DE1764790A1 - Electrodes that can be implanted in the living body - Google Patents

Description

Dr. Horst SchüJer Patent attorney

β Frankfurt / Main 1

fcliddaatr. 52

Aug 8, 1968

882-8DX-1212

General Electric Company, 1 River Road, Schenectady, N.Y. /UNITED STATES

Electrodes that can be implanted in the living body

The invention relates generally to an o-surgical instrument and, more particularly, to an instrument that can be implanted in the human body during surgical procedures to establish an electrical connection between an organ and a power source.

/ BAD ORIGINAL

10 9 845/0382

Pathological states of organs »for example des Heart's are often relieved by the fact that the activity of the organ is caused by electrical impulses from a Current source is excited, which is implanted in the body. Early in the development of this procedure the power source was implanted in one place, and from the power source conductors went out, the uninsulated ends of which were sewn into the organ, in order to make electrical connections To form connections. If the heart was to be stimulated, this procedure required opening the Chest, which undoubtedly had disadvantages. In addition, electrodes or conductors have been developed which no longer made it necessary to open the chest and in which at least the non-insulated ends were helical, rigid and sharply pointed, so that they could be screwed into the tissue of the organ. To do this, a hollow needle was inserted into the chest until the far end of the needle touched the heart muscle. Then the leader moved from the near to the distant End of the needle guided and screwed into the heart muscle; then the needle was withdrawn backwards from the conductor. The near end of the conductor was then connected to the implanted power source and sealed. Even though the surgical procedure by which this construction was simplified, it had the disadvantage that during the dee More intervention was required than simply inserting a release into the implanted sti oniqualle.

109845/0382

BATH

It is therefore an object of the invention to propose an electrode that can be implanted in the living body, which requires no opening of the chest, is easy to use, reduces patient injury, durable, is flexible and has a low budget, establishes a perfect electrical connection to the body tissue and simply to a-planted power source to stimulate the Organ activity can be connected.

The electrodes according to the invention allow electrical Making connections between an organ and a power source in new and easier ways. One embodiment of the new electrode has two conductors leading from run out of a plug that snaps into a planted power source and automatically forms a good seal with the power source. Each conductor has a cable of fine wires that insulates and is considered to be permanent deformed spiral is formed. The insulation of the cable consists of a thin coating of Teflon or the like; only at its end remote from the power source is the cable not insulated and rigid. The rigid end Like the cable, it is designed in a spiral shape and tapers to a point. At least one spiral turn in the end zone is deformed or made out of round so that inside the spiral a flat stylet can be inserted coaxially

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before it engages in the deformed coil or calibrates with it Wedges · The stylet is then rotated to move or screw the tip of the coil into the organ tissue.

All that is needed to perform this procedure is an incision or a mediastinoscope (not shown). which has a drum and a pistol grip. the Drum is approximately 19 mm (3/4 ") in diameter and is slit lengthways along its entire length. A light source is provided in the handle, and a small one metal shielded bundle of fiber optics extends from the light source to the End of the drum so that the distal end is illuminated when it is cut through a cavity in the body is introduced.

When the drum of the mediaetinoscope is inserted and if the far end is near the heart, if it is the heart, it becomes spiral Ladder lowered through the drum until its pointed sin touches the heart. A flat wire stiletto was previously lowered through the turns of the spiral and pushed forward within the spiral until " the end of the stylet hits the deformed turn of the coil. The stiletto is rotated around the top of the ladder to poke into the organ, and then withdrawn. The tip is eventually made up of fibrous tissue

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held. After all the conductors have been attached, the mediastinoscope is withdrawn; the drum of the However, the mediastinoscope does not need to be stripped off over the spiral-shaped conductors and the plug, because the Conductors can be pushed through the slot on the side of the drum.

In the following, the invention is intended to be based on a description preferred embodiments and the drawings described in more detail

1 shows a perspective view of an embodiment of an electrode arrangement which can be implanted in the body according to the invention.

FIG. 2 shows a longitudinal section through the connection end or the left end of the electrode according to FIG. 1.

Fig. 3 shows in perspective an enlarged section of the from the power source remote, spiral-shaped, rigid end of the conductor with inserted stylet, so that it can be seen how the coil can be screwed into an organ.

FIG. > \ Shows a sonicity along the line 4 - 4 in FIG. 3

Fig. 3 shows a plan view of another embodiment according to the invention, and

109845/0382 _BA D ORIGINAL

Pig. 6 shows a vertical partial section through the plug or the left end of the electrode arrangement after Pig. 5.

Now should on Pig. 1 should be referred to. The electrode arrangement according to the invention has a connecting stiffener 10 made of molded plastic with a pair of connecting pins 11 which protrude at one end. The pins are surrounded by a metal sleeve 12 which has a flattened point 13 which forces the correct plug connection with a suitable plug on the implantable power source (not shown). On the right-hand side of the plug 10, two insulating tubes 14 made of silicone rubber protrude, and two spirally wound, insulated conductors 15 lead out of these tubes. The tubes 14 are filled with a self-curing, flexible silicone adhesive for medical purposes on the inside in the area between the plug and the points provided with the reference number 16. This way, no body fluids can get into the plug

Further details about the plug 10 are from the Teilansioht after Pig. 2 ersiohtlioh. The plug 10 has an outer sheath 17 made of silicone rubber and an inner sheath 18, which encloses the tubes 14 that extend from the plug. The room marked 19 and others Silicone rubber boundary surfaces are filled with silicone adhesive, to prevent the ingress of liquids.

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The conductor 15 is an insulated cable, which consists of many extremely thin, silver-plated wires made of non- * rusting steel. The cable has a cross-sectional diameter of approximately 0.46 mm (0.018 inches) including its thin insulating cover. The thin flexible The insulating layer can consist of Teflon or another suitable insulating material, is 0.025 mm to 0.05 mm (0.001 to 0.002 inches) thick and is applied before the cable is permanently deformed into a spiral. That of the The end of the spiral remote from the power source, which is located in the region of the clamp 20 in FIG. 1 and is shown enlarged in FIG. 3, is not isolated; therefore it is conductive when it is screwed into an organ.

Referring now to FIGS. 3 and 4, the removed End 20 of the electrode can be viewed. The senior, from

lying The power source removed / tip must be rigid in order for it to be can be screwed into the tissue. To this end the cable end is preferably provided by die forging with a thin tube 21 made of stainless steel, the is ground to a sharp point 22. About four turns of the cable are covered with the tube 21, so that the rigid end, measured along the spiral axis, is approximately 1 cm long. Some further cable windings designated by 23, which are drawn in dotted lines in FIG. 3 and which are connected to the windings reinforced by the pipe 21 connect

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for reasons of greater flexibility and a gradual one The transitions8 of the stress are not isolated either. the a few uninsulated and flexible turns 23 can be screwed into the organ so that in the event of breakage an electrical line is still present at the transition point to the rigid section. All turns following these few turns 23 have insulation 30 made of Teflon or another material »which extends into the plug 10.

One of the rigid turns on the end portion is flattened as shown at 24 in FIGS. This deformation enables the spiral-shaped conductor to be gripped on the inside by a correspondingly designed end of a probe holder or stylet 25. When the end of the stylet 25 is fitted in the region of the deformed turn 2k , the tip 22 of the rigid end of the conductor screws into the organ by rotating the stylet. Normally, the stylet is inserted coaxially into the interior of the helical conductor through a winding gap some distance from the end to be inserted into the organ, and then the stylet is advanced axially until the stylet end with the deformed coil wedges in the rigid area of the conductor .

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As already mentioned, the tube 21 is drop forged onto a non-insulated part of the cable, before the cable is wound in a spiral. In a practical case, the tube had 21 internal and external Outside diameter of 0.43 mm (0.017 inch) or 3.1 mm (0.123 inch) and the length was sufficient for it to extend over four turns of the cable. The cross section of the The cable is usually a little larger than the inside diameter of the tube, so the cable can be removed while the Tube is absorbed, is stretched somewhat and its diameter decreases. The inside and outside diameters of the spiral wrap are approximately 1.17 mm (0.046 inches) and 1.98 mm (0.078 inches), respectively. It should be noted that the end of the cable also can be stiffened in other ways than by attaching a metal tube, for example by applying Silver solder.

Fig. 5 shows another embodiment according to the invention. Only one spiral-shaped conductor 15 is provided for direct connection to the organ to be excited. Of the other conductor, which closes the circuit from the organ back to the power source, consists of several groups 26 of numerous turns of uninsulated cable wrapped around connector 10, as shown in Pig. 5 shown is. Like from Big. 6, the spiral-shaped conductor 15 leads from an insulating tube 14 made of silicone rubber out, as has already been described in connection with the embodiment β form according to FIG. The other,

109845/0382 ORIGINAL BATHROOM

uninsulated conductor wrapped around the connector is, protrudes from a similar insulating tube 27 which ends inside the plug. A straight part 28 of the conductor runs parallel to the tube 14 up to an opening 29 in the sleeve 18 and is then outside in the manner shown wrapped around the plug. The different groups 2r> of the cable windings form a large-area electrode, the compensates for the increased impedance that would otherwise result from the length of the return path from the point in the organ from where the end of the spiral conductor 15 is screwed in, leads through other body tissue.

In summary, it should be said that an electrode has been described which enables a quick and permanent connection to a prgan to be established by having a spiral-shaped end with a stylet or probe guide is screwed into the organ. The spiral conductor is isolated and flexible in the space between the organ and the body surface, where a connecting stealer is a fast Connecting to a subcutaneously implanted power source makes it easier. The one required to attach the electrode surgical intervention is less serious for the patient; it consists merely in the fact that a comparative small incision is made for the leads of the electrodes or that a mediastinoscope is inserted, and that after attaching the electrodes to the organ, the conductors be laid in a surface section below the power source, and that the incisions are then sewn.

109845/0382

BATH ORIGINAL

Claims (1)

-5764790 Patent claims: I)) An electrode arrangement that can be inserted into a body is a flexible, insulated conductor coming out of a plug, the distal end of which is designed for attachment to an organ, marked as raw because * «in conductor (15) at its non-insulated end part (20 ) has the shape of a rigid spiral, which between its ends on at least one turn has a portion (2 * 0) that can be grasped, a slender base device (23) can be introduced coaxially into the rigid spiral, so that the spiral can be inserted into the rigid spiral by means of the ear-shaped Part (2k) can be robbed into an organ. 2) Implantable electrode arrangement according to claim 1, since marked duroh, daft the old a key detectable section a deformation in is at least one of the rigid turns. 3) Insertable electrode arrangement according to claim 1 or 2, characterized in that the conductor (15) comprises a flexible wire cable and at least the first turn behind the rigid, distant one End of the cable is not insulated. M) implantable electrode arrangement according to claim 1, 2 or 3, characterized in that the 109845/0382 BATH rigid spiral has a thin metal tube that is padded exactly onto the far end of the flexible cable and stiffens it. 5) implantable electrode arrangement according to one or more of claims 1-4, characterized ■ eiohnet that a second non-insulated conductor is led out of the plug and the Steoker insulation and is wound around the Steoker from the exit point (26), so that a large-area electrode is formed. « _ΛΑ «, BAD ORIGINAL 109845/038?