JP2011056184A - Defibrillation electrode - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a defibrillation electrode which is fixed credibly in a short time to the pericardial membrane via a trocar without being affected by heartbeat. <P>SOLUTION: The defibrillation electrode 10 includes an electrode for applying electric energy to the heart 1, an insulation member 12 that exposes only the operating surface of the electrode on the heart 1 side and buries and electrically insulates the other circumference of the electrode, and fixing holes 13 arranged on and extending in the thickness direction of the insulation member 12. The electrode is configured so that part of the pericardial membrane 2 is drawn into the fixing holes 13 when the electrode contacts the pericardium membrane 2. By heating and coagulating the drawn pericardial membrane 2, the drawn pericardial membrane 2 and the fixing holes 13 exert anchoring effect to fix the electrode to the pericardial membrane 2. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a defibrillation electrode that is implanted on the surface of the pericardial membrane in order to remove frequent arrhythmias and ventricular fibrillation occurring in the heart and to restore the functional state of the heart to normal.

Conventionally, in the field of defibrillation, an electrical pulse is applied according to the motion of the heart detected by an implantable cardioverter-defibrillator implanted subcutaneously for the purpose of removing fatal tachyarrhythmia and ventricular fibrillation. There has been known a treatment in which an electrode to be applied by shock discharge from the place where the electrode is placed to the heart is placed on the surface of the pericardial membrane covering the heart (for example, see Patent Document 1).
Patent Document 1 discloses a method of implanting a defibrillation / defibrillation patch electrode inserted through an endoscope hole or cannula into a body without performing a thoracotomy.

Japanese Patent No. 2744879

However, the conventional defibrillation electrodes have the following problems.
That is, conventional defibrillation electrodes including the electrode of Patent Document 1 are fixed (installed) on the pericardial membrane, although the implantation of the electrodes via an endoscope hole, so-called trocar, is considered. For the above, staples or sutures are used. In other words, the heart continues to beat, and it is required to be highly skilled to sew the electrode via the trocar using a gripper, etc., which leads to a prolonged implantation procedure time due to such a suturing operation. In addition, there is a problem that the burden on the patient increases.
Accordingly, there is a need for a suitable method for fixing the defibrillation electrode to the pericardium without using sutures, and there is room for improvement in that respect.

  The present invention has been made in view of the above-mentioned problems, and provides a defibrillation electrode that can be fixed to the pericardial membrane reliably and in a short time via a trocar without being affected by the heartbeat. With the goal.

  In order to achieve the above object, the defibrillation electrode according to the present invention is fixed on the pericardial membrane covering the heart and acts on the electrical energy from the implantable defibrillator via the lead. An electrode that applies electrical energy to the heart, an insulating member that exposes only the working surface on the heart side and embeds the other outer periphery of the electrode to electrically insulate, And a fixing hole arranged extending in the thickness direction of the insulating member, and with the electrode in contact with the pericardial membrane, a part of the pericardial membrane is drawn into the fixing hole. .

  In the defibrillation electrode according to the present invention, it is preferable that the fixing hole is extendable.

  In the defibrillation electrode according to the present invention, it is preferable that the insulating member is formed with a recessed portion in which the recessed portion protrudes from the working surface side on the heart side, and a fixing hole is disposed at the bottom of the recessed portion.

  Further, in the defibrillation electrode according to the present invention, a substantially cylindrical guide sleeve is detachably provided in the fixing hole, and a needle for grasping the pericardial membrane can be inserted into the guide sleeve cylinder. It may be a configuration.

  Further, in the defibrillation electrode according to the present invention, it is preferable that the guide sleeve is provided with a locking means for indwelling the needle inserted into the cylinder.

  In the defibrillation electrode according to the present invention, it is more preferable that the inner surface of the fixed hole has a tapered shape that gradually decreases in diameter from the acting surface of the insulating member toward the opposite surface.

  In the defibrillation electrode according to the present invention, the insulating member is provided with a hole communicating with a fixing hole opened on the pericardial membrane side, and the hole has one of the pericardial membranes via the fixing hole. There may be provided suction means for drawing the part into the inside and heating means for coagulating the drawn pericardial membrane by heating.

  In the defibrillation electrode according to the present invention, the suction means is preferably a heating wire exposed on the inner surface of the hole.

  In the defibrillation electrode according to the present invention, it is preferable that the suction means is a negative pressure container in which the inside is held at a negative pressure, and is provided so as to communicate with the inside of the hole.

  In the defibrillation electrode according to the present invention, the heating means is preferably a heating wire exposed on the inner surface of the hole.

  In the defibrillation electrode according to the present invention, it is preferable that the heating means is an optical fiber having a laser irradiation part at the tip, and the laser irradiation part is disposed in a hole.

  According to the defibrillation electrode of the present invention, a part of the pericardial membrane is drawn into the fixing hole, and the pericardial membrane drawn out to the side opposite to the heart side of the insulating member is solidified by heating, for example. An anchor effect is generated by the pericardial membrane and the fixing hole, whereby the defibrillation electrode can be fixed to the pericardial membrane. That is, the defibrillation electrode can be reliably fixed to the pericardium via the trocar in a short time and with minimal invasiveness without being affected by the heartbeat. Therefore, since a fixing method not based on suturing can be realized, the time required for implanting the defibrillation electrode into the living body can be shortened, and the burden on the patient can be reduced.

1 is a side sectional view showing a schematic configuration of a defibrillation electrode according to a first embodiment of the present invention. It is the figure which looked at the defibrillation electrode shown in FIG. 1 from the top. It is a sectional side view of the defibrillation electrode which shows the state which mounted | worn with a fixed hole in the fixing hole. (A)-(d) is a figure which shows the procedure which fixes a defibrillation electrode to a pericardial membrane using a can. (A)-(c) is a figure which shows the procedure following FIG.4 (d). It is a figure which shows the state mounted | worn with the needle | hook by a modification in the defibrillation electrode of 1st Embodiment. (A)-(c) is a figure which shows the procedure which fixes a defibrillation electrode to a pericardial membrane using the spring shown in FIG. It is a sectional side view which shows schematic structure of the 2nd defibrillation electrode by 2nd Embodiment. It is the figure which looked at the 2nd defibrillation electrode shown in FIG. 8 from the top. (A)-(d) is a figure which shows the procedure which fixes a 2nd defibrillation electrode to a pericardial membrane. It is a top view which shows schematic structure of the 3rd defibrillation electrode by 3rd Embodiment, Comprising: It is a figure corresponding to FIG. It is a sectional side view of a 3rd defibrillation electrode, (a) is a figure which shows the state at the time of guide sleeve mounting | wearing, (b) is a figure which shows the state at the time of detachment | leave of a guide sleeve. It is a perspective view which shows schematic structure of a guide sleeve. (A)-(d) is a figure which shows the procedure which fixes a 3rd defibrillation electrode to a pericardial membrane. (A)-(c) is a figure which shows the procedure following FIG.14 (d). It is a sectional side view which shows schematic structure of the 4th defibrillation electrode by 4th Embodiment. (A)-(c) is a figure which shows the procedure which fixes a 4th defibrillation electrode to a pericardial membrane. (A)-(c) is a figure which shows the procedure following FIG.17 (c). It is a sectional side view which shows schematic structure of the 5th defibrillation electrode by 5th Embodiment. It is a fragmentary sectional side view which shows schematic structure of the 6th defibrillation electrode by 6th Embodiment.

Hereinafter, a defibrillation electrode according to a first embodiment of the present invention will be described with reference to FIGS.
The defibrillation electrode 10 according to the first embodiment shown in FIG. 1 to FIG. 3 is implanted by using an endoscope hole on the surface of the pericardial membrane 2 covering the heart 1 shown in FIG. Electric energy from an implantable cardioverter defibrillator (not shown) is applied via the line 14. Here, in FIGS. 1 and 3, the lower side of the drawing is the heart 1 side (pericardial membrane 2 side). In the defibrillation electrode 10, the surface fixed to the pericardial membrane 2 is used as a “working surface”, and if necessary, the thickness direction of the defibrillation electrode 10 is set to the vertical direction so that the working surface side Is referred to as the lower side and the lower side, and the opposite side is referred to as the upper side and the upper side.

  The defibrillation electrode 10 includes an electrode 11 that applies electrical energy to the heart 1 and an insulation that electrically isolates the electrode 11 by exposing only the working surface on the heart 1 side and embedding the other outer periphery of the electrode 11. A member 12 and a fixing hole 13 extending in the thickness direction of the insulating member 12, and a portion of the pericardial membrane 2 is formed in the fixing hole 13 in a state where the electrode 11 is in contact with the pericardial membrane 2. It is configured to be pulled in.

The insulating member 12 is a thin plate made of a stretchable silicone resin or polyurethane resin, and has a rectangular shape in plan view.
The electrode 11 is made of a noble metal or a noble metal alloy, and is arranged in the center in the longitudinal direction of the insulating member 12 in plan view. A total of four fixing holes 13 are provided, two on each side of the electrode 11 in plan view.
Since the insulating member 12 has elasticity in the fixing hole 13, the hole diameter can be widened. As a result, as shown in FIG. 3, the gripping claws 71, 71 of the spring 7 are expanded to a predetermined width. Can be inserted.

Here, as shown in FIG. 3, the pusher 7 is provided with a heating portion 72 at the distal end portion of the bar member 70, and the proximal ends of the pair of gripping claws 71, 71 are closer to the distal end portion of the rod member 70. It is rotatably supported. That is, the heating unit 72 is positioned between the pair of gripping claws 71 and 71. The heating unit 72 is a means for locally burning the pericardial membrane 2 that is a protein (corresponding to a coagulation site 2b shown in FIG. 5C described later). For example, heating by heating wire or vibration friction by ultrasonic waves Heating by laser, laser irradiation, etc. can be employed.
As will be described in detail later, a portion of the pericardial membrane 2 is gripped by the pusher 7 and the picked portion is pulled out to the surface 12b (surface opposite to the working surface 12a) side of the insulating member 12 and then pulled out. A portion of the pericardial membrane 2 can be heated and solidified by the heating unit 72.

Next, the action of the defibrillation electrode 10 configured as described above and a method for fixing the defibrillation electrode 10 to the pericardial membrane 2 will be described in detail with reference to FIGS.
First, as shown in FIG. 4A, the grasping claw 71 of the pusher 7 is opened and inserted into the fixed hole 13 of the defibrillation electrode 10. At this time, the fixing hole 13 is in a state of being pushed and expanded by the gripping claws 71 due to its stretchability. Then, in this state, as shown in FIG. 4B, the defibrillation electrode 10 to which the fabric 7 is attached is brought into contact with a predetermined fixed position of the pericardial membrane 2.

Subsequently, as shown in FIG. 4C, a part of the pericardial membrane 2 is grasped by closing the grasping claw 71, and the stem 7 is moved upward from the fixing hole 13 (in a direction away from the pericardial membrane 2). As it is pulled out, a part of the pericardial membrane 2 grasped by the grasping nail 71 is dragged by the cantilever 7 and enters the fixing hole 13.
Further, as shown in FIG. 4D, when the punch 7 is pulled out until the gripping claws 71 are separated from the fixing hole 13, the stretchable fixing hole 13 that has been expanded by the insertion of the punch 7 becomes the size of the original hole. It shrinks to return to the height. As a result, the root 2 a of the pericardial membrane 2 that is gripped by the core 7 and dragged out from the fixing hole 13 toward the surface side of the insulating member 12 is pressed in a state of being sandwiched by the fixing hole 13.

  Next, as shown in FIG. 5 (a), in this state, the heating portion 72 of the pusher 7 is operated to perform heating. At the same time, the grasping claw 71 of the pusher 7 is loosened and the pericardium is pulled out from the fixing hole 13. The heating unit 72 is brought close to the top of 2. That is, the heating unit 72 is moved downward in the figure, and as shown in FIG. 5 (b), the heating unit 72 is pressed against the extracted pericardial membrane 2, and the pericardial membrane 2 is heated while being crushed in the vertical direction. By doing so, a part of the pericardial membrane 2 is coagulated.

Further, when the coagulation 7 (and the heating unit 72) is detached from the pericardial membrane 2 when the coagulation near the top of the pericardial membrane 2 is completed by heating, as shown in FIG. An anchor effect is generated by the pericardial membrane 2 and the fixed hole 13 drawn upward from the fixed hole 13 in a state of spreading and expanding in the radial direction of the fixed hole 13, and the defibrillation electrode 10 is fixed to the pericardial membrane 2. Will be. At this time, the size of the pericardial membrane 2 including the coagulation site 2b protruding to the surface 12b side of the insulating member 12 (the radial direction of the fixing hole 13) is smaller than the size (hole diameter) of the fixing hole 13 in a contracted state. Therefore, the protruding portion of the pericardial membrane 2 does not come out of the fixing hole 13 and returns to the heart 1 side, so that the fixing is performed reliably.
The coagulation site 2 b of the pericardial membrane 2 is preferably in a range excluding the vicinity of the root 2 a of the pericardial membrane 2 drawn out from the fixing hole 13. This is because the root 2a in the state of being tightened by the fixing hole 13 is easily damaged and is prevented from being further easily damaged by solidification. Moreover, adhesion between the heart 1 and the pericardial membrane 2 can be prevented by avoiding coagulation near the root 2a.

  As described above, in the defibrillation electrode according to the first embodiment, a part of the pericardium 2 is drawn into the fixing hole 13 and further drawn out to the side opposite to the heart side of the insulating member 12. By solidifying by heating, the anchor effect by the extracted pericardial membrane 2 and the fixing hole 13 is generated, whereby the defibrillation electrode 10 can be fixed to the pericardial membrane 2. That is, the defibrillation electrode 10 can be reliably fixed to the pericardial membrane 2 via the trocar in a short time and in a minimally invasive manner without being affected by the heartbeat. Therefore, since a fixing method not based on suturing can be realized, the time required for implanting the defibrillation electrode 10 into the living body can be shortened, and the burden on the patient can be reduced.

  Next, another embodiment of the defibrillation electrode of the present invention will be described with reference to the accompanying drawings. The same reference numerals are used for members and parts that are the same as or similar to those of the first embodiment described above. Description is omitted, and a configuration different from the first embodiment will be described. In the following description, the defibrillation electrode 10 according to the first embodiment described above is referred to as a “first defibrillation electrode 10”.

As shown in FIG. 6, in the modification according to the first embodiment, the structure of the first defibrillation electrode 10 is the same as that of the first embodiment described above. The drawer 7 used for fixing to the capsular membrane 2 has a structure in which the position of the heating unit is changed, and the heating wire 73 and the gripping claw 71 corresponding to the heating unit are integrally provided. In other words, a heating wire 73 is wound around each gripping claw 71, and the heating wire 73 is heated so that the entire gripping claw 71 is overheated.
Note that ultrasonic vibration may be generated in the grip claw 71 instead of the heating wire 73 to be heated, and friction heat may be generated between the grip claw 71 and the pericardial membrane 2.

  As in the first embodiment, the first defibrillation electrode 10 is fixed to the pericardial membrane 2 according to this modification, as shown in FIG. 13 through the surface 12b of the insulating member 12 (upward in the figure). Then, as shown in FIG. 7 (b), in order to solidify the drawn pericardial membrane 2 and obtain an anchor effect with the fixing hole 13, the shape of the drawn pericardial membrane 2 is slightly inflated by pushing down the pusher 7 Support with. In this state, the grasping nail 71 is heated by the heated heating wire 73, and the pericardial membrane 2 in contact with the grasping nail 71 is solidified.

As a result, as shown in FIG. 7C, an anchor effect is generated by the pericardial membrane 2 and the fixing hole 13 in a state of spreading and expanding in the lateral direction (the radial direction of the fixing hole 13), and the first defibrillation is performed. The electrode 10 is fixed to the pericardial membrane 2.
Thus, also in the present modification, as in the first embodiment described above, the coagulation site 2b of the pericardial membrane 2 is only the portion protruding toward the first defibrillation electrode 10, and the first Since the pericardial membrane 2 on the heart 1 side (working surface side) of the defibrillation electrode 10 is not coagulated, adhesion between the heart 1 and the pericardial membrane 2 can be prevented.

Next, as shown in FIGS. 8 to 10, the second defibrillation electrode 20 according to the second embodiment is obtained by replacing the structure of the fixing hole 13 (see FIG. 1) according to the first embodiment. It is.
As shown in FIGS. 8 and 9, the second defibrillation electrode 20 is integrally formed with the insulating member 22 with a recess 23 that protrudes downward from the working side (lower side in FIG. 8). A fixing slit 24 (corresponding to the fixing hole of the present invention) penetrating in the thickness direction is formed in the bottom 23a of the recess 23. The concave portion 23 has an elliptical shape in which the long axis direction is directed in the short direction of the insulating member 22 in a plan view, and gradually lowers from the peripheral portion 23b toward the bottom portion 23a located in the center of the ellipse in the plan view (pericardial membrane 2 side). ) Is formed as a tapered surface.
The second defibrillation electrode 20 locks the pericardial membrane 2 coagulated in the fixed slit 24 in the same manner as the fixed hole 13 (see FIG. 5C) of the first embodiment. Further, the direction of the concave and convex portions of the concave portion 23 is inverted upside down to prevent the drop and prevent the drop (see FIG. 10C).

  As shown in FIG. 10 (a), the second defibrillation electrode 20 is fixed to the pericardial membrane 2 according to the second embodiment. Contact the fixed position. Then, as shown in FIG. 10 (b), the edge 7 is inserted into the fixed slit 24, and at this time, the tapered surface of the recess 23 serves as a guide function for guiding the gripping claws 71 of the edge 7. The insulating member 22 is an elastic material such as silicon rubber or polyurethane, and the gripping claw 71 pushes the fixed slit 24 to spread and reaches the pericardial membrane 2.

  Further, as shown in FIG. 10C, the pericardium 2 is grasped by the pusher 7 and the pericardial membrane 2 is pulled out together with the pusher 7 as it is. At this time, the fixed slit 24 is pulled upward by the pericardial membrane 2 to be pulled up, and at a certain point, the taper surface of the recess 23 reverses up and down with the peripheral edge 23b as a fulcrum, and the working surface (heart 1 side) ) Is a convex portion (reference symbol T) that projects to the opposite side. The pericardial membrane 2 grasped by the cantilever 7 has its root 2 a dragged upward from the fixed slit 24 of the projecting portion T turned over, and is held down by the fixed slit 24.

Next, the vicinity of the apex of the pericardial membrane 2 drawn out from the fixed slit 24 is baked and solidified by the heating unit 72 of the cantilever 7, thereby, as shown in FIG. 10 (d), from the fixed slit 24 including the coagulation site 2b. An anchor effect is produced by the extracted pericardial membrane 2 and the fixing slit 24, and the second defibrillation electrode 20 is fixed to the pericardial membrane 2.
Moreover, the recessed part 23 becomes the convex part T turned over by pulling out the pericardial membrane 2, and the second defibrillation electrode 20 can be more firmly fixed to the pericardial membrane 2 together with the anchor effect described above. .

Next, as shown in FIGS. 11 to 15, the third defibrillation electrode 30 according to the third embodiment has a configuration in which a guide sleeve 8 detachably attached to the fixing hole 33 is provided. Here, in FIG. 11, the guide sleeves 8 are provided in four of the six fixing holes 33 for easy viewing.
As shown in FIGS. 11 and 12 (a) and 12 (b), the third defibrillation electrode 30 has a guide sleeve 8 for guiding the core 7 that pulls out the pericardial membrane 2 before the fixation to the pericardial membrane 2. The fixing hole 33 is mounted in advance. Here, since the electrode 31, the insulating member 32, and the lead wire 34 have the same configuration as the first defibrillation electrode 10 and the second defibrillation electrode 20 described above, detailed description thereof is omitted. As shown in FIG. 12B, the fixing hole 33 has a tapered shape that gradually decreases in diameter from the lower surface (the working surface 32 a) toward the upper surface (the front surface 32 b) in the thickness direction of the insulating member 32.

  As shown in FIG. 13, the guide sleeve 8 is made of a resin, has a guide function for guiding the stem 7 to the pericardial membrane 2, and after the third defibrillation electrode 30 is fixed to the pericardial membrane 2. It is designed to be discharged to the outside of the body together with the button 7. That is, the guide sleeve 8 has a cylindrical wall portion 81 having a flexible guide hole 81a for inserting the core 7 in the center, and a fixing formed on the circumferential surface in the cylindrical axial direction of the cylindrical wall portion 81 along the circumferential direction. A pin hanger 83 that restricts the movement of the sleeve 82 in the cylinder axis direction Y (vertical direction in FIG. 13) of the groove 82 and a locking pin 74 (see FIG. 14B described later) provided on the can 7 A pin insertion groove 84 that forms an insertion opening for inserting the locking pin 74 into the pin hanger 83, and a pin guide 85 that guides the locking pin 74 along the cylinder axis direction Y. It is configured.

The pin hanger 83 has a bowl shape having an upper wall 83b in a side sectional view, is provided along the circumferential direction on the upper surface 81b of the cylindrical wall portion 81, and the concave portion 83a surrounded by the upper surface 81b of the cylindrical wall portion 81 has the above-mentioned engagement. It is a passage for the stop pin 74. Further, the pin hanger 83 has a notch formed at a position opposed to the cylindrical wall portion 81 in the radial direction in a part of the circumferential direction, and the upper surface 81b of the cylindrical wall portion 81 at the notched position is the pin insertion groove described above. 84.
The guide sleeve 8 is attached to the insulating member 12 by engaging the fixing groove 82 with the fixing hole 33 of the third defibrillation electrode 30.

As shown in FIG. 14A, the third defibrillation electrode 30 is fixed to the pericardial membrane 2 according to the third embodiment in advance in the fixing hole 33 of the third defibrillation electrode 30. The third defibrillation electrode 30 to which the guide sleeve 8 is attached is brought into contact with a predetermined fixing position of the pericardial membrane 2 through the fixing groove 82 of the guide sleeve 8.
Then, as shown in FIGS. 13 and 14B, the branch 7 is inserted along the branch guide hole 81 a of the guide sleeve 8. At this time, a locking pin 74 projecting radially from the predetermined position of the bar 70 of the core 7 around the bar 70 is inserted in alignment with the pin insertion groove 84, and the locking pin 74 is directly inserted into the cylinder wall. By horizontally rotating on the upper surface 81b of the portion 81, the locking pin 74 is inserted into the recess 83a of the pin hanger 83, and at this time, the upward movement of the locking pin 74 is restricted by the upper wall 83b of the pin hanger 83. It becomes a state. That is, the stem 7 is left in the guide sleeve 8 and a part of the pericardium 2 is gripped by the gripping claws 71 in the guide sleeve 8 as shown in FIG.

  Next, as shown in FIG. 14 (d), the entire body 7 is pulled up with the pericardial membrane 2 held. At this time, since the locking pin 74 of the pusher 7 is hooked by the pin hanger 83 and the upward movement is restricted, the guide sleeve 8 is also lifted with the rise of the pusher 7, away from the fixing hole 33, and third defibrillation is performed. It is pulled out from the electrode 30.

  As shown in FIG. 15 (a), when the guide sleeve 8 is completely pulled out from the third defibrillation electrode 30, the fixing hole 33 to which the guide sleeve 8 has been mounted contracts due to elastic deformation until then. Press the pericardium 2 pulled out. Thus, the fixing hole 33 formed in a tapered shape is expanded by elastic deformation and securely fixed to the fixing groove 82 of the guide sleeve 8 and has a wedge when the fixing hole 33 contracts and closes. It has a function of holding down the root 2a of the pericardial membrane 2 drawn upward by the effect.

  Furthermore, as shown in FIG. 15 (b), when the pericardial membrane 2 is pressed by the fixing hole 33, the gripping claw 71 of the pusher 7 is opened and the pusher 7 is lowered again, so that The pericardial membrane 2 drawn out is pressed down in the vertical direction. Then, by opening the gripping claw 71, the cylinder wall portion 81 is lifted by the gripping claw 71. Here, the vicinity of the top of the pericardial membrane 2 is heated and coagulated while pressing a part of the pericardial membrane 2 drawn out by the heating unit 72 provided at the tip of the persimmon 7.

Thereafter, as shown in FIG. 15 (c), when the pericardial membrane 2 is solidified by heating, the cantilever 7 and the guide sleeve 8 in a state of being hooked thereto are retracted from the third defibrillation electrode 30. Thereby, the third defibrillation electrode 30 is fixed to the pericardial membrane 2 by the anchor effect of the extracted pericardial membrane 2 and the fixing hole 33.
As described above, also in the third embodiment, the coagulation site 2b of the pericardial membrane 2 is only the portion drawn upward from the fixing hole 33, and the vicinity of the root 2a around the fixing hole 33 and the portion close to the heart 1 Therefore, the adhesion between the heart 1 and the pericardial membrane 2 can be prevented.

  Next, as shown in FIG. 16, the fourth defibrillation electrode 40 according to the fourth embodiment is the first to third embodiments described above as means for dragging the pericardial membrane 2 into the fixing hole 43. In this way, a means for sucking the pericardial membrane 2 using a pressure difference due to temperature is used without using the spring 7. In particular, the heating unit 45 for coagulating the pericardial membrane 2 is also used to change the atmospheric pressure for dragging the pericardial membrane 2.

  Specifically, a hole 44 having a predetermined volume is provided in the insulating member 42 of the fourth defibrillation electrode 40, and a heating unit 45 (suction means, heating, etc.) such as a heating wire is formed on the inner surface of the hole 44. (Means) is exposed. The heating unit 45 is supplied with heat energy from the outside via a heating lead wire 47. The air hole 44 communicates with the fixed hole 43 that opens to the working surface 40a side. The fixing hole 43 is a small diameter hole with respect to the diameter dimension of the hole 44. Further, the size of the air hole 44 is such that when the part of the pericardial membrane 2 is sufficiently drawn and part of the pericardial membrane 2 is solidified, the drawn pericardial membrane 2 does not return through the fixing hole 43. Is set to the size of

The heating lead wire 47 is used when the fourth defibrillation electrode 40 is placed on the pericardial membrane 2 and can be detached from the connection terminal 48 placed inside the insulating member 42 after placement. ing.
Note that the electrode 41, the lead wire 46, and the like have the same configuration as that of the above-described embodiment, and thus description thereof is omitted here.

  As shown in FIG. 17 (a), the fourth defibrillation electrode 40 is fixed to the pericardial membrane 2 according to the fourth embodiment by first providing it in the hole 44 of the fourth defibrillation electrode 40. The heating unit 45 thus heated is heated so that the inside of the air holes 44 is at a pressure lower than the outside air.

  Then, as shown in FIG. 17 (b), after the fourth defibrillation electrode 40 is brought into contact with a predetermined fixed position of the pericardial membrane 2 with the holes 44 being heated, Stop heating. When the heating is stopped, the temperature in the air holes 44 decreases, and as shown in FIG. 17C, a part of the pericardial membrane 2 is maintained in order to maintain equilibrium with the outside air in accordance with the temperature decrease. Is sucked into the hole 44 through the fixing hole 43.

  Subsequently, as shown in FIG. 18A, when the pericardial membrane 2 is sufficiently sucked into the hole 44, heating by the heating unit 45 is started again. At this time, due to the elasticity of the pericardial membrane 2 along with reheating, the temperature is rapidly increased so that the pericardial membrane 2 does not return from the hole 44 through the fixing hole 43 and is drawn into the hole 44. The pericardial membrane 2 is coagulated at once. The heating necessary for this coagulation is not to raise the gas temperature in the air holes 44 but to cauterize the pericardial membrane 2 and may be heating at a high frequency.

Further, as shown in FIG. 18B, when the coagulation on the pericardial membrane 2 is completed, the heating is stopped and cooled. Along with this cooling, the air pressure in the air hole 44 is lowered again, so that a force in the direction of being sucked into the air hole 44 is generated again in the pericardial membrane 2. As a result, the size of the pericardial membrane 2 including the coagulation site 2b sucked into the hole 44 becomes larger than that of the fixing hole 43, so that the pericardial membrane 2 in the hole 44 passes through the fixing hole 43 and comes out. The fourth defibrillation electrode 40 is securely fixed to the pericardial membrane 2.
As shown in FIGS. 18B and 18C, when the fourth defibrillation electrode 40 is fixed, the heating part lead 47 for supplying power to the heating part 45 becomes unnecessary. It is pulled out from the connection terminal 48 and removed. At this time, since the connection terminal portion 48 is embedded in the insulating member 42, the hole of the lead wire 47 is closed by the elastic action of the insulating member 42 after the heating portion lead wire 47 is pulled out.

  As described above, in the fourth defibrillation electrode 40 according to the fourth embodiment, after being brought into contact with the pericardial membrane 2, by the suction action and the coagulation action of the pericardial membrane 2 by simple electrical processing, The fourth defibrillation electrode 40 can be reliably fixed to the pericardial membrane 2.

Next, as shown in FIG. 19, the fifth defibrillation electrode 50 according to the fifth embodiment has an optical fiber 56 (suction means) in the hole 44 (see FIG. 16) of the fourth defibrillation electrode 40 described above. ). Specifically, the fifth defibrillation electrode 50 is provided with an optical fiber 56 for irradiating laser light into the hole 54. The optical fiber 56 is inserted into the hole 54 from the surface 52 b side of the insulating member 52, and the irradiation part 56 a at the tip is exposed in the hole 54. That is, a part of the pericardial membrane 2 sucked into the hole 54 is solidified by the laser emitted from the irradiation part 56 a of the optical fiber 56. Here, as the laser, an Nd: YAG laser is preferable for coagulating the pericardial membrane 2.
The electrode 51, the insulating member 52, the fixing hole 53, the hole 54, the heating unit 55, and the like have the same configuration as the above-described fourth defibrillation electrode 40, and thus detailed description thereof is omitted here.

The method for fixing the fifth defibrillation electrode 50 to the pericardial membrane 2 according to the fifth embodiment is a procedure until a part of the pericardial membrane 2 is sucked into the air hole 54 by the heating of the heating unit 55. Is the same as the above-described fourth defibrillation electrode 40 (see FIG. 17), and then the pericardial membrane 2 drawn into the hole 54 is solidified by irradiating a laser with the irradiation part 56a of the optical fiber 56. . After the irradiation, the optical fiber 56 is pulled out from the insulating member 52 and removed from the body.
As described above, in the fifth defibrillation electrode 50 according to the fifth embodiment, after being brought into contact with the pericardial membrane 2, the suction action of the pericardial membrane 2 by electrical processing by the heating unit 45, and the optical fiber The fifth defibrillation electrode 50 can be reliably fixed to the pericardial membrane 2 by the coagulation action by 56.

  Next, as shown in FIG. 20, the sixth defibrillation electrode 60 according to the sixth embodiment is a negative electrode serving as a suction means in the hole 44 (see FIG. 16) of the fourth defibrillation electrode 40 described above. The pressure vessel 66 is provided. That is, the fourth defibrillation electrode 40 uses a pressure difference due to heating as means for sucking the pericardial membrane 2 into the air holes 64. Instead of such suction means, in the sixth defibrillation electrode 60 according to the sixth embodiment, the negative pressure container 66 previously held in the negative pressure state is connected in a state where it is communicated with the hole 64. A part of the pericardial membrane 2 is sucked into the hole 64 by using this negative pressure.

The negative pressure container 66 whose interior is maintained at a negative pressure is attached in advance through a passage 67 communicating with the air hole 64, and the passage 67 is, for example, a detachable closing member (not shown). It is closed. By removing this closing member, the passage 67 is opened, air flows to the negative pressure side, and is sucked into the hole 64 through the fixing hole 63.
The negative pressure container 66 may be a container maintained in such a negative pressure state, but may be an instrument such as a syringe.
In addition, the electrode 61, the insulating member 62, the fixing hole 63, the hole 64, the heating unit 65, and the like have the same configuration as the fourth defibrillation electrode 40 and the fifth defibrillation electrode 50 described above. Detailed description is omitted.

  The sixth defibrillation electrode 60 is fixed to the pericardial membrane 2 according to the sixth embodiment by first bringing the sixth defibrillation electrode 60 into contact with a predetermined fixing position of the pericardial membrane 2. Then, the closing member (not shown) is removed to open the passage 67. Then, since the inside of the negative pressure container 66 is maintained at a negative pressure, a part of the pericardial membrane 2 is sucked into the hole 64 by this negative pressure. Then, the drawn pericardium 2 is heated by the heating unit 65 and solidified. As a result, an anchor effect is generated by the pericardial membrane 2 sucked into the hole 64 and the fixing hole 63, and the sixth defibrillation electrode 60 and the pericardial membrane 2 are fixed. The negative pressure container 66 becomes unnecessary after the pericardial membrane 2 is sucked into the air hole 64, and is removed and removed from the body.

The first to sixth embodiments of the defibrillation electrode according to the present invention have been described above. However, the present invention is not limited to the above-described embodiment, and can be appropriately changed without departing from the spirit of the present invention. It is.
For example, the configuration of the defibrillation electrode, the fixed hole, the concave portion, the fixed slit, the shape, size, and quantity of the electrode is not limited to this embodiment, and can be set as appropriate. In particular, the size (hole diameter) of the fixing hole 13 and the fixing slit 24 is a necessary condition for exerting the anchor effect between the extracted pericardial membrane and the fixing hole. For example, the number of fixing holes provided in the defibrillation electrode, That is, it is necessary to set appropriately according to the number of fixed places.
Further, the structure of the guide sleeve 8 is not limited to the third embodiment. In short, it is only necessary to be attached to the fixed hole of the defibrillation electrode so as to be detachable and to have the same function, that is, the function of guiding the needle 7 or the function of placing the cloth 7 in the guide sleeve 8. is there.

Further, the structure of the cantilever 7 is not limited to the present embodiment, and a suitable heating means can be used for the cantilever 7.
Furthermore, in the present embodiment, a heating unit made of heating wire provided in the holes and an optical fiber are used as heating means, and a heating unit made of negative pressure container and heating wire is used as suction means. It is not limited to.

DESCRIPTION OF SYMBOLS 1 Heart 2 Pericardial membrane 2b Coagulation site | part 7 Kashimi 8 Guide sleeve 10 Defibrillation electrode (first defibrillation electrode)
11, 21, 31, 41, 51, 61 Electrode 12, 22, 32, 42, 52, 62 Insulating member 13, 33, 43, 53, 63 Fixed hole 20 Second defibrillation electrode 23 Recess 24 Fixed slit (fixed) Hole)
30 Third Defibrillation Electrode 40 Fourth Defibrillation Electrode 44, 54, 64 Hole 45 Heating Unit (Suction Unit, Heating Unit)
55, 65 Heating part (heating means)
50 5th defibrillation electrode 56 Optical fiber (suction means)
56a Irradiation part 60 6th defibrillation electrode 66 Negative pressure container (suction means)
71 Holding Claw 72 Heating Unit 73 Heating Wire 74 Locking Pin 83 Pin Hanger (Locking Means)

Claims (11)

A defibrillation electrode fixed on the pericardial membrane covering the heart and acting on electrical energy from the implantable defibrillator via the lead,
An electrode for applying electrical energy to the heart;
An insulating member that exposes only the working surface on the heart side of the electrode and electrically embeds the other outer periphery of the electrode;
A fixing hole arranged extending in the thickness direction of the insulating member;
With
A defibrillation electrode characterized in that a part of the pericardial membrane is drawn into the fixing hole in a state where the electrode is in contact with the pericardial membrane.   The defibrillation electrode according to claim 1, wherein the fixing hole is telescopic.   3. The removal according to claim 1, wherein the insulating member is formed with a recessed portion having a recessed portion protruding from a working surface side on the heart side, and the fixing hole is disposed at a bottom portion of the recessed portion. Fibrillation electrode. In the fixing hole, a substantially cylindrical guide sleeve is detachably provided,
The defibrillation electrode according to claim 1 or 2, wherein a needle for grasping the pericardial membrane can be inserted into a tube of the guide sleeve.   The defibrillation electrode according to claim 4, wherein the guide sleeve is provided with a locking means for placing the needle inserted into the cylinder.   6. The defibrillation electrode according to claim 4, wherein an inner surface of the fixing hole has a tapered shape that gradually decreases in diameter from the working surface of the insulating member toward the opposite surface. . The insulating member is provided with a hole communicating with the fixing hole opened on the pericardial membrane side,
The air holes are provided with suction means for drawing a part of the pericardial membrane through the fixing hole and heating means for coagulating the drawn pericardial membrane by heating. The defibrillation electrode according to claim 1.   The defibrillation electrode according to claim 7, wherein the suction means is a heating wire exposed on the inner surface of the hole.   8. The defibrillation electrode according to claim 7, wherein the suction means is a negative pressure container having a negative pressure inside, and is provided so as to communicate with the inside of the hole.   The defibrillation electrode according to claim 7, wherein the heating means is a heating wire exposed on an inner surface of the hole.   The defibrillation electrode according to any one of claims 7 to 9, wherein the heating means is an optical fiber having a laser irradiation part at a tip, and the laser irradiation part is disposed in the hole. .

Images