WO2013137094A1 - Dispositif médical et son procédé de production - Google Patents

Dispositif médical et son procédé de production Download PDF

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Publication number
WO2013137094A1
WO2013137094A1 PCT/JP2013/056233 JP2013056233W WO2013137094A1 WO 2013137094 A1 WO2013137094 A1 WO 2013137094A1 JP 2013056233 W JP2013056233 W JP 2013056233W WO 2013137094 A1 WO2013137094 A1 WO 2013137094A1
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WIPO (PCT)
Prior art keywords
engagement member
tube
protrusion
distal end
needle
Prior art date
Application number
PCT/JP2013/056233
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English (en)
Japanese (ja)
Inventor
長隆之
山口薫
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テルモ株式会社
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Publication date
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Publication of WO2013137094A1 publication Critical patent/WO2013137094A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1442—Probes having pivoting end effectors, e.g. forceps
    • A61B18/1445—Probes having pivoting end effectors, e.g. forceps at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1477—Needle-like probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00353—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery one mechanical instrument performing multiple functions, e.g. cutting and grasping
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, e.g. tourniquets
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00166—Multiple lumina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00357—Endocardium
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/0038—Foramen ovale
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1425—Needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1425—Needle
    • A61B2018/143—Needle multiple needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1475—Electrodes retractable in or deployable from a housing

Definitions

  • the present invention relates to a medical device and a manufacturing method thereof, and particularly to a medical device inserted into a lumen and a manufacturing method thereof.
  • 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 matters for the body, and blood clots are easily attached.
  • 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.
  • 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).
  • a living tissue is held by a positioning member provided at the tip of a shaft portion protruding from a catheter, and then the puncture member is inserted into a foramen ovale valve using a puncture member and a clamping member which are a pair of electrodes. After the puncture, the foramen ovale and the atrial septum are clamped between the clamping members, and electrical energy is applied to the living tissue for bonding.
  • the shaft portion on which the positioning member is provided can rotate around the axis inside the catheter (tube body) and can move forward and backward.
  • the positional relationship between the tube body and the shaft portion changes and the position with respect to the living tissue changes, which may make it difficult to perform puncture, clamping, or application of electric energy appropriately.
  • the present invention solves the above-mentioned problems, and can maintain a good positional relationship between the tubular body and the shaft portion even when a force such as extension or twisting acts on the shaft portion, improving operability and safety.
  • An object of the present invention is to provide a medical device that can be used and a method for manufacturing the same.
  • a medical device that achieves the above object includes a tube body that is inserted into a living body, and a shaft portion that is disposed so as to be capable of moving forward and backward in the tube body.
  • a protrusion is provided on one of the outer surfaces of the shaft, and a groove is provided on the other to allow the protrusion to enter as the shaft moves relative to the tubular body.
  • the projection portion enters the groove portion by moving the shaft portion relatively toward the tube body, even if a force such as extension or twisting acts on the shaft portion, The movement of the shaft portion in the axial direction and the circumferential direction with respect to the tube body is restricted, and a good positional relationship of the shaft portion with respect to the tube body can be maintained, so that operability and safety can be improved.
  • the groove and the protrusion are formed so that the circumferential gap between the protrusion and the groove is reduced by the relative movement of the protrusion toward the groove, the protrusion Is guided to the center of the groove portion as it enters the groove portion, the twist of the shaft portion where the protrusion portion is provided is corrected, and the displacement in the circumferential direction of the protrusion portion with respect to the tubular body is limited, thereby making it difficult to cause the twist. it can.
  • the protrusion and the groove are formed by an engagement member made of a material that can obtain higher rigidity than when formed by a material applied to the tube and the shaft, and the most distal portion of the engagement member is If the tube is provided at a distance of 90 mm or more from the most distal end of the tubular body to the proximal end side, it can be bent well because there is no engagement member on the distal end side of the device when inserted into the living body, and further, It is possible to suppress the joint member from being plastically deformed by bending, and the operability is not deteriorated and safety can be ensured.
  • the engaging member provided with the projection or groove provided in the tubular body has a concave portion or a convex portion formed at the distal end side or the proximal end side, the engaging member is attached to the tubular body.
  • the circumferential position of the engaging member can be accurately positioned by the concave portion or the convex portion.
  • a concave or convex portion is provided at the axial end of the engaging member, and the engaging member is inserted into the swollen tubular body by an auxiliary tool fitted to the concave or convex portion, When inserting, the rotation of the engaging member is limited, and the circumferential position of the engaging member can be accurately set.
  • 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. 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 hand operation unit taken along line 7-7 in FIG. 2;
  • FIG. 7 is an enlarged cross-sectional view of a hand operating unit taken along line 7-7 in FIG. 2;
  • FIG. 9B is a cross-sectional view of the hand operating portion along line 9-9 in FIG. 7 when moving the slide portion, and (A) is before the slide portion is advanced and the connecting member comes into contact with the displacement inducing portion; When the connecting member comes into contact with the displacement inducing portion, (C) is after the connecting member comes into contact with the displacement inducing portion, and (D) is when the connecting member reaches the proximal end side of the displacement inducing portion by retracting the slide portion. , (E) shows when the terminal is in contact with the contact member.
  • FIG. 10 is a cross-sectional view showing a coupling mechanism taken along line 10-10 in FIG.
  • FIG. 7 is a cross-sectional view of a lock-unlock mechanism portion taken along line 11-11 in FIG.
  • FIG. 12 is a cross-sectional view taken along line 12-12 of FIG. It is sectional drawing which shows the front-end
  • FIG. 1 It is a perspective view which shows an inner side engagement member
  • (A) connects a 1st main pipe member and a 2nd main pipe member to an inner side engagement member
  • (B) is a 1st main pipe member and a 2nd to an inner side engagement member. The case where the main pipe member was connected is shown.
  • FIG. 1 shows at the time of engaging an outer engagement member and an outer engagement member
  • (A) is before an inner engagement member engages with an outer engagement member
  • (B) is an inner side with an outer engagement member. It shows after the engaging member is engaged.
  • FIG. 1 It is a top view which shows the hand operation part at the time of operating a needle operation lever, (A) shows before operation, (B) shows after operation. It is an enlarged plan view which shows the hand operation part at the time of retreating a slide part, (A) is during retreating, (B) shows after retreating. It is an enlarged plan view which shows the hand operation part at the time of connecting an output connector to the input connector of a hand operation part. It is a top view of a hand operation part at the time of retracting a needle operation lever. It is the cross-sectional schematic when a positioning holding means is inserted in an oval hole. It is a cross-sectional schematic diagram at the time of hold
  • 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. It is a cross-sectional schematic diagram at the time of accommodating the positioning holding means in the device. It is a schematic cross-sectional view when the foramen ovale valve and the atrial septum are clamped by the needle unit and the clamping unit. (A) to (D) are schematic views showing the operating state of the positioning and holding means.
  • the medical device according to an embodiment of the present invention is a PFO closure device and will be outlined first with reference to FIGS. In FIG. 2, only the hand operating unit 70 is shown in a reduced state for the sake of space.
  • the PFO closure device is configured such that the proximal end of the catheter body 10 is attached to the proximal operation portion 70 and the proximal operation portion 70 can be connected to the proximal end.
  • a guiding catheter 3 through which the catheter body 10 can be inserted, and an energy supply means 4 for supplying electrical energy for fusing or necrosing the living tissue M (M1, M2).
  • 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.
  • the hand operating unit 70 side of the device is referred to as “base end side”
  • the pinching means K side is referred to as “tip side”.
  • the “catheter” represents one including a tube used for medical purposes.
  • the guiding catheter 3 is inserted from, for example, the femoral vein.
  • the guiding catheter 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 ( 7).
  • 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.
  • Perprene which is a thermoplastic polyester elastomer
  • the material of the catheter body 10 and the distal tip 40 is not limited to this.
  • nylon, polyethylene, polytetrafluoroethylene (PTFE) or the like may be used.
  • 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. 7) 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, and 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 operating unit 70 includes a gripping member 15 connected to a base end portion of the operation wire 14 for operating the operation wire 14, and a lock-unlock mechanism for locking and unlocking the sliding movement of the slide unit 100. 102 (see FIG. 12), and a push piece 109 for locking the axial movement of the operation wire 14 and an input connector 75 provided with an electrode terminal connected to the energy supply means 4 for applying thermal energy are provided. It has been.
  • a distal end member 68 is provided at the distal end of the operation wire 14, and a gripping member 15 is disposed at the proximal end.
  • the hand operation unit 70 is provided with various indications on the surface portion for guiding the operator to perform the correct operation in order to make the steps of various procedures visible.
  • a portion H (generic name for H1 to H6) is provided (see FIG. 18B for the process display portion H5).
  • the hand operation unit 70 includes a main body 71 on the side to which the guiding catheter 3 is connected and a main body 71 on the proximal end side of the main body 71. And a slide portion 100 connected via guide bars 88A, 88B, 88C so as to be close to and away from each other.
  • a needle operation lever 78 for operating the needle portion 30 is sandwiched on the upper surface of the main body portion 71.
  • a clamping unit operation lever 122 for operating the unit 20 is provided.
  • a recess 77 is formed on the 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 operation lever 78 has a bracket 80 that protrudes so as to reach the internal space 76 through a slit (not shown) formed in the main body 71.
  • 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 as shown in FIG. 8, and advances and retracts the needle 30.
  • a recess 121 is formed on the front surface (upper surface) of the main body 71, and a clamping unit operating lever 122 is 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 by an adhesive or the like (see FIG. 11), 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. 9), and an engaging portion 141 that can be engaged with and detached from the terminal 83 is formed on the distal end side (left side in FIG. 9).
  • 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.
  • 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. 9B, the tapered surface 151 is brought into contact with the projecting direction end of the first engaging portion 142 when the connecting member 140 moves to the tip end side, and the tip 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 clamping portion 20 is moved backward. 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 connecting mechanism 90 is for facilitating the attachment / detachment of the Y connector 72 to / from the main body 71, and the flange provided at the base end of the Y connector 72 is attached to the main body 71 while the push button 93 is pressed.
  • the push button 93 is released after being fitted into the formed insertion hole, the flange portion of the Y connector 72 is engaged with the engagement hole 94 of the sliding member 91 as shown in FIG. Then, the sliding member 91 is ejected by the spring member 92 to exhibit the function of preventing the flange portion from being detached, and the Y connector 72 can be detached by pressing the push button 93.
  • a Y connector 72 capable of injecting a contrast medium or the like to the distal end of the hand operation unit 70 by a connecting mechanism 90, but when the Y connector 72 is not used. Can directly connect the guiding catheter 3 having the flange portion to the main body portion 71.
  • 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 100, and the notch 89 is connected to the connection hole 74. 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 H6 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 H6 appears in the window 73.
  • a lock-unlock mechanism 102 shown in FIGS. 11 and 12 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.
  • the reference numeral “107” in FIGS. 11 and 12 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 elastic wire rods 66 and 67 in the holding part 62 automatically change the tip portion of the operation wire 14 into a straight shape so that the holding state of the foramen ovale valve M2 can be easily released.
  • a movement restricting hole 108 having a size in which the large diameter part 106 cannot pass through in the proximal direction is formed. Therefore, when pulling the operation wire 14, it can be pulled until the large-diameter portion 106 fixed to the operation wire 14 reaches the movement restriction hole 108, but beyond that, the operation wire 14 is moved with respect to the slide portion 100. It cannot be moved.
  • the energy supply means 4 shown in FIG. 1 supplies electric energy to the clamping means K. Since it is a known system configuration, a detailed description is avoided, but from the viewpoint of ease of control, a DC power supply or an AC power supply can be used. The electrical one is preferred. However, not only this but also the one that can melt the oval valve M2 and the atrial septum M1 clamped by the clamping means K with heat and supply energy that can be crimped with an adhesive factor such as collagen or elastin. Anything may be used. For example, ultrasonic waves, lasers, microwaves, or high frequencies can be used.
  • 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 catheter 3.
  • the guiding tube 3 is pushed out by operating the main tube 63.
  • 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.
  • a grasping member 15 is connected to the proximal end of the operation wire 14 for the operator to grasp with the finger in order to move the operation wire 14 forward and backward.
  • a needle positioning portion 61 is provided at the distal end portion of the main pipe 63.
  • the needle positioning portion 61 positions the needle portion 30 with respect to the foramen ovale O, and includes a pair of first elastic wire members 66 that are expanded and contracted by operation of the operation wire 14 as shown in FIG. ing.
  • the proximal end of the first elastic wire 66 is attached to the outer surface of the main pipe 63, and the distal end is attached to the proximal end side of the intermediate sleeve body 64 through which the operation wire 14 is inserted.
  • the needle positioning unit 61 displaces the first elastic wire 66 outward with the proximal end attached to the main pipe 63 as a fulcrum by an operation of moving the operation wire 14 in the axial direction, and each first elastic wire 66 is moved into the oval hole.
  • the inner edge of O is pressed with substantially equal elastic force, and the needle part 30 is aligned with the oval hole O. That is, the needle part 30 located between both the first elastic wires 66 has a function of being located in the central part of the foramen ovale O.
  • the holding portion 62 holds the needle portion 30 from the back side so that the foramen ovale valve M2 can be easily punctured.
  • a tip member 68 provided at the tip portion of the operation wire 14 is provided.
  • the distal end member 68 is fixed to the distal end of the operation wire 14, the distal end sleeve body 65 and the intermediate sleeve body 64 have the operation wire 14 inserted therein, and the second elastic wire 67 has a proximal end fixed to the distal end of the intermediate sleeve body 64.
  • the distal end side is fixed to the distal end sleeve body 65.
  • the intermediate sleeve body 64, the tip sleeve body 65, the second elastic wire 67 connecting the sleeve bodies 64 and 65, and the tip member 68 constitute a bending mechanism W that bends or curves the tip portion of the operation wire 14. .
  • the bending mechanism W is used for holding the foramen ovale valve M2.
  • the bending mechanism W causes the second elastic wire 67 to bend or bend between the distal end member 68 and the distal end side of the first elastic wire 66 by retracting the operation wire 14 in the axial direction.
  • the foramen valve M2 is held from the back side by the tip sleeve body 65. That is, the bending mechanism W is configured such that the distal end portion of the operation wire 14 is bent or curved with the distal end side of the first elastic wire 66 attached to the main pipe 63 as a fulcrum.
  • the bending mechanism W of the holding part 62 is bent after the first elastic wire 66 of the needle positioning part 61 aligns the needle part 30 with respect to the oval hole O and positions the oval hole valve M2. Since the first elastic wire 66 needs to be deformed prior to the second elastic wire 67 since it needs to be configured to be held, the rigidity of both elastic members is changed in this embodiment.
  • the main tube 63 fixed to the slide portion 100 can be drawn into the central lumen L5 of the catheter main body 10, and accordingly, the positioning and holding means 60 as a whole is catheterized. It can be collected in the main body 10.
  • the main pipe 63 is provided with an inner engagement member 180 having a projection 181 formed on the outer surface, and the inner surface of the lumen L5 at the center of the catheter main body 10 is provided with FIG.
  • an outer engagement member 190 is provided in which a protrusion 181 of the inner engagement member 180 enters and an engaging groove 191 is formed.
  • the inner engagement member 180 is formed with a protruding portion 181 linearly extending in the axial direction on the outer surface of a cylindrical shape having a through hole 183 therein.
  • a connecting outer surface 184 on which no projection is formed is formed at both ends in the axial direction.
  • the first main pipe member 63A and the second main pipe member 63B are formed of a flexible material.
  • the first main pipe member 63A and the second main pipe member 63B are provided with a layer made of polyimide on the inner and outer surfaces of a flexible tube formed by knitting a thin stainless steel wire.
  • a layer structure can be applied, but is not limited thereto.
  • the inner engagement member 180 is formed of a material that has higher rigidity than that produced by the material applied to the first main pipe member 63A and the second main pipe member 63B, and stainless steel can be applied as an example, but is not limited thereto. Alternatively, other metals or resins may be applied.
  • the outer engagement member 190 has a cylindrical shape having a through hole 193 having an inner diameter larger than the outer diameter of the first main pipe member 63A, and is cut out from the proximal end side toward the distal end side.
  • a groove portion 191 is formed.
  • the groove portion 191 has a width W2 wider than the width W1 of the projection portion 181 on the base end side, the width becomes narrower toward the distal end side, and a width W3 substantially the same as the width W1 of the projection portion 181 at the most distal end portion.
  • the width W2 on the base end side of the groove 191 is a width that allows the protrusion 181 to enter even if the main pipe 63 rotates within a range of ⁇ 30 degrees from the center of the width W2.
  • the lengths of the width W2 and the width W3 are not particularly limited as long as the width W1 is equal to or larger than the width W1 of the protrusion 181 and the protrusion 181 can enter.
  • the outer engagement member 190 has an outer diameter that is larger than the inner diameter of the lumen L5. Therefore, the outer engagement member 190 is fixed in close contact with the elastic force of the catheter body 10.
  • the outer engagement member 190 is formed of a material that can obtain higher rigidity than that produced by a material applied to the catheter body 10, and stainless steel can be applied as an example.
  • the outer engagement member 190 is not limited to this, and other metals and resins can be used. Etc. may be applied.
  • an insertion assisting portion 192 that is a groove (concave portion) extending so as to cut out from the distal end side toward the proximal end side is formed at the distal end side end portion of the outer engagement member 190.
  • Two insertion assisting portions 192 are provided at opposite positions in the circumferential direction, but the number is not limited as long as it is one or more.
  • the catheter body 10 When the outer engagement member 190 is installed in the lumen L5 of the catheter body 10, the catheter body 10 is first immersed in 1,2-dichloroethane to swell, and the inner diameter of the lumen L5 is set to the outer diameter of the outer engagement member 190.
  • the outer engagement member 190 is inserted from the opening on the distal end side of the lumen L5 in a state where the outer engagement member 190 is expanded to a greater extent.
  • a long insertion assisting tool 200 having a convex fitting portion 201 that fits into the insertion assisting portion 192 is used.
  • the fitting portion 201 is fitted to the insertion assisting portion 192, and the groove portion 191 is pushed to a predetermined position in the lumen L5 in a state where the groove portion 191 is directed to the proximal end side.
  • the fitting portion 201 By inserting the fitting portion 201 into the insertion assisting portion 192 and inserting it, the circumferential position of the outer engagement member 190 can be accurately positioned at a desired angle.
  • the pushing distance can be easily specified by providing a marker or the like at a predetermined length of the insertion assisting tool 200.
  • the inner diameter of the lumen L5 returns to a dimension before swelling, that is, a dimension smaller than the outer diameter of the outer engagement member 190, and the outer engagement member 190 is returned to the catheter body 10. It is fixed inside by an elastic force.
  • the swelling means that the solvent molecules enter between the polymer molecules, so that the polymer molecules expand and expand.
  • the magnitude of swelling depends on the affinity between the solvent and the polymer, and the greater the affinity between the two, the greater the swelling.
  • 1,2-dichloroethane is used in the present embodiment, but is not limited thereto.
  • the catheter body 10 When the catheter body 10 is swollen, the catheter body 10 is preferably immersed in a solvent, and the immersion time can be appropriately selected according to conditions such as the thickness of the catheter body 10, the material, the type of the solvent, and the like. preferable.
  • the solvent it is preferable to appropriately select according to conditions such as the thickness of the catheter body 10, the material, the type of the solvent, etc. from drying at normal temperature, drying by heating in an oven, ventilation drying, and the like.
  • the wall thickness S1 of the outer engagement member 190 is formed larger than the height E1 of the protrusion 181.
  • the circumferential position of the protrusion 181 of the inner engagement member 180 is located at the center of the circumferential width of the groove 191 of the outer engagement member 190 in a state where no external force acts on the catheter 1. Then, in a state where the main pipe 63 is driven to the proximal end side, as shown in FIG. 13A, the inner engagement member 180 is located on the proximal end side with respect to the outer engagement member 190, and the main pipe 63 is moved to the distal end. By moving to the side, the protrusion 181 of the inner engagement member 180 is engaged with the groove 191 of the outer engagement member 190 as shown in FIG.
  • the catheter main body 10 and the distal end of the inner engagement member 180 and the most distal end portion A1 of the outer engagement member 190 are 90 mm or more so that the flexibility of the distal end of the catheter 1 is not impaired by the rigid inner engagement member 180 and outer engagement member 190. It is preferable that the inner engagement member 180 and the outer engagement member 190 are not more than 300 mm so that the action when the inner engagement member 180 and the outer engagement member 190 are engaged with each other extends well to the distal end of the catheter 1. Next, the operation of this embodiment will be described. (1) Pre-process
  • the surgeon inserts an introducer (an assembly in which a dilator is inserted into a long sheath) from the femoral vein. After the distal end of the long sheath reaches the left atrium L via the inferior vena cava J and the right atrium R, the dilator is removed from the long sheath.
  • an introducer an assembly in which a dilator is inserted into a long sheath
  • 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 inner engagement member 180 provided in the main tube 63 is positioned on the proximal end side with respect to the outer engagement member 190 provided in the catheter body 10.
  • the device is inserted into the long sheath 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. 9A, 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 moves forward, 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 positioning and holding means 60 including the main pipe 63 advances, and as shown in FIG. 13B, the protrusion 181 of the inner engagement member 180 is engaged with the outer engagement. It enters the groove 191 of the member 190.
  • the groove portion 191 has a width W2 (see FIG. 15) wider than the width W1 (see FIG. 14) of the projection portion 181 on the proximal end side, the main tube 63 is circumferentially disposed with respect to the catheter body 10. Even if twisted, the protrusion 181 can be smoothly guided to the groove 191 while correcting the twist.
  • the width W2 of the groove portion 191 is set so that the main tube 63 can enter the groove portion 191 even if it rotates within a range of ⁇ 30 degrees from the center of the width W2. Since the height E1 of the protrusion 181 is smaller than the thickness S1 of the outer engagement member 190, the protrusion 181 does not contact the inner surface of the catheter body 10 when the protrusion 181 enters the groove 191. The groove portion 191 can be moved smoothly.
  • the protrusion 181 that has entered the groove 191 is gradually corrected in its circumferential position by the groove 191 whose width becomes narrower toward the tip side, and the outermost portion of the groove 191 having a width W3 substantially the same as the width W1 of the protrusion 181.
  • rotation (twisting) of the protrusion 181 in the circumferential direction is limited.
  • the protrusion 181 reaches the forefront of the groove 191, the protrusion 181 is restricted from moving further to the tip side.
  • the protrusion 181 of the inner engagement member 180 enters and engages with the groove 191 of the outer engagement member 190, so that the circumference of the main tube 63 that passes through the inside of the catheter main body 10 is engaged with the catheter main body 10.
  • the relative position in the direction and the axial direction can be fixed. Thereby, even if the main tube 63 is twisted or the main tube 63 is extended due to swelling or the like, the position of the main tube 63 with respect to the catheter body 10 can be kept good, and the needle positioning provided on the distal end side of the main tube 63 is possible.
  • the positions of the part 61 and the holding part 62 can be appropriately maintained, and the operability and safety of the device are improved.
  • the blood vessel is relatively straight from the femoral vein to the inferior vena cava J. However, since the blood vessel is curved at the entrance from the inferior vena cava J to the right atrium R, the distal end portion of the catheter 1 is curved. (See FIG. 1). Although there are individual differences in this bending position, generally, the bending position is about 70 mm to 80 mm from the most distal end portion A2 of the cylindrical body composed of the catheter body 10 and the distal tip 40 to the proximal end.
  • the distal end portion A1 when the inner engagement member 180 and the outer engagement member 190 having high rigidity are engaged with each other is at least 90 mm away from the distal end portion A2 of the cylindrical body.
  • the inner engagement member 180 and the outer engagement member 190 having high rigidity are not excluded and the operability is not deteriorated.
  • the inner engagement member 180 and the outer engagement member 190 are not located in a region where the blood vessel is strongly curved, the inner engagement member 180 and the outer engagement member 190 can be prevented from being plastically deformed, and the main pipe 63 can be prevented from being deformed. Maintains smooth slidability in the axial direction, ensuring safety and operability.
  • the inner engagement member 180 and the outer engagement member 190 exert the function of maintaining the proper positions of the needle positioning portion 61 and the holding portion 62 provided on the distal end side by engaging with each other.
  • the most distal end portion A1 is located within 300 mm from the most distal end portion A2 of the distal end tip 40, rotation and twist can be well suppressed, and operability and safety can be ensured.
  • the most distal portion A1 of the inner engagement member 180 and the outer engagement member 190 is located at a position immediately before entering the right atrium R from the inferior vena cava J. The operability and safety in operations such as pinching, puncturing, and fusing of the living tissue M can be improved.
  • the tip of the operation wire 14 is projected from the tip sleeve body 65 from the tip 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 member 15 until the distal end member 68 at the distal end of the operation wire 14 abuts on the distal end sleeve body 65 as shown in FIG.
  • the operation wire 14 is retracted by pulling (the amount of retreat is “ ⁇ 1” in FIG. 28B).
  • the large-diameter portion 106 is also retracted.
  • the operating member 104 is urged upward by the elastic force of the spring 107 unless the pressing piece 109 is pressed. Therefore, since the operation wire 14 is always held between the narrow width portion G2 of the wedge-shaped through hole 105 and the inner peripheral surface of the internal passage Qb, the retraction of the operation wire 14 makes the pulling operation smooth. Can be done.
  • the main-body part 71 is operated, the 2nd elastic wire 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 retreating is caused by the operation wire 14 by the tip member 68, the tip sleeve body 65, the second elastic wire 67 and The base end is transmitted to the first elastic wire 66 attached to the main pipe 63 through the intermediate sleeve body 64, and the first elastic wire 66 is directed radially outward as shown in FIG. Projecting and deforming into an arc shape.
  • the second elastic wire 67 is not deformed.
  • the first elastic wire 66 is deformed while expanding the lip portion of the foramen ovale O, so that the needle portion 30 provided in the immediate vicinity of the first elastic wire 66 is moved into the oval hole O.
  • the needle 30 is positioned at the center of the foramen ovale O.
  • the operation wire 14 When the operation wire 14 is further retracted and the rear end of the intermediate sleeve body 64 comes into contact with the front end of the main pipe 63 as shown in FIG. 28D, the first elastic wire 66 is not deformed so much and The second elastic wire 67 projects and deforms in an arc shape outwardly in the radial direction by an operating force.
  • the distal end member 68 and the distal end sleeve body 65 are curved so as to approach the needle portion 30. It abuts against the left atrial surface of M2 and holds it. Then, the main pipe 63 of the positioning and holding means 60 is pressed against the atrial septum M1 while holding the foramen hole valve M2.
  • 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 tip 31 of the needle 30 protrudes from the tip of the catheter body 10, and as shown in FIG.
  • the needle tip 31 is punctured.
  • 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. 25, 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 When the slide portion 100 is further retracted, 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.
  • the wire portion 22 When the wire portion 22 is drawn into the lumens L3 and L4, as shown in FIG. 27, 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 portion 31 is obtained.
  • 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 moves backward to contact the contact member 85, and the holding 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. 20 is moved back to the state shown in FIG. 21, and the needle portion 30 is accommodated in the tip tip 40.
  • the terminal 81 that moves together with the needle operating lever 78 moves away from the contact member 84 (see FIG. 7), and the state where electrical conduction to the pinching 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.
  • the push button 93 of the connecting mechanism 90 is pressed to release the connection between the Y connector 72 and the main body 71, thereby releasing the connection between the guiding catheter 3 and the main body 71, and separating the main body 71 from the living body.
  • the device When retracted, the device is pulled out using the guiding catheter 3 as a guide. Thereafter, when the guiding catheter 3 is removed from the living body, the procedure is completed.
  • the protrusion 181 is provided on the outer surface of the main tube 63, and the main tube 63 moves toward the distal end side relative to the catheter body 10 on the outer surface of the catheter body 10. Since the groove portion 191 with which the protrusion portion 181 is engaged is provided, the main tube 63 is moved and the protrusion portion 181 is engaged with the groove portion 191, thereby moving the main tube 63 in the axial direction and the circumferential direction with respect to the catheter body 10. Can be limited. For this reason, even if a force such as extending or twisting acts on the main tube 63, a good positional relationship between the catheter body 10 and the main tube 63 can be maintained, and operability and safety can be improved.
  • the groove portion 191 is formed to have a narrow width in a direction in which the protrusion portion 181 moves relatively toward the groove portion 191 (in this embodiment, a direction toward the tip), the protrusion portion 181 is formed in the groove portion 191. As it enters the groove, it is guided to a narrow groove, and the circumferential gap between the protrusion 181 and the groove 191 gradually decreases. For this reason, the twist of the main pipe 63 provided with the protruding portion 181 is corrected, and the displacement in the circumferential direction is limited to make it difficult to cause the twist.
  • the outer engagement member 190 and the inner engagement member 180 are formed of a material that can obtain higher rigidity than the case where the outer engagement member 190 and the inner engagement member 180 are formed of the material applied to the catheter body 10 and the main tube 63. Since the most advanced part A1 when the joint member 180 is engaged is provided at a distance of 90 mm or more from the most advanced part A2 of the tubular body constituted by the catheter body 10 and the distal tip 40 to the proximal end side, When the catheter 1 is inserted into the catheter, the distal end side of the catheter 1 can be bent well, and further, the inner engagement member 180 and the outer engagement member 190 can be prevented from being plastically deformed, the operability is not lowered, and safety is improved. It can be secured.
  • the outer engagement member 190 in which the groove portion 191 provided in the catheter main body is formed has the insertion assisting portion 192 formed at the end on the distal end side. Therefore, when the outer engagement member 190 is inserted into the catheter main body, The circumferential position of the outer engagement member 190 can be accurately determined.
  • the catheter body 10 and the distal tip 40 are formed with four lumens L1 to L4 that are different from the lumen L5 through which the main tube 63 is inserted. Therefore, the other lumens L1 to L4 that are different from the lumen L5 are used for gripping. Other functions such as puncture and puncture can be effectively provided. Further, since the main pipe 63 passing through the lumen L5 can maintain a good position with respect to the catheter body 10 by the engagement of the outer engagement member 190 and the inner engagement member 180, the main pipe 63 is passed through L1 to L4 provided in the catheter body 10. It is possible to coordinate the other functions acting on the main pipe 63 with the functions of the main pipe 63 with higher accuracy.
  • 30 and a sandwiching portion 20 that passes through the lumens L3 and L4, and the main pipe 63 has a portion that can be bent in the radial direction at the distal end portion. Therefore, after holding the living tissue M by the distal end portion of the main pipe 63 and piercing the needle portion 30 into the living tissue M, an electric current is passed between the living tissue M by the needle portion 30 and the holding portion 20, Tissue M can be fused. Even when a force such as extending or twisting acts on the main tube 63, a good positional relationship between the catheter body 10 and the main tube 63 can be maintained, and operability and safety in piercing, clamping, and fusion can be improved.
  • the method for manufacturing the medical device according to the present embodiment includes a step of swelling the tubular catheter body 10 and a case where the material is applied to the catheter body 10 inside the swollen catheter body 10.
  • the outer engagement member 190 can be fixed inside the catheter body 10 which is a tubular body without using an adhesive or the like.
  • an insertion assisting portion 192 (concave portion) is provided at the end of the outer engagement member 190, and the outer engagement member 190 is inserted into the swollen catheter body 10 by a member that fits into the insertion assisting portion 192. For this reason, the rotation of the outer engagement member 190 is restricted during insertion, and the circumferential position of the outer engagement member 190 can be accurately set.
  • 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 treatment used to close the PFO defect has been described.
  • the present invention is not limited to this.
  • a passage-like defect such as a left atrial appendage closure device is closed, or It can also be used when the biological tissue M at a predetermined site is thermally necrotized.
  • 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 groove portion 212 may be provided not only on the proximal end side groove portion 211 of the outer engagement member 210 but also on the distal end side.
  • the two groove portions 211 and 212 are provided so as to be shifted by 180 degrees in the circumferential direction, and thus the axial length of the outer engagement member 210 is made longer than necessary by making the circumferential position different.
  • Two groove portions 211 and 212 can be provided without any problem.
  • the main pipe 220 has a distal end inner engagement member 230 provided on the distal end side of the outer engagement member 210 and provided with a protrusion 231 that can be engaged with the groove portion 212 on the distal end side, and a base of the outer engagement member 210.
  • a proximal inner engagement member 240 provided with a projection 241 provided on the end side and engageable with the groove 211 on the proximal end side is provided.
  • the protrusion 241 of the proximal inner engagement member 240 is inserted into the proximal groove portion 211, as shown in FIG. Engage. Therefore, in both the case where the main tube 220 is accommodated in the catheter body 10 and the case where the main tube 220 is protruded, even if a force such as extension or twisting acts on the main tube 220, the catheter main body 10 and the main tube 220 are excellent. The positional relationship can be maintained, and operability and safety can be improved.
  • the protrusion 261 of the inner engagement member 260 provided in the main tube 250 is a groove having a constant width of the outer engagement member 270 provided in the catheter body 10.
  • the width may be narrowed in the direction toward 271. Even with such a configuration, when the main pipe 250 is twisted, the protruding portion 261 can be smoothly guided to the groove portion 271.
  • both the width of the protrusion and the width of the groove may be formed so as to narrow in the direction in which the protrusion moves relatively toward the groove (not shown).
  • a groove 281 is provided in the outer engagement member 280 provided on the catheter body 10 side, and a protrusion is formed on the inner engagement member 300 provided on the main tube 290 side, as in another modification of the medical device shown in FIG.
  • the part 301 may be provided.
  • a member 311 having high rigidity such as stainless steel is provided on the distal end side of the outer engagement member 310 that requires high rigidity for restraining the protrusion 181.
  • another flexible member 312 having a lower rigidity such as a resin on the base end side. In this way, it is possible to provide a device that can be bent flexibly while having a minimum function of guiding the protruding portion 181 to the distal end side by the flexible separate member 312.
  • the insertion assisting portion 192 used when inserting the outer engagement member into the catheter body 10 may be formed as a convex portion instead of a concave portion.
  • the protruding portion has a shape having a long width in the axial direction of the main pipe 63.
  • the protruding portion has a shape like a pin having a short width in the axial direction. It may be.
  • the width in the circumferential direction of the groove and the protrusion is not limited to a form that is constant or gradually decreases, and for example, it can be a constant width after gradually decreasing.
  • the protrusion and the groove may be formed integrally with the catheter body 10 (tubular body) and the main tube 63 (shaft portion).

Abstract

L'invention concerne: un dispositif médical dans lequel une bonne relation de position peut être maintenue entre un corps cylindrique et une partie de tige agencée à l'intérieur du corps cylindrique et qui permet d'améliorer la sécurité et rend son fonctionnement plus efficace; et un procédé de fabrication du dispositif médical. Ce dispositif médical comprend un corps tubulaire destiné à être inséré dans un corps vivant, et une partie de tige (63) agencée à l'intérieur du corps tubulaire (10) qui puisse avancer/se rétracter, dans lequel: (181) une partie en saillie est prévue sur l'un ou l'autre de la face intérieure du corps tubulaire (10) et la face extérieure de la partie de tige (63); et une partie de rainure (191) dans laquelle la partie saillante (181) est avancée en déplaçant de manière relative la partie de tige (63) vers le corps tubulaire (10), est prévue dans l'autre surface interne du corps tubulaire et la face extérieure de la partie de tige.
PCT/JP2013/056233 2012-03-10 2013-03-07 Dispositif médical et son procédé de production WO2013137094A1 (fr)

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JP2012-053871 2012-03-10
JP2012053871A JP2015097549A (ja) 2012-03-10 2012-03-10 医療用デバイスおよびその製造方法

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Cited By (1)

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Publication number Priority date Publication date Assignee Title
EP3735184A4 (fr) * 2018-01-05 2022-02-23 MITRX, Inc. Rétracteur de suture bourse et procédé d'utilisation

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Publication number Priority date Publication date Assignee Title
JP2000279508A (ja) * 1999-03-31 2000-10-10 Terumo Corp 留置カテーテルおよび留置針組立体
JP2004261372A (ja) * 2003-02-28 2004-09-24 Olympus Corp 内視鏡用処置具
JP2008534086A (ja) * 2005-03-25 2008-08-28 ミトラル・ソリューションズ・インコーポレイテッド 解剖学的なオリフィス又は内腔の内周を制御するための方法及び装置
JP2010220883A (ja) * 2009-03-24 2010-10-07 Terumo Corp 医療用デバイス

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000279508A (ja) * 1999-03-31 2000-10-10 Terumo Corp 留置カテーテルおよび留置針組立体
JP2004261372A (ja) * 2003-02-28 2004-09-24 Olympus Corp 内視鏡用処置具
JP2008534086A (ja) * 2005-03-25 2008-08-28 ミトラル・ソリューションズ・インコーポレイテッド 解剖学的なオリフィス又は内腔の内周を制御するための方法及び装置
JP2010220883A (ja) * 2009-03-24 2010-10-07 Terumo Corp 医療用デバイス

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3735184A4 (fr) * 2018-01-05 2022-02-23 MITRX, Inc. Rétracteur de suture bourse et procédé d'utilisation
US11406375B2 (en) 2018-01-05 2022-08-09 Mitrx, Inc. Pursestring suture retractor and method of use

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