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WO2012117637A1 - Dispositif médical - Google Patents

Dispositif médical Download PDF

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Publication number
WO2012117637A1
WO2012117637A1 PCT/JP2011/078181 JP2011078181W WO2012117637A1 WO 2012117637 A1 WO2012117637 A1 WO 2012117637A1 JP 2011078181 W JP2011078181 W JP 2011078181W WO 2012117637 A1 WO2012117637 A1 WO 2012117637A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
needle member
tip
medical device
distal end
Prior art date
Application number
PCT/JP2011/078181
Other languages
English (en)
Japanese (ja)
Inventor
裕充 橋本
明 澤田
Original Assignee
テルモ株式会社
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 テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2013502154A priority Critical patent/JP5873475B2/ja
Publication of WO2012117637A1 publication Critical patent/WO2012117637A1/fr

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Classifications

    • 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
    • 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
    • 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
    • A61B2018/0038—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
    • A61B2018/0091—Handpieces of the surgical instrument or device
    • A61B2018/00916—Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device
    • A61B2018/0094—Types of switches or controllers
    • A61B2018/00946—Types of switches or controllers slidable
    • 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

Definitions

  • the present invention relates to a medical device, and more particularly to a medical device inserted into a body cavity.
  • 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).
  • This PFO closure device uses a puncture part and a sandwiching member that are a pair of electrodes, punctures the foramen ovale valve, and then sandwiches the foramen valve and the atrial septum between the sandwiching member, Bonding is performed by applying electrical energy to living tissue.
  • the plurality of expanded needle members are in contact with the foramen ovale valve in a wide range, and after the puncture It is possible to widen the fusion range of living tissue by sandwiching the foramen ovale valve and the atrial septum in a wide range.
  • the needle member rotates and twists in the catheter, for example, when rotating the hand operating part for operating the needle member or the clamping member in the process of performing the procedure, There is a possibility that the needle member interferes with the catheter and it becomes difficult to protrude.
  • the present invention solves the above-described problems, and provides a medical device capable of improving safety by matching the direction of the needle member with the direction of the distal end of the catheter to suppress interference between the catheter and the needle member. With the goal.
  • the medical device according to the present invention that achieves the above object is a medical device in which a needle member is disposed in a lumen formed inside a cylinder so as to be movable back and forth, and is in a natural state at a distal end portion of the needle member.
  • a bent portion is formed, the lumen at the tip of the cylindrical body can accommodate the bent portion, and the inner wall surface shape in an orthogonal cross section orthogonal to the direction along the lumen is the first direction
  • the lumen at the distal end portion of the cylindrical body can accommodate the bent portion of the needle member, and the inner wall surface shape of the lumen in a cross section perpendicular to the direction along the lumen is formed long in one direction. Therefore, even if a rotational force is applied to the needle member, the needle member is held by the inner wall surface of the lumen and the rotation is suppressed. Therefore, the bending direction of the needle member is kept coincident with the direction in which the lumen has a long cross section, and interference with the cylindrical body of the needle member is suppressed and safety is improved.
  • the needle member is formed with a bent portion on a distal end side of a straight portion that linearly extends in a natural state, and a maximum separation distance from a reference line along the straight portion to the most distal end of the needle member is the second direction. Is larger than the width of the inner wall surface in the direction orthogonal to the rotation of the needle member, the rotation of the needle member is more reliably suppressed by the inner wall surface of the lumen.
  • the needle member does not receive a rotational force from the other connected member, so that the rotational force hardly acts on the needle member. Interference with the cylinder of a member can be controlled more certainly.
  • the inner wall surface of the lumen in which the needle member is disposed is formed with a step portion having a diameter that decreases in the distal direction, and a stopper having a size that cannot be inserted through the step portion is fixed to the needle member, the needle member The amount of protrusion is limited, and safety is improved.
  • a clamping member that cooperates with the needle member to clamp a living tissue around a defect existing in the living tissue and the needle member; and the needle member and the clamping member provided at a proximal end portion of the cylindrical body.
  • a hand operating part for operating, and an electric energy supply means for supplying electric energy to the needle member and the holding member, and the living tissue is clamped by the needle member and the holding member from the electric energy supply means. If the defect is closed by supplying electric energy and joining the living tissue, the defect can be closed by favorably holding the living tissue by suppressing interference with the cylindrical body of the needle member.
  • the hand operation unit is provided on the operation member, a contact member electrically connected to the electrical energy supply means, an operation member that moves the needle member, and the needle member is connected to be rotatable about the shaft, If there is a terminal that contacts the contact member by movement of the operation member, and a conduction assisting part that presses the needle member against the terminal when the terminal contacts the operation member, the needle
  • the needle member that is rotatably connected to the terminal can be reliably conducted to the terminal while making it difficult for a rotational force to act on the member to reduce interference with the cylinder of the needle member.
  • the two needle members are provided, and the needle members are expanded so as to be separated from each other by moving to the tip side in the lumen, the two needle members are projected in a wide range. be able to.
  • 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 the catheter front-end
  • Fig. 5 is a cross-sectional view of the distal end portion of the catheter taken along line 5-5 in Fig. 3.
  • FIG. 6 is a cross-sectional view of the distal end portion of the catheter taken along line 6-6 in FIG. It is a top view which shows the hand operation part of the medical device which concerns on this embodiment.
  • 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 the catheter front-end
  • Fig. 5 is a cross-sectional view of the distal end portion of the catheter taken along line 5-5 in Fig. 3.
  • FIG. 6 is a cross-sectional view of the distal end portion of the catheter taken along line 6-6 in
  • FIG. 8 is a cross-sectional view of the hand operation unit along line 8-8 in FIG. 2;
  • FIG. 8 is an enlarged cross-sectional view of a hand operating unit along line 8-8 in FIG. It is an expanded sectional view of a hand operation part showing when sliding a slide part backward.
  • FIG. 8 is a cross-sectional view showing a coupling mechanism taken along line 11-11 in FIG.
  • FIG. 12 is a cross-sectional view of a lock-unlock mechanism portion taken along line 12-12 in FIG.
  • FIG. 13 is a cross-sectional view taken along line 13-13 of FIG. It is a top view which shows the hand operation part at the time of operating a needle operation lever, (A) shows before operation, (B) shows after operation.
  • FIG. 1 It is a cross-sectional schematic diagram at the time of pinching a foramen ovale valve and an atrial septum by a puncture part and a clamping member.
  • FIG. 1 It is a cross-sectional schematic diagram at the time of pinching a foramen ovale valve and an atrial septum by a puncture part and a clamping member.
  • FIG. 1 is a cross-sectional schematic diagram at the time of pinching a foramen ovale valve and an atrial septum by a puncture part and a clamping member.
  • FIG. 1 It is a cross-sectional schematic diagram at the time of pinching a foramen ovale valve and an atrial septum by a puncture part and a clamping member.
  • FIG. 1 It is a cross-sectional schematic diagram at the time of pinching a foramen ovale valve and an atrial septum by a puncture part and a clamping member.
  • FIG. 1 It is a cross-sectional schematic diagram at the
  • 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 includes a catheter 1 (tubular body) configured by attaching a proximal operation unit 70 to the proximal end of the catheter body 10, and a proximal end that can be connected to the proximal operation unit 70. It has a guiding catheter 3 that can be inserted, and an energy supply means 4 that supplies electrical energy for fusing or necrotizing the living tissue M (a general term for M1 and M2).
  • the catheter 1 is provided at the distal end portion of the catheter body 10 and includes a pinching means K for pinching the foramen ovale valve M2 and the atrial septum M1, and a positioning and holding means for stably and accurately performing a procedure using the pinching means K. 60 (see FIG. 2).
  • 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, for example, from the femoral vein J.
  • This guiding catheter 3 is provided with a clamping means K provided at the distal end of the catheter body 10 therein. Inserted with the main body 10 in the housed state.
  • 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).
  • “L” indicates the left atrium and “R” indicates the right atrium.
  • the clamping means K is composed of a clamping member 11 that directly contacts one side of the atrial septum M1 and a puncture member 12 that punctures the foramen ovale valve M2.
  • the holding member 11 includes a flat plate-like flat plate portion 11 a that is entirely flat and a pair of wire rod portions 11 b that are connected to the base end portion of the flat plate portion 11 a.
  • the plane position is regulated by the lumens L3 and L4 (see FIG. 3) of the tip 40 fixed to the tip.
  • the clamping member 11 projects from the tip tip 40 by moving the two wire portions 11b in the axial direction to form a predetermined clamping width with the puncture member 12, or enters the tip tip 40. Sometimes it moves toward the puncture member 12 side so as to sandwich the living tissue M.
  • the puncture member 12 includes two needle members 12a that are separated from each other, and the needle member 12a is held in lumens L1 and L2 (see FIG. 3) formed in the distal tip 40 so as to be able to advance and retract. By moving the member 12a back and forth in the axial direction, a sharp tip portion can appear and disappear from the tip tip 40.
  • Each needle member 12a is a very thin member having a circular cross section perpendicular to the axis and having a sharp pointed tip. As shown in FIGS. In the state, a straight line portion 12d that extends substantially linearly and a bent portion 12b that is bent in a smooth arc shape on the tip side of the straight line portion 12d are formed. Note that the bent portion 12b may be bent and not bent smoothly. A distal end stopper 12c having a diameter larger than that of the needle member 12a is fixed to the proximal end side of the bent portion 12b of the needle member 12a.
  • the lumens L1 and L2 formed on the tip 40 are bent toward the outer peripheral surface of the tip 40 in the vicinity of the opening on the tip side.
  • the lumens L1 and L2 are bent and the inner wall surface shape in the orthogonal cross section Z (see FIG. 5) orthogonal to the direction along the lumens L1 and L2 is the direction in which the lumens L1 and L2 are bent (first).
  • an elliptical cross section having a major axis see FIG. 6).
  • the cross-sectional view of FIG. 5 is a cross-sectional view of a surface that is bent near the lumen L2 along the line 5-5 in FIG.
  • the inner wall surface 41 is formed in the lumens L1 and L2 so as to sandwich the bent portion 12b of each needle member 12a.
  • the width X of the inner wall surface 41 in the orthogonal short-axis direction in the orthogonal cross section Z is greater than the maximum separation distance Y from the reference line A along the linearly extending straight portion 12 d of the needle member 12 a to the forefront. Is also formed small.
  • the needle member 12a is held by the inner wall surface 41 and the rotation is suppressed, and the needle member 12a Is always coincident with the bending direction of the lumens L1 and L2.
  • the number of needle members 12a is not limited to two, and may be one or three or more.
  • the lumens L1 and L2 of the distal tip 40 are formed with stepped portions 42, and the inner diameter of the lumen on the proximal end side with respect to the stepped portions 42 is larger than that of the distal end stopper 12c fixed to the needle member 12a.
  • the inner diameter on the tip side from 42 is smaller than the tip stopper 12c. Therefore, the distal end stopper 12c fixed to the needle member 12a is accommodated and movable in the lumen on the proximal end side with respect to the stepped portion 42.
  • the distal end stopper 12c is disposed on the distal end side of the stepped portion 42. 42 prevents the needle member 12a from projecting.
  • the stepped portion 42 is formed at the boundary between the distal tip 40 and the catheter body 10, but the position of the stepped portion 42 is not limited to this, and is formed in the distal tip 40, for example. Or may be formed within the catheter body 10.
  • the sandwiching member 11 and the puncture member 12 both function as electrode members (heating units). However, the wire portion 11b and the puncture member 12 of the sandwiching member 11 are inserted into the catheter main body 10 to be described later.
  • one of the conductive wires d1 and d2 (conductive wire d1 in the present embodiment) is provided with a foot switch SW installed at the foot in order to turn on and off the current from the energy supply means 4. Instead of the foot switch SW, a switch that is easy to operate at hand may be used.
  • the hand operation unit 70 is a part that manipulates the pinching means K including a pair of electrode members that sandwich the living tissue M around the defect existing in the living tissue so as to be able to protrude and retract from the distal end of the catheter body 10.
  • 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 operation unit 70 includes a needle operation lever 78 that operates the puncture member 12 that is one electrode member, and a slide unit 100 that operates the clamping member 11 that is the other electrode member.
  • the operation wire 14 is provided to assist the operation of the clamping means K.
  • the operation wire 14 is inserted into the hand operation unit 70 and the catheter body 10 so as to be movable in the axial direction, and the operation wire 14 is operated to operate the operation wire 14.
  • the grip 20 that is connected to the end and the lock-unlock mechanism 102 (see FIG. 12) that locks / unlocks the slide movement of the slide 100 and the push that locks the axial movement of the operation wire 14
  • a piece 109 and an input connector 75 having electrode terminals connected to the energy supply means 4 for applying thermal energy are provided.
  • a distal end member 68 is provided at the distal end of the operation wire 14, and a gripping portion 20 is provided at the proximal end.
  • 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 can be, for example, nickel titanium alloy, silver brazing, but is not limited thereto.
  • the breaking strength with respect to the tensile force between the operation wire 14 and the holding part 20 is lower than the breaking strength with respect to the tensile force between the operation wire 14 and the tip member 68.
  • 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 H5) is provided (see FIG. 14B for the process display portion H5).
  • the process display unit H operates the push piece 109 to slide the display unit H1 for a pulling process for pulling the operation wire 14, the display unit H2 for a puncture process in which the puncture member 12 punctures a living tissue, and the slide unit 100.
  • the process display unit H5 (see FIG. 14B) is configured to display each process using an image display, a number, and an arrow in the moving direction.
  • the hand operation unit 70 includes a main body 71 on the side to which the guiding catheter 3 is connected and a main body 71 on the proximal end side of the main body 71. And a slide portion 100 connected via guide bars (guide portions) 88A, 88B, 88C so as to approach and separate from each other, and a needle operation lever 78 for operating the puncture member 12 on the upper surface of the main body portion 71. Is provided.
  • a concave portion 77 is formed on the front surface side (upper surface side) of the main body 71, and a needle operation lever 78 is slidably provided in the longitudinal direction (see the white arrow).
  • 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 provided on the proximal end side of the needle member 12a is connected.
  • the terminal 81 is formed with a through hole (not shown) through which the needle member 12a can rotate.
  • connection tips 12 e having a diameter larger than the inner diameter of the through hole are fixed on both sides of the through hole of the terminal 81, and the needle member 12 a is rotatably connected to the terminal 81. Therefore, when the needle operating lever 78 is slid along the slit, the terminal 81 slides along the guide groove 82 formed inside the main body 71 as shown in FIG. The needle member 12a is advanced and retracted.
  • a main pipe 63 which will be described in detail later, is inserted in the approximate center of the internal space 76 of the main body 71.
  • the proximal end side of the main pipe 63 is connected to the slide part 100 with an adhesive or the like (see FIG. 12), and slides while being guided by the main body part 71 according to the slide operation of the slide part 100.
  • a terminal 83 is attached to the main pipe 63 in the inner space 76 in the vicinity of the proximal end (see FIG. 8), and the terminal 83 slides as the main pipe 63 slides.
  • the wire 83 of the clamping member 11 is connected to the terminal 83.
  • 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 puncture member 12 and the electrical system of the clamping member 11 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 as the needle member 12a and the wire portion 11b move, 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.
  • a conduction assisting portion 86 which is a spring member (elastic member), is provided at the movement end position of the connection tip 12e provided on the needle member 12a, and the connection tip 12e moves.
  • the connection chip 12e is pressed against the terminal 81. That is, since the needle member 12a is rotatably connected to the terminal 81, the current flow between the terminal 81 and the needle member 12a may become unstable, but the conduction assisting portion 86 is rotatable. Since the connecting chip 12e is pressed against the terminal 81, the contact resistance between the terminal 81 and the connecting chip 12e can be reduced, and the current flow can be stabilized.
  • the spring member has a contact range of a certain length with the terminal 81, and can come into contact while absorbing individual differences between living bodies.
  • the guide bars 88A and 88B are provided in the grooves 96A and 96B inside the main body 71, and the guide bar 88C is provided in a groove (not shown).
  • the operation wire 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.
  • 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 at the proximal end portion of the main body 71, and the electrode terminal of the input connector 75 is disposed inside the connection hole 74 (FIG. 7). reference).
  • the guide bar 88A is arranged so that a part of the side enters the connection hole 74, and the guide bar 88A that has entered the connection hole 74 obstructs the insertion of the output connector 87 into the connection hole 74 and outputs the output. Connection of the connector 87 to the input connector 75 is prevented.
  • a notch 89 (see FIG. 9) is formed in a part of the side of the guide bar 88A, and when the guide bar 88A and the main pipe 63 are moved backward with respect to the main body 71 together with the slide 100, FIG. As shown, the notch 89 coincides with the connection hole 74 so that the output connector 87 can be connected to the input connector 75.
  • the terminal 83 fixed to the main pipe 63 comes into contact with the contact member 85, and the clamping member 11 and the input connector 75 are electrically connected.
  • connection between the energy supply means 4 and the input connector 75 which are the most important procedure among the procedures and require carefulness, can be performed only after the clamping of the living tissue M is completed. The safety of the procedure is enhanced.
  • the main body 71 is provided with a window 73 opened adjacent to the input connector 75.
  • an “OK” display portion H6 (see FIG. 9) is written in the vicinity of the notch portion 89, and numbers (1 to 5) are displayed at a constant pitch from the “OK” display portion H6.
  • the positioning and holding means 60 When the positioning and holding means 60 is pulled into the catheter body 10 and collected by retracting the slide part 100 from the main body part 71, the number displayed on the guide bar 88A is sequentially displayed in the window so that the number indicated on the guide bar 88A is counted down.
  • the terminal 83 that allows the holding member 11 to conduct is in contact with the contact member 85, the “OK” display portion H 6 finally appears in the window 73.
  • a lock-unlock mechanism 102 shown in FIGS. 12 and 13 is provided on the slide unit 100, and the slide movement of the slide unit 100 is locked-unlocked by pressing the push piece 109 and the operation wire 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. 12 and 13 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. Therefore, if the slide part 100 is moved backward, the holding member 11 can be operated close to the puncture member 12.
  • 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 operation wire 14 can be linked with the operation to make the operation wire 14 straight, and the operation wire 14 that may damage the living tissue M is curved. It is possible to prevent a pulling operation in the state of being held and a backward movement of the holding member 11 in the holding state, and prevent a situation in which the living tissue M is damaged or broken.
  • 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 or the like 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. If the wedge-shaped through hole is formed in this way, the operation wire 14 can be moved only in the through hole, and the large-diameter portion 106 can be clamped more strongly. It can be held in a fixed position, and the procedure can be performed easily, safely and reliably.
  • a puncturing operation is performed by the puncture member 12.
  • the holding and positioning of the living tissue M is performed by pulling the operation wire 14. 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 when 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 puncture member 12 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 holds a positioning portion 61 for positioning the puncture member 12 with respect to the oval hole O, and holds the oval hole valve M2 so as not to be retractable with respect to the puncture direction of the puncture member 12.
  • the holding portion 62 is normally housed in the guiding catheter 3, but when used, it is pushed out of the guiding catheter 3 by operating the operation wire 14 and the main tube 63 as shown in the figure.
  • 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 20 for an operator to grasp with the finger in order to move the operation wire 14 back and forth or rotate.
  • the positioning portion 61 of the positioning holding means 60 is provided at the distal end portion of the main pipe 63.
  • the positioning portion 61 is for positioning the puncture member 12 with respect to the foramen ovale O, and includes a pair of first elastic wires 66 that are expanded and contracted by operation of the operation wire 14 as shown in FIG. Yes.
  • 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 positioning portion 61 displaces the first elastic wire 66 outwardly 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 O.
  • the inner edge is pressed with substantially equal elastic force, and the puncture member 12 is aligned with the foramen ovale O. That is, the function of locating the puncture member 12 positioned between the first elastic wires 66 at the center of the foramen ovale O is exhibited.
  • the holding portion 62 holds the puncture member 12 from the back side so that the foramen ovale valve M2 can be easily punctured.
  • a tip member 68 provided at the tip 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 are inserted through the operation wire 14, and the second elastic wire 67 is welded at the proximal end to the distal end of the intermediate sleeve body 64.
  • the tip end side is welded to the tip sleeve body 65.
  • the intermediate sleeve body 64, the tip sleeve body 65, the second elastic wire 67 connecting the sleeve bodies 64 and 65, and the 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 puncture member 12 punctures the foramen valve M2
  • the thin foramen valve M2 is held from the back side to facilitate puncture. Therefore, the bending mechanism W causes the second elastic wire 67 to bend or bend between the tip member 68 and the tip 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 portion 62 is bent and holds the oval hole valve M2 after the first elastic wire 66 of the positioning portion 61 aligns and positions the puncture member 12 with respect to the oval hole O. Since the first elastic wire 66 needs to be deformed prior to the second elastic wire 67, the rigidity of both elastic members is changed in this embodiment.
  • 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.
  • pre-process The operator inserts an introducer (an assembly in which a dilator is inserted into a long sheath) from the femoral vein. After the distal end of the long sheath reaches the left atrium L via the right atrium R, the dilator is removed from the long sheath.
  • 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 is advanced with respect to the body part 71.
  • the flat plate portion 11a of the clamping member 11 protrudes from the distal end of the catheter body 10 via the terminal and the wire portion 11b, moves the main tube 63 forward, and presses the push piece 109 of the lock-unlock mechanism 102, A state in which the large diameter portion 106 of the operation wire 14 does not hit the narrow width portion G2 of the through hole 105 formed in the operating member 104, that is, the second lock portion R2 is in an unlocked state, and the operation wire 14 is in a free state. To do.
  • the tip of the operation wire 14 is protruded 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 hand operation unit 70 is pulled until the clamping member 11 reaches the right atrium R. At this time, the distal end of the operation wire 14 protrudes from the distal sleeve body 65 and is inserted into the left atrium L.
  • the operation wire 14 When the operation wire 14 is retracted, the large-diameter portion 106 is also retracted. However, in the lock-unlock mechanism 102, 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. And the main-body part 71 is operated, the 2nd elastic wire 67, the clamping member 11, and the puncture member 12 are located in the vicinity of the foramen ovale valve M2, and the whole holding
  • the operation force for retreating is caused by the operation wire 14 by the distal end member 68, the distal end sleeve body 65, the second elastic wire 67, and the intermediate sleeve body.
  • the base end is transmitted to the first elastic wire 66 attached to the main pipe 63 via 64, and the first elastic wire 66 is formed in an arc shape outward in the radial direction as shown in FIG. Protrusively deform.
  • the second elastic wire 67 is not deformed.
  • the first elastic wire 66 is deformed while expanding the lip portion of the oval hole O. Therefore, the puncture member 12 provided in the immediate vicinity of the first elastic wire 66 is moved into the oval hole O.
  • the puncture member 12 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. 22D, 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 puncture member 12. It abuts against the left atrial surface of M2 and holds it.
  • 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 is not loosened, and the operator advances the needle operation lever 78 with only one hand. be able to.
  • the breaking strength between the operation wire 14 and the grip portion 20 is the breaking strength between the operation wire 14 and the tip member 68. Therefore, before the distal end member 68 is broken from the operation wire 14, the proximal end member 21 is broken from the operation wire 14. For this reason, it is suppressed that the tip member 68 falls off from the operation wire 14, and the tip member 68 is not left in the blood vessel, and the tip member 68 is carried by the blood flow to suppress a possibility of causing a failure such as occlusion of the blood vessel. it can.
  • the needle member 12a since the distal end portion of the needle member 12a is bent in a smooth arc shape in a natural state, the needle member 12a comes into contact with the foramen ovale valve M2 more perpendicularly (the angle at which it occurs), and reliable puncture is possible. .
  • the lumens L1 and L2 have a cross section that is long in the bending direction in the orthogonal cross section Z (see FIG. 6), and the inner wall surface 41 sandwiching the bending portion 12b is formed. Even if a rotational force acts on the needle member 12a in the lumens L1 and L2 by a procedure such as the above, the needle member 12a is held by the inner wall surface 41 and the rotation is suppressed. Therefore, the bending direction of the needle member 12a is always kept in agreement with the bending direction of the lumens L1 and L2, and the sharp tip of the needle member 12a does not interfere with the member (tip tip 40) constituting the lumens L1 and L2. Therefore, the tip tip 40 can be prevented from being damaged by the sharp tip of the needle member 12a, and a smooth protrusion can be achieved, thereby improving safety.
  • the needle member 12a is rotatably connected to the terminal 81 in the hand operation unit 70, even if a procedure such as rotating the hand operation unit 70 is performed, the needle member 12a is hardly twisted, and the needle member Interference with other members of 12a can be reduced more reliably.
  • the needle member 12a is formed of the step portion 42 and the tip stopper 12c. No more than a certain length defined by the above, and safety is improved.
  • the hand operating unit 70 displays a display of the next moving direction and a number indicating the order of the operation steps from the lower surface.
  • the position of the puncture member 12 is determined by the positioning holding portion 62, there is no possibility of deviation, and once the puncture member 12 is punctured, the position of the puncture member 12 is a fixed position in relation to the oval hole valve M2. It becomes. Therefore, the surgeon can perform the puncture operation very easily.
  • the slide unit 100 is further advanced with respect to the main body unit 71.
  • the flat plate portion 11a of the holding member 11 protrudes from the distal end of the catheter body 10 via the terminal and wire portion 11b.
  • the terminal 81 attached to the needle operation lever 78 moves forward to contact the contact member 84, and the puncture member 12 and the input connector 75 are in an electrically conductive state (FIG. 10). reference).
  • the terminal 81 attached to the needle operation lever 78 advances and the connection tip 12e fixed to the needle member 12a contacts the conduction assisting portion 86, and the connection tip 12e becomes the conduction assisting portion 86. Is pressed against the terminal 81. As a result, the contact resistance between the rotatable connection chip 12e and the terminal 81 is reduced, and the current flow when applying electric energy can be stabilized.
  • the flat plate portion 11a Due to the retraction of the slide portion 100, the flat plate portion 11a is retracted via the wire portion 11b shown in FIG. 2, and the bent portion 11c of the wire portion 11b is affected when entering the lumen of the tip tip 40, and the flat plate portion 11a. Is displaced so as to approach the puncture member 12. By this displacement, the flat plate portion 11a presses the atrial septum M1 toward the foramen ovale valve M2, and the atrial septum M1 and the foramen ovale valve M2 are fixed in the thickness direction, that is, in the operation state, the front-rear direction position is fixed. As shown in FIG. 21, the atrial septum M1 and the foramen ovale M2 are present between the clamping member 11 and the puncture member 12.
  • the terminal 83 attached to the main pipe 63 is also moved backward to come into contact with the contact member 85, so that the holding member 11 and the input connector 75 are in an electrically conductive state. Then, the notch 89 of the guide bar 88A coincides with the connection hole 74, and the output connector 87 can be connected to the input connector 75 for the first time.
  • connection process The retraction of the slide part 100 at this stage is performed by holding the living tissue M and the contact state between the terminal 83 and the contact member 85 at once.
  • terminal 81 on the puncture member 12 side and the contact member 84 are in an electrically conductive state first, both the clamping member 11 and the puncture member 12 are in a state in which electrical energy can be supplied.
  • predetermined electrical energy controlled by the control unit 5 is supplied to the clamping member 11 and the puncture member 12, and the atrial septum M1 and the foramen ovale M2 are heated.
  • the electrical energy control unit 5 controls the output to be low and makes it difficult for blood clots to adhere. Therefore, even if a part of the pinching member 11 and the puncture member 12 is exposed in the blood, the pinching member 11 or the puncture member Thrombus can be prevented from adhering to the member 12.
  • connection mechanism 90 is pressed, and the connection between the Y connector 72 and the main body 71 is released, so that the guiding catheter 3 and the main body 71 are disconnected, and the main body 71 is separated from the living body.
  • 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 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.
  • a passage-like deficiency such as a left atrial appendage closure device (Left Trial Appendage) is closed. It can also be used when performing or when the living tissue M at a predetermined site is thermally necrotized.
  • the present invention can be applied to a device used for percutaneous septal myocardial cauterization (PTSMA) in which ethanol is injected into a hypertrophic portion of the heart to treat necrosis as a treatment method for obstructive hypertrophic cardiomyopathy (HOCM).
  • PTSMA percutaneous septal myocardial cauterization
  • HOCM obstructive hypertrophic cardiomyopathy
  • the needle member may be a hollow needle into which a medicine or the like can be injected.
  • the needle tip of the needle member 12a is not formed in a tapered shape as shown in FIGS. 4 and 5, but is formed in a conical shape as shown in FIG. You may form so that it may be located in the center.
  • the inner wall surface shape (see FIG. 6) of the lumens L1 and L2 in the orthogonal cross section Z orthogonal to the direction along the lumens L1 and L2 is not particularly limited as long as it is long in one direction even if it is not elliptical. It may be oval, rectangular or rhombus.

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Abstract

L'invention a pour but de proposer un dispositif médical apte à améliorer la sécurité de celui-ci en faisant correspondre la direction des éléments aiguilles avec la direction de la pointe de cathéter et en limitant l'interférence entre les éléments aiguilles et le cathéter. A cet effet, l'invention concerne un dispositif médical ayant des éléments aiguilles (12a) disposés pour être aptes à être avancés et rétractés dans des lumières (L1, L2) formées à l'intérieur d'un cathéter (1), où : des parties incurvées (12b) qui sont en permanence incurvées sont formées à la pointe des éléments aiguilles (12a) ; les lumières (L1, L2) dans la pointe du cathéter (1) sont aptes à recevoir les parties incurvées (12b) ; et la forme de la surface de paroi interne (41) dans une section transversale orthogonale qui est orthogonale à la direction des lumières (L1, L2) est telle qu'une première direction est formée pour être relativement plus longue que la seconde direction qui est orthogonale à ladite première direction.
PCT/JP2011/078181 2011-03-02 2011-12-06 Dispositif médical WO2012117637A1 (fr)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014049676A1 (fr) * 2012-09-25 2014-04-03 テルモ株式会社 Dispositif médical
JP7617073B2 (ja) 2019-07-17 2025-01-17 バイオセンス・ウエブスター・（イスラエル）・リミテッド 高密度電極アレイを有する開花状リーフレットカテーテル

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008534139A (ja) * 2005-03-30 2008-08-28 ボストン サイエンティフィック リミテッド オペレータが１人で交換する塞栓防護フィルタ
JP2009050592A (ja) * 2007-08-28 2009-03-12 Terumo Corp Ｐｆｏ閉鎖デバイス
JP2011019763A (ja) * 2009-07-16 2011-02-03 Terumo Corp 医療用デバイス

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008534139A (ja) * 2005-03-30 2008-08-28 ボストン サイエンティフィック リミテッド オペレータが１人で交換する塞栓防護フィルタ
JP2009050592A (ja) * 2007-08-28 2009-03-12 Terumo Corp Ｐｆｏ閉鎖デバイス
JP2011019763A (ja) * 2009-07-16 2011-02-03 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
WO2014049676A1 (fr) * 2012-09-25 2014-04-03 テルモ株式会社 Dispositif médical
JP7617073B2 (ja) 2019-07-17 2025-01-17 バイオセンス・ウエブスター・（イスラエル）・リミテッド 高密度電極アレイを有する開花状リーフレットカテーテル

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