JP2012200528A - Medical device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical device capable of easily and highly accurately positioning an electrode which can be projected from a catheter to living tissue, and improving safety.SOLUTION: In the medical device, a holding member 20 which is an electrode for applying electric energy to living tissue M is arranged in a catheter 1 so as to move forward and backward. The medical device includes a positioning assisting part 40 which is capable of moving forward and backward to the catheter 1 independent of the holding member 20 and forms a flat holding surface 42 capable of holding the living tissue M with the holding member 20.

Description

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

  Recently, patent foramen ovale (hereinafter referred to as PFO) has been cited as a cardiogenic factor of stroke and migraine. PFO is a symptom that remains even if an foramen ovale that short-circuits the blood in the fetal heart is left and right in an adult, and is said to be possessed by 20-30% of adults.

  The foramen ovale occurs in the secondary septum of the heart (Septum Secundum, hereinafter referred to as the atrial septum). In the normal heart, the pressure in the left atrium exceeds the pressure on the right atrium side, and therefore the primary septum (Septum Prime). However, when the pressure on the right atrium exceeds the pressure on the left atrium during tension (for example, when coughing or stroking), the oval hole valve It opens to the left atrium side, and blood flows from the right atrial side (venous side) to the left atrial side (arterial side). If the blood contains blood clots, the blood clots move from the vein side to the arterial side and flow from the left atrium → left ventricle → aorta → brain, causing a stroke or migraine.

  As a treatment for such a disease, a treatment using a percutaneous catheter procedure is regarded as a desirable method if the same effect as an open heart surgery can be obtained.

  Percutaneous catheter closure devices are used to close defects such as congenital atrial septal defect (ASD), PFO, ventricular septal defect (VSD), and patent ductus arteriosus (PDA) However, conventional devices use a disc-shaped membrane or anchor member that closes the defect to sandwich the foramen ovale and the atrial septum, which are placed in the body.

  The membrane and the anchor member are foreign matters for the body, and blood clots are easily attached. In particular, if a thrombus adheres to the disc-like membrane on the left atrium side, it may flow and cause a stroke, and there is a risk of damaging the thin-walled foramen valve. In addition, these members are not fixed in position in a sandwiched state, and there is a possibility of causing a positional shift.

  For this reason, recently, a PFO closure device has been proposed in which a foramen ovale and an atrial septum are sandwiched between a pair of electrodes, and tissue is joined by applying electrical energy from both electrodes (for example, Patent Document 1). reference). This PFO closure device uses a pair of electrodes, a puncture member and a pinching member, punctures the foramen ovale valve with the puncture member, and then clamps the foramen valve and the atrial septum with the pinching member, Bonding is performed by applying electrical energy to living tissue. By using this device, 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.

  And the clamping member is provided with the flat plate which contact | abuts a biological tissue in the front-end | tip of the wire-shaped wire curved in one direction, and when a wire is drawn in in the lumen | rumen of a catheter and a wire is elastically deformed linearly, The flat plate is pressed against the living tissue.

JP-T 2009-527258

  In the PFO closure device described above, puncture is performed by a puncture member, and further, living tissue is sandwiched between the puncture member that is an electrode and the sandwiching member, and electric energy is applied. Therefore, positioning of the catheter with respect to the biological tissue is important. The catheter has a structure that is easy to rotate around the axis, and it is not easy to pinch the intended position of the living tissue between the puncture member and the pinching member with an operation from the hand.

  The present invention solves the above-described problems, and provides a medical device that can easily and highly accurately position an electrode that can protrude from a catheter (tubular body) with respect to a living tissue, and that can improve safety. The purpose is to provide.

  The medical device of the present invention that achieves the above object is a medical device in which an electrode for applying electrical energy to a living tissue is movably disposed on a cylinder, and the cylinder is independent of the electrode. It has a positioning assisting portion that is formed with a flat holding surface that can move forward and backward with respect to the body and can sandwich the living tissue between the electrodes.

  In the medical device according to the present invention, a flat holding surface capable of sandwiching a living tissue between the electrode and the electrode is formed on the positioning auxiliary portion that can move forward and backward with respect to the cylindrical body independently of the electrode. The tissue can be held by pressing against a flat holding surface with an electrode. For this reason, before applying an electric current to a biological tissue with an electrode, a biological tissue can be hold | maintained and positioned between electrodes using a flat holding | maintenance surface, and an electric current can be carried out to the appropriate position of the biological tissue. Can be applied to improve safety.

  The cylindrical body is disposed so as to be movable forward and backward independently of the electrode, the cylindrical body has a distal end and a proximal end, and the electrode and the positioning assisting portion are disposed at the distal end, If there is a projecting and moving part that can project from the cylindrical body by an operation from the base end side, and the positioning assisting part can move in conjunction with the movement of the projecting moving part, the base end of the cylindrical body The positioning and holding part can be moved independently of the electrode by using the movement of the protruding moving part by the operation from the side.

  The positioning auxiliary portion has a restriction hole portion through which the protruding movement portion passes, and the protruding movement portion sandwiches the restriction hole portion with a separation distance longer than a length of the restriction hole portion in the penetration direction. If there is a pair of restricting portions that cannot pass through the restricting hole portion, the restricting portion can be brought into contact with the positioning assisting portion by the forward and backward movement of the projecting moving portion, and the positioning assisting portion can be moved. Furthermore, the movement of the protrusion moving part and the positioning auxiliary part can be made independent from each other within a range where the restricting part does not reach the restricting hole part.

  If the positioning assisting portion is provided non-rotatably with respect to the cylindrical body, the positioning assisting portion does not rotate when the living tissue is sandwiched between the electrode and the positioning assisting portion, and the electrode is placed with higher accuracy. Can be positioned relative to tissue.

  If an engaging part is formed between the positioning auxiliary part and the cylinder so as to stop the positioning auxiliary part when the positioning auxiliary part protrudes from the cylindrical body by a predetermined length, the positioning auxiliary part is It can project within the specified range.

  The protruding moving part has an elastic protruding part that can elastically protrude in a direction orthogonal to the advancing / retreating direction, and the positioning auxiliary part allows the elastic protruding part to protrude in the orthogonal direction. If it has it, an elastic protrusion part can be protruded in an orthogonal direction via a notch part, and it can contact a biological tissue.

  The living body tissue can be sandwiched between the needle member that punctures the living tissue around the defect existing in the living tissue and the positioning auxiliary part, and the living tissue is between the needle member A medical device that closes a defect by joining the biological tissue by sandwiching the biological tissue with the needle member and the clamping member and applying electric energy, The living tissue can be punctured by the needle member in a state where the living tissue is sandwiched between the positioning assisting portion and the clamping member, and the puncture positional accuracy is improved. Furthermore, the living tissue can be clamped between the needle member punctured with the biological tissue and the clamping member, and a current can be applied between the needle member and the clamping member constituting the electrode to close the defect.

It is a schematic sectional drawing which shows the medical device which concerns on this embodiment. It is a principal part perspective view which shows the medical device which concerns on this embodiment. It is sectional drawing of the catheter front-end | tip part which follows the 3-3 line of FIG. It is a side view which shows the catheter front-end | tip part at the time of making the positioning auxiliary | assistant part protrude. It is a top view which shows the catheter front-end | tip part at the time of making a positioning assistance part protrude. It is sectional drawing of the catheter front-end | tip part which follows the 6-6 line | wire of FIG. It is sectional drawing which shows the catheter front-end | tip part at the time of retracting the positioning assistance part. It is a top view which shows the hand operation part of the medical device which concerns on this embodiment. It is sectional drawing of the hand operation part in alignment with line 9-9 of FIG. It is an expanded sectional view of the hand operation part which follows the 9-9 line of FIG. It is an expanded sectional view of a hand operation part showing when sliding a slide part backward. It is sectional drawing which shows the connection mechanism in alignment with line 12-12 in FIG. It is sectional drawing of the lock-unlock mechanism part in alignment with line 13-13 in FIG. It is sectional drawing which follows the 14-14 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 when a positioning holding means is inserted in an oval hole. It is a cross-sectional schematic diagram at the time of temporarily grasping the atrial septum by a clamping member and a positioning auxiliary part. FIG. 5 is a schematic cross-sectional view when a puncture member is punctured while holding the foramen valve and the atrial septum. It is a top view of the catheter front-end | tip part at the time of separating the clamping member from the atrial septum. It is a top view of the catheter front-end | tip part at the time of accommodating the positioning holding means in a device. FIG. 6 is a schematic cross-sectional view when the foramen ovale valve and the atrial septum are clamped by the puncture member and the clamping member. (A)-(C) are schematic which shows the operation state of a positioning holding means. It is a top view which shows the modification of the medical device which concerns on this embodiment. It is sectional drawing which follows the 27-27 line | wire of FIG. It is sectional drawing which follows the 28-28 line | wire of FIG.

  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.

  The medical device according to an embodiment of the present invention is a PFO closure device and 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 (tubular body) configured by attaching a proximal operation unit 70 to the proximal end of the catheter body 10, and a proximal end that can be connected to the proximal operation unit 70. It has a guiding catheter 3 that can be inserted, and an energy supply means 4 that supplies electrical energy for fusing or necrotizing the living tissue M (a general term 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. 60 (protrusion moving unit) and a positioning auxiliary unit 40 (positioning auxiliary unit) that operates in conjunction with the positioning and holding unit 60 and assists the positioning of the clamping unit K. 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 accommodated 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 20 that directly contacts one side of the atrial septum M1, and a puncture member 30 (needle member) that punctures the foramen ovale valve M2. As shown in FIG. 2, the holding member 20 includes a flat plate-like flat plate portion 21 and a pair of wire rod portions 22 connected to the base end portion of the flat plate portion 21. The planar position is regulated by the lumens L3 and L4 (see FIG. 3) of the tip 11 fixed to the tip. The flat plate portion 21 is located at the distal end of the catheter 1.

  The wire portion 22 extends in the catheter body 10 to the hand operation portion 70 and is connected to a holding member operation lever 122 provided in the hand operation portion 70 in order to operate the holding member 20. The distal end side of the wire portion 22 is formed by bending (or bending) in a direction away from the puncture member 30 in a natural state protruding from the lumens L3 and L4, and by drawing the wire portion 22 into the lumens L3 and L4, The bending is extended and elastically deformed into a shape close to a straight line, and the flat plate portion 21 is moved in a direction approaching the puncture member 30.

  For the wire portion 22, for example, an elastic material such as stainless steel is applied, but it is not particularly limited.

  On the other hand, the puncture member 30 includes two needle portions 31 held in the distal tip 11 and two needle proximal ends provided to extend from the proximal end side of each needle portion 31 to the hand operating portion 70. Part 32. An end portion on the proximal end side of the needle proximal end portion 32 is connected to a needle operation lever 78 provided in the hand operation portion 70 for operating the puncture member 30. The needle part 31 and the needle base end part 32 are integrally formed of the same wire.

  The needle portion 31 is held by two lumens L1 and L2 (see FIG. 3) formed on the distal tip 11 so as to be able to advance and retract. The sharp distal portion is moved forward and backward in the axial direction by the sharp tip portion. 11 can appear and appear.

  The needle portion 31 is formed with a bent portion 33 that is smoothly curved so as to be separated from each other in a natural state where no force is applied from the outside. Note that the bent portion 33 may be formed by bending without being smoothly curved.

  The lumens L1 and L2 formed on the tip 11 are bent toward the outer peripheral surface of the tip 11 in the vicinity of the opening on the tip side. Therefore, the needle part 31 is oriented and protrudes so as to be separated from each other by the lumens L1 and L2.

  The sandwiching member 20 and the puncture member 30 both function as electrode members (heating units). However, the wire portion 22 and the puncture member 30 of the sandwiching member 20 are inserted through the catheter main body 10 and the hand operation unit 70. An input connector 75 provided in the output connector 87, an output connector 87 (see FIG. 1) that is a plug fitted to the input connector 75, a lead wire d connected to the electrode terminal of the output connector 87 (generically d 1 and d 2), and the control unit 5 Are electrically connected to the energy supply means 4. 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 30 that is one electrode member and a clamping member operation lever that operates the clamping member 20 that is the other electrode member. 122, the slide part 100 for operating the positioning and holding means 60, and the operation wire 6 that is operatively inserted into the hand operating part 70 and the catheter body 10 so as to be movable in the axial direction. , Is provided. Further, the hand operating unit 70 includes a gripping unit 7 connected to the base end of the operation wire 6 in order to operate the operation wire 6, and a lock-unlock mechanism that locks / unlocks the sliding movement of the slide unit 100. 102 (see FIG. 13), and a push piece 109 for locking the axial movement of the operation wire 6 and an input connector 75 provided with an electrode terminal connected to the energy supply means 4 for applying thermal energy are provided. It has been.

  A distal end member 68 is provided at the distal end of the operation wire 6, and a grip portion 7 is provided at the proximal end. The material of the operation wire 6 can be, for example, nickel titanium alloy, stainless steel or the like, but is not limited thereto. The material of the tip member 68 can be, for example, nickel titanium alloy, silver brazing, but is not limited thereto. And the breaking strength with respect to the tensile force between the operation wire 6 and the holding part 7 is lower than the breaking strength with respect to the tensile force between the operation wire 6 and the tip member 68. With such a configuration, when the gripping portion 7 is strongly pulled, a breakage occurs between the operation wire 6 and the gripping portion 7 before the tip member 68 falls off from the operation wire 6 in the living body, and safety is ensured. Will improve.

  As shown in FIG. 8, the hand operation unit 70 is provided with various indications on the surface portion for guiding the operator to perform a correct operation so that the steps of various procedures can be visually observed. Part H (generic name for H1 to H5) is provided (see FIG. 15B for process display part H5).

  The process display unit H includes a display unit H1 for a traction process for operating the push piece 109 to pull the operation wire 6, a display unit H2 for a puncture process in which the puncture member 30 punctures a living tissue, and a holding member operation lever 122. The display unit H3 of the slide unit moving process for sliding or moving and holding or releasing the living tissue, the display unit H3 of the positioning process for positioning the device by moving the positioning holding unit 60, and the input connector 75 are connected to the energy supply unit 4. And a display unit H4 for connecting the puncture member 30 to retract the puncture member 30 from the living tissue (see FIG. 15B). The arrows are used to display each process.

  When the needle operation lever 78 is moved in the puncture direction of the puncture member 30 (from the state shown in FIG. 15A to the state shown in FIG. 15B), 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 for operating the puncture member 30 on the upper surface of the main body portion 71. 78 and a clamping member operation lever 122 for operating the clamping member 20 are provided.

  As shown in FIG. 8, 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 slidably provided in the longitudinal direction (see the white arrow). . As shown in FIGS. 9 to 11, the needle operation lever 78 has a bracket 80 that is protruded so as to reach the internal space 76 through a slit (not shown) formed in the main body 71. Further, a terminal 81 to which the proximal end side of the needle proximal end portion 32 is connected is coupled. The terminal 81 is formed with a through hole (not shown) through which the needle base end portion 32 penetrates rotatably. In the needle base end portion 32, connection tips 34 having a diameter larger than the inner diameter of the through hole are fixed to both sides of the through hole of the terminal 81, and the needle base end portion 32 is rotatably connected to the terminal 81. The Therefore, when the needle operating lever 78 is slid along the slit, the terminal 81 slides along the guide groove 82 formed inside the main body 71 as shown in FIG. The needle base end portion 32 is advanced and retracted.

  Moreover, as shown in FIG. 8, the recessed part 121 is formed in the surface side (upper surface side) of the main-body part 71, and the clamping member operation lever 122 is provided here so that sliding is possible in a longitudinal direction. As shown in FIGS. 9 to 10, the holding member operation lever 122 is inserted into a slit (not shown) formed in the main body 71 and protrudes so as to reach the internal space 76 (see FIGS. 9 and 10). And a terminal 83 to which the wire base end portion 25 of the holding member 20 is connected.

  A main pipe 63, 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 63 is connected to the slide portion 100 with an adhesive or the like (see FIG. 13), and slides while being guided by the main body portion 71 according to the slide operation of the slide portion 100.

  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 30 and the electrical system of the clamping member 20 are insulated so as not to conduct.

  The contact members 84 and 85 are connected to both poles of the input connector 75 by conducting wires d3 and d4. When the contact members 84 and 85 come into contact with the terminals 81 and 83 that move with the movement of the needle base end portion 32 and the wire portion 22, the terminal 81, It is structured to retreat while in contact with 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.

  As shown in FIGS. 9 and 10, a conduction assisting portion 86, which is a spring member (elastic member), is provided at the movement end position of the connection tip 34 provided at the needle base end portion 32. As a result, the connection chip 34 is pressed against the terminal 81. That is, by connecting the needle base end portion 32 to the terminal 81 so as to be rotatable, there is a possibility that the current flow between the terminal 81 and the needle base end portion 32 may become unstable. Since the rotatable connection chip 34 is pressed against the terminal 81, the contact resistance between the terminal 81 and the connection chip 34 can be reduced, and the current flow can be stabilized. The spring member has a contact range of a certain length with the terminal 81, and can come into 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 6 is provided in the main pipe 63 and 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 operation wire 6 can be rotated 360 degrees, the tip of the operation wire 6 can be inserted to 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. Can directly connect the guiding catheter 3 having the flange portion to the main body portion 71.

  A connection hole 74 corresponding to the outer shape of the output connector 87 is provided at the proximal end portion of the main body 71, and the electrode terminal of the input connector 75 is disposed inside the connection hole 74 (FIG. 8). reference).

  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. 10) is formed in a part of the side of the guide bar 88A. When the guide bar 88A and the main pipe 63 are retracted with respect to the main body 71 together with the slide 100, FIG. As shown, the notch 89 coincides with the connection hole 74 so that the output connector 87 can be connected to the input connector 75.

  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. 8, 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. 10) 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 60 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 displayed in the window so that the number indicated on the guide bar 88A is counted down. When the terminal 83 that allows the holding member 20 to conduct is brought into contact with the contact member 85, the “OK” display portion H6 finally appears in the window 73.

  A lock-unlock mechanism 102 shown in FIGS. 13 and 14 is provided on the slide unit 100, and the slide movement of the slide unit 100 is locked-unlocked by pressing the push piece 109 and the operation wire 6 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 and holding means 60, which will be described later, provided at the distal end portion of the operation wire 6 holds or positions the living tissue M, the operation wire first that temporarily stops the advance / retreat operation of the operation wire 6 in the axial direction. 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. Reference numeral “107” in FIGS. 13 and 14 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. 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, so the long operation wire 6 is connected from the left atrial side. The pulling operation and the operation of making the operation wire 6 straight to pull out the operation wire 6 can be linked, and the pulling operation in a state where the operation wire 6 that may damage the living tissue M is curved. Can be prevented, and the situation where the living tissue M is damaged or broken can be prevented.

  On the other hand, the second lock portion R2 for the operation wire 6 includes a locking portion 105 formed on the operating member 104 and a large-diameter portion 106 that is fixed to the operation wire 6 and larger than the outer diameter of the operation wire 6. It is configured. As the material of the large diameter portion 106, for example, a stainless pipe or the like can be applied. The large-diameter portion 106 is fixed to the operation wire 6 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, and a locking portion 105 provided on the operating member 104 in order to temporarily stop the advance / retreat operation of the operation wire 6 in the axial direction. It is a through hole. By using the wedge-shaped through hole in this manner, the large-diameter portion 106 can be pinched more simply by moving the operation wire 6 through the through-hole.

  When performing a procedure, the living tissue M is held and positioned by the positioning and holding means 60 and then the puncture operation is performed by the puncture member 30. The living tissue M is held and positioned by pulling the operation wire 6. Even if the operation tissue 6 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 operation wire 6 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 6 Thus, even when the hand holding the operation wire 6 is released, the holding state and the positioning state can be maintained, and only the puncture operation by the puncture member 30 can be performed alone.

  When the lock is released, the tip of the operation wire 6 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.

  In the internal passage through which the operation wire 6 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 6, the operation wire 6 can be pulled until the large-diameter portion 106 fixed to the operation wire 6 reaches the movement restriction hole 108. 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 60 generally holds a positioning portion 61 for positioning the puncture member 30 with respect to the oval hole O, and holds the oval hole valve M2 so as not to be retractable with respect to the puncture direction of the puncture member 30. The holding portion 62 is normally housed in the guiding catheter 3, but when used, it is pushed out of the guiding catheter 3 by operating the operation wire 6 and the main tube 63 as shown in the figure. That is, the positioning and holding means 60 is disposed inside the catheter 1 so as to be able to advance and retract independently of the flat plate portion 21 that is an electrode, and is advanced and retracted by an operation by the proximal operation portion 70 on the proximal end side of the catheter 1. It is possible.

  More specifically, the central lumen L5 formed in the catheter body 10 is provided with a main tube 63 and an operation wire 6 provided in the main tube 63 so as to be movable forward and backward in the axial direction (see FIG. 3). . The main pipe 63 is fixedly held on the slide portion 100 at the base 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 holding means 60. Is also drawn into the catheter body 10. The operation wire 6 protrudes from the rear end from the distal end of the catheter body 10 through the main pipe 63 and through the internal passage of the slide portion 100. To the proximal end portion of the operation wire 6, a grasping portion 7 is connected for the operator to grasp with the finger in order to move the operation wire 6 back and forth or rotate.

  A positioning portion 61 of the positioning holding means 60 is provided at the distal end portion of the main pipe 63. The positioning part 61 positions the puncture member 30 with respect to the foramen ovale O and, as shown in FIG. 2, a pair of first elastic wire members 66 (elastic protrusions) that are expanded and contracted by operation of the operation wire 6. ). The proximal end of the first elastic wire 66 is attached to the outer surface of the main pipe 63, and the distal end is attached to the proximal end side of the intermediate sleeve body 64 through which the operation wire 6 is inserted.

  The positioning portion 61 displaces the first elastic wire 66 outward with the base end attached to the main pipe 63 as a fulcrum by an operation of moving the operation wire 6 in the axial direction, and each first elastic wire 66 is moved into the oval hole O. The inner edge is pressed with substantially equal elastic force, and the puncture member 30 is aligned with the foramen ovale O (see FIG. 25). That is, the function of locating the puncture member 30 located between the first elastic wires 66 in the center of the foramen ova O is exhibited.

  On the other hand, the holding part 62 is provided from the back side so that the puncture member 30 can easily puncture the foramen ovale valve M2, and is provided at the distal end of the operation wire 6 as shown in FIGS. The distal end member 68, the distal end sleeve body 65, and a pair of second elastic wires 67 that connect the intermediate sleeve body 64 and the distal end sleeve body 65 are provided. The distal end member 68 is fixed to the distal end of the operation wire 6, the distal end sleeve body 65 and the intermediate sleeve body 64 are inserted into the operation wire 6, and the second elastic wire 67 is fixed at the proximal end to the distal end of the intermediate sleeve body 64. The distal end side is fixed to the distal end sleeve body 65.

  A first restricting portion that has an outer diameter larger than the inner diameter of the restricting hole portion 41 that is a through hole formed in the positioning assisting portion 40 and cannot be inserted through the restricting hole portion 41 at the substantially leading end portion of the leading end sleeve body 65. 65A is formed. Further, a second restricting portion 64 </ b> A that has an outer diameter larger than the inner diameter of the restricting hole portion 41 and cannot be inserted through the restricting hole portion 41 is formed at a substantially central portion of the intermediate sleeve body 64. The positioning and holding means 60 penetrates the restriction hole 41 of the positioning assisting part 40, and the first restriction part 65A and the second restriction part 64A are positioned so as to sandwich the restriction hole part 41. As shown in FIGS. 5 and 6, the first restricting portion 65 </ b> A and the second restricting portion 64 </ b> A have a separation distance X that is farthest away from the penetration distance Y in the penetration direction of the restriction hole 41. Accordingly, the positioning and holding means 60 is movable relative to the positioning assisting portion 40 within the range of the length of the separation distance X. Therefore, not only can the positioning assisting part 40 be moved in conjunction with the forward / backward movement independent of the flat plate part 21 of the positioning / holding means 60, but also the positioning / holding means 60 and the positioning assisting part 40 can be moved within a certain range. Can be made independent of each other.

  The intermediate sleeve body 64, the tip sleeve body 65, the second elastic wire 67 connecting the sleeve bodies 64 and 65, and the tip member 68 constitute a bending mechanism W that bends or curves the tip portion of the operation wire 6. .

  The bending mechanism W is used to hold the foramen ovale valve M2. When the puncture member 30 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 distal end member 68 and the distal end side of the first elastic wire 66 by retracting the operation wire 6 in the axial direction. 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 operation wire 6 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 member 30 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 portion 100 is advanced and retracted with respect to the main body portion 71, the main tube 63 fixed to the slide portion 100 can be drawn into the central lumen L5 of the catheter main body 10, and the positioning and holding means 60 is accordingly moved to the catheter main body. 10 can be recovered.

  As shown in FIGS. 4 to 7, the positioning assisting portion 40 is located at the distal end of the catheter 1 and accommodated in the auxiliary plate accommodating portion 12 that is a space formed inside the distal tip 11 so as to be slidable toward the distal end side. Is done. The positioning auxiliary portion 40 is non-rotatable with respect to the central axis of the tip 11. The positioning assisting portion 40 is formed with a flat holding surface 42 so as to face the holding member 20 when protruding from the distal tip 11, and the atrial septum M <b> 1 is formed between the holding surface 42 and the holding member 20. It is possible to hold between. The term “flat” as used herein is not limited to a complete flat surface. For example, even if a convex portion or a concave portion is formed on the surface, it can be referred to as “flat” if the surface can contact the atrial septum M1. It is included in

  The positioning assisting portion 40 is formed with a slit-shaped cut portion 43 so as to be cut from the proximal end side toward the distal end side. The notch 43 communicates with the restriction hole 41 and allows the intermediate sleeve body 64 and the main pipe 63 to enter from the base end side. The first elastic wire 66 (elastic protrusion) provided between the intermediate sleeve body 64 and the main pipe 63 can be moved in the advancing / retreating direction of the positioning / holding means 60 by the notch 43, and It is possible to project in a direction Z (see FIGS. 3 and 6) orthogonal to the advancing / retreating direction. The distal tip 11 is also formed with a distal cut portion 13 so as to be cut from the distal end side to the proximal end side so that the cut portion 43 and the distal cut portion 13 overlap each other.

  Engaging protrusions 44 are formed on the base end sides of both surfaces including the holding surface 42 of the positioning auxiliary part 40, and the engaging protrusions are formed on the auxiliary plate housing part 12 of the tip chip 11. An engaging groove portion 14 is formed which can be slid by fitting 44. For this reason, the positioning assisting portion 40 can move forward and backward as long as the engaging protrusion 44 is within the range of the engaging groove portion 14, but when it moves to the distal end side, the engaging protrusion 44 finally engages. At the end of the groove portion 14 on the front end side (see FIGS. 4 to 6), further movement is restricted. Further, when the positioning assisting portion 40 moves to the proximal end side, the engagement protruding portion 44 finally comes into contact with the end of the engagement groove portion 14 on the proximal end side (see FIG. 7), and further movement is restricted. Thus, the engagement protrusion 44 and the engagement groove 14 function as engagement portions that engage with each other. In addition, although the engagement protrusion part 44 is provided in both surfaces of the positioning auxiliary | assistant part 40, and the two engagement groove parts 14 are also provided corresponding to it, you may provide in only one side. Further, the engagement protrusion 44 and the engagement groove 14 are not provided one on each surface, but a plurality of engagement protrusions 44 and engagement grooves 14 may be provided on each surface. Moreover, the engagement protrusion part 44 may be formed in the side surface of the positioning auxiliary | assistant part 40, and the two engagement groove parts 14 may be provided corresponding to it.

  In addition, it is necessary to set the magnitude | size according to the material applied so that the engagement protrusion part 44 may not be damaged. The positioning assisting part 40 is preferably formed of a metal material such as stainless steel, for example. In this case, even if the engagement protrusion 44 is made small, the rigidity can be kept high, and the miniaturization becomes easy. In addition, the material of the positioning auxiliary | assistant part 40 is not limited to a metal material, For example, you may form with resin.

  Next, the operation of this embodiment will be described.

(1) Pre-process The operator inserts an introducer (an assembly in which a dilator is inserted into a 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.

  Next, 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 moved backward with respect to the main body portion 71, the intermediate sleeve body 64 and the distal end sleeve body 65 move to the proximal end side together with the main pipe 63 fixed to the slide portion 100, as shown in FIG. At this time, since the first restricting portion 65A formed in the distal end sleeve body 65 cannot pass through the restricting hole portion 41 of the positioning assisting portion 40, the first restricting portion 65A pushes the positioning assisting portion 40 toward the proximal end side, thereby positioning. The auxiliary part 40 is accommodated in the auxiliary plate accommodating part 12.

  Further, when the needle operation lever 78 and the holding member operation lever 122 are also retracted, the wire portion 22 and the puncture member 30 of the holding member 20 are accommodated in the catheter 1. 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 main pipe 63 is moved forward, the push piece 109 of the lock-unlock mechanism 102 is pressed, and the large diameter portion 106 of the operation wire 6 is inserted into the narrow width portion G2 of the through hole 105 formed in the operation member 104. Is not hit, that is, the second lock portion R2 is unlocked, and the operation wire 6 is free.

  Then, by moving the main pipe 63 forward, as shown in FIG. 25 (A), when the intermediate sleeve body 64 is also moved to the distal end side, the second restricting portion 64A formed on the intermediate sleeve body 64 becomes the restriction hole. Since it cannot pass through the portion 41, the second restricting portion 64A pushes the positioning assisting portion 40 toward the distal end side. And since the engagement protrusion part 44 and the engagement groove part 14 which are engagement parts are provided between the positioning auxiliary | assistant part 40 which moves to the front end side, and the front-end | tip tip 11, the positioning auxiliary | assistant part 40 is predetermined length. When it moves, the engagement protrusion 44 reaches the end of the engagement groove 14, and further movement is restricted. In FIG. 25, the description of the clamping member 20 and the puncture member 30 is omitted in order to explain the operations of the positioning assisting section 40 and the positioning holding means 60.

  Then, the distal end of the operation wire 6 protrudes from the distal end sleeve body 65 from the distal end of the main tube 63 and is inserted into the pulmonary vein. This protruding state can be visually recognized from the outside since the tip member 68 is provided with an X-ray opaque marker. Since the operation wire 6 can rotate 360 degrees, the operation wire 6 can be advanced while rotating, and can be easily inserted into the pulmonary vein.

  With the operation wire 6 inserted into the pulmonary vein, the hand operation unit 70 is pulled until the distal tip 11 reaches the right atrium R as shown in FIG. At this time, the distal ends of the operation wire 6 and the positioning and holding means 60 are inserted into the left atrium L.

  Thereafter, the holding member operation lever 122 is operated to move the wire portion 22 to the distal end side. Thereby, the wire part 22 is protruded from the lumens L3 and L4. Thereby, the flat plate part 21 will be in the state which left | separated from the atrial septum M1.

(2) Operation wire pulling step In the pulling step, the operator pulls the gripping portion 7 until the distal end member 68 at the distal end of the operation wire 6 contacts the distal end sleeve body 65 after confirming the distal end position of the operation wire 6. Then, the operation wire 6 is retracted.

  When the operation wire 6 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, since the operation wire 6 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 6 makes the pulling operation smooth. Can be done. And the main-body part 71 is operated, the 2nd elastic wire 67, the clamping member 20, and the puncture member 30 are located in the vicinity of the foramen ovale valve M2, and it is set as the state which inserted the holding | maintenance part 62 to the left atrium L side.

  When the operation wire 6 is further retracted, the operation force for retracting the operation wire 6 causes the proximal end to move to the main pipe 63 via the distal end member 68, the distal end sleeve body 65, the second elastic wire 67, and the intermediate sleeve body 64. The first elastic wire 66 is transmitted to the attached first elastic wire 66, and as shown in FIG. 25 (B), the first elastic wire 66 protrudes and deforms in an arc shape toward the orthogonal direction Z that is radially outward. However, at this time, the second elastic wire 67 is not deformed. At this time, although the intermediate sleeve body 64 is retracted, the positioning assisting portion 40 is not retracted and is maintained in a protruding state because the first restricting portion 65A of the tip sleeve body 65 is separated from the restricting hole portion 41. And since the notch part 43 and the tip notch part 13 are formed in the positioning auxiliary | assistant part 40 and the tip chip | tip 11, the 1st elastic wire 66 is outward from the notch part 43 and the tip notch part 13. FIG. Further, the first elastic wire 66 can be moved in the forward / backward movement direction. In addition, as a method of causing the first elastic wire 66 to protrude in the orthogonal direction Z, not only the position of the main pipe 63 is fixed and the intermediate sleeve body 64 is retracted, but the movement toward the distal end side is restricted by the second restricting portion 64A. The first elastic wire 66 can be protruded in the orthogonal direction Z by moving the main pipe 63 toward the distal end side with respect to the intermediate sleeve body 64 that is formed.

  As a result, the first elastic wire 66 is deformed while expanding the lip portion of the oval hole O. Therefore, the puncture member 30 provided in the immediate vicinity of the first elastic wire 66 is moved into the oval hole O. Alignment is performed, and the puncture member 30 is positioned at the center of the foramen ovale O.

  When the operation wire 6 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. 25C, the first elastic wire 66 is not deformed so much and The second elastic wire 67 projects and deforms in an arc shape outwardly in the radial direction by an operating force. As a result, as shown in FIG. 19, in the left atrium L, the distal end member 68 and the distal end sleeve body 65 are curved so as to approach the puncture member 30. The foramen ovale valve M2 is held between the positioning assisting portion 40 or the portion that protrudes from the positioning assisting portion 40 of the positioning and holding means 60 in contact with the left atrial surface of M2. And the holding surface 42 of the positioning auxiliary | assistant part 40 is pressed against the atrial septum M1 with the oval hole valve M2 held.

  Next, in the second lock portion R2 in the lock-unlock mechanism 102 shown in FIGS. 13 and 14, the large-diameter portion 106 is pushed into the locking portion 105 that is a wedge-shaped through hole, and the operation wire 6 is locked. As a result, even if the operator releases the hand from the grasping portion 7, 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. It becomes possible.

  In the step of pulling the operation wire 6, when the operator pulls the grasping portion 7 too strongly, the breaking strength between the operation wire 6 and the grasping portion 7 is the breakage between the operation wire 6 and the tip member 68. Since the strength is lower than the strength, the grip portion 7 is broken from the operation wire 6 before the tip member 68 is broken from the operation wire 6. For this reason, the tip member 68 is prevented from falling off the operation wire 6. Even if the gripping portion 7 is not broken from the operation wire 6, if the operation wire 6 is pulled more than necessary, the large-diameter portion 106 fixed to the operation wire 6 becomes a movement restriction hole of the slide portion 100. 108 is reached. Since the large-diameter portion 106 cannot pass through the movement restricting hole 108, the operation wire 6 cannot be pulled any further, and the increase in tensile force between the operation wire 6 and the tip member 68 is restricted, and the tip member It is suppressed that 68 falls off from the operation wire 6. FIG.

(3) Temporary gripping step In the temporary gripping step, the clamping member operation lever 122 is operated so as to be pulled into the lumens L3 and L4 by a predetermined length from the state in which the wire portion 22 protrudes from the lumens L3 and L4. As a result, as shown in FIG. 20, the bending of the wire portion 22 is extended and elastically deformed into a shape close to a straight line, and the flat plate portion 21 comes into close contact with the atrial septum M1. By this operation, the atrial septum M <b> 1 is sandwiched between the flat plate portion 21 and the holding surface 42 of the positioning assisting portion 40 to perform temporary grasping. By this temporary grasping, the rotational direction position of the catheter 1 that is easy to rotate around the axis is corrected, and the catheter 1 is positioned at an appropriate rotational direction position with respect to the atrial septum M1. Thereby, it becomes possible to perform the puncture and heating of the living tissue M performed thereafter at an intended appropriate position.

  Since the advancement / retraction of the positioning assisting part 40 is independent of the advancement / retraction of the flat plate part 21 which is an electrode, the positioning assisting part 40 moves to the proximal end side even if the flat plate part 21 moves to the proximal end side. do not do. Therefore, it is possible to avoid that the atrial septum M1, which is a living tissue to be sandwiched, other tissues, a thrombus, or the like is dragged into the distal tip 11 together with the positioning auxiliary unit 40.

  Further, for example, when the atrial septum M1 is temporarily gripped between the intermediate sleeve body 64 or the main tube 63 of the positioning holding means 60 and the flat plate portion 21 without providing the positioning auxiliary portion 40, the pressing force of the flat plate portion 21 causes The positioning and holding means 60 is easy to bend and it is difficult to pinch the atrial septum M1 with a desired force. However, the positioning auxiliary means 40 is provided in addition to the positioning and holding means 60, so that the strength is improved and the bending is suppressed. Thus, the atrial septum M1 can be held with a desired force.

  In addition, since the positioning assisting part 40 is provided non-rotatably with respect to the distal tip 11, the positioning assisting part 40 does not rotate during temporary gripping, and the temporary gripping can be performed satisfactorily.

  Further, since the atrial septum M1 is gripped between the plane of the flat plate portion 21 and the holding plane 42, that is, between the planes, the catheter 1 can be positioned with high accuracy with respect to the atrial septum M1.

(4) Puncturing step When the needle operating lever 78 is advanced in the direction of the arrow (see FIG. 15), the needle portion 31 of the puncturing member 30 protrudes from the distal end of the catheter body 10, and as shown in FIG. The needle portion 31 is punctured at a predetermined position. At this time, since the bending portion 33 is formed in the needle portion 31 and the lumens L1 and L2 are also curved, the two needle portions 31 protrude while expanding outward (FIG. 2). reference). Therefore, puncture can be performed while holding the living tissue so as not to be retracted, the puncture property is high, and the two needle portions 31 protrude in a wide range, and the biological tissue M can be held in a wide range. Further, since the distal end portion of the needle portion 31 is bent in a smooth arc shape in a natural state, the needle portion 31 comes into contact with the foramen ovale valve M2 at a more vertical angle (the angle at which it has occurred), and reliable puncture is possible. .

  When puncturing, the atrial septum M1 is temporarily grasped between the flat plate portion 21 and the positioning assisting portion 40, so that the rotational position of the distal end portion of the catheter 1 is an appropriate position with respect to the living tissue M. Furthermore, since the foramen ovale valve M2 is held by the positioning and holding means 60, the needle portion 31 can be punctured at an appropriate position of the ovus hole valve M2. For this reason, the needle part 31 can be prevented from being punctured to a site where puncture is not desirable, such as the atrial septum M1 and the artery M3. Furthermore, since the needle portion 31 can be punctured at an appropriate position, for example, the first elastic wire 66 or the second elastic wire 67 that is twisted by the rotation of the catheter 1 interferes with the protruding needle portion 31, and the needle portion 31 or The possibility of difficulty in collecting the positioning and holding means 60 can also be suppressed. In particular, in the present embodiment, since the first elastic wire 66 protrudes through the notch 43 of the positioning assisting part 40, the direction of the first elastic wire 66 is defined by the notch 43 and the first elastic wire. 66 is suppressed, and interference between the needle portion 31 and the positioning and holding means 60 can be suppressed more reliably.

  Once the puncture member 30 is punctured, the position of the puncture member 30 is a fixed position in relation to the foramen ovale valve M2. Therefore, the surgeon can carry out the process after the puncture operation very easily.

  When the puncture member 30 is moved in the puncturing direction, as shown in FIG. 15 (B), the hand operating unit 70 displays from the bottom surface the direction of the next movement and a number indicating the order of the operation steps.

  When the puncturing is completed, the holding member operation lever 122 is operated to move the wire portion 22 to the distal end side. Thereby, as shown in FIG. 22, the wire portion 22 protrudes from the lumens L3 and L4, the elastic deformation of the wire portion 22 is eliminated, and the flat plate portion 21 is separated from the atrial septum M1. At this time, since the clamping member 20 can be operated independently of the positioning assisting part 40 and the like by the clamping member operating lever 122, the positioning can be performed even if an operation of separating the flat plate part 21 from the living tissue M is performed. Other parts such as the auxiliary unit 40 do not move in conjunction with each other. For this reason, even if the operation of moving the flat plate portion 21 away from the living tissue M by the holding member operation lever 122 is performed, the positioning holding means 60 or the like does not move carelessly and the positioning position of the foramen ovale valve M2 remains appropriate. Can be maintained.

  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 30 and the input connector 75 are in an electrically conductive state (FIG. 11). reference).

  Further, in the hand operation unit 70, the terminal 81 attached to the needle operation lever 78 advances and the connection tip 34 fixed to the needle base end portion 32 contacts the conduction assisting portion 86, and the connection tip 34 assists the conduction. The portion 86 is pressed against the terminal 81. Thereby, the contact resistance between the rotatable connection chip 34 and the terminal 81 is reduced, and the current flow when applying electric energy is stabilized.

(5) Moving Step of Slide Part When the flat plate part 21 comes to 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.

  At this stage, in order to unlock the second lock portion R2 in the lock-unlock mechanism 102 shown in FIGS. 13 and 14, if the push piece 109 is pushed and the operation wire 6 is unlocked, the operation wire 6 and the tip The first elastic wire 66 and the second elastic wire 67 are no longer pressed by the member 68, and the first elastic wire 66 and the second elastic wire 67 are stretched straight by their own elastic force. In this state, when the slide unit 100 is retracted as shown in FIG. 16, the positioning and holding means 60 is collected into the lumen L5 of the catheter body 10 via the main tube 63 as shown in FIG. When the main pipe 63 moves to the proximal end side, the first restricting portion 65A formed in the distal end sleeve body 65 cannot pass through the restricting hole portion 41 of the positioning assisting portion 40. Therefore, the first restricting portion 65A is positioned in the positioning assisting portion 40. Is pushed to the proximal end side, and the positioning auxiliary portion 40 is accommodated in the auxiliary plate accommodating portion 12 (see FIG. 7).

Then, as shown in FIG. 16B, when the “OK” display portion H6 appears in the window 73, it can be seen that the collection is completed. Further, the notch 89 of the guide bar 88A coincides with the connection hole 74, so that the output connector 87 can be connected to the input connector 75 for the first time.
(6) Holding process Next, when the holding member operation lever 122 is operated and the wire portion 22 is pulled back into the lumens L3 and L4, the bending of the wire portion 22 extends and is close to a straight line as shown in FIG. By being elastically deformed into a shape, the flat plate portion 21 approaches the needle portion 31 and comes into contact with the atrial septum M1. And the flat plate part 21 contact | abuts to the atrial septum M1 with an elastic force stronger than the pressing force of temporary holding in a temporary holding process. Thereby, between the needle part 31 and the flat plate part 21, the atrial septum M1 and the foramen ovale valve M2 are favorably clamped.

  On the other hand, in the hand operation section 70, the terminal 83 attached to the holding member operation lever 122 also moves backward to contact the contact member 85, and the holding member 20 and the input connector 75 are in an electrically conductive state.

(7) Connection process At this stage, since the terminal 81 on the puncture member 30 side and the contact member 84 are in an electrically conductive state first, both the clamping member 20 and the puncture member 30 can supply electric energy. It becomes a state.

  Then, as shown in FIG. 17, 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 clamping member 20 and the puncture member 30, and the atrial septum M1 and the foramen ovale M2 are heated. At this time, since the pinching member 20 and the puncture member 30 are in the proper positions intended with respect to the living tissue M by the temporary grasping process performed previously, the proper positions of the atrial septum M1 and the foramen ovale valve M2 Can be heated, and heating of an undesirable part can be suppressed.

  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 thrombus to adhere. Thrombus can be prevented from adhering to the member 30.

(8) Puncture part retraction process When the fusion is completed, the needle operating lever 78 shown in FIG. 17 is retracted to the state shown in FIG. 18, and the puncture member 30 is accommodated in the distal tip 11. As a result, the terminal 81 that moves together with the needle operating lever 78 is separated from the contact member 84 (see FIG. 9), 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. Before the puncture member 30 is retracted, the clamping member operation lever 122 may be advanced to project the wire portion 22 from the lumens L3 and L4, and the flat plate portion 21 may be separated from the atrial septum M1. In this case, after the puncture member 30 is retracted, the holding member operation lever 122 is retracted to accommodate the wire portion 22 in the lumens L3 and L4 again.

  Thereafter, the push button 93 of the connecting mechanism 90 is pressed to release the connection between the Y connector 72 and the main body 71, thereby releasing the connection between the guiding catheter 3 and the main body 71, and separating the main body 71 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.

  Note that the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, in the present embodiment, the treatment used to close the PFO defect has been described. However, the present invention is not limited to this, and a passage-like defect such as a left atrial appendage closure device (Left Atrial Appendage) is closed. It can also be used when performing or when the living tissue M at a predetermined site is thermally necrotized.

  In addition, as in the modified example of the medical device shown in FIGS. 26 to 28, the engagement protrusion 15 may be provided in the distal tip 11, and the engagement groove 46 may be provided in the positioning auxiliary portion 40. In the modification, two engagement groove portions 46 are formed on the opposite surface 45 of the holding surface 42, and two engagement protrusions 15 that are fitted in the two engagement groove portions 46 are formed on the tip chip 11. The In this way, the positioning assisting portion 40 and the tip tip 11 can be slidably engaged without forming the engaging groove portion 46 in the holding surface 42. The engaging groove 46 may be formed on the holding surface 42 or may be formed on both surfaces of the holding surface 42 and the opposite surface 45.

  Further, the member that moves the positioning assisting part 40 may not necessarily be the positioning and holding means 60, and may be a separate member that protrudes from the catheter body 10, for example.

  Further, the positioning assisting part 40 does not necessarily have to be provided with the notch part 43.

  In addition, if the restriction hole 41 formed in the positioning assisting part 40 can not pass through the first restriction part 65A and the second restriction part 64A, for example, a slit-like shape opened laterally perpendicular to the penetration direction. It may be a hole.

1 catheter (cylinder),
10 catheter body,
11 Tip,
14, 46 engagement groove (engagement portion),
15, 44 engagement protrusion (engagement portion),
20 clamping member (electrode),
30 Puncture member (needle member, electrode),
40 positioning aid,
41 restriction hole,
42 holding surface,
43 notch,
44 engaging protrusion,
60 positioning holding means (protrusion moving part),
64A 1st regulation part,
65A 2nd regulation part,
66 1st elastic wire (elastic protrusion part),
L1-L5 lumens,
M biological tissue,
M1 Atrial septum,
M2 follicle valve,
M3 artery,
O deficiency,
X separation distance,
Y penetration distance,
Z Orthogonal direction.

Claims (7)

A medical device in which an electrode for applying electrical energy to living tissue is disposed on a cylindrical body so as to be movable back and forth,
A medical device having a positioning auxiliary portion that is capable of moving back and forth with respect to the cylindrical body independently of an electrode and having a flat holding surface capable of sandwiching the living tissue between the electrode and the electrode. The cylindrical body is disposed so as to be movable forward and backward independently of the electrode, the cylindrical body has a distal end and a proximal end, and the electrode and the positioning assisting portion are disposed at the distal end, Further having a projecting moving part that can project from the cylindrical body by an operation from the base end side of
The medical device according to claim 1, wherein the positioning assisting part is movable in conjunction with the movement of the protruding moving part. The positioning auxiliary part has a restriction hole part through which the protruding moving part passes,
The projecting and moving part is provided so as to sandwich the restriction hole part with a separation distance longer than the length of the restriction hole part in the penetrating direction, and has a pair of restriction parts that cannot pass through the restriction hole part. The medical device according to claim 2.   The medical device according to any one of claims 1 to 3, wherein the positioning auxiliary portion is provided non-rotatably with respect to the cylindrical body.   An engaging portion is formed between the positioning assisting portion and the cylinder so as to engage the positioning assisting portion so as to stop the projection when the positioning assisting portion protrudes a predetermined length from the cylinder. The medical device according to any one of the above. The protruding moving part has an elastic protruding part that can elastically protrude in a direction orthogonal to the advancing / retreating direction,
4. The medical device according to claim 2, wherein the positioning assisting portion has a cut portion that enables movement of the elastic protrusion in the orthogonal direction. 5. The electrode is
A needle member that punctures a living tissue around a defect present in the living tissue;
A holding member that can hold the living tissue between the positioning auxiliary portion and the needle member and the holding member.
The medical device according to any one of claims 1 to 6, wherein the living tissue is sandwiched by the needle member and the sandwiching member and electrical energy is applied to join the living tissue and close the defect.