WO2014125588A1

WO2014125588A1 - Medical device

Info

Publication number: WO2014125588A1
Application number: PCT/JP2013/053466
Authority: WO
Inventors: 加藤幸俊
Original assignee: テルモ株式会社
Priority date: 2013-02-14
Filing date: 2013-02-14
Publication date: 2014-08-21

Abstract

Provided is a medical device which is capable of improving safety by enabling easy retrieval of an operation rod which operates a deformation part that deforms inside a lumen of a body. This medical device comprises a moving member (110) which is disposed on a hand operation part (70) that is provided on a distal end part of a catheter main body (10), is capable of moving in a direction that intersects with an axis of an operation rod (14) that operates a deformation part (60), abuts the operation rod (14) at a first abutting part (G2) by being biased to one side of the direction of movement to restrict movement of the operation rod (14) with respect to the hand operation part (70), moves in a direction of release which is the opposite direction to the direction of bias by operation of the hand operation part (70) to release the movement restriction of the operation rod (14), and abuts the operation rod (14) at a second abutting part (G3) by moving further in the direction of release to restrict movement of the operation rod (14) with respect to the hand operation part (70).

Description

Medical device

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

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

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

As a treatment for such a disease, a treatment using a percutaneous catheter 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) However, conventional devices use a disc-shaped membrane or anchor member that closes the defect to sandwich the foramen ovale and the atrial septum, which are placed in the body.

The membrane and the anchor member are foreign bodies for the body, and thrombus is easily formed. In particular, when a thrombus is formed in the disc-like membrane on the left atrium side, it may flow and cause a stroke, and there is a possibility that the thin-walled foramen valve is damaged. In addition, these members are not fixed in position in a sandwiched state, and there is a possibility of causing a positional shift.

For this reason, recently, a PFO closure device has been proposed in which a foramen ovale and an atrial septum are sandwiched between a pair of electrodes, and tissue is joined by applying electrical energy from both electrodes (for example, Patent Document 1). reference). In this PFO closing device, first, the positioning holding part (deformation part) protrudes from the catheter to the distal end side, reaches the left atrium side through the foramen ovale from the right atrium side, and pulls the operating rod penetrating the positioning holding part. By doing so, the positioning holding portion is deformed so as to be bent, and the foramen ovale valve is held so as to be pressed from the left atrial side to the atrial septum. Next, the puncture member, which is an electrode, is pierced into the foramen valve from the right atrium side to the left atrium side, and the foramen valve and the atrial septum are placed between the clamping member and the puncture member, which are electrodes located on the right atrium side. Hold it. Thereafter, electrical energy is applied between the puncture member and the clamping member to join the foramen valve and the atrial septum together. On the hand side of this PFO closure device, a relatively movable main body and slide are provided, and by moving the slide relative to the main body, the positioning holding portion protrudes from the distal end of the catheter. The electrode can be moved backward or moved. An operation rod penetrating the positioning holding portion is inserted into the slide portion, and a lock mechanism is provided to restrain the operation rod to the slide portion by the force of a spring. Therefore, the operation rod can be moved not only with the movement of the slide part, but also by releasing the lock mechanism by pushing the pushing piece provided on the slide part, and the operation rod is moved independently from the slide part. It becomes possible. With such a structure, after the electrode is moved by the movement of the slide part, the position of the slide part with respect to the main body part is maintained and the position of the electrode (clamping member and puncture member) is maintained, and the lock mechanism is It can cancel | release and can make an operation rod movable independently from a slide part. Thereby, the positioning holding | maintenance part bent by pulling of the operation rod can be returned to linear form, and a positioning holding | maintenance part can be extracted from an oval hole.

JP 2010-220883 A

The above-mentioned PFO closure device can retract the positioning holding part and the electrode by retracting the slide part with respect to the main body part and collect it in the catheter. When the operation rod is retracted with respect to the part, the restriction on the slide part is released, so if the operation rod is not pulled separately from the slide part, the operation rod penetrating the positioning holding part remains, The positioning holding part (deformation part) and the electrode can be recovered. In such a case, there is a possibility that the PFO may be closed while the operation rod remains between the foramen ovale valve and the atrial septum. Further, even when the operator notices that the operating rod has not been collected before the PFO is closed, it is necessary to move the operating rod again, which increases the work process of the doctor and increases the burden during medical practice.

The present invention solves the above-described problems, and provides a medical device that can improve the safety and workability by facilitating the recovery of an operation rod that operates a deformable portion that deforms in a living body lumen. For the purpose.

A medical device according to the present invention that achieves the above object includes a catheter that is inserted into a living body lumen, a hand operation unit provided at a proximal end of the catheter, the hand operation unit, and an axial direction in the catheter. An operation rod that is movably inserted, a deformation portion that is provided at a distal end portion of the operation rod, is deformed by movement of the operation rod in an axial direction and comes into contact with a living tissue, and is provided at the hand operation portion, It is movable in a direction crossing the axis of the rod, and is biased to one side of the moving direction so as to come into contact with the operating rod at the first abutting portion to move the operating rod relative to the hand operating portion. Restricting, moving in a release direction that is opposite to the direction of the urging by an operation in the hand operation unit to release the movement restriction of the operation rod, and further moving in the release direction , Having a moving member capable restricting the movement with respect to the operation portion of the operation rod abuts at said operating rod and the second contact portion.

The medical device configured as described above regulates the movement of the operating rod with respect to the hand operating portion by maintaining the movement of the moving member after the moving member is moved in the releasing direction to release the deformation of the deforming portion. Thus, the operation rod can be moved together with the hand operation unit, and the operation rod can be easily collected and the safety and workability can be improved.

If the second abutting portion is configured by a through hole whose width becomes narrower in the moving direction in the moving member, the operation rod comes into contact with the second abutting portion so as to be operated. The clamping of the rod can be made stronger and the reliability of the operation can be improved.

If the through hole of the moving member is configured such that the length between the first abutting portion and the second abutting portion is shorter than the moving distance in the releasing direction of the moving member. Any shape of the second contact portion can be used to restrict the movement of the operation rod because the second contact portion presses the operation rod in the release direction.

If the through hole of the moving member is configured to be trapezoidal, the first contact portion and the second contact portion that can appropriately perform restriction and release of movement of the operation rod with respect to the hand operation portion, Easy to configure.

The hand operating part is provided with a main body part connected to the catheter, a slide part that is connected to the deforming part and movable with respect to the main body part, and is rotatably provided. A wheel that moves the slide portion relative to the main body portion, and if the moving member moves in the release direction by pushing the wheel, the wheel is rotated to turn the slide portion into the main body portion. When moving the operation rod, the movement of the operation rod is regulated by the second contact portion in conjunction with the pushing operation of the wheel, and the operation rod can be moved together with the slide portion.

The deforming portion is inserted through the catheter, the proximal end portion is connected to the hand operation portion, the main tube through which the operation rod is inserted, the distal end side of the main tube, and fixed to the distal end of the operation rod. A holding portion that is deformed so as to bend between the distal end member and the main tube by holding the distal end member to the proximal end side, and holds the biological tissue. After holding the living tissue, the moving member is moved to release the holding by the holding unit, and further, the movement of the operating rod is regulated by the second contact portion, and the operating rod is collected together with the holding unit. It becomes possible.

The deforming portion is provided on the distal end side of the main pipe, and a distal end member fixed to the distal end of the operation rod moves to the proximal end side so as to protrude radially outward between the distal end member and the main pipe. If the medical device has a positioning part for positioning the medical device with respect to the living tissue, the positioning is performed by the positioning part deformed by the operating rod, and then the moving member is moved to While releasing the positioning, the movement of the operating rod is further restricted by the second contact portion, and the operating rod can be collected together with the positioning portion.

An electrode capable of applying electrical energy between the needle part, which is an electrode that pierces the living tissue around the defect existing in the living tissue, and the needle part between the needle part and the needle part If there is a holding part, the needle part and the holding part are inserted into the living tissue while the deforming part operated by the operating rod is brought into contact with the living tissue around the defect and the needle part is inserted into the living tissue. The living tissue can be satisfactorily bonded by applying electric energy while sandwiching the living tissue.

It is a schematic sectional drawing which shows the medical device which concerns on this embodiment. It is a principal part perspective view which shows the medical device which concerns on this embodiment. 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 | tip part which shows the time of a clamping part and a needle part projecting from a lumen. It is a top view of a catheter front-end | tip part which shows the time of a clamping part and a needle part being accommodated in the lumen | rumen. It is a top view which shows the hand operation part of the medical device which concerns on this embodiment. It is sectional drawing of the main-body part of the hand operation part of the medical device which concerns on this embodiment. It is an expanded sectional view of the main-body part of the hand operation part of the medical device which concerns on this embodiment. 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. It is sectional drawing of the slide part which follows the 11-11 line of FIG. 6, (A) shows before pushing in a wheel, (B) shows immediately after pushing in a wheel, (C) is when pushing a wheel further. Indicates. FIG. 12 is a cross-sectional view taken along line 12-12 of FIG. FIG. 13 is a cross-sectional view taken along line 13-13 in FIG. It is a figure which shows a positioning holding | maintenance part, (A) is the top view seen from one side, (B) is the top view seen from the other side. It is a top view which shows a flexible member. It is the arrow view seen from the arrow 16 of FIG. It is the arrow view seen from the arrow 17 of FIG. It is a top view which shows the hand operation part at the time of operating a needle operation lever, (A) shows before operation, (B) shows after operation. It is an enlarged plan view which shows the hand operation part at the time of retreating a slide part, (A) is during retreating, (B) shows after retreating. It is an enlarged plan view which shows the hand operation part at the time of connecting an output connector to the input connector of a hand operation part. It is a top view of a hand operation part at the time of retracting a needle operation lever. It is a schematic sectional drawing at the time of inserting the positioning holding | maintenance part in an oval hole. It is a schematic sectional drawing at the time of hold | maintaining an oval valve and an atrial septum with a positioning holding | maintenance part. It is a schematic sectional drawing at the time of puncturing a needle part holding an oval hole valve and an atrial septum. It is a schematic sectional drawing at the time of separating the clamping part from the atrial septum. It is a schematic sectional drawing at the time of releasing holding by a positioning holding part and accommodating a positioning holding part in a device. It is a schematic sectional drawing at the time of pinching a foramen-valve valve and an atrial septum by a needle part and a clamping part. It is a schematic plan view which shows the operation state of a positioning holding | maintenance part, (A) is before operation, (B) shows the time of operating a positioning part, (C) shows the time of operating a holding part. It is a top view which shows the modification of the through-hole of a moving member, (A) shows a 1st modification, (B) shows a 2nd modification, (C) shows a 3rd modification.

Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.

The medical device according to the embodiment of the present invention is a PFO closure device. In FIG. 2, only the hand operating unit 70 is shown in a reduced state for the sake of space.

As shown in FIGS. 1 and 2, 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 sheath 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 functions as a clamping means K that clamps the foramen ovale valve M2 and the atrial septum M1, and an assist for performing the procedure by the clamping means K stably and accurately. And a positioning / holding part 60 (deformation part) that holds and positions the living tissue M. In the following description, the hand operating unit 70 side of the device is referred to as “base end side”, and the pinching means K side is referred to as “tip side”. Further, the “catheter” represents one including a tube used for medical purposes.

In using the device, first, the guiding sheath 3 is inserted, for example, from the femoral vein. The guiding sheath 3 is provided with a clamping means K provided at the distal end of the catheter body 10 therein. 10 is inserted together with 10. After the distal end reaches the part of the heart where the procedure is performed, the hand operating unit 70 is operated to cause the pinching means K to protrude from the catheter body 10 and the oval hole defect O (hereinafter simply referred to as the oval hole O). The tissue of the atrial septum M1 and the foramen ovale M2 of the heart where the In this clamping state, electric energy is supplied to the clamping means K, both tissues are heated and fused, and the defect O is closed. That is, the pinching means K functions as a heating unit. In the figure, “L” indicates the left atrium and “R” indicates the right atrium.

The 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. In the present embodiment, polyether ether ketone (PEEK) is used as the material of the catheter body 10 and the distal tip 40, but the material is not limited to this. For example, perprene (registered trademark) nylon which is a thermoplastic polyester elastomer. 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.

On the other hand, 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 | hook base end part 32 are provided. A terminal 81 on the proximal end side of the needle proximal end portion 32 is connected to a needle operation lever 78 provided in the hand operation portion 70 for operating the needle portion 30. Needle tip 31 and needle base 32 are integrally formed of the same wire.

The needle tip 31 is movably held by two lumens L1 and L2 (see FIG. 3) formed on the catheter body 10 and the tip 40, and as shown in FIGS. The sharp tip can be projected and retracted from the tip 40 by advancing and retracting in the axial direction.

The sandwiching part 20 and the needle part 30 function as electrodes for applying an electric current to the living tissue M, but the wire part 22 and the needle part 30 of the sandwiching part 20 are inserted through the catheter body 10. , An input connector 75 provided in the hand operation unit 70, an output connector 87 (see FIG. 1) that is a plug fitted to the input connector 70, a lead wire d (generic name for d1 and d2) connected to the electrode terminal of the output connector 87 It is electrically connected to the energy supply means 4 via the controller 5. Further, 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. Here, the following means and the like are provided in a lump so that all operations can be performed within a small area without much movement of the hand.

That is, as shown in FIG. 2, the hand operation unit 70 includes a main body 71 on the side to which the guiding sheath 3 is coupled, a slide unit 100 for operating the positioning holding unit 60, and a needle that is one electrode member. It assists the operation of the needle operating lever 78 for operating the part 30, the clamping part operating lever 122 for operating the clamping part 20 as the other electrode member, and the clamping means K. The hand operating part 70 and the catheter body 10 And an operation rod 14 which is inserted so as to be movable in the axial direction. Further, the hand operating unit 70 includes a gripping member 15 coupled to a base end portion of the operating rod 14 for operating the operating rod 14, a wheel 160 for sliding the sliding unit 100, and a sliding unit 100. A lock mechanism 101 (see FIG. 13) capable of restricting the sliding movement and releasing the restriction, and an input connector 75 having an electrode terminal connected to the energy supply means 4 for applying thermal energy are provided. .

More specifically, the hand operating section 70 is connected to the slide section 100 via the guide bars 88A and 88B so that the base end side is close to and away from the main body section 71. On the upper surface of the main body 71, a needle operation lever 78 that operates the needle unit 30 and a clamping unit operation lever 122 that operates the clamping unit 20 are provided. The guide bars 88A and 88B are fixed to the slide portion 100 and are slidably provided inside the main body portion 71.

As shown in FIG. 6, 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. As shown in FIGS. 7 and 8, 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. Further, 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.

Further, as shown in FIG. 6, 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. As shown in FIGS. 7 and 8, 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, 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.

Contact members

84 and 85 functioning as switches are provided at the movement end positions of these

terminals

81 and 83. Of course, 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. When 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.

A distal end member 68 is provided at the distal end of the operation rod 14, and a gripping member 15 is disposed at the proximal end. The operation rod 14 is provided in the main pipe 63 and has a function of assisting the operation of the pinching means K by pulling in the axial direction, and can be rotated 360 degrees around the axis in the main pipe 63. If the operating rod 14 can be rotated 360 degrees, the tip of the operating rod 14 can be inserted up to the vicinity of the foramen ovale O, and can be inserted into the oval hole 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.

As shown in FIG. 9A, 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 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, and 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. Therefore, when the connecting member 140 is moved to the distal end side with the terminal 83 sandwiched between the first engaging portion 142 and the second engaging portion 143, the terminal 83 is moved to the distal end side by the second engaging portion 143. When the connecting member 140 is moved to the proximal end side, the terminal 83 is pushed to the proximal end side by the first engaging portion 142. (See FIGS. 9D and 9E). An inclined surface 144 having an acute angle on the top side is formed on the base end side surface of the second engagement portion 143.

The deformation inducing portion 150 is disposed on the distal end side of the connecting member 140, and a tapered surface 151 that is inclined with respect to the advancing / retreating direction of the connecting member 140 is formed on the base end side surface. As shown in FIG. 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. When 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 engaging of the connecting member 140 and the terminal 83 is released. As a result, as shown in FIG. 9C, even if the connecting member 140 is further moved to the distal end side, the terminal 83 is not moved to the distal end side, and the clamping portion 20 is operated independently from the slide portion 100. Is possible.

Then, when the connecting member 140 moved in the distal direction is pulled back to the proximal end side and the first engaging portion 142 moves to the proximal end side relative to the deformation inducing portion 150, as shown in FIG. 140 returns to its original shape from the bent state. And since the inclined surface 144 is formed in the base end side of the 2nd engaging part 143, the 2nd engaging part 143 moves over the terminal 83 smoothly, moves to the base end side of the terminal 83, and is 1st again. The terminal 83 is sandwiched between the engaging portion 142 and the second engaging portion 143. When the connecting member 140 is further moved to the proximal end side, as shown in FIG. 9E, 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. In this way, the operation switching unit 130 can connect or independent the movement of the holding unit 20 with respect to the slide unit 100 due to the forward / backward movement of the slide unit 100.

A push button 93 of a coupling mechanism 90 (see FIG. 2) is provided at the tip of the main body 71. The coupling mechanism 90 is for facilitating the attachment / detachment of the guiding sheath 3 with respect to the main body 71, and the flange provided at the proximal end of the guiding sheath 3 is inserted into the main body with the push button 93 pressed. When the push button 93 is released after being fitted into the insertion hole formed in 71, the flange portion of the guiding sheath 3 is engaged with the engagement hole 94 of the sliding member 91 as shown in FIG. To do. Then, the sliding member 91 is ejected by the spring member 92 to exert a function of preventing the flange portion from being detached, and the guiding sheath 3 can be detached by pressing the push button 93. A side port 3A is formed on the proximal end side of the guiding sheath 3, and a contrast agent or the like can be injected from the side port 3A.

As shown in FIGS. 6 to 8, a connection hole 74 corresponding to the outer shape of the output connector 87 is provided at the base end portion of the main body 71, and the 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 A, and the guide bar 88 A and the main pipe 63 retreat with respect to the main body 71 together with the slide part 100. If they match, the output connector 87 can be connected to the input connector 75. As a result, 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.

Further, as shown in FIG. 6, the main body 71 is provided with a window 73 opened adjacent to the input connector 75. In the guide bar 88 A, an “OK” display portion H is written in the vicinity of the notch portion 89.

By retracting the slide part 100 from the main body part 71 and withdrawing and collecting the positioning holding part 60 into the catheter main body 10 and the terminal 83 enabling the holding part 20 to be in contact with the contact member 85, the final result is “OK”. The display portion H appears in the window 73.

Also, an operating member 170 extending in the proximal direction is fixed to the base end side of the main body 71, and the operating member 170 is slidably provided inside the slide unit 100. The actuating member 170 includes a first rack gear 171 (contact portion) provided with a tooth groove arranged in one direction on a side portion on which the wheel 160 is provided, and a tooth groove arranged in one direction on a side portion on the opposite side. A second rack gear 172 (contact portion) is formed.

As shown in FIG. 11, the lock mechanism 101 includes a wheel 160, a moving member 110 that moves in the slide unit 100 by a pushing operation of the wheel 160, and a long operating member 170.

The wheel 160 is provided on the slide unit 100 with a part of the outer periphery exposed to the outside so that the operator can rotate it with a finger. The wheel 160 is formed integrally with a cylindrical portion 161 that rotates coaxially, a pinion gear 162 that is a gear that rotates coaxially, and a rotating shaft 163 that is coaxially supported so as to be rotatable with respect to the slide portion 100. . The rotating shaft 163 is rotatably held by a bearing portion 102 formed inside the slide portion 100. The bearing portion 102 is formed by a horizontally long groove that allows the rotation shaft 163 to move in a direction orthogonal to the slide direction of the slide portion 100. For this reason, the wheel 160 is orthogonal to the slide direction of the slide portion 100. It can move when pressed in the direction. In a state where the wheel 160 is not pushed in, the pinion gear 162 does not mesh away from the first rack gear 171 of the operating member 170 as shown in FIGS. 11A and 13A, and the wheel 160 is pushed in. Only in this state, the rotational movement of the pinion gear 162 can be converted into the linear movement of the actuating member 170 by meshing with the first rack gear 171 as shown in FIGS. The column portion 161 is rotatably held by an arc-shaped receiving portion 113 of the moving member 110 provided in the pushing direction of the wheel 160.

The moving member 110 is movable in a direction orthogonal to (intersects) the axis of the operation rod 14, is held by the slide unit 100 via the spring 104, and is pressed against the pushing direction of the wheel 160 by the elastic force of the spring 104. It is biased in the opposite direction (biasing direction). Further, the moving member 110 has a tooth groove portion 111 that can mesh with the second rack gear 172. In a state where the wheel 160 is not pushed in, the tooth gap portion 111 meshes with the second rack gear 172 of the operating member 170 to limit the movement of the operating member 170 (see FIGS. 11A and 13A). Only in the state where the wheel 160 is pushed in, the movement restriction of the operating member 170 is released away from the second rack gear 172 (see FIGS. 11B and 13B). Therefore, in a state where the wheel 160 is not pressed, the pinion gear 162 provided integrally with the wheel 160 does not mesh with the first rack gear 171, and the tooth gap portion 111 meshes with the second rack gear 172 and moves within the slide portion 100. The movement of the actuating member 170 is restricted. When the wheel 160 is pushed in, the pinion gear 162 meshes with the first rack gear 171, the tooth groove portion 111 is separated from the second rack gear 172, and the movement restriction of the operating member 170 in the slide portion 100 is released. Thus, by rotating the wheel 160 with a finger, the operating member 170 is moved within the slide portion 100 by the rotational force of the pinion gear 162, and the slide portion 100 is moved relative to the main body portion 71.

In addition, as shown in FIGS. 11 and 12, the moving member 110 is formed with a through hole 112 through which the operating rod 14 penetrates and which can lock the operating rod 14, so that the outer diameter of the operating rod 14 is large. The diameter portion 106 can be locked. As the material of the large-diameter portion 106, for example, a stainless pipe can be applied. The large-diameter portion 106 is formed by fixing a tubular member to a wire constituting most of the operation rod 14 by a known technique corresponding to a material such as welding, adhesion, or fusion. The through-hole 112 provided in the moving member 110 is provided from the wide portion G1 on both sides in the moving direction of the moving member 110 with the wide portion G1 interposed therebetween in order to temporarily stop the advance / retreat operation of the operating rod 14 in the axial direction. It has the 1st narrow part G2 (1st contact part) and the 2nd narrow part G3 (2nd contact part) which become narrow as it leaves | separates. When the moving member 110 is moved in the biasing direction by the elastic force of the spring 104, as shown in FIG. 11A, the operation rod 14 is sandwiched between the first narrow portions G2 having a small width. The movement of the operation rod 14 with respect to the hand operation unit 70 is restricted. From this state, when the wheel 160 is pushed in by the operator, the moving member 110 moves in the release direction opposite to the urging direction so as to oppose the elastic force of the spring 104 as shown in FIG. The operating rod 14 is positioned in the wide wide portion G1 and does not contact the wide width portion G1, so that the operating rod 14 can move with respect to the hand operating portion 70. From this state, when the wheel 160 is further pushed in by the operator, the moving member 110 further moves in the releasing direction so as to oppose the elastic force of the spring 104 as shown in FIG. The second narrow width portion G3 is in contact with and sandwiched by the second narrow width portion G3, and the movement of the operation rod 14 relative to the hand operation portion 70 is restricted again. In this way, the first narrow portion G2 and the second narrow portion are sandwiched between the first narrow portion G2 and the second narrow portion G3 so that the width decreases as the distance from the wide portion G1 increases. The holding of the operation rod 14 by G3 can be made stronger and the reliability of the operation can be improved.

Further, the form of the second contact portion of the through hole of the moving member is not particularly limited as long as it can contact the operation rod and restrict the movement of the operation rod. For example, if the length between the first contact portion and the second contact portion of the moving member is shorter than the moving distance in the releasing direction of the moving member, the through hole of the moving member is the second contact hole. Regardless of the shape of the contact portion, the second abutting portion presses the operation rod in the release direction, so that the movement of the operation rod is restricted. Here, “the length between the first contact portion and the second contact portion of the moving member” is an operation when the first contact portion is located in the cross section of the through hole of the moving member. The length of a perpendicular line between two straight lines when a perpendicular line is drawn between a straight line passing through the center of the circular cross section of the rod and a straight line passing through the center of the circular cross section of the operating rod when positioned at the second contact portion. . The “movement distance of the moving member in the releasing direction” refers to the distance that the moving member has moved in the releasing direction when the wheel is pushed.

In such a configuration, even when the through hole of the moving member is a triangle or a trapezoid as shown in FIG. For example, in FIG. 29B, “the length between the first contact portion and the second contact portion of the moving member” means that the operating rod 14 is in contact with the first contact portion G1. A perpendicular line is drawn between a straight line passing through the center of the circular cross section of the operating rod 14 and the straight line passing through the center of the circular cross section of the operating rod 14 when the operating rod 14 is in contact with the second contact portion G5. It is the length of the perpendicular between two straight lines.

When performing a procedure, the holding and positioning of the living tissue M is performed by the positioning and holding unit 60, and then the 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 rod 14. Do it. Even if the operating tissue 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. Accordingly, when the operating rod 14 is pulled, the large-diameter portion 106 is brought into contact with and locked with the first narrow portion G2 of the through hole 112 (in some cases, the lip portion 112a of the first narrow portion G2). The operation rod 14 is temporarily locked, and even if the hand holding the operation rod 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 independently. I have to.

When the wheel 160 is pushed in, the movement restriction of the operation rod 14 relative to the slide portion 100 is released at the moment when the operation rod 14 is positioned at the wide portion G1 having a wide width, and the

linear portions

66 and 67 of the holding portion 62 described later are released. Due to the elasticity, the tip of the operating rod 14 automatically becomes straight, and the holding state of the foramen ovale valve M2 can be easily released.

Further, when the wheel 160 is pushed in and rotated in order to move the slide portion 100 relative to the main body portion 71, the operation rod 14 is held between the narrow second narrow portion G3. The wheel 160 can be pushed in until it comes into contact, and the movement of the operation rod 14 relative to the slide portion 100 is restricted, and the operation rod 14 can be moved together with the slide portion 100.

In the internal passage through which the operation rod 14 of the slide portion 100 is inserted, a movement restricting hole 108 having a size in which the large diameter portion 106 cannot pass in the proximal direction is formed. Therefore, when the operating rod 14 is pulled, it can be pulled until the large-diameter portion 106 fixed to the operating rod 14 reaches the movement restriction hole 108, but beyond that, the operating rod 14 is moved with respect to the slide portion 100. It cannot be moved.

As described above, since the release of the movement restriction of the operating member 170 and the release of the movement restriction of the operation rod 14 are interlocked by the pushing operation of the wheel 160, an operation of pulling out the long operation rod 14 from the left atrium side; In order to pull out the operation rod 14, the operation rod 14 can be operated in a straight line to prevent the pulling operation in a state where the operation rod 14 that may damage the living tissue M is curved. It is possible to prevent a situation in which the living tissue M is damaged or broken.

The energy supply means 4 shown in FIG. 1 supplies electric energy to the clamping means K. Since it is a known system configuration, a detailed description is avoided, but from the viewpoint of ease of control, a DC power supply or an AC power supply can be used. The electrical one is preferred. However, not only this but also the one that can melt the oval valve M2 and the atrial septum M1 clamped by the clamping means K with heat and supply energy that can be crimped with an adhesive factor such as collagen or elastin. Anything may be used. For example, ultrasonic waves, lasers, microwaves, or high frequencies can be used.

As shown in FIG. 2, the positioning and holding unit 60 generally includes a needle positioning unit 61 that positions the needle unit 30 with respect to the foramen ovale O and the oval hole valve M 2 that cannot retract with respect to the puncture direction of the needle unit 30. The holding portion 62 to be held and the main pipe 63 to be fixedly held on the slide portion 100 are normally housed in the guiding sheath 3. It is pushed out from the guiding sheath 3 by operating the main pipe 63 and the like.

More specifically, the central lumen L5 formed in the tip 40 is provided with a main pipe 63 and an operation rod 14 provided in the main pipe 63 so as to be movable back and forth in the axial direction (see FIG. 3). . The main pipe 63 is fixedly held on the slide part 100 at the base end side and exhibits the function of the central axis of this device, but also reinforces the catheter body 10, and further, the positioning holding part 60. Is also drawn into the catheter body 10 and collected. The operating rod 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 rod 14 so that the operator can grasp the operation rod 14 with fingers in order to move the operation rod 14 forward and backward.

A needle positioning portion 61 is provided at the distal end portion of the main pipe 63. The needle positioning part 61 positions the needle part 30 with respect to the oval hole O. As shown in FIG. 14, the needle positioning part 61 is elastically expanded / reduced by operation of the operating rod 14 (shaft part). It is composed of two linear portions 66. The proximal end of the second linear portion 66 is attached to the outer surface of the main pipe 63, and the distal end is attached to an intermediate cylindrical body 64 through which the operation rod 14 is inserted. The two first linear portions 67 are formed of, for example, a NiTi alloy or the like, are elastically deformable, and bend in a direction away from each other at a substantially central portion so as to bend away from each other when a compressive force is applied. The curved portion 66A is formed.

On the other hand, the holding portion 62 holds the needle portion 30 from the back side so that the foramen ovale valve M2 can be easily punctured. The tip portion 68 provided at the tip portion of the operation rod 14, the tip cylinder 65, the tip portion A pair of first linear portions 67 formed integrally with the cylindrical body 65 and a reinforcing member 69 for reinforcing the distal end cylindrical body 65 are provided.

The distal end member 68 is fixed to the distal end of the operation rod 14, the distal end cylindrical body 65 and the intermediate cylindrical body 64 are inserted through the operation rod 14, and the first linear portion 67 has a proximal end fixed to the distal end of the intermediate cylindrical body 64. The distal end side is fixed to the distal end cylindrical body 65.

The intermediate cylinder body 64 is provided on the distal end side of the intermediate cylinder base end section 641 with the base end side slidably inserted into the main pipe 63 on the base end side, and has an outer diameter of the main pipe 63. An intermediate cylindrical abutting portion 642 that is larger than the inner diameter, an intermediate cylindrical proximal end fixing portion 643 that is provided on the distal end side of the intermediate cylindrical abutting portion 642 and to which the distal end of the second linear portion 66 is fixed, An intermediate cylinder distal end side fixing portion 644 provided on the distal end side of the intermediate cylinder 64 and to which the proximal end of the first linear portion 67 is fixed.

The intermediate cylinder 64 is formed by processing a metal tube such as stainless steel. Since the intermediate cylinder abutting portion 642 has an outer diameter larger than the inner diameter of the main pipe 63, even if the intermediate cylinder base end 641 is accommodated inside the main pipe 63, the intermediate cylinder abutting portion 642 is not connected to the main pipe 63. The main pipe 36 is abutted against the intermediate cylinder abutting portion 642 without being housed inside.

The intermediate cylinder base end side fixing portion 643 has

notches

643A and 643B formed on the distal end side and the proximal end side thereof, and the two second linear portions 66 are intruded into the inside from the notch portion 643B on the proximal end side. The second linear portion 66 is fixed so as to be sandwiched between the crushed tube bodies by caulking the tube body in a state of being crushed. In the intermediate cylinder base end side fixing portion 643, the operation rod 14 is disposed not on the inside of the crimped tube body but on the outside (see FIG. 14B).

The intermediate cylinder distal end side fixing portion 644 has a notch 644A formed on the proximal end side thereof, so that the tubular body is crushed in a state where the two first linear portions 67 have entered from the opening on the distal end side. The first linear portion 67 is fixed so as to be sandwiched between the crushed tube bodies. Note that, in the intermediate cylinder distal end side fixing portion 644, the operation rod 14 is disposed not on the inside of the crimped tube body but on the outside (see FIG. 14A).

The needle positioning portion 61 displaces the second linear portion 66 outward with the proximal end attached to the main pipe 63 as a fulcrum by an operation of moving the operating rod 14 in the axial direction, so that each second linear portion 66 is egg-shaped. The inner edge of the circular hole O is pressed with substantially equal elastic force, and the needle part 30 is aligned with the oval hole O. That is, it is possible to exert a function of positioning the needle part 30 located between the second linear parts 66 in the central part of the foramen ovale O.

The reinforcing member 69 is formed by processing a metal tube such as stainless steel. The reinforcing member 69 is provided on the base end side, the reinforcing member fixing portion 691 to which the front end of the first linear portion 67 is fixed, the base end side of the front end cylindrical body 65 and the front end side of the first linear portion 67. The tube-shaped reinforcing member tubular portion 692 is covered.

The reinforcing member fixing portion 691 has a notch portion 691A formed at the distal end side thereof, and is squeezed so as to crush the tubular body with the two first linear portions 67 entering the inside from the opening portion on the proximal end side. Thus, the first linear portion 67 is fixed so as to be sandwiched between the crushed tube bodies. In the reinforcing member fixing portion 691, the operation rod 14 is arranged not on the inside of the crimped tube body but on the outside (see FIG. 14A).

The reinforcing member tubular portion 692 covers the outer peripheral surface of the proximal end side of the distal end cylindrical body 65, and is fixed to the distal end cylindrical body 65 by welding or using an adhesive.

The intermediate cylindrical body distal end side fixing portion 644 of the intermediate cylindrical body 64 and the reinforcing member fixing portion 691 of the reinforcing member 69 have crimped side surfaces in the same direction (see FIG. 14A). The cylinder base end side fixing portion 643 is crimped on the side surface in the opposite direction (see FIG. 14B).

As shown in FIGS. 15 and 16, the tip cylindrical body 65 and the first linear portion 67 are formed of, for example, a NiTi alloy or the like, and are included in the flexible member 6 configured by the same wire. The distal end cylindrical body 65 is formed in a cylindrical shape by alternately winding two wires, and the first linear portion 67 is configured such that the two wires constituting the distal end cylindrical body 65 are wired from the distal end cylindrical body 65. It is formed extending in a shape. The two first linear portions 67 are elastically deformable, and are bent at a substantially central portion so as to bend away from each other when a compressive force is applied. have. As shown in FIG. 16, the two first linear portions 67 are positioned at a position less than 180 degrees relative to the winding direction of the wire at the end of the distal end cylindrical body 65 (see the angle α in FIG. 16). ) To the proximal side. Since the distal end cylindrical body 65 and the first linear portion 67 are integrally formed of the same wire, there is no need to join the distal end cylindrical body 65 and the first linear portion 67, and the number of parts is reduced. Adjustment of the direction of the bending portion 67A is unnecessary, and a desirable positional relationship can be easily realized.

As shown in FIG. 17, the side that is less than 180 degrees of the two first linear portions 67 is connected to the intermediate cylindrical body 64 and the reinforcing member 69, and the intermediate cylindrical distal end side fixing portion 644 and the reinforcing member are connected. The fixing portion 691 is arranged on the side (lower side in FIG. 17) opposite to the crimped and recessed side (upper side in FIG. 17). For this reason, the pair of first linear portions 67 are biased with respect to the operation rod 14 penetrating the distal end cylindrical body 65.

The intermediate cylinder 64, the tip cylinder 65, the first linear portion 67, the tip member 68, and the reinforcing member 69 that connect both the

cylinders

64 and 65 are a bending mechanism W that bends or curves the tip of the operation rod 14. Is configured.

The bending mechanism W is used for holding the foramen ovale valve M2. When the needle portion 30 punctures the foramen ovale valve M2, puncture is facilitated by holding the thin foramen valve M2 from the back side. Therefore, the bending mechanism W causes the first linear portion 67 to bend or bend between the distal end member 68 and the distal end side of the second linear portion 66 by retreating the operation rod 14 in the axial direction, and the distal end member The oval hole valve M2 is held from the back side by 68 and the front end cylinder 65. That is, the bending mechanism W is configured such that the distal end portion of the operating rod 14 is bent or curved with the distal end side of the second linear portion 66 attached to the main pipe 63 as a fulcrum.

However, the bending mechanism W of the holding portion 62 is bent after the second linear portion 66 of the needle positioning portion 61 aligns and positions the needle portion 30 with respect to the oval hole O, and the oval hole valve M2 is bent. Since the second linear portion 66 needs to be deformed prior to the first linear portion 67, both elastic members (first linear portion 67 are required in this embodiment. And the rigidity of the second linear portion 66) is changed.

When the slide portion 100 is advanced and retracted with respect to the main body portion 71, the main tube 63 fixed to the slide portion 100 can be drawn into the central lumen L5 of the catheter main body 10, and accordingly, the positioning holding portion 60 as a whole is catheterized. It can be collected in the main body 10.
Next, the operation of the medical device according to the first embodiment will be described.
(1) Pre-process

The surgeon inserts an introducer (an assembly in which a dilator is inserted into the guiding sheath 3) from the femoral vein. After the distal end of the guiding sheath 3 reaches the left atrium L via the inferior vena cava J and the right atrium R, the dilator is removed from the guiding sheath 3.

Next, as shown in FIG. 11B, when the wheel 160 is pressed inward of the slide portion 100, the pinion gear 162 moves inward together with the wheel 160 and meshes with the first rack gear 171. Further, the moving member 110 moves so as to contract the spring 104, the tooth gap portion 111 moves away from the second rack gear 172, and the movement restriction of the operating member 170 in the slide portion 100 is released. As a result, the slide unit 100 becomes movable with respect to the main body unit 71. Note that a part of the side of the guide bar 88A enters the connection hole 74, and the connection of the output connector 87 to the input connector 75 is obstructed, so that unexpected power supply from the energy supply means 4 is reliably suppressed. , Safety is ensured.

Next, when the wheel 160 is rotated while maintaining the state where the wheel 160 is pushed in, as shown in FIG. 13B, the pinion gear 162 meshing with the first rack gear 171 is rotated, and the slide portion 100 is moved to the main body. Retreat in a direction away from the portion 71. Further, when the needle operation lever 78 and the holding portion operation lever 122 are also retracted, the main tube 63, the wire portion 22 of the holding portion 20, the needle portion 30, and the like are accommodated in the catheter body 10. At this time, the connecting member 140 of the operation switching unit 130 moves to the proximal end side together with the slide portion 100, and the terminal 83 is pushed to the proximal end side by the first engagement portion 142 (see FIG. 9E), and is sandwiched. The part 20 is in a retracted state.

When the pressing of the wheel 160 is stopped, as shown in FIG. 11A, the moving member 110 and the wheel 160 are returned to their original positions by the elastic force of the spring 104, and the pinion gear 162 is separated from the first rack gear 171 to become the pinion gear. The rotational force of 162 is not transmitted to the operating member 170, and the tooth groove 111 is engaged with the second rack gear 172, so that the movement of the operating member 170 is restricted.

In this state, the device is inserted into the guiding sheath 3 and passes through the inferior vena cava J / right atrium R to reach the left atrium L. When the distal end of the catheter 1 reaches the left atrium L, the wheel 160 is pushed in again to make the slide portion 100 movable with respect to the main body portion 71, and the wheel 160 is rotated to advance the slide portion 100 relative to the main body portion 71. . As a result, the main pipe 63 moves forward, and the large diameter portion 106 of the operating rod 14 does not hit the narrow width portion G2 of the through hole 105 formed in the moving member 110, that is, the operating rod is free. .

Then, when the slide part 100 is moved forward with respect to the main body part 71, the positioning holding part 60 is moved forward by the main pipe 63 fixed to the slide part 100, and the holding part 20 is also moved forward. 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. As described above, the positioning and holding unit 60 and the sandwiching unit 20 can be simultaneously moved only by moving the slide unit 100.

When the slide part 100 is advanced by a predetermined length, as shown in FIG. 9B, 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. When 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.

Thereafter, the tip of the operation rod 14 is projected from the tip cylinder 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 rod 14 can rotate 360 degrees, the operation rod 14 can be advanced while rotating, and can be easily inserted into the left atrium L.

With the operating rod 14 inserted into the left atrium L, the hand operating section 70 is pulled until the openings of the lumens L1 to L5 reach the right atrium R as shown in FIG. At this time, the distal end of the operation rod 14 protrudes from the distal end cylindrical body 65 and is located in the left atrium L. And the wire part 22 will be in the state protruded from the lumens L3 and L4, and the flat plate part 21 will be in the state which left | separated from the atrial septum M1.
(2) Operation rod pulling process

In the pulling step, after confirming the distal end position of the operation rod 14, the operator holds the grasping member 15 until the distal end member 68 at the distal end of the operation rod 14 comes into contact with the distal end cylindrical body 65 as shown in FIG. Tow the operating rod 14 backward.

When the operating rod 14 is retracted, the large-diameter portion 106 shown in FIG. 12 is also retracted. However, in the lock mechanism 101, the moving member 110 is attached by the elastic force of the spring 104 unless the wheel 160 is pressed, as shown in FIG. Therefore, the operation rod 14 has a force that can always slide between the first narrow portion G2 of the wedge-shaped through hole 112 and the inner peripheral surface of the internal passage of the slide portion 100. Since the holding pressure is maintained, the pulling operation can be performed smoothly when the operating rod 14 is retracted. And the main-body part 71 is operated, the 1st linear part 67, the clamping part 20, and the needle part 30 are located in the vicinity of the foramen ovale valve M2, and it is set as the state which inserted the holding | maintenance part 62 whole in the left atrium L side. .

When the operating rod 14 is further retracted, the operating force for retracting the operating rod 14 causes the base end to be connected to the main pipe 63 via the distal end member 68, the distal end cylindrical body 65, the first linear portion 67 and the intermediate cylindrical body 64. As shown in FIG. 28 (B), the second linear portion 66 is deformed so as to project in an arc shape radially outward. However, at this time, the first linear portion 67 is not deformed.

As a result, since the second linear portion 66 is deformed while expanding the lip portion of the oval hole O, the needle portion 30 provided in the immediate vicinity of the second linear portion 66 is moved into the oval hole. Aligning with O, the needle part 30 is positioned at the center of the foramen ovale O.

When the operating rod 14 is further retracted and the intermediate cylinder abutting portion 642 of the intermediate cylinder 64 abuts against the tip of the main pipe 63 as shown in FIG. Thus, the second linear portion 66 does not deform so much, and the first linear portion 67 on the distal end side protrudes and deforms in an arc shape radially outward due to the operating force, and more than the first linear portion 67. The distal end cylindrical body 65 and the distal end member 68 on the distal end side move radially outward so as to approach the needle portion 30. The movement direction of the distal end cylinder 65 and the distal end member 68 at this time is exposed to the outside at a portion where the operation rod 14 is caulked and recessed of the intermediate cylinder distal end side fixing portion 644 and the reinforcing member fixing portion 691. Direction. And since the side which becomes less than 180 degree | times of the two 1st linear parts 67 is arrange | positioned on the opposite side (upper side in FIG. 17) of the side (lower side in FIG. 17) which is crimped, the operating rod 14 The position of the two first linear parts 67 serving as the fulcrum of deformation is biased from the position where the force is applied by the pulling of the operating rod 14, and the front end side of the first linear part 67. The distal end cylindrical body 65 and the distal end member 68 are easily moved outward in the radial direction. Since the proximal end portion of the distal end cylindrical body 65 is covered by the reinforcing member 69, the first linear portion 67 can be mainly deformed without bending the proximal end portion of the distal end cylindrical body 65. As a result, the distal end cylindrical body 65 and the distal end member 68 on the distal end side with respect to the first linear portion 67 are inclined toward the outer side in the radial direction, and can be moved to contact with the intermediate cylindrical body 64 so as to draw an arc. .

As a result, as shown in FIG. 23, in the left atrium L, the distal end member 68 and the distal end tubular body 65 move so as to approach the needle portion 30, so that the distal end member 68 and the distal end tubular body 65 can be It abuts against the left atrial L side surface of M2 and holds it. At this time, the portion of the tip member 68 that is not covered with the reinforcing member 69 on the tip side has a coil shape that can be elastically deformed, and thus can be bent and smoothly contact the oval valve M2. To do.

Next, in the moving member 110 of the lock mechanism 101 shown in FIGS. 11 and 12, the large diameter portion 106 is pushed into the through hole 112, and the large diameter portion 106 comes into contact with the first narrow width portion G 2 of the through hole 112. The operating rod 14 is temporarily locked. As a result, even if the operator releases the hand from the grasping member 15, the holding state is reliably maintained, the holding of the foramen valgus valve M2 is not loosened, and the operator advances the needle operation lever 78 with only one hand. It becomes possible.
(3) Temporary gripping process

In the temporary gripping process, 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. At this time, 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.

Then, as shown in FIG. 23, by operating the wire portion 22 so as to be slightly pulled into the lumens L3 and L4, the bending of the wire portion 22 extends within the lumens L3 and L4 and elastically forms a shape close to a straight line. The flat plate portion 21 is pressed against the atrial septum M1. By this operation, the atrial septum M1 is sandwiched between the flat plate portion 21 and the main tube 63. In the process of sandwiching the atrial septum M1 between the flat plate portion 21 and the main tube 63, the rotational direction position of the catheter body 10 that is easy to rotate around the axis is corrected, and an appropriate rotational direction with respect to the atrial septum M1. Positioned. Thereby, it becomes possible to perform the puncture and heating of the living tissue M performed thereafter at an intended appropriate position.
(4) Puncture process

When the needle operating lever 78 is advanced in the direction of the arrow (see FIG. 18), the needle tip 31 of the needle 30 protrudes from the tip of the catheter body 10, and as shown in FIG. Needle tip 31 is pierced. At this time, since the needle tip 31 is curved and the lumens L1 and L2 are also curved, the two needle tips 31 protrude while expanding outward (see FIG. 2).

And when puncturing, by temporarily grasping the atrial septum M1 by the flat plate portion 21, 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 holder 60, the needle tip 31 can be punctured at an appropriate position of the oval hole valve M2.

And once the needle part 30 is punctured, 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.

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. At this time, the clamping unit 20 can be operated independently of the positioning and holding unit 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 portion 60 do not move in conjunction with each other, and the positioning position of the foramen ovale valve M2 can be maintained as appropriate.

In the hand operation unit 70, the terminal 81 attached to the needle operation lever 78 moves forward to contact the contact member 84, and the needle unit 30 and the input connector 75 are in an electrically conductive state (FIG. 8). reference).
(5) Moving process of slide part

When the flat plate portion 21 is at a position facing the atrial septum M1, the slide portion 100 is moved backward from the main body portion 71 by rotating the wheel 160 while pushing the wheel 160, as shown in FIG. Even at this time, a part of the guide bar 88A enters the connection hole 74 and the connection of the output connector 87 to the input connector 75 is obstructed, and safety is ensured.

When the wheel 160 is pushed in, the movement restriction of the operation rod 14 with respect to the slide portion 100 is released at the moment when the operation rod 14 is positioned in the wide portion G1 having a wide width (see FIG. 11B). Becomes free, the pressurization of the second linear portion 66 and the first linear portion 67 by the operating rod 14 and the tip member 68 is eliminated, and the second linear portion 66 and the first linear portion 67 are elastic. It becomes a straight state due to the force.

In this state, when the wheel 160 is rotated and the slide unit 100 is retracted as shown in FIG. 19, the inner engagement member 180 moves toward the proximal side with respect to the outer engagement member 190 as shown in FIG. 26. The protrusion 181 is released from being fixed in the groove 191, and the entire positioning holder 60 is collected in the lumen L 5 of the catheter body 10 through the main tube 63. At this time, since the state where the wheel 160 is pushed in is maintained, the operation rod 14 comes into contact with the narrow second narrow portion G3 (see FIG. 11C), and the operation rod 14 The movement with respect to the slide part 100 is again regulated, and the operation rod 14 is moved together with the slide part 100 and collected in the lumen L5. For this reason, the operation rod 14 can be reliably recovered from the body cavity without pulling the gripping member 15 connected to the proximal end portion of the operation rod 14, and safety and workability are improved.

Thereafter, as shown in FIG. 19B, when the “OK” display portion H appears in the window 73, it is understood that the collection is completed. 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.
(6) Clamping process

Then, in the process of moving the slide portion 100 backward, when the operation switching portion 130 moves backward together with the slide portion 100 and the first engagement portion 142 moves further to the proximal end side than the deformation inducing portion 150, FIG. As shown, the connecting member 140 returns to its original shape from the bent state. And since the inclined surface 144 is formed in the base end side of the 2nd engaging part 143, the 2nd engaging part 143 moves over the terminal 83 smoothly, moves to the base end side of the terminal 83, and is 1st again. The terminal 83 is sandwiched between the engaging portion 142 and the second engaging portion 143. 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. 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.

Then, in the hand operation unit 70, as shown in FIG. 9E, 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.

As described above, in conjunction with the backward movement of the slide unit 100, the operation of the clamping unit 20 that has been separated by the operation switching unit 130 is interlocked with the movement of the slide unit 100 again. It is possible to operate the part 60 and the clamping part 20.

Since the slide unit 100 can move only while the wheel 160 is pushed in and the lock mechanism 101 is released, unintended movement of the slide unit 100 is restricted. Furthermore, since the slide part 100 is moved backward by rotating the wheel 160, the rapid movement of the slide part 100 with respect to the main body part 71 is suppressed, and the rapid movement of the positioning holding part 60 and the clamping part 20 in the living body. Limited. Thereby, the safety | security with respect to a biological body is improved. Further, if the pushing of the wheel 160 is stopped, the movement of the slide part 100 with respect to the main body part 71 is surely restricted, so the return of the slide part 100 due to the elasticity of the living tissue M, the positioning holding part 60, the clamping part 20, and the like. Is limited, and a desirable positional relationship among the living tissue M, the positioning and holding unit 60, the clamping unit 20, and the like can be maintained.
(7) Connection process

At this stage, since the terminal 81 and the contact member 84 on the side of the needle part 30 are in an electrically conductive state first, both the clamping part 20 and the needle part 30 are in a state capable of supplying electrical energy. .

Then, as shown in FIG. 20, when the output connector 87 is connected to the input connector 75, the power supply from the energy supply means 4 becomes possible. Thereafter, by operating the switch SW, predetermined electrical energy controlled by the control unit 5 is supplied to the sandwiching unit 20 and the needle unit 30, and the atrial septum M1 and the foramen ovale valve M2 are heated.

When heating is continued while maintaining the fusion temperature, the tissues of the atrial septum M1 and the foramen ovale valve M2 are melted and fused to each other by an adhesion factor such as collagen or elastin.
(8) Puncture part retraction process

When the fusion is completed, 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. As a result, 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. Thereafter, the output connector 87 is removed from the input connector 75. Before the needle part 30 is retracted, 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. In this case, after the needle part 30 is retracted, 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.

Thereafter, when the push button 93 of the connection mechanism 90 is pressed to release the connection between the guiding sheath 3 and the main body 71 and the main body 71 is moved away from the living body, the device is pulled out using the guiding sheath 3 as a guide. It is. Thereafter, when the guiding sheath 3 is removed from the living body, the procedure is completed.

As described above, according to the present embodiment, the movement rod 110 is moved in the release direction to release the operation of the positioning holding portion 60 (deformation portion), and then the movement of the movement member 110 is maintained, whereby the operation rod is maintained. The movement of the control rod 14 with respect to the hand operating section 70 is restricted again, and the operating rod 14 can be moved together with the hand operating section 70. The recovery of the operating rod 14 is facilitated, and safety and workability can be improved. .

Further, since the second narrow portion G3 (second abutting portion) is configured by a through-hole that becomes narrower in the moving direction in the moving member 110, the operation rod 14 is formed in the second narrow portion G3. It will contact | connect so that it may be pinched | interposed, pinching of the operating rod 14 can be made stronger, and the reliability of operation | movement can be improved.

Further, the hand operating unit 70 is connected to the main body unit 71 connected to the catheter main body 10, the slide unit 100 connected to the positioning holding unit 60 (deformation unit) and movable relative to the main body unit 71, and rotatable. And a wheel 160 that moves the slide unit 100 relative to the main body unit 71 by rotating while pushing, and the moving member 110 moves in the release direction when the wheel 160 is pushed. Then, when moving the slide part 100 relative to the main body part 71, the movement of the operation rod 14 is regulated by the second narrow part G3 (second contact part) in conjunction with the pushing operation of the wheel 160, The operating rod 14 can be moved together with the slide unit 100.

In addition, a positioning holding portion 60 (deformation portion) is provided on the distal end side of the main tube 63 and a main tube 63 inserted through the catheter body 10 and having a proximal end connected to the hand operation unit 70 and the operation rod 14 inserted. A holding portion 62 that holds the living tissue M by being deformed to bend between the distal end member 68 and the main pipe 63 by moving the distal end member 68 fixed to the distal end of the operation rod 14 toward the proximal end side. Therefore, after holding the living tissue M by the holding portion 62 deformed by the operation rod 14, the holding member 62 is moved to release the holding of the living tissue M by moving the moving member 110, and the second narrow portion G3 ( The movement of the operating rod 14 is restricted by the second contact portion), and the operating rod 14 can be recovered together with the position holding portion 62.

Further, a positioning holding portion 60 (deformation portion) is provided on the distal end side of the main pipe 63, and the distal end member 68 fixed to the distal end of the operation rod 14 moves to the proximal end side, so And the positioning means 61 for positioning the pinching means K with respect to the living tissue M by being deformed so as to protrude outward in the radial direction, and after the positioning by the positioning part 61 deformed by the operation rod 14, the movement is performed. While the positioning by the positioning portion 61 is released by moving the member 110, the movement of the operating rod 14 is further restricted by the second narrow width portion G3 (second abutting portion), and the operating rod 14 together with the positioning portion 61 is controlled. Can be recovered.

In addition, the medical device sandwiches the living tissue M between the needle portion 30 and the needle portion 30 which is an electrode that pierces the living tissue M around the defect existing in the living tissue, and Between the living tissue M and the clamping means K while assisting the clamping means K by the positioning holding part 60 (deformation part) operated by the operation rod 14. After the portion 30 is pierced, the living tissue M can be sandwiched between the needle portion 30 and the sandwiching portion 20 to apply electrical energy, and the living tissue M can be satisfactorily joined.

Note that 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. For example, in the present embodiment, the treatment used to close a PFO defect has been described. However, the present invention is not limited to this. It can also be used when the biological tissue M at a predetermined site is thermally necrotized.

Further, the form of the second abutting portion is not particularly limited as long as it can abut against the operating rod and restrict the movement of the operating rod. For example, as shown in FIG. 29A, the moving member may be provided with a second narrow portion G4 (second abutting portion) whose width becomes narrower in the moving direction. Further, as shown in FIG. 29B, the moving member may be provided with a second contact portion G5 that can contact the operating rod 14 without narrowing the width in the moving direction. In addition, as shown in FIG. 29C, the second contact portion G6 formed on the moving member so as to protrude without being narrowed toward the moving direction and capable of contacting the operation rod 14. May be provided.

Further, in the present embodiment, the main body 71 and the slide part 100 have a structure that is close to and away from each other, but the structure is not limited to this structure as long as there are two parts that move relatively. Moreover, in this embodiment, although the moving member 110 becomes a structure pushed in with the wheel 160, the structure for pushing in does not need to be a wheel, For example, the pushing piece which does not rotate may be sufficient.

Further, a member having a large friction such as rubber may be provided on the second contact portions G3 to G6 provided on the moving member to increase the regulating force of the operating rod 14.

10 catheter body,
14 Operation rod,
20 clamping part (electrode),
30 Needle part (electrode),
60 positioning holding part (deformation part),
61 Positioning part,
62 holding part,
63 Main line,
71 body,
100 slide part,
110 moving member,
112 through holes,
160 wheels,
G1 wide part,
G2 first narrow portion (first contact portion),
G3, G4 second narrow part (second contact part),
G5, G6 second contact portion,
K clamping means,
M biological tissue,
M1 Atrial septum,
M2 follicle valve,
O deficiency (foramen ovale).

Claims

A catheter to be inserted into the body lumen;
A hand operating part provided at the proximal end of the catheter;
An operating rod inserted into the hand operating portion and the catheter so as to be axially movable;
A deforming portion that is provided at a distal end portion of the operation rod and is deformed by movement in an axial direction of the operation rod to contact a living tissue;
Provided at the hand operating portion, movable in a direction intersecting the axis of the operating rod, urged to one side of the moving direction, abutted on the operating rod and the first contact portion, and The movement of the operating rod with respect to the hand operating part is restricted, and the operation of the hand operating part moves in a release direction opposite to the biasing direction to release the restriction of the operation rod, and in the release direction. A medical device comprising: a moving member that is further moved so as to be in contact with the operation rod at a second contact portion and restrict movement of the operation rod relative to the hand operation portion.
The medical device according to claim 1, wherein the second contact portion is configured by a through hole having a width that narrows in the moving direction in the moving member.
The through hole of the moving member is configured such that a length between the first abutting portion and the second abutting portion is shorter than a moving distance in a releasing direction of the moving member. Item 2. The medical device according to Item 1.
The medical device according to claim 3, wherein the moving member has a trapezoidal through hole.
The hand operating unit is
A main body connected to the catheter;
A slide part coupled to the deformation part and movable relative to the body part;
A wheel that is rotatably provided and moves the slide part relative to the main body part by rotating while pushing,
The medical device according to any one of claims 1 to 4, wherein the moving member moves in the release direction by pushing the wheel.
The deformation part is
A main pipe that is inserted through the catheter and connected to the proximal operation portion, and the operation rod is inserted;
A holding portion that is provided on the distal end side of the main tube and that is deformed so as to bend between the distal end member and the main tube by moving a distal end member fixed to the distal end of the operation rod toward the proximal end side, and holds biological tissue. The medical device according to any one of claims 1 to 5, comprising:
The deformation part is
A distal end member provided on the distal end side of the main pipe and fixed to the distal end of the operation rod is deformed so as to protrude radially outward between the distal end member and the main pipe by moving to the proximal end side. The medical device according to any one of claims 1 to 6, further comprising a positioning portion that positions the medical device with respect to the living tissue.
A needle that is an electrode that pierces the living tissue around the defect present in the living tissue;
The medical device according to any one of claims 1 to 7, further comprising: a sandwiching portion that is an electrode capable of sandwiching the living tissue between the needle portion and applying electric energy to the needle portion. Device.