Abstract: An electrical nerve and an electrical muscle stimulation device used in association with a support unit. The stimulation device is adaptable to be selectively engageable with a plurality of different body braces such that output connectors associated with the stimulation device electrically contact keyed connectors associated with a mounting carrier secured to the particular support unit. The support means includes at least two electrode pads which are selectively positionable at different locations on the support means. The connection between the output connectors of the stimulation device and the keyed connectors applies a stimulation signal to the electrode pads the size of which determines the carrier frequency of the stimulation signal which is impedance matched to the electrode size.

Abstract: A simple and reliable system for anchoring a lead to the sacrum. The system provides a pliant slid-on anchoring sleeve featuring a suturing groove for lead fixation and a base having screw tabs for anchoring the sleeve and thus the lead to the sacrum. The base is reinforced, preferably through a mesh, to prevent tearing caused by screw forces. In addition an elongate washer may be further used in conjunction with screws to anchor the system to bone.

Abstract: A bracelet comprising at least one band of physiologically compatible material deformable elastically in a direction perpendicular to the band, which is preloaded in the form of a C, and presents a first arm fitted with an electrode having a pad, and a second arm with nonslip means, e.g. in the form of ribs or teeth. The bracelet is fitted on to the limb by parting the arms of the band, the residual elastic deformation of which exerts such pressure on the electrode as to hold it in place contacting the skin. At the same time, the nonslip means produce a temporary impression in the skin, for preventing both axial and angular slippage of the bracelet in relation to the limb.

Abstract: A wearable iontophoresis system includes a control housing having a connector and an iontophoretic drug delivery patch for placement against the skin of a patient. The patch has a device for retaining the control housing connector which permits the connector to be removably attached to the patch. The control housing also has at least a power supply device and a current delivery device. The control housing has top and bottom surfaces wherein the top surface has raised, recessed and sloping regions. The thickness of the connector is tapered from a second end to a first end. Furthermore, the second end of the connector is attached to the control housing and oriented so that the first end is unattached to the control housing and proximate to the control housing bottom surface. The iontophoretic drug delivery patch includes top and bottom surfaces wherein mounted to the top surface is the device for retaining the control housing connector.

Abstract: A medical electrode system includes an electrically non-conductive backing material and a flexible, electrically conductive patch disposed on the backing material. An electrically non-conductive facing material is disposed over the patch which includes an aperture therein for exposing a portion of the patch, said aperture having a maximum dimension smaller than a minimum dimension of the patch. A lead wire electrically connected to the patch, and a separate electrically conductive gel pad is provided for releasably coupling the patch to a body part, the gel pad having a minimum dimension larger than the aperture's maximum dimension and formed from a material enabling the gel means to be removed, intact, from said body part and patch. The gel pad may further include a drug suitable for iontophoretic delivery. A strap system enables the patches and backing material to be applied in a compressing manner on a body part and in one embodiment, the entire system is both stretchable and flexible.

Abstract: An electrotransport drug delivery device (1) including a reusable component (2), a disposable component (4), and a removable liner (8) temporarily separating the mating surfaces of the components (2,4) during alignment and assembly of the components (2,4). At least one of the components (2,4) has an adhesive mating surface (11) facing the removable liner (8). Also disclosed are a disposable assembly (4) for an electrotransport device (1) and a method for assembling reusable and disposable components (2,4), the components (2,4) of the electrotranport device assembly (1) are adhesively mated.

Abstract: In the invention, at least one electrode is placed in contact with a user's skin such that it transmits electric impulses produced by a current generator to the skin. The support comprises a projecting support element, supporting two electrodes rotatably connected to the belt device such as to rotate with respect to the belt device, so that the electrodes can be positioned longitudinally or transversally to the device, correspondingly to the development direction of a muscle to be stimulated.

Abstract: A hydrophilic, pressure-sensitive adhesive composition prepared by irradiating solid poly(N-vinyl lactam) with ionizing radiation to crosslink the poly(N-vinyl lactam) and thereafter mixing the radiation-crosslinked poly(N-vinyl lactam) with essentially unirradiated plasticizer in an amount sufficient to form a cohesive, pressure-sensitive adhesive composition. The composition is useful as a biomedical adhesive for transmitting or receiving electrical signals as a component of a biomedical electrode. The composition is also useful as a drug delivery device to deliver pharmaceuticals or other active ingredients to or through mammalian skin. The composition is also useful as a component in a skin covering for protecting mammalian skin or mammalian skin openings with antimicrobial agents. A method of preparation of the composition is also disclosed.

Abstract: An electrode having an extremely low profile and suitable for disposable use includes a base sheet constructed of a flexible conductive polymer. A tab is laminated to the top of the base sheet to form a pocket between the tab and the base sheet extending along the base sheet for receiving a hook connector. The hook connector has a bill and shank joined by a bend, the bill fitting between the pocket and the shank lying on top of the tab when the bill is so engaged to allow a low profile connection to the electrode. The elimination of rigid parts from the electrode improves its comfort and functionality.

Abstract: A water-degradable electrode, its method of preparation and a method or reclaiming valuable metal or metal alloy from such water-degradable electrode after use are provided. The water-degradable electrode contains a water-degradable, electrically nonconductive substrate and a nonphotosensitive, electrically conductive layer containing a metal or metal alloy. The metal- or metal-alloy-containing, nonphotosensitive, electrically conductive layer is disposed on the water-degradable nonconductive substrate. After the electrode has been used, the nonphotosensitive, electrically conductive material can be reclaimed by degrading in water the electrically nonconductive substrate on which the conductive material is disposed.

Abstract: An iontophoretic device having a two-layer active electrode element is disclosed. The active element is composed of overlapping skin contact hydrogel and carrier layers. The carrier layer contains dispersed or dissolved active agent. The active electrode element maintains the active agent in stable form and permits efficient transport of the active agent to the host. Also disclosed is an iontophoretic device having a single layer active electrode element. The single layer is a hydrogel as manufactured or substantially dry and capable of being hydrated before use. The skin contact hydrogel of the two-layer active electrode element preferably.

Abstract: Improved methods of ionophoretic drug delivery are described. By the intentional selection of drug(s) with specific characteristics, of ionotophoresis device, components or both permits the efficiency of drug delivery is increased.

Abstract: A disposable biomedical electrode having a one-piece terminal secured therein without washers, retaining rings or other securement means is provided. The electrode also includes an electrolytic gel which exhibits greater patient comfort without any decrease in electrical performance. The gel layer is preferably a hydrogel material formed from an aqueous mixture of polyhydric alcohol, aliphatic diisocyanate terminated prepolymer, polyethylene oxide based polyamine, and sodium chloride.

Abstract: An electrically powered iontophoretic delivery device is provided. The device utilizes electrodes composed of a preferably hydrophobic polymeric matrix. The matrix contains about 10 to 50 vol % of a material capable of absorbing a liquid solvent, typically water, to provide a plurality of ion conducting pathways through the matrix. The matrix also contains about 5 to 40 vol % of a chemical species which is able to undergo either oxidation or reduction during operation of the device. Preferably, the solvent absorbing material is a hydrophilic polymer such as polyvinylpyrrolidone. For the anodic electrode, the chemical species should be able to undergo oxidation and is preferably either silver or zinc. For the cathodic electrode, the chemical species should be able to undergo reduction and is preferably silver chloride or a reducible metal.

Abstract: The specification discloses a medical electrode particularly well suited for use as a diagnostic or monitoring electrode wherein conductive elements comprising a gel layer and a conductive bridge are intimately mounted on the adhesive top surface of a carrier layer, which includes an opening of dimensions similar to but smaller than the gel layer. A top layer, of at least equal surface area, is also affixed to the adhesive top surface of the carrier layer, sandwiching the indicated conductive elements between the top layer and the carrier layer such that the gel layer is exposed to a patient's skin but cannot be removed from the electrode. An electrically conductive contact means is provided to connect the conductive bridge to the desired monitoring/diagnostic apparatus. The carrier layer also includes an adhesively coated undersurface, which attaches to a patient's skin.

Abstract: An electrotherapy device for delivering electrical energy to subcutaneous, excitable tissues in and around the joints of the human body for the purposes of pain control and the promotion of tissue healing post injury is provided. The device includes a housing containing at least one pair of electrodes connected to an electronics unit. The device is specifically designed to be small, potable and lightweight so as to not interfere with user movements and/or function. The electronics unit consists of a housing that contains batteries, a microcontroller integrated circuit (including associated control software) coupled to a transistor-based intensity stage, which is then coupled to a transformer-based output stage coupled to subminiature jacks used to connect the electronics unit to the electrodes. Control software monitors user-controlled mechanical switches for the selection of one of six operational modes (TENS, MENS, or iontophoresis) and one of six discrete intensity levels within each operational mode.

Abstract: An electrical circuit (21) for an electrotransport agent delivery device (10), and a method for making same, is provided. The circuit (21) generally includes a plurality of electrically conductive circuit traces (71-77) deposited on a substrate (42). One or more electrical circuit components (61-63), such as batteries, resistors, capacitors and/or transistors, is mounted on the substrate (42) and are electrically connected to the circuit traces (71-77), using an electrically conductive adhesive. The circuit traces (71-77) and the adhesive contain an electrically conductive filler which renders the traces and the adhesive electrically conductive. Preferably, the electrically conductive filler is a material which is relatively non-toxic, such as silver, carbon and/or graphite. The electrical circuit components (61-63) may be connected to the circuit traces (71-77) using automated component attachment procedures.

Abstract: An improved electrode is disclosed for use in administering drug by means of iontophoresis, comprising a conductive element for receiving an electric current from a current source; a reticulated element having a plurality of reticulum for receiving an ionic drug solution for iontophoretic delivery, the reticulum being loaded or having applied thereto a hydrophilic polymer which is viscous when hydrated; and means for securing the reticulated element to the conductive element so that electric current will be distributed substantially uniformly through the reticulated element when hydrated and when current is delivered to the conductive element. The presently preferred embodiment utilizes open cell polyurethane foam as the reticulated element and high molecular weight polyethylene oxide as the hydrophilic polymer. The reticulum is further loaded with Tween 20, a surfactant, which serves to improve the rate of hydration.

Abstract: An electrophoretic/electro-osmotic transdermal drug delivery system for passing at least one drug, or therapeutic compound, through the skin membrane of a patient by way of a drug reservoir or gel for delivery to the systemic blood of a patient in selected, periodic pulsations. The system can be varied to accommodate various types of therapeutic compounds having varied characteristics and purposes. The system includes a current oscillator that applies periodic electrical variations to the system in order to trigger rhythmical variations of the potential and resistance of the skin membrane so as to cause oscillatory electro-osmotic streaming of the liquid with the therapeutic compound across the skin membrane in synchronization with the oscillator to the systemic blood of the patient in response to the rhythmical variations.

Abstract: A novel biomedical electrode comprising 1) a non-conductive backing layer with instructions printed on one surface, 2) an ink layer having either a) an ink comprising silver and silver salt, or b) a blend of inks including a first ink comprising silver and silver salt and a second ink comprising an inert carbon based material printed in a pattern onto the second surface of the non-conductive backing layer, 3) a conductive-adhesive electrolyte layer coated directly onto the inked surface of the non-conductive backing layer, and 4) a protective release liner which covers the conductive adhesive layer. Certain preferred embodiments correspond to situation wherein the body parts being monitored display diverse impedances. In those embodiments, parameters such as ink blend, ink amount (i.e., ink thickness and ink pattern) are varied in order to vary the impedance of a given electrode.

Abstract: An improved method and apparatus for stimulating the growth and healing of living, especially human, tissues, promoting the healing of wounds and skeletal fractures. An electrical apparatus consists of a baseplate, made of lightweight nonconductive material, for encompassing all or a portion of a body member. A multiplicity of generally evenly spaced holes are provided in the baseplate and a probe adapter including a moveable electrically conductive probe is situated within the holes, as desired. An electric contact connects the interior of each adapter and the probe situated therein to a terminal on the baseplate. Each probe is individually adjustable to contact the wearer's body part within the base member regardless configuration of the body part, thus allowing treatment of all or a selected portion of the body part.

Abstract: A biosignal electrode 10 which comprises a flexible substrate 1 having an obverse side and a reverse side, the obverse side having printed thereon an electrically conductive layer 2 comprising an ink having electrically conductive particles or mixture of particles therein, the layer in plan comprising a first or sensor end 11, a second or connecting end 12 and an interconnecting portion 13, and the sensor end in plan resembling a hollow figure.

Abstract: An electrical stimulation heat/cool pack includes a nonconductive pouch and straps for positioning and holding the nonconductive pouch against a body part. Flexible conductive fabric patches may be removeably attached, or permanently fixed, to the nonconductive pouch along with lead wires for electrically connecting the fabric patches to a remote pulse generator. An electrically conductive adhesive gel pad is provided for releasably coupling the flexible conductive fabric patch to the body part.

Abstract: An electrode for providing TCET, especially via the earlobes of the patient, comprises an electrical conductor for application to the skin, connected to a lead for supplying the TCET signal from a signal generating device, characterized in that the conductor comprises a generally conical needle point capable of penetrating the epidermis so as to provide good electrical contact over a very small area. The electrode can be used in the impedance of less than 100 k.OMEGA.; and with apparatus for generating an electrical signal for use in TCET, adapted to provide a signal at a current of less than 200 .mu.A (0.2 mA), especially when adapted to provide an AC signal in which each positive pulse is relatively short and high without being spiked and the following negative pulse is relatively wide and low, the total amount of positive and negative charge being balanced. Methods of providing TCET treatment to patients using the electrode and apparatus are also provided.

Abstract: A device for generating hand function, having an S-type splint consisting a forearm portion extending along the palmar side of the forearm, a palmo-dorsal transition portion leading to a dorsal portion extending across the dorsal side of the carpal bones of the hand, and a palmar portion, at least the end of which touches the palm of the hand of the wearer of the device at least indirectly, and a plurality of electrodes, at least indirectly mounted on the splint in positions in which they can make contact with skin portions directly overlying muscles to be stimulated. The electrodes are connectable to an electronic circuit adapted to produce, upon activation, stimulation currents delivered via combinations of the electrodes in predetermined, timed sequences to preselected groups of muscles. At least one switch is actuatable by the wearer of the device, by which switch the predetermined, timed sequences can be initiated.

Abstract: A hydrogel matrix is provided for a multipupose medical electrode having an electrically conductive backing. The matrix comprises a dispersion of a natural or a synthetic hydrophilic polymer, e.g., polyacrylamide, polyacrylic acid, modified starch, or gum karaya, gum acacia, locust bean gum or the like, water, and a humectant such as triethylene glycol or glycerol. The matrix is a flexible sheet having a tacky lower surface for establishing a bond to provide electrical contact with the skin of a patient. The matrix has a resistivity greater than the resistivity of the electrical conductive backing and includes a gelation inhibitor such as a salt of a weak acid, e.g., Mg(OAc).sub.2 uniformly distributed within the matrix in an amount sufficient to retard gelation of the matrix prior to forming the matrix into a flexible sheet.

Abstract: An iontophoretic agent delivery device having donor and counter electrodes comprised of either metal or a hydrophobic polymer loaded with a conductive filler is provided. The agent reservoir in the donor electrode assembly contains about 10 to 60 wt. % hydrophobic polymer, about 10 to 60 wt. % hydrophilic polymer, and up to 50% agent. Similarly, the electrolyte reservoir contains about 10 to 60 wt. % hydrophobic polymer, about 10 to 60 wt. % hydrophilic polymer, and up to 50% electrolyte. The agent reservoir, the electrolyte reservoir and the electrodes are preferably in the form of films which are laminated to one another. The hydrophobic polymer component in the agent/electrolyte reservoir prevents the reservoir from delaminating from the metal/hydrophobic polymer based electrode, even after hydration of the reservoirs.

Abstract: The present invention provides an iontophoretic drug delivery device having electrode renewing features includes a housing having a first electrode, a second electrode, a circuit for providing electrical communication between the first and second electrodes. The circuit is capable of engaging a source of current. Control means is provided for effecting the amount of current passing between the electrodes. A removable electrolyte reservoir is capable of holding electrolyte and removably engaging the housing so that one of the electrodes can contact electrolyte contained within the reservoir. A removable active agent reservoir is capable of holding an active agent for iontophoretic delivery. The active agent reservoir is capable of removably engaging the housing so that the active agent contacts one of the electrodes.

Abstract: An iontophoretic agent delivery device having a simplified structure and ease of manufacture. The device utilizes an electrical pathway comprising a source of electrical energy and an output means. The electrical pathway is disposed upon one of the two sides of a flexible, non-conductive substrate (e.g., a film). The output means of the pathway are connected directly or indirectly, e.g., by means of an electrically conductive adhesive tape, to the remaining components of the device such as current distribution members, lead wires, or electrodes. In this arrangement, the circuit is inverted from that of conventional devices. Economical, reel-to-reel methods of manufacturing a one-sided iontophoretic circuit apparatus of the invention are disclosed.

Abstract: An electrophoretic/electro-osmotic transdermal drug delivery system for passing at least one drug, or therapeutic compound, through the skin membrane of a patient by way of a drug reservoir or gel for delivery to the systemic blood of a patient in selected, periodic pulsations. The system can be varied to accommodate various types of therapeutic compounds having varied characteristics and purposes. The system includes a current oscillator that applies periodic electrical variations to the system in order to trigger rhythmical variations of the potential and resistance of the skin membrane so as to cause oscillatory electro-osmotic streaming of the liquid with the therapeutic compound across the skin membrane in synchronization with the oscillator to the systemic blood of the patient in response to the rhythmical variations.

Abstract: An iontophoresis system includes an iontophoretic drug delivery device for placement against the skin of a patient and having a pair of electrodes, and a circuit for delivering and controlling the current and voltage provided to the electrodes. The current and voltage controlling circuit includes a power supply for generating a voltage or current, an intermediary storage device and a first switching circuit interposed and coupled to the power supply and the intermediary storage device. The intermediary storage device is selectively coupled to the drug delivery device through a second switching circuit or device. Energy from the power supply is transferred and stored in the intermediary storage device for later delivery to the transdermal drug delivery device. In this way, should a component of the circuit fail, the energy or power delivered to the drug delivery device is interrupted or maintained at least equal to a predetermined safe level to avoid damage or injury to the patient's skin.

Abstract: An iontophoretic agent delivery device, having a layered structure and peripheral insulation, wherein ion transport occurs through two opposing surfaces of said device. The device is especially suited to agent delivery through body surfaces exposed to body fluids. A method of delivering an agent through a body surface exposed to body fluids is also disclosed.

Abstract: A hydratable iontophoretic bioelectrode includes a plurality of layers of material capable of absorbing and holding an ionized fluid when placed in contact with the fluid. Adjacent layers are maintained at least partially out of contact from one another by disposition between the layers of spacing elements such as sugar or other dissolvable particles or cellulose. The edges of the layers may be crimped to maintain the layers in a stack for assembly with an electrode sheet; such a sheet would be provided for receiving an electrical current to thereby produce an electric field and cause a migration of ions of the ionized fluid away from the electrode sheet and into the skin or tissue of a person or animal against which the bioelectrode is placed.

Abstract: A transdermal drug delivery device includes a liquid reservoir for a liquid drug to be delivered, and a drug delivery body which includes a plurality of tubular elements extending through the body, each having an inlet end communicating with the liquid reservoir, and an outlet end engageable with the subject's skin to conduct the liquid drug directly to the subject's skin.

Abstract: One aspect of the invention is a cooling pillow comprising a flexible pouch and thermal transfer fluid composition hermetically filled in the pouch. A second aspect of the invention is a cooling device which comprises a pad having a flexible pouch and a thermal transfer fluid composition hermetically filled in the pouch, and means for holding the pad therewith to bring the pad in contact with the human body. The fluid composition comprises a mixture of fine particles of hard or graphitic carbon having good thermal conductivity and water. Sodium chloride, surface active agents, bactericides and preservatives may be further added to the composition. Since the carbon particles have good thermal conductivity, the fluid readily reaches a temperature close to ambient temperatures and can gently cool the human body. Long use allows the body to be continuously cooled down to a temperature close to the ambient temperature.

Abstract: An electrode system includes a nonconductive material and straps for positioning and holding the nonconductive material against a body part. Flexible conductive fabric patches are attached to the nonconductive material along with lead wires for electrically connecting the fabric patches to a remote monitor or pulse generator. An electrically conductive adhesive gel pad is provided for releasably coupling the flexible conductive fabric patch to the body part. The pad is selectively removable from the fabric patch, enabling removal of the patch from the gel pad while the latter remains adhered to a body part. This facilitates release of the conductive fabric patch and separate disposal of the adhesive gel pad.

Abstract: A disposable electrode for use in electromyography and/or nerve conduction velocity testing has a tab for connection to a cable connector and is laminated of a plurality of layers including first and second outer layers. The first layer is a backing member with exposed adhesive, a hydrogel layer intermediate the outer layers and a conductive foil layer between the hydrogel layer and the second outer layer. The electrode may be a disc electrode, a ground electrode or an elongated flexible digital ring electrode. The disc electrode includes two identical disc electrode elements having circular portions separably joined to each other at a central portion and the tab of each element is remote from the central portion. A kit contains a plurality of disposable electrodes packaged in a blister pack, the packaged electrodes including a plurality of such disc electrodes, a plurality of such ground electrodes and a plurality of such elongated flexible digital ring electrodes.

Abstract: A biphasic power source for use in an iontophoretic system, which system includes a transdermal drug delivery device attachable to a patient and having a positive electrode and a negative electrode, includes a constant current source and a voltage limiting circuit. The constant current source has two outputs and provides a constant current on the outputs. The outputs are connected to the positive and negative electrodes of the transdermal drug delivery device. The voltage limiting circuit is connected in parallel with the outputs of the constant current source to limit the voltage across the electrodes to a predetermined voltage. The voltage limiting circuit may be a zener diode.

Abstract: A multiple site drug iontophoresis electronic device configured for controlling infusion of ionic drugs into a patient through a plurality of electrode pairs. The device includes a plurality of electrode driver channels wherein each driver channel includes an electrode output configured for electrical connection to at least one of the plurality of electrode pairs through lead wires. Each driver channel is electrically isolated from the other driver channels and includes an independent current sink which controls current intensity through the electrode output. A common controller operates the driver channels as a function of treatment parameters supplied by the patient.

Abstract: An iontophoretic bioelectrode includes an enclosure forming upper sheet of material having a generally planar outer section circumscribing a raised central section which defines an interior compartment. A compliant, resilient and sticky raised barrier is formed on the underside of the outer section of the upper sheet of material to circumscribe the central section. When placed against the skin of a person, the barrier adheres to the skin to form a seal completely around the central section and interior compartment into which an ion carrying solution may then be introduced for administration, by iontophoresis, into a persons' skin.

Abstract: A two phase adhesive matrix for use in an electrically powered iontophoretic delivery device is provided. The adhesive matrix comprises an adhesive hydrophobic polymer phase and about 15 to 60 wt % on a dry weight basis of a hydrophilic polymer phase distributed through the hydrophobic polymer phase. The hydrophilic phase forms upon hydration an interconnecting network of aqueous pathways for passage of the agent through the adhesive. The adhesive can be used to adhere an electrode assembly of an iontophoretic delivery device to a body surface such as skin or a mucosal membrane. Alternatively, the adhesive can be used to adhere together two or more elements of an iontophoretic delivery device.

Abstract: A hydratable iontophoretic bioelectrode includes a plurality of layers of material capable of absorbing and holding an ionized fluid when placed in contact with the fluid. Adjacent layers are maintained at least partially out of contact from one another by disposition between the layers of spacing elements such as sugar or other dissolvable particles or cellulose. The edges of the layers may be crimped to maintain the layers in a stack for assembly with an electrode sheet; such a sheet would be provided for receiving an electrical current to thereby produce an electric field and cause a migration of ions of the ionized fluid away from the electrode sheet and into the skin or tissue of a person or animal against which the bioelectrode is placed.