JP2009050586A - Pfo closing device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a PFO (patent foramen ovale) closing device simplifying the configuration of a hand operation part, making electricity flow to a desired part at a desired point of time without making the electricity flow to unneeded parts, and smoothly, safely and surely performing the technique. <P>SOLUTION: Operation levers 76a and 76b for operating a puncture part and a clamping member and an electric energy supply means are freely detachably connected so as to supply electric energy to clamped body tissue while keeping the state after performing the operation of the puncture part of puncturing and pulling out the puncture part to/from the valve of foramen ovale, which is the main technique. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a PFO closure device for closing a defect generated in a living body.

  Recently, patent foramen Ovale (PFO) has been cited as a cardiogenic factor for 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 in the right atrium, so the primary septum (Septum Primum 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 described in Patent Document 1 has been proposed. This PFO closure device joins tissues by inserting the foramen ovale from the right atrium to the left atrium, pulling the oval valve close to the foramen oval, and applying electrical energy. is there. However, not only the size of the foramen ovale, the foramen ovale valve and the atrial septum, but also the thickness, shape, etc., vary from person to person. Also, when performing a procedure, it may be difficult to always reliably attract various forms of the foramen valve to the foramen.

  In view of this, a PFO closure device has been proposed in which a foramen ovale valve and an atrial septum are sandwiched between a pair of electrodes and tissue is joined by applying electrical energy from both electrodes (see Patent Document 2 below). This PFO closure device uses a pinching means, one of which is a puncture part composed of a needle electrode, and the other is a clamping member that clamps the foramen valve and the atrial septum between the puncture part. After puncturing the foramen valve, the oval hole valve and the atrial septum are sandwiched between a pinching member as the other electrode, and electrical energy is applied to the living tissue for bonding. 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.

However, when operating this device, there are cables for supplying electrical energy and thin and long linear members for remotely controlling the clamping means at the hand operating part. Since there are various operation means, there is a risk of erroneous operation. In particular, when electric energy is applied and fused after sandwiching tissue, if electric energy is always applied, electricity may flow not only to a desired site but also to an unnecessary site, and the temperature of a puncture site, etc. There is also a risk of blood clots adhering to the rise.
WO2004 / 086944 A2 (see summary, FIG. 10 etc.) Japanese Patent Application No. 2006-47636 (Summary, see FIG. 10 etc.)

  The present invention has been made in order to solve the above-described problem. The present invention simplifies the configuration of the hand operation unit, and allows electricity to flow to a desired site at a desired time without flowing electricity to an unnecessary site. An object of the present invention is to provide a PFO closure device that can perform a procedure smoothly, safely and reliably.

  The PFO closure device of the present invention that achieves the above-mentioned object performs an operation to puncture or withdraw the puncture portion of the oval hole valve, which is the main procedure, and then keeps this state while the electric energy is applied to the clamped living tissue. The electric energy is supplied through the operation lever.

  In the present invention, the operation lever of the pinching means is provided in the hand operation portion of the PFO closing device, and the electric energy is supplied to the operation lever. Therefore, the operation of both operation levers is performed and the living tissue is sandwiched. The predetermined electrical energy can be supplied to the clamped living tissue, and the convenience of the procedure and operation is greatly improved.

  If the pinching means comprises a puncture part that punctures the foramen ovale valve and a clamping member that cooperates with the puncture part and clamps the living tissue, the puncture part is punctured into the oval hole valve, A part of the foramen valve and the atrial septum can be clamped by the clamping member, so that the oval valve and the atrial septum can be securely clamped and the procedure can be facilitated.

  According to the present invention, since the operation lever for the puncture unit or the operation lever for the holding member and the electric energy supply means are detachably connected to the hand operation unit of the PFO closure device, a procedure using both operation levers is performed. After that, that is, after the foramen ovale and the atrial septum are clamped by the puncture portion and the clamping member, when the electric energy supply means is connected to each operation lever in this state, the predetermined electrical energy is applied only to the clamped living tissue. Can be supplied.

  The hand operating part is provided with a flat handle member that can be grasped with one hand, the operating lever for the puncturing part protrudes on the front surface side of the handle member, and the operating lever for the clamping member protrudes on the back surface side. The operation of the holding member is not mistaken, and the puncture portion can be punctured or pulled out by a so-called one-hand operation, so that the operability is further improved.

  In particular, if the puncture portion is protruded from the distal end portion of the catheter during one-hand operation and is locked using a lock mechanism, the puncture portion is securely held, so that the procedure can be performed accurately and smoothly. It can be carried out.

  The lock mechanism is provided with a contact member for fixing the position of a contact member for restricting the sliding movement of the needle operating lever on the tip end side of the slide groove on which the needle operating lever slides formed on the handle member. Therefore, it is an easy and simple lock mechanism, and the hand operating unit does not become large, and the device has good operability.

  If the long main operating rod provided in the main pipe of the positioning holding means of the PFO closing device is capable of rotating 360 degrees around the axis in the main pipe, the state of the oval hole is determined. Regardless, the foramen ovale can be inserted through the tip of the device, not only facilitating the procedure but also quickly.

  If the tip of the guiding catheter that guides the catheter is curved, the catheter is placed more in the oval valve and the atrium than in the straight case, regardless of the state of the oval valve and the atrial septum, which differ from person to person. It is easy to be directed to the foramen between the gap and the safety, convenience, and speed of the procedure are improved.

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

  1 is a schematic cross-sectional view showing a PFO closure device according to the present invention, FIG. 2 is a perspective view of an essential part showing an example of the device, FIG. 3 is a cross-sectional view taken along line 3-3 in FIG. 2, and FIG. FIG. 4 is a cross-sectional equivalent view taken along line 4-4. In FIG. 2, only the hand operating unit 70 is shown in a reduced state for the sake of space.

  First, the PFO closure device of this embodiment will be outlined. As shown in FIGS. 1 and 2, the 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, and the guiding catheter 31. Catheter 30, the clamping means K provided at the distal end portion of the catheter 30 and sandwiching the foramen ovale valve M 2 and the atrial septum M 1, and the living tissue M (M 1, M 2) of the portion sandwiched by the clamping means K Energy supply means 20 for supplying energy for fusing or joining, and positioning and holding means 60 for performing the procedure by the clamping means K stably and accurately. In the following description, the hand operating part side of the device is referred to as “proximal end side”, and the pinching means K or the foramen ovale valve M2 side is referred to as “distal end side”.

  In use, this device is first inserted from, for example, the femoral vein J in a state where the entire clamping means K provided at the distal end of the catheter 30 is housed in the guiding catheter 31. When the distal end reaches the heart part where the procedure is performed, the pinching means K protrudes from the distal end of the guiding catheter 31, and a defect O of the foramen ovale (hereinafter sometimes simply referred to as the foramen ovale O) occurs. The tissue of the atrial septum M1 and the foramen ovale valve M2 of the heart is sandwiched. 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.

  Further details will be described. As shown in FIG. 2, the pinching means K of the present embodiment includes a pinching 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. . The sandwiching member 1 and the puncture portion 2 both function as electrode members. When the base portion is held by the support tool 50 provided at the distal end of the catheter 30 and protrudes from the support tool 50, they face each other. It comes to take a position.

  The sandwiching member 1 is composed of a main body portion 1a having a flat plate shape and a predetermined width L, and a pair of wire portions 1b connected to a base end portion, and is formed in a U-shape. One operating member 7b is connected to the proximal end side of 1b, and is moved from the distal end of the catheter 30 by moving the operating member 7b back and forth in the axial direction or displaced so as to approach the puncture portion 2 side.

  The wire portion 1b has a bent portion 1c and a straight portion 1d, and the straight portion 1d is inserted into the lumens L3 and L4 (see FIG. 4) of the support tool 50 so as to be able to advance and retract. If the bending portion 1c enters the entrance portions of the lumens L3 and L4 of the support 50 by pulling operation, the holding member 1 can be displaced so as to approach and separate from the puncture portion 2, and the distal end of the thin catheter 30 can be displaced. Even if it is a part, the biological tissue can be easily and smoothly held by both electrode members.

  The sandwiching member 1 may be a SUS material as a material of the main body 1a, but does not adversely affect the living body, for example, gold, silver, platinum, tungsten, palladium or an alloy containing these, Ni- It is preferable to use a Ti alloy, a titanium alloy, or the like.

  The puncture unit 2 is held by the lumens L1 and L2 formed in the support tool 50 so as to be able to advance and retreat, and the distal end portion can appear and disappear from the support tool 50 by operating the operation member 7c connected to the base end side. It has become.

  As shown in FIG. 2, the puncture unit 2 of the present embodiment is formed by arranging two extremely thin needle members 2 a having a circular cross section perpendicular to the axis and having sharply pointed tips, spaced apart from each other. When the foramen ovale valve M2 is punctured by such a puncture unit 2, at least one electrode member is positioned on the foramen ovale valve M2, even in various forms of the foramen valve or the atrial septum. This makes it easy to hold the living tissue M.

  Needle member 2a does not necessarily need to be solid, and may be a hollow annular shape. The outer diameter is preferably 0.1 mm to 2 mm for incorporation into catheter 30. . As the material, SUS is used, but materials that do not adversely affect the living body, such as gold, silver, platinum, tungsten, palladium, titanium, alloys containing these, Ni-Ti alloys, and the like can also be used. The distance between the two needle members 2a is not particularly limited as long as the oval valve M2 and the atrial septum M1 can be clamped within a certain range. There may be more than just two.

  As the operation members 7b and 7c for causing the holding member 1 and the puncture portion 2 to move in and out of the catheter 30, they are thin linear members, and the holding means K can be advanced and retracted in the catheter 30, and if there is electrical conductivity, For example, it is preferable to use a wire such as stainless steel, Ni—Ti, or titanium. Both operation members 7b and 7c are inserted into the catheter 30 and connected to the energy supply means 20 via operation levers 76a and 76b, connection members 21a and 21b, conductive wires d1 and d2 and a control unit 22 which will be described later.

  In the pinching means K of this embodiment, both the puncture unit 2 and the pinching member 1 can move independently in the axial direction with respect to the catheter 30. As described above, if the puncture unit 2 and the holding member 1 can be independently moved using the operation members 7b and 7c, the puncture unit 2 can be punctured at an arbitrary position, and the procedure is extremely suitable depending on the condition of the living tissue M. The atrial media M1 is pressed against the foramen ovale valve M2 that has been punctured by the movement or operation of the clamping member 1, and the living tissue M can be positioned in the thickness direction.

  As shown in FIG. 4, the support 50 has a plurality of lumens L1 to L5, but each of the lumens L1 to L5 may be configured by a catheter.

  As shown in FIGS. 1 to 3, the hand operation unit 70 includes a handle member 75 formed of a flat member so that the operator can hold it with one hand. An operation lever 76b connected to the proximal end side of the operation member 7c of the puncture unit 2 is projected on the front surface side (upper surface side) of the handle member 75, and the holding member 1 is disposed on the rear surface side (lower surface side) of the handle member 75. An operating lever 76a for operating the operating member 7b is projected.

  The operation levers 76a and 76b are slidably provided in a slide groove 77 formed in the handle member 75, but a lower end portion is provided with a flange portion 78 so that the lever can be smoothly slid and moved without falling. Yes.

  In particular, in this embodiment, the operation members 7b and 7c are wired up to the upper ends of the operation levers 76a and 76b, and are constituted by sockets or couplers provided at the ends of the conductive wires d1 and d2 from the electric energy supply means 20. The connecting members 21a, 21b and the upper end portions of the operation levers 76a, 76b are configured to be detachably fitted to each other so that the electric energy supply means 20 and the operation levers 76a, 76b are electrically connected. It becomes.

  Therefore, it is possible to supply predetermined electrical energy to the clamped living tissue while performing the procedure with both operation levers and clamp the living tissue, and the convenience of the procedure and operation is greatly improved. In addition, after the procedure of puncturing and clamping by both the operating levers 76a and 76b is completed, if the connecting members 21a and 21b are connected to the operating levers 76a and 76b, the foramen ovale valve M2 and the atrial septum M1 are fused. Electrical energy can be supplied. That is, not only can electric energy be supplied at a desired point of time, but also the wires d1 and d2 do not get in the way when performing a procedure, and the procedure can be performed accurately and smoothly.

  Although each operation member 7b, 7c and each operation lever 76a, 76b may be directly connected by brazing or the like, in this embodiment, the slide piece is slid so as to slide in the slide groove 77 formed in the handle member 75. 79a and 79b are provided, and the base ends of the operation members 7b and 7c are brazed to the distal ends of the slide pieces 79a and 79b, and the inner ends of the operation levers 76a and 76b are brazed to the base ends of the slide pieces 79a and 79b. . This is preferable because not only the operability of the device is improved, but also the strength and durability are improved.

  In addition, the hand operation unit 70 of the present embodiment also has a lock mechanism 80 that locks a state in which the puncture unit 2 protrudes from the distal end portion of the catheter 30 at the distal end portion of the handle member 75.

  The lock mechanism 80 is provided with a contact member that restricts the sliding movement of the needle operation lever 76b on the distal end side of the slide groove 77 formed in the handle member 75, and presses the needle operation lever 76b against the contact member. The slide movement is locked. If the puncture unit 2 is locked in a state protruding from the distal end of the catheter 30, electric energy can be supplied while maintaining the protruding state of the puncture unit 2, and the puncture unit 2 is not displaced during the supply of electric energy, The procedure can be performed more stably and accurately.

  The lock mechanism 80 may be any mechanism as long as it can lock the needle operation lever 76b. However, as shown in FIG. If the slide member 82 is movably provided in the block 81, the fixing position of the needle operating lever 76b can be adjusted, which is preferable.

  The energy supply means 20 supplies electric energy to the clamping means K, and will not be described in detail because of a known system configuration. However, from the viewpoint of ease of control, the electric power supply means 20 can be used regardless of whether it is a DC power supply or an AC power supply. Is preferable. 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.

  In addition, as an electric energy supply method, a monopolar method in which current is passed between the puncture portion 2 or holding member 1 on the right atrium R side and a counter electrode provided on the back portion, the holding member 1 on the right atrium R side and the left atrium L The bipolar system etc. which energize between the side puncture part 2 can be used. In particular, if the bipolar system controls the current based on the tissue impedance between the puncture unit 2 and the clamping member 1, it can be easily adapted according to the tissue state of the foramen ovale valve M2 and the atrial septum M1 which differ from person to person. There is an advantage that safety and convenience of the procedure can be obtained.

  As shown in FIG. 4, the support tool 50 has five lumens L1 to L5, and the first and second lumens L1 and L2 and the third and fourth lumens L3 and L4 include As described above, the puncture portion 2 and the clamping member 1 are inserted, and the positioning and holding means 60 is provided in the fifth lumen L5 having the largest central aperture.

  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. However, when it is used, it is pushed out from the guiding catheter 31 by operating the main operating rod 7a and the main pipe 63.

  More specifically, in the central lumen L5, the positioning and holding means 60 is drawn into the catheter 30 and collected, and a main pipe 63 provided for the purpose of reinforcing the catheter 30, and an axial advance and retreat in the main pipe 63. A freely provided main operating rod 7a is provided.

  At the distal end of the main pipe 63, the main operation rod 7a is operated to expand and contract, and a positioning part 61 including a pair of first elastic wire members 66 connecting the main pipe 63 and the intermediate sleeve body 64, and the main operation rod 7a. And a pair of second elastic wires 67 for connecting the intermediate sleeve body 64 and the tip sleeve body 65, and the contact member 68 and the tip sleeve body 65. And a holding unit 62 that holds the foramen ovale valve M2 is provided.

  The positioning portion 61 projects the main operating rod 7a from the tip of the main pipe 63, and displaces the first elastic member 66 outward by an operation of moving the main operating rod 7a in the axial direction. The inner edge of the hole O is pressed with substantially equal elastic force, and the puncture part 2 is aligned with the oval hole O. That is, the function to position the puncture part 2 located between both the 1st elastic members 66 in the center part of the foramen ovale O is exhibited.

  The holding unit 62 has a bending mechanism W that bends the tip of the main operation rod 7a by moving the main operation rod 7a in the axial direction. The bending mechanism W exhibits a function of holding the oval hole valve M2 by bending the holding part 62 so as to face the direction in which the puncture part 2 punctures the oval hole valve M2. Here, the bending mechanism W includes an intermediate sleeve body 64, a tip sleeve body 65, a second elastic wire 67 connecting the both sleeve bodies 64, 65, and a contact member 68.

  The proximal end of the first elastic wire 66 is welded to the distal end of the main pipe 63, and the distal end side is welded to the intermediate sleeve body 64. On the other hand, the proximal end of the second elastic wire 67 is welded to the distal end of the intermediate sleeve body 64, and the distal end side is welded to the distal sleeve body 65.

  Specific examples of the first and second elastic wires 66 and 67 have an outer diameter of about 0.1 mm to 0.5 mm, stainless steel, nickel-titanium, superelastic alloy (for example, Ni-Ti alloy), etc. It is preferable to use a metal wire. Moreover, you may prevent the damage | wound of a structure | tissue by coat | covering a resin (soft) tube to a metal wire.

  In the holding portion 62, the first elastic wire 66 on the proximal end side is curved prior to the second elastic wire 67 on the distal end side to position the puncture portion 2, and then the main operation rod 7a itself contacts the contact member 68 and The tip sleeve body 65 is deformed and the oval valve M2 is held after the positioning portion 61 positions the puncture portion 2.

  As this configuration, for example, the second elastic wire 67 is made of a material having higher rigidity than the first elastic wire 66, or a part of the first elastic wire 66 is bent and deformed in advance. A method in which the first elastic wire 66 is bent before the second elastic wire 67 due to the deformation of the easily deformable portion when the deformable portion is formed and a traction force acts can be used.

  In this way, the first elastic wire 66 on the proximal end side abuts on the inner edge of the oval hole O only by pulling the main operating rod 7a rearward, positioning the puncture portion 2 and further pulling, The second elastic wire 67 on the side protrudes and deforms in an arc shape outward in the radial direction, so that the foramen ovale valve M2 can be held unretractable so that the puncture portion 2 can be easily punctured.

  Further, the main operation rod 7a can be rotated 360 degrees around the axis in the main pipe 63. If the main operation rod 7a can rotate 360 degrees, when the tip of the main operation rod 7a is inserted to the vicinity of the foramen ovale O, the main operation rod 7a can be rotationally displaced, Even if the state of O is variously deformed, the tip of the device can be inserted into the foramen ova O regardless of the shape state, and not only the procedure can be facilitated, but also the operation can be performed quickly.

  At the rear end of the handle member 75, a main pipe handle member 85 for moving the main pipe 63 forward and backward through two slide rails 86 is provided. Since the proximal end side of the main pipe 63 is fixed to the main pipe handle member 85, when the main pipe handle member 85 is pulled away from the handle member 75, that is, rearward, the main pipe 63 is pulled through the lumen L5 at the center of the catheter 30. Accordingly, the entire positioning and holding means 60 can be collected in the catheter 30.

  The main operation rod 7a is extended through the through hole 87 of the main pipe handle member 85 so that the main operation rod 7a can be rotated 360 degrees.

  As the material constituting the main pipe 63, a deformable elastic material such as polyimide resin, polyurethane, PET, nylon, fluorine resin, polypropylene, or the like can be used.

  The main operation rod 7a may be any thin hollow wire and relatively rigid. For example, a thin tube made of stainless steel, Ni-Ti, titanium, or the like is used. It is preferable.

  A Y connector 72 capable of injecting a contrast medium or the like is connected to the distal end of the handle member 75 via a connecting member 71. The connecting member 71 is connected to the proximal end of the catheter 30 and the guiding catheter 31. The end is held.

  The guiding catheter 31 of the present embodiment has a tip that is gently curved in an arc shape so that it can easily be directed to the foramen ovale O between the foramen valve M2 and the atrial septum M1. Yes. Since the foramen valve M2 and the atrial septum M1 differ from person to person, if the tip of the guiding catheter 31 is curved, it can be directed to the foramen ova O only by rotating the guiding catheter 31 itself. The safety and convenience of the procedure are improved compared to the case of straight.

  Next, the operation of this embodiment will be described.

  5 is a schematic cross-sectional view of the main operating rod inserted into the foramen ovale, FIG. 6 is a schematic cross-sectional view of the state where the puncture part is punctured while holding the oval hole valve, and FIG. FIGS. 8A to 8D are schematic views showing the operating state of the distal end portion of the PFO closure device, with the cross-sectional schematic view sandwiching the foramen valve and the atrial septum. In FIGS. 8A to 8D, the shape and position of the second elastic wire 66 are substantially flush with the holding member 1 and the puncture portion 2, but for ease of understanding. The illustrated position is shown as being displaced by 90 degrees, which is different from the actual deformed state.

  First, the surgeon retracts the main tube handle member 85 of the hand operation unit 70 with respect to the handle member 75 and stores the holding member 1 and the puncture unit 2 in the guiding catheter 31, and in this state, the guide The tip of the guiding catheter 31 is inserted from a predetermined position of the living body using a wire as a guide, and reaches the right atrium R through the femoral vein J. Note that only the guiding catheter 31 may be inserted into the living body, and the catheter 30 may be inserted into this later as a guide.

  When the distal end of the guiding catheter 31 reaches the right atrium R, the catheter 30 is pushed out and directed toward the foramen ovale O between the foramen valve M2 and the atrial septum M1. Since the distal end of the guiding catheter 31 is curved, it can be directed to the foramen ova O relatively easily.

  Next, the main operation rod 7a is advanced, and the distal end of the main operation rod 7a protrudes from the distal sleeve body 65 and is inserted into the left atrium L as shown in FIG. This protruding state can be visually recognized from the outside if a marker is provided on the contact member 68 or the like, but if the tip of the main operating rod 7a hits the inner wall of the left atrium L or the like due to this protrusion, it is difficult to visually recognize this protruding state. Even in this case, the position of the main operation rod 7a can be confirmed sensuously. In the present embodiment, since the main operation rod 7a can be rotated 360 degrees, as shown in FIG. 5, when the main operation rod 7a is advanced while rotating, the oval hole O can be easily inserted.

  After confirming the distal end position of the main operating rod 7a, as shown in FIG. 8B, the main operating rod 7a is retracted until the contact member 68 at the distal end of the main operating rod 7a contacts the distal end sleeve body 65 (the retraction amount is “Δ1” in FIG. 8B). And the handle member 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. 8C), 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 intermediate. The first elastic wire 66 is transmitted to the first elastic wire 66 fixed to the tip of the main pipe 63 via the sleeve body 64, and the first elastic wire 66 is formed in an arc shape outwardly in the radial direction as shown in FIG. Protrusively deformed. 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.

  As shown in FIG. 8D, when the main operation rod 7a is further retracted and the rear end of the intermediate sleeve body 64 is brought into contact with the tip of the main tube 63, the first elastic wire 66 is not deformed so much. The second elastic wire 67 on the side projects and deforms in a circular arc shape outwardly in the radial direction by the operating force. As a result, as shown in FIG. 6, in the left atrium L, the contact member 68 and the distal sleeve body 65 come close to the puncture part 2, so that the contact member 68 and the distal sleeve body 65 are connected to the left atrium of the foramen ovale valve M2. It abuts against the side surface and holds it.

  In this state, when the needle operating lever 76a is advanced until it comes into contact with the lock mechanism 80, the puncture portion 2 protrudes from the distal end of the catheter 30 via the operating member 7b, and the needle operating lever 76a is advanced, the oval hole A predetermined position of the valve M2 can be punctured.

  The position of the puncture unit 2 is such that the needle operating lever 76a is in contact with the lock mechanism 80, so that there is no possibility of deviation. Once the puncture unit 2 is punctured, the position of the puncture unit 2 is the same as that of the oval hole valve M2. In this relationship, the position is fixed, that is, the positioning is performed. Therefore, the surgeon can concentrate on the clamping by the clamping member 1 without considering the state of the puncture unit 2, and the clamping operation is facilitated.

  When the holding member operation lever 76b is moved forward, the holding member 1 protrudes from the distal end of the catheter 30 via the operation member 7c, and the operation member 7c presses the atrial septum M1 toward the foramen ovale valve M2, and the atrial septum The position of M1 and the foramen ovale valve M2 is fixed in the thickness direction, that is, the front-rear direction in the operation state, and as shown in FIG. 7, the atrial septum M1 and the egg circle are interposed between the holding member 1 and the puncture portion 2. The hole valve M2 is present.

  At this stage, the main operating rod 7a is temporarily returned, and after the first elastic wire 66 and the second elastic wire 67 are straightened as shown in FIG. 8B, the main pipe handle member 85 is retracted, The main tube 63 is retracted, and the entire positioning and holding means 60 is collected in the lumen L5 of the catheter 30.

  After the collection, when the holding member operation lever 76b is moved backward and the holding member 1 is moved backward via the operation member 7c, the bent portion 1c of the holding member 1 is moved to the puncture portion 2 side by the end of the support 50. As shown in FIG. 7, the atrial septum M <b> 1 and the foramen ovale valve M <b> 2 are firmly held between the holding member 1 and the puncture unit 2.

  If the needle operating lever 76a is pressed against the lock mechanism 80 to hold the locked state, the holding state of the atrial septum M1 and the foramen ovale M2 by the holding member 1 and the puncture unit 2 is held. Since there is no possibility that the puncture portion 2 is displaced due to this lock, if the connecting members 21a and 21b are concavo-convexly fitted to the needle operation lever 76a and the holding member operation lever 76b, a predetermined current controlled by the control portion 22 is applied to the needle. The operation lever 76a and the holding member operation lever 76b flow to the holding member 1 and the puncture portion 2 through the operation members 7b and 7c. By supplying this electric energy, the atrial septum M1 and the foramen ovale M2 are heated.

  By controlling the electrical energy by the control unit 22, even if a part of the holding member 1 and the puncture unit 2 is exposed in the blood, at this stage, adhesion of thrombus to the holding member 1 and the puncture unit 2 is prevented. Is possible. However, it is preferable to provide a coating for preventing thrombus adhesion on the surface of the clamping member 1 or the puncture portion 2 because adhesion of the thrombus will be prevented more reliably.

  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.

  When the fusion is completed, the energization is stopped, the needle operation lever 76b and the holding member operation lever 76a are retracted and housed in the guiding catheter 31. When the guiding catheter 31 is removed from the living body, the procedure is completed. After the procedure is completed, an extremely small hole remains in the foramen ovale valve M2 by removing the puncture unit 2, but it is healed later, and there is no adverse effect such as generation of a thrombus.

  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 above-described embodiment, the needle operating lever 76b and the clamping member operating lever 76a are individually connected to the connecting members 21a and 21b to supply power, but not only this but also both operating levers and connecting members are connected. May be connected together so that power can be supplied.

  The positioning and holding means 60 in the above-described embodiment has the intermediate sleeve body 64, but is not limited to this. For example, FIG. 9 is a schematic view showing another example of the positioning and holding means. As shown in FIG. 9A, the intermediate sleeve body 64 provided in the present embodiment is not provided, and the distal sleeve body 65 and the main pipe 63 are not provided. A first elastic wire 66 and a second elastic wire 67 may be provided between them. In this embodiment, when the main operating rod 7a is retracted, the second elastic wire 67 is arcuate while the first elastic wire 66 is projecting and deforming in an arc shape radially outward as shown in FIG. Bends and deforms. That is, the positioning of the puncture portion 2 to the center of the oval hole O by the first elastic wire 66 and the holding of the oval hole valve M2 by the contact member 68 bent by the second elastic wire 67 and the tip sleeve body 65 are mainly performed. The operation rod 7a is simultaneously performed in one operation by retreating.

  In the above-described embodiment, the treatment used to close the defect of PFO has been described. However, the present invention is not limited to this, and a channel-like shape such as a left atrial appendage closure device (Left Atrial Appendage) is used. It can also be used to close a defect or to thermally necrotize a living tissue at a predetermined site.

  The PFO closure device of the above embodiment is simply housed in a catheter and the clamping means is operated by an operating member. However, not only this, but also a combination with a catheter having a so-called balloon, for example, is transported to a predetermined position. Is also possible.

  INDUSTRIAL APPLICABILITY The present invention can be used as a device capable of easily and safely closing a PFO defect.

1 is a schematic cross-sectional view showing a PFO closure device according to the present invention. It is a principal part perspective view which shows an example of the device. It is sectional drawing which follows the 3-3 line of FIG. FIG. 4 is a cross-sectional equivalent view taken along line 4-4 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)-(D) are schematic which shows the operation state of a PFO closure device. It is a schematic perspective view which shows the other example of a positioning holding means, (A) shows the state at the time of normal, (B) shows the state at the time of positioning holding.

Explanation of symbols

1 ... clamping member,
2 ... Puncture part,
2a ... needle member,
7a ... main operation rod,
7b, 7c ... operation members,
20: Energy supply means,
30 ... catheter,
31 ... guiding catheter,
60: Positioning and holding means,
61 ... positioning part,
62 ... holding part,
63 ...
66 ... an elastic member,
70: Hand control unit,
75 ... handle member,
76a, 76b ... control lever,
77 ... Slide groove,
79 ... Lock mechanism,
80 ... Hit member,
M ... living tissue,
M1 ... Atrial septum,
M2 ... foramen valve,
O ... Oval hole.

Claims (9)

A pinching means provided at the distal end portion of the catheter, for pinching a living tissue composed of an oval valve and an atrial septum;
Electrical energy supply means for supplying electrical energy to the clamping means;
A hand operating part provided at the proximal end of the catheter for operating the clamping means;
Have
The pinching means is an electrode member, and the foramen valve and the atrial septum are clamped by the pinching means to supply electric energy from the electric energy supply means to A PFO closure device to be joined together,
The hand operation unit has an operation lever connected to a proximal end side of an operation member for projecting and retracting the pinching means from the distal end portion of the catheter, and supplies the electric energy via the operation lever. A PFO closure device characterized in that.   The PFO closure device according to claim 1, wherein the pinching means includes a puncturing unit that punctures the foramen ovale valve, and a clamping member that cooperates with the puncturing unit and clamps the living tissue.   The PFO closure device according to claim 1 or 2, wherein the operation lever and the electric energy supply means are detachably connected.   The hand operation unit has a handle member that can be held with one hand, and the handle member is provided with slidable operation levers for the puncture unit and the holding member for operating the puncture unit and the holding member, respectively. The PFO closure device according to claim 1.   The hand operation part is configured such that the handle member is a flat member, the operation lever for the puncture part protrudes on one surface side of the handle member, and the operation for the clamping member on the other surface side of the handle member The PFO closure device according to claim 4, wherein the lever protrudes.   The said hand operation part provided the lock mechanism which locks the state which the said puncture part protruded from the front-end | tip part of the said catheter in the said handle member, The Claim 1 characterized by the above-mentioned. PFO closure device.   The lock mechanism is provided with a contact member for restricting the sliding movement of the puncture operation lever on the distal end side of the slide groove on which the puncture operation lever slides formed on the handle member. 7. The PFO closing device according to claim 6, wherein the sliding movement of the operation lever is locked by pressing the operation lever for puncturing. The PFO closing device comprises positioning and holding means comprising a positioning part for positioning the puncture part with respect to the foramen ovale, and a holding part for holding the oval hole valve so as not to be retractable in the puncture direction of the puncture part. Have
The positioning portion is provided with a long main operation rod capable of moving forward and backward in an axial direction in a main tube provided so as to be able to advance and retreat in the catheter, and the main tube protrudes from the catheter at a distal end portion of the main operation rod, The elastic member is displaced outward by operating the main operating rod forward and backward in the axial direction, and the puncture portion is moved to the center of the oval hole by elastic contact with the inner edge of the oval hole of the elastic member. Configured to position
The holding portion projects the main operation rod from the tip of the main tube and advances and retracts in the axial direction to bend the tip of the main operation rod, and faces the direction in which the puncture portion punctures the oval hole valve So that the tip of the main operating rod is configured to hold the foramen ovale valve,
The PFO closure device according to any one of claims 1 and 4, wherein the main operating rod is rotatable 360 degrees around the axis in the main pipe.   9. The catheter is guided by a guiding catheter whose tip is curved so as to be easily directed to the foramen ovale between the foramen valve and the atrial septum. A PFO closure device according to any of the above.

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