JPWO2018163899A1 - Puncture device, medical device and treatment method - Google Patents

Abstract

Provided are a puncture device, a medical device, and a treatment method that can puncture a living tissue in a living body with high positional accuracy and improve operability. A puncture device (10) inserted into a tubular sheath assembly (20) for cauterizing an ovarian fossa (O) in vivo through the sheath assembly (20) to form a hole. A distally located conductive metal puncture (31) for puncturing the fossa ovalis (O), a proximally located elongated proximal shaft (33), and a puncture A flexible portion (32) located between the (31) and the proximal shaft (33) and having a bending rigidity lower than that of the puncture portion (31) and the proximal shaft (33).

Description

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

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

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

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

  Before performing atrial septum puncture, the distal part of the dilator is usually brought into contact with the fossa ovalis and pressed against the dilator. As a result, the fossa ovale is pushed into the left atrium and deformed. Thereafter, the ovaries are punctured with a puncture needle penetrating the dilator, and the dilator is inserted into the punctured hole.

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

US Patent Publication No. 2002/0169377

  When the puncture needle moves inside the dilator when puncturing the fossa ovalis with the puncture needle, the shape such as the curvature of the puncture needle may interfere with the dilator. If the dilator is bent due to the movement of the bending portion of the puncture needle, the position where the dilator is in contact with the fossa ovale may shift, and the puncturing position may shift. In addition, when the curved portion of the puncture needle moves in the dilator, the sliding resistance is high, so that the operability is low.

  The present invention has been made in order to solve the above-described problems, and provides a puncture device, a medical device, and a treatment method that can puncture a living tissue in a living body with high positional accuracy and improve operability. Aim.

  The puncture device according to the present invention that achieves the above object is a puncture device that is inserted into a tubular elongate body and forms a hole by cauterizing a living tissue in a living body through the elongate body, A metal puncture portion having a conductive property for cauterizing and puncturing a living tissue located on a distal side, a long proximal shaft located on a proximal side, and a puncture portion and a proximal shaft. A flexible portion located between the flexible portions and having a bending rigidity lower than that of the puncture portion and the proximal shaft.

  A medical device according to the present invention for achieving the above object is a medical device for cauterizing a living tissue in a living body to form a hole, and a puncturing device for cauterizing the living tissue and puncturing the living tissue. A tubular dilator into which the puncture device is inserted, and a tubular outer sheath into which the dilator is inserted, wherein the puncture device is located at a distal side and is a conductive metal for puncturing living tissue. Puncture portion, and a long proximal shaft located on the proximal side, located between the puncture portion and the proximal shaft, lower than the bending stiffness of the puncture portion and the proximal shaft, and A flexible portion having a lower bending rigidity than a sheath assembly in which the dilator is inserted into the outer sheath.

  A treatment method according to the present invention for achieving the above object is a treatment method for cauterizing a living tissue in a living body using the medical device to form a hole, wherein the sheath assembly and the puncture device are provided. A step of inserting the body into the living body, and a step of moving the flexible portion inside the sheath assembly so that the puncturing portion projects distally from the sheath assembly to puncture the living tissue.

  In the puncture device, the medical device and the treatment method configured as described above, since the flexible portion is more flexible than the puncture portion and the proximal shaft, even when the flexible portion is inserted into the elongated body, the flexible portion has the shape of the elongated body. Hard to interfere. Therefore, when the puncture portion is projected from the elongated body to the distal side, the shape of the elongated body is maintained, and the target position can be punctured with high positional accuracy. In addition, since the flexible portion does not easily interfere with the shape of the elongated body, sliding resistance when the puncture device is moved inside the elongated body is reduced. For this reason, the puncture device can be easily inserted into the elongated body, and the operability is improved.

It is a top view showing the medical device concerning an embodiment. It is sectional drawing which shows the medical device which concerns on embodiment. It is sectional drawing which shows the state which combined each part of the medical device which concerns on embodiment. It is a partial sectional view showing the inside of the heart. It is sectional drawing which shows the state at the time of performing a puncture by a medical device, (A) is a state which inserted the sheath assembly in the right atrium along the guide wire, (B) is abutting the sheath assembly to the fossa ovale. (C) shows a state where the puncture device is inserted into the sheath assembly, and (D) shows a state where the ovaries are punctured by the puncture part. It is sectional drawing which shows the state at the time of performing puncture by a medical device, (A) the state which inserted the sheath assembly in the hole of the fossa ovalis, (B) the state which pulled out the puncture device from the sheath assembly, ( (C) shows a state in which a guide wire and an ablation catheter have been inserted into the outer sheath. It is a top view showing the 1st modification of a medical device. It is a top view which shows the 2nd modification of a puncture device. It is a perspective view which shows the 3rd modification of a puncture device, (A) shows the state where a flexible part is linear, (B) shows the state where the flexible part was bent. It is a perspective view which shows the 4th modification of a puncture device, (A) shows the state where a flexible part is linear, (B) shows the state where the flexible part was bent. It is a perspective view which shows the 5th modification of a puncture device, (A) shows the state where a flexible part is linear, (B) shows the state where the flexible part was bent. It is sectional drawing which shows the 6th modification of a puncture device, (A) shows the state before bending a flexible part, (B) shows the state which bent the flexible part.

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

  The medical device 1 according to the embodiment of the present invention inserts a needle from the right atrium into the oval fossa O of the atrial septum to form a hole leading from the right atrium R to the left atrium L (see FIG. 4). Used. When there is a hole in the fossa ovalis, the 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 the area around the pulmonary vein ostium. Can be. That is, the medical device 1 is a device for forming an access route of the ablation catheter in the fossa ovale.

  As shown in FIGS. 1 to 3, the medical device 1 includes a puncture device 10 for performing puncture, and a sheath assembly 20 that houses the puncture device 10. The puncture device 10 has a long needle unit 30 and an operation unit 60 for grasping and operating. The sheath assembly 20 has a dilator 40 into which the puncture device 10 is inserted, and an outer sheath 50 into which the dilator 40 is inserted.

  The needle portion 30 is a substantially straight tube for puncturing. The needle portion 30 has a puncture portion 31 located on the distal side, a proximal shaft 33 located on the proximal side, and a flexible portion 32 located between the puncture portion 31 and the proximal shaft 33. . The proximal shaft 33 is a hollow tube. The proximal portion of the proximal shaft 33 is fixed to the operation unit 60. The distal part of the proximal shaft 33 is fixed to the flexible part 32. The proximal shaft 33 has a proximal inner layer 33A made of a conductive metal and an insulating proximal outer layer 33B covering the outer peripheral surface of the proximal inner layer 33A. The proximal inner layer 33A is connected to the connector 62 of the operation unit 60 and can transmit a current to the distal side. Proximal outer layer 33B insulates proximal inner layer 33A. Note that the proximal shaft 33 does not have to have a two-layer structure. The proximal shaft 33 does not need to have conductivity as long as a conductive wire having conductivity can be arranged inside the proximal shaft 33. The bending stiffness of the proximal shaft 33 is greater than the bending stiffness of the sheath assembly 20. The bending rigidity of the proximal shaft 33 is larger than the bending rigidity of the dilator 40 and larger than the bending rigidity of the outer sheath 50.

  The puncture unit 31 is a hollow tubular body whose distal end is closed, and has an electrode 34 at the distal end. The electrode 34 outputs high-frequency energy for making a hole in the fossa ovalis O. The puncture portion 31 has a distal inner layer 31A made of a metal having conductivity, and an insulating distal outer layer 31B covering an outer peripheral surface of a proximal portion of the distal inner layer 31A. The part of the distal inner layer 31A that is not covered by the distal outer layer 31B is the electrode 34. The electrode 34 can output high-frequency energy by contacting the living tissue, and can alter the living tissue. A counter electrode plate (not shown) forming a pair with the electrode 34 is attached to the body surface. Distal outer layer 31B insulates distal inner layer 31A. The puncture section 31 has a side hole 35 that opens to the outer peripheral surface. Note that puncturing section 31 does not have to have a two-layer structure. If the entire puncture portion 31 is the electrode 34, the insulating distal outer layer 31B may not be provided. In addition, as long as a conductive wire having conductivity can be arranged inside the puncture portion 31, the proximal portion of the puncture portion 31 does not need to have conductivity. The outer diameter of the puncture portion 31 is smaller than the outer diameter of the proximal shaft 33 and the flexible portion 32. The inner diameter of the puncture section 31 substantially matches the inner diameters of the needle section 30 and the flexible section 32. The inner diameter of the puncture portion 31 may be different from the inner diameters of the needle portion 30 and the flexible portion 32. The bending stiffness of the puncture portion 31 is greater than the bending stiffness of the sheath assembly 20. The bending stiffness of the puncture section 31 is larger than the bending stiffness of the dilator 40 and larger than the bending stiffness of the outer sheath 50.

  The flexible part 32 is a tube located between the proximal shaft 33 and the puncture part 31. The length of the flexible portion 32 is preferably longer than the length of the puncture portion 31 and longer than the length of the proximal shaft 33. The flexural rigidity of the flexible portion 32 is lower than the flexural rigidity of the proximal shaft 33 and the puncture portion 31. The bending rigidity of the flexible portion 32 is lower than the bending rigidity of the sheath assembly 20 in which the dilator 40 and the outer sheath 50 are combined. In particular, the bending rigidity of the flexible portion 32 is lower than the bending rigidity of the sheath assembly 20 in a range where the flexible portion 32 can be inserted.

  Further, the bending rigidity of the flexible portion 32 is lower than the bending rigidity of the dilator 40. In particular, the bending rigidity of the flexible part 32 is lower than the bending rigidity of the range in which the flexible part 32 of the dilator 40 can be inserted.

  Further, the bending rigidity of the flexible portion 32 is lower than the bending rigidity of the outer sheath 50. In particular, the bending rigidity of the flexible portion 32 is lower than the bending rigidity of the range in which the flexible portion 32 of the outer sheath 50 can be inserted.

  The flexible portion 32 has a flexible and flexible insulating insulating support portion 32A and a support portion 32B embedded in the flexible support portion 32A. The support portion 32B is formed in a net shape by braiding a plurality of conductive wires while crossing each other. The support portion 32B has a plurality of gaps penetrating in the radial direction, and the flexible support portions 32A enter the gaps. Since the support portion 32B has a gap, high flexibility can be obtained. Further, the support portion 32B suppresses the kink of the flexible portion 32. The distal end of the support 32B is connected to the distal inner layer 31A. The proximal end of the support 32B is connected to the proximal inner layer 33A. Therefore, the support portion 32B having conductivity can transmit the current supplied from the proximal inner layer 33A to the electrode 34 of the distal inner layer 31A. The flexible support 32A insulates the support 32B. The flexible support portion 32A closes the gap between the support portions 32B while maintaining the flexibility of the flexible portion 32. For this reason, the flexible support part 32A maintains the lumen of the needle part 30 in a liquid-tight manner. Thereby, a medicine, a contrast medium, a physiological saline, blood, and the like can be delivered using the lumen of the needle unit 30. The flexible support portion 32A may be composed of one layer, but may be composed of two or more layers so as to sandwich the support portion 32B. The outer diameter of the flexible portion 32 substantially matches the proximal shaft 33, but may be different. The inner diameter of the flexible portion 32 substantially matches the proximal shaft 33, but may be different.

  The puncture section 31 may not be formed by a high-frequency current, but may be formed by, for example, outputting energy such as electromagnetic waves, lasers, and cooling to denature a living tissue to form a hole. The puncture unit 31 may be a mechanically puncture needle that is structurally sharp. Further, the needle portion may be solid.

  The constituent material of the proximal inner layer 33A, the distal inner layer 31A, and the support portion 32B is not particularly limited as long as it has conductivity, and is, for example, stainless steel, Au (gold), Pt (platinum), tungsten, titanium, or the like. Note that the proximal inner layer 33A, the distal inner layer 31A, and the support portion 32B do not have to have conductivity. In this case, the insulating proximal outer layer 33B and distal outer layer 31B may not be provided.

  The constituent material of the proximal outer layer 33B and the distal outer layer 31B is not particularly limited as long as it has insulating properties. For example, polyolefin such as polyethylene and polypropylene, polyamide, polyester such as polyethylene terephthalate, PTFE (polytetrafluoroethylene), Fluorine-based polymers such as ETFE (ethylene / tetrafluoroethylene copolymer), PEEK (polyetheretherketone), and polyimide can be suitably used. The constituent material of the proximal outer layer 33B and the distal outer layer 31B is particularly preferably a low friction material that easily slides on the inner peripheral surface of the dilator 40, for example, PTFE (polytetrafluoroethylene), ETFE (ethylene Fluorinated polymers such as fluorinated ethylene copolymers) are preferred.

  The constituent material of the flexible support portion 32A is preferably flexible and flexible. For example, polyolefin such as polyethylene and polypropylene, polyester such as polybutylene terephthalate, polyamide and polyethylene terephthalate, PTFE (polytetrafluoroethylene), ETFE Fluoropolymers such as (ethylene / tetrafluoroethylene copolymer), PEEK (polyetheretherketone), and polyimide can be suitably used.

  The length of the needle portion 30 is appropriately set, and is, for example, 500 to 1100 mm. The length of the puncture portion 31 is appropriately set, but is, for example, 5 to 30 mm, more preferably 5 to 25 mm, and still more preferably 10 to 20 mm. The length of the flexible portion 32 is appropriately set, but is, for example, 20 to 90 mm, more preferably 30 to 80 mm, and still more preferably 40 to 70 mm. The length of the proximal shaft 33 is appropriately set, but is, for example, 350 to 1800 mm, more preferably 380 to 1200 mm, and still more preferably 400 to 1000 mm. The outer diameter of the puncture unit 31 is appropriately set, and is, for example, 0.5 to 1.0 mm. The inner diameter of the needle part 30 is appropriately set, and is, for example, 0.3 to 0.8 mm.

  The operation part 60 is a part that operates the needle part 30 by grasping. In the operation section 60, a proximal portion of the needle section 30 is fixed. The operation unit 60 includes a proximal opening 61 and a connector 62. Proximal opening 61 communicates with the lumen of needle 30. By connecting a syringe or the like to the proximal opening 61, the lumen of the needle 30 can be primed, or a contrast agent, a medicine, or the like can be injected into the needle 30. In addition, blood in the living body can be guided to the outside from the proximal opening 61 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 connector 62 is connectable to an external power supply that supplies a high-frequency current to the electrode 34.

  The constituent material of the operation unit 60 is not particularly limited. For example, a hard resin such as polycarbonate, polyethylene, polypropylene, ABS resin (a generic name of acrylonitrile, butadiene, and styrene copolymerized synthetic resin), and a metal such as stainless steel are preferable. Can be used.

  The dilator 40 is used to widen the hole of the fossa ovalis O formed by the needle part 30. The dilator 40 has a tapered portion 42 at the distal end, the diameter of which is tapered toward the distal side. The lumen of the dilator 40 is open at the end of the tapered portion 42 where the diameter is reduced most. The inclination angle α1 with respect to the center axis of the tapered portion 42 is appropriately set, but is, for example, 1 to 20 degrees, more preferably 3 to 15 degrees, and further preferably 4 to 10 degrees. A connection portion 41 that can be connected to a Y connector or the like is provided on an outer peripheral surface of a proximal portion of the dilator 40. The 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 distal portion 43 can be slidably contacted with the outer peripheral surface of the puncture portion 31 of the needle unit 30. The inner diameter of the proximal part 44 of the dilator is larger than the outer diameter of the needle part 30. For this reason, the needle part 30 can be easily inserted into the dilator proximal part 44. The inner diameter of the dilator distal section 43 is equal to or larger than the outer diameter of the puncture section 31 and smaller than the outer diameter of the flexible section 32. Therefore, the dilator distal section 43 can accommodate the puncture section 31 but cannot accommodate the flexible section 32. When the needle part 30 is inserted into the dilator 40, the puncture part 31 passes through the dilator distal part 43, is guided to the inner diameter reduced diameter part 45, and enters the dilator distal part 43. The puncture section 31 is in close contact with the inner peripheral surface of the dilator distal section 43, and thus is accurately positioned with respect to the dilator 40. When the needle portion 30 is further pushed into the dilator 40, the electrode 34 protrudes from the dilator 40, and the step between the flexible portion 32 and the puncture portion 31 hits the inner diameter reduced diameter portion 45. Thereby, it is possible to suppress the electrode 34 from protruding too much from the dilator 40, and the safety is high. Note that the step abutting on the inner diameter reduced diameter portion 45 may not be the step between the flexible portion 32 and the puncture portion 31. The step abutting on the inner diameter reducing part 45 may be a step between the flexible part 32 and the proximal shaft 33 or a step provided in another part.

  The dilator 40 has a dilator bent portion 46 which is bent at a predetermined angle at a distal portion in a natural state. The angle β1 of the dilator bent portion 46 with respect to the proximal portion of the dilator 40 is not particularly limited, but is, for example, 10 to 120 degrees, more preferably 20 to 100 degrees, and still more preferably 30 to 90 degrees. The dilator bending part 46 plays a role in directing the puncture part 31 of the needle part 30 inserted into the right atrium R and the tapered part 42 of the dilator 40 toward the fossa ovalis O. It is preferable that the length of the dilator bending portion 46 is substantially equal to the length of the flexible portion 32.

  The length of the dilator 40 is appropriately set, and is, for example, 400 to 1500 mm. The outer diameter of the dilator 40 is appropriately set, and is, for example, 2 to 6 mm. The inner diameter of the dilator distal portion 43 is appropriately set, and is, for example, 0.5 to 1.5 mm. The inner diameter of the dilator proximal portion 44 is appropriately set, and is, for example, 1.0 to 2.0 mm. The length of the dilator distal portion 43 is appropriately set, but is, for example, 1 to 15 mm, more preferably 2 to 12 mm, and still more preferably 3 to 10 mm.

  The constituent material of the dilator 40 is preferably flexible, for example, polyolefins such as polyethylene and polypropylene, polyamides and polyesters such as polyethylene terephthalate, PTFE (polytetrafluoroethylene), and ETFE (ethylene / tetrafluoroethylene). (Polyether ether ketone), polyimide, shape memory alloy, stainless steel, tantalum, titanium, platinum, gold, tungsten, and other metals. Further, the dilator 40 may include an X-ray contrast material or an ultrasonic contrast material.

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

  The sheath main body 51 is a long tubular body that accommodates the dilator 40 movably in the axial direction. The sheath body 51 has an inner peripheral surface that slides smoothly with the dilator 40. The sheath main body 51 has a sheath bent portion 52 bent at a predetermined angle at a distal portion in a natural state. The angle β2 of the sheath bending portion 52 with respect to the proximal portion of the sheath body 51 is not particularly limited, but is, for example, 10 to 180 degrees, more preferably 30 to 150 degrees, and still more 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 R and the distal part of the sheath body 51 toward the fossa ovalis. The length of the sheath bending portion 52 is preferably substantially equal to the length of the flexible portion 32.

  The sheath main body 51 has a sheath taper portion 53 at the distal end, the diameter of which decreases in a tapered shape toward the distal side. The lumen of the sheath body 51 is open at the end of the sheath taper portion 53 where the diameter is most reduced. The inclination angle α2 of the sheath taper portion 53 with respect to the central axis is appropriately set, but is, for example, 1 to 15 degrees, more preferably 2 to 10 degrees, and further preferably 3 to 7 degrees. In the sheath assembly 20 in which the dilator 40 is inserted into the outer sheath 50, the sheath taper portion 53 is located on the proximal side of the taper portion 42 of the dilator 40 and can be located so as to be continuous with the taper portion 42. The inner peripheral surface of the sheath body 51 preferably has a clearance between the inner peripheral surface of the dilator 40 and the outer peripheral surface of the dilator 40 so that the outer peripheral surface of the dilator 40 slidably contacts.

  The dilator 40 can penetrate the sheath main body 51 over its entire length. Therefore, the axial length of the sheath body 51 is shorter than that of the dilator 40.

  The length of the sheath body 51 is appropriately set, and is, for example, 400 to 1000 mm. The outer diameter of the sheath body 51 is appropriately set, and is, for example, 2.5 to 7.0 mm. The inner diameter of the sheath body 51 is appropriately set, and is, for example, 2 to 6 mm. The clearance at the radius between the inner peripheral surface of the sheath body 51 and the outer peripheral surface of the dilator 40 is appropriately set, and is, for example, 0.01 to 0.5 mm.

  The constituent material of the sheath body 51 is preferably a flexible material, for example, polyolefin such as polyethylene and polypropylene, polyamide such as polyamide and polyethylene terephthalate, PTFE (polytetrafluoroethylene), and ETFE (ethylene / 4. Fluorine-based polymers such as fluorinated ethylene copolymer), PEEK (polyetheretherketone), and polyimide can be suitably used. In addition, the constituent material of the sheath body 51 may include an X-ray contrast material, an ultrasonic contrast material, a metal wire, and a coil.

  The hub 54 is provided at a proximal portion of the sheath body 51 and communicates with the lumen of the sheath body 51. The dilator 40 passes through the hub 54. The sheath port 56 is connected to the hub 54 and communicates with the lumen of the sheath body 51 via the lumen of the hub 54. The sheath port portion 56 has a three-way cock 57 at an end. By connecting a syringe or the like to the three-way cock 57, it is possible to prime the lumen of the sheath body 51 or to inject a contrast agent, a medicine, or the like into the sheath body 51.

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

  In the state where the dilator 40 and the outer sheath 50 are combined, it is preferable that the positions and the bending directions of the dilator bending portion 46 and the sheath bending portion 52 match or substantially match. Thereby, the puncture part 31 can be protruded in a desired direction.

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

  First, a needle is punctured into the femoral vein and a short guidewire is inserted into the needle. Next, the needle is withdrawn and a catheter introducer is inserted into the blood vessel along the short guidewire. Next, the sheath assembly 20 in which the dilator 40 is inserted into the outer sheath 50 is prepared. Subsequently, the short guidewire is removed, and the guidewire 70 is inserted into the catheter introducer. Next, while leaving the guidewire 70 in the blood vessel, the catheter introducer is withdrawn, and the proximal end of the guidewire 70 is inserted into the dilator 40 from the distal end. Next, the sheath assembly 20 is inserted into a catheter introducer and inserted into a blood vessel. Subsequently, as shown in FIG. 5 (A), the distal portion of the sheath assembly 20 is gradually pushed to the right atrium R with the guide wire 70 being advanced. Next, the sheath assembly 20 is once inserted from the right atrium R into the superior vena cava along the guide wire 70. Subsequently, once the distal end of the guide wire 70 is stored in the sheath assembly 20, the sheath assembly 20 is retracted and pulled into the right atrium R, as shown in FIGS. 4 and 5B. The distal end of the sheath assembly 20 is guided to naturally abut the oval fossa O.

  Next, as shown in FIG. 5C, the puncture device 10 is inserted into the lumen of the dilator 40 from the proximal side of the dilator 40. The puncture part 31 of the puncture device 10 reaches the dilator distal part 43 through the dilator proximal part 44 and the inner diameter reducing part 45. Then, the electrode 34 at the most distal portion of the puncture device 10 is arranged at a position approximately 5 mm proximal from the distal opening of the dilator 40. That is, the electrode 34 is arranged at a position immediately before protruding from the dilator 40. At this time, the flexible part 32 is located inside the sheath bending part 52 and the dilator bending part 46. When the needle portion 30 is inserted into the dilator 40, the flexible portion 32 of the needle portion 30 has a low bending rigidity, and therefore can be easily deformed following the shape of the dilator 40. For this reason, sliding resistance when inserting the needle part 30 into the dilator 40 becomes small, and operability is improved. In particular, when the needle part 30 is inserted into the dilator bending part 46 and the sheath bending part 52, the flexible part 32 bends easily and the sliding resistance is reduced, and the operability is improved. Further, since the flexible portion 32 is easily bent, the shapes of the dilator 40 and the outer sheath 50 are less likely to be interfered by the flexible portion 32. Therefore, a change in the positions of the dilator 40 and the outer sheath 50 is small, and a desired position can be maintained. When inserting puncturing device 10 into dilator 40, dilator 40 may be pulled out from outer sheath 50 once. In this case, the puncture device 10 is inserted into the lumen of the extracted dilator 40, and the dilator 40 containing the puncture device 10 is inserted into the outer sheath 50 again.

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

  Next, a high-frequency current is applied to the electrode 34 by operating the external power supply device. Subsequently, as shown in FIG. 5D, the operation unit 60 located outside the body is pushed in, and the puncture unit 31 is moved to the distal side. Thereby, the electrode 34 protrudes from the dilator 40 to the distal side. The electrode 34 cauterizes the living tissue in contact, and forms a hole in the fossa ovalis O. When the needle portion 30 is further pushed into the dilator 40, the step between the flexible portion 32 and the puncture portion 31 abuts on the inner diameter reduced diameter portion 45. Thereby, it is possible to suppress the electrode 34 from protruding from the dilator 40 too much. Therefore, erroneous puncture of a part other than the purpose can be suppressed, and safety is high.

  The flexible part 32 of the needle part 30 has lower bending rigidity than the sheath assembly 20. For this reason, when the electrode 34 protrudes from the dilator 40, the flexible portion 32 can easily deform by following the shape of the sheath assembly 20. That is, the flexible portion 32 can be positioned inside the dilator bending portion 46 and the sheath bending portion 52 in a state where the puncture portion 31 protrudes from the dilator 40 to the distal side. For this reason, when the needle part 30 moves inside the dilator bending part 46 and the sheath bending part 52, the flexible part 32 bends easily and the sliding resistance is reduced, and the operability is improved. Further, since the flexible portion 32 is easily bent, the shape of the sheath assembly 20 is less likely to be interfered by the flexible portion 32. In particular, the bending angles of the dilator bending portion 46 and the sheath bending portion 52 are unlikely to change. Therefore, when puncturing, the change in the position of the sheath assembly 20 is small. Therefore, the position where the tapered portion 42 abuts on the fossa ovalis O is unlikely to shift when puncturing. For this reason, the accurate position can be punctured by the electrode 34.

  When the puncture part 31 penetrates the fossa ovale O, a part of the distal end of the dilator 40 that has pressed the fossa ovale O toward the left atrium L enters the hole formed in the fossa ovale O. . Note that a part of the dilator 40 does not have to enter the hole of the fossa ovalis O. When the electrode 34 penetrates the fossa ovalis O, the blood pressure is measured from the proximal opening 61 through the side hole 35 located at the electrode 34, thereby accurately determining that the puncture unit 31 has reached the left atrium L. Can be confirmed. In addition, the contrast agent can be discharged from the side hole 35 of the needle unit 30 to the left atrium L, and it can be confirmed that the puncture unit 31 has reached the left atrium L.

  Next, the medical device 1 is moved to the distal side. As a result, as shown in FIG. 6A, the taper portion 42 of the dilator 40 and the sheath taper portion 53 of the outer sheath 50 pass through the fossa ovalis O while expanding the hole of the fossa ovalis O, and the left atrium L To reach. At this time, the diameter of the tapered portion 42 and the sheath tapered portion 53 is reduced toward the distal side, so that the hole of the fossa ovalis O can be smoothly expanded. In addition, since the puncture portion 31 is maintained in a protruding state in which the puncture portion O is punctured, the dilator 40 and the outer sheath 50 can be easily pushed into the hole of the ovale O along the puncture portion 31. it can. Moreover, when the ovaries O are punctured by the puncture part 31, a part of the taper portion 42 of the dilator 40 enters the holes of the ovaries O, so that the dilator 40 and the outer sheath 50 are attached to the ovaries O. It is easy to push into O holes.

  Next, as shown in FIG. 6B, the puncture device 10 is pulled out of the body while leaving the dilator 40 and the outer sheath 50. The hole of the fossa ovalis O widened by the dilator 40 is maintained by the outer sheath 50. Next, the guide wire 70 is inserted into the lumen of the dilator 40, and the guide wire 70 is inserted into the pulmonary artery while the guide wire 70 precedes. Next, when the guide wire 70 and the dilator 40 are removed from the outer sheath 50, the valve body 55 is closed, so that leakage of blood and entry of air or the like into blood vessels can be suppressed. Thereafter, as shown in FIG. 6C, the ablation catheter 71 is inserted from the proximal side of the outer sheath 50 via the valve body 55. Thus, the ablation catheter 71 can be inserted into the left atrium L using the outer sheath 50 penetrating the fossa ovalis O. After performing ablation in the left atrium L using the ablation catheter 71, when the ablation catheter 71 and the outer sheath 50 are removed outside the body, the hole of the fossa ovalis O contracts. Thus, the procedure is completed.

  As described above, the puncture device 10 of the present embodiment is inserted into the tubular sheath assembly 20 (elongate body), and cauterizes the ovaries O (living tissue) in the living body through the sheath assembly 20. A puncture device 10 for forming a puncture hole, which is located on the distal side and is made of a conductive metal puncture part 31 for puncturing the fossa ovalis O; It has a proximal shaft 33 and a flexible portion 32 located between the puncture portion 31 and the proximal shaft 33 and having a bending rigidity lower than that of the puncture portion 31 and the proximal shaft 33. The elongated body into which the puncture device 10 is inserted may be the sheath assembly 20 or the dilator 40.

  In the puncture device 10 configured as described above, since the flexible portion 32 is more flexible than the puncture portion 31 and the proximal shaft 33, even when the flexible portion 32 is inserted into the sheath assembly 20, the shape of the sheath assembly 20 is reduced. Hard to interfere with Therefore, when the puncture section 31 is projected from the sheath assembly 20 to the distal side, the shape of the sheath assembly 20 is maintained, and the target position can be punctured with high positional accuracy. Further, since the flexible portion 32 hardly interferes with the shape of the sheath assembly 20, the sliding resistance when the puncture device 10 is moved inside the sheath assembly 20 is reduced. For this reason, the insertion of the puncture device 10 into the sheath assembly 20 becomes easy, and the operability is improved.

  Further, the flexible portion 32 has a metal supporting portion 32B having conductivity. For this reason, the flexible part 32 can supply high-frequency energy to the puncture part 31 using the conductive support part 32.

  Further, the flexible portion 32 has a conductive metal support portion 32B provided with a gap penetrating in the radial direction. For this reason, the flexible portion 32 can maintain flexibility while suppressing the occurrence of kink by the metal support portion 32.

  The proximal shaft 33 is made of a metal having conductivity, and the proximal shaft 33, the support portion 32B, and the puncture portion 31 are electrically connected. Thereby, high-frequency energy supplied from the external power supply device can be transmitted to the puncture unit 31 via the proximal shaft 33 and the support unit 32B. In addition, since the puncture portion 31 and the proximal shaft 33 are made of metal, it is easy to set a high bending rigidity with respect to the flexible portion 32.

  Further, the flexible portion 32 has a flexible support portion 32A made of resin for closing a gap between the support portions 32B. Thereby, the lumen of the flexible portion 32 can be made liquid-tight while the flexible portion 32 is maintained flexible. Note that the flexible support portion 32A may not be provided.

  Further, the medical device 1 according to the present embodiment is a medical device 1 for cauterizing the fossa ovalis O (living tissue) in a living body to form a hole, and cauterizing and puncturing the fossa ovalis O. Device, a tubular dilator 40 into which the puncture device 10 is inserted, and a tubular outer sheath 50 into which the dilator 40 is inserted. A puncture portion 31 for puncturing the fossa O, a long proximal shaft 33 located on the proximal side, and a puncture portion 31 and a proximal shaft located between the puncture portion 31 and the proximal shaft 33; A flexible portion 32 having a lower bending rigidity than the bending rigidity of the sheath assembly 20 in which the dilator 40 is inserted into the outer sheath 50;

  In the medical device 1 configured as described above, since the flexible portion 32 is more flexible than the puncture portion 31 and the proximal shaft 33 and more flexible than the sheath assembly 20, the puncture device 10 is attached to the sheath assembly 20. Even when inserted, the flexible portion 32 does not easily interfere with the shape of the sheath assembly 20. Therefore, when the puncture section 31 is projected from the sheath assembly 20 to the distal side, the shape of the sheath assembly 20 is maintained, and the target position can be punctured with high positional accuracy. Further, since the flexible portion 32 hardly interferes with the shape of the sheath assembly 20, the sliding resistance when the puncture device 10 is moved inside the sheath assembly 20 is reduced. For this reason, it becomes easy to insert the puncture device 10 into the sheath assembly 20, and the operability is improved.

  The bending rigidity of the flexible portion 32 is lower than the bending rigidity of the dilator 40 and lower than the bending rigidity of the outer sheath 50. Therefore, when the puncturing section 31 is made to protrude distally from the dilator 40 or the outer sheath 50, the shape of the dilator 40 or the outer sheath 50 is maintained, and the target position can be punctured with high positional accuracy. Further, even when the puncture device 10 is inserted into the dilator 40 or the outer sheath 50, the flexible portion 32 does not easily interfere with the shape of the dilator 40 or the outer sheath 50. For this reason, it becomes easy to insert the puncture device 10 into the dilator 40 or the outer sheath 50, and the operability is further improved.

  In addition, at least one of the dilator 40 and the distal portion of the outer sheath 50 is bent with respect to the central axis, and when the puncture portion 31 projects from the dilator 40 to the distal side, the bent portion (the dilator bent portion) The flexible part 32 can be positioned inside the sheath 46 and the sheath bending part 52). Thereby, the dilator bending section 46 and the sheath bending section 52 make it easy to direct the puncturing section 31 to a target position for puncturing. Furthermore, since the puncture device 10 has the flexible portion 32, the bent shape of the dilator 40 and the outer sheath 50 can be appropriately maintained when the puncture portion 31 projects from the sheath assembly 20 to the distal side. For this reason, it is possible to puncture the target position with high positional accuracy while directing the puncturing section 31 in an appropriate direction by the dilator bending section 46 and the sheath bending section 52.

  The present invention also includes a treatment method (cure method) for cauterizing the fossa ovalis O (living tissue) in vivo using the medical device 1 to form a hole. The treatment method includes the steps of inserting the sheath assembly 20 and the puncture device 10 into a living body, and moving the flexible portion 32 inside the sheath assembly 20 to cause the puncture portion 31 to protrude from the sheath assembly 20 and to form an oval. Puncturing the fossa O.

  In the treatment method configured as described above, the bending stiffness of the flexible portion 32 of the puncture device 10 to be used is lower than the bending stiffness of the puncture portion 31 and the proximal shaft 33 and lower than the bending stiffness of the sheath assembly 20. Therefore, even when the puncture device 10 is inserted into the sheath assembly 20, the flexible portion 32 hardly interferes with the shape of the sheath assembly 20. Therefore, when the puncture section 31 is projected from the sheath assembly 20, the shape of the sheath assembly 20 is maintained, and the target position can be punctured with high positional accuracy. Further, since the flexible portion 32 hardly interferes with the shape of the sheath assembly 20, the sliding resistance when the puncture device 10 is moved inside the sheath assembly 20 is reduced. For this reason, it becomes easy to insert the puncture device 10 into the sheath assembly 20, and the operability is improved.

  Note that the present invention is not limited to only the above-described embodiment, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, the medical device described above may be used to puncture a living tissue in a living body other than the fossa ovalis.

  Further, as in the first modification shown in FIG. 7, the proximal shaft 81 of the puncture device 80 may have a shaft bending portion 82 that bends with respect to the central axis on the proximal side at the distal portion. . Parts having the same functions as those of the above-described embodiment are denoted by the same reference numerals, and description thereof will be omitted. The proximal shaft 81 has a higher bending rigidity than the sheath assembly 90. The angle β3 of the shaft bending portion 82 with respect to the proximal portion is not particularly limited, but is, for example, 10 to 120 degrees, more preferably 20 to 100 degrees, and still more preferably 30 to 90 degrees. The shaft bending portion 82 may be deformable by an operator before being inserted into the dilator 40. Thereby, it is possible to adjust the angle β of the shaft bending portion 82 to a desired angle. In this case, the constituent material of the proximal shaft 81 preferably includes a material that can be plastically deformed. Moreover, the angle of the flexible part 32 and the puncture part 31 with respect to the central axis on the proximal side may be adjustable to a desired angle. The proximal shaft 81 has higher bending rigidity than the sheath assembly 90 in which the dilator 91 and the outer sheath 92 are combined. The dilator 91 is straight without having a dilator bend. Note that the dilator may have a dilator bending portion 46 (see FIG. 1). The outer sheath 92 is straight without having a sheath bending portion. Note that the outer sheath may have a sheath bending portion 52 (see FIG. 1). Since the proximal shaft 81 has the shaft bending portion 82, it becomes easy to direct the puncture portion 31 to a target position for puncturing. Further, even if the shaft bending portion 82 exists in the proximal shaft 81, the flexible portion 32 is provided on the distal side of the proximal shaft 81. For this reason, even if the puncture device 80 is inserted into the sheath assembly 90, the interference of the shaft bending portion 82 with the sheath assembly 90 can be reduced. Thereby, sliding resistance between puncturing device 80 and dilator 91 is reduced, and operability can be improved. Further, when the puncture portion 31 is projected from the sheath assembly 90 to the distal side, the target position can be punctured with high positional accuracy while the puncture portion 31 is directed in an appropriate direction by the shaft bending portion 82. Further, the bending portion 82 has higher bending rigidity than the sheath assembly 90. For this reason, even if the sheath assembly 90 does not include a bent portion, the puncture section 31 can be directed to a target position to be punctured by the shape of the puncture device 80 without depending on the shape of the sheath assembly 90. .

  Further, as in the second modification shown in FIG. 8, the flexible portion 101 of the puncture device 100 may have a flexible bent portion 102 that bends with respect to the central axis on the proximal side. This makes it easier to direct puncturing section 31 to the target position for puncturing.

  In addition, the proximal shaft 33 in the above-described embodiment is independently configured by one member, but may be configured by a part of one member. When the proximal shaft is part of one member, the member on which the proximal shaft is provided may also have a flexible or punctured portion. That is, the proximal shaft and the flexible portion may be comprised of one member. In addition, the proximal shaft, the flexible part, and the puncture part may be configured by one member. When the proximal shaft is a part of one member, the portion located on the proximal side of the flexible portion of the member is the proximal shaft.

  As in the third modification shown in FIG. 9A, the puncture portion 112, the flexible portion 113, and the proximal shaft 114 of the puncture device 110 may be formed by one tubular member 111 having conductivity. The portion corresponding to the flexible portion 113 of the tubular member 111 has a lower bending rigidity than the puncture portion 112 and the proximal shaft 114 due to the formation of the spiral slit 115. The slit 115 penetrates from the inner peripheral surface to the outer peripheral surface of the tubular member 111 and has a gap (width). The slit 115 can be easily formed by laser processing or the like. The proximal portions of the proximal shaft 114, the flexible portion 113, and the puncture portion 112 are covered with a covering portion 116 made of an insulating material. The tubular member 111 located in the flexible part 113 is a support part having a gap (slit 115), and the covering part 116 located in the flexible part 113 is a flexible support part closing the gap in the support part. As a constituent material of the tubular member 111, a material applicable to the above-described distal inner layer 31A and proximal inner layer 33A can be applied. As a constituent material of the covering portion 116, a material applicable to the above-described distal outer layer 31B and proximal outer layer 33B can be applied. Since the flexible part 113 of the puncture device 110 is more flexible than the puncture part 112 and the proximal shaft 114, it is easy to bend at the flexible part 113 as shown in FIG. 9B. In addition, since the proximal shaft 114, the flexible portion 113, and the puncture portion 112 are formed by one tubular member 111 having conductivity, current can be reliably transmitted to the electrode 112A.

  Further, as in a fourth modification shown in FIG. 10A, the puncturing portion 122, the flexible portion 123, and the proximal shaft 124 of the puncturing device are connected to one tubular member 121 having conductivity and the tubular member 121. It may be formed by a flexible support 126 to be fitted. A portion corresponding to the flexible portion 123 of the tubular member 121 has a cutout portion 125 in which a part in the circumferential direction is cutout along the axial direction. The tubular member 121 located in the flexible portion 123 is a support portion having a gap (a notch portion 125), and the flexible support portion 126 closes the gap between the support portions. The notch 125 penetrates from the inner peripheral surface of the tubular member 121 to the outer peripheral surface. The notch 125 can be easily formed by laser processing or the like. The flexible support part 126 is joined to the tubular member 121 so as to supplement the notch 125. The flexible support 126 is made of a material that is more flexible than the tubular member 121. The proximal portions of the proximal shaft 124, the flexible portion 123, and the puncture portion 122 are covered with a covering portion 127 made of an insulating material. As a constituent material of the tubular member 121, a material applicable to the above-described distal inner layer 31A and proximal inner layer 33A can be applied. As the constituent material of the flexible support portion 126 and the covering portion 127, a material applicable to the distal outer layer 31B and the proximal outer layer 33B described above can be applied. The flexible portion 123 has a first side surface 128 and a second side surface 129 with the central axis interposed therebetween. The flexible support 126 is disposed on the second side surface 129. Therefore, the second side surface 129 side of the flexible portion 123 can be contracted and expanded with a smaller force along the axial direction than the first side surface 128 side. Thereby, as shown in FIG. 10B, the second side 129 side of the flexible portion 123 contracts, so that the flexible portion 123 can be easily curved. Furthermore, by expanding the second side surface 129 side of the flexible portion 123, the flexible portion 123 can easily return from a curved state to a shape close to a straight line. In addition, since the proximal shaft 124, the flexible portion 123, and the puncture portion 122 are formed by one tubular member 121 having conductivity, current can be reliably transmitted to the electrode 122A.

  The puncture device 130 of the fifth modified example shown in FIG. 11A has one conductive tubular member 131 that forms the puncture part 132, the flexible part 133, and the proximal shaft 134. In a portion corresponding to the flexible portion 133 of the tubular member 131, a plurality of cutouts 135 are formed by partially cutting out the circumferential direction. The plurality of cutouts 135 are arranged in the axial direction. The notch 135 penetrates from the inner peripheral surface of the tubular member 131 to the outer peripheral surface. The notch 135 can be easily formed by laser processing or the like. The flexible portion 133 has a lower bending rigidity than the puncture portion 132 and the proximal shaft 134 due to the formation of the plurality of notches 135. Proximal portions of the proximal shaft 134, the flexible portion 133, and the puncture portion 132 are covered with a covering portion 137 made of an insulating material. The tubular member 131 located in the flexible portion 133 is a support portion having a gap (a cutout 135), and the covering portion 137 located in the flexible portion 133 is a flexible support portion that closes the gap between the support portions. As a constituent material of the tubular member 131, a material applicable to the above-described distal inner layer 31A and proximal inner layer 33A can be applied. As a constituent material of the covering portion 137, a material applicable to the above-described distal outer layer 31B and proximal outer layer 33B can be applied. The flexible portion 133 has a first side surface 138 and a second side surface 139 with the central axis interposed therebetween. The plurality of cutouts 135 are arranged on the second side surface 139. For this reason, the second side surface 139 side of the flexible portion 133 can contract and expand with a smaller force along the axial direction than the first side surface 138 side. As a result, as shown in FIG. 11B, the second portion 139 of the flexible portion 133 contracts, so that the flexible portion 133 can be easily curved. Furthermore, by expanding the second side surface 139 side of the curved portion, the flexible portion 133 can easily return from a curved state to a shape close to a straight line. Further, since the proximal shaft 134, the flexible portion 133, and the puncture portion 132 are formed by one tubular member 131 having conductivity, current can be reliably transmitted to the electrode 132A.

  In addition, as in the fifth modification shown in FIG. 12A, puncturing device 140 may include a pulling wire 141 for bending flexible portion 32 by an operation at hand. The pull wire 141 is slidably disposed in the lumen of the needle part 142 and extends along the needle part 142. The distal end of the pulling wire 141 is fixed to a fixing part 143 located on the inner peripheral surface of the distal part of the flexible part 32. In addition, the distal end of the pulling wire 141 may be fixed to the puncture part 31 on the distal side of the flexible part 32. The proximal end of the pulling wire 141 is fixed to a slide portion 145 slidably provided on the operation portion 144. A proximal portion of the pulling wire 141 is led out of an opening 146 formed on a side surface of the needle portion 142 located inside the operation portion 144. The pulling wire 141 introduced from the opening 146 passes through the seal member 147 and is fixed to the slide 145. When the flexible portion 32 is in a linear shape and the slide portion 145 at hand is moved to the proximal side, the pulling wire 141 moves inside the needle portion 142 to the proximal side, and the fixing portion 143 of the flexible portion 32 is moved. Towed. Thereby, a contraction force acts on the side of the flexible portion 32 where the fixing portion 143 is provided, and the flexible portion 32 can be bent as shown in FIG. Therefore, it is easy to direct puncturing section 31 to the target position for puncturing by a hand operation, and operability is improved.

  Also, the proximal shaft need not be made of metal. For example, the proximal shaft may be made of resin. In this case, the puncture device has a conducting wire inside or outside the proximal shaft for transmitting high-frequency energy. The conductor is connected to the proximal shaft 33 and the support 32B. Thereby, high-frequency energy supplied from the external power supply device can be transmitted from the conducting wire to the support portion 32B or the puncture portion 31 without passing through the proximal shaft.

Hereinafter, examples and comparative examples of the present invention will be described. The puncture devices of Examples 1 and 2 and Comparative Example 1 were produced, and the sliding resistance when inserted into a dilator was measured.
<Example 1>

  A stainless steel pipe having an outer diameter of 0.7 mm, an inner diameter of 0.6 mm, and a length of 15 mm was coated with PTFE having a thickness of 0.05 mm to form a distal inner layer and a distal outer layer of the puncture portion. Next, the PTFE at the distal part of the puncture part was sanded off and soldered. Further, the shape of the solder was adjusted with sandpaper to form electrodes.

  The flexible part was formed with high-density polyethylene for the inner layer and polybutylene terephthalate for the outer layer. A support was formed between the inner layer and the outer layer by braiding a stainless steel wire. The distal part of the support part was electrically connected to the distal inner layer (stainless steel pipe) of the puncture part. The proximal portion of the support was electrically connected to the proximal inner layer (stainless steel pipe) of the proximal shaft. The outer diameter of the flexible part was 1.05 mm, the inner diameter was 0.8 mm, and the length was 50 mm.

A stainless steel pipe having an outer diameter of 1.2 mm, an inner diameter of 0.85 mm, and a length of 680 mm was coated with PTFE having a thickness of 0.05 mm to form a proximal inner layer and a proximal outer layer of the proximal shaft. The puncture part, the flexible part, and the proximal shaft were joined, and the operating part was attached to the proximal shaft to produce the puncture device of Example 1. In addition, the needle part of the puncture device of Example 1 was not bent and had a substantially linear shape.
<Example 2>

After creating the same structure as in Example 1, the distal portion of the proximal shaft was bent at about 30 degrees to produce the puncture device of Example 2.
<Comparative Example 1>

The puncture part of Comparative Example 1 had the same structure as the puncture part of Example 1. The shaft provided on the proximal side of the puncture part was formed by coating a stainless steel pipe having an outer diameter of 1.2 mm, an inner diameter of 0.85 mm, and a length of 710 mm with PTFE having a thickness of 0.02 mm. The puncture part and the proximal shaft were joined, and the operation part was attached. Further, the distal portion of the proximal shaft was bent at about 45 degrees to produce the puncture device of Comparative Example 1.
<Sliding test>

  A dilator having an outer diameter of 2.7 mm, an inner diameter of the distal portion of 0.9 mm, an inner diameter of the proximal portion of 1.31 mm, and a constituent material of polypropylene was prepared. Next, the puncture devices of Examples 1 and 2 and Comparative Example 1 were inserted into the dilator. Then, the electrode was stopped immediately before projecting from the dilator (about 5 mm before the distal opening). Thereafter, the puncture device was moved 45 mm to the distal side with respect to the dilator, and the maximum load (N) and impulse (N · s) were measured. Table 1 shows the results.

  As a result, the maximum load and impulse of Examples 1 and 2 having the flexible portion were lower than the maximum load and impulse of Comparative Example 1. Therefore, it was confirmed that the sliding resistance of the puncture device with respect to the dilator was reduced by having the flexible portion.

  Also, the maximum load and impulse of Example 1 in which the proximal shaft was not bent were lower than the maximum load and impulse of Example 2 in which the proximal shaft was bent. Therefore, it was confirmed that the sliding resistance of the puncture device with respect to the dilator was reduced when the proximal shaft was not bent.

  This application is based on Japanese Patent Application No. 2017-041543 filed on March 6, 2017, the disclosures of which are incorporated herein by reference.

1 medical device,
10, 80, 100, 120, 130, 140 lancing device,
20, 90 sheath assembly;
30, 142 needle part,
31, 112, 122, 132 puncture unit,
32, 101, 113, 123, 133 flexible part,
32A, 126 flexible support,
32B support,
33, 114, 124, 134 proximal shaft,
34, 112A, 122A, 132A electrodes,
35 side holes,
40, 91 dilator,
46 dilator bend,
50, 92 outer sheath,
52 sheath bending part,
60 operation unit,
102 flexible bend,
115 slit (gap),
116, 127, 137 coating part,
125, 135 Notch (gap),
128, 138 first aspect,
129, 139 second aspect,
141 traction wire,
143 fixing part,
O fossa ovalis (living tissue),
L left atrium,
R Right atrium.

Claims (13)

A puncture device to be inserted into a tubular elongate body and cauterize living tissue in a living body through the elongate body to form a hole,
A metal puncture unit having a conductive property for cauterizing and puncturing a living tissue located on the distal side,
A long proximal shaft located on the proximal side,
A flexible portion located between the puncture portion and the proximal shaft, the flexible portion having a bending rigidity lower than that of the puncture portion and the proximal shaft.   The puncture device according to claim 1, wherein the flexible unit has a support unit having conductivity.   The puncture device according to claim 2, wherein the proximal shaft is made of a metal having conductivity, and the proximal shaft, the support portion, and the puncture portion are electrically connected.   The puncture device according to claim 2, wherein the flexible portion has a flexible support portion made of resin that closes a gap between the support portions.   The puncture device according to any one of claims 1 to 4, wherein the proximal shaft has a shaft bending portion that bends with respect to a central axis on a proximal side.   The puncture device according to any one of claims 1 to 5, wherein the flexible portion has a flexible bending portion that is bent with respect to a central axis on a proximal side.   The flexible portion has a first side surface and a second side surface with a central axis interposed therebetween, and the second side surface of the flexible portion has a smaller force along the axial direction than the first side surface. The lancing device according to any one of claims 1 to 6, wherein the lancing device is contractible and expandable. A medical device for cauterizing a living tissue in a living body to form a hole,
A puncture device for cauterizing and puncturing the living tissue,
A tubular dilator into which the puncture device is inserted,
Having a tubular outer sheath into which the dilator is inserted,
The puncture device includes a conductive metal puncture portion located on the distal side for puncturing living tissue, a long proximal shaft located on the proximal side, and the puncture portion and the proximal shaft. A flexible portion, which is lower than the bending stiffness of the puncture portion and the proximal shaft and lower than the bending stiffness of the sheath assembly in which the dilator is inserted into the outer sheath.   The medical device according to claim 8, wherein a bending rigidity of the flexible portion is lower than at least one of the dilator and the outer sheath.   10. The medical device according to claim 8 or 9, wherein the proximal shaft has a shaft bend that bends with respect to a proximal central axis.   The medical device according to any one of claims 8 to 10, wherein the flexible portion has a flexible bending portion that is bent with respect to a central axis on a proximal side.   At least one of the distal portion of the dilator and the outer sheath is bent with respect to a central axis on the proximal side, and in a state where the puncture portion projects distally from the dilator, the inside of the bent portion is formed. The medical device according to any one of claims 8 to 11, wherein the flexible portion is positionable. A treatment method for cauterizing living tissue in a living body to form a hole using the medical device according to claim 8,
Inserting the sheath assembly and a puncture device into a body lumen;
Moving the flexible portion inside the sheath assembly to project the puncture portion distally from the sheath assembly to puncture living tissue.