JPS58500190A - implantable cardiac defibrillation electrodes - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] implantable cardiac defibrillation electrodes Technical field Cardiac arrhythmias, such as atrial fibrillation and ventricular fibrillation, cause electrical energy to flow into the fibrillating heart muscle. It is known that it can be removed by giving This technique, defibrillation, is Electrical energy is delivered through a conductive metal motherboard held in place on the patient's chest by a doctor. This conductive mother needle can be applied directly to the surface of the heart during cardiac surgery. It is done by touching and holding it. Such techniques are well known and It has been found to be generally effective.

Recently, efforts have been made to automatically detect the onset of cardiac arrhythmias and automatically correct such arrhythmias. Implantable defibrillators have been proposed. These automatic defibrillators operate on the surface of the heart. using a conformal electrode held in contact with a surface or placed in an intravascular catheter or a combination of these. in any case , these electrodes work to deliver the desired electrical energy to the heart muscle to defibrillate it. .

The intravascular catheter-type electrode solution is different from the extracorporeal chest/maternal solution. This requires less electrical energy to be delivered to the heart than when the electrodes are placed directly on the heart surface. It has been found that more energy is required than when placed in contact.

In other words, if the electrodes are physically placed in contact with the outer surface of the heart, electrical energy can be It is known that energy can be used more efficiently and that less energy is required. Plant In embedded medical-electronic devices, energy consumption1 is clearly of paramount importance. It is.

Automatic defibrillators that have been considered so far have a defibrillating electrode that is inserted into the chest cavity and connected to the heart. Apply these electrodes to the heart by suturing or placing them on the surface of the heart. Designed. Implantation of such electrodes is recommended during cardiac surgeries such as collateral surgery. It is often done. However, such cardiac surgery itself is not necessary. However, conventional defibrillation electrodes require an incision in the chest cavity to be implanted. Ru. This surgical procedure requires intubation of the lung and exposes the surface of the lung to pathogens. May be exposed.

Furthermore, in order for the surgeon to have sufficient working space to effectively place and attach the electrodes, , further surgery is required, such as widening one adjacent rib or opening the sternum. It is said that Therefore, it is currently difficult to attach any form of cardiac electrode to the heart surface. Even so, extensive surgery is required. Therefore, we left the thoracic cavity in its original state. It would be desirable to be able to implant electrodes without the need to open the chest cavity.

Additionally, known cardiac surface electrodes suffer from poor uniformity of energy density due to electrical discharge. There is a point. The energy density is high at the edge of the electrode, and high discharge levels can cause damage to the heart surface. Facial tissues may be damaged. Naturally, the discharge spreads over the entire surface of the electrode. It is desired that the energy density is uniform throughout and that there are no deposits of high energy density. .

Disclosure of invention FIELD OF THE INVENTION The present invention relates generally to the field of cardioversion, and more particularly to implantable defibrillators. RELATING TO SPECIFIC FORMS OF CARDIOPARTINING ELECTRODES AND METHODS OF IMPLANTING SUCH ELECTRODES .

The term “cardioparting” or “cardiogusion” used here corrects numerous cardiac arrhythmia conditions, both fatal and non-fatal. shall mean. These cardiac arrhythmia conditions include atrial tachycardia, atrial flutter, Atrial fibrillation, connected rhythm, ventricular tachycardia, ventricular flutter, ventricular fibrillation, and other cardiac rhythms These include arrhythmia conditions that do not contribute to It is corrected by administering a strong electric shock to the heart. Therefore, “defibrillation” delivers an electric shock to the heart to defibrillate the fibrillating atria or ventricles. It is clear that the term “cardioversion” includes Dew.

In a seventh embodiment of the invention, the cardioparting electrode has a rectangular shape. , which is inserted through the soft tissue outside the thoracic cavity and placed in contact with the heart. Designed. This electrode increases energy efficiency while also delivering electrical energy to the heart. Optimizes the transmission of current and prevents high current density at the edge of the electrode. It has a specific shape.

The electrode is formed from a chemically formed metal mesh or screen. this so that the part of the electrode facing away from the heart surface, i.e. does not touch the heart surface. The electrode portion is electrically isolated from the human body. Alternatively, although the efficiency will be slightly lower, Use 7 insulating layers only on the back side of the metal screen and sew this layer to the metal screen. You can wear it anytime. Defibrillation electrodes are used to perform functions such as beating the heart. Further electrodes are provided. After the surgical implantation, the pace of the heart will be determined. If it is legitimately determined that there is no need to Means are also provided by which the cord can be cut.

Additionally, the electrodes of the present invention can be used in electrocardiography (ECG) devices that detect the electrical activity of the heart. It may also be used as a big up electrode. You will never need both features at the same time. This allows the same electrical lead to be used for both defibrillation and EC0 functions. Wear.

In the electrode implantation method of the present invention, first, the skin is incised on the chest wall or abdominal wall of the body; A hand-held instrument is then used to separate the tissue planes and remove the intrathoracic tissue. By forming a tunnel outside the thoracic cavity through the soft tissue surrounding the heart. This involves placing electrodes on the surface of the heart. formed a tunnel Sometimes seven or more electrodes are placed inside the tunnel and placed near the surface of the heart. . In/embodiments of the invention, two electrodes are placed on either side of the heart and and means for securing the electrode by suturing the proximal end of the electrode to its adjacent tissue. is provided. In another implementation of the method of the invention, the inner surface of the sternum; A tunnel space is located between the outer surface of the 6 membranes of the heart, and the 6 membranes and the diaphragm. A tunnel is formed on the lower surface of the heart between the membrane and the membrane.

In order to carry out the method of the invention described above, a special implantation device according to the invention is provided. The device interacts with the implanted electrode and compares it to the heart. The implant can be easily installed and later withdrawn.

In seven embodiments of the electrode of the invention, by eliminating the so-called "repetition" The edges of the electrodes are shaped so that the transfer of energy is efficient and relatively uniform. The central portion of the oscillator is also constructed to have a large impedance to the current. child The impedance has spaced holes located at the edge of the mesh electrode. controlled using an electrical filter that is mechanically configured to

Therefore, seven objects of the present invention are to provide an ablation area with high efficiency of transmitting electrical energy to the heart. The purpose is to provide electrodes.

Another object of the invention is to provide a defibrillator that minimizes electrical damage to the myocardium during defibrillation. An object of the present invention is to provide a fibrillation electrode.

It is a further object of the present invention to provide implants near the heart that require minimal surgery. An object of the present invention is to provide a defibrillation electrode that can be placed in a defibrillation electrode.

Yet another object of the present invention is to provide a defibrillation electrode having a cardiac rhythm control electrode. It is to provide.

Yet another object of the invention is to provide both a defibrillation electrode and an ECG signal pick-up electrode. The purpose of the present invention is to provide electrodes that can be used for

Yet another object of the invention is to perform defibrillation adjacent to the heart without the need for major surgery. An object of the present invention is to provide a method for implanting electrodes.

Yet another object of the invention is to perform only a skin incision and, using special instruments, to Inserting electrodes into the human body by forming a tunnel inside the thoracic cavity but outside the thoracic cavity. The purpose is to provide a method.

A further object of the invention is to provide a method for inserting an electrode according to the invention according to the method according to the invention. The aim is to provide special equipment that can be used to

Yet another object of the invention is a defibrillation electrode having a cardiac pacing electrode tip. and a link that connects this pacing electrode tip to a cardiac pacer placed outside the patient's body. Temporary pacing electrode leads are provided with individual connectors on the leads after surgery. To provide a defibrillation electrode that can be cut and removed.

Yet another object of the invention is to provide a special receptacle for receiving the tip of an implantable device. By providing a state-of-the-art implantable defibrillation electrode, The recessed device allows the electrode to be inserted through the soft tissue of the thorax, while the After the electrodes have been placed, the device can be withdrawn.

How these and other objects are achieved by the present invention; The numerous effects associated with this will become readily apparent from the following description with reference to the accompanying drawings. Dew.

Brief description of the drawing , 1'-7 are perspective views of the electrode of the present invention, and the arrow λ diagram is taken along the line λ in Figure 17. FIG. Figure 3 is a perspective view showing the bottom surface of the electrode in Figure 17, and figure 3 is a perspective view showing the electrode of the present invention inserted. 1 is a perspective view of a device suitable for Figure S is a cross-sectional view of the insertion instrument taken along line S-5 in Figure ++. Figure 6 is a perspective view of another embodiment of a device suitable for inserting the electrode of the present invention. C, Figure 7 is a schematic diagram showing the electrode of the present invention inserted into the human body. Figure G is a schematic diagram showing the electrode of the present invention inserted into the human body in a different manner. , Figure 9 is a perspective view of the electrode of the present invention placed in the insertion instrument prior to implantation of the electrode of the present invention. Adashi, Figure 10 is a sectional view of the detachable coupler used in the embodiment of Figure 17. ,and Figure 1 is a perspective view showing yet another embodiment of the electrode of the present invention.

BEST MODE FOR CARRYING OUT THE INVENTION Now, referring to FIG. 17, the electrode 10 of the present invention is formed into a substantially rectangular shape, and each The side dimensions are approximately 1 to 4' cm and 3 to 6', respectively. Preferably Pole 10 is about <zxgcrn. In special cases, the electrodes are formed as squares. You may be The actual metal electrode element is a mesh made of titanium or platinum. This is screen 12.

Alternatively, the electrodes may be formed from expanded platinum.

The mesh is an ISO mesh, which consists of individual ISO elements per finch. It has wires. The diameter of the wire is selected between 1 and 3 mils.

The electrode mesh 12 is first created by spot welding the wires around the mesh together. Processed by contact. After this spot weld, the extra length of wire The edges are polished or flattened and the edges are smoothed to create a continuous A rim forms.

The electrode body has a metal electrode element between two Silistic layers. Consists of sandwiched meat. The electrode 10 is prepared by preparing a lower layer 14 and then Place the titanium mesh 12 on top of this, and then place the upper layer 16 on top of this. formed by. The thickness of this assembly should be approximately 1 to 3 cm. . A rectangular hole is cut out in the upper layer 16, which allows the titanium mesh 12 to be cut out. can make electrical contact with the surface of the heart. Reinforced to give structural strength embedding Dacron mesh 7 into both plastic layers. However, such a reinforcing mesh must be used at least for the lower layer 14. Must be.

The electrode 10 of the present invention is also provided with a cardiac pacing electrode button 18, which is made of gold. The mesh 12 is located in the center of the mesh 12 and is connected to the mesh 1 by a suitable insulating material 20. electrically isolated from 2. This heart pace electrode button 18 is made of platinum or formed of any other suitable inert conductor.

This step electrode button 18 is placed on the surface of the titanium mesh 120 at a distance of about 1 to 3 mm. It must extend.

The electrical lead of the button 18 is marked 22, and a special disconnect A removable coupler 24 is provided at the end of this conductor 22. This can be removed The capable coupler 24 will be described in detail below. Come out from this connector 24 Another conductor 26 is connected to a suitable plug 2 for connection to a suitable electronic cardiac pacer. Connected to 8. When implanting electrode 10, conductor 26 is placed outside the patient's body. Coupler 24 is then placed just inside the patient's skin. In this way , If necessary after surgery, connect the leads 26 to perform the cardiac pacing function. I can do it. After that, the patient's condition stabilized and the pacing function was no longer needed. When it suits the physician, simply pull the lead 26 out of the coupler 24. , no further surgery is required.

The mesh 12 of the electrode 10 is connected by an insulated cable 30 to a suitable current source; A suitable electrical connector 32 is provided at the end of the cable 30. cable 3 The other end of 0 connects mesh 12 at a low resistance connection located within insulating boot 33. electrically connected to.

As mentioned above, the purpose of the present invention is to provide a large To provide an energy efficient electrode that eliminates the need to make an incision in the thorax. That is. Another object of the present invention is to prevent damage to the heart when the electrode is used for defibrillation. The goal is to configure the electrodes in such a way as to minimize the risk of damage. Regarding this point , using a defibrillation electrode with a single opposed conductor as contemplated by the present invention. Sometimes a parallel-grate type carrier is added to the electric field formed between these single conductors. It has been found that a phenomenon commonly seen in tandem plants, ie, repeated effects, occurs. To explain briefly , this repetition is related to the electric field between the two greats of the capacitor, and this The electric field is perpendicular to the grate except at the plate line, but at the edges of the grate. In this case, the electric lines of force tend to bulge outward.

These swollen electric lines of force are concentrated near the edge of the capacitor 7, and the present invention In some cases, the current density is concentrated near the edge of the titanium mesh), and the current density is at the center of the metal electrode surface. The current density is greater than the current density at

This repeated action is equivalent to eliminating the negative effects of increasing current density. Sometimes to maximize the available surface area to reduce the current density at the metal electrode surface. , in the present invention, the upper layer 16 of the mesh 12 is coated with mesh near the edge of the mesh 12 Multiple holes are cut out that go through to the surface of 2). These holes 17 is representatively shown at Vc34, and as shown, through these holes. The surface of the titanium mesh screen 12 is exposed. These holes 34 , it is possible to substantially eliminate repetitive effects that lead to large current densities, and to eliminate these holes 34. The mesh 12 exposed through h provides electrode surface area available for contact with the cardiac surface. was found to be increased, thereby lowering the current density of the metal electrode element.

The above two layers and metal mesh are made of Dacron-based or similar material. By sewing 36 around the electrode 10 with a general sewing machine using a similar material, fixed to each other.

Lead 22.30 is a highly flexible material particularly suited for use with implantable cardiac electrodes. Preferably, it is made of a special electric cable with a high temperature. Don't hurt your heart This kind of flexibility is extremely important in order to operate effectively. This cable is Commonly known as gold thread wire, it has a central braid of polyester threads. A conductive silver braid is wrapped around the central braid six or more times. Each conductivity The braid consists of its own polyester yarn core and a conductive braid concentrically wound around it. We are prepared. This gold thread wire has a very long lifespan against mechanical stress such as bending. Life is long. Furthermore, since this gold thread wire is made of silver, it has very low electrical resistance. small. This gold thread wire cable 30 should not be electrically connected to the titanium mesh 12. This must be done by crimping, welding, or other similar electrical connection operations. This is done on the lower surface of the shell 12. Alternatively, the cable 30 may have "electrical contacts". Special Licensing Disclosures Disclosed in Applicant's U.S. Patent Application entitled ``Apparatus and Method for Performing It may be attached to the mesh 12 by a wedge.

Now, to explain Figure 12, the structure of various elements forming the electrode 10 in the figure is 1 It is shown in a sectional view taken along line 2-- in FIG. Looking at this cross section, the sill The upper layer 16 of the plastic is bonded to the lower layer 14 of the plastic and the titanium mesh is bonded to the lower layer 14 of the plastic. An electrode 12 is sandwiched between them. Mesh 12 by hole 34 It will be apparent that a further surface area of the heart is exposed to the surface of the heart.

A cardiac pacing electrode tip 18 is connected to its flexible cable 22 and insulated. The material 20 is electrically insulated from the mesh 12.

Also, in the cross-sectional view of the Fang λ diagram, any of the 7 rustic layers or both of the Sandwich body are shown. Also shown is a layer of Dacron mesh used as a reinforcing element for the elastic layer of There is.

In this example, the mesh is the assembly where stress occurs during implantation. is disposed within the lower layer 14 at the leading edge of which is shown in cross section at 42. child It is also possible to strengthen the upper layer 16 using a Daktron mesh 7 unit similar to this one. minimum Interoperable with the special insertion device or implant device used to place the electrode 10 during the limited surgical procedure. The special bag construction 44 used is also shown in cross-section. This bag 44 is located at the tip of the electrode. extending the top layer 16 of the silastic downwardly beyond the top layer 16 of the silastic to extend parallel to the bottom layer 14 of the electrode. forming a ridge 48 that extends from the electrode to a pocket 50 for receiving an insertion instrument; It is formed by forming the entire width of. Furthermore, it will not be torn by insertion tools. In order to increase the strength of this bag, 7 parts of the Dacron mesh 52 are placed inside this bag 44. embedded in.

Figure 3 is a perspective view of the electrode 10 of the present invention viewed from below, and this figure shows a bag structure 44. is shown in detail. In addition, in Fig. 3 of the fang, there is a Also shown is the Dacron mesh 42. Used when inserting the electrode of the present invention A special bag 44 is raised above the lower layer 14 to form the desired pocket 50. ing.

The opening of this pocket 50 is oriented rearward to accommodate the electrodes, for reasons that will become clear below. Must be open towards the rear. Yet another reinforced layer of Dacron mesh 52. The position of the connection between the electrical conductor 30 and the wire mesh 12 is 5. 4, and after making the appropriate electrical connections, the 33 is placed over this connection area, which provides electrical insulation and mechanical strain relief. It serves both functions.

The present invention for implanting the defibrillation electrode and cardiac pace tracking electrode chip of the present invention The method will be described below, but before doing so, we will explain the appropriate methods used in carrying out the method of this invention. It may be necessary to describe a preferred embodiment of a suitable insertion instrument. Fang q diagram Preferably, the insertion device is formed as an essentially elongated flat rod-shaped Zolo-Pro 0. FIG. 3 is a perspective view showing a different embodiment. This Zoro Pro 0 has a long and thin flat handle part 62. , and a blunt, rigid tip 64 that is capable of penetrating soft tissue surfaces during electrode insertion. It is used to form tunnels. The handle 620 has a raised tip 64. It has changed slightly as it forms.

The fang S diagram is a cross-sectional view of seven parts of the tooth diagram insertion tool 60, with respect to the surface of the handle 62. The position of the raised tip 64 is shown. This tip 64 is attached to the bottom surface of the electrode 10. It is configured to interact with the formed pocket 50, and is configured to interact with the formed pocket 50. As can be seen by comparison, the interaction portion 64 is inserted into the pocket 50 in the easily into the handle 62 so that the electrode is parallel to the surface of the handle 62. Therefore, the insertion tool 60 and The possible relative movement with the electrode io is unidirectional movement. insert the electrode When the device 60 is pulled, the electrode is held near the heart, but the tip of the device is End 64 is slid out of pocket 50. Furthermore, this tip 64 is attached to the electrode 10. When inserted into the pocket 50, the electrode itself becomes part of the means for insertion into the human body.

Fig. 6 shows another implementation of an insertion device 70 having an elongated handle portion 72 and a tip 74. An example is shown. The tip 74 is inserted into the pocket 50 of the electrode. This instrument 70 is formed as a flat device.

As mentioned above, an object of the present invention is to remove the chest inside the human body without performing major chest surgery. Insert the defibrillation electrode by making only a skin incision on either the wall or the abdominal wall. The purpose is to provide a method for implantation. Here, specially made hand-held instruments The tissue planes are separated and the soft tissues around the heart are exposed inside the thoracic cavity but outside the thoracic cavity. A tunnel is formed through the fabric. After forming the tunnel, more than 7 electrodes It is inserted into this tunnel and placed near the surface of the heart. The present invention is directed to the inner surface of the thorax. and the outer surface of the six membranes of the heart, and then into these tunnels seven tunnels. Relates to the insertion and eventual placement of more than one electrode near the heart. Furthermore, books The invention forms another tunnel on the rear surface of the 6th membrane between the 6th membrane and the diaphragm, and It also relates to placing cardiac electrodes through the tunnel.

When explaining the tooth diagram, the chest area of patient 100 is shown in silhouette, etc. The incision locations are indicated at 102 and 104. Diagram 7 shows the location of the patient's heart. and a general outline is shown at 106. Looking at the abdominal incision 102, the incisor Tool 60 is shown partially protruding from the body through this incision, and includes membranes 6 and lateral. A tunnel is formed on the lower surface of the 6 membranes between the diaphragm and the diaphragm. The electrode 10 of the present invention is inserted It is shown in position and retained on instrument 60. Also, the lead of the book 22 and 30 are shown protruding from the incision 102.

18, the electrode 10 of the present invention is shown installed in a special insertion tool 60. The tip 64Fi of the insertion instrument 60 is formed on the rear surface of the electrode 10 of the present invention. It is inserted into Kerato 50. As shown in phantom, the rigid tip of insertion instrument 60 The end 64 is at the front of the electrode 10. During insertion through the soft tissue plane, the electrode 1 0 and the stiff tip 64 of the insertion tool interact to form a tunnel.

Returning to Figure 7, it is clear that a tunnel is formed as described above. Will. For the upper incision 104 made in the chest area, the tunnel 108 A tunnel 110 similar to the above is formed between the inner surface of the thorax and the anterior surface of the ventral heart, Handle 621d of instrument 60 protrudes from incision 104 similarly to IJ-dos 22 and 30 It is shown as

Referring to FIG. 9, by fully inserting the insertion tool 60, the tunnel 108 and 110 are completed and the insertion instrument 60 is withdrawn, the distal end 64 of the instrument is It slides out of the pocket 50 of the electrode 10 and the electrode remains in place. It should be obvious. Figure 9 shows an electrode inserted into a tunnel formed on the soft tissue surface. The electrode is shown in its position after the insertion tool is withdrawn from this tunnel. Ru. Although the lead is shown extending through the incision in Figure 9, these The leads are ultimately placed based on the desired condition, i.e. the heart's pace and and whether the defibrillation is fully implantable. Placed.

It is also possible to apply the electrodes of the invention to the heart according to an alternative procedure, which is the preferred combination. The obvious ones are as follows. superior vena cava electrode; tunnel type diaphragm electrode; combined. Another combination is the substernal/Yatuchi electrode and the diaphragm/(’Sochi electrode). There is a combination of poles, but in this case both electrodes have a subziph root. oid route). Of course, the location shown in Figure 9 is different. It is a combination of

Figure 2 is a cross-section of the separable reed cassoller of the present invention, indicated by 24 in the figure. It is a front view. As mentioned above, this type of canoler has a cardiac pacing electrode tip and After implantation of the electrodes of the present invention, the pace of the heart can be adjusted as needed. Quickly and easily establish an electrical connection to the heart 4-sample. I will do it. The cazoler of the present invention can be used when it is found that the cadence of the heart is unnecessary. The lead can be pulled out while the lar remains in the patient's body to avoid the need for further surgery. It is set up for the purpose of

To explain the fang 70 diagram, the outer case 130 of the cazoler 24 has a female metal connector 1. 32, which connector is electrically connected to the cardiac pacing electrode lead 22. There is. Forming the electrical connection with female connector 132 is male lug 134, which This is electrically connected to the external pacing lead 26 by soldering or crimping. There is. At 136, the case 130 of the cudler is connected to the insulated lead 22 for pacing. configured to form a tight mechanical connection with the case 130. , while for the extracorporeal pacing lead 26, the emergency The housing 130 is formed to have a large passageway with a diameter of It is larger than the outer diameter of the pacing lead 26. Detach the external pacing lead When necessary, pull this external lead 26 to separate parts 132 and 134 and remove the external lead. The passageway is made of such a large size in order to allow the cord 26 to be withdrawn from the patient itself. diameter.

The figure shows another embodiment of the electrode of the invention.

Electrode 150 in this example is constructed similarly to electrode 10 in the figure, but with an upper layer of the electrode. 16 is provided with a plurality of holes 152 rather than seven large openings. these Hole 152 is created by cross member 154 formed in top layer 16 . This multi-hole structure The cardiac pace tracking electrode chip f1B can also be used in placed in one of the number holes.

These cross members 154 and additional sutures 156 preserve the function and original shape of the electrode. I found it to be effective in that respect. Tissue adjacent to metal mesh after electrode implantation can attach to the metal mesh and grow on and through the metal mesh. I understood. At this time, the tissue reaches the back of the mesh and the mesh is removed from the back layer of the electrode. exert force to try to separate the grip. This eventually distorts the shape of the electrode and causes contact reduce the performance of the electrode by adversely affecting the surface. Additional suture section 1 above 56 keeps the mesh firmly attached to the rear of the electrode.

Of course, the above explanation is only an example, and the present invention is not limited thereto. I would like you to understand that.

sac ・ Mr. Kazuo Wakasugi, Commissioner of the Agency 1 Patent application indication PCT/US 8 tlo O1632, name of invention planted Built-in cardiac defibrillation electrode 3, patent applicant Name Mirowski Meek Zislow 4. Agent 6. List of attached documents The scope of the claims / A type of implantable defibrillator that can be implanted into a patient to connect to an electrical cardioverter defibrillator. In a dynamic electrode assembly, a flat surface having a tissue-contacting surface and an insulation-contacting surface. conductive metal electrode, Electrical insulation placed in contact with and covering the entire surface that contacts the above insulation material a first layer of material and a surface having substantially the same dimensions as the first layer and in contact with said tissue; a second layer of electrically insulating material disposed in contact with and covering the entire surface of the electrically insulating material; The second layer consists of at least seven large layers exposing the central part of the tissue-contacting surface. having holes and covering the periphery of the surface that contacts the tissue; Furthermore, the surface of the electrode that contacts the insulating material is brought into close contact with the first layer of electrical insulation. maintain the condition to prevent the growth of tissue between them, and also to The exposed portion of the contacting surface is brought into conductive contact with cardiac tissue, and the second electrode and the first An electrode assembly characterized by comprising a fixing means for separating the layers.

λ Placed around the surface that contacts the above tissue, and in the area around the above electrode. increases the electrical impedance at The electrode assembly according to claim 7, further comprising means for maintaining the quality constant; Three-dimensional.

3. Disposed on the surface of the flat electrode that contacts the tissue, and electrically conducts from the surface. 9 electrodes are electrically connected to the heart rate electrodes, which are insulated from the and a second contact electrically connected to a heart wave sensor placed outside the patient's body. and an electrical connector that can be disconnected by hand. By disconnecting the point 9 from the electrical connector, the pace electrode can be connected to the heart wave. 2. The electrode assembly according to claim 1, wherein the electrode assembly is capable of being isolated from heat.

The electrode according to claim 1, wherein the flat electrode is formed of titanium mesh. Polar assembly.

The cap should be designed to receive the tip of the instrument used to implant the electrode assembly described above. Claim 1 further comprising an exposed two-butt formed in said first layer of edge material. Electrode assembly as described in Section.

At least the first and second layers of the electrical insulating material are added to increase mechanical strength. The electrode according to claim 2, further comprising a reinforcing mesh embedded in one side. assembly.

7. The means disposed around the surface that contacts the tissue is arranged around the periphery of the electrode. It has several small holes located in the surrounding area, through which the tissue is also connected. The contact surfaces are exposed, so that the multiple small holes are An electrode assembly according to claim 1, wherein the electrode assembly substantially eliminates the concentration of .

& of said flat electrode and said electrically insulating material so as to mechanically join said assembly. An electrode assembly according to claim 7, wherein the first and first layers are stitched with Dacron. body.

9. Further comprising flexible electrical conductor means connected to the flat electrode and the cardioverter defibrillator. This allows the electrode to be placed in contact with the heart to perform defibrillation. The electrode assembly according to claim 1.

/θ　The above titanium mesh is a /Sθ mesh with a wire diameter of 7 to 3 mils. 2. The electrode assembly according to claim 1.

/l according to claim 1, wherein the flat electrode is formed of an expanded platinum sheet. Electrode assembly.

/2 The second layer of electrical insulation material is such that the flexible electrical conductor is attached to the flat electrical conductor. an upper layer of electrically insulating material extending beyond the edge of said first layer of electrically insulating material at a location opposite to where it is connected; The first layer is configured to surround the edge of the first layer, thereby providing seven points on the lower surface of the electrode. A raised receptacle is formed with only the sides open, which requires special electrode insertion equipment. An electrode assembly as claimed in claim 9.

/3 Formed into a substantial rectangle whose long and short sides are tIca and 6-bi, respectively. An electrode assembly according to claim 1.

A plurality of λth small holes are arranged around the electrode, and these holes are connected to the through both the first and second insulation layers, and these holes are a series of sutures. Claim No. The electrode assembly according to item 7.

/S The at least seven large holes are formed in the second layer of electrical insulation material. Claim 1 comprising six large holes separated from each other by cross members. Electrode assembly on board.

/& said first layer of insulating material is arranged to extend to /& side edges of said flat electrode. According to the claim, the above-mentioned I kerato is formed with only seven sides open to receive the above-mentioned installation equipment. An electrode assembly according to scope 5.

/7 The fixing means comprises a suture that fixes the flat electrode to the first layer. The electrode assembly according to claim 7.

7g To prevent the exposed tissue contact surface from becoming distorted due to tissue growth. further comprising a structure of reinforcing ribs disposed across the exposed portion of the flat electrode. An electrode assembly according to claim 1, comprising:

/9 The flexible electrical conductor means comprises silver gold thread electrical cable. Electrode assembly as described in Section.

The electrode assembly of claim 1, wherein the first and second layers are separate parts. body.

J. Claim that the seventh and second layers are formed as an integral structure from the same piece of insulating material. The electrode assembly according to claim 1.

between the first flexible layer and the first layer that is electrically connected to the cardioverter defibrillation device; a connection such that the flat electrode is between the first layer and the first layer; a connecting hand for electrically connecting said flexible electrical conductor means to said planar electrode in a region; An electrode assembly according to claim 1, further comprising a step.

n further comprising means for covering the connection area so as to alleviate mechanical strain in the connection area; An electrode assembly according to claim 2.

Commentary: The second layer forms a substantially flat surface in the region of the connecting means; the planar surface is substantially in the same plane as the plane formed by the planar electrical conductor; An electrode assembly according to claim 1.

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Claims (1)

[Claims] 1. An implantable defibrillator that can be placed near the heart and connected to an appropriate defibrillator. In a polar assembly, a flexible flat conductive electrode means placed near the heart; , an electrical conductor arranged to electrically connect the electrode means and the defibrillator; means and placed on the surface of said electrode means closer to the heart and in the peripheral area of said electrode means. Current density relative to the plane of the flat electrode means increases the electrical impedance at and means for maintaining substantially constant. 2. It is further equipped with an electrically insulating element that covers the surface of the flat electrode facing away from the heart. An assembly according to the appended claims. 3 Placed on the surface of the Doi flat electrode so as to be in contact with the heart surface, and Electrically insulated heart rate tracking electrodes and snow, gas A broken connection/contact and an electrical connection broken to the heart PA4-sa placed outside the patient's body. and a manually disconnectable electrical connector having fang-contacts, thereby: By disconnecting the fang 2 contact from the electrical connector, the pacing electrode is raised. 6. The assembly according to claim 1, wherein the assembly can be shielded from the ether. 4. The assembly according to claim 1, wherein the flat electrode is made of titanium metal. Three-dimensional. 5. Adjust the top to receive the tip of the instrument used to implant the electrode assembly. and further comprising a pocket formed on the rear surface of the flat electrode. Assemblies on board. 6 Reinforced mesh embedded in the electrical insulation element to increase mechanical strength An assembly as claimed in claim 1, further comprising: 7. The means disposed on the surface of the electrode exposes the central part of the electrode and at least seven central opening regions substantially covering the periphery of the electrode; a layer of electrically insulating material located around said periphery of said electrode; It has several small holes through which the electrode surface is exposed and The plurality of small holes substantially eliminates the concentration of current due to repetitive action. The assembly described in Section 2 of the scope. 8. On the mesh and the electrical insulation material so as to mechanically join the assembly. 8. The assembly according to claim 7, wherein the front and back layers are sewn with Dacron. 9. In a type of electrode implanted in a patient for connection to a cardioverter defibrillation device, a flat electrical conductor, 17 layers of electrical insulation material placed in contact to cover one entire side of this flat electrical conductor and, It has substantially the same dimensions as this 17 layer, and the central part of the conductor is exposed, but the upper test conductor is It has at least seven large holes so as to cover the circumference of the body, and furthermore, it has at least seven large holes so as to cover the circumference of the body. It has several small holes located in it, and the relevant part of the conductor is inserted through these holes. of electrical insulation that is exposed and thereby eliminates the concentration of current due to repeated effects. a flat electrical conductor and a flexible electrical conductor connected to a cardioverter defibrillator; means, whereby the electrodes are fully placed in contact with the heart to perform defibrillation. An electrode characterized by being 10 The flat electrical conductor is used with a heart 4-sa located outside the patient's body. The cardiac pacing electrode, which is located in and electrically insulated from this, and the fang/ and a hand-disconnectable electrical connector having mating contacts of λ; a fang/aether conductor connecting the pacing electrode and the fang l fitting contact; further comprising a fang-insulating air conductor connecting the heart cover and the fang-fitting point ◇; If you disconnect the connector by hand, the mating contacts and electrical conductors of 10. The electrode according to claim 9, which is removed from the public. 11. According to claims 3 and 9, the flat electrical conductor is made of titanium metal. The stated completion. 12 The above titanium mesh has a wire diameter of / to 3 mil /Sθ mesh /yu. An electrode according to claim 5//. 13. The flat electrical conductor is formed of expanded platinum sheet. electrodes. 14. The two layers of electrical insulation material are such that the flexible electrical conductor is connected to the flat electrical conductor. Extending beyond the edge of the first layer of electrical insulation at a location opposite to where it is connected, The first layer is configured to surround the edge of the first layer, so that the bottom surface of the electrode is A raised receiving part is formed with only seven sides open, and this is a special electrode insertion device. The electrode according to claim 1. 15 Shaped into a substantial rectangle whose long and short sides are tIcIn and 6bi, respectively. An electrode according to claim 9. 16. A plurality of small holes are arranged around the electrode, and these holes are connected to the The holes pass through both the first and third insulation layers, and these holes are filled with a series of sutures. The claimed invention is arranged such that the threads of the The electrode according to item 9. 17. The at least seven large holes are formed in the electrical insulation material of the first layer. Claim 9 comprising six large holes separated from each other by cross members. electrodes. ]8. An implantable flexible flat electrode assembly placed near the heart. A pocket is formed on the flat side facing away from the heart, and this pocket wherein the kit interacts with an installation tool used to implant the electrode assembly. electrode assembly. 19. The electrode comprises a layer of electrically insulating material selectively disposed on the surface of the flat electrode. and the layer of insulating material is arranged to extend to/side edges of the electrode. forming the pocket with only seven sides open to receive the installation equipment. An electrode assembly according to claim 1/g.