WO2011094464A1

WO2011094464A1 - Devices, systems, and methods to deliver electric stimulation to a targeted area of a user using a portable, self-powered, stimulation device

Info

Publication number: WO2011094464A1
Application number: PCT/US2011/022809
Authority: WO
Inventors: Jay T. Hamlin
Original assignee: Medtronic, Inc.
Priority date: 2010-01-28
Filing date: 2011-01-28
Publication date: 2011-08-04

Abstract

The present disclosure provides for devices, systems, and methods which deliver electric stimulation to a targeted area of a user using a portable, self-powered, stimulation device. In some embodiments, a piezoelectric cell generates voltage resulting from pressure or displacement on the piezoelectric cell which is caused by a users movement. This voltage is then used to provide electrical stimulation to an area of the users body via one or more conductive leads. Other embodiments may be powered by a small battery, or combination of a battery and a piezoelectric cell. In these embodiments, the piezoelectric cell may also be utilized to recharge the battery. Embodiments may be contained in a users garment such as shoes, socks, gloves, and the like.

Description

DEVICES, SYSTEMS, AND METHODS TO DELIVER ELECTRIC

TECHNICAL FIELD

The present disclosure relates to the treatment of neuropathic disorders and apparatus for the same. More specifically, one aspect of the present disclosure relates to the treatment of peripheral neuropathy due to diabetes, injuries, infections and the like, and apparatus for the same.

BACKGROUND

An estimated 23.6 million people in the United States or 7.8% of the population have diabetes. Of those, it is estimated that 17.9 million have been diagnosed and about 5.7 million people remain undiagnosed. A common complication of diabetes is diabetic neuropathy. Diabetic neuropathy is damage to the nerves that causes patients to feel sensations of pain. Symptoms may also include tingling, burning and numbness, The areas of the body most commonly affected by diabetic peripheral neuropathy are the feet and legs. Due to the lack of sensation, injuries and sores may go unrecognized, increasing the risk of more severe foot problems.

While diabetes is a common cause for peripheral neuropathy, other factors can cause this disorder, such as physical injur}_' or trauma to a nerve, tumors, nutritional deficiencies, alcoholism, vascular and metabolic disorders, and the like. Accordingly, an even greater portion of the population may potentially suffer from the debilitating symptoms associated with neuropathy disorders.

Electrical stimulation has proven effective in treating a wide variety of diseases and conditions. Examples include pacemakers and defibrillators in treating cardiac conditions, neurostimulators for the relief of chronic pain, and Deep Brain Stimulation (DBS) Systems for the treatment of essential tremor and tremor associated with Parkinson's disease, Electrical stimulation therapy may also be useful for general relaxation and comfort for a user of a device. However, existing electrical stimulation systems are configured in a manner that are not conducive for convenient or portable use. For example, current systems are generally powered either by a fixed power source or battery. Fixed sources are generally not sufficiently mobile for convenient use by a patient. Moreover, devices with better resources generally have battery life limitations. The battery of an implanted stimulator should last as long as possible, thus saving the patient from frequently having to recharge the battery or replace the entire device if it contains a non-rechargeable battery .

BRIEF SUMMARY

The present disclosure provides for devices, systems, and methods that deliver electric stimulation to a targeted area of a user using a portable, self-powered, stimulation device, in some embodiments, a piezoelectric cell generates voltage resulting from a pressure displacement or other mechanical action, which is caused by a user's movement, on the piezoelectric cell. This voltage is then used to provide electrical stimulation to an area of the user's body via one or more conductive leads. Other embodiments may be powered by a small battery, or combination of a batter}_' and a piezoelectric cell, in these embodiments, the piezoelectric cell may also be utilized to recharge the battery. Embodiments may be contained in a user's garment such as shoes, socks, gloves, and the like.

In one example embodiment, a shoe insert is adapted to stimulate the foot of a user having leg and/or neuropathic pain. The shoe insert may include one or more piezoelectric cells. One piezoelectric cell may be attached to electrically conductive thread that is woven or otherwise integrated into or onto the shoe insert near either the ball or heel of the foot. Another piezoelectric cell may be attached to another piece of electrically conductive thread and woven into the shoe insert near the other end of the foot near either the ball or heel of the foot. As the person applies pressure to the shoe insert, while walking, a voltage is generated across the piezoelectric cell, in turn, the generated voltage provides stimulation to the foot via the electrically conductive thread. While certain embodiments are described as using a piezoelectric ceil for a voltage-generating (or current) device, any other device that generates a current or voltage based on pressure displacement or mechanical action, would be suitable,

The foregoing has outlined rather broadly the features and some technical advantages of embodiments of the present disclosure in order that the detailed description that follows may be better understood. Additional features and advantages of embodiments of the present disclosure will be described hereinafter which form the subject of the claims. It should be appreciated by those skilled in the art that the conception and specific embodiment disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of embodiments of the present disclosure. It should also be realized by those skilled in the art that such equivalent constructions do not depart, from the spirit and scope of the embodiments of the present disclosure as set forth in the appended claims. The novel features which are believed to be characteristic of embodiments of the present disclosure, both as to its organization and method of operation, together with further objects and advantages will be better understood from the following description when considered in connection with the accompanying figures. It is to be expressly understood, however, that each of the figures is provided for the purpose of illustration and description only and is not intended as a definition of the limits of the embodiments of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

Fig, 1 is an illustration of an exemplary embodiment of a device that delivers electric stimulation to a targeted area of a user in accordance with an example embodiment of the presen t discl osure;

Fig. 2 is an illustration of an exemplary embodiment of the device of Fig, 1 as embodied into a footwear insert adapted to stimulate the foot of a person ha ving leg and/or neuropathic pain that includes at least one anode and cathode and a power source in accordance with an example embodiment of the present disclosure;

Fig. 3 is a cross sectional view of another exemplary embodiment of footwear, which includes an insole in accordance with an example embodiment of the present disclosure;

Fig, 4 is a cross sectional view of another exemplar}' embodiment of footwear in accordance with an example embodiment of the present disclosure;

Fig. 5 illustrates a flowchart depicting a method of making a device for electrically stimulating a user in accordance with an example embodiment of the present disclosure;

Fig, 6 illustrates a flowchart depicting a method of delivering electrical stimulation to an area of a user's body in accordance with an example embodiment of the present disclosure; Fig. 7 illustrates a flow chart depicting a method of treating or inhibiting effects caused by peripheral neuropathy in accordance with an example embodiment of the present disclosure;

Fig, 8 illustrates a flow chart depicting a method of making a garment in accordance with an example embodiment of the present disclosure; and

Fig. 9 is an illustration of an exemplar}' embodiment of a device that delivers electric stimulation to a targeted area of a user device, as embodied into a footwear insert adapted to stimulate the foot of a person having leg and/or neuropathic pain that includes at least one anode and cathode and a power source in accordance with an example embodiment of the present disclosure,

DETAILED DESCRIPTION

Based on Applicant's personal experience with the available technology, Applicant believes he has identified a previously unarticulated and unappreciated need for a system that provides stimulation in the treatment of peripheral neuropathy pain that contains a power source that does not require frequent replacement or recharging. Applicant further believes that the system described herein can also be used in a variety of other applications, such as, for example, running, hiking, walking, skiing, or any other activity that can include the use of footwear, or other garment or equipment, to deliver stimulation to an area for relief of fatigue, pain, or generally anywhere that stimulation is desired, wherein the activity of the user, in conjunction with the system of the present disclosure, creates the voltage or current to be delivered to the area to be stimulated. Other exemplary applications would be in activities or professions that require a great deal of time on one's feet.

Fig, 1 illustrates a device 100 that delivers electric stimulation to a targeted area of a user according to an example embodiment of the present disclosure. The device 100 may have at least one conductive lead (e.g., cathode 102 and anode 104) configured to provide electrical stimulation to the user. In the illustrated embodiment, a cathode 102 and an anode 104 are connected to a power source 106. The power source 106 may comprise one or more piezoelectric cells 110 that generate voltage as a result of pressure or displacement, either directly or indirectly on the cell by a user. This voltage may then be used to provide electrical stimulation to an area of the user's body via the cathode 102 and the anode 104, The power source 106 may also comprise a small battery 112, which functions to provide stimuiation via the cathode 102 and the anode 104. Moreover, the power source 106 may include a combination of a battery 112 and one or more piezoelectric cells 110 to provide stimulation. In these embodiments, the piezoelectric cell 110 may also be utilized to recharge the battery. The piezoelectric cells 110 may be comprised of a ceramic material, such as, for example, piezoelectric ceils sold under the designation Piezo Ceramic Elements available from Kyocera (Japan) but any suitable piezoelectric material may be used, such as, for example, flexible piezoelectric fiber composites available from Advanced Cerametrics Inc. (ACI), Lambertvi!Ie, NJ.

In one exemplary embodiment, the anode 104 and the cathode 102 of the device 100 are constructed of an electrically conductive thread, such as, for example, silver-infused nylon thread, carbon-infused thread, carbon-nanofiber thread, or the like. However, any suitable material may be used that may be adequately housed within the device 100 and may be placed proximate to a user. One of ordinary skill in the art, upon appreciating the teaching of the present disclosure, will be able to select an appropriate material based on the needs of a particular application. As illustrated in Fig. 1 , it is noted that a partial circuit pathway 108 is formed when the power source 106 is coupled to the anode 104 and the cathode 102, In some embodiments, this circuit may be completed when a portion of a user, such as, for example, a user's hand or foot, comes in contact with the anode 104 and the cathode 102. Alternatively, the circuit can be completed even if there is an intervening material between the anode and cathode and the user, such as a sock worn on a foot. In the present disclosure, the terms cathode and anode are used for convenience of understanding the partial circuits formed, and that one skilled in the art will appreciate that, regardless of the convention or terminology used herein, the point of the partial circuit is to provide an open circuit that uses the user's anatomy to complete all or part of the completed stimuia tion circuit,

The device 100 may be also implemented in the form of a garment that is worn by a user, For example, the device 100 may be part of a footwear device (e.g., footwear insert, shoe, sock, etc.), and may use pressure or displacement that is created by a user when making normal movements, such as when weight is displaced when walking or standing, to create electrical stimuiation. This electrical stimulation may, in turn, be targeted to a user's foot, ankle, calf, and the like, The device 100 may also be implemented as part of a glove, in this embodiment, electrical stimulation may be delivered to a user's fingers, hands, wrists, and the like. The power source 106 may be implemented as discussed above using piezoelectric materials, batteries, or a combination of both. Further, in the glove embodiment, the user may provide pressure to the piezoelectric materials by squeezing a portion of the device 100 with a user's hand. Alternatively, by using appropriately placed piezoelectric cells, the normal movement of the wrist or fingers can be used to generate a voltage in the circuit across the anode and cathode. For example, a glove with appropriately placed stimulation portions can be used to deliver electrical stimulation to a user during keyboarding, or other activity involving constant and/or repetitive hand motion, and thus can be useful in alleviating pain due to repetitive motion or typing, such as carpal tunnel syndrome,

Fig, 2 illustrates an exemplary embodiment of the device 100 as embodied into a garment, in this example a footwear insert 200, employed to stimulate the foot of a user. The example of Fig. 2 is a footwear insert 200 with at least one cathode 102, one anode 104, and a power source 106. A partial circuit pathway 108 is formed when the power source 106 is coupled to the anode 104 and the cathode 102. in this exemplary embodiment, the partial circuit pathway 108 forms a complete circuit when insert 200 comes in contact with a user's foot, either directly or indirectly, but in either case, being electrically coupled to the foot. The footwear insert 200 may be in the form of a removable insole which can have features depending on a particular application, whether it be walking, hiking, running, or any other particular application that would benefit from the application of stimulation to the feet or leg. Alternatively, the partial circuit may be employed in insoles that are glued or sewn into footwear and are, therefore, not generally viewed as removable. The insert 200 may also be formed with molded material, such as foam and/or gel, for example, and also may be a cushion insole, or any other device suitable for implementation of these embodiments. Further, in some embodiments the piezoelectric cells, wires, electrical connectors, anode and cathode may be adhered to the bottom or underside of the shoe insert so as to make the shoe insert easily removable.

In an exemplary embodiment, the anode 104 and the cathode 102 of the insert 200 are comprised of an electrically conductive thread such as e.g., silver-infused nylon thread, carbon-infused thread, carbon-nano fiber thread, and/or the like. Further, the anode 104 may be positioned proximate to the position of the heel of a user's foot, while the cathode 102 may be positioned proximate to the position of the bail of a user's foot (or vice versa). Embodiments may also place either the anode 104 or the cathode 102 proximate to other areas corresponding to a user, such as at the arch, toes, and the like, depending on the needs of the user or the specific application for the device. Additionally, multiple anodes and cathodes may be utilized to target multiple areas or to deliver additional electrical stimulation to a particular area. In some embodiments, the delivered stimulation may be applied in pulses. Moreover, other embodiments may implement continuous stimulation.

Upon reading this disclosure, one skilled in the art will appreciate that there are a variety of possible ways in which an insert or insole may be made. One exemplary method is to modify anti-static, or electro-static discharge, insoles or inserts, which are commonly available from a number of manufacturers, such as those available from the Lehigh Safety Shoe Company. Such insoles include a conductive pathway from a user's foot, through the insole or insert, to ground through footwear. Such inserts or insoles are used to avoid build-up of static discharge on a user. Such inserts or inserts typically use a separate conductive thread or material in each of the ball and heel portions of the insert or insole to complete the electrical path from the user to ground through the bottom of the footwear,

Starting with such an insole or insert, a piezoelectric power source can be attached too, in, or on, the insole or insert and then electrically coupled to the conductive threads in the ball and heel portions to form a partial electrical circuit that is powered by a user's motion or movement. The power source is coupled to the conductive threads directly or indirectly.

An exemplary method of coupling the power source to the threads includes intertwining, but twisting, a length of wire (with insulation removed) from the power source together with an approximately equal length of conductive thread, inserting the intertwined arrangement into a shrink-wrap sleeve, and applying heat to the sleeve to securely bond the wire to the conductive thread.

After reading this disclosure, one skilled in the art will appreciate there can be a variety of ways to make a garment including a partial electrical circuit adapted to be completed using a user's anatomy, with suitable components for a particular application or use, where the user's movement or motion powers or energizes the completed circuit.. In an exemplary embodiment, the power source 106 may have two or more voltage sources, such as piezoelectric cells 110 placed in series to increase voltage output, The power source 106 may be flexible so as to accommodate the arching of the foot or vigorous activity that strains the part of the footwear where the partial circuitry is located, In one exemplary embodiment, the piezoelectric cells comprising the power source 106 may have a voltage of at least 2.5 V, and generate a current of 500 μA. In another exemplar}_' embodiment, the piezoelectric ceils comprising the power source 106 may also have a voltage up to, or within the range of, 250 V, and generate a current up to, or within the range of, 25 μΑ. However, it is noted that voltages and currents may be adjusted significantly depending on the particular stimulation desired. Additionally, in one embodiment, the piezoelectric cells have a nominal diameter of approximately 30 mm. However, it is further noted that depending on the placement within the specific device, cell diameters as low as 10 mm and higher than 40 mm may be used, and even less than 10 mm in certain applications. Moreover, in some embodiments, piezoelectric cells 110 may be in other shapes and forms such as an elongated shape, ribbon shaped, or other irregular shapes to suit a particular application. These other shapes may be sized according to their specific use. For example, in some embodiments a ribbon shaped strip which measures approximately 12x150 millimeters is used. The specific dimensions given herein are not intended to be limiting, but intended to illustrate particular sizes that may be employed in particular circumstances and applications.

The power source, or sources, can be configured to deliver electrical stimulation that is above, at, or below the threshold of human sensation.

Further, in exemplar}' embodiments that include multiple piezoelectric cells, the insert 200 may have at least one piezoelectric ceil of the power source 106 coupled to the anode 104 by way of soldering. A second piezoelectric cell contained in the power source 106 may also be coupled to the cathode 102 by way of soldering. It should be noted, though, that any acceptable method for conduct! vely coupling a piezoelectric cell to a lead or to another piezoelectric cell or battery may be used in various embodiments. The soldered subassembly forms the partial circuit pathway 108,

Fig, 3 illustrates another exemplary embodiment of the footwear 300 configured to stimulate the foot of a user that is in the form of an insole 111, The example system of Fig. 3 adapts an insole 111 with at least one cathode 102 and one anode 104 and a power source 106, A partial circuit pathway 108 is formed when the power source 106 is coupled to the anode 104 and the cathode 102. The partial circuit pathway 108 forms a complete circuit when the insole 111 is electrically coupled, either directly or indirectly, to a foot 110. The footwear 300 can be in the form of a shoe, boot, sandal, and the like.

Fig. 9 illustrates an exemplary embodiment of a stimulation device embodied in a garment, in this example a footwear insole or insert 900, employed to stimulate the foot of a user. The footwear insole or insert 900 includes at least one cathode 902, one anode 904, and a power source 906, in particular one or more piezoelectric cells or devices 910. A partial circuit pathway 908 is formed when the power source 906 is coupled to the anode 904 and the cathode 902. in this exemplary embodiment, the partial circuit pathway 908 forms a complete circuit when insole insert 900 comes in contact with a user's foot, either directly or indirectly, but in either case, being electrically coupled to the foot. In this exemplary embodiment, the power source 906 is an elongate piezoelectric cell or array. The particular shape of the power source 906 can be any size or arrangement suitable for the particular application. For example, the power source in a glove will likely Fig, 4 illustrates another exemplary embodiment of footwear 400 employed to stimulate the foot of a user in the form of a unitary sole 114 or sole portion, such as, for example, those used on Keen® footwear or Crocs® footwear. The exemplary system adapts a unitary sole 114 having a partial circuit pathway (not shown) with at least one cathode 102 and one anode 104 and a power source 106. A partial circuit pathway (not shown) is formed when the power source 106 is coupled to the anode 104 and the cathode 102. The partial circuit pathway forms a complete circuit when the unitary sole 114 is electrically coupled, either directly or indirectly, to a foot 110. The

footwear 400 can be in the form of, for example, a sandal or other item with a unitary sole.

The schematic flow chart diagrams that follow are generally set forth as logical flow chart diagrams. As such, the depicted order and labeled steps are indicative of one possible embodiment of the method presented. One of ordinary skill in the art, upon reading the present disclosure, will appreciate that other steps and methods may be implemented that are equivalent in function, logic, or effect to one or more steps, or portions thereof, of the illustrated method. Moreover, in some instances embodiments may omit certain steps altogether. Additionally, the order in which a particular method occurs need not strictly adhere to the order of the corresponding steps shown. Fig. 5 illustrates a flowchart depicting a method 500 of making a device for providing electrical stimulation to a user. The method 500 starts at block 502. A circuit module 504 includes a partial circuit, such as the partial circuit 108 of Fig. 1, within the device, including an anode, a cathode, and a power generating device in which the partial circuit is adapted to be completed when coupled to a user. The circuit module 504 may include disposing the power source within the device and may also include disposing electrical leads (e.g., wire or conductive thread) through a surface of the device and connecting to leads to the power source perhaps by soldering. A stimulation module 506 administers electrical stimulation to the user when the user device is worn, and the user generates power within the power source by normal movements of the user. The device itself may be embodied in a garment such as a shoe, sock, removable insert for a shoe, glove, and the like. The method 500 ends at block 508,

Fig, 6 illustrates a flowchart depicting a method 600 of delivering electrical stimulation to an area of a user's body via a garment worn by the user, wherein the garment comprises a power source coupled to one or more electrical leads and the garment is further configured to be at least partially powered from the power source as a result of pressure exerted or displacement caused by a user upon movement of the user. The method 600 of this embodiment starts at block 602. A generate module 604 generates electrical current by the power source resulting at least in part from pressure exerted or displacement caused by the user, A deliver module 606 delivers the electrical current via the one or more electrical leads to the area of the user's body. The method 600 ends at block 608.

Fig. 7 illustrates a flowchart depicting a method 700 for treating or inhibiting effects caused by peripheral neuropathy. The method 700 of this embodiment starts at block 702. A diagnose module 704 diagnoses a patient with peripheral neuropathy. A treat module 706 includes commencing treatment, by administering to a subject in need of such treatment, a regimen of electrical stimulation directed to an area of the patient. The electrical stimulation is conveyed by a device that comprises a garment that houses a power source and one or more electrical leads configured to deliver electrical stimulation to said area, wherein at least a portion of the power is generated by pressure or displacement on said power source as a result of regular movements of said user. The method 700 ends at block 708. It is noted that while the specific embodiment illustrated herein is for treating peripheral neuropathy, similar methods and devices may be utilized for users who experience muscle fatigue and may benefit from targeted electrical stimulation to relieve general discomfort.

Fig, 8 illustrates a flow chart depicting a method 800 of making a garment. The method 800 starts at block 802. A form module 804 forms a potential, or partial, circuit, such as the partial circuit 108 of Fig. 1, within a garment to be worn by a patient. The circuit may include an anode, a cathode, and a power generating device in which the partial circuit is adapted to be completed when coupled to the patient and furthermore in which the power generating device is placed within the garment such that the power generating device uses the movement of the user to provide the electrical stimulation.

Although the present disclosure and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the disclosure as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the present disclosure, processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present disclosure. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps.

Claims

What is claimed is:

1. A system configured to be worn by a user and to provide electrical stimulation to the user, the system comprising:

a power source configured to generate power at least partially using pressure or displacement resulting from normal movement of said user: and

at least one conductive lead coupled to the power source, wherein the at least one conductive lead is configured to convey electrical stimulation from said power source to a pre-determined area of the user,

2. The system of claim 1 wherein the at least one conductive lead includes an anode and cathode configured to form a complete circuit when the user is comes in contact with said system.

3. The system of claim 1 , where the power source is a piezoelectric cell,

4. The system of claim 3, where the piezoelectric cell ranges from approximately 10 to 40 mm in diameter, 5. The system of claim 3, where the piezoelectric cell has a voltage within an approximate range of at least 2.

5-250 volts (V) and generates a current of within an approximate range of 25-500 microamps (μΑ).

6. The system of claim 1, where the power source includes at least two piezoelectric cells in series.

7. The system of c laim 6, where the piezoelectric cells are flexible.

8. The system of claim 1, where the power source and at least one conductive lead are included within one of a glove or a footwear.

9. The system of claim 8, where the power source is disposed between the ball and heel of the footwear,

10. The system of claim 8, where the at least one conductive lead comprises a plurality of leads configured to provide electrical stimulation to at least one of a heel, a ball, and toes of the user.

11. The system of claim 8, where the footwear comprises an insert formed at least in part from at least one of a molded gel and foam rubber,

12. The system of claim 8, where the power source is located in a palm side of a glove.

13. The system of claim 8, where the at least one conductive lead comprises a plurality of leads configured to provide electrical stimulation to at least one of a palm, fingers and a wrist of the user.

14. The system of claim 1 , where the at least one conductive lead comprises an item selected from the list consisting of wire and thread.

15. The system of claim 14 where the at least one conductive lead is selected from a material consisting of silver-infused nylon thread, carbon infused thread, or carbon nanofiber thread.

16. The system of claim 14, where the at least one conductive lead is woven through the surface of the system.

17. The system of claim 14, where the at least one conductive lead protrudes through the surface of the system.

18. A method of making a garment for providing electrical stimulation to a user, the method comprising:

forming a partial circuit within the garment including an anode and cathode and power generating device in which the partial circuit is adapted to be completed when coupled to a user and furthermore in which the power generatmg device is placed within the garment such that the power generating device uses the movement of the user to provide the electrical stimulation.

19. The method of claim 18, where the power source includes a piezoelectric cell.

20. The method of claim 19, where the power source includes at least two piezoelectric cells in series.

21. The method of claim 18 where the power source includes a battery.

22. The method of claim 18, where the power source is disposed between the ball and heel of a user's foot.

23. The method of claim 1 8, where the cathode and anode comprise one or more of electrically conductive wire and thread.

24. The method of claim 23, in which the forming of the partial circuit within the garment includes weaving at least one of the anode and cathode through the surface of the garment.

25. The method of claim 18, in which the forming of the partial circuit within the garment includes positioning the anode and cathode on the garment approximately underneath the heel of the foot.

26. The method of claim 18, in which the forming of the partial circuit within the garment includes positioning the anode and cathode on the garment approximately underneath the ball of the foot.

27. The method of claim 18, in which the forming of the partial circuit within the garment includes positioning the anode and cathode on the garment approximately underneath the toes of the foot.

28. The method of claim 18, where the garment comprises one of a glove, shoe, sock, unitary sole, and removable insert.

29. A method of delivering electrical stimulation to an area of a user's body via a garment worn by the user, wherein the garment comprises a power source coupled to one or more electrical leads and the garment is further configured to be at least partially powered from the power source, the method comprising:

generating electrical current by said power source resulting at least in part from pressure exerted by the user; and

delivering the electrical current via the one or more electrical leads to the area of the user's body.

30. The method of claim 29 wherein the garment is embodied as a removable shoe insert,

31. The method of claim 30 wherein the removable shoe insert is formed at least in part from a gel material.

32. A method for treating or inhibiting effects caused by peripheral neuropathy comprising:

commencing treatment, by administering to a subject in need of such treatment, a regimen of electrical stimulation directed to a area of the subject wherein said electrical stimulation is conveyed by a device which comprises a garment which houses a power source and one or more electrical leads configured to deliver electrical stimulation to said area, wherein at least a portion of power of the electrical stimulation is generated by pressure displacement on said power source as a result of regular movements of said user.

33. The method of claim 32 wherein the garment is embodied as a removable shoe insert.

34. The method of claim 32 wherein the removable shoe insert is formed at least in part from a gel material.

35. The method of claim 32 wherein the garment is embodied as one of a sock, shoe, and glove.

36. A footwear insert including:

a partial electrical circuit pathway adapted to be completed by electrically coupling to a user's anatomy.

37. The insert of claim 36, wherein the partial electrical circuit pathway includes an anode and a cathode and a piezoelectric power source therebetween,

38. The insert of claim 36, wherein the partial electrical circuit pathway adapted to be completed by electrically coupling indirectly to a user's anatomy,

39. An article of clothing including:

a partial electrical circuit pathway adapted to be completed by electrically coupling to a user's anatomy, wherein the partial circuit pathway includes a power source powered by the user's movement.

40. The article of claim 39, wherein the article is footwear.

41. The article of claim 40, wherein the footwear includes a unitary sole.

42. The article of claim 41, wherein the partial electrical circuit pathway is molded into the unitary sole.

43. The article of claim 40, wherem the footwear is a shoe, a hoot, or a sandal .