JP2013252156A - Medical device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical device which can ensure safety even if a member attached to the tip end of an operating wire inserted in a catheter is detached from the operating wire.SOLUTION: A medical device includes: an operating wire 14 which is inserted into a catheter 1 and can be moved forwards and backwards with respect to the catheter 1 in an insertion direction; a tip end member 28 which is linked to the tip end side of the operating wire 14; and an actuating part 20 which is provided on the tip end side of the catheter 1 and is actuated by movement of the tip end member 28 by the pull of the operating wire 14. The actuating part 30 has a housing part 33 which internally houses the tip end member 28 movably forwards and backwards and undetachably to the outside, and insertion holes 34 and 35 through which the operating wire 14 is inserted and through which the tip end member 28 cannot pass are formed on at least the base end side of the tip end side and the base end side of the housing part 33.

Description

  The present invention relates to a medical device, and more particularly to a medical device that is inserted into a body cavity.

  Recently, as a therapeutic device for patent foramen ovale (hereinafter referred to as PFO) as a cardiogenic factor of stroke or migraine, a device described in Patent Document 1 below has been proposed.

  This PFO closing device is designed to insert the foramen into the foramen from the right atrium to the left atrium, and pull the foramen valve so as to close the foramen by a pressing means that bends in the left atrium. A perforated valve and an atrial septum are clamped by a pair of electrodes, and living tissue is joined by applying electric energy from both electrodes.

  The above-mentioned pressing means moves the tip member fixed to the tip of the operation wire to the hand side by pulling the operation wire extending from the hand control portion of the device in the direction of pulling out at the hand operation portion. Using the moving force of the tip member, the pressing means provided at the tip of the device is bent.

International Publication No. 2007/100067 Pamphlet

  By the way, when a foreign substance is mixed in a blood vessel, the foreign substance may be carried to the brain by blood flow and cause cerebral infarction. Accordingly, when pulling the operation wire in order to bend the pressing means, it is necessary to adjust the traction force so that the tip member fixed to the operation wire does not fall off.

  The present invention has been made to solve the above-described problems, and provides a medical device that can ensure safety even if a member attached to the distal end of an operation wire inserted through a catheter falls off the operation wire. For the purpose.

  The medical device of the present invention that achieves the above-described object includes an operation wire that is inserted through a catheter and is capable of moving forward and backward in the insertion direction with respect to the catheter, a distal end member that is connected to a distal end side of the operation wire, and the catheter A medical device provided on the distal end side of the device and operated by movement of the distal end member by pulling the operation wire, wherein the operating portion is capable of moving the distal end member forward and backward and detaching to the outside The housing has an accommodating portion that cannot be accommodated inside, and an insertion hole through which the operation wire is inserted and the distal end member cannot pass is formed at least on the proximal end side of the distal end side and the proximal end side of the accommodating portion. It is characterized by that.

  The medical device according to the present invention has an accommodating portion that accommodates the tip member therein so that the tip member can be advanced and retracted and cannot be detached to the outside, and an insertion wire through which the operation wire is inserted and the tip member cannot pass through. Therefore, even if the tip member is detached from the operation wire, the tip member is not left in the blood vessel, and the tip member is transported to the brain by the blood flow to suppress the possibility of causing cerebral infarction. Can be improved.

  The operation wire has a wire tip portion that extends to the tip side of the tip member, and the wire tip portion is inserted into the insertion hole on the tip side of the housing portion. Since the wire tip can protrude from the insertion hole, the living tissue can be probed by the wire tip.

  If the tip of the wire has a tip covering portion coated with a material having a lower rigidity than the wire constituting the operation wire, the living tissue is damaged when the living tissue is probed by the tip of the wire. Can be suppressed and safety is improved.

  If the distal end side of the housing portion is formed of a material having relatively lower rigidity than the proximal end side, the distal end side of the housing portion can be probed without damaging the living tissue.

  The insertion hole on the distal end side of the housing portion is configured so that the distal end member cannot pass through to the outside and is elastically deformed by passing through the distal end member from the distal end side so that it can pass through to the inside. By pulling the operation wire, the distal end member can be accommodated in the accommodation space. Even if the distal end member falls off from the operation wire, the distal end member is not left in the blood vessel, and safety is improved.

It is a schematic sectional drawing which shows the PFO closure device which concerns on 1st Embodiment. It is a principal part perspective view which shows the PFO closure device which concerns on 1st Embodiment. It is sectional drawing of the catheter front-end | tip part which follows the 3-3 line of FIG. It is sectional drawing which shows the front-end | tip sleeve body of the PFO closure device which concerns on 1st Embodiment. It is a top view which shows the hand operation part of the PFO closure device which concerns on 1st Embodiment. FIG. 6 is a cross-sectional view of the hand operation unit along line 6-6 in FIG. 2. It is sectional drawing which shows the connection mechanism in alignment with line 7-7 in FIG. It is sectional drawing of the lock-unlock mechanism part which follows the 8-8 line of FIG. It is sectional drawing which follows the 9-9 line | wire of FIG. It is a top view which shows the hand operation part at the time of operating a needle operation lever, (A) shows before operation, (B) shows after operation. It is an enlarged plan view which shows the hand operation part at the time of retreating a slide part, (A) is during retreating, (B) shows after retreating. It is an enlarged plan view which shows the hand operation part at the time of connecting an output connector to the input connector of a hand operation part. It is a top view of a hand operation part at the time of retracting a needle operation lever. It is the cross-sectional schematic which inserts an operation wire in an oval hole. It is a cross-sectional schematic diagram of the state which hold | maintained the oval hole valve and punctured the puncture part. It is the cross-sectional schematic which clamped the foramen ovale valve and the atrial septum by the puncture part and the clamping member. (A)-(D) are schematic which shows the operation state of a PFO closure device. It is sectional drawing of the front-end | tip sleeve body at the time of a front-end | tip member dropping out from an operation wire, (A) shows before dropping and (B) shows after dropping. It is sectional drawing which shows the front-end | tip sleeve body of the PFO closure device which concerns on 2nd Embodiment. It is sectional drawing which shows the front-end | tip sleeve body of the PFO closure device which concerns on 3rd Embodiment. It is sectional drawing which shows when the front-end | tip member of the PFO closure device which concerns on 3rd Embodiment enters a front-end | tip sleeve body, (A) is before entering, (B) is in the middle of entering, (C) shows after entering. . It is sectional drawing which shows the front-end | tip sleeve body of the PFO closure device which concerns on 4th Embodiment.

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.
<First Embodiment>
The medical device according to the first embodiment of the present invention is a PFO closure device, which will first be outlined with reference to FIGS. In FIG. 2, only the hand operating unit 70 is shown in a reduced state for the sake of space.

  The PFO closure device includes a catheter 1 configured by attaching a proximal operation unit 70 to the proximal end of the catheter body 10, and a guide that can be connected to the proximal operation unit 70 at the proximal end and into which the catheter body 10 can be inserted. And an energy supply means 4 for supplying electric energy for fusing or necrosing the living tissue M (generic name for M1 and M2). The catheter 1 is provided at the distal end portion of the catheter body 10 and includes a pinching means K for pinching the foramen ovale valve M2 and the atrial septum M1, and a positioning and holding means for stably and accurately performing a procedure using the pinching means K. 20 (see FIG. 2). In the following description, the hand operating unit 70 side of the device is referred to as “base end side”, and the pinching means K side is referred to as “tip side”. Further, the “catheter” represents one including a tube used for medical purposes.

  In using the device, first, the guiding catheter 3 is inserted, for example, from the femoral vein J. This guiding catheter 3 is provided with a clamping means K provided at the distal end of the catheter body 10 therein. Inserted with the main body 10 in the housed state. After the distal end reaches the part of the heart where the procedure is performed, the hand operating unit 70 is operated to cause the pinching means K to protrude from the catheter body 10 and the oval hole defect O (hereinafter simply referred to as the oval hole O). The tissue of the atrial septum M1 and the foramen ovale M2 of the heart where the In this clamping state, electric energy is supplied to the clamping means K, both tissues are heated and fused, and the defect O is closed. That is, the pinching means K functions as a heating unit. In the figure, “L” indicates the left atrium and “R” indicates the right atrium.

  The clamping means K includes a clamping member 11 that directly contacts one side of the atrial septum M1 and a puncture member 12 that punctures the foramen ovale valve M2. As shown in FIG. 2, the holding member 11 includes a flat plate-like flat plate portion 11 a and a pair of wire portions 11 b connected to the proximal end portion, and is fixed to the distal end of the catheter body 10. The planar position is regulated by the lumens L3 and L4 (see FIG. 3) of the distal tip 15. Further, the holding member 11 is protruded from the distal tip 15 by connecting one operation cord 13a to the proximal end side of the wire portion 11b formed in a U-shape, and moving the operation cord 13a in the axial direction. A predetermined clamping width is formed between the puncture member 12 or the puncture member 12 is displaced so as to approach the puncture member 12 and clamp the living tissue M when entering the distal tip 15.

  On the other hand, the puncture member 12 is held so as to be able to advance and retreat in a state where the plane position thereof is regulated by the lumens L1 and L2 (see FIG. 3) formed in the distal tip 15 and is formed in a U shape. By operating the operation cord 13 b connected to the proximal end side, the distal end portion can be projected and retracted from the distal end tip 15.

  The puncture member 12 is provided with elasticity so that two very thin needle members having a circular cross section perpendicular to the axis and sharply pointed at the tip are separated from each other, and the tip expands when protruded. . Further, the number of needle members may be one or three or more.

  The sandwiching member 11 and the puncture member 12 both function as electrode members (heating units). However, the operation codes 13a and 13b (see FIG. 2) for causing the sandwiching member 11 and the puncture member 12 to appear and disappear from the catheter body 10 are used. The catheter is inserted into the catheter body 10 and connected to an input connector 75 provided in a hand operating section 70 described later, an output connector 87 (see FIG. 1) as a plug fitted to the input connector 75, and an electrode terminal of the output connector 87. It is electrically connected to the energy supply means 4 via the lead wire d (generic name for d 1 and d 2) and the control unit 5. In addition, one of the conductive wires d1 and d2 (conductive wire d1 in the present embodiment) is provided with a foot switch SW installed at the foot in order to turn on and off the current from the energy supply means 4. Instead of the foot switch SW, a switch that is easy to operate at hand may be used.

  The hand operation unit 70 is a part that manipulates the pinching means K including a pair of electrode members that sandwich the living tissue M around the defect existing in the living tissue so as to be able to protrude and retract from the distal end of the catheter body 10. Here, the following means and the like are provided in a lump so that all operations can be performed within a small area without much movement of the hand.

  That is, as shown in FIG. 2, the hand operation unit 70 includes a needle operation lever 78 that operates the puncture member 12 that is one electrode member, and a slide unit 100 that operates the clamping member 11 that is the other electrode member. , Which assists the operation of the clamping means K, and the proximal end of the manipulation wire 14 for operating the manipulation wire 14 and the manipulation wire 14 inserted so as to be movable in the axial direction in the hand manipulation section 70 and the catheter body 10. And a push piece for operating the lock-unlock mechanism 102 (see FIG. 8) for locking and unlocking the slide movement of the slide section 100 and for locking the movement of the operation wire 14 in the axial direction. 109 and an input connector 75 having an electrode terminal connected to the energy supply means 4 for applying thermal energy.

  A distal end member 28 is provided on the distal end side of the operation wire 14. The operation wire 14 further has a wire tip portion 14 </ b> A that extends to the tip side of the tip member 28.

  The operation wire 14 is formed of nickel titanium, but is not limited thereto. The tip member 28 is made of silver brazing or nickel titanium, but is not limited to this. The tip member 28 is fixed to the operation wire 14 by a known technique such as welding, adhesion, or fusion depending on the material, or by melting the end of the operation wire 14 made of metal or resin, The member 28 may be formed by being deformed. The tip member 28 is spherical in this embodiment, but is not necessarily limited to a spherical shape.

  As shown in FIG. 5, the hand operation unit 70 is provided with various indications on the surface portion for guiding the operator to perform correct operations in order to make the steps of various procedures visible. A part H (generic name for H1 to H5) is provided (see FIG. 10B for the process display part H5).

  The process display unit H operates the push piece 109 to slide the display unit H1 for a pulling process for pulling the operation wire 14, the display unit H2 for a puncture process in which the puncture member 12 punctures a living tissue, and the slide unit 100. A display portion H3 for a slide portion moving process for holding or releasing the living tissue, a display portion H4 for a connecting step for connecting the input connector 75 to the energy supply means 4, and a puncture portion retreat for retracting the puncture member 12 from the biological tissue. The process display unit H5 (see FIG. 10B) is configured to display each process using an image display, a number, and an arrow in the moving direction.

  When the needle operation lever 78 is moved in the direction of puncturing the puncture member 12 (from the state shown in FIG. 10A to the state shown in FIG. 10B), as a foolproof function, from the lower surface of the needle operation lever 78, A display indicating the next moving direction and a number indicating the order of the operation steps appear.

  Further, the hand operation unit 70 will be described in detail. As shown in FIG. 2, the hand operation unit 70 includes a main body 71 on the side to which the guiding catheter 3 is connected and a main body 71 on the proximal end side of the main body 71. And a slide portion 100 connected via guide bars (guide portions) 88A, 88B, 88C so as to approach and separate from each other, and a needle operation lever 78 for operating the puncture member 12 on the upper surface of the main body portion 71. Is provided.

  As shown in FIG. 5, a concave portion 77 is formed on the front surface side (upper surface side) of the main body 71, and a needle operation lever 78 is provided slidably in the longitudinal direction (see the white arrow). . As shown in FIG. 6, the needle operation lever 78 has a bracket 80 that protrudes so as to reach the internal space 76 through a slit (not shown) formed in the main body 71. An L-shaped terminal 81 provided on the proximal end side of the operation cord 13b for the puncture member 12 is connected. Therefore, when the needle operating lever 78 is slid along the slit, the terminal 81 slides along the guide groove 82 formed in the main body 71 as shown in FIG. Thus, the puncture member 12 is advanced and retracted.

  A main pipe 23, which will be described in detail later, is inserted in the approximate center of the internal space 76 of the main body 71. The proximal end side of the main pipe 23 is connected to the slide part 100 with an adhesive or the like (see FIG. 8), and slides while being guided by the main body part 71 according to the slide operation of the slide part 100.

  A terminal 83 is attached to the main pipe 23 in the internal space 76 in the vicinity of the proximal end, and the terminal 83 slides as the main pipe 23 slides. An operation cord 13 a is connected to the terminal 83, and the operation cord 13 a is disposed on the side portion of the main pipe 23. Contact members 84 and 85 functioning as switches are provided at the movement end positions of the terminals 81 and 83. Of course, the electrical system of the puncture member 12 and the electrical system of the clamping member 11 are insulated so as not to conduct.

  The contact members 84, 85 are connected to both poles of the input connector 75 by conducting wires d 3, d 4, and the terminals 81, which move along with the movement of the operation cord 13 b for the puncture member 12 and the operation cord 13 a for the holding member 11. When it comes into contact with 83, it is configured to retreat while being in contact with the terminals 81 and 83. That is, the contact members 84 and 85 and the terminals 81 and 83 have a contact range with a certain length, and can contact while absorbing individual differences between living bodies.

  The guide bars 88A and 88B are provided in the grooves 96A and 96B inside the main body 71, and the guide bar 88C is provided in a groove (not shown).

  The operation wire 14 is provided in the main tube 23 and has a function of assisting the operation of the pinching means K by pulling in the axial direction, and can be rotated 360 degrees around the axis in the main tube 23. If the operation wire 14 can be rotated 360 degrees, the tip of the operation wire 14 can be inserted into the vicinity of the foramen ovale O and can be inserted into the foramen ovale O by rotationally displacing it. As a result, even if the state of the foramen ova O is variously deformed, the tip of the device can be inserted into the foramen ova O regardless of the shape state, thereby facilitating and speeding up the procedure. Can do.

  A push button 93 of a coupling mechanism 90 (see FIG. 2) is provided at the distal end of the main body 71. The connecting mechanism 90 is for facilitating the attachment / detachment of the Y connector 72 to / from the main body 71, and the flange provided at the base end of the Y connector 72 is attached to the main body 71 while the push button 93 is pressed. When the push button 93 is released after being fitted into the formed insertion hole, the flange portion of the Y connector 72 is engaged with the engagement hole 94 of the sliding member 91 as shown in FIG. Then, the sliding member 91 is ejected by the spring member 92 to exhibit the function of preventing the flange portion from being detached, and the Y connector 72 can be detached by pressing the push button 93.

  As shown in FIG. 2, it is preferable to connect a Y connector 72 capable of injecting a contrast medium or the like to the distal end of the hand operation unit 70 by a connecting mechanism 90, but when the Y connector 72 is not used. That is, the guiding catheter 3 having the flange portion is directly connected to the main body portion 71.

  A connection hole 74 corresponding to the outer shape of the output connector 87 is provided at the base end of the main body 71, and the electrode terminal of the input connector 75 is disposed inside the connection hole 74.

  The guide bar 88A is arranged so that a part of the side enters the connection hole 74, and the guide bar 88A that has entered the connection hole 74 obstructs the insertion of the output connector 87 into the connection hole 74 and outputs the output. Connection of the connector 87 to the input connector 75 is prevented. A notch 89 (see FIG. 6) is formed in a part of the side of the guide bar 88A. When the guide bar 88A and the main pipe 23 are retracted with respect to the main body 71 together with the slide part 100, the notch 89 is formed. Coincides with the connection hole 74, and the output connector 87 can be connected to the input connector 75. Further, as the slide portion 100 is retracted, the terminal 83 fixed to the main pipe 23 comes into contact with the contact member 85 and the clamping member 11 and the input connector 75 are electrically connected.

  By providing such a configuration, the connection between the energy supply means 4 and the input connector 75, which are the most important procedure among the procedures and require carefulness, can be performed only after the clamping of the living tissue M is completed. The safety of the procedure is enhanced.

  As shown in FIG. 4, the main body 71 is provided with a window 73 opened adjacent to the input connector 75. In the guide bar 88A, an “OK” display portion H6 (see FIG. 5) is written in the vicinity of the notch portion 89, and numbers (1 to 5) at a constant pitch from the “OK” display portion H6. Are listed in order with a triangular arrow.

  When the positioning and holding means 20 is pulled into the catheter body 10 and collected by retracting the slide part 100 from the main body part 71, the number displayed on the guide bar 88A is sequentially counted by the hand operation part 70 so that the number is counted down. When the terminal 83 that allows the holding member 11 to conduct is in contact with the contact member 85, the “OK” display portion H 6 finally appears in the window 73.

  A lock-unlock mechanism 102 shown in FIGS. 8 and 9 is provided on the slide portion 100, and by pressing the push piece 109, the slide movement of the slide portion 100 is locked-unlocked and the operation wire 14 is moved in the axial direction. Lock-unlock.

  The lock-unlock mechanism 102 connects the slide part 100 and the main body part 71 by sliding the operating member 104, or allows the slide part to move by releasing the lock. When the positioning / holding means 20 provided at the distal end portion of the operation wire 14 holds or positions the living tissue M, the operation wire first for temporarily stopping the advance / retreat operation of the operation wire 14 in the axial direction is provided. 2 lock part R2.

  The first lock portion R1 is provided integrally with the operating member 104 and the operating member 104 slidably provided in the slide hole 103 formed in the slide portion 100, and the first lock portion R1 is provided with respect to the main body 71. It is comprised from the control rod 110 which controls a movement. The reference numeral “107” in FIGS. 8 and 9 is a spring.

  Since the restricting rod 110 is provided with an engaging protrusion 111a that engages with the engaging recess 111b of the main body 71, when the operating member 104 is pressed, the engagement protrusion 111a and the engaging recess 111b are engaged. The combination is released, and the slide part 100 can slide with respect to the main body part 71. Therefore, if the slide part 100 is moved backward, the holding member 11 can be moved close to the puncture member 12 via the operation cord 13a. The operating member 104 is also provided with a second lock portion R2, and the second lock portion R2 is also released when the operating member 104 is pressed.

  By operating the push piece 109 and the actuating member 104 in this way, the release of the first lock portion R1 and the release of the second lock portion R2 are interlocked. When pulling out the long operation wire 14 from the left atrium side, the operation wire 14 can be linked with the operation to make the operation wire 14 straight, and the operation wire 14 that may damage the living tissue M is curved. It is possible to prevent a pulling operation in the state of being held and a backward movement of the holding member 11 in the holding state, and prevent a situation in which the living tissue M is damaged or broken.

  On the other hand, the second lock portion R2 for the operation wire 14 includes a locking portion 105 formed on the operation member 104 and a large-diameter portion 106 that is fixed to the operation wire 14 and is larger than the outer diameter of the operation wire 14. It is configured. The material of the large diameter portion 106 can be a metal material such as SUS, but is not limited thereto. The large-diameter portion 106 is fixed to the operation wire 14 by a known technique corresponding to a material such as welding, adhesion, or fusion. The second lock portion R2 has a wedge shape having a wide width portion G1 and a narrow width portion G2 as a locking portion 105 provided on the operating member 104 in order to temporarily stop the advance / retreat operation of the operation wire 14 in the axial direction. It is a through hole. If the wedge-shaped through hole is formed in this way, the operation wire 14 can be moved only in the through hole, and the large-diameter portion 106 can be clamped more strongly. It can be held in a fixed position, and the procedure can be performed easily, safely and reliably.

  When performing a procedure, after the positioning and holding means 20 holds and positions the living tissue M, a puncturing operation is performed by the puncture member 12. The holding and positioning of the living tissue M is performed by pulling the operation wire 14. Even if the operation wire 14 is pulled to hold and position the living tissue M, the puncture operation cannot be performed unless the holding state and the positioning state are maintained. Therefore, when the operation wire 14 is pulled, the second lock portion R2 locks the large-diameter portion 106 to the locking portion 105 (in some cases, the edge portion 105a of the through hole), and temporarily holds the operation wire 14 in place. Thus, even when the hand holding the operation wire 14 is released, the holding state and the positioning state can be maintained, and only the puncture operation by the puncture member 12 can be performed alone.

  When the lock is released, the tip of the operation wire 14 automatically becomes straight due to the elasticity of the elastic wires 26 and 67 in the holding portion 22, and the holding state of the foramen ovale valve M2 can be easily released.

  In the internal passage through which the operation wire 14 of the slide part 100 is inserted, a movement restricting hole 108 having a size in which the large diameter part 106 cannot pass in the proximal direction is formed. Therefore, when pulling the operation wire 14, it can be pulled until the large-diameter portion 106 fixed to the operation wire 14 reaches the movement restriction hole 108, but beyond that, the operation wire 14 is moved with respect to the slide portion 100. It cannot be moved.

  The energy supply means 4 shown in FIG. 1 supplies electric energy to the clamping means K. Since it is a known system configuration, a detailed description is avoided, but from the viewpoint of ease of control, a DC power supply or an AC power supply can be used. The electrical one is preferred. However, not only this but also the one that can melt the oval valve M2 and the atrial septum M1 clamped by the clamping means K with heat and supply energy that can be crimped with an adhesive factor such as collagen or elastin. Anything may be used. For example, ultrasonic waves, lasers, microwaves, or high frequencies can be used.

  As shown in FIG. 2, the positioning and holding means 20 (operating unit) generally includes a positioning unit 21 that positions the puncture member 12 with respect to the foramen ovale O and an oval valve M2 with respect to the puncture direction of the puncture member 12. It is comprised of a holding portion 22 that holds it in a non-retractable manner and is normally housed in the guiding catheter 3, but when in use, the operating wire 14 and the main tube 23 are operated to operate the guiding catheter 3 as shown in the figure. Extruded.

  More specifically, the central lumen L5 formed in the distal tip 15 is provided with a main tube 23 and an operation wire 14 provided so as to be movable forward and backward in the axial direction within the main tube 23 (see FIG. 3). . The main tube 23 is fixedly held by the slide portion 100 at the proximal end side and exhibits the function of the central axis of the device, but also reinforces the catheter body 10, and further includes a positioning and holding means 20. Is also drawn into the catheter body 10 and collected. The operation wire 14 protrudes from the rear end from the distal end of the catheter body 10 through the main pipe 23 and through the internal passage of the slide portion 100. To the proximal end portion of the operation wire 14, a grasping portion 16 is connected for the operator to grasp with his / her finger in order to move the operation wire 14 forward / backward or rotate.

  A positioning portion 21 of the positioning holding means 20 is provided at the distal end portion of the main pipe 23. The positioning portion 21 positions the puncture member 12 with respect to the foramen ovale O, and is composed of a pair of first elastic wires 26 that are expanded and contracted by operation of the operation wire 14 as shown in FIG. Yes. The proximal end of the first elastic wire 26 is attached to the outer surface of the main tube 23, and the distal end is attached to the proximal end side of the intermediate sleeve body 24 through which the operation wire 14 is inserted.

  The positioning portion 21 displaces the first elastic wire 26 outward with the base end attached to the main pipe 23 as a fulcrum by an operation of moving the operation wire 14 in the axial direction, and each first elastic wire 26 is moved into the oval hole O. The inner edge is pressed with substantially equal elastic force, and the puncture member 12 is aligned with the foramen ovale O. That is, the function of positioning the puncture member 12 positioned between the first elastic wires 26 in the center of the foramen ova O is exhibited.

  On the other hand, the holding part 22 holds the puncture member 12 from the back side so that the foramen ovale valve M2 can be easily punctured, and as shown in FIG. 2, a tip member 28 provided at the tip of the operation wire 14 is provided. And a pair of second elastic wires 27 for connecting the intermediate sleeve body 24 and the tip sleeve body 30 to each other. The distal end member 28 is fixed to the distal end of the operation wire 14, the distal end sleeve body 30 and the intermediate sleeve body 24 are inserted through the operation wire 14, and the second elastic wire 27 is welded to the distal end of the intermediate sleeve body 24. The tip end side is connected to the tip sleeve body 30 by welding, caulking, or the like.

  As shown in FIG. 4, the distal end sleeve body 30 covers the opening of the cylindrical tube portion 31 whose one end is opened with a lid body 32, thereby forming a cylindrical accommodation space 33 therein. The inner diameter D of the accommodation space 33 is formed larger than the outer diameter Da of the tip member 28, and the tip member 28 is accommodated in the accommodation space 33 so as to be able to move forward and backward. A proximal end insertion hole 35 and a distal end insertion hole 34 penetrating into the accommodation space 33 are formed on the proximal end side and the distal end side of the distal end sleeve body 30. The operation wire 14 passes through the accommodation space 33 through the proximal end insertion hole 35 and the distal end insertion hole 34, and the distal end member 28 is fixed to the operation wire 14 in the accommodation space 33. The inner diameter D1 of the proximal end insertion hole 35 and the inner diameter D2 of the distal end insertion hole 34 are both formed smaller than the outer diameter Da of the distal end member 28. Therefore, the distal end sleeve body 30 passes through the housing space 33 to the outside. It is impossible. If the distal end sleeve body 30 cannot pass through the accommodation space 33 to the outside, the distal end member 28 is not necessarily limited to a spherical body, and the proximal end insertion hole 35 and the distal end insertion hole 34 are not limited to holes having a circular cross section. In addition, if the distal end sleeve body 30 cannot pass from the accommodation space 33 to the outside, the distal end sleeve body 30 may have a hole portion communicating with the outside in addition to the proximal end insertion hole 35 and the distal end insertion hole 34. Good.

  For example, a metal material such as SUS or a non-metal material such as polycarbonate can be applied to the material of the cylindrical portion 31 and the lid body 32, but the material is not limited thereto. The cylindrical portion 31 and the lid body 32 are coupled by a known method according to the material such as welding, fitting, fusion bonding, or adhesion.

  The wire tip portion 14A is provided with a tip covering portion 17 coated with a material more flexible than the wire constituting the operation wire 14, and this tip covering portion 17 is used for exploration that touches a living tissue during operation. Projecting from the distal end insertion hole 34 of the distal end sleeve body 30 toward the distal end side. The tip covering portion 17 is covered with, for example, urethane, but is not limited thereto as long as it is more flexible than the wire rod.

  The intermediate sleeve body 24, the tip sleeve body 30, the second elastic wire 27 connecting the sleeve bodies 24 and 30, and the tip member 28 constitute a bending mechanism W that bends or curves the tip of the operation wire 14. .

  The bending mechanism W is used to hold the foramen ovale valve M2. When the puncture member 12 punctures the foramen valve M2, the thin foramen valve M2 is held from the back side to facilitate puncture. Therefore, the bending mechanism W bends or curves the second elastic wire 27 between the distal end member 28 and the distal end side of the first elastic wire 26 by retracting the operation wire 14 in the axial direction. The oval hole valve M2 is held from the back side by the tip sleeve body 30. That is, the bending mechanism W is configured such that the distal end portion of the operation wire 14 is bent or curved with the distal end side of the first elastic wire member 26 attached to the main pipe 23 as a fulcrum.

  However, the bending mechanism W of the holding part 22 is bent and holds the oval hole valve M2 after the first elastic wire 26 of the positioning part 21 aligns and positions the puncture member 12 with respect to the oval hole O. Since the first elastic wire 26 needs to be deformed prior to the second elastic wire 27, the rigidity of both elastic members is changed in this embodiment.

  When the slide part 100 is moved back and forth with respect to the main body part 71, the main tube 23 fixed to the slide part 100 can be drawn into the central lumen L5 of the catheter main body 10, and accordingly, the positioning and holding means 20 as a whole is catheterized. It can be collected in the main body 10.

  Next, the operation of this embodiment will be described.

(pre-process)
The surgeon inserts an introducer (dilator long sheath) from the femoral vein. After the distal end of the long sheath reaches the left atrium L via the right atrium R, the dilator is removed from the long sheath.

  The push piece 109 of the first lock portion R1 in the lock-unlock mechanism 102 is pressed inward of the slide portion 100, the operating member 104 is lowered in the slide hole 103, and the restriction of the restriction rod 110 is removed. As a result, the slide unit 100 becomes movable with respect to the main body unit 71. Note that a part of the side of the guide bar 88A enters the connection hole 74, and the connection of the output connector 87 to the input connector 75 is obstructed, so that unexpected power supply from the energy supply means 4 is reliably suppressed. , Safety is ensured.

  When the slide portion 100 is retracted relative to the main body portion 71 and the needle operation lever 78 is also retracted, the wire portion 11b of the holding member 11 and the puncture member 12 are housed in the catheter main body 10.

  In this state, it is inserted into the long sheath, passes through the femoral vein J and the right atrium R, and reaches the left atrium L.

  When the distal end of the catheter body 10 reaches the left atrium L, the slide part 100 is advanced relative to the body part 71. As a result, the flat plate portion 11a of the clamping member 11 protrudes from the distal end of the catheter body 10 via the terminal and the operation cord 13a, moves the main tube 23 forward, and presses the push piece 109 of the lock-unlock mechanism 102, A state where the large diameter portion 106 of the operation wire 14 does not hit the narrow width portion G2 of the locking portion 105 which is a through hole formed in the operation member 104, that is, the second lock portion R2 is in an unlocked state, and the operation wire 14 To free state.

  Then, the distal end of the operation wire 14 protrudes from the distal end sleeve body 30 from the distal end of the main tube 23 and is inserted into the pulmonary vein Q. This protruding state can be visually recognized from the outside since the tip member 28 is provided with an X-ray opaque marker. Since the operation wire 14 can be rotated 360 degrees, the operation wire 14 can be advanced while rotating, and can be easily inserted into the pulmonary vein Q while exploring the living tissue M by the distal end covering portion 17.

  With the operation wire 14 inserted into the pulmonary vein Q, the hand operation unit 70 is pulled until the clamping member 11 reaches the right atrium R. At this time, the distal end of the operation wire 14 protrudes from the distal sleeve body 30 and is inserted into the left atrium L.

(1) Operation wire pulling step (Note that in the drawings, the order of the steps is indicated by a circle number, but in the specification it is a number in parenthesis. The same applies hereinafter.)
As shown in FIG. 5, a display for towing the gripping part 16 is attached to the display part H1 for the towing process together with the number (1). According to this display, after confirming the distal end position of the operation wire 14, the surgeon moves the distal end member 28 at the distal end of the operation wire 14 within the accommodation space 33 as shown in FIGS. 17 (B) and 18 (A). The gripping portion 16 is pulled to retract the operation wire 14 until it comes into contact with the inner wall surface where the proximal end insertion hole 35 is formed (retraction amount is “δ1” in FIG. 17B).

  When the operation wire 14 is retracted, the large-diameter portion 106 is also retracted. However, in the lock-unlock mechanism 102, the operating member 104 is urged upward by the elastic force of the spring 107 unless the pressing piece 109 is pressed. Therefore, since the operation wire 14 is always held between the narrow width portion G2 of the wedge-shaped through hole 105 and the inner peripheral surface of the internal passage Qb, the retraction of the operation wire 14 makes the pulling operation smooth. Can be done. And the main-body part 71 is operated, the 2nd elastic wire 27, the clamping member 11, and the puncture member 12 are located in the vicinity of the foramen ovale valve M2, and the holding | maintenance part 22 whole is inserted in the left atrium L side.

  When the operation wire 14 is further pulled and retracted (the retraction amount is “δ2” in FIG. 17C), the operation force for retreating causes the operation wire 14, the tip sleeve body 30, the second elastic wire 27, and the intermediate sleeve body 24 to move. The base end is transmitted to the first elastic wire 26 attached to the main pipe 23, and the first elastic wire 26 is deformed so as to project in an arc shape radially outward as shown in FIG. Let However, at this time, the second elastic wire rod 27 is not deformed.

  As a result, the first elastic wire 26 is deformed while expanding the lip portion of the oval hole O, so that the puncture member 12 provided in the immediate vicinity of the first elastic wire 26 is moved to the oval hole O. The puncture member 12 is positioned at the center of the foramen ovale O.

  When the operation wire 14 is further retracted and the rear end of the intermediate sleeve body 24 comes into contact with the front end of the main tube 23 as shown in FIG. 17D, the first elastic wire 26 is not deformed so much and The second elastic wire rod 27 is projected and deformed in an arc shape radially outward by an operating force. As a result, as shown in FIG. 14, in the left atrium L, the distal end member 28 and the distal end sleeve body 30 are curved so as to approach the puncture member 12. It abuts against the left atrial surface of M2 and holds it.

  Next, in the second lock portion R2 in the lock-unlock mechanism 102 shown in FIGS. 8 and 9, the large diameter portion 106 is pushed into the locking portion 105 which is a wedge-shaped through hole, and the operation wire 14 is locked. As a result, even if the operator releases the hand from the grasping portion 16, the holding state is reliably maintained, the holding of the foramen valgus valve M2 is not loosened, and the operator advances the needle operation lever 78 with only one hand. be able to.

  In the operation wire pulling process, if the operator pulls the grip portion 16 too strongly, the distal end member 28 may fall off the operation wire 14. However, since the tip member 28 is housed in the housing space 33 so as not to be detached outside, even if the tip member 28 is detached from the operation wire 14, the tip member 28 is placed in the blood vessel as shown in FIG. 18) B). The possibility that the tip member 28 is not left behind and is transported to the brain by blood flow to cause cerebral infarction can be suppressed.

  When the operation wire 14 is pulled more than necessary, the large diameter portion 106 fixed to the operation wire 14 reaches the movement restricting hole 108 of the slide portion 100. Since the large-diameter portion 106 cannot pass through the movement restricting hole 108, the operation wire 14 can no longer be pulled, and the increase in tensile force between the operation wire 14 and the tip member 28 is restricted, and the tip member It is suppressed that 28 falls off from the operation wire 14.

  As described above, the present embodiment includes the large-diameter portion 106 whose movement is restricted by the movement restriction hole 108 as a safety mechanism for preventing the tip member 28 from falling off, and the safety mechanism when the tip member 28 falls off. As a result, the distal end sleeve body 30 in which the accommodating space 33 for accommodating the distal end member 28 is formed is provided, and safety is improved. Further, since the tip member 28 is housed in the housing space 33 and the tip member 28 is not exposed to the outside, the tip member 28 can be prevented from being caught and dropped.

(2) Puncturing step When the needle operation lever 78 is advanced in the direction of the arrow (see FIG. 10), the puncture member 12 protrudes from the distal end of the catheter body 10 via the operation cord 13b, and as shown in FIG. The puncture member 12 is punctured at a predetermined position of the valve M2. There is no possibility that a situation where puncture is impossible due to loose holding of the foramen ovale valve M2 will not occur.

  When the puncture member 12 is moved in the puncturing direction, as shown in FIG. 10 (B), the hand operating unit 70 displays a display of the next moving direction and a number indicating the order of the operation steps from the lower surface.

  Since the position of the puncture member 12 is determined by the positioning holding portion 22, there is no possibility of deviation. Once the puncture member 12 is punctured, the position of the puncture member 12 is a fixed position in relation to the oval hole valve M2. It becomes. Therefore, the surgeon can perform the puncture operation very easily.

  When the puncturing is completed, the slide unit 100 is further advanced relative to the main body unit 71. Thereby, the flat plate part 11a of the clamping member 11 protrudes from the distal end of the catheter body 10 via the terminal and the operation cord 13a.

  In the hand operation unit 70, the terminal 81 attached to the needle operation lever 78 moves forward to contact the contact member 84, and the puncture member 12 and the input connector 75 are in an electrically conductive state (FIG. 6). reference).

(3) Moving Step of Slide Part When the flat plate part 11a reaches a position facing the atrial septum M1, the slide part 100 is retracted from the main body part 71 as shown in FIG. Even at this time, a part of the guide bar 88A enters the connection hole 74 and the connection of the output connector 87 to the input connector 75 is obstructed, and safety is ensured.

  Due to the retraction of the slide portion 100, the flat plate portion 11a is retracted via the operation code 13a shown in FIG. 2, and the bent portion 11c of the wire rod portion 11b is affected when entering the lumen of the tip tip 15, and the flat plate portion 11a. Is displaced so as to approach the puncture member 12. By this displacement, the flat plate portion 11a presses the atrial septum M1 toward the foramen ovale valve M2, and the atrial septum M1 and the foramen ovale valve M2 are fixed in the thickness direction, that is, in the operation state, the front-rear direction position is fixed. As shown in FIG. 16, the atrial septum M1 and the foramen ovale M2 are present between the clamping member 11 and the puncture member 12.

  At this stage, in order to unlock the second lock portion R2 in the lock-unlock mechanism 102 shown in FIGS. 8 and 9, if the push piece 109 is pushed and the operation wire 14 is unlocked, the operation wire 14 and the tip The first elastic wire 26 and the second elastic wire 27 are no longer pressed by the member 28, and the first elastic wire 26 and the second elastic wire 27 are stretched in a straight line by their own elastic force. In this state, when the slide unit 100 is retracted as shown in FIG. 11, the entire positioning and holding means 20 is collected into the lumen L <b> 5 of the catheter body 10 via the main tube 23. As shown in FIG. 11B, when the “OK” display portion H6 appears in the window 73, it can be seen that the collection is completed.

  On the other hand, in the hand operation unit 70, the terminal 83 attached to the main pipe 23 is also retracted to contact the contact member 85, and the holding member 11 and the input connector 75 are in an electrically conductive state. Then, the notch 89 of the guide bar 88A coincides with the connection hole 74, and the output connector 87 can be connected to the input connector 75 for the first time.

(4) Connection process The retraction of the slide part 100 at this stage is performed by holding the living tissue M and the contact state between the terminal 83 and the contact member 85 at a time. In addition, since the terminal 81 on the puncture member 12 side and the contact member 84 are in an electrically conductive state first, both the clamping member 11 and the puncture member 12 are in a state in which electrical energy can be supplied.

  Then, as shown in FIG. 12, when the output connector 87 is connected to the input connector 75, power can be supplied from the energy supply means 4.

  Thereafter, by operating the switch SW, predetermined electrical energy controlled by the control unit 5 is supplied to the holding member 11 and the puncture member 12 via the operation cords 13a and 13b, and the atrial septum M1 and the foramen ovale Valve M2 is heated.

  When heating is continued while maintaining the fusion temperature, the tissues of the atrial septum M1 and the foramen ovale valve M2 are melted and fused to each other by an adhesion factor such as collagen or elastin. The electrical energy control unit 5 controls the output to be low and makes it difficult for blood clots to adhere. Therefore, even if a part of the pinching member 11 and the puncture member 12 is exposed in the blood, the pinching member 11 or the puncture member Thrombus can be prevented from adhering to the member 12.

(5) Puncture part retraction process When the fusion is completed, the needle operation lever 78 shown in FIG. 12 is retracted according to the indication of the arrow displayed in the vicinity of the number (5) to obtain the state of FIG. Housed in the tip 15. As a result, the terminal 81 that moves together with the needle operating lever 78 is separated from the contact member 84 (see FIG. 6), and the state of being able to conduct electricity to the clamping means K is released. Thereafter, the output connector 87 is removed from the input connector 75. Then, the push button 93 of the connection mechanism 90 is pressed, and the connection between the Y connector 72 and the main body 71 is released, so that the guiding catheter 3 and the main body 71 are disconnected, and the main body 71 is separated from the living body. When retracted, the device is pulled out using the guiding catheter 3 as a guide. Thereafter, when the guiding catheter 3 is removed from the living body, the procedure is completed.
Second Embodiment
The medical device which concerns on 2nd Embodiment is a PFO closure device from which only the structure of the front-end | tip sleeve body 40 (accommodating part) and the front-end | tip part of the operation wire 14 differs with respect to the PFO closure device which concerns on 1st Embodiment. In addition, about the site | part which has the same function as 1st Embodiment, the same code | symbol is attached | subjected and description is abbreviate | omitted in order to avoid duplication.

  As shown in FIG. 19, the distal end sleeve body 40 of the PFO closure device according to the second embodiment is formed of a flexible resin made of a flexible resin such as urethane on the distal end side of a cylindrical tube portion 41 constituting the distal end sleeve body 40. It has a portion 42, and a tip insertion hole for the operation wire 14 to pass to the tip side is not formed. Furthermore, the tip of the operation wire 14 is not a tip covering portion made of urethane or the like, but a tip member 48 is fixed.

In the PFO closure device according to the second embodiment, since the distal end side of the distal sleeve body 40 is formed of a flexible member, when inserted through the pulmonary vein Q, at the distal end of the operation wire 14 as in the first embodiment. Instead of searching, the tip sleeve body 40 itself can be searched without damaging the living tissue M.
<Third Embodiment>
The medical device which concerns on 3rd Embodiment is a PFO closure device from which only the structure of the front-end | tip sleeve body 50 (accommodating part) and the front-end | tip part of the operation wire 14 differs with respect to the PFO closure device which concerns on 1st Embodiment. In addition, about the site | part which has the same function as 1st Embodiment, the same code | symbol is attached | subjected and description is abbreviate | omitted in order to avoid duplication.

  In the tip sleeve body 50 of the PFO closure device according to the third embodiment, the tip insertion hole 54 on the tip side of the cylindrical tube portion 51 that constitutes the tip sleeve body 50 is increased in diameter toward the outside in a tapered shape. The tip member 58 is formed so that the tip member 58 can pass through the tip insertion hole 54 to the inside, but cannot pass to the outside.

When the PFO closure device according to the third embodiment is inserted into the pulmonary vein Q, as shown in FIG. When the operation wire 14 is pulled when operating the positioning and holding means (operation part), the tip insertion hole 54 is tapered, so that the tip insertion hole 54 is formed by the tip member 58 as shown in FIG. The tip member 58 enters the inside of the accommodation space 53 by elastically deforming and expanding. Thereafter, even if the tip member 58 falls off, the tip member 58 is housed in the housing space 53 so as not to be detached to the outside, so that the tip member 58 can be prevented from being left in the blood vessel.
<Fourth embodiment>
The medical device according to the fourth embodiment is a PFO closure device that is different from the PFO closure device according to the first embodiment only in the configuration of the distal end sleeve body 60 (accommodating portion) and the distal end member 68. In addition, about the site | part which has the same function as 1st Embodiment, the same code | symbol is attached | subjected and description is abbreviate | omitted in order to avoid duplication.

  As shown in FIG. 22, the distal end sleeve body 60 of the PFO closure device according to the fourth embodiment does not have the distal end side end insertion hole formed in the cylindrical tube portion 61 constituting the distal end sleeve body 60. Unlike the first embodiment, the distal end member 68 is an elastic member such as a spring provided between the distal end side inner wall surface of the accommodation space 63 of the distal end sleeve body 60 and the distal end portion of the operation wire 14. The tip member 68 has a structure that cannot pass through to the outside.

  In the PFO closing device according to the fourth embodiment, when the operation wire 14 is pulled when operating the positioning holding means (operation unit), the traction force is transmitted to the tip sleeve body 60 while the tip member 68 that is an elastic member is extended. By applying a certain amount of traction force, the positioning and holding means (operation unit) is activated. Even if the tip member 68 falls off the inner wall surface of the operation wire 14 and the tip sleeve body 60, the tip member 68 is housed in the housing space 63 so as not to be detached to the outside. It can suppress being left behind.

  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.

  In the first to fourth embodiments, the treatment used to close the PFO deficiency has been described. However, the present invention is not limited thereto, and a passage-like deficiency such as a left atrial appendage closure device (Left Atrial Appendage) is described. It can also be used when closing the body or when the living tissue M at a predetermined site is thermally necrotized. That is, the present invention can be applied to, for example, a thrombus capture catheter or the like as long as the device includes a distal end member fixed to an operation wire operated on the proximal end side at the distal end portion of the device inserted into the living body.

1 catheter,
14 Operation wire,
14A wire tip,
17 Tip cover,
20 positioning holding means (operation part),
28, 48, 58, 68 Tip member,
30, 40, 50, 60 Tip sleeve body (accommodating portion),
33, 53, 63 accommodation space,
34, 54 Tip insertion hole,
35 proximal insertion hole,
Da outer diameter of the tip member,
D inner diameter of the accommodation space,
D1 inner diameter of the base end insertion hole,
D2 Inner diameter of the tip insertion hole.

Claims (5)

An operation wire that is inserted into the catheter and can be moved forward and backward in the insertion direction with respect to the catheter, a distal end member that is connected to the distal end side of the operation wire, and provided at the distal end side of the catheter, and by pulling the operation wire An operating part that operates by movement of the tip member, and a medical device comprising:
The operating portion has an accommodating portion that accommodates the distal end member therein so that the distal end member can be advanced and retracted and cannot be detached to the outside, and the operation wire is inserted through at least the proximal end side of the distal end side and the proximal end side of the accommodating portion. The medical device is characterized in that an insertion hole through which the tip member cannot pass is formed. The operation wire has a wire tip extending to the tip side than the tip member,
The medical device according to claim 1, wherein the wire distal end portion is inserted into an insertion hole on a distal end side of the housing portion.   The medical device according to claim 2, wherein the wire distal end portion has a distal end covering portion coated with a material having rigidity lower than that of the wire constituting the operation wire.   The medical device according to any one of claims 1 to 3, wherein a distal end side of the housing portion is formed of a material having relatively lower rigidity than a proximal end side.   The insertion hole on the distal end side of the housing part is characterized in that the distal end member cannot pass through to the outside and is elastically deformed by passing through the distal end member from the distal end side and can pass through to the inside. The medical device according to any one of claims 1 to 4.

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