US3516412A - Bipolar electrode having irregularity at inserting end thereof and method of insertion - Google Patents

Description

June 23, 1970 B. ACKERMAN BIPOLAR ELECTRODE HAVING IRREGULARITY AT INSERTING END THEREOF AND METHOD OF INSERTION Flled March 5, 1969 INVENTOR. BERNARD ACKERMAN .s V.. E N /n o T T WA Y/ UD United States Patent O BIPOLAR ELECTRODE HAVING IRREGULARITY AT INSERTING END THEREOF AND METHOD F INSERTION Bernard Ackerman, Metuchen, NJ., assignor to Electro- Catheter Corporation, Rahway, NJ., a corporation of New Jersey Continuation-impart of application Ser. No. 480,020,

Aug. 16, 1965. This application Mar. S, 1969, Ser.

Int. Cl. A61m 1/04 U.S. Cl. 128-418 5 Claims ABSTRACT OF THE DISCLOSURE A bipolar electrode apparatus comprising a flexible inner conductive element and a ilexible outer conductive element fabricated from an extremely flexible and resilient coil spring. An insulating element is disposed between said llexible inner and outer conductors. The outer conductive element is formed having a bend in the form of an elbow at one end thereof. The bipolar electrode apparatus is adapted for insertion through the chest wall into the ventricular cavity in cases of cardiac arrest. The elbow provides an irregularity in the apparatus such that a physician can readily ascertain, by frictional drag, when the apparatus has penetrated a suicient distance into the ventricular cavity. The resiliency of the elbow permits the electrode to be positioned immediately adjacent the interior wall of the heart and thus make positive contact therewith.

This application is a continuation-in-part of co-pending application Ser. No. 480,020, '.tiled Aug. 16, 1965.

The use of bipolar electrodes for insertion into the ventricular cavity for the purpose of restarting the heart function by the transmission thereto of electrical impulses has been disclosed and claimed in patent application Ser. No. 480,020, iiled Aug. 16, 1965. Thus, and as described in greater detail in the aforementioned application, a bipolar electrode pair may comprise an electrode Wire coated with insulating material though bared for purposes of electrical contact at either end thereof. The second electrode of the pair is in the form of an extremely flexible and resilient coil spring which, to all intent and purposes, is coiled closely around the inner insulated electrode.

The electrode pair is inserted into the ventricular cavity by puncturing the chest wall and the wall of the heart with a needle of conventional structure. The needle comprises a cylindrical sheath or sleeve in which is inserted a substantially rigid pointed needle to achieve puncture without clogging the sleeve portion. After puncture is achieved, the needle portion is withdrawn and the electrode pair inserted through the sleeve portion into the ventricular cavity. The sleeve is then withdrawn leaving the bipolar electrode pair in place.

Although this novel electrode pair constituted a considerable advance over the prior ait, it left unresolved two important matters in this clinical procedure. First, the inserting physician could not readily determine, except by the provision of markers, when the electrodes had been inserted a suicient distance into the ventricular cavity. Furthermore, he could not determine with accuracy, except by the use of X-ray observation, whether proper electrical contact was being achieved inside the cavity.

The bipolar electrode of the present invention is similar to the electrode pair of the aforementioned application but is constructed so as to have a linear irregularity close to the end thereof which is inserted into the venrice tricular cavity. The purpose of this irregularity is to increase the drag on the electrode as it passes through the sleeve of the inserting needle. This drag will cease abruptly when the portion of the electrode at which the irregularity is located passes out of the needle sleeve. Then, simply removing the sleeve portion or the cannula of the needle places the tip or distal end of the stylet against the endocardium automatically. It is disclosed in the aforementioned application Ser. No. 480,020 that the outer electrode is fabricated of an extremely flexible and resilient coil spring which, to all intent and purposes, is coiled closely around the inner insulated electrode. The resiliency of the outer electrode, in conjunction with the permanent linear irregularity adjacent the distal end of the electrode pair defines an unbiased or unstressed position or condition for that part or portion of the electrode pair between the distal end and the linear irregularity thereof. As will be explained in greater detail hereinafter, this portion of the electrode pair, in its unbiased or unstressed condition, defines an angle with the remainder of the stylet of the present invention, and while the angle subtended between these two portions is not critical, the angle is preferably acute. Accordingly, the cessation of the frictional drag resulting from the linear irregularity exiting the cannula of the needle enables the portion of the electrode pair between the distal end and the linear irregularity to automatically return to its unbiased or unstressed condition in which an angle is subtended between that portion and the rest of the stylet. As a result, and as hereinbefore pointed out, the distal end or tip of the stylet is automatically placed against the endocaridum. Preferably, and as will also be described in greater detail hereinafter, the entire portion between the distal end of the stylet and the linear irregularity is disposed adjacent the endocardium, and this is accomplished, after the distal end is automatically placed against the endocardium, by withdrawing the cannula, and by applying a gentle withdrawing force to the stylet itself. When the linear irregularity encounters the endocardium, the attending physician will experience an increase in the withdrawing force necessary to continue to withdraw the electrode pair, thus recognizing the location of the linear irregularity with respect thereto.

The present invention therefore enables an attending physician to automatically place the distal end or tip of the stylet or electrode pair against the endocardium, and also enables the physician to readily ascertain the position of the linear irregularity with respect thereto. Furthermore, the physician is enabled to place the portion of the electrode pair or stylet between the distal end or tip and the linear irregularity substantially adjacent to the endocardium with much greater ease and facility. Additionally, and because the distal end or tip of the stylet is automatically placed against the endocardium, the region of highest current density, located at the distal end or tip of the stylet, will be placed closest to the endocardium so that the electrical stimulation has the highest possibility of successful capture. This is true because the materials from `which the electrode pair of this invention are fabricated present lesser resistance to the passage of electrical current than the blood within the body, the tissue thereof, and the like.

In accordance with the principles of the present invention, therefore, procedures of this type can thus be eiected more rapidly and with much greater facility because the linear irregularity or distal curve of this invention will enable the attending physician to easily feel when the linear irregularity of the electrode pair clears the tip of the cannula of the needle and has entered the ventricular cavity or, for that matter, any other portion of the body under examination.

short distance from the distal end, that is,` the end to be inserted. While the bend angle is not critical, it is preferred that an acute angle is subtended between the end of the electrode and main body thereof. Since this bend is in a substantially flexible body, the electrode may be temporarily straightened during passage through the needle sleeve. However, even in its straightened condition, the bend produces the necessary irregularity to generate the desired frictional drag. When the portion of the electrode having the bend therein passes out of the needle sleeve, the bend portion will automatically spring into its desired position placing the region of highest current density adjacent the inner wall of the organ punctured, while at the same time eliminating the frictional drag such that the physician will be sure of proper placement.

Accordingly, it is an object of the instant invention to provide a bipolar, flexible electrode pair and a method of inserting same, having an irregularity at one end thereof whereby an inserting physician can easily determine when the electrode pair has been inserted in the body the desired amount.

Another object of the instant invention is to provide such a bipolar electrode pair wherein such irregularity automatically places or positions the region of highest current density adjacent or against the inner lwall of the organ punctured, so that the electrical stimulation has the highest probability of successful capture.

Still another object of the instant invention is to provide such an electrode pair wherein the aforementioned irregularity is defined `by a bend provided at one end thereof.

Yet another object of the present invention, in addition to all of the foregoing objects, is to provide bipolar electrode apparatus having an irregularity at one end thereof whereby an inserting physician can easily determine when the electrode pair has been inserted in the @body the desired amount, said irregularity automatically placing or positioning the region of highest current density adjacent or against the inner wall of the organ punctured, to present the highest probability of successful capture of electrical stimulation, and, in addition, to avoid accidental dislodgement of said bipolar electrode apparatus.

The present invention will best be understood, and objects and important features other than those specifically enumerated above, will become apparent when consideration is given to the following detailed description, which, when taken in conjunction with the annexed drawings, describes, discloses, illustrates and shows a preferred embodiment of the present invention and what is presently considered to be the best mode of practicing the principles thereof. Other embodiments or modifications may be suggested to those having the benefit of the teachings herein, and such other embodiments or modifications are intended to be reserved especially as they fall within the scope and spirit of the subjoined claims.

In the drawings:

lFIG. 1 shows the end portion of a bipolar electrode apparatus constructed in accordance with the instant invention.

FIG. 2 illustrates a puncturing needle and sleeve useful for inserting the electrode apparatus of FIG. l.

FIG. 3 illustrates the needle sleeve with the electrode apparatus of the invention passing through an illustrative wall which could be any portion or organ of the body; and

FIG. 4 illustrates the electrode apparatus operating position on the inner side of the wall and connected to the impulse generator.

With reference to the drawings, there is illustrated therein one particular embodiment of electrode apparatus constructed in accordance with the principles of the present invention. It is generally designated by the reference character 10. Before going into detail, it is to be understood that although the invention is described herein with reference to the therapeutic application of electrical current to the heart, the apparatus may equally be utilized as a monitoring device. Similarly, the applicability of this apparatus is in no way limited to thetreatment or diagnosis of the heart. It may Ibe utilized in the interior of any portion of the vbody where diagnostic measurements or the application of externally generated electrical pulses may be considered desirable.

In FIG. l, there is illustrated the bipolar electrode apparatus 10 which comprises a first or inner electrode 12 which terminates at one end thereof in a hook or loop 14. The inner electrode 12 may lbe fabricated of any suitable electrically conductive material and is coated with an insulating sheath 22 which coats substantially the entire length of the electrode 12 with the exception of exposed tip 14 and the other end 15 which is to be connected to the pulse generator 575 (see FIG. 4).

The second or outer electrode 16 of the electrode apparatus 10 is fabricated of suitable, electrically conductive material in the form of an extremely flexible and resilient coil spring, the coils of which surround the insulating layer 22. The outer electrode 16 extends substantially as far as the tip 14 but is separated therefrom by a rigid joint of non-conductive material 18, which is fabricated of any suitable material, an epoxy resin or the like. It will be appreciated that the insulative sheath 22 and the tip 18 prevents the shorting of electrodes 12 and 16.

In the preferred modification of the invention, the bipolar electrode apparatus 10 is bent into the shape of an elbow at 17. This bend may Ibe introduced into the bipolar electrode apparatus 10 in any suitable matter, such as, for example, by a suitable process for applying heat. As will ibe further described, this Ibend is such that the entire length of the apparatus 10 may be temporarily straightened during the insertion process; but upon release of the defiecting force, the unit will again return to the elbow shape.

In FIG. 2 there is illustrated a composite puncturing needle 42 comprising an inner needle or stylet 50 having a pointed tip 51 at one end thereof and an enlarged head 52 at its opposite end. The inner needle 50 is removably inserted in a cylindrical sleeve or cannula 53 which terminates in an enlarged, substantially hollow head 54.

In the operation of the device as applied to the heart, the needle 42 is passed through the chest wall substantially at the fourth and fifth intercostal space (occurring between the ribs of the torso) and further passed through the ventricular wall 47 until it enters the ventricle cavity 48. This may 4be the left ventricle of the heart.

The inner needle or stylet 50 is then removed and the electrode apparatus 10 is passed into the sleeve portion or cannula 53 via the hollow head 54. Because of the elbow 17, some difficulty may be experienced in guiding the unit 10 into the sleeve portion S3. This insertion may be facilitated by initially inserting the unit 10 into a small length of tubing `49 having an internal diameter approximately equal to that of sleeve 53. Tube 49 is then inserted into head 54 and placed adjacent to the beginning portion of sleeve S3. Unit 10 may then be easily slid into sleeve 53.

It will be understood that due to the distortion of elbow 17 a certain amount of frictional resistance will be felt while unit 10 is pushed through sleeve 53. This resistance will cease as soon as elbow 17 passes out of the end of sleeve 53 inside the ventricular cavity 48. Therefore, in a very simple manner, the physician will be apprised of the fact that the apparatus has reached the desired depth in the body.

Then, simply removing the sleeve or cannula 53 by withdrawing it from the ventricular cavity 48 and from the chest `wall will automatically place or position the tip 14 of the electrode pair or stylet 10 against the endocardium. That is, and as hereinbefore pointed out, the coil spring from which the outer electrode of the stylet of this invention is fabricated introduces a certain resiliency which, when taken in conjunction with the linear irregularity or elbow 17 results in that portion of the stylet between the distal end and the elbow having an unbiased or unstressed condition enabling the aforesaid portion to define an angle with respect to the remainder of the stylet. When the elbow 17 exits from the sleeve or cannula of the needle, the resiliency of the coil spring and the elbow 17 automatically causes the portion of the stylet @between the distal end or tip and the elbow to tend to return to its unbiased or unstressed condition` This automatically places the distal end or tip against the endocardium.

In addition, cessation of the frictional drag resulting from the elbow 17 passing through the cannula 53 enables the attending physician to recognize that the elbow 17 has, indeed, entered into the ventricular cavity'. If the attending physician will now withdraw the cannula 53, and then apply a gentle withdrawing force to the stylet, the physician will find it necessary to increase his withdrawing force when the elbow 17 approaches a position against or substantially adjacent the endocardium. In this manner, the attending physician will be able to position the aforesaid portion of the stylet between the distal end or tip 14 and the elbow 17 substantially adjacent the endocardium along the length of that portion.

It will be understood that automatically placing the distal end or tip 14 of the stylet 10 of this invention against or substantially adjacent the endocardium places the region of highest current density in such a position with respect thereto that the electrical stimulation, hereinafter to be described, has the highest probability of successful capture. This is true because the materials from which the electrodes of the present invention are fabricated have lesser resistance to the passage of electrical current than the blood within the body, the tissues thereof, and the like. For these reasons, it is the distal end or tip 14 that is the region of highest current density.

In addition to achievinf7 the foregoing objects, the present invention, in general, enables procedures of this type to be effected more rapidly and with much greater facility because the linear irregularity or distal curve at the elbow 17 enables the attending physician to easily feel when it clears the end of the needle sleeve or cannula, and has entered the ventricular cavity or, for that matter, any other portion of the body under examination.

An impulse generator 55 is then connected to the inner electrode 12 by lead 56 and to the outer electrode 16 via lead 58. Electrical current of the desired strength and frequency may then be applied through the circuit which comprises inner electrode 12, the tip 14 thereof, the Wall of cavity 48, and outer electrode 16.

While the invention has been shown, illustrated, described and disclosed in terms of embodiments or modifications which it has assumed in practice, the scope of the invention should not be deemed to be limited by the precise embodiments or modifications herein shown, illustrated, disclosed or described, such other embodiments or modifications intended to be reserved especially as fi they fall within the scope of the claims here appended.

What is claimed is:

1. A bipolar electrode apparatus comprising, in combination, an inner and an outer electrically conductive element, an insulating element disposed between said inner and outer electrically conductive elements, said insulating element terminating at a region beyond which a current transmitted to said outer electrically conductive element will be transmitted to said inner electrically conductive element, said inner electrically conductive element cornprising an electrode fabricated of a flexible material, said outer electrically conductive element comprising at least one coil spring fabricated of an extremely flexible and resilient material, and said apparatus having an elbow formed near one end thereof and defined by a short length of said bipolar electrode apparatus being disposed in nonalignment with the remaining length thereof when said apparatus is in its natural configuration.

2. A bipolar electrode apparatus as defined in claim 1, wherein the angle subtended by said elbow is an acute angle.

3. A bipolar electrode apparatus as defined in claim 1, wherein said insulating element is fiexible about at least the elbow portion of said apparatus.

4. Method of automatically positioning the region of highest current density of bipolar electrode apparatus adjacent the wall of a body to enable electrical stimulation applied to said body to present the highest probability of successful capture, comprising the step of puncturing said Wall with a needle comprising a pointed inner portion and an outer sleeve portion; withdrawing said pointed inner portion; inserting bipolar electrode apparatus having an irregularity near one end thereof into said sleeve portion until the frictional resistance generated by said irregularity disappears; and removing said sleeve portion from said wall.

5. Method as defined in claim 4, comprising the steps of initially inserting said bipolar electrode apparatus into a guide tube; and placing said guide tube substantially adjacent the sleeve portion of said needle to facilitate the passage of said electrode apparatus into the sleeve portion, enabling procedures contemplating the use of bipolar electrode apparatus to be effected more rapidly and with the greatest facility further enabling a distal end of said bipolar electrode apparatus to be placed adjacent to or against the wall of a body automatically upon removing said needle.

References Cited UNITED STATES PATENTS 2,022,065 11/1935 Wappler 12S-407 2,496,111 1/1950 Turkel 128-2 3,087,486v 4/ 1963 Kirkpatrick 12S-418 OTHER REFERENCES Zuder et al.: Journal of American Medical Association, vol. 184, No. 7, May 18, 1963, pp. 13S-138.

WILLIAM E. KAMM, Primary Examiner

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