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WO2014049675A1 - Dispositif médical - Google Patents

Dispositif médical Download PDF

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Publication number
WO2014049675A1
WO2014049675A1 PCT/JP2012/074465 JP2012074465W WO2014049675A1 WO 2014049675 A1 WO2014049675 A1 WO 2014049675A1 JP 2012074465 W JP2012074465 W JP 2012074465W WO 2014049675 A1 WO2014049675 A1 WO 2014049675A1
Authority
WO
WIPO (PCT)
Prior art keywords
operation wire
end side
distal end
respect
fastening
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2012/074465
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English (en)
Japanese (ja)
Inventor
博務 杉山
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Terumo Corp filed Critical Terumo Corp
Priority to PCT/JP2012/074465 priority Critical patent/WO2014049675A1/fr
Publication of WO2014049675A1 publication Critical patent/WO2014049675A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623—Introducing or retrieving devices therefor

Definitions

  • the present invention relates to a medical device, and more particularly to a medical device that is inserted into a lumen.
  • PFO patent foramen ovale
  • the foramen ovale occurs in the secondary septum of the heart (Septum Secundum, hereinafter referred to as the atrial septum).
  • the atrial septum In the normal heart, the pressure in the left atrium exceeds the pressure on the right atrium side, so the primary septum (Septum Prime)
  • 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.
  • a treatment using a percutaneous catheter technique 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)
  • ASD congenital atrial septal defect
  • VSD ventricular septal defect
  • PDA patent ductus arteriosus
  • 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 bodies for the body, and thrombus is easily formed.
  • a thrombus is formed in the disc-like membrane on the left atrium side, it may flow and cause a stroke, and there is a possibility that the thin-walled foramen valve is damaged.
  • these members are not fixed in position in a sandwiched state, and there is a possibility of causing a positional shift.
  • a PFO closure device 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 positioning member projecting from the catheter to the distal end side to hold the biological tissue, and then punctures the foramen ovale valve using the puncture part and the clamping part, which are a pair of electrodes, The foramen ovale and the atrial septum are sandwiched between the clamping parts, and electrical energy is applied to the living tissue to perform bonding.
  • the positioning member has a cylindrical body connected to the distal end side of the elastic wire, and pulls the operation wire penetrating the cylindrical body to move the distal end member fixed to the distal end of the operation wire to the proximal side.
  • the structure is such that the moving force of the member is applied to the cylindrical body to deform the elastic wire, and the cylindrical body is moved to incline radially outward.
  • a gripping part (torque device) that is gripped and operated by hand is connected to the proximal end side of the operation wire in order to move the operation wire forward and backward and to rotate the operation wire.
  • the tip member may fall off the operation wire in the lumen.
  • the gripping portion is separated from the operation wire before the tip member to prevent the tip member from falling off.
  • the PFO closing device described above has a structure in which the grip portion is separated from the operation wire by an excessive tensile load, but not only the tensile load but also the torsional load acts on the separated portion. For this reason, even if the tensile load is within the range where there is no problem, if a strong torsional load is applied, the gripping part may be separated from the operation wire by the torsional load, and the gripping part is separated from the operation wire. The tensile load may become unstable.
  • the present invention solves the above-described problems, and an object thereof is to provide a medical device that can reduce the influence of a torsional load and stably separate a grip portion from an operation wire by a predetermined tensile load. To do.
  • the medical device that achieves the above object includes an operation wire that is inserted into a tubular body that is inserted into a lumen and is capable of moving forward and backward in the axial direction with respect to the tubular body, and a base of the operational wire.
  • a gripping portion connected to the end side, a first fastening portion that is connected to the operation wire and restricts movement of the operation wire in the axial direction with respect to the gripping portion, and is connected to the operation wire
  • a second fastening portion that restrains movement of the operation wire in the rotation direction with respect to the gripping portion and allows movement of the operation wire in the axial direction with respect to the gripping portion; is there.
  • the medical device configured as described above restrains the movement of the operation wire in the rotation direction with respect to the gripping portion by the second fastening portion and does not restrain the movement in the axial direction
  • the tensile load is applied by the first fastening portion.
  • the effect of the torsional load on the first fastening part can be reduced while transmitting the gripping part to the gripping part, and the gripping part is stably separated from the operation wire by the predetermined tensile load in the first fastening part that receives the tensile load. Can do.
  • the torsional load transmitted from the distal end side with respect to the second fastening portion of the operation wire is second fastening portion.
  • the torsional load is hardly transmitted to the first fastening part on the base end side with respect to the second fastening part, and the grip part is separated more stably by a predetermined tensile load. be able to.
  • the gripping part has an open part on the front end side where the second fastening part can escape, the second fastening part will not be caught by the gripping part when the first fastening part is separated from the operation wire. It is possible to escape from the open portion, and the grip portion can be stably separated from the operation wire.
  • Constraining strength in a direction that is connected to the distal end side of the operation wire and is separated in the axial direction with respect to the operation wire is constrained in a direction in which the first fastening portion is separated in the axial direction with respect to the operation wire. If a higher tip member is provided, even if a strong tensile load acts between the operation wire and the tip member, the first fastening portion is separated from the operation wire before the tip member is separated from the operation wire. The tip member is prevented from falling off the operation wire, and safety is improved.
  • the first fastening portion is larger than the outer diameter of the operation wire, and the gripping portion has a restriction hole having a size through which the operation wire is inserted and the first fastening portion cannot pass through, If the cross-sectional area of the connecting portion with respect to the first fastening portion of the wire is smaller than the cross-sectional area of the connecting portion with respect to the tip member of the operation wire, before the tip member breaks from the operation wire, The connecting portion with respect to the first fastening portion can be broken.
  • the cylindrical part is provided in a holding part that is inserted into the foramen ovale, which is a defect in living tissue, and holds the oval hole valve while pressing it toward the atrial septum, it can move radially outward.
  • the cylindrical tube portion can press the oval hole valve toward the atrial septum and hold the oval valve well.
  • An electrode capable of passing an electric current between the needle portion that is an electrode that pierces the living tissue around a defect existing in the living tissue and the needle portion between the needle portion and the needle portion If the needle portion is further inserted into the living tissue, the living tissue is sandwiched between the needle portion and the holding portion, and an electric current is passed between them so that the living tissue is satisfactorily bonded. Can do.
  • the electrode further includes a second linear portion for positioning the electrode with respect to the foramen by deforming by the axial movement of the operation wire and contacting the inner edge of the foramen hole,
  • the electrode can be positioned at an appropriate position with respect to the foramen ovale, and a current can be passed to the appropriate position.
  • the needle part, the holding part and the operation wire, the needle part, the holding part and the shaft part can be operated only by the operation on the hand operation part without moving the entire medical device back and forth. Can be easily operated, and the operability is improved.
  • FIG. 3 is a cross-sectional view of the distal end portion of the catheter taken along line 3-3 in FIG. It is a top view of a catheter front-end
  • FIG. 7 is a cross-sectional view of the grip portion along line 7-7 in FIG. It is a top view which shows the hand operation part of the medical device which concerns on 1st Embodiment.
  • FIG. 9 is a cross-sectional view of the hand operating portion taken along line 9-9 in FIG.
  • FIG. 9 is an enlarged cross-sectional view of a hand operating unit taken along line 9-9 in FIG.
  • FIG. 11B is a cross-sectional view of the hand operation unit along the line 11-11 in FIG.
  • FIG. 10 is a cross-sectional view showing a coupling mechanism taken along line 12-12 in FIG.
  • FIG. 13 is a cross-sectional view of a lock-unlock mechanism portion taken along line 13-13 in FIG.
  • FIG. 14 is a cross-sectional view taken along line 14-14 of FIG.
  • FIG. 1 It is sectional drawing of the holding part which shows when a base end member fractures
  • FIG. 6 is a schematic cross-sectional view when a needle part is punctured while holding a foramen valve and an atrial septum. It is the cross-sectional schematic when the clamping part is spaced apart from the atrial septum.
  • FIG. 32 is a cross-sectional view taken along line 32-32 in FIG. 31. It is sectional drawing of the holding part which shows when a base end member fractures
  • 35 is a cross-sectional view taken along line 35-35 in FIG. 34. It is sectional drawing of the holding part which shows when a base end member fractures
  • the medical device according to the first embodiment of the present invention is a PFO closure device.
  • 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 hand operation unit 70 to the proximal end of the catheter body 10, and a hand operation unit 70. And a power supply means for supplying electrical energy for fusing or necrosizing the living tissue M (generic name for M1 and M2) and a guiding sheath 3 into which the catheter main body 10 can be inserted.
  • the catheter 1 is provided at the distal end portion of the catheter body 10, and includes a clamping means K that clamps the foramen ovale valve M2 and the atrial septum M1, and a living tissue M in order to perform a procedure using the clamping means K stably and accurately.
  • Positioning holding means 60 for holding and positioning for holding and positioning.
  • 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”.
  • the “catheter” represents one including a tube used for medical purposes.
  • the guiding sheath 3 is inserted, for example, from the femoral vein.
  • the guiding sheath 3 is provided with a clamping means K provided at the distal end of the catheter body 10 therein. 10 is inserted together with 10.
  • 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.
  • “L” indicates the left atrium and “R” indicates the right atrium.
  • the pinching means K is composed of a pinching portion 20 that directly contacts one side of the atrial septum M1 and a needle portion 30 that pierces the foramen ovale valve M2.
  • the sandwiching portion 20 includes a flat plate-like flat plate portion 21 that is entirely flat, a pair of wire rod portions 22 connected to the base end portion of the flat plate portion 21, and a terminal 83 ( 9).
  • a distal tip 40 is bonded and fixed to the distal end of the catheter body 10, and the sandwiching portion 20 is formed by lumens L 3 and L 4 formed in communication with the catheter body 10 and the distal tip 40, as shown in FIG. The plane position is regulated.
  • polyether ether ketone is used as the material of the catheter body 10 and the distal tip 40, but the material is not limited to this.
  • PEEK polyether ether ketone
  • Perprene registered trademark
  • Nylon polyethylene
  • PTFE polytetrafluoroethylene
  • the wire portion 22 is formed with a bent end, and when the wire portion 22 is drawn into the lumens L3 and L4, as shown in FIGS.
  • the flat plate portion 21 provided on the distal end side with respect to the wire portion 22 moves toward the needle portion 30 side.
  • the needle portion 30 includes two needle tip portions 31 held in the tip tip 40 and two needles provided to extend from the proximal end side of each needle tip portion 31 to the hand operation portion 70.
  • the base end part 32 and the terminal 81 (refer FIG. 9) provided in the base end side of the needle
  • a terminal 81 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 needle portion 30.
  • Needle tip 31 and needle base 32 are integrally formed of the same wire.
  • the needle tip 31 is movably held by two lumens L1 and L2 (see FIG. 3) formed on the catheter body 10 and the tip 40, and as shown in FIGS.
  • the sharp tip can be projected and retracted from the tip 40 by advancing and retracting in the axial direction.
  • the sandwiching part 20 and the needle part 30 function as electrodes for applying an electric current to the living tissue M, but the wire part 22 and the needle part 30 of the sandwiching part 20 are inserted through the catheter body 10.
  • An input connector 75 provided in the hand operation unit 70, an output connector 87 (see FIG. 1) that is a plug fitted to the input connector 70, a lead wire d (generic name for d1 and d2) connected to the electrode terminal of the output connector 87 It is electrically connected to the energy supply means 4 via the controller 5.
  • one of the conductive wires d1 and d2 (in this embodiment, the conductive wire d1) is provided with a foot switch SW installed at the foot for on / off control of 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.
  • 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.
  • the hand operating section 70 includes a needle operating lever 78 that operates the needle section 30 that is one of the electrode members, a slide section 100 that operates the positioning and holding means 60, and the other electrode member.
  • the hand operation unit 70 includes a grip 50 connected to the base end of the operation wire 14 to operate the operation wire 14 and a lock-unlock mechanism that locks / unlocks the slide movement of the slide 100. 102 (see FIG. 14), and a push piece 109 for locking the movement of the operation wire 14 in the axial direction, and an input connector 75 having 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 14, and a first fastening portion 15 is provided at the proximal end (see FIG. 6).
  • the distal end member 68 and the first retaining portion 15 are larger than the outer diameter of the operation wire 14, and the cross-sectional area of the connecting portion between the operation wire 14 and the first retaining portion 15 is between the operation wire 14 and the distal end member 68. It is smaller than the cross-sectional area of the connecting portion.
  • a nickel titanium alloy, stainless steel, or the like can be used as the material of the operation wire 14, but is not limited thereto.
  • the material of the tip member 68 and the first fastening portion 15 may be, for example, nickel titanium alloy, silver brazing, or the like, but is not limited thereto.
  • the tip member 68 and the first fastening portion 15 are fixed to the operation wire 14 by a known technique corresponding to a material such as welding, adhesion, or fusion, or the end portion of the operation wire 14 made of metal or resin is used. By melting, the tip member 68 and the first fastening portion 15 may be deformed and formed.
  • the tip member 68 and the first fastening portion 15 are spherical in this embodiment, but are not necessarily limited to spherical.
  • the breaking strength (restraint strength) with respect to the tensile load between the operation wire 14 and the first fastening portion 15 is the breaking with respect to the tensile load between the operation wire 14 and the tip member 68. It is lower than the strength (restraint strength).
  • a second fastening portion 16 having an elliptical cross section (non-perfect circle) is fixed to the distal end side of the operation wire 14 from the first fastening portion 15.
  • the second fastening portion 16 has the same elliptical cross-sectional shape at each point in the axial direction.
  • a resin material such as polycarbonate (PC) or polyacetal resin (POM), a metal such as nickel titanium alloy, stainless steel, or the like can be applied to the second fastening portion 16, but is not limited thereto.
  • the second fastening portion 16 is fixed to the operation wire 14 by a known technique corresponding to a material such as welding, adhesion, or fusion.
  • the grip portion 50 includes an open portion 51 that is a space through which the operation wire 14 is inserted from the distal end side together with the second fastening portion 16, and an insertion hole that communicates from the open portion 51 to the proximal end side. 52, a restriction hole 53 formed to communicate from the insertion hole 52 to the proximal end side, and a storage portion 54 communicated from the restriction hole 53 to the proximal end side and opened to the proximal end side of the grip portion 50.
  • an open portion 51 that is a space through which the operation wire 14 is inserted from the distal end side together with the second fastening portion 16, and an insertion hole that communicates from the open portion 51 to the proximal end side. 52, a restriction hole 53 formed to communicate from the insertion hole 52 to the proximal end side, and a storage portion 54 communicated from the restriction hole 53 to the proximal end side and opened to the proximal end side of the grip portion 50.
  • the open portion 51 has an elliptical shape in which an axial orthogonal cross section of the inner peripheral surface is in contact with the outer peripheral surface of the second fastening portion 16 with a clearance, and can slide in the axial direction with the outer peripheral surface of the second fastening portion 16. It is. For this reason, the second fastening portion 16 is restrained so as not to rotate with respect to the gripping portion 50 inside the opening portion 51, but is allowed to move in the axial direction without being restrained with respect to the gripping portion 50.
  • the regulation hole 53 is formed in such a size that the operation wire 14 can pass therethrough but the first fastening portion 15 cannot pass therethrough.
  • the accommodating portion 54 is accommodated while the first fastening portion 15 is in contact with the restriction hole 53, and the adhesive 55 is injected from the base end side and sealed with the adhesive 55. Therefore, the first fastening portion 15 is fixed to the grip portion 50 in the housing portion 54 by the adhesive 55, and the movement of the operation wire 14 in the axial direction is restrained with respect to the grip portion 50. Since the first fastening portion 15 is in close contact with the regulation hole 53, the adhesive 55 does not enter the portion where the operation wire 14 and the first fastening portion 15 are connected. For this reason, the operation wire 14 is connected to the grip portion 50 only through the first fastening portion 15, and the breaking strength between the operation wire 14 and the first fastening portion 15 is not affected by the adhesive 55.
  • the material of the grip 50 can be, for example, polycarbonate (PC), polyacetal resin (POM), or the like, but is not limited thereto.
  • the gripping part 50 When the gripping part 50 is gripped by hand and moved forward and backward, the movement of the first fastening part 15 in the axial direction with respect to the gripping part 50 is restricted, and therefore the operation wire 14 connected to the first fastening part 15 is moved. It can be moved forward and backward. At this time, since the second fastening portion 16 is allowed to move in the axial direction with respect to the gripping portion 50, the tensile load of the operation wire 14 does not act on the gripping portion 50 from the second fastening portion 16.
  • the gripping part 50 when the gripping part 50 is gripped and rotated by hand, the movement of the second fastening part 16 in the rotational direction with respect to the gripping part 50 is restrained, and therefore the operation wire 14 connected to the second fastening part 16. Can be rotated via the second fastening part 16. At this time, since the second fastening part 16 is located on the tip side of the first fastening part 15, the torsional load can be received by the second fastening part 16 and hardly acts on the first fastening part 15.
  • the breaking strength is evaluated based on the size of the cross-sectional area of the operation wire 14, but when the first fastening portion 15 (or the tip member 68) breaks, the first fastening portion 15 (or the tip member 68). ) May cause shear fracture, and in this case, the shear area can also be evaluated.
  • the 1st fastening part 15 does not need to be joined with respect to the operation wire 14, for example, can be pinched or made into a screw-in type, and if it can restrain with respect to the operation wire 14,
  • the connection method is not limited.
  • the hand operating unit 70 includes a main body 71 on the side to which the guiding sheath 3 is coupled, and a guide bar 88 ⁇ / b> A so as to be close to and away from the main body 71 on the proximal end side of the main body 71. , 88B, 88C, and a slide unit 100 connected to each other via a needle operation lever 78 for operating the needle unit 30 and a clamping unit operation lever 122 for operating the clamping unit 20 on the upper surface of the main body 71. And are provided.
  • a recess 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). Yes.
  • the needle operating lever 78 has a bracket 80 that protrudes so as to reach the internal space 76 through a slit (not shown) formed in the main body 71.
  • a terminal 81 to which the proximal end side of the needle proximal end portion 32 is connected is coupled. Therefore, when the needle operating lever 78 is slid along the slit, the terminal 81 advances and retracts inside the main body 71 and advances and retracts the needle 30 as shown in FIG.
  • a recess 121 is formed on the front surface (upper surface) of the main body 71, and a clamping unit operating lever 122 is provided slidable in the longitudinal direction.
  • the holding portion operation lever 122 includes a bracket 123 that protrudes so as to reach the internal space 76 through a slit (not shown) formed in the main body portion 71. 123 is connected to a terminal 83 to which the wire portion 22 of the sandwiching portion 20 is connected.
  • a main pipe 63 (shaft portion), which will be described in detail later, is inserted in the approximate center of the internal space 76 of the main body portion 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 these terminals 81 and 83.
  • the electrical system of the needle part 30 and the electrical system of the clamping part 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.
  • the contact members 84 and 85 come into contact with the terminals 81 and 83 that move with the movement of the needle part 30 and the clamping part 20, the contact members 84 and 85 It is structured to retreat while touching. That is, the contact members 84 and 85 and the terminals 81 and 83 have a contact range with a certain length, and can contact while absorbing individual differences between living bodies.
  • the operation wire 14 is provided in the main pipe 63 and has a function of assisting the operation of the clamping means K by pulling in the axial direction, and can be rotated 360 degrees around the axis in the main pipe 63. If the operation wire 14 can be rotated 360 degrees, the tip of the operation wire 14 can be inserted into the vicinity of the foramen ovale O and can be inserted into the foramen ovale O by rotationally displacing it. As a result, even if the state of the foramen ova O is variously deformed, the tip of the device can be inserted into the foramen ova O regardless of the shape state, thereby facilitating and speeding up the procedure. Can do.
  • the guide bars 88A, 88B, 88C are slidably provided inside the main body 71.
  • the hand operating section 70 includes an operation switching section 130 that is coupled to the guide bar 88A and can be connected to and disconnected from the terminal 83 inside the main body 71.
  • the operation switching unit 130 moves forward and backward together with the guide bar 88 ⁇ / b> A according to the sliding operation of the slide unit 100, and moves forward and backward with the pinching unit 20 connected to the terminal 83 by being connected to the terminal 83. By releasing, it becomes possible to operate the clamping unit 20 independently of the slide unit 100.
  • the operation switching unit 130 includes a beam-shaped connecting member 140 extending from the portion fixed to the guide bar 88A to the distal end side, and a deformation inducing unit 150 that is formed on the main body 71 and contacts the connecting member 140 to deform the connecting member 140. And.
  • the connecting member 140 is fixed to the guide bar 88A on the base end side (right side in FIG. 11), and an engagement portion 141 that can be engaged with and detached from the terminal 83 is formed on the distal end side (left side in FIG. 11).
  • the terminal 83 is releasably connected.
  • the engaging portion 141 is provided on the proximal end side of the first engaging portion 142 that protrudes from the distal end portion of the connecting member 140 in a direction orthogonal to the forward / backward moving direction, and the first engaging portion 142 of the connecting member 140.
  • a first engagement portion 142 and a second engagement portion 143 projecting in the same direction are provided.
  • the first engagement portion 142 can abut on the distal end surface of the terminal 83
  • the second engagement portion 143 can abut on the proximal end surface of the terminal 83, and the first engagement portion
  • the terminal 83 is sandwiched between the second engaging portion 143 and the second engaging portion 143.
  • FIG. 11 (A) and FIG. 11 (B). See FIGS. 11D and 11E).
  • An inclined surface 144 having an acute angle on the top side is formed on the base end side surface of the second engagement portion 143.
  • the deformation inducing portion 150 is disposed on the distal end side of the connecting member 140, and a tapered surface 151 that is inclined with respect to the advancing / retreating direction of the connecting member 140 is formed on the base end side surface. As shown in FIG. 11B, the tapered surface 151 is brought into contact with the projecting direction end portion of the first engaging portion 142 when the connecting member 140 moves to the tip end side, and the tip end of the connecting member 140 is moved to the first end.
  • the engaging part 142 and the second engaging part 143 are deformed so as to bend in a direction opposite to the protruding direction.
  • the terminal 83 is pushed toward the proximal end side by the first engaging portion 142 and moved together, and the holding portion 20 is retracted. Will do.
  • the operation switching unit 130 can connect or independent the movement of the holding unit 20 with respect to the slide unit 100 due to the forward / backward movement of the slide unit 100.
  • a push button 93 of a coupling mechanism 90 (see FIG. 2) is provided at the tip of the main body 71.
  • the coupling mechanism 90 is for facilitating the attachment / detachment of the guiding sheath 3 with respect to the main body 71, and the flange provided at the proximal end of the guiding sheath 3 is inserted into the main body with the push button 93 pressed.
  • the push button 93 is released after being fitted into the insertion hole formed in 71, the flange portion of the guiding sheath 3 is engaged with the engagement hole 94 of the sliding member 91 as shown in FIG. To do.
  • a side port 37 is formed on the proximal end side of the guiding sheath 3, and a contrast agent or the like can be injected from the side port 37.
  • connection hole 74 corresponding to the outer shape of the output connector 87 is provided in the base end portion of the main body 71, and an electrode of the input connector 75 is provided in the connection hole 74. Terminals are arranged.
  • 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 is formed in a part of the side of the guide bar 88 ⁇ / b> A, and the guide bar 88 ⁇ / b> A and the main pipe 63 retreat with respect to the main body 71 together with the slide part 100. If they match, the output connector 87 can be connected to the input connector 75.
  • the connection between the energy supply means 4 and the input connector 75 which is the most important procedure in the procedure and requires carefulness, can be performed only after the clamping of the living tissue M is completed. Is increased.
  • the main body 71 is provided with a window 73 opened adjacent to the input connector 75.
  • an “OK” display portion H is written in the vicinity of the notch portion 89.
  • the positioning and holding means 60 is drawn into the catheter main body 10 and recovered, and when the terminal 83 that allows the holding portion 20 to conduct is in contact with the contact member 85, finally, “OK” is obtained.
  • the display portion H appears in the window 73.
  • a lock-unlock mechanism 102 shown in FIGS. 13 and 14 is provided on the slide portion 100, and by pressing the push piece 109, the slide movement of the slide portion 100 is locked-unlocked and the operation wire 14 is moved in the axial direction. Lock-unlock.
  • the lock-unlock mechanism 102 connects the slide part 100 and the main body part 71 by sliding the operating member 104, or allows the slide part to move by releasing the lock.
  • the positioning / holding means 60 which will be described later, provided at the distal end of the operation wire 14 holds or positions the living tissue M, the operation wire first that temporarily stops the advance / retreat operation of the operation wire 14 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.
  • 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.
  • the release of the first lock portion R1 and the release of the second lock portion R2 are interlocked, so that the long operation wire 14 is connected from the left atrial side.
  • the pulling operation and the operation of making the operation wire 14 straight to pull out the operation wire 14 can be linked, and the pulling operation in a state where the operation wire 14 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.
  • the second lock portion R2 for the operation wire 14 includes a locking portion 105 formed on the operation member 104 and a large-diameter portion 106 that is fixed to the operation wire 14 and is larger than the outer diameter of the operation wire 14. It is configured.
  • a stainless pipe can be applied as the material of the large-diameter portion 106.
  • the large-diameter portion 106 is fixed to the operation wire 14 by a known technique corresponding to a material such as welding, adhesion, or fusion.
  • the second lock portion R2 has a wedge shape having a wide width portion G1 and a narrow width portion G2 as a locking portion 105 provided on the operating member 104 in order to temporarily stop the advance / retreat operation of the operation wire 14 in the axial direction. It is a through hole. By using the wedge-shaped through hole as described above, the large-diameter portion 106 can be pinched more simply by moving the operation wire 14 through the through-hole.
  • a puncture (puncture) operation is performed by the needle unit 30, but the holding and positioning of the living tissue M is performed by pulling the operation wire 14. Do it. Even if the operation wire 14 is pulled to hold and position the living tissue M, the puncture operation cannot be performed unless the holding state and the positioning state are maintained. Therefore, when the operation wire 14 is pulled, the second lock portion R2 locks the large-diameter portion 106 to the locking portion 105 (in some cases, the edge portion 105a of the through hole), and temporarily holds the operation wire 14 in place. Thus, even if the hand holding the operation wire 14 is released, the holding state and the positioning state can be maintained, and only the puncture operation by the needle portion 30 can be performed alone.
  • the tip of the operation wire 14 automatically becomes straight due to the elasticity of the linear portions 66 and 67 in the holding portion 62 described later, and the holding state of the oval hole valve M2 is easily released. it can.
  • a restriction hole 108 having a size in which the large diameter part 106 cannot pass in the proximal direction is formed in the internal passage through which the operation wire 14 of the slide part 100 is inserted. Therefore, when the operation wire 14 is pulled, the operation wire 14 can be pulled until the large-diameter portion 106 fixed to the operation wire 14 reaches the restriction hole 108, but beyond that, the operation wire 14 is moved with respect to the slide portion 100. It is impossible to let them.
  • 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.
  • the positioning and holding means 60 generally makes the needle positioning portion 61 for positioning the needle portion 30 with respect to the foramen ovale O and the oval hole valve M ⁇ b> 2 not retractable with respect to the puncture direction of the needle portion 30.
  • the holding portion 62 to be held and the main pipe 63 to be fixedly held on the slide portion 100 are normally accommodated in the guiding sheath 3. By operating the main pipe 63, it is pushed out from the guiding sheath 3.
  • the central lumen L5 formed in the tip 40 is provided with a main pipe 63 and an operation wire 14 provided so as to be movable forward and backward in the axial direction within the main pipe 63 (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 and collected.
  • the operation wire 14 protrudes from the rear end of the catheter body 10 through the main pipe 63 and through the internal passage of the slide portion 100.
  • the proximal end of the operation wire 14 is connected to a grasping portion 50 for an operator to grasp with the finger in order to move the operation wire 14 back and forth or rotate.
  • a needle positioning portion 61 is provided at the distal end portion of the main pipe 63.
  • the needle positioning portion 61 is for positioning the needle portion 30 with respect to the oval hole O.
  • the needle positioning portion 61 is elastically expanded / reduced by operation of the operation wire 14 (shaft portion). It is composed of two linear portions 66. The proximal end of the second linear portion 66 is attached to the outer surface of the main pipe 63, and the distal end is attached to an intermediate cylindrical body 64 through which the operation wire 14 is inserted.
  • the two first linear portions 67 are formed of, for example, a NiTi alloy or the like, are elastically deformable, and bend in a direction away from each other at a substantially central portion so as to bend away from each other when a compressive force is applied.
  • the curved portion 66A is formed.
  • the first linear portion 66 is formed of a NiTi alloy or the like, but the material is not limited to this, and for example, stainless steel or the like may be used.
  • the holding part 62 holds the needle part 30 from the back side so that the foramen ovale valve M2 can be easily punctured, and includes a tip member 68 provided at the tip part of the operation wire 14, a tip cylinder 65 (cylinder). Part), a pair of first linear portions 67 formed integrally with the distal end cylindrical body 65, and a reinforcing member 69 for reinforcing the distal end cylindrical body 65.
  • the distal end member 68 is fixed to the distal end of the operation wire 14, the distal end tubular body 65 and the intermediate tubular body 64 are inserted through the operation wire 14, and the first linear portion 67 has a proximal end fixed to the distal end of the intermediate tubular body 64.
  • the distal end side is fixed to the distal end cylindrical body 65.
  • the intermediate cylinder body 64 is provided on the distal end side of the intermediate cylinder base end section 641 with the base end side slidably inserted into the main pipe 63 on the base end side, and has an outer diameter of the main pipe 63.
  • An intermediate cylindrical abutting portion 642 that is larger than the inner diameter
  • an intermediate cylindrical proximal end fixing portion 643 that is provided on the distal end side of the intermediate cylindrical abutting portion 642 and to which the distal end of the second linear portion 66 is fixed
  • An intermediate cylinder distal end side fixing portion 644 provided on the distal end side of the intermediate cylinder 64 and to which the proximal end of the first linear portion 67 is fixed.
  • the intermediate cylinder 64 is formed by processing a metal tube such as stainless steel. Since the intermediate cylinder abutting portion 642 has an outer diameter larger than the inner diameter of the main pipe 63, even if the intermediate cylinder base end 641 is accommodated inside the main pipe 63, the intermediate cylinder abutting portion 642 is not connected to the main pipe 63. The main pipe 36 is abutted against the intermediate cylinder abutting portion 642 without being housed inside.
  • the intermediate cylinder base end side fixing portion 643 has notches 643A and 643B formed on the distal end side and the proximal end side thereof, and the two second linear portions 66 are intruded into the inside from the notch portion 643B on the proximal end side.
  • the second linear portion 66 is fixed so as to be sandwiched between the crushed tube bodies by caulking the tube body in a state of being crushed.
  • the operation wire 14 is arrange
  • the intermediate cylinder distal end side fixing portion 644 has a notch 644A formed on the proximal end side thereof, so that the tubular body is crushed in a state where the two first linear portions 67 have entered from the opening on the distal end side.
  • the first linear portion 67 is fixed so as to be sandwiched between the crushed tube bodies.
  • the operation wire 14 is arrange
  • the needle positioning part 61 displaces the second linear part 66 outward with the base end attached to the main pipe 63 as a fulcrum by an operation of moving the operating wire 14 in the axial direction, and each second linear part 66 is moved to the egg.
  • the inner edge of the circular hole O is pressed with substantially equal elastic force, and the needle part 30 is aligned with the oval hole O. That is, it is possible to exert a function of positioning the needle part 30 located between the second linear parts 66 in the central part of the foramen ovale O.
  • the reinforcing member 69 is formed by processing a metal tube such as stainless steel.
  • the reinforcing member 69 is provided on the base end side, the reinforcing member fixing portion 691 to which the tip of the first linear portion 67 is fixed, the base end side of the tip cylindrical body 65, and the tip end side of the first linear portion 67.
  • the tube-shaped reinforcing member tubular portion 692 is covered.
  • the reinforcing member fixing portion 691 has a notch portion 691A formed at the distal end side thereof, and is squeezed so as to crush the tubular body with the two first linear portions 67 entering the inside from the opening portion on the proximal end side. Thus, the first linear portion 67 is fixed so as to be sandwiched between the crushed tube bodies.
  • the operation wire 14 is disposed not on the inside of the crimped tube body but on the outside (see FIG. 16A).
  • the reinforcing member tubular portion 692 covers the outer peripheral surface of the proximal end side of the distal end cylindrical body 65, and is fixed to the distal end cylindrical body 65 by welding or using an adhesive.
  • the intermediate cylindrical body distal end side fixing portion 644 of the intermediate cylindrical body 64 and the reinforcing member fixing portion 691 of the reinforcing member 69 have crimped side surfaces in the same direction (see FIG. 16A).
  • the cylinder base end side fixing portion 643 is crimped on the side surface in the opposite direction (see FIG. 16B).
  • the distal end cylindrical body 65 and the first linear portion 67 are formed of, for example, stainless steel and are included in the flexible member 6 configured by the same wire.
  • the distal end cylindrical body 65 is formed in a cylindrical shape by alternately winding two wires, and the first linear portion 67 is configured such that the two wires constituting the distal end cylindrical body 65 are wired from the distal end cylindrical body 65. It is formed extending in a shape.
  • the two first linear portions 67 are elastically deformable, and are bent at a substantially central portion so as to bend away from each other when a compressive force is applied. have. As shown in FIG.
  • the two first linear portions 67 are located at positions relatively less than 180 degrees in the winding direction of the wire at the end portion of the distal end cylindrical body 65 (see the angle ⁇ in FIG. 18). ) To the proximal side.
  • the distal end cylindrical body 65 and the first linear portion 67 are integrally formed of the same wire.
  • the side of the two first linear portions 67 that is less than 180 degrees is connected to the intermediate cylindrical body 64 and the reinforcing member 69, and the intermediate cylindrical distal end side fixing portion 644 and the reinforcing member are connected.
  • the fixing portion 691 is arranged on the side (lower side in FIG. 19) opposite to the crimped and recessed side (upper side in FIG. 19). For this reason, the pair of first linear portions 67 are biased with respect to the operation wire 14 that penetrates the distal end cylindrical body 65.
  • the intermediate cylinder 64, the tip cylinder 65, the first linear portion 67, the tip member 68, and the reinforcing member 69 that connect both the cylinders 64 and 65 are a bending mechanism W that bends or curves the tip of the operation wire 14. Is configured.
  • the bending mechanism W is used for holding the foramen ovale valve M2.
  • the needle portion 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 bends or curves the first linear portion 67 between the distal end member 68 and the distal end side of the second linear portion 66 by retracting the operation wire 14 in the axial direction, thereby The oval hole valve M2 is held from the back side by 68 and the front end cylinder 65. That is, the bending mechanism W is configured such that the distal end portion of the operation wire 14 is bent or curved with the distal end side of the second linear portion 66 attached to the main pipe 63 as a fulcrum.
  • the bending mechanism W of the holding portion 62 is bent after the second linear portion 66 of the needle positioning portion 61 aligns and positions the needle portion 30 with respect to the oval hole O, and the oval hole valve M2 is bent. Since the second linear portion 66 needs to be deformed prior to the first linear portion 67, the first linear portion 67 and the second line are required to be deformed prior to the first linear portion 67. The rigidity of the shape portion 66 is changed.
  • the surgeon inserts an introducer (an assembly in which a dilator is inserted into the guiding sheath 3) from the femoral vein. After the distal end of the guiding sheath 3 reaches the left atrium L via the inferior vena cava J and the right atrium R, the dilator is removed from the guiding sheath 3.
  • an introducer an assembly in which a dilator is inserted into the guiding sheath 3
  • the pressing 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.
  • 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.
  • the slide part 100 When the slide part 100 is retracted with respect to the main body part 71 and the needle operation lever 78 and the sandwiching part operation lever 122 are also retracted, the main pipe 63, the wire part 22 of the sandwiching part 20, the needle part 30 and the like are accommodated in the catheter body 10. It will be in the state. At this time, the connecting member 140 of the operation switching unit 130 moves to the base end side together with the slide unit 100, the terminal 83 is pushed to the base end side by the first engagement unit 142, and the clamping unit 20 is retracted. ing.
  • the device is inserted into the guiding sheath 3 and passes through the inferior vena cava J / right atrium R to reach the left atrium L.
  • the slide part 100 is advanced relative to the main body part 71.
  • the main pipe 63 moves forward, the pressing piece 109 of the lock-unlock mechanism 102 is pressed, and the large diameter portion 106 of the operation wire 14 is inserted into the narrow width portion G2 of the through hole 105 formed in the operating member 104. Is not hit, that is, the second lock portion R2 is unlocked, and the operation wire 14 is free.
  • the positioning holding means 60 is advanced by the main pipe 63 fixed to the slide part 100, and at the same time, the clamping part 20 is also advanced. That is, as shown in FIG. 11A, when the slide portion 100 is advanced relative to the main body portion 71, the operation switching portion 130 connected to the guide bar 88A fixed to the slide portion 100 is advanced, The terminal 83 sandwiched between the first engaging portion 142 and the second engaging portion 143 is pushed and moved by the second engaging portion 143 to the distal end side. In this way, the positioning and holding means 60 and the clamping unit 20 can be moved simultaneously by simply moving the slide unit 100.
  • the tip of the connecting member 140 comes into contact with the tapered surface 151 of the deformation inducing part 150, and the connecting member 140 is connected to the first engaging part 142 and The second engaging portion 143 is deformed so as to bend in a direction opposite to the protruding direction.
  • the connecting member 140 is deformed, the terminal 83 is detached from between the first engaging portion 142 and the second engaging portion 143, and the engagement between the operation switching portion 130 and the terminal 83 is released. Thereby, even if the slide part 100 is further moved to the front end side, the terminal 83 does not move to the front end side, and the movement of the clamping part 20 is independent from the connecting member 140.
  • the distal end of the operation wire 14 is projected from the distal end cylindrical body 65 from the distal end of the main pipe 63.
  • 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 14 can rotate 360 degrees, the operation wire 14 can be advanced while rotating, and can be easily inserted into the left atrium L.
  • the operator holds the grasping portion 50 until the distal end member 68 at the distal end of the operation wire 14 abuts on the distal end cylindrical body 65 as shown in FIG. Tow the operating wire 14 backward.
  • the large-diameter portion 106 shown in FIGS. 13 and 14 also retracts.
  • the operating member 104 is moved upward by the elastic force of the spring 107 unless the pressing piece 109 is pressed. Therefore, the operation wire 14 is held between the narrow-width part G2 of the wedge-shaped through hole 105 and the inner peripheral surface of the internal passage Qb with a force that can be slid at all times.
  • the pulling operation can be smoothly performed when the operation wire 14 is retracted.
  • the main-body part 71 is operated, the 1st linear part 67, the clamping part 20, and the needle part 30 are located in the vicinity of the foramen ovale valve M2, and it is set as the state which inserted the holding
  • the operation force for retracting the operation wire 14 causes the proximal end of the main pipe 63 to pass through the distal end member 68, the distal end cylindrical body 65, the first linear portion 67, and the intermediate cylindrical body 64.
  • the second linear portion 66 is deformed so as to project in an arc shape radially outward.
  • the first linear portion 67 is not deformed.
  • the needle portion 30 provided in the immediate vicinity of the second linear portion 66 is moved into the oval hole. Aligning with O, the needle part 30 is positioned at the center of the foramen ovale O.
  • the operation direction of the distal end cylinder 65 and the distal end member 68 is exposed to the outside at the caulked and recessed portions of the intermediate tubular body distal end side fixing portion 644 and the reinforcing member fixing portion 691.
  • the operation wire 14 The position of the two first linear portions 67 that are the fulcrums of the deformation is pulled from the position where the force is applied by the pulling of the operation wire 14, and is more distal than the first linear portion 67.
  • the distal end cylindrical body 65 and the distal end member 68 are easily moved outward in the radial direction. Since the proximal end portion of the distal end cylindrical body 65 is covered by the reinforcing member 69, the first linear portion 67 can be mainly deformed without bending the proximal end portion of the distal end cylindrical body 65. As a result, the distal end cylindrical body 65 and the distal end member 68 on the distal end side with respect to the first linear portion 67 are inclined toward the outer side in the radial direction, and can be moved to contact with the intermediate cylindrical body 64 so as to draw an arc. .
  • the distal end member 68 and the distal end tubular body 65 move so as to approach the needle portion 30, so that the distal end member 68 and the distal end tubular body 65 are connected to the oval hole valve. It abuts against the left atrial surface of M2 and holds it. At this time, the portion of the tip member 68 that is not covered with the reinforcing member 69 on the tip side has a coil shape that can be elastically deformed, and thus can be bent and smoothly contact the oval valve M2. To do.
  • the large-diameter portion 106 is pushed into the locking portion 105, which is a wedge-shaped through hole, and the operation wire 14 is locked.
  • the holding state is reliably maintained, the holding of the foramen valgus valve M2 does not loosen, and the operator advances the needle operation lever 78 with only one hand. It becomes possible.
  • the tensile load of the operation wire 14 does not act on the gripping part 50 from the second fastening part 16. It acts on the gripping part 50 only from the part 15. For this reason, the fracture
  • the torsional load can be received by the gripping part 50 via the second fastening part 16, and the torsional load hardly acts on the first fastening part 15 located on the proximal end side with respect to the second fastening part 16. For this reason, the influence of the torsional load is reduced between the first fastening portion 15 and the operation wire 14, and the gripping portion 50 can be stably separated from the operation wire 15 by a predetermined tensile load.
  • the operation wire 14 and the second fastening portion 16 in the gripping portion 50 escape from the opening portion 51 to the distal end side.
  • the second fastening portion 16 is not caught by the grip portion 50, and an unnecessary tensile load is not generated between the tip member 68 and the operation wire 14, and the tip member 68 can be more reliably prevented from falling off.
  • a tensile load generated between the operation wire 14 and the tip member 68 when the large diameter portion 106 reaches the restriction hole 108 In order to prevent the tip member 68 from dropping before the large diameter portion 106 reaches the restriction hole 108, a tensile load generated between the operation wire 14 and the tip member 68 when the large diameter portion 106 reaches the restriction hole 108.
  • the positional relationship between the large-diameter portion 106 and the restriction hole 108 needs to be set so as to be lower than the breaking strength between the operation wire 14 and the tip member 68.
  • this embodiment is provided with a safety mechanism for preventing the tip member 68 from falling off, this safety mechanism does not operate only when the surgeon pulls the grip portion 50 too strongly. For example, even when the tip member 68 is caught by something and an excessive force acts between the tip member 68 and the operation wire 14, the tip member 68 operates effectively.
  • the clamping portion operation lever 122 is operated so as to be slightly pulled into the lumens L3 and L4 from the state in which the wire portion 22 protrudes from the lumens L3 and L4.
  • the operation switching unit 130 since the operation switching unit 130 has already been released and the movement of the clamping unit 20 is already independent of the slide unit 100, without affecting the main pipe 63 that moves in conjunction with the slide unit 100, Only the wire portion 22 can be operated by the holding portion operation lever 122.
  • the needle distal end portion 31 of the needle portion 30 protrudes from the distal end of the catheter main body 10, and as shown in FIG. Needle tip 31 is pierced. At this time, since the needle tip 31 is curved and the lumens L1 and L2 are also curved, the two needle tips 31 protrude while expanding outward (see FIG. 2).
  • the rotational direction position of the distal end portion of the catheter body 10 is an appropriate position with respect to the living tissue M, Since the oval hole valve M2 is held by the positioning holding means 60, the needle tip 31 can be punctured at an appropriate position of the oval hole valve M2.
  • the position of the needle part 30 becomes 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.
  • the holding portion operation lever 122 When the puncturing is completed, the holding portion operation lever 122 is operated to cause the wire portion 22 to protrude from the lumens L3 and L4 to the distal end side. Thereby, as shown in FIG. 27, the flat plate portion 21 is separated from the atrial septum M1.
  • the clamping unit 20 can be operated independently of the positioning and holding means 60 and the like by the clamping unit operating lever 122. Therefore, even if an operation for separating the flat plate unit 21 from the living tissue M is performed, the positioning unit 20 is positioned. Other parts such as the holding means 60 do not move in conjunction with each other, and the positioning position of the foramen ovale valve M2 can be maintained as appropriate.
  • the terminal 83 is pushed toward the proximal end side by the first engaging portion 142 of the operation switching portion 130 and moves together, and the flat plate portion 21 is retracted. Then, when the wire portion 22 is drawn into the lumens L3 and L4, as shown in FIG. 29, the wire portion 22 is deformed in a straight shape, so that the flat plate portion 21 comes into contact with the atrial septum M1 and the needle tip 31 is formed. The atrial septum M1 and the foramen ovale M2 are sandwiched between the flat plate portion 21 and the atrial septum M1.
  • the terminal 83 is retracted to contact the contact member 85, and the clamping unit 20 and the input connector 75 are in an electrically conductive state.
  • both the clamping part 20 and the needle part 30 are in a state capable of supplying electrical energy.
  • the needle operation lever 78 shown in FIG. 22 is retracted to the state shown in FIG. 23, and the needle portion 30 is accommodated in the tip tip 40.
  • 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.
  • the output connector 87 is removed from the input connector 75.
  • the clamping part operation lever 122 or the slide part 100 may be advanced to advance the flat plate part 21, and the flat plate part 21 may be separated from the atrial septum M1.
  • the holding part operation lever 122 or the slide part 100 is operated to retract, and the wire part 22 is accommodated in the lumens L3 and L4 again.
  • connection mechanism 90 is pressed to release the connection between the guiding sheath 3 and the main body 71 and the main body 71 is moved away from the living body, the device is pulled out using the guiding sheath 3 as a guide. It is. Thereafter, when the guiding sheath 3 is removed from the living body, the procedure is completed.
  • a second fastening portion that is coupled to the operation wire and restricts movement of the operation wire in the rotation direction with respect to the grip portion, and allows movement of the operation wire in the axial direction with respect to the grip portion.
  • the movement of the operation wire 14 in the rotational direction is restrained with respect to the grip 50 by the second fastening portion 16, and the axial movement in the axial direction is performed. Since the movement is permitted with respect to the gripping portion 50, the first fastening portion 15 hardly generates a twisting load. In the first fastening portion 15 that receives a tensile load, the gripping portion 50 is moved by the predetermined tensile load. Can be separated stably.
  • the torsional load transmitted from the distal end side than the second fastening portion 16 of the operation wire 14 is first.
  • the torsional load is hardly transmitted to the first fastening part 15 received by the two fastening parts 16 and closer to the base end side than the second fastening part 16, and the influence of the torsional load on the first fastening part 15 is further reduced.
  • the holding part 50 has the open part 51 from which the 2nd fastening part 16 can escape at the front end side, when the 1st fastening part 15 isolate
  • the restraining strength (breaking strength) in the direction that is connected to the distal end side of the operation wire 14 and is separated in the axial direction with respect to the operation wire 14 is separated in the axial direction with respect to the operation wire 14 of the first fastening portion 15. Since the distal end member 68 is higher than the restraining strength (breaking strength) in the direction in which the distal end member 68 is pulled, even if a strong tensile load acts between the distal end member 68 and the operation wire 14, before the distal end member 68 falls off the operation wire 14. Moreover, since the 1st fastening part 15 isolate
  • the first fastening portion 15 is larger than the outer diameter of the operation wire 14, and the gripping portion 50 has a restriction hole 53 having a size that the operation wire 14 is inserted and the first fastening portion 15 cannot pass through.
  • the restriction hole 53 causes the first fastening portion 15 to move in the axial direction. Before the tip member 68 is broken from the operation wire 14, the connecting portion of the operation wire 14 to the first fastening portion 15 can be broken.
  • a distal end cylinder 65 (cylinder portion) having a through-hole through which the operation wire 14 is inserted and the distal end member 68 cannot pass, and extends from the distal end cylinder 65 to the proximal end side. Since it has the 1st linear part 67 which deform
  • the distal end cylindrical body 65 (cylinder portion) is provided in the holding portion 62 that is inserted into the foramen ovale O, which is a defect of the living tissue M, and holds the foramen ovale valve M2 while pressing it toward the atrial septum M1. Therefore, the foramen ovale valve M2 can be favorably held by pressing the foramen ovale valve M2 toward the atrial septum M1 by the distal end cylinder 65 that is movable radially outward.
  • the living tissue M is sandwiched between the needle portion 30 and the needle portion 30, which is an electrode that pierces the living tissue M around the defect O existing in the living tissue M, and current is passed between the needle portion 30. Since it has the clamping part 20 which is an electrode which can be made to flow, after piercing the needle part 30 in the biological tissue M, the biological tissue M is clamped between the needle part 30 and the clamping part 20, and an electric current is sent.
  • the tissue M can be bonded well.
  • the second linear portion 66 for positioning the needle portion 30 as an electrode with respect to the foramen ovale O by deforming by the axial movement of the operation wire 14 and coming into contact with the inner edge of the foramen ovale O. Therefore, the needle part 30 can be positioned at an appropriate position with respect to the oval hole O, and an electric current can be passed to the appropriate position.
  • a large diameter portion 106 larger than the outer diameter of the operation wire 14 is fixed to the operation wire 14, and the operation wire 14 is inserted into the proximal end of the catheter 1 and the large diameter portion 106 cannot pass through in the proximal direction. Since the restriction hole 108 having a large size is formed, when the operation wire 14 is pulled and the large diameter portion reaches the restriction hole 108, the operation wire 14 cannot be pulled, and the operation wire 14 and the tip member 68 are not pulled. The increase in the tensile load is restricted, and the tip member 68 is prevented from dropping from the operation wire 14.
  • the medical device according to the second embodiment is a PFO closure device that is different from the PFO closure device according to the first embodiment only in the configuration of the grip portion 160, the first fastening portion 171 and the second fastening portion 172.
  • part which has the same function as 1st Embodiment the same code
  • the gripping portion 160 of the PFO closure device has a second fastening portion 172 fixed to the proximal end portion of the operation wire 14, and is more distal than the second fastening portion 172.
  • the first fastening portion 171 is fixed to the operation wire 14.
  • the first fastening portion 171 is larger than the outer diameter of the operation wire 14, and the cross-sectional area of the connection portion between the operation wire 14 and the first fastening portion 171 is the disconnection of the connection portion between the operation wire 14 and the tip member 68. It is smaller than the area.
  • the 1st fastening part 171 is spherical in this embodiment, it is not necessarily limited to spherical.
  • the second fastening portion 172 has an elliptical cross-sectional shape that is elliptical (non-perfect circle), and the axially orthogonal sectional shape at each point in the axial direction is the same elliptical shape.
  • the gripping portion 160 includes a restriction hole 161 through which the operation wire 14 is inserted from the distal end side, an accommodation portion 162 that is formed to communicate from the restriction hole 161 to the proximal end side and accommodates the first fastening portion 171, and an accommodation portion An insertion hole 163 communicating from the 162 to the proximal end side, and an opening portion 164 communicating from the insertion hole 163 to the proximal end side and opened to the proximal end side of the gripping portion 160 are provided.
  • the open portion 164 has an elliptical shape in which the axially orthogonal cross section of the inner peripheral surface is in contact with the outer peripheral surface of the second retaining portion 172 with a clearance, and can slide in the axial direction with the outer peripheral surface of the second retaining portion 172. It is. For this reason, the second fastening portion 172 is restrained so as not to rotate with respect to the gripping portion 160 inside the opening portion 164, but is allowed to move in the axial direction without being restrained with respect to the gripping portion 160.
  • the regulation hole 161 is formed in such a size that the operation wire 14 can pass through, but the first fastening portion 171 cannot pass through.
  • the accommodating part 162 accommodates the 1st fastening part 171 rotatably. Therefore, the movement of the operation wire 14 in the axial direction of the first fastening portion 171 is restrained with respect to the grip portion 160 in the housing portion 162.
  • the gripping part 160 When the gripping part 160 is gripped by hand and moved forward and backward, the movement of the first fastening part 171 in the axial direction with respect to the gripping part 160 is restrained, so the operation wire 14 connected to the first fastening part 171 is moved. It can be moved forward and backward. At this time, since the second fastening portion 172 is allowed to move in the axial direction with respect to the gripping portion 160, the tensile load of the operation wire 14 does not act on the gripping portion 160 from the second fastening portion 172.
  • the grip portion 160 when the grip portion 160 is gripped and rotated by hand, the movement of the second fastening portion 172 with respect to the grip portion 160 in the rotational direction is restricted, and thus the operation wire 14 connected to the second fastening portion 172 is used. Can be rotated.
  • the 2nd fastening part 172 is located in the front end side rather than the 1st fastening part 171, since the 1st fastening part 171 can rotate within the accommodating part 162, it receives the torsional load in the 2nd fastening part 172. Can do.
  • the gripping part 160 When the operation wire 14 is twisted by gripping and rotating the gripping part 160 by hand, the gripping part 160 receives a twisting load via the second fastening part 172 away from the first fastening part 171. As shown in FIG. 33, it is possible to reduce the influence of the torsional load at the first fastening part 171 where the breakage is caused by the tensile load, and to stabilize the gripping part 160 from the operation wire 14 by a predetermined tensile load. Can be separated. ⁇ Third Embodiment>
  • the medical device according to the third embodiment is a PFO closure device that is different from the PFO closure device according to the first embodiment only in the configuration of the gripping portion 180 and the second fastening portion 190.
  • part which has the same function as 1st Embodiment the same code
  • the first fastening portion 15 is fixed to the proximal end portion of the operation wire 14, and the first fastening portion 15 of the operation wire 14. Further, a cylindrical second fastening portion 190 is fixed to the distal end side.
  • the second fastening portion 190 includes at least one (four in the present embodiment) convex portion 191 extending toward the proximal end side in the axial direction.
  • the gripping portion 180 includes an opening portion 181 having a space through which the operation wire 14 is inserted from the distal end side together with the second fastening portion 190, an insertion hole 182 communicating from the opening portion 181 to the proximal end side, and a proximal end from the insertion hole 182.
  • a restriction hole 183 formed to communicate with the side, and a receiving portion 184 communicating from the restriction hole 183 to the proximal end side and opened to the proximal end side of the gripping portion 180.
  • the opening portion 181 is formed such that the axial orthogonal cross section of the inner peripheral surface is larger than the second fastening portion 190.
  • a concave portion 185 is formed in which the convex portion 191 of the second fastening portion 190 is slidably inserted in the axial direction.
  • the second fastening portion 190 is restrained so as not to rotate with respect to the grip portion 50 by inserting the convex portion 191 into the concave portion 185 inside the open portion 181, but in the axial direction, the grip portion 180. The movement is allowed without being restricted.
  • the regulation hole 183 is formed in such a size that the operation wire 14 can pass through but the first fastening portion 15 cannot pass through.
  • the first fastening portion 15 is fixed to the gripping portion 180 in the housing portion 184 by the adhesive 55, and the movement of the operation wire 14 in the axial direction is restrained with respect to the gripping portion 180.
  • the gripping part 180 When the gripping part 180 is gripped by hand and moved forward and backward, the movement of the first fastening part 15 in the axial direction with respect to the gripping part 180 is restricted, so the operation wire 14 connected to the first fastening part 15 is moved. It can be moved forward and backward. At this time, since the second fastening part 190 is allowed to move in the axial direction with respect to the gripping part 180, the tensile load of the operation wire 14 does not act on the gripping part 180 from the second fastening part 190.
  • the gripping part 180 is gripped and rotated, the movement of the second fastening part 190 with respect to the gripping part 180 in the rotational direction is restrained, and therefore the operation wire 14 connected to the second fastening part 190. Can be rotated.
  • the second fastening portion 190 is located on the tip side of the first fastening portion 15, the torsional load can be received by the second fastening portion 190 and hardly acts on the first fastening portion 15.
  • the medical device includes a snare catheter 200 that is used to collect and remove vascular embolization substances that are misplaced in a living body, broken pieces such as catheters and guide wires, and foreign substances in blood vessels such as stents. It is.
  • the snare catheter 200 includes a catheter main body 201 (tubular body), an introducer 202 inserted into the catheter main body 201, a snare wire 203 (operation wire) inserted into the introducer 202, It has a loop 204 (tip member) connected to the distal end of the snare wire 203 and a grip portion 205 connected to the proximal end of the snare wire 203.
  • any of the gripping units described in the first to third embodiments is applied to the gripping unit 205 of the fourth embodiment, but the description thereof is omitted here.
  • the loop 204 When using the snare catheter 200, the loop 204 is inserted into the blood vessel while being accommodated in the catheter main body 201, and then the loop 204 is projected from the catheter main body 201 by the gripping portion 205 to be deployed. To capture. Thereafter, the grasping portion 205 is pulled to draw the foreign matter into the catheter body 201, and the foreign matter in the blood vessel is collected and removed. At this time, since the grip portion 205 is provided, when a strong tensile load acts on the snare wire 203, the snare wire 203 is pulled from the grip portion 205 by a predetermined tensile load before the loop 204 is dropped from the snare wire 203. Separation is stable, and dropping of the loop 204 in the lumen is suppressed.
  • the present invention is not limited to the above-described embodiment, and various modifications can be made by those skilled in the art within the technical idea of the present invention.
  • the first to third embodiments have been described for use in the treatment of closing a PFO deficiency.
  • the present invention is not limited to this, and a passage-like deficiency such as a left atrial appendage closure device is closed. It can also be used in the case of or when necrotizing a living tissue at a predetermined site.
  • any device that is provided with a tube body and a shaft portion that move relatively in the living body can be applied to various devices that are not thermal processing devices.
  • the shape of the cross section perpendicular to the axis of the second fastening portion is not particularly limited as long as the second fastening portion is non-rotating in the gripping portion.
  • the two fastening portions 211 may be provided inside the gripping portion 210, or the second fastening portion 221 having a triangular axis orthogonal cross section may be provided inside the gripping portion 220 as shown in FIG. 39.
  • the second fastening portion 231 can be easily configured and provided inside the grip portion 230 by caulking the pipe after the pipe is put on the operation wire 14. Further, the operation wire itself may be deformed to form the second fastening portion.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
PCT/JP2012/074465 2012-09-25 2012-09-25 Dispositif médical Ceased WO2014049675A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/JP2012/074465 WO2014049675A1 (fr) 2012-09-25 2012-09-25 Dispositif médical

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS54150796U (fr) * 1978-04-13 1979-10-19
JP2009018160A (ja) * 2007-07-10 2009-01-29 Olympus Medical Systems Corp 内視鏡用処置具
WO2012043066A1 (fr) * 2010-09-29 2012-04-05 テルモ株式会社 Dispositif médical

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS54150796U (fr) * 1978-04-13 1979-10-19
JP2009018160A (ja) * 2007-07-10 2009-01-29 Olympus Medical Systems Corp 内視鏡用処置具
WO2012043066A1 (fr) * 2010-09-29 2012-04-05 テルモ株式会社 Dispositif médical

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