KR20080101931A - Method of routing electrical current to bodily tissues via implanted passive conductors - Google Patents

Abstract

The invention provides an implant, system and method for electrically stimulating a target tissue to either activate or block neural impulses. The implant provides a conductive pathway for a portion of electrical current flowing between surface electrodes positioned on the skin and transmits that current to the target tissue. The implant has a passive electrical conductor of sufficient length to extend from subcutaneous tissue located below a surface cathodic electrode to the target tissue. The conductor has a pick-up end which forms an electrical termination having a sufficient surface area to allow a sufficient portion of the electrical current to flow through the conductor, in preference to flowing through body tissue between the surface electrodes, such that the target tissue is stimulated to either activate or block neural impulses. The conductor also has a stimulating end which forms an electrical termination for delivering the current to the target body tissue.

Description

METHOOD OF ROUTING ELECTRICAL CURRENT TO BODILY TISSUES VIA IMPLANTED PASSIVE CONDUCTORS}

The present invention is directed to implants, systems, and methods for treating diseases of the nervous system of a subject. The method includes using a passive electrical conductor that delivers a current to electrically stimulate the target body tissue to activate or block nerve excitability depending on the treatment frequency and disease.

Neurons consist of axons for delivery activity potentials or nerve excitation and dendrites to receive such excitation. In general, nerves carry an action potential from the excitatory-transmitting axon of one neuron to the excitatory-receiving dendrites of adjacent neurons. In synapses, axons secrete neurotransmitters to trigger receptors in the next neuronal dendrites to initiate new currents.

In some pathological conditions, the transfer of active potentials is weakened; Therefore, activation of nerve excitability is required to restore general functionality. Electrically exciting body tissues such as nerves and muscles can be activated by an electric field supplied between electrodes supplied from the outside to the skin. Current flows through the skin between the cathode active and anode electrodes, inducing active potentials in the nerves and muscles under the electrodes. These methods include transcutaneous electrical nerve stimulators (TENS) to relieve pain, therapeutic electrical stimulators to activate muscles for athletic purposes (Vodovnik, 1981), and functional electrical stimulators to activate muscles for daily performance. (Kralj et al., 1989; US Pat. No. 5,330,516 to Nathan; US Pat. No. 5,562,707 to Prochazka et al.) And other types of stimulators, including stimulators that promote regeneration of damaged bone, have been used for a long time. .

In other pathological conditions, the action potentials are delivered unsuitable for useful purposes; Thus, blocking of unnecessary nerve excitability is required to restore normal function. It has been reported that it can produce transient reversible blockade of high frequency neural axons (Solomonow et at., 1983; Tai et al., 2004; Bhadra and Kilgore, 2005). In general, the frequency range is between 500 and 30,000 Hz.

Stimulation of nerves to activate or block nerve excitability is commonly accomplished using implanted stimulators (also known as neurological implants or neuroprostheses) (Peckham et al., 2001; Horch and Dhillon, 2004). Neural implants have been developed for the restoration of hearing, restoring movement of paralyzed muscles, regulating activity in nerves regulating urinary tract function and suppressing pain and tremor. In some cases, nerve implants have been designed to inhibit or inhibit unwanted neuronal activity, for example to inhibit pain sensation or progression. However, all neural implants intended for long-term use require implantation of stimulators that include electronic components and often batteries. In the case of pain and tremor suppression, the activated nerves reactively inhibit the activity of neural circuits in the central nervous system. This non-indirect mode of reducing unwanted neuronal activity is sometimes named neuromodulation (Landau and Levy, 1993; Groen and Bosch, 2001).

Surface electrical stimulation is used reactively, for example, to reduce convulsive hypertension (Vodovnik et al., 1984; Apkarian and Naumann, 1991). A disadvantage of stimulation via electrodes attached to the body surface is that many non-target deposits can be co-activated with the target tissue. This lack of selectivity often results in unwanted sensory and / or unwanted movement. In addition, since most of the current between the electrodes flows through tissue closer to the electrode than the target tissue, it is difficult or impossible for the tissue deep within the body to be properly stimulated. Selectivity can be improved by implanting wires in the body that carry current from the stimulator to near the target tissue. These methods include pacemakers (Horch et al, 2004), dorsal column stimulators (Waltz, 1997), deep brain stimulators (Benabid et al., 1987), and sacral root stimulators (Brindley). et al., 1982). Cuffs containing uninsulated distal wire can be located around the peripheral nerve, limiting most of the current near the nerve and limiting the expansion of the current around the tissue to improve selectivity (Haugland et al., 1999). In general, when wires were implanted, stimulators complete with energy sources were also implanted (Strojnik et al., 1987). Implanted stimulators are expensive and often require a regulator and / or power source externally to the body. Batteries in implanted stimulators require periodic replacement with surgery.

In a few cases, the stimulation wire was implanted through the skin (transdermally) into body tissues and legs with connectors attached to the surface of the body to which the external stimulator was attached (Peckham et al., 1980; Handa et al., 1998; Shaker and Hassouna, 1999; Yu et al., 2001). External stimulators are considerably cheaper than implanted stimulators, but percutaneous wire provides a conduit for infection and therefore needs to be cleaned and maintained daily. This is generally limited to the use of transdermal electrodes for short term applications. There is a need for a system that solves these problems and has the ability to activate or block nerve excitation depending on the condition being treated.

FIELD OF THE INVENTION The present invention relates to implants, systems, and methods that employ passive electrical conductors that deliver electrical currents that electrically stimulate target body tissue to activate or block nerve excitability depending on the frequency and disease to be treated broadly.

In one aspect, the present invention provides an implant for electrically stimulating a subject's target body tissue extensively, wherein once implanted, the implant is a surface cathode located in a spaced relationship on the subject's skin and At least a portion of the current flows between the anode electrodes to provide a conductive path for delivering a portion of the current to the target body tissue, the implant comprising:

Once implanted, a passive electrical conductor of sufficient length to extend from the subcutaneous tissue located below the surface cathode electrode to the target body tissue, the electrical conductor is insulated between these ends with a pick-up end and a pole end, The pick-up end consists of an electrical termination with an appropriate surface area that allows for an appropriate portion of the current flowing through the conductor, preferably flowing through body tissue between the surface cathode and anode electrodes, as the target body tissue is stimulated, The distal end is formed by an electrical termination for transporting a portion of the current to the target body tissue.

In another aspect, the present invention provides a system for electrically stimulating a target body tissue of a subject comprising the implant in combination with:

Surface cathode and anode electrodes for making electrical contact with the skin of the test subject, when placed in a spaced relationship on the skin of the test subject, which delivers current to the target body tissue; And

A stimulator or stimulator outside the body of the test subject electrically connected to the surface cathode and anode electrodes transports direct current, pulsating current, or alternating current to the surface cathode and anode electrodes.

In another aspect, the present invention provides a method of electrically stimulating target body tissue in a subject, comprising the following steps:

Providing the implant;

Implanting the implant completely under the skin of the subject having a pickup end located in the subcutaneous tissue located below the cathode electrode and a stimulus end located near the target body tissue;

Allows a portion of the current to pass through the conductor to the target body tissue, and the current flows through the target body tissue through an implanted electrical return conductor extending between the target body tissue and the subcutaneous tissue located below the surface anode electrode or the body. Positioning the surface cathode and anode electrodes located in a spaced apart relationship on the subject's skin with the surface cathode electrode located across the pick-up end of the electrical conductor to return the anode surface electrode through the tissue; And

Applying a direct current, pulsating current or alternating current between the surface cathode electrode and the surface anode electrode to allow a portion of the electrical current to flow through the implant suitable for stimulating the target body tissue.

In another aspect, the invention broadly provides an implant for electrically stimulating a subject's target body tissue, and once implanted, the implant is present between the surface cathode and anode electrodes located in a spaced apart relationship on the subject's skin. At least a portion of the flow provides a conductive path for delivering a portion of the electrical current to the target body tissue, the implant comprising:

Once implanted, a passive electrical conductor of sufficient length to extend from the subcutaneous tissue located below the surface cathode electrode to the target body tissue, the electrical conductor is insulated between these ends with a pick-up end and a pole end, The pick-up end consists of an electrical end with an appropriate surface area that allows a suitable portion of the current to flow through the conductor, preferably flowing through body tissue between the surface cathode and anode electrodes, and the pole end of the current to the target body tissue. Formed with electrical terminations for transporting parts,

This allows the implant to electrically block the target body tissue when the current is in the form of a cyclical waveform applied at a frequency that can block the target body tissue.

In another aspect, the present invention provides a system for electrically blocking target body tissue of a subject, comprising:

i) target cathode and anode electrodes that are in electrical contact with the subject's skin when positioned in a spaced relationship on the subject's skin to allow current to be delivered to the target body tissue;

ii) a stimulator external to the subject's body in electrical contact with the surface cathode and anode electrodes, the stimulator supplies direct current, pulsating current or alternating current to the surface cathode and anode electrodes; And

iii) Implants to capture a portion of the current flowing between the surface cathode and anode electrodes and allow a portion of the current to be delivered to the target body tissue, since the implant extends from the subcutaneous tissue located below the surface cathode electrode to the target body tissue. Once implanted, a passive electrical conductor of sufficient length, the electrical conductor having a pick-up end and a pole end, insulated between these ends, the pick-up end allowing a proper ratio of current to flow through the conductor. Preferably an electrical termination having an appropriate surface area for flowing through body tissue between the surface cathode and anode electrodes, the pole end forming an electrical termination for transporting a portion of the current to the target body tissue,

This allows the implant to electrically block the target body tissue when the current is in the form of a circulating waveform applied at a frequency that can block the target body tissue.

In another aspect, the present invention provides a method for treating a subject's disease comprising the following steps:

a) providing an implant acting as a conductive pathway to allow at least some of the current to flow between the surface cathode and the anode electrode located in a spaced apart relationship on the subject's skin, the implant being once implanted, the surface cathode electrode A passive electrical conductor of sufficient length to extend from the underlying subcutaneous tissue to the target body tissue, the electrical conductor having a pick-up end and a pole end, insulated between these ends, the pick-up end being a conductor Consisting of an electrical termination having an appropriate surface area to allow an appropriate portion of the current to flow through, preferably flowing through the body tissue between the surface cathode and anode electrodes, as the target body tissue is stimulated, the stimulus end being the target body Formed as an electrical termination for transporting a portion of the current to the tissue;

b) implanting the implant completely under the skin of the subject having a pickup end located in the subcutaneous tissue located below the cathode electrode and a stimulus end located near the target body tissue;

c) allowing a portion of the current to pass through the conductor to the target body tissue and through an implanted electrical return conductor extending through the target body tissue and between the target body tissue and the subcutaneous tissue located below the surface anode electrode. Or positioning the surface cathode and anode electrodes located in a spaced apart relationship on the subject's skin, having the surface cathode electrode located across the pick-up end of the electrical conductor to return the anode surface electrode through body tissue; And

d) applying a current between the surface cathode electrode and the surface anode electrode in the form of a circulating waveform applied at a frequency capable of blocking the target body tissue to treat the disease.

In another aspect, the present invention provides the use of a system comprising: electrically blocking a subject's target body tissue:

i) target cathode and anode electrodes that are in electrical contact with the subject's skin when positioned in a spaced relationship on the subject's skin to allow current to be delivered to the target body tissue;

ii) a stimulator outside the body of the subject in electrical contact with the surface cathode and anode electrodes, the stimulator supplies direct current, pulsatile current or alternating current to the surface cathode and anode electrodes; And

iii) Implants to capture a portion of the current flowing between the surface cathode and anode electrodes and allow a portion of the current to be delivered to the target body tissue, since the implant extends from the subcutaneous tissue located below the surface cathode electrode to the target body tissue. Once implanted, a passive electrical conductor of sufficient length, the electrical conductor having a pick-up end and a pole end, insulated between these ends, the pick-up end allowing a proper ratio of current to flow through the conductor. Preferably an electrical termination having an appropriate surface area for flowing through body tissue between the surface cathode and anode electrodes, the pole end forming an electrical termination for transporting a portion of the current to the target body tissue,

This allows the implant to electrically block the target body tissue when the current is in the form of a circulating waveform applied at a frequency that can block the target body tissue.

As used herein and in the claims, the following terms and phrases have the following definitions.

"Blocking" or "blocking" or "blocking" means preventing the conduction or propagation of active charge or nerve excitation along the axon of the target nerve.

"Body tissue" refers to nerve tissue (peripheral or central nervous system), nerves, muscles (skeleton, respiratory or myocardium) or organs such as the brain, cochlea, optic nerve, heart, bladder, urethra, kidneys and bones.

By "cyclical waveform" is meant any form of current in a repeating waveform that is not limited to its shape or form, including but not limited to alternating, pulsatile, sinusoidal, triangular, rectangular and sawtooth waveforms.

By "disorder" is meant to include motility disorders, muscular disorders, incontinence, nystagmus, pain, epilepsy, cerebral vascular disorders, sleep disorders, autonomic disorders, vision, hearing and balance disorders and neuropsychiatric disorders do.

“Current” means the current that is applied to the surface of the skin that is resistively and capacitively coupled to an implanted passive conductor and in turn delivered to the target nervous tissue.

"Biphasic waveform" means that current passes in one direction to the primary phase and then in the opposite direction to the secondary phase.

A "monophasic waveform" means the current passes in only one direction.

"Subject" means animals including humans.

1 is a three-dimensional schematic representation of an embodiment of the present invention having implanted electrical conductors, surface cathode and anode electrodes, and implanted return conductors.

2 is a side view of a cutaway view of an embodiment of the present invention with implanted electrical conductors and surface cathode and anode electrodes.

3 is a side view of a cutaway view of an alternative embodiment of the present invention having implanted electrical conductors and surface cathode and anode electrodes and electrical return conductors.

4 is a side view of a cutaway view of an alternative embodiment of the present invention having two implanted electrical conductors, two surface cathode electrodes, an anode electrode and an electrical return conductor.

5A and 5B are graphs showing the effects of frequency and amplitude on vulvar nerve block with single phase stimulation. 5A shows the maximum decrease in urethral pressure induced by stimulation of the vulvar nerve at different amplitudes and frequencies, with the maximum decrease defined as the difference between intraurethral pressure immediately before and during high frequency stimulation. 5B shows the difference between background intraurethral pressure and intraurethral pressure obtained during high frequency stimulation at different amplitudes and frequencies.

FIG. 6 is a graph showing the effect of vulvar nerve block in bipolar nerve cuff with frequency and amplitude of an abnormal charge-balance current control pulse. FIG.

7A and 7B are graphs showing the effect of stimulation amplitudes of 1 mA (FIG. 7A) and 3 mA (FIG. 7B) with a frequency of 1 kHz in vulvar nerve block in one animal.

8A and 8B are graphs showing the effect of stimulation amplitudes of 1 mA (FIG. 87A) and 3 mA (FIG. 8B) with a frequency of 2 kHz in vulvar nerve block in one animal.

9 is a graph showing the relationship between urethral pressure and bladder pressure during vulvar nerve block in one animal.

The present invention provides an implant for electrically stimulating target body tissue to activate or block nerve excitability according to a wide range of frequencies and disorders to be treated. Once implanted, the implant provides a conductive path for at least a portion of the current flowing between the surface cathode and anode electrodes located in a spaced apart relationship on the subject's skin and directs current to the target body tissue to activate or block nerve excitability. Send this. In a further aspect, the present invention provides a system and method for inserting an implant.

The test subject may be an animal including a human. Body tissues can be nerve tissue (peripheral or central nervous system), nerves, muscles (skeleton, respiratory or myocardium) or organs such as the brain, cochlea, optic nerve, heart, bladder, urethra, kidneys and bones.

The present invention can be applied to treat a variety of symptoms that require stimulation to activate or block nerve excitability. These symptoms may include dyskinesia (eg, dystonia, hypertension, stiffness, tremor and / or muscle weakness, Parkinson's disease, dystonia, cerebral palsy), muscular disorders (eg, muscle atrophy), incontinence (eg For example, bladder disorders, urinary tract, pain (eg, migraine, neck and back pain, pain resulting from other medical symptoms), epilepsy (eg, generalized seizure and partial seizure disorders), cerebral vascular disorders ( Ataxia, aneurysms), sleep disorders (eg sleep apnea), autonomic disorders (eg gastrointestinal disorders, cardiovascular disorders), vision, hearing and balance disorders, and neurophysiological disorders (eg depression) It may include. The present invention can also be used to promote bone growth (eg, as required in the repair of fractures), wound recovery or tissue regeneration.

To stimulate target body tissue, the specific frequency to be applied depends on many factors; For example, the type of nerve to block, the tissue the nerve stimulates, the size of the nerve, the subject to be treated, the type of symptom, the severity of the symptom, and the patient's acceptability for treatment. In general, for blocking, high frequencies are useful, for example, a cyclic waveform can be applied at frequencies in the range between 100 and 30,000 Hz or alternatively in the range between 100 and 20,000 Hz. Still alternatively, the cyclic waveform can be applied at frequencies in the range between 100 and 10,000 Hz or in the range between 200 and 5,000 Hz. For activation, low frequencies are generally useful, for example low frequencies in the range between 1 and 100 Hz or alternatively in the range between 1 and 50 Hz. Still alternatively, the frequency may range between 1 and 20 Hz.

A. Router System

The present invention is described with reference to the drawings as shown by the same reference numerals in Figs. The present invention is generally shown in FIG. 1, which schematically illustrates a portion of a subject's body tissue comprising skin 10, nerves 12 having nerve sheaths covering nerves, and muscles 16. 1 also illustrates the implant, surface cathode electrode 20 and surface anode cathode 22, generally indicated at 18. The implant 18 is provided to electrically stimulate a target body tissue, such as the subject's nerve 12, to activate or block nerve excitability. Once implanted, the implant 18 provides a conductive path for at least a portion of the current to flow between the surface cathode and anode electrodes 20, 22.

When placed in a spaced relationship on the subject's skin 10, the surface cathode and anode electrodes 20, 22 allow electricity to contact the skin and transmit current to the target body tissue. The surface cathode and anode electrodes 20, 22 can be selected from conductive rubber or polymer electrodes or damp absorbent pad electrodes that can be partially coated with conductive plates or sheets, conductive gel electrodes, electrode pastes or gels. Particularly effective are self-adhesive hydrogel electrodes of the type used to stimulate the muscle, having a surface area of one square centimeter or more. Platinum iridium electrodes generally consisting of 80% or more platinum and 20% or less iridium can also be used (eg, 85% platinum-15% iridium alloy; 90% platinum-10% iridium alloy). The position of the surface cathode and anode electrodes 20, 22 on the skin 10 may vary depending on the location and nature of the target body tissue.

 Multiple surface electrodes 20, 22 can be assembled on a single non-conductive substrate to shape an electrode array that can be conveniently attached to skin 10 in one manoeuvre. Similarly, multiple ends of implanted conductors 24 can be assembled on a substrate to form an array. By matching the physical layout of the surface electrode array to the physical layout of the implanted termination arrangement, good spatial matching of the surface and implanted conductors can be made in a convenient and reproducible manner. Surface electrode arrays in which the conductivity of each element of the array is controlled independently can also be used to adjust the conductivity between the surface electrode and the termination in the implanted array.

The implant 18 includes a passive electrical conductor 24 of sufficient length to extend from subcutaneous tissue located below the surface cathode electrode 20 to a target body tissue, such as the nerve 12, once implanted. The electrical conductors 24 may be formed from metal wires, carbon fibers, conductive rubber or other conductive polymers or solutions of conductive salts in the rubber. It has been found that multistranded Teflon ^® -insulated stainless-steel wire conductors of the type used in cardiac pacemaker leads can be particularly effective. ^® MP35N alloy which is divided in a medical application using general ㅅsa (non-magnetic, nickel-cobalt-chromium-molybdenum alloy), are also suitable. The electrical conductor has a pick-up end 26 and a pole end 28 and are insulated between these ends 26 and 28.

The electrical impedance of the interface between the ends 26, 28 of the conductor and the surrounding body tissue can be reduced by enlarging the surface area of the ends 26, 28. For this purpose, one or both pick-up ends and pole ends 26, 28 are used to reduce the electrical impedance of the interface between the pick-up and pole ends 26, 28 of the electrical conductor 24 and the surrounding body tissue. Form an end 30 having an appropriate surface area. Preferably, the pick-up end 26 forms an end 30. The pick-up end 26 is an electrical termination 30 having an appropriate surface area for the proper portion of the current to flow through the electrical conductor 24, preferably through the body tissue between the surface cathode and the anode electrodes 20, 22. ), The target body tissue is stimulated to activate or block nerve excitability. Stimulus end 28 also forms an electrical termination 30 for transmitting a current of current to the target body tissue (ie, nerve 12).

Termination 30 should have sufficient surface area to provide high conductivity in contact with body tissue to lower the electrical impedance between body tissue and conductors. If the surface area is minimal, the amount of current flowing through the conductor to the termination is reduced to an ineffective amount. The surface area required is therefore determined by the information of the electrical impedance of the interface between the tissue and the end 30 at the ends 26, 28 that receive and stimulate. Beneficial results were obtained when the surface area of the metal end 30 at the ends 26, 28 was made about 0.5 cm 2. The electrical impedance of each interface between the tissue and the ends 30 of the ends 26, 28 is then about five times the electrical impedance of both the subcutaneous tissue between the surface electrodes 20, 22. Typical values of tissue impedance are 200 Hz. The impedance of the conductor itself is chosen to be very small, for example 5 kW. In the given example only, the sum of the two interface impedances of the terminations 30 added to the conductor impedance is about 2000 Hz, which is about 10 times the tissue impedance. Thus, about 10% of the current applied between the surface electrodes 20, 22 flows through the conductor 24 to the target tissue. In the case of target tissue, which is the nerve 12 applied to the muscle, the amount of current between the surface electrodes 20, 22 required to produce useful muscle contraction of the target muscle 16 is adjacent between the surface electrodes 20, 22. The subcutaneous tissue remains below the threshold of activation of nerve endings. This is a useful concern because it means that the target muscle 16 may activate little local sensation below the surface electrodes 20, 22 or not activate the local sensation at all.

Terminations 30 of various shapes, materials, and spatial arrangements may be used; For example, the end 30 provides an expanded surface in the form of a coil, cuff, rod or plate or sheet in the form of an oval or polygon. As an example, FIG. 1 illustrates the termination 30 as a plate or sheet that is elliptical in shape at the pick-up end 26 of the electrical conductor 24 and cuff-shaped at the pole end 28. The cuff or part thereof may completely or partially surround all or part of the nerve sheath 14 of the nerve 12. The cuff or part thereof may be located near the nerve sheath 14 and the inner surface of the cuff or part thereof may be in direct contact with the nerve sheath 14.

Beneficial results have been obtained with stainless-steel plates or sheets of oval form of about 0.5 cm 2 area and 1 mm thick or with metal foils and stainless-steel meshes of 0.5 cm 2 surface area and 0.3 mm thick. At the end 30 of the conductor with the neural cuff, neural cuffs made of metal foil and stainless-steel mesh 0.5 to 1 cm 2 surface area and 0.3 mm thick are suitable. In addition, silicone elastomer cuffs of 5 mm to 15 mm length and 4 mm to 6 mm inner diameter ranges are suitable.

Termination 30 may be formed from non-insulated ends 26, 28 of electrical conductor 24 or other conductive or capacitive material. Termination 30 may be formed by coiling, spiraling or corrugating long or non-insulated length pickup or pole ends 26, 28 to provide a suitable surface. In addition, the surface area of the termination extends compared to the surface area of the shorter length electrical conductor. This results in an effective surface area of the termination 30 within a small area to provide high conductive contact with body tissue and to lower the electrical impedance between body tissue and conductor 24 to allow current flow in the conductor in preference to body tissue. do. Appropriate current flow is thereby provided in the conductor 24 to stimulate the target tissue. Alternatively, the pre-made terminal 30 can be coated or modified with a conductive material to maximize the flow of current through the target body tissue.

The spatial arrangement of the terminations 30 can be varied; For example, multiple terminations 30 can also be applied to other parts of body tissue (Grill et al., 1996). Advantageously, the ends 30 themselves may be in the form of closely-spaced contacts wrapped in the surrounding cuff 32 located around the nerve 12. The surrounding cuff 32 may be formed from conductive silicone rubber.

Electrical impedance can be further reduced by providing an oxide layer at the conductive or capacitive coating or termination 30. The coating can be selected from materials whose structural or electrical properties enhance the electrical conductivity between the tissue and the conductor, for example by providing a composite surface on which the tissue can grow (eg, with poly-diethoxy-thiophene A suitable oxide layer comprising the same polymer or tantalum and sintered iridium). In addition, the termination 30 can have a coating that provides an anti-inflammatory, anti-bacterial or tissue ingrowth effect. The coating may be a material selected from anti-inflammatory agents, antibacterial agents, antibiotics, or tissue ingrowth promoters.

Optionally, the performance of the present invention is enhanced by implanting an electrical return conductor 34 of appropriate length to extend from target body tissue to subcutaneous tissue located below the surface anode electrode 22. Electrical return conductor 34 provides a low-impedance conductive path from the target body tissue to the surface anode electrode 22 to concentrate the electric field through the target tissue. The electrically conductive conductor 34 can be formed from a metal wire, carbon fiber, conductive rubber or other conductive polymer or conductive salt solution in the rubber. The electrical feedback conductor 34 has a collecting end 36 and a return end 38 and is insulated between these ends 36 and 38. Both the collecting end 36 and the return end 38 are electrical ends 30 for reducing the electrical impedance of the interface between the collecting end 36 and the return end 38 of the electrical return conductor 34 around body tissue. (As mentioned above). The collection end 36 has an electrical termination 30 (cuff of the cuff) having a suitable surface to allow a portion of the current to be transported to the target body tissue for return via the electrical return conductor 34 prior to returning through body tissue. In the form shown in Figure 1). The return end 38 represents an electrical termination 30 (shown in FIG. 1 as a plate or sheet in the form of an oval) in which current returns to the surface anode electrode 22 through the subcutaneous tissue and skin under the surface anode electrode 22. Form.

A power source 40 (shown in FIGS. 2-4) supplies operating power to a stimulator (not shown) external to the subject's body. The stimulator is electrically connected to the surface cathode and anode electrodes 20, 22 to supply current to the surface cathode and anode electrodes 20, 22. The current may be resistive or capacitive, depending on the net impedance that intersects between the electrodes 20, 22.

While most of the current flows through body tissues proximate the surface cathode and anode electrodes 20, 22, the current flows through the electrical conductors 24, nerves 12, and electrical return conductors 34. As shown in FIG. 1, the surface cathode electrode 20 transmits a portion of the current through the conductor 24 to body tissue such that the current flows through the target body tissue and back through the body tissue to the anode surface electrode 22. Is located on the pick-up end 26 of the electrical conductor 24. This can also be done via implanted electrical return conductors 34 extending between target body tissue and subcutaneous tissue located below surface anode electrode 22.

The complete electrical path of some current is as follows: cathode wire 42, surface cathode electrode 20, skin 10, termination 30, pickup end 26, electrical conductor 24, pole end 28. ), Terminal 30, nerve sheath 14, nerve 12, terminal 30, collection terminal 36, electrical feedback conductor 34, feedback terminal 38, terminal 30, skin 10 Surface anode electrode 22 and anode wire 44. The pulse of current can cause an active potential that is conducted along the nerve 12 to the muscle 16, causing it to contact. Alternatively, the high frequency waveform current can block the active potential that is conducted through the nerve 12 to the muscle 16 to prevent muscle contraction.

Various disorders can be treated by the present invention as shown in FIG. As described below, the implanted passive electrical conductors of the present invention can route currents to stimulate various target body tissues to stimulate or block neural excitability depending on frequency and disorder to be treated. The application of the present invention is provided below to illustrate examples of useful disorders and target body tissues.

B. Activation of Neural Excitement Using a Router System

In some pathological conditions, the transmission of the active potential is impaired; Therefore, activation of nerve excitement is required to restore normal function. In the present invention, the stimulator is a direct current, pulsatile between surface cathode and anode electrodes 20, 22 to allow a portion of the current to flow through the implant 18 sufficient to stimulate target body tissue to activate nerve excitability. Can supply current or alternating current.

Exemplary pulse parameters of the current flowing between the surface cathode and anode electrodes 20, 22 for activation of nerve excitation are as follows: ideal current pulse, 30 pulses per second, 200 microseconds each phase in the period and 0.7 to 2 Peak current per pulse in the milliampere range. Although it has been found that other waveforms and modes of regulation of current or voltage also provide satisfactory results, a beneficial effect can be obtained with a rectangular feedback-regulating current pulse waveform. The inventors have discovered that between 10% and 20% of the current flowing between the surface electrodes 20, 22 propagates through the implanted conductor 24 even without the current return conductor 34. The type of current will depend on the intended application of the present invention; For example, when the target body tissue is bone and acceleration of bone growth is required, direct current rather than pulsating current will be applied.

As is known to those skilled in the art, the current delivered to the plurality of electrodes 20, 22 by the pulse generator can be independently controlled by the use of interleaved pulse trains. It includes a sequence of stimulus pulses of different amplitudes, pulses separated in time by very few milliseconds and transmitted to each electrode in turn, and the sequence as a whole is repeated at a rate equal to 30 times per second. The amplitude of the pulses flowing through each electrode can thereby be adjusted independently.

For activation, low frequencies are generally used, for example in the range between 1 and 100 Hz, alternatively in the range between 1 and 50 Hz. Still alternatively, the frequency may range between 1 and 20 Hz.

By way of example, FIG. 2 illustrates the present invention for use in the treatment of motor disorders requiring activation of the central nerve 46. The central nerve 46 stimulates most flexors in front of the forearm, most short muscles of the thumb and short muscles of the hand. The subject's arm 48 is shown with implant 18 implanted in the forearm. Electrical conductor 24 is shown as pick-up end 926 which forms end 30 which receives current from surface cathode electrode 20. Stimulus end 28 forms an end 30 for carrying current to central nerve 46. The surface anode electrode 22 is located on the skin. The flow of current from the power source 40 is supplied to the skin 10 through the cathode wire 42 at the surface cathode electrode 20 and through the anode wire 44 at the surface anode electrode 22. The current includes a surface comprising a terminal 30, a pickup end 26, an electrical conductor 24, a stimulus end 28, a portion of the central nerve 46, a stimulus end 28 and a skin below the electrode 22. The electrical circuit is completed by flowing into the tissue between the anode electrodes 22, the surface anode electrode 22, the anode wire 44 and the power source. A portion of the current flowing between the pole end 28 and the surface anode electrode 22 passes through the target tissue (eg, the central nerve 46), thereby stimulating the muscle 16 of the arm 48. have.

As a further example, FIG. 3 illustrates the invention for use in the treatment of motor disorders in which activation of the central nerve 46 is required. However, in addition to the components shown in FIG. 2, FIG. 3 also shows an electrical feedback conductor 34. The electrical circuit flows through the stimulus end 28 and the central nerve 46 and then terminates 30, collecting end 36, electrical return conductor 34, return end 38, termination 30, surface anode electrode. (22), the current flows through the anode wire 44 and the power supply essentially as shown in FIG. 2 except that the electrical circuit is completed. Advantageously, the electrical return conductor 34 acts to collect current flowing from the electrical conductor 24 through the target body tissue (ie, the central nerve 46) and returns to the surface anode electrode 22. To focus the electric field through the target body tissue (ie, the central nerve 46).

As another further example, FIG. 4 illustrates multiple implants 18 for electrically stimulating one or more target body tissues, independently or in combination, to activate neuronal excitability. Each implant 18 is entirely implanted under the subject's skin 10 and is long enough to extend to other target body tissues. The presence of multiple implants 18, independently or in combination, allows for multiple surface cathode electrodes 20 and one or more surface anode electrodes 22 to respond appropriately to implant 18 to stimulate other target body tissues. ) Position adjustment is essential. 4 shows the onset used in the treatment of motility disorders requiring stimulation of the central nerve 46 and the radial nerve 50. Radial nerve 50 stimulates the extensors of the back of the arms and forearms, the short muscles of the thumb and the extensors of the forefinger. Each of the two separate surface cathode electrodes 20 is electrically connected through two cathode wires 42 separated by a stimulator (not shown) that is activated by the power source 40. Current is transmitted to two separate electrical conductors, one extending to the central nerve 46 and the other to the radial nerve 50. Electrical return conductor 34 extends from target tissue (ie, below central nerve 46) to subcutaneous tissue located below one target anode electrode 22.

The electrical path of the current is as follows. Cathode Wire 42, Surface Cathode Electrode 20, Skin 10, Termination 30, Pickup End 26, Electrical Conductor 24, Stimulus End 928, Termination 30, Central Nerve 46 And / or radial nerve 50, termination 30, collection end 36, electrical return conductor 34, feedback end 38, termination 30, surface anode electrode 22, anode wire 44. And power supply 40. The central nerve 46 and the radial nerve 50 may first be curved or upper position (via the central nerve 46) of the folding of the wrist and fingers, and then the kidney or lower position of the kidneys of the wrist and fingers (the radial nerve ( Are independently stimulated by a pulsating current to provide). Alternatively, the central nerve 46 and the radial nerve 50 may be stimulated simultaneously, for example to straighten a finger (ie, the wrist is positioned horizontally). It will be apparent to those skilled in the art that the present invention can be applied to other target body tissues and disorders in which activation of nerve excitability is required to restore normal function.

C. Blocking Neural Excitement Using a Router System

In some pathological conditions, the transfer of active potentials does not serve a useful purpose; Thus, blocking of non-necessary neuronal excitability is required to restore normal function. The present invention provides a method of treating a disorder by applying a current in the form of a periodic waveform at a frequency that can block the target body tissue to treat the disorder. The current waveform is generated at a frequency high enough to cause conduction blockage in the target nervous tissue. For example, the current can be applied in the form of a pulse, generally at a rate high enough to cause 20 to 1,000 microseconds in the period and conduction blocking of the target axon. Pulse parameters, including frequency and pulse amplitude, pulse duration and pulse rate, vary with many factors as are well known to those skilled in the art; For example, the type of nerve to block (peripheral or central nervous system), the tissue that the nerve stimulates (for example, an autonomic organ such as the bladder or a body organ such as a muscle), the size of the nerve, the subject to be treated, the type of symptom, the symptom Subject's severity and acceptability of the subject for treatment.

It has been reported that a wide frequency range of 100 Hz to 30 kHz produces an effective cutoff according to the various parameters of the above mentioned and the specific stimulation technique used; For example, 1--0300 Hz in the hypothalamus nucleus in human deep brain to reduce motor symptoms (Ashkan et al., 2004; Filali et al., 2004); 500 Hz in muscle nerves (Solomonow et al., 1983); 600 Hz in sacral nerve roots in acute spinal cord dogs for bladder urination (Shaker et al., 1998); 600 Hz in sacral muscle to inhibit urethral sphincter contraction in chronic spinal cord injured dogs (Abdel-Gawad et al., 2001); 200-1400 Hz in epidural stimulation in humans to alleviate dyskinesia (Broseta et al., 1987); 4 kHz in vulvar stimulation in cats to block external urethral sphincter contraction (Tai et al., 2004, 2005); And 10-30 kHz in peripheral nerves for treating myotonia and pain (Bhadra and Kilgore, 2005).

For the blocking of nerve excitability, a frequency higher than that generally required for stimulating the nerve to conduct the action potential and higher enough to block the contraction of the action potential in the target body tissue is required. In general, for blocking, high frequencies are useful, for example, periodic waveforms may be applied at frequencies in the range between 100 and 30,000 Hz, or alternatively in the range between 100 and 20,000 Hz. Still alternatively, the periodic waveform can be applied at frequencies in the range between 100 and 10,000 Hz or in the range between 200 and 5,000 Hz.

Example 1 (described below) describes the use of the present invention, and the results suggest that a stimulus with an amplitude greater than 3 mA and a frequency greater than 200 Hz may block the transmission of nerve excitability in the vulvar nerve of the cat. . The stimulator of the present invention is very useful because it supplies a high frequency current waveform to the surface cathode and anode electrodes 20, 22 that are outside of the subject's body and outside of the subject's skin. A wide range of pulse parameters can be easily and easily tested and adjusted to determine the optimal parameters for achieving the desired pathological results of the subject following implantation of the electrical conductor 24.

Exemplary pulse parameters of a high frequency column of current flowing between the surface cathode and anode electrodes 20, 22 are as follows: current- or voltage-controlled abnormal pulses, phase periods or sinusoids ranging from 10 microseconds to 1,000 microseconds. Periodic waveforms, such as shapes, or triangles, rectangles, or sawtooth waveforms.

Blocking nerve excitability using the present invention is reversible at all frequencies, as the nerves again carry an active potential when no high frequency stimulation is produced and no damage is caused. In addition, partial or complete blockade of nerve excitation can be made depending on the condition to be treated. For example, complete blockade of sensory nerves is required to relieve pain and partial or complete blockade of sensory and motor nerves may be required to reduce myotonia.

Other embodiments of the invention are possible. For example, multiple implants 18 may be used to electrically block one or more target body tissues, independently or in combination. The presence of multiple implants may be used to independently or in combination the positioning of multiple surface cathode electrodes 920 and one or more surface anode electrodes 22 that respond appropriately to implant 18 to block other target body tissues. It is essential.

In other embodiments, a plurality of implants 18 for electrically activating neuronal excitability in one or more body tissues, independently or in combination, may be provided with the implants 18 for electrically blocking neuronal excitability in target body tissues. It can be used together. Two separate signals are needed: the low frequency signal required to activate the nerve and the high frequency signal required to block other nerves. For example, bladder urination can be achieved by simultaneously supplying a low frequency pulse train to the sacral nerve root S1 causing bladder and sphincter contraction and simultaneously supplying a high frequency waveform to the vulvar nerve to block the sphincter contraction caused by stimulating the sacral nerve root S1. have.

Various disorders that require blocking of nervous excitement can be treated by the present invention as shown in FIG. 1. By way of example, the present invention may be used to achieve bladder urination (see Example 1). When the bladder is filled, nerve signals are usually sent to the brain to convey the desire for urination. In response, the brain initiates a contractile response in which the bladder wall contracts, creating a pressure that pushes urine into the urethra, causing the sphincter around the urethra to open out. In certain disorders, for example in spinal cord injury, the bladder is generally impossible to empty due to over-reactive contractions of the external sphincter. Closure of the sphincter is maintained by reflexes intended to maintain defecation control. Vulvar nerves stimulate the pelvic floor and muscle tissue of the external urethra and external anal sphincter. The motor component of the urinary branch of the vulva nerve activates the external urethral sphincter muscle. This branching block relaxes the sphincter and causes the bladder to empty.

To achieve bladder urination, the electrical conductor 24 was implanted into the subject with a stimulus end 28 located in contact with or near the vulvar nerve. The pick-up end 26 of the electrical conductor 24 extends into the subcutaneous tissue located below the surface cathode electrode 20. Surface cathode and anode electrodes 20, 22 are preferably located on the skin of the subject above the hip. Since the vulvar nerves are present on both the left and right sides of the body, the two electrical conductors 24 can be positioned on both sides to arbitrarily block. This may be necessary for one surface cathode electrode 20 and one or two surface anodes 22. The electrical conductor 24, in the form of a high frequency wave, provides a conductive path through which at least a portion of the current flows between the cathode and anode electrodes 20, 22, and a portion of the current is transmitted to the vulva nerve. Blockage of the vulvar nerve by stimulation with high frequency electric pulses results in the opening of the urethral sphincter, which allows bladder urination (as observed by sudden large drops in intraurethral pressure). The vulva is blocked to allow bladder urination until the bladder is empty.

The present invention can also be used to relieve pain generally exhibiting unpleasant local sensations resulting from stimulation of characterized nerve endings. Peripheral nerves are nerves and ganglia outside the brain and spinal cord. In mixed peripheral nerves, the thinnest externally soluble sensory fibers deliver the excitement that is accepted as pain in the senses. Therefore, the present invention can be used to block sensory axons in peripheral nerves to reduce pain. For example, trigeminal neuralgia is repeated incompetent pain resulting from dysfunction of the trigeminal nerve and affecting the lower part of the face, which transmits sensory information from the face to the brain and controls the muscles involved in chewing. The electrical conductor 24 was implanted with a pick-up end 26 in contact with or near the cranial nerve (such as the trigeminal nerve) and a stimulus end 28 located subcutaneously in the head. Surface cathode and anode electrodes 20, 22 are located at the skin yarn of the head. Electrical conductor 24 provides a conductive path through which at least a portion of the current flows between the surface cathode and anode 20, 22 in the form of a high frequency periodic waveform that transmits a portion of the current to the trigeminal nerve. Blockage of the trigeminal nerve may result in decreased pain in patients with trigeminal neuralgia.

Myotonia, tremor and / or muscle weakness are examples of additional disorders to which the present invention may be applied to block nerve excitability. Myotonia is characterized by a hypertonicity state (ie, excessive tension in skeletal muscle with prominent deep key reflections) and causes muscle stiffness and uncomfortable mobility. It may appear as a result of sleepiness, cerebral palsy, multiple sclerosis or spinal cord injury. Nerve fibers related to myotonia include sensory and motor nerves. The present invention can be used to block sensory and motor neurons to block muscle spasms. Referring again to FIG. 3, the central nerve 46 may be blocked (rather than activated as described above) to relieve flexion spasms caused by ataxia or multiple sclerosis. The flow of current from the power source 40 is supplied in the form of a high frequency periodic waveform through the cathode wire 42 from the surface cathode electrode 20 and the surface anode electrode 22 to the skin 10. The current is a surface anode comprising a terminal 30, a pickup end 26, an electrical conductor 924, a stimulus end 28, a portion of the central nerve 46, a stimulus end 28 and the skin under the electrode 22. The electrical circuit flowed through the tissue between the electrodes 22, the surface anode electrode 22, the anode wire 44, and the power supply 40 to complete the electrical circuit. The current flowing between the pole end 28 and the surface anode electrode 22. A portion of passes through the target body tissue (in this embodiment, the central nerve 46), blocks nerve excitation along the central nerve 46 and prevents contraction of the muscle 16 of the arm 48.

The invention can also be used to reduce pain and myotonia by blocking the spinal cord. For example, back pain or leg muscle spasms may be alleviated to block the spinal cord nerves in the lumbar spine. The lumbar nerves L1-L5 supply the lower part of the abdomen and the back, the hips, some parts of the external reproductive organs and parts of the legs. The electrical conductor 24 was implanted with a pole end 28 located between the lumbar vertebrae into the lumbar duct. The pole end 28 is located around the epidural space between the dura mater and the wall of the spinal cord. Pick-up end 26 is located subcutaneously, such as under the body. The surface cathodes and anodes 20, 22 are located on the skin of the lower back. The electrical conductor 24 provides a conductive path through which at least a portion of the current flows between the surface cathode and anode electrodes 20, 22 in the form of a high frequency periodic waveform and transmits a portion of the current to the spinal cord. Blockage of the lumbar nerve can result in reduced pain or muscle tone in the affected part of the lower body.

The invention can be used to treat pathological progress, Parkinson's disease, dystonia, and other disorders by blocking deep brain nuclei. Such target tissue may include the basal ganglia including the hypothalamus and medulla. Parkinson's disease is a disorder of the basal ganglia. The electrical conductor 24 was implanted with a pole end 28 located in contact with or near the base nucleus. Surface cathode and anode electrodes 20, 22 are located on the skin of the head. The electrical conductor 24 provides a conductive path through which at least a portion of the current flows between the surface cathode and anode electrodes 20, 22 in the form of a high frequency periodic waveform and transmits a portion of the current to the base nucleus. The electrical current blocks the electrical signals that cause symptoms of motility disorders. Therefore, the present invention will be useful for blocking basal ganglia or other target deep brain nuclei for treating impaired mobility disorders.

When a Markush group or other group is used herein, all individual members of the group and combinations and possible subcombinations of the group are intended to be included individually in the specification. All formulations or combinations described and illustrated herein are otherwise Unless stated, it can be used to practice the present invention. Those skilled in the art will recognize that, in addition to those explicitly illustrated, methods, device elements and materials may be used in the practice of the present invention without resorting to undue experimentation. All methods, device elements, and functional equivalents known in the art are intended to be included in the present invention. Whenever a range is given in the specification, for example, the temperature range, frequency range, time bump or composition range, all intermediate ranges and all subranges, as well as all individual numerical values within a given range are intended to be included in the specification. Any individual member of one or more of the ranges or groups described herein may be excluded from the claims of the present invention. The invention, suitably described herein, may be practiced without the elements or limitations not explicitly described herein.

As used herein, "comprising" is synonymous with "including, containing" or "characterized by" and is inclusive, open, and additional, not listed. Does not exclude elements or method steps that are not. As used herein, "consisting of" excludes any element, step or ingredient not specified in the claims element. As used herein, “consisting essentially of” does not exclude a substance or step that does not substantially affect the basic and novel properties of the claims. In particular, any reference herein to the term "comprising" in the description of the elements of the equipment or in the details of the components of the composition may be exchanged for "essentially configured" or "consisting of".

Although the detailed description of the invention herein includes many specificities, these should not be construed as limiting the scope of the invention but are primarily provided to describe some of the embodiments of the invention. Each reference mentioned herein is incorporated by reference in its entirety. However, in case of inconsistency between the referenced reference and this specification, the present specification takes precedence. Some references provided herein have been added as references to provide a detailed description relating to the state of the art prior to the submission of this application, while other references are additional and alternative device elements, additional and alternative materials, and additional references. Mention may be made to provide alternative or alternative assays or methods of application of the invention.

The invention is described in detail in the following non-limiting examples.

Example  One

Three experiments were performed on cats anesthetized using the present invention to achieve high frequency blockade of the vulvar nerve.

Way

Surgical Methods: Cats are given preoperatively with acepromazine (0.25 mg / kg intramuscular), glycopyrrolate (0.01 mg / kg intramuscular) and buprenorphine (0.01 mg / kg intramuscular). Anesthetized with a mixture of isoflurane (2-3% in carbogen, flow rate 2 L / min). A cannula is inserted into the trachea and connected to a closed loop anesthetic system that monitors respiratory rate and aids in aeration. A catheter was inserted into one wood vein or cephalic vein to allow the introduction of fluids and drugs. A catheter was inserted to expose the bladder through a centralline abdominal incision and to add and stop body fluids and to measure the pressure in the bladder with a pressure transducer (see below). A secondary catheter (Kendall, closed end Tom Cat catheter) is inserted into the urethra and connected to a secondary pressure transducer for the measurement of pressure in the urethra. Vulvar nerves were exposed by excision of the sides of the base of the tail. The cuff or hook electrode is placed on the vulva nerve or branch thereof. At the end of the experiment, animals were euthanized with Euthanyl ™.

Pressure Measurements: Bladder pressure and urethral pressure were monitored in most stimulation attempts. A urethral catheter was attached to a Harvard Apparatus Pump 22 syringe pump and set to inject saline at 0.2 mL / min for measurement of intraurethral pressure according to Brown and Wickham's method. Both the bladder and the urethral catheter were connected to the Neurolog NL108D4 / 10 dome and NL108T4 separate pressure transducers through the Luer port. The pressure signal was low-pass filtered at 30 Hz and sampled at a speed of 100 samples per second using the CED 1401 laboratory computer interface and sampling software.

Stimulators: Neurologs (Digitimer Ltd., Welwyn Garden City, UK) Modules NL304 (cycle generator), NL403 (delay-width), NL510 (pulse buffer) and NL800 (stimulus separator) are routed to the vulvar nerve through the router system High frequency constant current single phase pulses were used to transport the glass (Grass-Telefactor, West Warwick, RI, USA) SD9 and S48 stimulators were used to transport constant voltage single phase pulses directly to the vulvar nerve. Custom laboratory stimulators were used to transmit high frequency constant current, transient, and potential-balance pulses through the router system through the skin to the vulvar nerves.

Average of transport stimuli: Two types of stimuli were tested. That is, direct stimulation of the vulva and stimulation through a router system. In direct stimulation, the stimulation electrode was placed on the exposed vulvar nerve and connected to the negative output of the glass stimulator through an insulated lead wire. A secondary (independent) electrode containing a crocodile clip attached to the incised skin near the exposed vulvar nerve was connected to the anode output of the glass stimulator. In the case of a stimulus applied through a router system, an electrode comprising a pick-up end in the form of a metal disk or coil wire connected to the pole end via an insulated lead wire is placed subcutaneously on the lumbar spine below the surface cathode electrode and the pole end with the vulva Contact. The surface cathode electrode is a conductive gel electrode (Kendall, H59P) which is fed to the shaved skin covered by the pick-up end and connected to the cathode output of the stimulator. In the case of a single-phase stimulator, the secondary surface electrode is positioned a few centimeters away from the cathode and connected to the anode output of the neurolog stimulator. In the case of aberrant stimulation, the two stimulus ends in the bipolar nerve cuff located on the vulva nerves are connected to separate pickup ends located subcutaneously on the lumbar spine, respectively via insulated lead wires. Two surface electrodes were placed on the pick-up end and connected to the positive and negative ends of the fabrication order stimulator.

Low frequency (20 Hz) direct stimulation via a hook electrode located near the vulvar nerve is used to induce contraction of the external urethral sphincter. This contraction was monitored by intraurethral pressure as the increase in intraurethral pressure indicated contraction of the external urethral sphincter. During the period of low frequency direct stimulation, a burst of high frequency stimulation was transmitted through the router system through a more distal hook electrode or neural cuff on the vulvar nerve. This determined the efficiency of router-mediated high frequency stimulation, which blocks the neuronal activity caused by direct low frequency stimulation.

result

5A and 5B are graphs showing the effects of frequency and amplitude on vulvar nerves blocked by single phase stimuli. In single phase pulsed, the constant current passes through the time period and then the external stimulus circuit is an open circuit (effectively electrically removed from the electrode) until the next pulse (Merrill, et al., 2005). 5A and 5B show the results obtained in one animal when the stimulation frequency and amplitude changed and the efficacy of vulvar nerve block was observed. Efficacy was measured by observing a change in intraurethral pressure with an open port of an intraurethral catheter located in the region of the external sphincter. The part adjacent to the right vulvar nerve was stimulated directly at low frequency to induce external urethral sphincter contraction, and the high frequency stimulus applied through the skin was partially transported through the router system to the distal end of the vulvar nerve to block the contraction. The maximum decrease in intraurethral pressure (FIG. 5A) is defined as the difference between the intraurethral pressure and the minimum stimulus obtained during the high frequency stimulus immediately before the high frequency stimulus is applied. At high stimulus amplitudes there was a significant decrease in intraurethral pressure. The cutoff was obtained at all stimulus frequencies tested (ie 200, 500, 1000 and 2000 Hz).

5B shows the effect of stimulation pulse frequency and amplitude on the ability of high frequencies to return intraurethral pressure to the baseline. This provides a measure of complete shutoff. Most complete blockade occurs at a stimulus amplitude of 3 mA and is more applied through the skin and partially transmitted to the vulvar nerve through the router system. At the stimulus pulse amplitude of 3 mA, all test frequencies (ie 200, 500, 1000 and 2000 Hz) induced almost complete blocking. It is common to have a more complete cutoff at high stimulus pulse amplitudes. A Y-axis value of zero indicates that the pressure in the urethra during the high frequency stimulation is equal to the base pressure previously stimulated.

FIG. 6 shows data from experiments where potential-balance, constant current, high frequency stimulation is applied through the skin and partially transmitted to the vulvar nerve through a router system incorporating a bipolar nerve cuff. The figure shows the effect of pulse frequency and amplitude of stimulation on the efficacy of vulvar nerve block. In an ideal pulse, the primary phase is used to induce the desired pathological effect and the secondary phase is used to redirect the electrochemical process occurring during the primary phase (Merrill et al., 2005). Therefore, compared to single phase pulses, the abnormal potential-balance pulses are more suitable for long-term nerve stimulation to avoid tissue damage. In addition, blockade induced by a single phase stimulus will act through a mechanism different from that caused by aberrant stimuli. A wide frequency range (1 kHz to 10 kHz) was also investigated in the experiment. 100% blockage indicates that the pressure in the urethra returned to baseline during the period of radiofrequency stimulation. Similar to single phase stimulation, increasing the stimulation current increases the blocking efficacy. Higher stimulation frequencies require higher stimulation amplitudes to achieve the same blocking efficacy.

7A and 7B show the effect of the pulse amplitude of a stimulus applied through the skin in one animal and partially transmitted onto the vulvar nerves via a router system. Traces represent intraurethral pressures obtained at 1 mA (FIG. 7A) and 3 mA (FIG. 7B) with dash bars indicating the duration of low frequency stimulation and solid bars indicating the duration of high frequency stimulation. Low frequency direct stimulation was applied to the vulva nerves closest to the hook electrode. Radiofrequency stimulation was applied through the skin and partially transmitted through the router system to the peripheral vulva nerve with a unipolar hook electrode. The anode-independent surface electrode was positioned several centimeters behind the cathode surface electrode. The low frequency stimulus was transported at a frequency of 20 Hz with a pulse having an amplitude of 520 μA and a pulse width of 300 μs. The high frequency stimulus was transported at a frequency of 1 kHz with single phase pulses with a pulse width of 100 μs. Stimulation with a 1 mA pulse amplitude had very little effect of intraurethral pressure and induced very little blockage of sphincter activity. However, with stimulus pulse amplitude increased up to 3 mA, complete transient and reversible blockade of sphincter activity was achieved.

In the experiments shown in FIGS. 8A and 8B, low frequency pulse trains (pulse at 300 μA, 200 μs, 20 Hz) applied directly to the vulva nerves were indicated by dash bars. High-frequency single-phase pulse trains (150 μs, pulses at 2 kHz) are transported through the skin and partially transmitted through the router system to the vulvar nerves. At 6 mA pulse amplitude (FIG. 8A), almost complete blocking was achieved, but the stimulation involved contraction of the leg under the surface cathode electrode. This contraction was maintained for the cycle of stimulation. At a pulse amplitude of 3 mA, similar blocking efficacy was achieved without accompanying leg contraction (FIG. 8B).

In a further experiment, in addition to the direct low frequency stimulation of the proximal vulvar nerve and the high frequency stimulation of the distal vulvar nerve through the router system, the increase in bladder pressure is caused by manually applied abdominal pressure. 9 shows an embodiment in which this combined process is executed. 9 shows the effect of vulvar nerve block on intraurethral pressure in one animal. The solid trace is the pressure in the urethra, the point trace is the bladder pressure, the dash bar represents the period of the low frequency stimulus and the solid bar represents the period of the high frequency stimulus. The low frequency stimulus is transported at a frequency of 20 Hz with a pulse having an amplitude of 330 μA and a pulse width of 200 μs. The radiofrequency stimulus is transported through the skin and partially transmitted to the distal vulva nerve at a frequency of 2 kHz with a single phase pulse having an amplitude of 4 mA and a pulse width of 100 μs. Early low frequency stimulation is used to generate external urethral sphincter contraction after the bladder pressure is increased by manual application of pressure to the abdomen. Urination that occurs during the first 20 seconds as intraurethral pressure does not remain higher than bladder pressure manually generated by direct vulva stimulation. When radiofrequency stimulation of the distal vulvar nerve is applied, the pressure in the urethra becomes equal to the bladder pressure, which means that the external sphincter is relieved, resulting in urination.

Several experiments were performed in which the urethral catheter was removed to test urination. Complete urination occurs when high frequency stimulation is used to block low frequency stimulus-induced external urethral sphincter contractions and the bladder pressure is passively increased. In general, the results suggest that the use of the present invention and stimulation through the skin with amplitudes greater than 3 mA and frequencies greater than 200 Hz contribute to blocking the transmission of activity in the vulvar nerves. Determination of stimulation parameters that produce optimal blockade is under investigation. It will be understood by those skilled in the art that other stimulation parameters may produce better blocking results, particularly in the peripheral and other parts of the central nervous system. Such parameters would be desirable to determine the stimulation parameters required to generate optimal nerve block on an individual basis, as may vary from subject to subject, depending on the skin's characteristics as well as the exact positioning of the elements of the present invention. It will also be appreciated.

D. Advantages of Router Systems

As described above, the present invention provides several advantages, firstly the ability to stimulate target body tissue to activate or block nerve excitability depending on the frequency and the disorder to be treated. In addition, the present invention includes the meaning of "remote" stimulation, which means that the surface cathode and anode electrodes 20, 22 are not located on the target body tissue. Remote target body tissues, such as nerves 12, are neurally spaced from closely spaced surface cathode and anode electrodes 20, 22 by simultaneously transmitting current simultaneously to multiple remote target body tissues through separate electrical conductors 24. It can be stimulated to activate or block excitement.

In addition, good selectivity is provided to stimulate target body tissue to activate or block neuronal excitability. Electrical conductors 24 may extend to specific target tissues or multiple electrical conductors 24 may extend to multiple target body tissues. Thus, stimulation is specific to target body tissues and stimulation of non-target body tissues is avoided. Electrical conductors 24 of appropriate length are used to reach target body tissues and stimulate target body tissues deep within the body or organs such as muscles, brain, cochlea, optic nerve, heart, bladder, urethra, kidneys and bones. This can be achieved.

Stimulus to activate or block nerve excitability is reproducible at will. The electrical conductor 24 is passive and permanently implanted with a pick-up end 26 and a pole end 28 located near the target body tissue beneath the skin 10 just below the site where the surface cathode electrode 20 will be located. Can be maintained. To the best of the inventors' knowledge, the difficulties encountered the difficulty of accurately determining the position of the surface electrodes in order to obtain acceptable selectivity of stimulation of body tissues. The inventor has surprisingly found that the present invention requires much less accuracy in the positioning of the surface cathode and anode electrodes 20, 22; As a result, stimulation of body tissues to activate or block nerve excitability is more accurately reproducible.

In addition, the present invention prevents problems inherent in other forms of stimulation. Conductors (ie, electrical conductors 24, electrical return conductors 34) do not escape through the skin, reducing the risk of infection that may occur in transdermal devices. There is no need to construct their own stimulator, signal generator or powered implant, or to provide other telemetry indication signals or radio frequencies through the skin.

It will be apparent to those skilled in the art that modifications can be made to the described embodiments without departing from the spirit and scope of the invention as defined in the following claims.

All documents mentioned in the specification of the present invention are indicative of the level of skill in the art to which the present invention relates. All documents are incorporated herein by reference to the same extent as if each individual document were specifically and individually incorporated by reference. The foregoing invention has been described in some detail by way of the drawings and examples, and specific changes and variations may be made without departing from the spirit or scope of the invention as defined by the following claims for the purpose of clarity and understanding. I can understand that.

Claims (81)

An implant comprising: electrically stimulating a target body tissue in a subject, the implant comprising: conducting a conductive pathway that, once implanted, causes at least a portion of current to flow between the surface cathode and anode electrodes located in a spaced apart relationship on the subject's skin; Implants that provide and transmit part of the electrical current to the target body tissue: Once implanted, a passive electrical conductor of sufficient length to extend from the subcutaneous tissue located below the surface cathode electrode to the target body tissue, the electrical conductor is insulated between these ends with a pick-up end and a pole end, The pick-up end consists of an electrical termination with an appropriate surface area that allows for an appropriate portion of the current flowing through the conductor, preferably flowing through body tissue between the surface cathode and anode electrodes, as the target body tissue is stimulated, The distal end is formed by an electrical termination for transporting a portion of the current to the target body tissue. The implant of claim 1, wherein the implant further comprises: Once implanted, an electrical return conductor of sufficient length to extend from the target tissue to the subcutaneous tissue located below the surface cathode electrode, the return conductor having a collection end and a return end, insulated between these ends, and the collection end being connected to the return conductor. Forming an electrical termination with an area suitable for transporting a portion of the current to the target body tissue for return through, preferably through body tissue, and the return end being the surface cathode through the skin and subcutaneous tissue underneath the electrode. It forms an electrical termination through which current returns to the electrode. The implant of claim 1, wherein one or both of the conductor and the return conductor are formed from a metal wire, carbon fiber, conductive rubber or other conductive polymer or conductive salt solution in the rubber. The implant of claim 2 wherein one or both of the conductor and the return conductor are formed from metal wire, carbon fiber, conductive rubber or other conductive polymer or conductive salt solution in the rubber. The implant of claim 3, wherein the ends of one or both of the conductors and the return conductors provide an expanded surface in the form of a coil, a spiral, a cuff, a rod, or a plate or sheet in the form of an oval or polygon. The implant of claim 4, wherein the ends of one or both of the conductor and the return conductor provide an expanded surface in the form of a coil, a spiral, a cuff, a rod, or a plate or sheet in the form of an oval or polygon. The implant of claim 5, wherein the one or more terminations are formed from an isolated end of the conductor or return conductor or from another conductive or capacitive material. The implant of claim 6, wherein one or more terminations are formed from the insulated ends of the conductors or feedback conductors or from other conductive or capacitive materials. 8. The implant of claim 7, further comprising a coating on one or both ends, wherein the coating is selected from a conductive or capacitive coating, an oxide layer, an anti-inflammatory agent, an antibacterial agent, an antibiotic, and a tissue intrinsic growth promoter. The implant of claim 8, further comprising a coating on one or both ends, wherein the coating is selected from a conductive or capacitive coating, an oxide layer, an anti-inflammatory agent, an antibacterial agent, an antibiotic and a tissue ingrowth promoter. A system for electrically stimulating a subject's target body tissue, comprising: i) target cathode and anode electrodes that are in electrical contact with the subject's skin when positioned in a spaced relationship on the subject's skin to allow current to be delivered to the target body tissue; ii) a stimulator outside the body of the subject in electrical contact with the surface cathode and anode electrodes, the stimulator supplies direct current, pulsatile current or alternating current to the surface cathode and anode electrodes; And iii) Implants to capture a portion of the current flowing between the surface cathode and anode electrodes and allow a portion of the current to be delivered to the target body tissue, since the implant extends from the subcutaneous tissue located below the surface cathode electrode to the target body tissue. Once implanted, it includes a passive electrical conductor of sufficient length, the electrical conductor having a pick-up end and a pole end, insulated between these ends, and as the target body tissue is stimulated, the pick-up end is applied through the conductor. It forms an electrical termination with an appropriate surface area that allows an appropriate proportion of current to flow, preferably through which current flows through the body tissue between the surface cathode and anode electrodes, and the pole end transports a portion of the current to the target body tissue. An electrical termination is formed. 12. The method of claim 11, further comprising an electrical return conductor of sufficient length to extend from the target tissue to the subcutaneous tissue located below the surface cathode electrode once implanted, the return conductor having a collection end and a return end and between these ends. Is insulated, and the collecting end forms an electrical termination having an area suitable for transporting a portion of the current to the target body tissue for returning through the return conductor, preferably for returning through body tissue. A system that forms an electrical termination through which the current returns to the surface cathode electrode through the skin and subcutaneous tissue below the electrode. The system of claim 11, wherein one or both of the conductor and the return conductor are formed from a metal wire, carbon fiber, conductive rubber or other conductive polymer or a solution of a conductive salt in the rubber. 13. The system of claim 12, wherein one or both of the conductor and the return conductor are formed from a metal wire, carbon fiber, conductive rubber or other conductive polymer or conductive salt solution in the rubber. The system of claim 13, wherein the end of one or both of the pick-up end or pole end provides an expanded surface in the form of a coil, a spiral, a cuff, a rod, or a plate or sheet in the form of an oval or polygon. 15. The system of claim 14, wherein the end of one or both of the pick-up end or pole end provides an expanded surface in the form of a coil, a spiral, a cuff, a rod, or a plate or sheet in the form of an oval or polygon. The system of claim 15, wherein the surface cathode and anode electrodes comprise a conductive rubber or polymer electrode or a damp absorbent pad electrode that can be partially coated with a conductive plate or sheet, conductive gel electrode, electrode paste or gel. The system of claim 16, wherein the surface cathode and anode electrodes comprise a conductive rubber or polymer electrode or a damp absorbent pad electrode that can be partially coated with a conductive plate or sheet, conductive gel electrode, electrode paste or gel. 18. The system of claim 17, wherein the termination can be formed from the insulated ends of the conductors themselves or from other conductive or capacitive materials. 19. The system of claim 18, wherein the termination can be formed from the insulated ends of the conductors themselves or from other conductive or capacitive materials. 20. The system of claim 19, further comprising a coating on one or both ends, wherein the coating is selected from conductive or capacitive coatings, oxide layers, anti-inflammatory agents, antibacterial agents, antibiotics, and tissue ingrowth promoters. The system of claim 20, further comprising a coating on one or both ends, wherein the coating is selected from conductive or capacitive coatings, oxide layers, anti-inflammatory agents, antibacterial agents, antibiotics, and tissue in-growth promoters. The method of claim 21, comprising implanting a plurality of implants, independently or in combination, to electrically stimulate one or more target body tissues, each implant being implanted entirely under the subject's skin and extending to other target body tissues. And a positioning of the plurality of surface cathode electrodes and one or more surface anode electrodes that are of sufficient length to respond independently to or in combination to stimulate other target body tissues, independently or in combination. 23. The method of claim 22, comprising implanting a plurality of implants, independently or in combination, to electrically stimulate one or more target body tissues, each implant being entirely implanted under the subject's skin and extending to other target body tissues. And a positioning sufficient of the plurality of surface cathode electrodes and one or more surface anode electrodes that are of sufficient length to respond independently to or in combination to stimulate other target body tissues, independently or in combination. A method for treating a subject's disorder, comprising the following steps: a) providing an implant acting as a conductive pathway to allow at least some of the current to flow between the surface cathode and the anode electrode located in a spaced apart relationship on the subject's skin, the implant being once implanted, the surface cathode electrode A passive electrical conductor of sufficient length to extend from the underlying subcutaneous tissue to the target body tissue, the electrical conductor having a pick-up end and a pole end, insulated between these ends, the pick-up end being a conductor Consisting of an electrical termination having an appropriate surface area to allow an appropriate portion of the current to flow through, preferably flowing through the body tissue between the surface cathode and anode electrodes, as the target body tissue is blocked, with the stimulus end being the target body Formed as an electrical termination for transporting a portion of the current to the tissue; b) implanting the implant completely under the skin of the subject having a pickup end located in the subcutaneous tissue located below the cathode electrode and a stimulus end located near the target body tissue; c) allowing a portion of the current to pass through the conductor to the target body tissue and through an implanted electrical return conductor extending through the target body tissue and between the target body tissue and the subcutaneous tissue located below the surface anode electrode. Or positioning the surface cathode and anode electrodes located in a spaced apart relationship on the subject's skin, having the surface cathode electrode located across the pick-up end of the electrical conductor to return the anode surface electrode through body tissue; And d) applying direct current, pulsating current, or alternating current between the surface cathode electrode and the surface anode electrode to allow a portion of the current to flow through an appropriate implant to stimulate target body tissue. 27. The method of claim 25, further comprising a return conductor completely under the skin of the subject, the return conductor comprising a length sufficient to extend from the target tissue to the subcutaneous tissue located below the surface cathode electrode once the return conductor is collected It has an end and a return end and is insulated between these ends, and the collecting end provides a region suitable for transporting a portion of the current to the target body tissue for return via the return conductor, preferably for return through body tissue. A method of forming an electrical termination having an electrical termination having a return terminal and a current returning to the surface cathode electrode through the skin and subcutaneous tissue beneath the electrode. The method of claim 26, wherein the body tissue is selected from nerve tissue in the peripheral or central nervous system, nerves, muscles, or organs. 28. The method of claim 27, wherein the stimulation of body tissues is impaired in motility, muscular disorders, incontinence, congestion, pain, epilepsy, cerebral vascular disorders, sleep disorders, autonomic neuropathy, vision, hearing and balance disorders, and neuropsychiatric ) A method performed to treat a disorder selected from among disorders or to promote bone growth or wound recovery or tissue regeneration. 29. The method of claim 28 wherein one or both of the conductor and the return conductor are formed from a metal wire, carbon fiber, conductive rubber or other conductive polymer or solution of a conductive salt in the rubber. 30. The method of claim 29, wherein the end of one or both of the pick-up end or pole end provides an expanded surface in the form of a coil, a spiral, a cuff, a rod, or a plate or sheet in the form of an oval or polygon. 31. The method of claim 30, wherein the surface cathode and anode electrodes comprise a conductive rubber or polymer electrode or a damp absorbent pad electrode that can be partially coated with a conductive plate or sheet, conductive gel electrode, electrode paste or gel. 33. The method of claim 32, wherein the termination can be formed from the insulated ends of the conductors themselves or from other conductive or capacitive materials. 33. The method of claim 32, further comprising a coating on one or both ends, wherein the coating is selected from conductive or capacitive coatings, oxide layers, anti-inflammatory agents, antibacterial agents, antibiotics, and tissue ingrowth promoters. 29. The method of claim 28, further comprising implanting a plurality of implants, independently or in combination, to electrically stimulate one or more target body tissues, each implant being implanted entirely under the subject's skin and having other target body tissues. And further comprising positioning of the plurality of surface cathode electrodes and the one or more surface anode electrodes that are of sufficient length to extend to the target and independently or in combination appropriately respond to the implant to stimulate other target body tissues. . The method of claim 28, wherein activation of the nerve tissue or nerve is in the range between 1 and 100 Hz, alternatively between 1 and 50 Hz, or more alternatively between 1 and 20 Hz, by providing pulsatile currents or alternating current. Method performed at frequency. 36. The method of claim 35, wherein the current is in the form of a single phase waveform. 36. The method of claim 35, wherein the current is in the form of a biphasic waveform. An implant comprising: for stimulating a subject's target body tissue electrically, once implanted, the implant flows at least a portion of the current between the surface cathode and anode electrodes located in a spaced apart relationship on the subject's skin Implants that provide a conductive pathway for delivering a portion of electrical current to body tissue: Once implanted, a passive electrical conductor of sufficient length to extend from the subcutaneous tissue located below the surface cathode electrode to the target body tissue, the electrical conductor is insulated between these ends with a pick-up end and a pole end, The pick-up end consists of an electrical end with an appropriate surface area that allows a suitable portion of the current to flow through the conductor, preferably flowing through body tissue between the surface cathode and anode electrodes, and the pole end of the current to the target body tissue. Formed with electrical terminations for transporting parts, This allows the implant to electrically block the target body tissue when the current is in the form of a cyclical waveform applied at a frequency that can block the target body tissue. The implant of claim 38, wherein the implant further comprises: Once implanted, an electrical return conductor of sufficient length to extend from the target tissue to the subcutaneous tissue located below the surface cathode electrode, the return conductor having a collection end and a return end, insulated between these ends, and the collection end being connected to the return conductor. Forms an electrical termination with a suitable area for returning through, preferably a portion of the current to be transported to the target body tissue for returning through body tissue, and the return terminal passes through the skin and subcutaneous tissue underneath the electrode It forms an electrical termination through which current returns to the electrode. The implant of claim 38, wherein one or both of the conductor and the return conductor are formed from metal wire, carbon fiber, conductive rubber or other conductive polymer or conductive salt solution in the rubber. 40. The implant of claim 39, wherein one or both of the conductor and the return conductor are formed from a metal wire, carbon fiber, conductive rubber or other conductive polymer or conductive salt solution in the rubber. 41. The implant of claim 40, wherein the termination of one or both of the conductor and the return conductor provides an expanded surface in the form of a coil, spiral, cuff, rod, or a plate or sheet in the form of an oval or polygon. 42. The implant of claim 41, wherein the ends of one or both of the conductor and the return conductor provide an expanded surface in the form of a coil, a spiral, a cuff, a rod, or a plate or sheet in the form of an oval or polygon. 43. The implant of claim 42, wherein one or more terminations are formed from the insulated ends of the conductors or feedback conductors or from other conductive or capacitive materials. The implant of claim 43, wherein the one or more terminations are formed from the insulated ends of the conductors or feedback conductors or from other conductive or capacitive materials. 45. The implant of claim 44, further comprising a coating on one or both ends, wherein the coating is selected from a conductive or capacitive coating, an oxide layer, an anti-inflammatory agent, an antibacterial agent, an antibiotic and a tissue ingrowth promoter. The implant of claim 45, further comprising a coating on one or both ends, wherein the coating is selected from a conductive or capacitive coating, an oxide layer, an anti-inflammatory agent, an antibacterial agent, an antibiotic, and a tissue intrinsic growth promoter. 48. The implant of claim 46 or 47, wherein the current in the form of a periodic waveform is a single phase waveform. 48. The implant of claim 46 or 47, wherein the current in the form of a periodic waveform is an abnormal waveform. A system for electrically blocking a subject's target body tissue, comprising: i) target cathode and anode electrodes that are in electrical contact with the subject's skin when positioned in a spaced relationship on the subject's skin to allow current to be delivered to the target body tissue; ii) a stimulator outside the body of the subject in electrical contact with the surface cathode and anode electrodes, the stimulator supplies direct current, pulsatile current or alternating current to the surface cathode and anode electrodes; And iii) Implants to capture a portion of the current flowing between the surface cathode and anode electrodes and allow a portion of the current to be delivered to the target body tissue, since the implant extends from the subcutaneous tissue located below the surface cathode electrode to the target body tissue. Once implanted, a passive electrical conductor of sufficient length, the electrical conductor having a pick-up end and a pole end, insulated between these ends, the pick-up end allowing a proper ratio of current to flow through the conductor. Preferably an electrical termination having an appropriate surface area for flowing through body tissue between the surface cathode and anode electrodes, the pole end forming an electrical termination for transporting a portion of the current to the target body tissue, This allows the implant to electrically block the target body tissue when the current is in the form of a circulating waveform applied at a frequency that can block the target body tissue. 51. The apparatus of claim 50, further comprising an electrical return conductor of sufficient length to extend from the target tissue to the subcutaneous tissue located below the surface cathode electrode once implanted, the return conductor having a collection end and a return end between the ends. Is insulated, and the collecting end forms an electrical termination having an area suitable for transporting a portion of the current to the target body tissue for returning through the return conductor, preferably for returning through body tissue. A system that forms an electrical termination through which the current returns to the surface cathode electrode through the skin and subcutaneous tissue below the electrode. 51. The system of claim 50, wherein one or both of the conductor and the return conductor are formed from a metal wire, carbon fiber, conductive rubber or other conductive polymer or solution of a conductive salt in the rubber. 53. The system of claim 51, wherein one or both of the conductor and the return conductor are formed from a metal wire, carbon fiber, conductive rubber or other conductive polymer or solution of a conductive salt in the rubber. 53. The system of claim 52, wherein one or both ends of the pick-up or pole ends provide an expanded surface in the form of a coil, a spiral, a cuff, a rod, or a plate or sheet in the form of an oval or polygon. 54. The system of claim 53, wherein the end of one or both of the pick-up end or pole end provides an expanded surface in the form of a coil, spiral, cuff, rod or plate or sheet in the form of an oval or polygon. 55. The system of claim 54, wherein the surface cathode and anode electrodes comprise a conductive rubber or polymer electrode or a damp absorbent pad electrode that can be partially coated with a conductive plate or sheet, conductive gel electrode, electrode paste or gel. 56. The system of claim 55, wherein the surface cathode and anode electrodes comprise a conductive rubber or polymer electrode or a damp absorbent pad electrode that can be partially coated with a conductive plate or sheet, conductive gel electrode, electrode paste or gel. 57. The system of claim 56, wherein the termination can be formed from the insulated ends of the conductors themselves or from other conductive or capacitive materials. 58. The system of claim 57, wherein the termination can be formed from the insulated ends of the conductors themselves or from other conductive or capacitive materials. 59. The system of claim 58, further comprising a coating on one or both ends, wherein the coating is selected from conductive or capacitive coatings, oxide layers, anti-inflammatory agents, antibacterial agents, antibiotics, and tissue ingrowth promoters. 60. The system of claim 59, further comprising a coating on one or both ends, wherein the coating is selected from conductive or capacitive coatings, oxide layers, anti-inflammatory agents, antibacterial agents, antibiotics, and tissue in-growth promoters. 62. The system of claim 60 or 61, wherein the current in the form of a periodic waveform is a single phase waveform. 62. The system of claim 60 or 61, wherein the current in the form of a periodic waveform is an abnormal waveform. 61. The method of claim 60, comprising implanting a plurality of implants independently or in combination to electrically block one or more target body tissues, each implant being implanted entirely under the subject's skin and extending to other target body tissues. And a positioning of the plurality of surface cathode electrodes and one or more surface anode electrodes that are of sufficient length to respond independently or in combination to block other target body tissues. 62. The method of claim 61, comprising implanting a plurality of implants independently or in combination to electrically block one or more target body tissues, each implant being entirely implanted under the subject's skin and extending to other target body tissues. And a positioning sufficient of the plurality of surface cathode electrodes and one or more surface anode electrodes that are of sufficient length to respond independently to or in combination to block other target body tissues, independently or in combination. A method for electrically stimulating target body tissue, comprising the following steps: a) providing an implant acting as a conductive pathway to allow at least some of the current to flow between the surface cathode and the anode electrode located in a spaced apart relationship on the subject's skin, the implant being once implanted, the surface cathode electrode A passive electrical conductor of sufficient length to extend from the underlying subcutaneous tissue to the target body tissue, the electrical conductor having a pick-up end and a pole end, insulated between these ends, the pick-up end being a conductor Consisting of an electrical termination having an appropriate surface area to allow an appropriate portion of the current to flow through, preferably flowing through the body tissue between the surface cathode and anode electrodes, as the target body tissue is stimulated, the stimulus end being the target body Formed as an electrical termination for transporting a portion of the current to the tissue; b) implanting the implant completely under the skin of the subject having a pickup end located in the subcutaneous tissue located below the cathode electrode and a stimulus end located near the target body tissue; c) allowing a portion of the current to pass through the conductor to the target body tissue and through an implanted electrical return conductor extending through the target body tissue and between the target body tissue and the subcutaneous tissue located below the surface anode electrode. Or positioning the surface cathode and anode electrodes located in a spaced apart relationship on the subject's skin, having the surface cathode electrode located across the pick-up end of the electrical conductor to return the anode surface electrode through body tissue; And d) a current is applied between the surface cathode electrode and the surface anode electrode in the form of a circulating waveform applied at a frequency capable of blocking the target body tissue to treat the disorder. 67. The apparatus of claim 66, further comprising a return conductor completely under the skin of the subject, the return conductor comprising a length sufficient to extend from the target tissue to the subcutaneous tissue located below the surface cathode electrode once the return conductor is collected It has an end and a return end and is insulated between these ends, and the collecting end provides a region suitable for transporting a portion of the current to the target body tissue for return via the return conductor, preferably for return through body tissue. A method of forming an electrical termination having an electrical termination having a return terminal and a current returning to the surface cathode electrode through the skin and subcutaneous tissue beneath the electrode. 68. The method of claim 67, wherein the disorder is selected from urine retention, incontinence, pain, epilepsy, cerebral vascular disorders, sleep disorders, autonomic neuropathy disorders, vision, hearing and balance disorders, and neurophysiological disorders and motility disorders. The method of claim 68, wherein the body tissue is selected from the peripheral or central nervous system or nerve tissue of the nerve. 70. The method of claim 69, wherein the current is in the form of a periodic waveform applied at a frequency in the range between 100 and 30,000 Hz. The method of claim 70, wherein the current is a periodic waveform applied at a frequency in the range between 100 and 20,000 Hz, alternatively in the range between 100 and 10,000 Hz, more alternatively in the range between 200 and 5,000 Hz. The method of claim 71, wherein the current applied to the periodic waveform is a single phase waveform. The method of claim 71, wherein the current applied to the periodic waveform is an abnormal waveform. The method of claim 71, wherein one or both of the conductor and the return conductor are formed from a metal wire, carbon fiber, conductive rubber or other conductive polymer or solution of conductive salts in the rubber. 75. The method of claim 74, wherein one or both ends of the pick-up or pole ends provide an expanded surface in the form of a coil, a spiral, a cuff, a rod, or a plate or sheet in the form of an oval or polygon. 76. The method of claim 75, wherein the surface cathode and anode electrodes comprise a conductive rubber or polymer electrode or a damp absorbent pad electrode that can be partially coated with a conductive plate or sheet, conductive gel electrode, electrode paste or gel. 77. The method of claim 76, wherein the termination can be formed from the insulated ends of the conductors themselves or from other conductive or capacitive materials. 78. The method of claim 77, further comprising a coating selected from a conductive or capacitive coating, an oxide layer, an anti-inflammatory agent, an antibacterial agent, an antibiotic, and a tissue ingrowth promoter. 71. The method of claim 70, further comprising implanting a plurality of implants, independently or in combination, to electrically block one or more target body tissues, each implant being implanted entirely under the subject's skin and having other target body tissues. And further comprising positioning of the plurality of surface cathode electrodes and the one or more surface anode electrodes that are of sufficient length to extend to and to respond appropriately to the implant to block other target body tissues, independently or in combination. . 71. The method of claim 70, further comprising implanting a plurality of implants, independently or in combination, to electrically stimulate an action potential in one or more target body tissues, each implant being implanted entirely under the subject's skin and the other It is additionally long enough to extend into the target body tissue and, in isolation or in combination, further controls the positioning of the plurality of surface cathode electrodes and one or more surface anode electrodes that respond appropriately to the implant to stimulate other target body tissues. How to include. Use of a system to electrically block a subject's target body tissue, including: i) target cathode and anode electrodes that are in electrical contact with the subject's skin when positioned in a spaced relationship on the subject's skin to allow current to be delivered to the target body tissue; ii) a stimulator external to the subject's body, which is in electrical contact with the surface cathode and anode electrodes, to supply direct current, pulsating current or alternating current to the surface cathode and anode electrodes; And iii) Implants to capture a portion of the current flowing between the surface cathode and anode electrodes and allow a portion of the current to be delivered to the target body tissue, since the implant extends from the subcutaneous tissue located below the surface cathode electrode to the target body tissue. Once implanted, a passive electrical conductor of sufficient length, the electrical conductor having a pick-up end and a pole end, insulated between these ends, the pick-up end allowing a proper ratio of current to flow through the conductor. Preferably an electrical termination having an appropriate surface area for flowing through body tissue between the surface cathode and anode electrodes, the pole end forming an electrical termination for transporting a portion of the current to the target body tissue, This allows the implant to electrically block the target body tissue when the current is in the form of a circulating waveform applied at a frequency that can block the target body tissue.

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