion 110 moves to the distal side by the expansion force of the biasing portion 100 and abuts against the wall portion 133. .

  Next, when the surgeon presses the release portion 123, the release portion 123 bends and the pressing portion 124 pushes down the receiving portion 82. Accordingly, the bending portion 81 is bent, and the moving engagement portion 83 provided in the bending portion 81 moves in a direction away from the engagement portion 125. For this reason, the engagement between the engagement portion 125 and the movement engagement portion 83 is released. As a result, as shown in FIG. 4C, the contracting force generation unit 90 expands, and the moving unit 80 moves to the distal side with respect to the operation unit 70. Accordingly, the needle unit 30 connected to the moving unit 80 moves to the distal side with respect to the outer tube 60 connected to the operation unit 70. For this reason, the puncture part 31 protrudes from the outer tube 60 (and the dilator 40) to the distal side. When the moving part 80 moves distally, the receiving part 82 abuts against the engaging part 125. Thereby, since the protrusion of the puncture part 31 stops at the preset distance, safety is high. In this protruding state, the distance L1 between the proximal side action part 121 and the distal side action part 86 is longer than the natural length L0 of the force generation part 90. Due to the expansion force of the force generating unit 90 that expands beyond the natural length L0 from the contracted state and the inertial force of the moving unit 80 and the needle unit 30, the moving unit 80 and the needle unit 30 become the natural length L0 of the force generating unit 90. Can move longer. When the force generator 90 expands and returns to the natural length L0, the force generator 90 stops at a position between the proximal action part 121 and the distal action part 86. When the puncture unit 31 is in the protruding state, the distance between the bottom surface 113 of the gripping unit 110 and the hook unit 87 is shortened, and the urging unit 100 contracts due to the expansion force of the force generation unit 90. However, the urging force of the urging unit 100 is less than the minimum force necessary for the needle unit 30 to start moving proximally from the state where the needle unit 30 protrudes most distally from the outer tube 60 and stops. . For this reason, the needle part 30 does not move even if it receives an urging force, and the state where the puncture part 31 projects from the outer tube 60 can be maintained.

  When a force in the proximal direction acts on the puncture portion 31 and the resultant force and the resultant force of the biasing portion 100 exceed the maximum static frictional force when the needle portion 30 begins to move proximally, The biasing unit 100 expands. Thereby, the hook part 87 receives force from the urging | biasing part 100 via the ring part 131, and the moving part 80 moves to a proximal side. At this time, the proximal side action part 121 and the distal side action part 86 are separated longer than the natural length L0 of the force generation part 90. For this reason, the moving part 80 can move to the proximal side with respect to the operating part 70 as shown in FIG. Thereby, the puncture part 31 is accommodated in the outer tube 60. That is, since the force of the urging unit 100 acts on the moving unit 80, the puncture unit 31 is accommodated in the outer tube 60 only by a small force acting on the puncture unit 31 in the proximal direction. When the force generation unit 90 comes into contact with the proximal side action unit 121 and the distal side action unit 86, the movement of the moving unit 80 and the needle unit 30 with respect to the operation unit 70 is stopped. Or the movement with respect to the operation part 70 of the moving part 80 and the needle part 30 may stop because the distal inclined surface 127 and the proximal inclined surface 85 contact.

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

  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 140 is inserted into the catheter introducer. Next, the catheter introducer is removed while leaving the guide wire 140 in the blood vessel, and the proximal end portion of the guide wire 140 is inserted into the inside from the distal end portion of the dilator 40. Next, the sheath assembly 20 is inserted into the catheter introducer and 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 140 is advanced. Next, the sheath assembly 20 is temporarily inserted along the guide wire 140 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. 5 and 6A, the distal end of the sheath assembly 20 is located in the vicinity of the foveal fossa O. Naturally guided to. Thereafter, as shown in FIG. 6B, the guide wire 140 is removed from the sheath assembly 20.

  Next, as shown in FIGS. 6C and 7A, the puncture device 10 is inserted into the lumen of the dilator 40 from the proximal side of the dilator 40. The puncture device 10 is in an initial state in which the puncture unit 31 is completely accommodated in the outer tube 60. For this reason, the damage of the dilator 40 by the puncture part 31 can be suppressed. Next, the puncture device 10 is pushed forward, and the distal end of the outer tube 60 is abutted against the inner diameter reduced portion 45 of the dilator 40. Then, the 1st connection part 72 and the 2nd connection part 41 are connected. Thereby, the puncture device 10 is accurately positioned with respect to the dilator 40. Subsequently, the dilator 40 is pushed distally while observing the left atrium L and the right atrium R with an intracardiac echo catheter (ICE). Thereby, the oval fossa O will be in the state protruded by the dilator 40 being pushed to the left atrium L side. At this time, since the distal portions of the outer sheath 50, the dilator 40, the outer tube 60, and the needle portion 30 are bent, the end portion on the distal side of the dilator 40 can be easily directed to the oval fossa O. Note that the oval fossa O does not have to protrude to the left atrium L side.

  Next, as shown in FIG. 7B, the operator holds the operation unit 70 located outside the body and moves the grasping unit 110 to the proximal side. Thereby, the moving part 80 moves to the proximal side, the force generating part 90 contracts, and the engaging part 125 engages with the moving engaging part 83. When the proximal engagement surface 126 of the engagement portion 125 engages with the distal engagement surface 84 of the movement engagement portion 83, the movement portion 80 moves relative to the operation portion 70 in a state where the force generation portion 90 contracts. Cannot move distally. The operation of contracting the force generation unit 90 can be performed before inserting the puncture device 10 into the lumen of the dilator 40.

  Next, the surgeon presses the release portion 123. Thereby, the pressing part 124 of the releasing part 123 pushes down the receiving part 82, and the engagement between the engaging part 125 and the moving engaging part 83 is released. As a result, as shown in FIG. 7C, the force generation unit 90 expands, and the needle unit 30 moves to the distal side together with the moving unit 80. Thereby, the puncture part 31 moves from the outer tube 60 to the inside of the dilator distal part 43, and further protrudes from the dilator 40 to the distal side. Therefore, the puncture part 31 punctures the oval fossa O. When the moving part 80 moves distally, the receiving part 82 abuts against the engaging part 125. Thereby, the puncture part 31 protrudes with the preset force and stroke. For this reason, it is possible to prevent the puncture unit 31 from erroneously puncturing to an unintended position. When the protrusion of the puncture unit 31 stops, the protruding state of the puncture unit 31 is maintained by the static frictional force between the needle unit 30 and the outer tube 60. In this protruding state, the separation distance between the proximal side action part 121 and the distal side action part 86 is longer than the natural length L0 of the force generation part 90. When the puncture unit 31 penetrates 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 enters a hole formed in the foveal fossa O. . Note that a part of the dilator 40 may not enter the hole of the oval fossa O. Thereby, it is possible to accurately confirm that the puncture unit 31 has reached the left atrium L by measuring the blood pressure through the through-hole 32. Further, the contrast agent can be released from the through hole 32 of the needle portion 30 to the left atrium L.

  Next, the operation part 70 outside the body is pushed in, and the medical device 10 is moved to the distal side. As a result, as shown in FIG. 8A, the taper portion 42 of the dilator 40 and the sheath taper portion 53 of the outer sheath 50 pass through the foveal fossa O while expanding the hole of the foveal fossa O, and the left atrium L To reach. At this time, since the tapered portion 42 and the sheath tapered portion 53 are reduced in diameter toward the distal side, the hole of the oval fossa O can be smoothly expanded. Moreover, since the puncture part 31 is maintained in the protruding state in which the ovum fossa O is punctured, the dilator 40 and the outer sheath 50 can be easily pushed into the hole of the ovary fossa O along the puncture part 31. it can. Further, when the oval fossa O is punctured by the puncture unit 31, a part of the tapered portion 42 of the dilator 40 has entered the hole of the oval fossa O, so that the dilator 40 and the outer sheath 50 are connected to the oval fossa. It is easy to push into the O hole.

  When the puncture part 31 comes into contact with a blood vessel wall or the like to which the puncture part 31 should not contact in the state where the puncture part 31 punctures the oval fossa O, a force in the proximal direction acts on the puncture part 31. When the resultant force of the acting force and the urging force of the urging portion 100 exceeds the maximum static frictional force when the needle portion 30 starts to move proximally, as shown in FIG. Begins to expand. Thereby, the puncture part 31 moves to the proximal side together with the moving part 80, and the puncture part 31 is accommodated in the outer tube 60. Alternatively, as shown in FIG. 8C, the puncture portion 31 is accommodated in the lumen of the distal portion of the dilator 40 located on the distal side of the outer tube 60. At this time, since the proximal side action part 121 and the distal side action part 86 are separated longer than the natural length L0 of the force generation part 90, it is not necessary to contract the force generation part 90. Therefore, the puncture part 31 is accommodated in the lumen of the dilator 40 located on the distal side of the outer tube 60 or the outer tube 60 only by applying a small force to the puncture unit 31 in the proximal direction. Thus, for example, when the puncture unit 31 comes into contact with a blood vessel wall that should not be contacted, the puncture unit 31 is applied when the force of the force generation unit 90 is applied (when the force to project is applied), Compared with the case where there is no urging portion 100 (when the pullback force does not act), the force can be returned to the proximal side with a small force. Therefore, damage to the blood vessel wall with which the puncture unit 31 comes into contact is reduced, or no damage occurs. For this reason, the erroneous puncture by the puncture part 31 can be suppressed.

  After the dilator 40 and the outer sheath 50 reach the left atrium L, when the protruding state of the puncture unit 31 is maintained, the surgeon moves the grasping unit 110 proximally with respect to the operation unit 70. . As a result, a force in the proximal direction acts on the needle unit 30 via the moving unit 80, and the puncture unit 31 is accommodated in the lumen of the outer tube 60 or the dilator 40.

  Next, as shown in FIG. 9A, the puncture device 10 and the dilator 40 are removed from the body, leaving the outer sheath 50. The hole of the oval fossa O expanded by the dilator 40 is maintained by the outer sheath 50. When the dilator 40 is removed from the outer sheath 50, the valve body 55 is closed, and leakage of blood and mixing of air or the like into the blood vessel can be suppressed. Thereafter, as shown in FIG. 9B, the guide wire 140 is inserted through the valve body 55 from the proximal side of the outer sheath 50 to reach the left atrium L. Thereafter, an ablation catheter is inserted through the valve body 55 from the proximal side of the outer sheath 50 along the guide wire 140. Accordingly, the ablation catheter can be inserted into the left atrium L using the outer sheath 50 penetrating the oval fossa O. After ablation is performed in the left atrium L with the ablation catheter, when the ablation catheter and the outer sheath 50 are removed from the body, the hole of the fossa fossa O contracts. This completes the procedure.

  As described above, the medical device 1 according to the first embodiment is a medical device 1 for forming a hole in the oval fossa O (living tissue) in a living body, and a puncture portion is provided at a distal end. A long needle part 30 provided with 31, a tubular outer tube 60 (long body) that accommodates the needle part 30 so as to be able to protrude to the distal side, and an operation part to which the proximal part of the outer tube 60 is connected 70 and the proximal portion of the needle portion 30 are connected, a moving portion 80 movable along the axial direction of the needle portion 30, and a force acting on the moving portion 80 in a direction in which the puncture portion 31 protrudes from the outer tube 60. The operation unit 70 has a proximal action part 121 (first action part) that receives a force from the force generation part 90, and the moving part 80 has a force generation part 90. A distal action portion 86 (second action portion) that receives force from the at least one of the proximal action portion 121 and the distal action portion 86. The force generating unit 90 can be separated from the force generating unit 90, and the force generating unit 90 expands from the contracted state to apply force to the proximal operating unit 121 and the distal operating unit 86, thereby moving the moving unit 80 distally. The distance between the proximal action part 121 and the distal action part 86 is longer than the natural length L0 of the force generation part 90.

  In the medical device 1 configured as described above, the distance between the proximal side action part 121 and the distal side action part 86 is longer than the natural length L0 of the force generation part 90, and the proximal side action part 121 and the distal side At least one of the side action portions 86 can be separated from the force generation portion 90. Thereby, after the force generation part 90 expands and the puncture part 31 protrudes from the outer tube 60 and punctures the oval fossa O, at least one of the proximal action part 121 and the distal action part 86 generates a force. Separated from the portion 90. For this reason, the puncture part 31 does not return into the outer tube 60, and the state where the puncture part 31 has punctured the oval fossa O can be maintained. For this reason, a tube body such as the outer tube 60 and the dilator 40 arranged further outside the outer tube 60 can be easily pushed into the hole formed in the oval fossa O along the needle portion 30. Further, in a state where the puncture unit 31 protrudes from the outer tube 60, at least one of the proximal side action part 121 and the distal side action part 86 is separated from the force generation part 90. For this reason, the needle part 30 is not biased by the force generation part 90. Thereby, when the puncture part 31 receives the force which goes to the proximal side, the puncture part 31 can return to the lumen | bore of the dilator 40 located in the distal side rather than the outer tube 60 or the outer tube 60 easily. Therefore, when the puncture unit 31 comes into contact with a portion that should not contact, such as a blood vessel wall, the puncture unit 31 is accommodated in the outer tube 60 or the lumen of the dilator 40 located on the distal side of the outer tube 60, and the puncture unit 31. It is possible to improve the safety by suppressing erroneous puncture caused by. In addition, since the oval fossa O can be punctured with a force and a puncture stroke set in advance by the force of the force generation unit 90, erroneous puncture can be suppressed and safety can be improved.

  Further, the distance between the proximal side action part 121 and the distal side action part 86 can be changed, can be shorter than the natural length L0 of the force generation part 90, and is longer than the natural length L0 of the force generation part 90. Can also be long. Since the distance between the proximal side action part 121 and the distal side action part 86 becomes shorter than the natural length L0 of the force generation part 90, the expansion force of the force generation part 90 can act on the needle part 30. . Since the distance between the proximal action part 121 and the distal action part 86 is longer than the natural length L0 of the force generation part 90, at least one of the proximal action part 121 and the distal action part 86 is Separated from the force generator 90. Thereby, it can be set as the state where the force of the force generation part 90 does not act on the needle part 30.

  Further, the operation unit 70 includes an engagement unit 125 that engages with the moving unit 80 in a state where the force generation unit 90 contracts, and a release unit 123 that releases the engagement between the engagement unit 125 and the moving unit 80. . Thereby, the puncture part 31 can be protruded from the outer tube | pipe 60 by operating the cancellation | release part 123, and operativity improves.

  Further, the operation unit 70 includes a gripping unit 110 that is exposed to the outside of the operation unit 70 and moves the moving unit 80 relative to the operation unit 70. Thereby, the force generation part 90 can be contracted by operating the grip part 110. And the moving part 80 can be moved with respect to the operation part 70, and the engaging part 125 and the moving part 80 can be engaged.

  The medical device 1 further includes an urging unit 100 that is disposed in the operation unit 70 and applies a force toward the proximal side to the needle unit 30 in a state where the puncture unit 31 protrudes from the outer tube 60. Thereby, in a state where the puncture unit 31 protrudes from the outer tube 60, the urging force of the urging unit 100 moves the puncture unit 31 to the inner tube 60 or the lumen of the dilator 40 located on the distal side of the outer tube 60. Helps to return. For this reason, if the puncture part 31 contacts the part which should not contact and receives the force which goes to a proximal side, with the assistance of the urging | biasing force of the urging | biasing part 100, the puncture part 31 will be easily to the outer tube | pipe 60 or the dilator 40. Contain. For this reason, the erroneous puncture by the puncture part 31 can be suppressed, and safety can be improved.

  Further, the urging force of the urging unit 100 in a state where the puncture unit 31 protrudes most from the outer tube 60 and stops with respect to the outer tube 60 is the maximum stationary when the puncture unit 31 starts to move proximally from this state. Less than frictional force. Thereby, even if the urging force of the urging portion 100 acts on the needle portion 30, the state where the puncture portion 31 protrudes from the outer tube 60 can be maintained by the static frictional force between the needle portion 30 and the outer tube 60. For this reason, the state where the puncture part 31 punctured the oval fossa O can be maintained. Therefore, it is possible to easily push the tubular body such as the outer tube 60 and the dilator 40 disposed further outside the outer tube 60 into the hole formed in the oval fossa O along the needle portion 30. Since the urging force of the urging portion 100 acts on the needle portion 30, the puncturing portion 31 is assisted by the urging force of the urging portion 100 when the puncturing portion 31 receives even a force toward the proximal side. Is easily accommodated in the outer tube 60 or the dilator 40 located on the distal side of the outer tube 60. For this reason, the erroneous puncture by the puncture part 31 can be suppressed, and safety can be improved.

  Further, the spring constant of the urging unit 100 is smaller than the spring constant of the force generating unit 90. Thereby, the pushing force of the force generation unit 90 necessary for puncturing by the puncture unit 31 can be increased, and the urging force for pulling back the puncture unit 31 can be set small. Further, the urging force can be generated by contracting the urging portion 100 by the expansion force of the force generating portion 90 when puncturing.

  The needle portion 30 is hollow, has a side hole 33 in the proximal portion, and the operation portion 70 has a port portion 73 that communicates with the side hole 33 and can be connected to an external instrument (for example, a syringe). . Thereby, the lumen of the needle part 30 can be primed from the port part 73. Further, by using the lumen of the needle part 30, it is possible to inject a drug or a contrast medium, or to guide blood in the living body to the outside to measure blood pressure. By measuring the blood pressure, it can be accurately confirmed that the puncture unit 31 has reached the target position.

  The elongated body that accommodates the needle portion 30 is an outer tube 60 that can be inserted into the dilator 40. Thereby, the needle part 30 and the outer pipe 60 can be attached to and detached from the dilator 40 while the needle part 30 is accommodated in the outer pipe 60 to ensure safety. For this reason, damage to the dilator 40 by the puncture unit 31 can be suppressed by the outer tube 60. In addition, after guiding the dilator 40 to a predetermined position using the guide wire 140 or the like, the outer tube 60 and the needle part 30 can be attached to the dilator 40. Furthermore, depending on the case, the outer tube 60 and the needle part 30 can be removed from the dilator 40. For this reason, various operations are possible, and the operability is improved.

  Moreover, the elongate body which accommodates the needle part 30 may be the dilator 40 in which the outer diameter of the distal end portion decreases toward the distal side. Thereby, the dilator 40 can be smoothly inserted into the hole of the oval fossa O opened by the needle part 30, and the hole of the oval fossa O can be easily expanded. Moreover, although the dilator 40 and the outer tube 60 are separate bodies, they may be integrated. Further, if there is a dilator 40 (long body), the outer tube may not be provided.

  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. The treatment method includes a step of preparing the medical device 1 in a state where the force generation unit 90 contracts and the puncture unit 31 is accommodated in the outer tube 60 (long body), and the outer tube 60 and the puncture unit of the medical device 1 A step of inserting 31 into the living body, a state where the puncture portion 31 protrudes from the outer tube 60 to puncture the oval fossa O, and the puncture portion 31 protrudes from the outer tube 60, and the proximal action portion Maintaining at least one of 121 (first action part) and the distal action part 86 (second action part) while being separated from the force generation part 90.

In the treatment method configured as described above, after the puncture unit 31 protrudes from the outer tube 60 and punctures the oval fossa O, the puncture unit 31 does not return into the outer tube 60, and the puncture unit 31 moves the oval fossa O. Maintain the puncture state. For this reason, the outer tube 60 and the dilator 40 disposed further outside the outer tube 60 can be easily pushed into the hole formed in the oval fossa O along the needle portion 30. Further, the needle 30 is not biased by the force generator 90 in a state where the puncture unit 31 protrudes from the outer tube 60. For this reason, if the puncture part 31 receives the force which goes to a proximal side, the puncture part 31 can return to the inside of the outer tube | pipe 60 easily. Accordingly, when an unintended part comes into contact with the puncture unit 31, the puncture unit 31 is accommodated in the outer tube 60, and erroneous puncture by the puncture unit 31 can be suppressed and safety can be improved. In addition, since the oval fossa O can be punctured with a force and a puncture stroke set in advance by the force of the force generation unit 90, erroneous puncture can be suppressed and safety can be improved.
Second Embodiment

  As shown in FIG. 10A, the medical device according to the second embodiment is different from the first embodiment in that an urging portion is not provided in the puncture device 200. 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. The ring part 201 located inside the grip part 110 is longer in the axial direction than the ring part 131 of the first embodiment. Thereby, even if there is no urging portion, the force can be transmitted between the hook portion 87 and the grip portion 110.

  Next, the operation of the puncture device 200 will be described. In the initial state, as shown in FIG. 10 (A), puncture portion 31 is accommodated in outer tube 60. The distal inclined surface 127 of the engaging portion 125 is in contact with the proximal inclined surface 85 of the moving engaging portion 83. The distal end portion of the force generation unit 90 is in contact with the distal action portion 86, and the proximal end portion of the force generation portion 90 is in contact with the proximal action portion 121. At this time, the length of the force generator 90 is the natural length L0. Note that the force generation unit 90 does not have to contact the distal action unit 86 and the proximal action unit 121. Further, the distal inclined surface 127 may not be in contact with the proximal inclined surface 85.

  Next, as illustrated in FIG. 10B, the grasping unit 110 is moved proximally with respect to the operation unit 70. As a result, the force acting on the grip portion 110 is transmitted to the hook portion 87 via the ring portion 201. Thereby, the movement part 80 moves to the proximal side, and the force generation part 90 contracts. When the moving part 80 moves to the proximal side, the moving engaging part 83 moves to the proximal side from the engaging part 125 and engages. Accordingly, the moving unit 80 cannot move distally with respect to the operation unit 70 in a state where the force generating unit 90 is contracted.

  Next, when the release portion 123 is pressed, the press portion 124 pushes down the receiving portion 82 and the engagement between the engagement portion 125 and the movement engagement portion 83 is released. Thereby, as shown in FIG. 10C, the contracting force generation unit 90 expands, and the moving unit 80 moves to the distal side with respect to the operation unit 70. Thereby, the puncture part 31 of the needle part 30 connected to the moving part 80 protrudes from the outer tube 60 and the dilator 40. In this protrusion, the moving part 80 and the needle part 30 move longer than the natural length L0 of the force generating part 90. The length of the force generator 90 returns to the natural length L0, and is shorter than the distance between the proximal action part 121 and the distal action part 86.

When the puncture part 31 comes into contact with a blood vessel wall or the like that should not contact, a force in the proximal direction acts on the puncture part 31. When this acting force exceeds the maximum static frictional force when the needle part 30 starts to move proximally, the puncture part 31 moves proximally as shown in FIG. 10 (D). At this time, the proximal side action part 121 and the distal side action part 86 are separated longer than the natural length L0 of the force generation part 90. For this reason, it is possible to move the movement part 80 to the proximal side with respect to the operation part 70, without contracting the force generation part 90. FIG. Thereby, the moving part 80 moves to the proximal side with respect to the operation part 70, and the puncture part 31 is accommodated in the lumen | bore of the dilator 40 located in the distal side rather than the outer tube 60 or the outer tube 60. That is, in the state where the puncture part 31 protrudes, the expansion force of the force generating part 90 does not act on the needle part 30, so that only a small force acts on the puncture part 31 in the proximal direction, Housed in a tube 60. For this reason, since the puncture part 31 will be accommodated in the outer tube | pipe 60 or the dilator 40 when it contacts the site | part which should not contact in the protruded state, it can suppress an erroneous puncture.
<Third Embodiment>

  The medical device which concerns on 3rd Embodiment differs from 1st Embodiment by the point which has the puncture adjustment part 300 for adjusting the protrusion length of the puncture part 31, as shown to FIGS. 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.

The puncture adjusting unit 300 is a member for adjusting the protruding length of the puncture unit 31 from the outer tube 60 or the dilator 40, and is the position where the receiving unit 82 of the moving unit 80 abuts, that is, the second storage unit 120. It is arranged at the distal part inside. The puncture adjusting unit 300 is a ring-shaped member that can rotate inside the second storage unit 120. The puncture adjusting unit 300 has a plurality of step portions 301 arranged in the circumferential direction on the proximal surface. The plurality of step portions 301 differ in the amount of protrusion toward the proximal side. The stepped portion 301 can come into contact with the distal end surface of the receiving portion 82 that is disengaged and moves in the second accommodating portion 120 to the distal side. In addition, puncture adjusting unit 300 has an operation convex portion 302 for an operator to operate on the outer peripheral surface. The operation convex portion 302 protrudes to the outside from a third opening 305 provided on the side surface of the second accommodating portion 120. The third opening 305 has a size capable of rotating the operation convex portion 302 in the circumferential direction. When the operation convex portion 302 protruding from the third opening 305 is operated to rotate the puncture adjusting portion 300, the stepped portion 301 with which the distal end face of the receiving portion 82 contacts can be selected. In addition, a scale, a character, a symbol, a figure, a color, etc. may be provided in the outer peripheral surface of the 2nd accommodating part 120 so that the selected step part 301 may be understood. By rotating the puncture adjusting unit 300 and selecting the stepped portion 301 with which the distal end surface of the receiving portion 82 contacts, the length that the moving unit 80 can move can be adjusted. For this reason, it is possible to adjust the protrusion length from the outer tube 60 (or the dilator 40) of the puncture unit 31 that moves together with the moving unit 80. Therefore, the puncture part 31 can be always protruded with the optimal protrusion length and protrusion output for puncture, and the operability and safety are improved. Further, the puncture operation becomes less dependent on the skill of the operator, and the operability and safety are improved.
<Fourth embodiment>

  As shown in FIG. 14, the medical device according to the fourth embodiment is mainly different from the first embodiment in the structure of the operation unit 410 and the biasing unit 430. In addition, the same code | symbol is attached | subjected to the site | part which has a function similar to 1st Embodiment, and description is abbreviate | omitted.

  As shown in FIG. 14A, the puncture device 400 includes a long needle part 30, an outer tube 60 that houses the needle part 30, and an operation part 410. Furthermore, the puncture device 400 includes a moving unit 420, a force generating unit 90, a biasing unit 430, and a gripping unit 440 inside the operation unit 410.

  The gripping part 440 is movable inside the operation part 410 and can enter the inside of the force generation part 90. When the urging portion 430 is located on the most distal side, the urging portion 430 contacts the edge 411 on the distal side of the second opening 132 from which the protrusion 112 is led out.

  The biasing portion 430 is disposed inside the grip portion 440. The outer diameter of the urging unit 430 is smaller than the inner diameter of the force generating unit 90. For this reason, the urging unit 430 can enter the force generating unit 90. The natural length of the urging unit 430 is longer than the natural length of the force generating unit 90. The length change amount from the natural length until the urging portion 430 contracts most is longer than the length change amount from the natural length until the urging portion 90 contracts most. For this reason, the urging | biasing part 430 can move the needle part 30 long. The length from the initial position to the position where the needle portion 30 protrudes most is equal to the length at which the biasing portion 430 contracts, and is about 10 to 15 mm.

  The wire diameter of the urging unit 430 is smaller than the wire diameter of the force generating unit 90. For this reason, the urging force (expansion force) of the urging unit 430 can be made smaller than the expansion force of the force generating unit 90.

  Next, the operation of the puncture device 400 will be described. In the initial state, as shown in FIG. 14A, puncture portion 31 is accommodated in outer tube 60. The moving part 420 is urged proximally by the urging part 430. For this reason, the puncture part 31 does not protrude from the outer tube 60, and safety can be ensured. Further, a part of the urging unit 430 and the gripping unit 440 enters the inside of the force generating unit 90. Therefore, the urging portion 430 that is longer and longer than the force generation portion 90 can be accommodated in the operation portion 410 in a compact manner. Therefore, it can suppress that the length of the operation part 410 becomes unnecessarily long, and the operativity of the operation part 410 improves.

  Next, the grip portion 440 is moved proximally with respect to the operation portion 410 as indicated by a two-dot chain line shown in FIG. Thereby, after the urging portion 430 having a smaller spring constant than the force generating portion 90 contracts, the force acting on the grip portion 440 is transmitted to the hook portion 87 via the ring portion 131. Thereby, the moving part 420 moves to the proximal side, the distal side action part 86 and the proximal side action part 121 approach, and the force generation part 90 contracts. When the moving part 420 moves to the proximal side, the moving engaging part 83 engages with the engaging part 125, and the moving part 420 cannot move to the distal side with respect to the operation part 410. Thereafter, when the surgeon releases the grip portion 440, the grip portion 440 moves to the distal side by the expansion force of the biasing portion 430 and abuts on the distal edge 411 of the second opening 132. .

  Next, when the surgeon presses the release portion 123, the press portion 124 pushes down the receiving portion 82, and the engagement between the engagement portion 125 and the movement engagement portion 83 is released. Thereby, as shown in FIG. 14C, the contracting force generation unit 90 expands, and the moving unit 420 moves to the distal side with respect to the operation unit 410. Thereby, the puncture part 31 of the needle part 30 connected to the moving part 420 protrudes from the outer tube 60 and the dilator 40 to the distal side. When the moving part 420 moves to the distal side, the distal action part 86 abuts against the pressing part 124. Thereby, since the protrusion of the puncture part 31 stops at the preset distance, safety is high. In the state in which the puncture unit 31 protrudes most, the force generation unit 90 stops at a position between the proximal side action part 121 and the distal side action part 86. When the puncture unit 31 is in the protruding state, the distance between the bottom surface 113 of the gripping unit 440 and the hook unit 87 is shortened, and the biasing unit 430 contracts due to the expansion force of the force generation unit 90. However, the urging force of the urging portion 430 is less than the minimum force necessary for the needle portion 30 to start moving proximally from the state where the needle portion 30 protrudes most distally from the outer tube 60 and stops. . For this reason, the needle part 30 does not move even if it receives an urging force, and the state where the puncture part 31 protrudes from the outer tube 60 can be maintained.

  When the puncture part 31 comes into contact with a blood vessel wall or the like that should not contact, a force in the proximal direction acts on the puncture part 31. When the resultant force of the acting force and the urging force of the urging portion 430 exceeds the maximum static frictional force when the needle portion 30 starts to move proximally, the urging portion 430 expands. Thereby, the hook part 87 receives force from the biasing part 430 through the ring part 131, and the moving part 420 moves to the proximal side. At this time, the force generation part 90 is separated from at least one of the proximal action part 121 and the distal action part 86. For this reason, as shown in FIG. 14D, the puncture portion 31 is accommodated in the outer tube 60 or the dilator 40 only by a small force acting on the puncture portion 31 in the proximal direction. When the force generator 90 comes into contact with the proximal action part 121 and the distal action part 86, the movement of the moving part 420 and the needle part 30 with respect to the operation part 410 stops. The length change amount of the biasing portion 430 when the needle portion 30 is pulled back is longer than the length change amount when the force generating portion 90 is expanded. For this reason, the needle portion 30 that receives the expansion force from the force generation portion 90 and moves to the distal side beyond the expandable length of the force generation portion 90 using the inertial force has a long length change amount. The urging unit 430 can be pulled back to the inside of the outer tube 60 or the dilator 40.

  As described above, in the medical device according to the fourth embodiment, at least a part of the urging unit 430 can enter the force generation unit 90. Thereby, it can prevent that the operation part 410 becomes long too much, and can improve operativity.

  Further, the natural length of the urging unit 430 is longer than the natural length of the force generating unit 90. Thereby, the outer tube 60 or the dilator 40 is received by the urging unit 430 that is longer than the force generating unit 90 by moving the needle unit 30 that has received the expansion force from the force generating unit 90 and moved longer than the natural length of the force generating unit 90. Can be pulled back to the inside.

  Note that the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, the medical device described above may be used to puncture living tissue in a living body other than the foveal fossa. Also, the medical device may not be used to widen the pores of living tissue. For example, the medical device may be used as an injection tool that punctures a living tissue (for example, myocardium, organ) in a living body and injects a drug, a contrast medium, a physiological saline, or the like. The agent may include cells for injection into the myocardium, for example. Although the elongate body which accommodates the needle part may be pushed into the hole formed in the living tissue, it does not need to be pushed. In addition, the medical device may be used for the purpose of puncturing a living tissue in a living body and discharging body fluid or the like in the living body.

  Further, the outer tube that accommodates the needle part 30 may penetrate the dilator 40 and protrude from the dilator 40 to the distal side. In this case, for example, as in the first modification shown in FIG. 15A, the outer diameter of the distal end portion 311 of the outer tube 310 decreases in a tapered shape toward the distal side. Good. As a result, the outer tube 310 can be pushed into the living tissue with a small resistance.

  Moreover, the weak part 321 with low bending rigidity may be provided in the distal part of the needle part 320 like the 2nd modification shown in FIG.15 (B). For example, the fragile portion 321 is subjected to spiral processing. By spiral processing, the needle part 320 is formed with a spiral continuous cut 322. The fragile portion 321 is preferably a portion that slides inside the outer tube bending portion 62 when the needle portion 320 protrudes from the outer tube 60 and is accommodated. Thereby, the sliding resistance with respect to the outer tube bending part 62 of the needle part 320 decreases. For this reason, the frictional force between the needle part 320 and the outer tube 60 is reduced. For this reason, the protruding puncture part 31 can be accommodated in the outer tube 60 with a small force, and safety is improved.

1 medical device,
10, 200, 400 Puncture device,
20 sheath assembly;
30, 320 needle part,
31 Puncture part,
32 through holes,
33 side holes,
40 Dilator,
42 taper part,
60, 310 outer tube,
70, 410 operation unit,
80, 420 moving part,
86 Distal action part (second action part),
90 force generator,
100, 430 biasing section,
110, 440 gripping part,
121 proximal action part (first action part),
125 engaging portion,
L0 natural length,
L1 distance,
O foveal fossa (living tissue),
L left atrium,
R Right atrium.

Claims (9)

A medical device for forming a hole in a living body tissue,
A long needle part provided with a puncture part at the distal end; and
A tubular elongated body that accommodates the needle portion so as to protrude distally; and
An operation unit to which a proximal portion of the elongated body is coupled;
A proximal part of the needle part is connected, and a moving part movable along the axial direction of the needle part,
A force generation unit that applies a force to the moving unit in a direction in which the puncture unit protrudes from the elongated body,
The operation part has a first action part that receives force from the force generation part,
The moving part has a second action part that receives a force from the force generating part,
At least one of the first action part and the second action part can be separated from the force generation part,
The force generating part can be moved from the contracted state to apply force to the first acting part and the second acting part to move the moving part to the distal side,
The distance between the first action part and the second action part is a medical device longer than the natural length of the force generation part.   The distance between the first action part and the second action part can be changed, can be shorter than the natural length of the force generation part, and can be longer than the natural length of the force generation part. The medical device according to claim 1, wherein The operation unit is
An engaging portion that engages with the moving portion in a state where the force generating portion contracts;
The medical device according to claim 1, further comprising a release portion that releases the engagement between the engagement portion and the moving portion.   4. The urging portion that is disposed in the operation portion and further exerts a force toward the proximal side on the needle portion in a state where the puncture portion protrudes from the elongated body. 5. Medical device as described in.   The urging force of the urging portion in a state where the puncture portion protrudes most from the long body and stops with respect to the long body is the maximum stationary when the puncture portion starts to move proximally from the state. The medical device according to claim 4, wherein the medical device has a frictional force or less.   The medical device according to any one of claims 4 and 5, wherein a spring constant of the urging portion is smaller than a spring constant of the force generating portion.   The medical device according to any one of claims 4 to 6, wherein at least a part of the urging portion can enter the inside of the force generating portion.   The medical device according to any one of claims 4 to 7, wherein a natural length of the urging portion is longer than a natural length of the force generating portion. A treatment method for forming a hole in a biological tissue in a living body using the medical device according to claim 1,
Preparing the medical device in a state in which the force generating portion contracts and the puncture portion is accommodated in the elongated body;
Inserting the elongated body and puncture portion of the medical device into a living body;
The puncture portion is protruded from the elongated body to puncture living tissue, and the puncture portion is protruded from the elongated body, and at least one of the first action portion and the second action portion Maintaining a distance from the force generator.

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