JP2011019763A - Medical device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical device, restraining a thrombus from adhering to an electrode in applying electric energy to improve the safety. <P>SOLUTION: This medical device includes: a puncture part projected from a catheter to puncture living body tissue in the periphery of a deficit; a holding member for holding the living body tissue in a space up to the puncture part; and an energy supply means for supplying electric energy for fusing or necrosing the living body tissue held by the puncture part and the holding member to choke the deficit to the puncture part and the holding member. The puncture part is capable of moving in a direction different from the puncture direction from the state of being projected from the catheter to puncture the living body tissue. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a medical device that closes a defect generated in a living body, and particularly to an improvement of an electrode member that clamps a living tissue.

  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 closure device joins living tissue by applying electrical energy by inserting the foramen ovale from the right atrium to the left atrium and pulling the foramen valve to close the foramen ovale To do.

  In addition, the present applicant has previously proposed a PFO closure device that sandwiches a foramen ovale valve and an atrial septum with a pair of electrodes, and reliably joins living tissues by applying electric energy from both electrodes (described below). Patent Document 2).

  This device uses a pinching means, one of which is a puncture member made of a needle electrode, and the other is a pinching member that clamps the oval valve and the atrial septum between the puncture member, and the puncture member is the oval hole valve. After the puncture, the foramen ovale and the atrial septum are sandwiched between the other electrode, ie, the clamping member, and electrical energy is applied to the living tissue for bonding.

  This device can also be used to close defects such as congenital atrial septal defect (ASD), PFO, ventricular septal defect (VSD), patent ductus arteriosus (PDA), and is highly versatile In particular, no foreign substance is placed in the body, the structure is simple, the procedure is easy, and the foramen valve and the atrial septum can be reliably joined.

WO2004 / 086944 WO2007 / 100067

  However, when electrical energy is applied to the clamping means (electrode) exposed to blood, thrombus tends to adhere to the clamping means, and thus the site of the electrode exposed to blood is usually difficult to adhere to the blood. Measures such as coating with a material and adjusting applied electric energy are required.

  The present invention has been made to solve the above-described problems, and suppresses exposure of an electrode for applying electric energy to blood, and more reliably suppresses adhesion of thrombus. An object is to provide a high medical device.

  The medical device of the present invention that achieves the above object includes a puncture portion that protrudes from a catheter and can puncture a living tissue around a defect, a holding member that holds the biological tissue between the puncturing portion, and the puncture device And an energy supply means for supplying the puncture portion and the holding member with electrical energy for fusing or necrosing the living tissue held between the portion and the holding member to close the defect, and the puncture portion from the catheter It is possible to move in a direction different from the puncturing direction from the state of protruding and puncturing the living tissue.

  In the medical device according to the present invention, since the puncture part can move from a state of protruding from the catheter and puncturing the living tissue in a direction different from the puncture direction, the puncture part can be moved to a position where it is not exposed to blood. it can. Thereby, when applying electrical energy to a puncture part, it can suppress more reliably that a thrombus adheres to a puncture part, and can improve the safety | security of a medical device.

  If the puncture portion has at least two needle members that can be separated from or approached from the state where the puncture portion protrudes from the catheter and punctures the living tissue, the needle member can be separated or approached from each other by moving the needle members away from each other. The needle member can be moved to a position where it is not exposed to blood by being buried in a living tissue.

  Puncture accommodated in the catheter so that it can be moved forward and backward so that it can be operated from the proximal side of the catheter, and by the forward and backward movement, the side of the protruding puncture part is pressed to move the puncture part in a direction different from the puncture direction By providing the part moving means, the puncture part can be moved to a position where it is not exposed to blood by an operation from the hand side.

  If the puncture portion moving means has a guide portion that contacts and presses the side portion of the protruding puncture portion by advancing and retreating, the side portion of the puncture portion is pressed by the guide portion to move the puncture portion. be able to.

  The puncture portion has at least two needle members that project so as to expand from the catheter and puncture the living tissue, and the guide portion approaches a side portion of the needle members that are separated from each other. If the guide portion is pressed, the guide portion comes into contact with at least two of the expanding needle members, and the needle member can be moved in the direction of proximity by simply moving the guide portion forward and backward.

  The puncture portion has at least two needle members that project so as to expand from the catheter and puncture the living tissue, and the guide portion is located between the needle members, and the advance and retreat By having a partition wall portion that presses the adjacent side portions of the needle member in a direction away from each other, the guide portion is in contact with at least two needle members that are expanded just by moving the guide portion forward and backward. The needle member can be moved away from the needle member.

It is a schematic sectional drawing which shows the PFO closure device which concerns on 1st Embodiment of this invention. It is a principal part perspective view which shows an example of the device. It is a top view which shows the catheter front-end | tip part of the device. FIG. 4 is a cross-sectional view taken along line 4-4 of FIG. It is a top view of the catheter front-end | tip part which shows the time of moving a puncture part. It is a top view of a hand operation part. It is a top view of the hand operation part of the state which operated the operation lever. It is a top view of the hand operation part of the state which operated the guide part operation lever. It is sectional drawing which shows a connection mechanism. It is sectional drawing of a lock-unlock mechanism part. It is sectional drawing which follows the 11-11 line of FIG. It is the cross-sectional schematic which inserts a main operation rod into 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)-(C) are the cross-sectional schematic diagrams which show the motion of the puncture part in a puncture part burial process. (A)-(D) are schematic which shows the operation state of a PFO closure device. It is a top view which shows the catheter front-end | tip part of the PFO closure device which concerns on the 2nd Embodiment of this invention. It is sectional drawing which follows the 18-18 line of FIG. It is a top view of the catheter front-end | tip part which shows the time of moving a puncture part. (A)-(C) are the cross-sectional schematic diagrams which show the motion of the puncture part in a puncture part embedding process.

  Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.

<First Embodiment>
The medical device of this embodiment is a PFO closure device and is 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 proximal operation unit 70 provided on the proximal end side, a guiding catheter 31 having a proximal end attached to the proximal operation unit 70, a catheter 30 provided in the guiding catheter 31, and a catheter 30. Of the foramen ovale M2 and the atrial septum M1, and the living tissue M of the part clamped by the clamping means K (generic name for M1 and M2). Energy supply means 20 for supplying the energy to be applied, and positioning and holding means 60 (see FIG. 2) for performing the procedure by the clamping means K stably and accurately. In the following description, the hand operating unit side of the device is referred to as “base end side”, and the pinching means K side is referred to as “tip side”.

  In using the device, first, the guiding catheter 31 is inserted, for example, from the femoral vein J. The guiding catheter 31 is provided with a clamping means K provided at the distal end of the catheter 30 therein. And insert it in the stored state. When the tip reaches the heart part where the procedure is performed, the hand operating unit 70 is operated, the pinching means K protrudes from the catheter 30, and a foramen ovale defect O (hereinafter sometimes simply referred to as an oval hole O). The tissue of the atrial septum M1 and the foramen ovale M2 of the heart where 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. In the figure, “L” indicates the left atrium and “R” indicates the right atrium.

  The clamping means K includes a clamping member 1 that directly contacts one side surface of the atrial septum M1, and a puncture unit 2 that punctures the foramen ovale valve M2. As shown in FIG. 2, the clamping member 1 is composed of a flat plate portion 1a having a flat plate shape having a predetermined width L, and a pair of wire rod portions 1b connected to the base end portion. The plane position is regulated by 50 lumens L3 and L4. Further, the clamping member 1 is protruded from the distal tip 50 by connecting one operation cord 7b to the proximal end side of the U-shaped wire rod portion 1b and moving the operation cord 7b in the axial direction. A predetermined clamping width is formed between the puncture unit 2 and when entering the distal tip 50, it is displaced so as to approach toward the puncture unit 2 and clamp the living tissue.

  On the other hand, the puncture unit 2 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 formed on the distal tip 50, and is connected to the proximal end formed in a U shape. By operating the operation code 7c, the tip portion can appear and disappear from the tip tip 50.

  The puncture section 2 is provided with elasticity so that two very thin needle members having a circular cross section perpendicular to the axis and having a sharp pointed tip are separated from each other, and the tip expands when protruded. . In addition, if the lumens L1 and L2 are formed so as to be inclined so that the outlet side is expanded, the needle member is expanded along the lumens L1 and L2 even if the needle member is not elastic. be able to. Further, the number of needle members may be one or three or more.

  As shown in FIGS. 3 and 4, the PFO closure device according to the present embodiment presses the side portion of the protruding needle member (puncture portion 2) and moves the needle member in a direction different from the puncture direction. Part moving means 40 is provided.

  The puncture portion moving means 40 includes a rod 41 that is held so as to be able to advance and retreat in a lumen L6 formed on the tip 50, and a guide portion 42 that is fixed to the tip of the tip 50 with respect to the rod 41. Yes. The lumen L6 and the rod 41 are preferably non-circular in cross section in the direction perpendicular to the axis so that the rod 41 is held non-rotatably with respect to the lumen L6. In addition, it can also hold | maintain non-rotatingly by forming multiple rods. Moreover, you may provide the other structure which makes a cross section perpendicular to an axis | shaft a circular diameter, and can control the rotation with respect to a lumen | rumen. The proximal end side of the rod 41 is connected to the operation cord 7d, and the guide portion 42 can be moved closer to and away from the distal tip 50 by operating the operation cord 7d. The rod 41 can be inserted through other lumens such as the central lumen L5 instead of the lumen L6.

  The guide part 42 is a ring-shaped member formed so as to surround the outlets on the distal end side of the lumens L1 and L2 while being in contact with the distal tip 50. Therefore, when the two needle members of the puncture unit 2 are protruded from the lumens L1 and L2 with the guide portion 42 in contact with the tip 50, the needle member becomes a ring of the guide portion 42 as shown in FIGS. Is inserted. Since the tip of the needle member expands when it protrudes, when the guide portion 42 is moved to the tip side in this expanded state, the inside of the ring of the guide portion 42 is separated from the needle member as shown in FIG. The side part is pressed, and the two needle members are moved in directions close to each other.

  The sandwiching member 1 and the puncture unit 2 function as electrode members, but the operation codes 7b and 7c (see FIG. 2) for moving the sandwiching member 1 and the puncture unit 2 out of the catheter 30 are provided inside the catheter 30. Inserted and electrically connected to a connecting portion 27 of the hand operating portion 70 described later, a coupler 87 (see FIG. 1) fitted to the connecting portion 27, a lead wire d (general name of d1 and d2), and the control portion 22, electric energy Electric energy is supplied from the supply means 20.

  The hand operating unit 70 is a part for operating the pinching means K composed of a pair of electrode members for holding the living tissue around the defect existing in the living tissue so as to be able to protrude and retract from the distal end of the catheter 30. The following means are provided in a lump so that all operations can be performed within a small zone without much movement of the hand.

  That is, as shown in FIG. 2, the hand operating unit 70 includes an operating lever 78 that operates the puncture unit 2 that is one electrode member, a slide unit 100 that operates the clamping member 1 that is the other electrode member, The operation of the clamping means K is assisted, and the main operation rod 7a inserted through the hand operation unit 70 and the catheter 30 so as to be movable in the axial direction, and the lock-unlock that locks / unlocks the slide movement of the slide unit 100. While operating the lock mechanism 102 (see FIG. 10), the pressing piece 109 for locking the axial movement of the main operating rod 7a, and the thermal energy application for applying the thermal energy for closing the defect O to the clamping member 1 and the puncture portion 2 A connecting portion 27 for connecting with the means 20 is provided. Further, the hand operating section 70 is provided with a guide section operating lever 79 connected to the operation cord 7d for operating the puncture section moving means 40.

  The hand operation unit 70 is provided with a process display unit H with various displays attached to the surface portion for guiding the operator to perform a correct operation so that the steps of various procedures can be visually observed. Yes.

  The process display unit H operates a push piece 109 to display a rod pulling process display unit H1 that pulls the main operation rod 7a, a puncture process display unit H2 in which the puncture unit 2 punctures a living tissue, and a slide unit 100. The display unit H3 in the slide unit moving step that slides and moves to or from the main body unit 75, and the puncture unit that moves the puncture unit 2 in a direction different from the puncture direction and embeds the puncture unit 2 in the biological tissue. Display unit H4 in the burying process, display unit H5 in the connection process for connecting the connection part 27 exposed from the main body part 75 to the thermal energy applying means 20, and puncture part burying for releasing the puncture part 2 from being embedded in the living tissue Display unit H6 for releasing process and display unit H7 (see FIGS. 7 and 8) for puncture unit retraction process for retracting puncture unit 2 from the living tissue, each of which uses a display to display each process. To have.

  As described above, when the process display unit H is provided in the hand operation unit 70 so that the order of various processes can be visually confirmed, the operator does not need to fully master the process sequence in advance, and can view the process display unit. Can be easily understood, reduce the mental burden during use, and perform the procedure smoothly and reliably. In addition, the process display part H may display not only using a picture display but on the surface of the main-body part 75 in itemized form.

  In the process display part H, the number of each process is attached to the surface of each operation member so as to be visible. In this way, when a display is used to image each process using a picture display and numbers are assigned, it is only necessary to operate each operation member according to the assigned number, and the operation members to be operated and their order can be visually confirmed. In addition to reducing the mental burden, the procedure can be performed smoothly and reliably.

  In the process display portions H1 to H7, arrows of movement directions of the operation members are also displayed. In this way, the moving direction of the operating member to be operated becomes clear, which not only reduces the mental burden during use, but also increases the safety of the procedure.

  In the process display part H, the color which each operation member colored is the same color as the color of the arrow which shows the moving direction of each operation member. If it does in this way, operation of an operation member will become intelligible and safety of a procedure will increase further.

  In particular, when the slide part 100 is slidably arranged with respect to the main body part 75 of the hand operating part 70 and the slide part 100 is separated from the main body part 75 (the state of FIG. 2), the living tissue is clamped by the clamping means K. In addition, as shown in FIG. 6, the connecting portion 27 is exposed from the main body portion 75 so that it can be connected to the thermal energy applying means 20 (see FIG. 1).

  When the slide part 100 is moved with respect to the main body part 75 in this way, if the connection part 27 is exposed from the main body part 75, it is the most important technique in the procedure, and thermal energy application requiring carefulness is required. The connection between the means 20 and the connecting portion 27 can be performed only after the clamping of the living tissue is completed, and the safety of the procedure is naturally increased regardless of the physical or mental state of the operator. Enhanced. The connecting portion 27 is disposed below the guide portion operating lever 79, and only after the guide portion operating lever 79 is moved to the distal end side in the puncture portion burying process, which is the immediately preceding procedure, from the main body portion 75 to the connecting portion 27. May be exposed so that the thermal energy application means 20 can be connected.

  Needless to say, the operation immediately before the connection is not limited to the case where the living tissue is clamped by the clamping means K, but may be another procedure. In other medical devices, there are various operations immediately before the connection between the thermal energy applying means 20 and the connection portion 27, and this embodiment can be applied to such a case.

  When the operation lever 78 is moved in the direction of puncturing the puncture unit 2 (from the state shown in FIG. 6 to the state shown in FIG. 7), as shown in FIG. A number indicating the display and the order of the operation steps appears. Further, with respect to the guide portion operation lever 79, when the guide portion 42 is moved in the distal direction (from the state shown in FIG. 7 to the state shown in FIG. 8), the next moving direction is displayed from the lower surface of the guide portion operation lever 79. And the number which shows the number which shows the order of an operation process is made to appear. As described above, the foolproof function, that is, the safety function designed so as not to cause a dangerous situation even if the operator performs an erroneous operation is exhibited, and the certainty and safety of the procedure are improved.

  Further, the hand operation unit 70 will be described in detail. The hand operation unit 70 is, as shown in FIG. 2, the main body part 75 and the slide part 100 connected via the guide bar 95 so as to be close to and away from the main body part 75. A needle operation lever 78 for operating the puncture unit 2 and a guide unit operation lever 79 for operating the puncture unit moving means 40 are provided on the upper surface of the main body 75.

  When the needle operating lever 78 connected to the puncture unit 2 is operated, the body portion 75 is electrically contacted at the puncture terminal sliding along with the puncture terminal 2 and at the sliding end position of the puncture terminal. When the slide member 100 connected to the contact member and the holding member 1 is operated, a holding terminal that slides in accordance with this operation and a contact member that comes into electrical contact at the sliding end position of the holding terminal are provided. (Both not shown). Of course, the electrical system of the puncture part 2 and the electrical system of the clamping member 1 are insulated so as not to be unnecessarily conducted.

  Further, in the main body 75, there are also provided a main pipe 63 shown in FIG. 2, a main operation rod 7a provided in the main pipe 63, and operation cords 7b, 7c, 7d extending the side parts of the main pipe 63. The main operation rod 7a provided in the main pipe 63 has a function of assisting the operation of the pinching means K by pulling in the axial direction, and can rotate 360 degrees around the axis in the main pipe 63. . If the main operating rod 7a can be rotated 360 degrees, the tip of the main operating rod 7a can be inserted to the vicinity of the foramen ovale O, and can be inserted into the oval hole 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 portion of the main body portion 75. The coupling mechanism 90 is for facilitating the attachment / detachment of the Y connector 72 to / from the main body 75, and the flange provided at the base end of the Y connector 72 is fitted into the annular groove formed in the main body 75. In this case, as shown in FIG. 9, the sliding member 91 is ejected by the spring member 92, exhibits the function of preventing the flange portion from coming off, and the Y connector 72 is detachable.

  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. The guiding catheter 31 having the flange portion is directly connected to the main body portion 75. The Y connector 72 may be provided at any position of the guiding catheter 31.

  In the slide portion 100, a main operation rod 7a inserted through the main body portion 78 is extended to the outside through an internal passage formed in the center. As shown in FIGS. A push piece 109 of a lock-unlock mechanism 102 that locks-unlocks the slide movement of the slide unit 100 and locks-unlocks the axial movement of the main operating rod 7a is provided.

  The lock-unlock mechanism 102 moves the operating member 104 up and down to connect the slide unit 100 and the main body unit 75, or to release the lock, and allows the slide unit to move. And a main operation rod that temporarily stops advancing and retreating operation of the main operation rod 7a in the axial direction when a positioning and holding unit 60, which will be described later, holds or positions the living tissue M provided at the tip of the main operation rod 7a. 2nd lock part R2 for use.

  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 portion 75. It is comprised from the control rod 110 which controls a movement. Reference numerals “107” in FIGS. 10 and 11 are springs, and reference numeral “108” in FIG. 11 is a stopper member.

  Since the restricting rod 110 is provided with an engaging protrusion 111a that engages with the engaging recess 111b of the main body 75, the engagement between the engaging protrusion 111a and the engaging recess 111b when the operating member 104 is pressed. The combination is released, and the slide part 100 can slide with respect to the main body part 75. Therefore, if the slide part 100 is moved backward, the holding member 1 can be operated close to the puncture part 2 via the operation cord 7b. 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.

  If the release of the first lock portion R1 and the release of the second lock portion R2 are interlocked by operating the push piece 109 and the operation member 104 in this way, the storing operation of the holding member 1 in the catheter, When the long main operation rod 7a is pulled out from the left atrium side, the main operation rod 7a can be linked with an operation for making the main operation rod 7a straight. It is possible to prevent the pulling operation in the holding state and the backward movement operation of the holding member 1 in the holding state, and it is possible to prevent the situation where the living tissue M is damaged or broken.

  On the other hand, the second lock portion R2 for the main operation rod 7a includes a locking portion 105 formed on the operating member 104 and a large diameter portion 106 formed on the main operation rod 7a. The second lock portion R2 has a locking portion 105 provided on the actuating member 104, a wide width portion G1 and a narrow width portion G2, in order to temporarily stop the advance / retreat operation of the main operation rod 7a in the axial direction. It has a wedge-shaped through hole. If the wedge-shaped through hole is formed in this way, the main operating rod 7a can be simply moved in the through hole, and the large-diameter portion 106 can be clamped more strongly. 7a can be held at a fixed position, and the procedure can be performed easily, safely and reliably.

  When performing a procedure, the positioning and holding means 60 holds and positions the living tissue M, and then performs a puncturing operation by the puncture unit 2. The holding and positioning of the living tissue M is performed by pulling the main operation rod 7a. . Even if the main tissue rod 7a 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. Accordingly, when the main operating rod 7a 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 the main operating rod 7a. Is temporarily locked, and even if the hand holding the main operation rod 7a is released, the holding state and the positioning state can be maintained, and only the puncture operation by the puncture unit 2 can be performed independently. .

  Further, in the second lock portion R2, the convenience of operation can be enhanced by the position where the large diameter portion 106 is provided. For example, when pulling the main operation rod 7a from the slide portion 100 in the pulling direction, the main operation rod 7a is held by the holding portion 62 if the large diameter portion 106 is pushed into the locking portion 105 and locked at the position where the drawing is stopped. Can be locked and maintained. When the lock is released, the tip of the main operation rod 7a automatically becomes straight due to the elasticity of the elastic wires 66 and 67 in the holding portion 62, and the holding state of the oval hole valve M2 can be easily released.

  The energy supply means 20 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 60 generally holds a positioning part 61 for positioning the puncture part 2 with respect to the oval hole O and the oval valve M2 so as not to be retractable with respect to the puncture direction of the puncture part 2. The holding portion 62 is normally housed in the guiding catheter 31, but when used, it is pushed out of the guiding catheter 31 by operating the main operating rod 7 a and the main tube 63 as shown in the figure.

  More specifically, a central lumen L5 formed in the tip 50 is provided with a main pipe 63 and a main operation rod 7a provided in the main pipe 63 so as to be movable back and forth in the axial direction. The main pipe 63 is fixedly held by the slide portion 100 at the base end side and exhibits the function of the central axis of this device, but also reinforces the catheter 30, and further includes a positioning holding means 60. They are also drawn into the catheter 30 and collected. The main operation rod 7 a protrudes from the rear end of the catheter 30 through the main pipe 63 and through the internal passage of the slide portion 100.

  When the positioning and holding means 60 is drawn into the catheter 30 and collected, the “OK” display portion H8 (see FIG. 6) indicated on the guide bar 95 is opened in the window 60a opened adjacent to the connection portion 27 in the hand operation portion. It has come to appear. This is also a foolproof function.

  Positioning / holding means 60 is provided at the tip of the main pipe 63. The positioning portion 61 is for positioning the puncture portion 2 with respect to the foramen ovale O and, as shown in FIG. 2, is composed of a pair of first elastic wires 66 that are expanded and contracted by operation of the main operation rod 7a. ing. The proximal end of the first elastic wire 66 is guided by a guide groove 51 formed in the distal tip 50 and then attached to the outer surface of the main pipe 63 in the distal tip 50, and the main operating rod 7 a is inserted into the distal end. The intermediate sleeve body 64 is attached to the proximal end side.

  The positioning portion 61 projects the main operation rod 7a from the distal end of the main tube 63, and displaces the first elastic wire 66 outward with the base end attached to the main tube 63 as a fulcrum by an operation of moving the main operation rod 7a in the axial direction. Then, each first elastic wire 66 presses the inner edge of the foramen ovale O with substantially equal elastic force, and aligns the puncture portion 2 with respect to the oval hole O. That is, the function of positioning the puncture part 2 located between both first elastic wires 66 in the central part of the foramen ovale O is exhibited.

  On the other hand, the holding portion 62 holds the puncture portion 2 from the back side so that the foramen ovale valve M2 can be easily punctured, and as shown in FIG. 2, a contact member provided at the tip of the main operation rod 7a. 68, a tip sleeve body 65, and a pair of second elastic wires 67 that connect the intermediate sleeve body 64 and the tip sleeve body 65. The contact member 68 is caulked and fixed to the distal end of the main operation rod 7 a, the main operation rod 7 a is inserted into the distal sleeve body 65 and the intermediate sleeve body 64, and the proximal end of the second elastic wire 67 is the distal end of the intermediate sleeve body 64. The tip end side is welded to the tip sleeve body 65.

  The intermediate sleeve body 64, the tip sleeve body 65, the second elastic wire 67 connecting the sleeve bodies 64 and 65, and the contact member 68 constitute a bending mechanism W that bends or curves the tip portion of the main operation rod 7a. Yes.

  The bending mechanism W is used to hold the foramen ovale valve M2. When the puncture unit 2 punctures the foramen ovale valve M2, puncture is facilitated by holding the thin foramen valve M2 from the back side. Therefore, the bending mechanism W causes the second elastic wire 67 to bend or bend between the contact member 68 and the distal end side of the first elastic wire 66 by retreating the main operating rod 7a in the axial direction, and the contact member 68. In addition, the foramen valve M2 is held from the back side by the tip sleeve body 65. That is, the bending mechanism W is configured such that the distal end portion of the main operation rod 7a is bent or curved with the distal end side of the first elastic wire 66 attached to the main pipe 63 as a fulcrum.

  However, the bending mechanism W of the holding portion 62 is bent and holds the oval hole valve M2 after the first elastic wire 66 of the positioning portion 61 aligns and positions the puncture portion 2 with respect to the oval hole O. Since the first elastic wire 66 needs to be deformed prior to the second elastic wire 67, the rigidity of both elastic members is changed in this embodiment.

  When the slide part 100 is advanced and retracted with respect to the main body part 75, the main tube 63 fixed to the slide part 100 can be drawn into the lumen L5 at the center of the catheter 30. Can be recovered within.

  Next, the operation of this embodiment will be described.

  12 is a schematic cross-sectional view of the main operating rod inserted into the foramen ovale, FIG. 13 is a schematic cross-sectional view of the state where the puncture part is punctured while holding the oval hole valve, and FIG. 14 is an oval by the puncture part and the holding member. FIGS. 15A to 15C are schematic sectional views showing the movement of the puncture portion in the puncture portion burying process, and FIGS. 16A to 16D are PFO closures. It is the schematic which shows the operation state of the front-end | tip part of a device. In FIGS. 16A to 16C, the shape and position of the second elastic wire 66 are substantially flush with the holding member 1 and the puncture portion 2, but are shown for ease of understanding. Is shown in a state displaced by 90 degrees, which is different from the actual deformation state.

(pre-process)
The surgeon inserts an introducer (dilator long sheath) from the femoral vein. When 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 part 100 becomes movable with respect to the main body part 75.

  When the slide unit 100 is retracted with respect to the main body unit 75 and the needle operation lever 78 is also retracted, the holding member 1, the puncture unit 2, and the like are housed in the catheter 30.

  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 30 reaches the left atrium L, the slide part 100 is advanced relative to the main body part 75. Accordingly, the flat plate portion 1a of the clamping member 1 protrudes from the distal end of the catheter 30 via the terminal and the operation cord 7b, and the main tube 63 is moved forward, and the push piece 109 of the lock-unlock mechanism 102 is pressed to operate. A state in which the large diameter portion 106 of the main operation rod 7a does not hit the narrow width portion G2 of the through hole 105 formed in the member 104, that is, the second lock portion R2 is in an unlocked state, and the main operation rod 7a is in a free state. To.

  Then, the tip of the main operation rod 7 a is projected from the tip sleeve body 65 from the tip of the main tube 63 and inserted into the pulmonary vein Q. This projecting state can be visually recognized from the outside since the contact member 68 is provided with an X-ray opaque marker. Since the main operation rod 7a can be rotated 360 degrees, as shown in FIG. 5, the main operation rod 7a can be advanced while rotating, and can be easily inserted into the pulmonary vein Q.

  With the main operation rod 7a inserted into the pulmonary vein Q, the hand operation unit 70 is pulled until the gripping member 1 reaches the right atrium R. At this time, the distal end of the main operation rod 7 a protrudes from the distal sleeve body 65 and is inserted into the left atrium L.

(1) Step of pulling the main operating rod 7a (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 parentheses. The same applies hereinafter.)
As shown in FIG. 2, a display for pulling the main operation rod 7a with a finger is attached to the display portion H1 of the rod pulling step together with the number (1). According to this display, after confirming the distal end position of the main operation rod 7a, the operator operates the main operation until the contact member 68 at the distal end of the main operation rod 7a comes into contact with the distal end sleeve body 65 as shown in FIG. The rod 7a is retracted (the retract amount is “δ1” in FIG. 16B).

  When the main operating rod 7a is retracted, the large-diameter portion 106 is also retracted. However, in the lock-unlock mechanism 102, the operating member 104 is biased upward by the elastic force of the spring 107 unless the pressing piece 109 is pressed. Therefore, the main operation rod 7a 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. Can be performed smoothly. And the main-body part 75 is operated, the 2nd elastic wire 67, the clamping member 1, and the puncture part 2 are located in the vicinity of the foramen ovale valve M2, and the whole holding | maintenance part 62 is inserted in the left atrium L side.

  When the main operating rod 7a is further retracted (the amount of retreat is “δ2” in FIG. 16C), the operating force for retreating is caused by the main operating rod 7a by the contact member 68, the tip sleeve body 65, the second elastic wire 67, and the middle. The base end is transmitted to the first elastic wire 66 attached to the main pipe 63 via the sleeve body 64, and the first elastic wire 66 is circularly directed outward in the radial direction as shown in FIG. Deform and project in an arc. However, at this time, the second elastic wire 67 is not deformed.

  As a result, the first elastic wire 66 is deformed while expanding the lip portion of the oval hole O, so that the puncture portion 2 provided in the immediate vicinity of the first elastic wire 66 is moved into the oval hole O. Alignment is performed, and the puncture portion 2 is positioned at the center of the foramen ovale O.

  When the main operating rod 7a is further moved backward and the rear end of the intermediate sleeve body 64 comes into contact with the front end of the main pipe 63 as shown in FIG. 16D, the first elastic wire 66 is not deformed so much, and the front end side. The second elastic wire 67 protrudes and deforms in an arc shape radially outward by an operating force. As a result, as shown in FIG. 13, in the left atrium L, the contact member 68 and the distal sleeve body 65 are curved so as to approach the puncture portion 2. It abuts against the left atrial surface of M2 and holds it.

  In the second lock portion R2 in the lock-unlock mechanism 102, the large diameter portion 106 is pushed into the locking portion 105, which is a wedge-shaped through hole, and the main operation rod 7a is locked. As a result, even if the operator releases the hand from the main operation rod 7a, the holding state is reliably maintained, the holding of the foramen ovale valve M2 is not loosened, and the operator advances the needle operation lever 78 with only one hand. Can be made.

(2) Puncturing step When the needle operating lever 78 is advanced in the direction of the arrow (see FIG. 7), as shown in FIGS. 2 and 3, the puncturing unit 2 protrudes from the distal end of the catheter 30 via the terminal and the operating cord 7c. As shown in FIG. 13, the puncture unit 2 is punctured at a predetermined position of the foramen ovale 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 puncturing unit 2 is moved in the puncturing direction, the hand operating unit 70 displays a display indicating the next moving direction and a number indicating the order of the operation steps from the lower surface as shown in FIG. In this way, it is possible to prevent forgetting to remove the puncture part 2 after puncture, and the reliability and safety of the procedure are improved.

  Since the position of the puncture unit 2 is determined by the positioning holding unit 62, there is no possibility of deviation, and once the puncture unit 2 is punctured, the position of the puncture unit 2 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 75. Thereby, the flat plate part 1a of the clamping member 1 protrudes from the distal end of the catheter 30 via the terminal and the operation cord 7b.

(3) Moving Step of Slide Part 100 At this stage, the push piece 109 is pushed to unlock the second lock part R2 in the lock-unlock mechanism 102 shown in FIGS. 10 and 11, and the main operating rod 7a is locked. Is released, the first elastic wire 66 and the second elastic wire 67 are no longer pressed by the main operating rod 7a and the contact member 68, and the first elastic wire 66 and the second elastic wire 67 are straightened by their own elastic force. It will be in a stretched state.

  When the flat plate portion 1a is positioned to face the atrial septum M1, the slide portion 100 shown in FIG. That is, the push piece 109 is pushed and moved in the arrow direction. Due to the backward movement of the slide portion 100 with respect to the main body portion 75, the connection portion 27 (see FIG. 6) is exposed from the main body portion 75. At this time, the “OK” display portion H8 does not appear in the window 60a. It can be seen that connection to the connection unit 27 cannot be made.

  Due to the retraction of the slide portion 100, the flat plate portion 1a is retracted via the operation cord 7b shown in FIG. 2, and the bent portion 1c of the wire rod portion 1b is affected when it enters the lumen of the tip 50, and the flat plate portion 1a. Is displaced so as to approach the puncture portion 2. By this displacement, the flat plate portion 1a 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. 14, the atrial septum M <b> 1 and the foramen ovale M <b> 2 exist between the clamping member 1 and the puncture unit 2.

(4) Punctured portion burying step After the atrial septum M1 and the foramen ovale M2 are clamped between the clamping member 1 and the puncture unit 2, the guide operation lever 79 shown in FIG. 7 is displayed in the vicinity of the number (4). The needle member of the puncture unit 2 is moved by moving forward in the direction of the arrow. That is, as shown in FIG. 4, since the two needle members of the puncture unit 2 protrude from the lumens L1 and L2 in a state where the guide unit 42 is in contact with the distal tip 50, the needle member circulates the ring of the guide unit 42. It is inserted. From this state, as shown in FIG. 5, when the guide portion operation lever 79 is moved to the distal end side, and the guide portion 42 is moved to the distal end side via the operation cord 7d and the rod 41, the distal end of the needle member is moved. Since it has already expanded, the inner side of the ring of the guide portion 42 presses the side portions of the needle member that are separated from each other, and the two needle members move in the direction of approaching each other. Thereby, as shown in FIGS. 14 and 15, the needle member exposed in the blood on the left atrial side is buried in the living tissue.

  In this state, when the slide part 100 is operated backward, the entire positioning / holding means 60 is recovered into the lumen L5 of the catheter 30 via the main pipe 63. When the “OK” display portion H8 (see FIG. 6) appears in the window 60a, it can be seen that the collection is completed.

  The backward movement of the slide portion 100 is deformed so that the bent portion 1c of the clamping member 1 is brought closer to the puncture portion 2 side by the end portion of the distal tip 50 via the operation cord 7b, as shown in FIG. The septum M1 and the foramen ovale M2 are firmly clamped between the clamping member 1 and the puncture portion 2. On the other hand, in the hand operation unit 70, the terminal attached to the main pipe 63 is also retracted and comes into contact with the contact member, so that electric conduction is possible.

(5) Connection process That is, the retraction of the slide unit 100 at this stage is performed by holding the living tissue M and the contact state between the terminal and the contact member all at once. In addition, since the terminal on the puncture unit 1 side and the contact member are in a state in which electrical conduction is possible first, both the clamping member 1 and the puncture unit 2 are in a state in which electrical energy can be supplied.

  Therefore, since the “OK” display portion H8 appears in the window 60a, the operator knows that the coupler 87 (see FIG. 1) may be connected to the connection portion 27, and the switch SW is activated. The predetermined electrical energy controlled by the control unit 22 is supplied to the clamping member 1 and the puncture unit 2 through the operation cords 7b and 7c, and the atrial septum M1 and the foramen ovale valve M2 are 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 22 controls the output to be low and makes it difficult for thrombus to adhere. Therefore, even if a part of the sandwiching member 1 and the puncture unit 2 is exposed in the blood, the sandwiching member 1 or the puncture unit Although the thrombus can be prevented from adhering to the part 2, the safety can be further improved by burying the needle member located on the left atrial side in the living tissue. That is, by suppressing exposure of the puncture unit 2 to blood, it is possible to suppress thrombus from adhering to the needle member (puncture unit 2) that is an electrode due to application of energy. Since blood clots cause cerebral infarction, myocardial infarction, and the like, the safety of the device can be improved by more reliably suppressing thrombus generation.

(6) Puncture part retraction process When the fusion is completed, the needle operation lever 78 shown in FIG. 8 is retracted according to the indication of the arrow displayed in the vicinity of the number (7), and the puncture part 2 is accommodated in the distal tip 50. To do. Then, when the push button 93 of the connection mechanism 90 is pressed to release the connection between the guiding catheter 31 and the main body 75 and the main body 75 is retracted away from the living body, the device is pulled out using the guiding catheter 31 as a guide. . Thereafter, when the guiding catheter 31 is removed from the living body, the procedure is completed.

Second Embodiment
As shown in FIGS. 17 and 18, the PFO closure device according to the second embodiment is different from the PFO closure device according to the first embodiment only in the structure of the puncture unit moving means 140. Therefore, since the configuration other than the puncture unit moving means 140 is the same as that of the first embodiment, the same reference numerals are given and description thereof is omitted.

  The puncture portion moving means 140 is fixed to the distal end side of the distal tip 50 with respect to the rod 141 that is held so as to be able to advance and retreat in a state where the planar position is regulated by the lumen L6 formed in the distal tip 50. And a guide portion 142. The base end side of the rod 141 is connected to the operation cord 7d, and the guide portion 142 can be moved closer to and away from the distal tip 50 by operating the operation cord 7d.

  The guide portion 142 is a ring-shaped member into which two needle members protruding from the lumens L1 and L2 can be inserted while being separated from the tip 50. In addition, a partition wall 143 that separates the inserted needle member is formed at the center of the ring shape. The thickness of the partition wall 143 in the direction separating the needle members is set to be larger than the separation distance between the lumens L1 and L2. Accordingly, when the two needle members of the puncture unit 2 are protruded from the lumens L1 and L2 with the guide unit 142 away from the distal tip 50, the guide unit 142 is retracted to the proximal end side as shown in FIG. As described above, the partition wall 143 of the guide portion 142 presses the side portions of the needle member that are close to each other, and the two needle members can be moved away from each other. In addition, since the guide part 142 can press the puncture part 2 if there is the partition part 143, it does not necessarily need to be formed in a ring shape through which the needle member is inserted.

  When carrying out the puncture part burying step with the PFO closure device according to the second embodiment, after pinching the atrial septum M1 and the foramen ovale valve M2 between the pinching member 1 and the puncture part 2, By moving the guide portion 142 operating lever 79 to the proximal end side, the partition wall portion 143 of the guide portion 142 presses the side portion of the needle member, and moves the two needle members in directions away from each other. Thereby, as shown in FIG. 20, the needle member exposed in the blood on the left atrial side is buried in the living tissue.

  Thereafter, the tissues of the atrial septum M1 and the foramen ovale valve M2 are fused to each other by a connecting process. At this time, since the exposure of the needle member to the blood is suppressed, as in the first embodiment, the application of energy suppresses the thrombus from adhering to the needle member and improves the safety of the device. be able to. Furthermore, since the two needle members are spread apart, the wide range between the atrial septum M1 and the foramen ovale valve M2 can be melted and fused together.

  Thereafter, in the puncture portion embedment release step, the guide portion 142 operation lever 79 is advanced to release the needle member from the restraint of the guide portion 142, and the needle member of the puncture portion 2 is buried from the state embedded in the living tissue. Open.

  Since steps other than the puncture portion burying step and the puncture portion burying release step are the same as those in the first embodiment, description thereof will be omitted.

  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. Although the embodiment has been described with respect to a treatment used to close a PFO deficiency, the present invention is not limited thereto, and a passage-like deficiency such as a left atrial appendage closure device (Left Atrial Appendage) is not limited. It can also be used when closing or when the living tissue M at a predetermined site is thermally necrotized.

  INDUSTRIAL APPLICATION This invention can be utilized as a medical device which can close the defect | deletion part of a biological tissue safely, suppressing generation | occurrence | production of a thrombus.

1 ... clamping member,
2 ... Puncture part,
20: Electrical energy supply means (thermal energy application means)
30 ... catheter,
40, 140 ... puncture section moving means,
41, 141 ... rod,
42, 142 ... guide part,
143 ... partition wall,
K ... clamping means,
M ... living tissue,
O ... missing.

Claims (6)

A puncture part protruding from the catheter and capable of puncturing the living tissue around the defect;
A clamping member that clamps the living tissue between the puncture unit;
Energy supply means for supplying electric energy for fusing or necrosing the living tissue sandwiched between the puncture unit and the sandwiching member and closing the defect to the puncture unit and the sandwiching member;
The medical device according to claim 1, wherein the puncture unit is movable from a state of protruding from the catheter and puncturing the living tissue in a direction different from the puncture direction.   2. The medical device according to claim 1, wherein the puncture unit has at least two needle members that protrude from the catheter and can be separated from or approached from the state of puncturing the living tissue.   Puncture accommodated in the catheter so that it can be moved forward and backward so that it can be operated from the proximal side of the catheter, and by the forward and backward movement, the side of the protruding puncture part is pressed to move the puncture part in a direction different from the puncture direction The medical device according to claim 1, further comprising a part moving unit.   The medical device according to claim 3, wherein the puncture portion moving means includes a guide portion that contacts and presses a side portion of the protruding puncture portion by advancing and retreating. The puncture portion has at least two needle members that project so as to expand from the catheter and puncture the living tissue,
The medical device according to claim 4, wherein the guide portion presses the side portions of the needle members that are separated from each other in the approaching direction. The puncture portion has at least two needle members that project so as to expand from the catheter and puncture the living tissue,
The said guide part is located between the said needle members, and has a partition part which presses the side part which the said needle member adjoins mutually by the said advance / retreat to the direction which spaces apart, The Claim 4 characterized by the above-mentioned. Medical devices.

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