CA1226628A

CA1226628A - Means for transferring electrical energy to and from living tissue

Info

Publication number: CA1226628A
Application number: CA000443890A
Authority: CA
Inventors: Philip Katz; Henry S. Brenman; Mark Singer
Original assignee: Biosonics Inc
Current assignee: Biosonics Inc
Priority date: 1982-12-22
Filing date: 1983-12-21
Publication date: 1987-09-08
Also published as: JPS59135047A; WO1984002459A1; PT77870B; DE114511T1; KR840007521A; EP0114511A1; NO843334L; US4510939A; IL70455A0; ES285337U; MX154750A; BR8306974A; AU2272683A; ES285337Y; PT77870A; AU563375B2; DK582783D0; DK582783A; ZA839061B; PH20803A

Abstract

Abstract Means for transferring electrical energy to and from living tissue comprises a glove of thin, flexible elastomeric material, which carries electrodes, elec-trically connected to a connector disposed at the cuff of the glove. The connector permits the electrodes to be electrically connected to a source of electrical energy or to a load, so that electrical energy may be applied to or drawn from living tissue.

Description

I

MEANS FOR TRANSFERRING ELECTRIC ENERGY
TO AND FROM LIVING TISSUE

This invention relates to apparatus for applying elect tribal stimuli to living tissue, and more particularly, to apparatus for applying electrical stimuli for diagnostic purposes. In addition, this invention relates to apparatus for transferring electrical energy from living tissue to ; measuring, display and recording equipment used in operating rooms or physicians offices In some medical procedures, it is useful or desirable to apply electrical energy to tissues of the body. For example, in connection with co-pending United States Patent No.
4,542,753, issued September 24, 1985, for "APPARATUS AND
METHOD FOR STIMULATING PENILE ERECTLY TISSUE", assigned to the assignee of the present application, the suitability of a particular candidate for use of the apparatus disclosed therein may be determined by palpation of the prostate gland, and the application of electrical energy to that gland so as to simulate the action of the apparatus. Similarly, the locations of critical regions or spots on the prostate gland can be deter-Jo "
, . .

I 62~

mined by applying electrical energy to the prostate gland from a generator via the apparatus to the living tissue. The regions or spots at which a desired reaction, in that ins-lance incipient erection, is stimulated, can thus be identi-fled, Further, in connection with the above application, top-teal application of electrical energy to the anal area is de-sizable to induce contraction of the musculature of the feat-us as an aid to intimately fitting a device to the rectal cavity.
It is, therefore, one object of this invention to provide apparatus for applying electrical stimuli to living tissue for diagnostic purposes.

Other diagnostic procedures involve the transference of elect tribal energy from tissues to recording devices. In cowardly-orgy, for example, certain diagnostic techniques involve the receipt of low voltages produced by the heart, and transferring these voltages to recording or display devices, as in cardiac mapping.

Another object of this invention is to provide an apparatus which is inexpensive to manufacture, easy to use, and which is of such a nature that it is disposable after usage.
Other objects will appear hereinafter.

According to the invention, there is provided an apparatus for selectively transferring electrical energy to and from critical localities in living tissue for diagnostic purposes.
The apparatus includes a glove of flexible fluid impervious elastomeric material, the material being sufficiently thin and flexible to afford the wearer substantially unimpeded feel and manual dexterity so as to enable use of said glove for digital palpitation while transferring energy to and from said tissue. An electrode is affixed to the index finger of foe the glove and covers the area of the glove beneath the tip of the distal phalanges of the index finger of a wearer of the glove, thereby to facilitate application of said electrode directly to a palpated locality of tissue. A second electrode is disposed adjacent to the tip of the thumb of the glove and an electrical connector is coupled to the glove and adapted to be electrically connected to electrical circuitry external to the glove. A plurality of flexible electrical connectors are adhesively coupled to the glove and electrically connect the electrodes and connector.

The electrical circuitry to which the apparatus is coupled may be a source of electrical energy or amplifying or display devices. The source of electrical energy may be a signal generating circuit, or simply a source of electrical potential, as the application may require. The electrodes and associated conductors may, in the presently preferred form of the apparatus, be applied to the glove by electrode position or other means, so as not to impede the normal flexibility of the glove or to render the glove less useful for normal pulp-anion than conventional gloves, not fitted with electrodes and conductors.

There are seen in the drawings forms of the invention which are presently preferred (and which present the best mode contemplated for carrying the invention into effect), but it should be understood that the invention is not limited to the precise arrangements and instrumentalities shown.

Figure 1 is a plan view of the palmer aspect of a glove incorporating the principles of the present invention.

Figure 2 is a cross-sectional view, taken along the line 2-2 in Figure 1.
Figure 3 is a schematic diagram illustrating exemplary I

- pa -", electronic circuit means, which may be used to generate a signal for use with the present apparatus.

Figure 4 is a partial side elevation view, illustrating an aspect of the invention.

Figure 5 is a partial side elevation view, illustrating an alternative form of the invention.

OF

Figure 6 is a schematic view, illustrating diagram mat-icily an application of the present invention in which electrical energy is received from tissue and repro-sensed on a display device.

Referring now to the drawings in detail, wherein like reference numerals indicate like elements, there is seen in Figure 1 apparatus designated generally by the reference numeral 10.
The apparatus 10 includes a glove 12, of natural or synthetic rubber or rubber-like elastomeric material.
The glove 12, but for the special features to be de-scribed below, may be a conventional surgical glove of 15 the well-known and readily available kind. Such gloves are "thin," in the sense that they are so designed as to allow for a sensitive "feel" through their material, and highly flexible so as not to impede to any signify leant degree the manual dexterity of a wearer. Disk 20 posed upon the glove 12 are a plurality of planar electrodes whose shape may conform to that of a user's finger. In Figure 1, for example, an electrode 14 is disposed beneath the distal phalanges of the index finger 16. An electrode 18 is disposed approximately 25 beneath the joint between the middle and proximal phalanges of the index finger 16. A third electrode 20 is disposed adjacent the end of the thumb 22. Another electrode 24 is disposed beneath the distal extremity of the phalanges of the middle finger 26.
Referring again to Figure 1, it will be seen that the various electrodes are electrically connected to con doctors, such as the illustrated conductors 28, 30, 32 and 34. In the illustrated form of the apparatus 10, Sophie the conductor I is associated with the electrode 14;
the conductor 30 is associated with the electrode 18;
the conductor 32 is associated with the electrode 20;
and the conductor 34 is associated with the electrode 5 24. Numerous other specific arrangements will occur to those skilled in the art.

As is apparent from Figure l, the conductors 28, 30, 32 and 34, like the electrodes themselves, are affixed to lo the external surface of the glove 12. The electrodes 14, 18, 20 and 24 and the respective conductors 28, 30, 32 and 34 may advantageously be applied by known tech-nigues of electron or chemical deposition, or may be I; redeposited on a substrate, such as Mylar* and then 15 attached to the glove 12 by suitable adhesives. The material of the electrodes 14, 18, 20 and 24 and the conductors 28, 30, 32 and 34 may be platinum or another suitable conductive, inert, non-polarizing material.

20 After application of the conductors to the glove 12, an insulating over layer see in Figure 4 but omitted elsewhere), such as the insulating strip 46 seen in Figure 4, may be applied over them to limit electrical contact with the subject to the areas of the elect ; 25 troves.

Referring to Figure 4, the preferred location for the conductors 2B, 30, 32 and 34, where they pass along the fingers of the glove 12, is on or near lateral plane 30 ("P") passing through a medial axis of the finger of the glove 12. When so disposed, the conductor 28 is subjected to a minimum of stretching in an axial direct lion, and thus exhibits maximum durability and least susceptibility to damage due to flexing of the glove 1 35 and finger.
Lowry f c -f wreck r ,4 ~.2~jfi2~

Referring again to Figure 1, the conductors 28, 30, 32 and 34 run from the respective electrodes 14, 18, 20 and 24 to one-half of a multiple pin type connector 38, secured to the cuff 40 of the glove 12. The connector 5 38 typically comprises two snap or frictionally inter-engage able parts 42 and 44, provided, respectively, with male and female elements. Other suitable connect ions may be used. The elements may by SO connected to the electrodes as to render selected electrodes lung-10 tonal in a given situation. For example, for certain palpation procedures and applications, such as the diagnostic technique set forth in the above-identified co-pending application, it may be desirable to use the electrode 14 as an active or stimulating electrode, and 15 the electrodes 20 and 24 as "return" or ground elect troves. In such a situation, it is feasible to apply stimulating voltage only to those elements of the connector 38 which are electrically connected to the conductor 28, and to connect the conductors 32 and 34 20 associated, respectively, with the electrodes 20 and 24, to a return or ground wire.

Referring now to Figure 5, there is seen an alternative form of the apparatus 10, in which elements correspond-25 in to those previously described are designated byline primed (') reference numerals. The form of the apparatus 10 illustrated in Figure 5 employs as the electrode 14' (which is representative of the other electrodes) a solder-filled dish-shaped disc of plats 30 inum or other appropriate material, affixed to the glove 12' by a suitable adhesive. Such electrodes, unlike those described above, are rigid. The electrode 14', and other electrodes (not shown in the figure) are electrically connected to an insulated wire 28' affixed to the glove 12' and associated with a connector (not shown) like the above-described connector 38.

Us Figure 6 illustrates, somewhat diagramically, the manner in which the present invention may be used for transferring electrical energy from living tissue to measuring, displaying and recording equipment. In S Figure 6, the glove-mounted electrode 14 as shown, schematically, as an input for an oscilloscope 48.
Thus, just as the electrode 14 may be used to apply electrical stimuli in certain procedures, it may also be used as a receptor of electrical energy from certain 10 tissues.

Figure 3 illustrates an example of an electronic air-cult by which a stimulating signal can be produced for diagnostic purposes, although numerous other specific 15 sources of potential or signal generators may be used in conjunction with the apparatus 10. The illustrated circuitry, designated generally by the reference number-at 50, includes an actable multi vibrator, designated generally by the reference numeral 52; a monostable 20 multi vibrator, designated generally by the reference numeral 54; RAND grating 56; a pair of inserters 58 and : 60; and an emitter-follower 62 providing a stimulating voltage (about 20 volts) output.

25 A power supply, not shown, may provide the signal generator circuitry 50 with logic level voltage tap-proximately 6 v. DO and stimulating level voltage (approximately 24 v. DO inputs, the logic level voltage inputs serving to power the circuitry 50 and 30 the signal level voltage inputs providing the signal to be applied through selected electrodes.

The actable multi vibrator 52 and monostable multivi-orator 54, which comprise the first and second stages 35 of the circuitry 50, provide pulses of logic level voltage and of a desired pulse-width and frequency. In ~.2Z~ Jo the illustrated circuitry 50, the actable multi vibrator 52 produces a series of square pulses at an amplitude of about 6 volts and a frequency of about 30 to 33 Ho, and the monostable multi vibrator 54 serves to shape the 5 pulses to a presently preferred width of 500 microsec-onus.

The principal components of the illustrated actable and monostable multi vibrators 52, 54 are commercially 10 available integrated circuits. The integrated circuit 64, for example, in Figure 3, and the other integrated circuits labeled "Icily" and "ISSUE," may be CMOS No.
4011 integrated circuits available from numerous menu-lecturers, including, among others, RCA, Texas Incitory-15 mint Corp., National Semiconductor, and Solid State Scientific. All of the other components in the thus-treated circuitry 50 are also commercially available items. The NUN transistor 66 used in the inventor circuit 58 may be of the ON 3904 type. The PUP tray-sister 68 in the inventor circuit 60 may be of the ~N3906 type. The NUN transistor 70 in the emitter-follower 62 may also be of the ON 3906 type.

Operation of the switch 72 applies to the actable multi vibrator 52, monostable multi vibrator 54, and other aspects of the circuitry 50, the logic voltage supply. An output pulse will be repetitively supplied during the time in which the circuitry 50 is so power-Ed In other words, output is enabled by closing of the switch 72, and inhibited when the switch 72 is open. The output of the circuitry illustrated in Figure 3 may be applied to the connector 38, and through the connector 38 to the electrodes 14, 18, 20 and 24. The switch 72 enables the glove 12 to be used for palpation or to be otherwise positioned with assure ante that the circuitry 50 is inhibited, thus elimina-Ski tying undesirable effects such as untimely or unwanted stimulation affecting extraneous tissues. In the circuitry 50, when the output pulse is inhibited, the output is zero volts. When the output is enabled, the S actual output level is a function of the voltage of the stimulating voltage supply. In one operative embody-mint, the stimulating voltage supply provides about twenty-four volts, and the output is within 0.5 volts of this voltage and substantially constant for 500 10 microseconds when driving a 330 ohm load.

The present invention may be embodied in other specific forms without departing from its spirit and essential attributes and, accordingly, reference should be made 15 to the appended claims rather than the foregoing specs ifications as indicating the scope of the invention.

Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. Apparatus for selectively transferring electrical energy to and from critical localities in living tissue for diagnostic purposes, comprising a glove of flexible fluid impervious elastomeric material, said material being suf-ficiently thin and flexible to afford to the wearer sub-stantially unimpeded feel and manual dexterity so as to enable use of said glove for digital palpation while trans-ferring energy to and from tissue, an electrode affixed to the index finger of said glove and covering the area of the glove beneath the tip of the distal phalange of the index finger of a wearer of said glove, thereby to facilitate application of said electrode directly to a palpated locality of tissue, a second electrode disposed adjacent to the tip of the thumb of said glove, an electrical connector coupled to said glove and adapted to be electrically connected to elect-rical circuitry external to said glove, and a plurality of flexible electrical conductors adhesively coupled to said glove and electrically connecting said electrodes and said connector.

2. Apparatus in accordance with claim 1, wherein said electrodes and said conductors comprise flexible films of electrically conductive material affixed to the surface of said glove.

3. Apparatus in accordance with claim 1, and a third electrode affixed to the middle finger of said glove and covering an area on said middle finger beneath the tip of the distal phalanges of the middle finger of a wearer, thereby to facilitate the application of said last-mentioned electrode directly to a locality palpated by said middle finger.

4. Apparatus in accordance with claim 3, wherein said electrodes and said conductors comprise flexible films of electrically conductive material affixed to the surface of said glove.

5. Apparatus in accordance with claim 4, wherein port lions of said conductors extend along the fingers of said glove, said portions being so disposed on the fingers as to be adjacent a medial plane passing laterally through the fin-gets, so that stretching of said conductors is minimized, and insulating means overlying said conductors.

6. Apparatus in accordance with claim 1, and a third electrode on said index finger of said glove, said third electrode being disposed approximately beneath the joint between the middle and proximal phalanges of the index finger of a wearer, thereby to facilitate the application of pressure by said joint.

7. Apparatus in accordance with claim 6, wherein said electrodes and said conductors comprise flexible films of electrically conductive material affixed to the surface of said glove.

8. Apparatus in accordance with claim 7, wherein port lions of said conductors extend along the fingers of said glove, said portions being so disposed on the fingers as to be adjacent a medial plane passing laterally through the fin-gers, so that stretching of said conductors is minimized.

9. Apparatus in accordance with claim 1, and a third electrode on the index finger of said glove, said third elec-trode being disposed beneath the joint between the middle and proximal phalanges of the index finger of a wearer, thereby to facilitate the application of pressure on said third elec-trode by said joint, and a fourth electrode affixed to the middle finger of said glove and covering an area thereon beneath the tip of the distal phalange of the middle finger of a wearer, thereby to facilitate the application of said last-mentioned electrode directly to a locality palpated by said middle finger.

10. Apparatus in accordance with claim 9, wherein said electrodes and said conductors comprise flexible films of electrically conductive material affixed to the surface of said glove.

11. Apparatus in accordance with claim 10, wherein por-tions of said conductors extend along the fingers of said glove, said portions being so disposed on the fingers as to be adjacent a medial plane passing laterally through the fin-gers, so that stretching of said conductors is minimized.

12. Apparatus in accordance with claim 11, wherein said electrical connector is coupled to said glove adjacent to the cuff.