Self-powered bioelectric stimulation device and system

Abstract

A self-powered bioelectric stimulation device configured to deliver electrical stimulation to biological tissue. The device includes a flexible support structure containing at least one energy-harvesting element capable of converting mechanical, thermal, acoustic, or vibrational energy into electrical energy. The generated electrical energy is transmitted through a conductive interface positioned adjacent to biological tissue. The device, in embodiments, may be configured as a bandage, patch, wrap, garment, or other wearable therapeutic structure. In some embodiments, the energy-harvesting element includes piezoelectric or pyroelectric materials embedded within a flexible substrate. In embodiments, electrical energy may be generated based on body movement, pressure, temperature variation, or vibration. The device, in embodiments, provides a wearable platform for delivering bioelectric stimulation without requiring batteries or external electrical power sources.

Description

Atty. Dkt. No. 00876-5SELF-POWERED BIOELECTRIC STIMULATION DEVICE AND SYSTEMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to and benefit of U.S. Provisional Patent Application Serial No. 63 / 777,963 filed March 26, 2025 and entitled Ultra-Bandage, the entire content of which is incorporated by reference herein.BACKGROUNDField

[0002] The present disclosure relates to wearable therapeutic devices and bioelectric stimulation systems. More particularly, the present disclosure relates to self-powered devices capable of generating electrical stimulation using energy harvested from mechanical, thermal, or vibrational inputs.Related Art

[0003] Electrical stimulation has been shown to influence biological processes including cellular migration, tissue repair, and inflammation modulation. Existing electrotherapy devices typically require batteries, wired power sources, or external equipment. These requirements limit portability and ease of use.

[0004] Accordingly, it would be beneficial to provide a wearable device capable of generating therapeutic electrical stimulation without relying on external electrical power sources that avoids these and other problems.SUMMARY

[0005] The present invention provides a self-powered bioelectric stimulation device that generates electrical energy from physical inputs such as movement, pressure, temperature variation, or vibration.

[0006] In one embodiment, the device includes a flexible support structure containing an energy-harvesting element capable of converting mechanical, thermal, or acoustic energy into4915-1390-8123v.lAtty. Dkt. No. 00876-5electrical energy. The generated electrical energy is transmitted through a conductive interface to biological tissue positioned adjacent to the device.

[0007] The device may be configured in multiple forms including a wearable patch, a bandage, a wrap, a garment, or another therapeutic surface.

[0008] A wearable bioelectric stimulation device configured for placement adjacent to biological tissue in accordance with an embodiment of the present disclosure includes: a flexible support structure; an energy-harvesting element disposed within the support structure and configured to generate an electrical charge based on a combination of mechanical, thermal, acoustic, or vibrational inputs; and a conductive interface electrically connected to the energy harvesting element and in contact with the biological tissue to transmit the generated electrical charge to the biological tissue.

[0009] In embodiments, the device includes an outer protective layer, wherein the energy-harvesting element is positioned between the outer protective layer and the conductive interface.

[0010] In embodiments, the protective outer layer, support structure and the conductive interface are formed in a multilayer configuration.

[0011] In embodiments, the flexible support structure comprises a biocompatible material.

[0012] In embodiments, the biocompatible material is selected from a group consisting of textile materials, polymer films, elastomeric materials, and combinations thereof.

[0013] In embodiments, the conductive interface comprises one of the group consisting of conductive fabric, conductive polymer, conductive thread, metallic elements, and conductive hydrogel.

[0014] In embodiments, the electrical charge is provided to the biological tissue through a conductive medium.

[0015] In embodiments, the energy-harvesting element is configured to generate electrical energy in response to mechanical pressure.

[0016] In embodiments, the mechanical pressure is the result of movement of a user associated with the biological tissue.

[0017] In embodiments, the energy-harvesting element generates the electrical charge in response to thermal variation.24915-1390-8123v.lAtty. Dkt. No. 00876-5

[0018] In embodiments, the energy-harvesting element generates the electrical charge in response to an acoustic input.

[0019] In embodiments, the energy-harvesting element generates the electrical charge in response to a vibrational input.

[0020] In embodiments, the energy-harvesting element generates the electrical charge in response to deformation of the device during use.

[0021] In embodiments, the energy-harvesting element generates the electrical charge based on more than one of a mechanical input, a thermal input, an acoustic input, and a vibrational input.

[0022] In embodiments, the energy-harvesting element includes a piezoelectric material.

[0023] In embodiments, the energy-harvesting element includes a pyroelectric material.

[0024] In embodiments, the energy-harvesting element includes crystalline material arranged within the flexible support structure and responsive to at least one of mechanical pressure, thermal variation, acoustic stimulation, or vibrational input, such that electrical energy is generated and transmitted to biological tissue through the conductive interface.

[0025] In embodiments, the crystalline material includes at least one of the group comprising quartz, tourmaline, Rochelle salt, topaz, zincite and selenite.

[0026] In embodiments, the energy-harvesting element includes particles, fibers, powders, plates, or embedded structures within the support structure.

[0027] In embodiments, the energy-harvesting element includes a combination of crystalline materials and synthetic piezoelectric materials.

[0028] In embodiments, the device operates without external activation.

[0029] In embodiments, the electrical charge is provided based on natural body movement and environmental interaction.

[0030] In embodiments, the device is configured as one of a group consisting of a bandage, a patch, a wrap, a compression sleeve, a garment, and a wearable textile.

[0031] In embodiments, the device includes a sensor configured to monitor conditions of the biological tissue.

[0032] A method for stimulating biological tissue in accordance with an embodiment of the present disclosure includes: placing a wearable device adjacent to the biological tissue, the34915-1390-8123v.lAtty. Dkt. No. 00876-5device including an energy-harvesting element; generating, by the energy-harvesting element, an electrical charge from a mechanical input, a thermal input, an acoustic input, or a vibrational input; and transmitting the generated electrical charge to the biological tissue through a conductive interface.

[0033] In embodiments, the electrical charge has a voltage in the range of approximately 1 mV to 10 V.

[0034] In embodiments, the electrical charge provides a current in the range of approximately 0.1 pAto 1000 pA.

[0035] In embodiments, the generating and transmitting steps provide electrical stimulation continuously or intermittently over a period of time ranging from minutes to multiple days.

[0036] In embodiments, the conductive interface is configured to contact both healthy tissue and affected tissue to facilitate electrical gradients across a treatment area.

[0037] In embodiments, the electrical charge varies based on orientation of the wearable device relative to applied mechanical forces.

[0038] In embodiments, electrical charge generation increases in response to temperature variation across the device.

[0039] A wearable bioelectric stimulation device configured for placement adjacent to biological tissue in accordance with an embodiment of the present disclosure includes: a flexible support structure; an energy-harvesting element disposed within the support structure, the energy-harvesting element comprising one or more crystalline materials configured to generate electrical energy in response to a mechanical input, a thermal input, an acoustic input, or a vibrational input; and a conductive interface electrically connected to the energy-harvesting element configured to transmit the generated electrical charge to the biological tissue.

[0040] In embodiments, the crystalline materials are arranged within the support structure in a selected configuration to influence electrical generation characteristics.

[0041] In embodiments, the crystalline materials are arranged with a defined spatial distribution, orientation, density, and alignment within the support structure.

[0042] In embodiments, a configuration of the crystalline material enhances responsiveness to one or more of a mechanical input, a thermal input, or a vibrational input.44915-1390-8123v.lAtty. Dkt. No. 00876-5

[0043] In embodiments, different configurations of the crystalline material produce different electrical output profiles.

[0044] In embodiments, the crystalline material is arranged in a repeating geometric lattice configuration.BRIEF DESCRIPTION OF THE DRAWINGS

[0045] FIG. 1 illustrates a cross-sectional view of a wearable bioelectric stimulation device in accordance with an embodiment of the present disclosure;

[0046] FIG. 2 illustrates an exemplary device applied to a human forearm indicating electrical energy transfer from the energy-harvesting element toward the skin biological tissue of the human; and

[0047] FIG. 3 illustrates an exemplary flow chart showing a method of providing bioelectric stimulation to biological tissue.DESCRIPTION OF THE EMBODIMENTS

[0048] In embodiments, a wearable bioelectric stimulation system 10 includes a flexible support structure 12 including an energy -harvesting element 14 and a conductive interface 16. In embodiments, the system 10 may be implemented as a wound dressing, however, in not limited to this configuration and may be implemented as any wearable structure, for example, a patch, dressing, sleeve, garment, to name a few.

[0049] In embodiments, the energy-harvesting element 14 may include crystalline material. In embodiments, the crystalline material may be arranged in the support structure in a desired pattern or configuration to generate electricity. In embodiments, the crystalline material may be arranged in a repeating geometric configuration within the support structure 12. In embodiments, the crystalline material may be arranged in a lattice-based configurations within the support structure 12. In embodiments, the crystalline material may be arranged in a symmetrical configuration. In embodiments, the crystalline material may be arranged in an overlapping configuration. In embodiments, the crystalline material may be arranged in a multidirectional arrangement. In embodiments, the crystalline material may be provided with a desired the spatial distribution. In embodiments, the crystalline material may be positioned to54915-139C)-8123v.lAtty. Dkt. No. 00876-5allow for interaction to generate electricity. In embodiments, the arrangement of the crystalline material provides for uniform generation of electricity across the device 10.

[0050] In embodiments, the flexible support structure 12 may be configured for contact with biological tissue. In embodiments, the flexible support structure 12 may include materials suitable for prolonged skin contact. In embodiments, these materials may include cotton, polymer mesh, silicone-coated fabric, medical textiles, elastomeric materials, or other biocompatible flexible substrates.

[0051] In embodiments, the support structure 12 may be configured as a bandage, patch, wrap, garment, or other wearable element that positions the device 10 adjacent to biological tissue on a user’s body.

[0052] In embodiments, the energy-harvesting element 14 is disposed within or integrated into the flexible support structure 12 and converts physical input into electrical energy. In embodiments, the energy-harvesting element 14 comprises the crystalline material. In embodiments, the crystalline material may be a piezoelectric material or a pyroelectric material. Piezoelectric material generates an electric charge in response to mechanical stress applied to the material. In embodiments, the mechanical stress applied to the piezoelectric material may be the result of user movements while wearing the device 10. In embodiments, the crystalline material may be configured in the support structure 12 such that user movement while wearing the device 10 provides sufficient mechanical pressure to generate electricity. In embodiments, sufficient mechanical pressure may be applied to the piezoelectric material using a sonic input or a vibrational input. In embodiments, sound waves of a specific frequency may be sufficient to generate electricity.

[0053] Suitable crystalline material may include quartz, tourmaline, Rochelle salt, topaz, zincite, selenite, synthetic piezoelectric materials or piezoelectric ceramics, to name a few. In embodiments, the crystalline material may be present in various forms, including particles, fibers, plates, powders, or embedded structures. In embodiments, the energy-harvesting element 14 may include additional passive energy-conversion materials capable of generating electrical energy in response to physical stimuli. In some embodiments, the energy-harvesting element 14 may not be limited to a fixed material composition. In embodiments, the energy harvesting element 14 may include a single-layer film or multiple layers. In embodiments, the energy harvesting element 14 may include a laboratory -fabricated structure. In embodiments, the energy harvesting element 1464915-139C)-8123v.lAtty. Dkt. No. 00876-5may include distributed materials integrated within a flexible substrate in specific configurations to influence electrical generation characteristics. In embodiments, multiple substrates may be used, with the substrates using different materials and / or having different orientations.

[0054] In embodiments, the configuration of materials in the harvesting element 14 may include variations in spatial distribution, orientation, density, or alignment of the crystalline materials. In embodiments, the crystalline materials may be randomly distributed within the support structure 12. In embodiments, the crystalline material may be oriented or aligned to enhance responsiveness to specific types or directions of applied force to aid in electric generation.

[0055] In embodiments, the crystalline material may be concentrated in regions of the support structure 14 that experience increased mechanical deformation, such as areas near joints or regions of repeated movement. In embodiments, multiple regions or layers of crystalline material may be provided, each configured to respond to different physical inputs or to produce different electrical output characteristics.

[0056] In embodiments, the configuration and arrangement of the crystalline material may influence the amplitude, frequency, duration, or consistency of the generated electrical charge.

[0057] In embodiments, the conductive interface 16 is electrically connected to the harvesting element 14 to provide electrical energy to the biological tissue. In embodiments, the conductive interface 16 may include conductive textile materials, conductive polymer films, conductive threads or fibers, metallic elements, conductive hydrogels, or other conductive materials. In some embodiments, the conductive interface 16 is positioned directly adjacent to the skin to facilitate efficient transmission of electrical charge to the user’s skin. In embodiments, the conductive interface 16 may be configured to contact healthy tissue, injured tissue, or both, and may be arranged to promote electrical gradients across a treatment area of tissue.

[0058] In embodiments, the energy-harvesting element 14 generates electrical energy in response to physical inputs such as mechanical pressure (for example resulting from body movement), vibration, temperature changes, acoustic stimulation and combinations of these inputs. In embodiments, electrical charge generation may occur during bending, flexing, compression, stretching, or deformation of the device during normal use on the user’s body. In embodiments, electrical charge generation may be the result of multiple physical inputs which74915-1390-8123v.lAtty. Dkt. No. 00876-5enhances output consistency and responsiveness. Tn embodiments, the device 10 dynamically responds to variations in user movement, environmental conditions and physiological interactions to modulate electrical output.

[0059] In embodiments, the device 10 generates electrical energy charges based on one or more of the above inputs which include including mechanical, thermal, vibrational or acoustic stimulation. In embodiments, these different inputs enable operation under a wide range of conditions, including movement, rest, or environmental exposure. In embodiments, the device 10 may generate electrical charge through the combined interaction of multiple physical inputs, for example, including movement, vibration, deflections, etc., enabling adaptive and continuous bioelectric stimulation across a range of conditions. In embodiments, the device 10 provides a simplified, passive architecture that enables scalable and accessible bioelectric therapy without reliance on external system. In embodiments, the device 10 may be used to provide bioelectric stimulation to aid in wound healing, inflammation modulation, nerve stimulation, muscle recovery, pain management, and other therapeutic uses. In embodiments, the crystalline materials may be arranged to influence electrical output and generation characteristics.

[0060] In embodiments, the energy -harvesting element 14 generates an electrical charge suitable for bioelectric stimulation of tissue. In embodiments, the electrical charge may have a voltage between 1 mV to 10 V. In embodiments, the electrical signal may provide a current in the biological tissue from approximately 0.1 pA to 1000 pA. In embodiments, the electrical charge may be used to encourage wound healing. In embodiments, the electrical stimulation may be continuous, intermittent, or pulsed depending on the nature of the physical input. In embodiments, the electrical output may correspond to levels associated with natural bioelectric signaling within the biological tissue.

[0061] In embodiments, the device 10 may operate continuously during wear. In embodiments, electrical generation may be limited to specific time intervals, ranging from minutes to hours or days, depending on exposure to physical inputs. In embodiments, the therapeutic effect may increase with prolonged or repeated exposure to low-level electrical stimulation.

[0062] In embodiments, the electrical characteristics at the conductive interface 16 may vary depending on the condition of the biological tissue. In embodiments, healthy tissue may exhibit different electrical resistance compared to injured or damaged tissue. In embodiments,84915-139C)-8123v.lAtty. Dkt. No. 00876-5the device 10 may facilitate electrical gradients between regions of tissue, which may support biological processes associated with tissue repair.

[0063] In embodiments, the orientation of the energy -harvesting element 14 relative to applied forces may influence electrical generation efficiency and the device 10 may be positioned to maximize generation. In embodiments, electrical output may increase when the device 10 is positioned in areas subject to repeated mechanical deformation such as joints. In embodiments, the device 10 may be configured to respond to forces applied in multiple directions, which may be accomplished by using multiple layers of crystallin material with different orientations, for example.

[0064] In embodiments, where pyroelectric material is used, the energy-harvesting element 14 is responsive to temperature variations associated with body heat as well as environmental conditions. In embodiments, electrical generation may increase in response to temperature gradients or fluctuations. In embodiments, the device 10 may be configured to operate across a range of environmental conditions encountered during normal wear.

[0065] Since the device 10 is self-powered using passive power generation, the device operates without batteries, wired connections, or externally supplied electrical power. The passive nature of the power generation allows the device 10 to rely solely on energy generated from interactions with the body or environment and is activated by users performing normal daily activities.

[0066] In embodiments, the device 10 may be implemented in a variety of items including a bandage, an adhesive bandage, a wearable patch, a therapeutic wrap or compression sleeve, a wearable garment, a therapeutic mat or cushion or a gel-based patch, a modular wearable treatment system. In embodiments, the energy-harvesting element 14 may be removable, replaceable, or modular within the support structure 12.

[0067] The passive, material -based power generation used in the device 10 provides for passive power generation and comfort based on its flexible wearable structure. In embodiments, the device 10 avoids storing electrical energy, external power connections or complex fabrication requirements.

[0068] In embodiments, the energy-harvesting element 14 includes discrete materials embedded within the support structure 12 enabling a simplified and scalable device architecture that may generate electricity in response to common body movements and interactions between94915-139C)-8123v.lAtty. Dkt. No. 00876-5the body and the environment, including movement, temperature variation, and vibration. The device 10 provides a wearable bioelectric stimulation system that is adaptable, passive, and capable of operating under a wide range of conditions. The passive nature of the device 10 and its use of materials based generation allows for variation in material composition a well as fabrication process and allows implementation using a variety of materials and configurations.[0069J In embodiments, the device 10 may be held in place on a user’s body using a layer of adhesive and / or an adhesive that is applied to the conductive interface 16. In embodiments, the device 10 may be integrated into a sleeve or garment and held in place by the sleeve or garment. In embodiments, the device may be held in place by a wrap, or integrated into a wrap that is wrapped around a user’s body part. In embodiments, the device 10 may be held in place using a strap with a fastener such as a snap, a hook and loop fastener, or a buckle, to name a few to allow the device 10 to be secure and removed from the user’s body.

[0070] A method of providing an electrical charge to biological tissue suitable for use with the device 10 discussed above is illustrated in FIG. 3. In step S30, the wearable device 10 may be placed adjacent to the biological tissue, where the device includes an energy-harvesting element. In step S32, the energy-harvesting element generates an electrical charge from a mechanical input, a thermal input, an acoustic input, or a vibrational input. In step S34, the generated electrical charge may be transmitted to the biological tissue through a conductive interface. As is noted above, the electrical charge may be used to create electrical gradients across a treatment area of tissue. In embodiments, such gradients may aid in wound healing. In embodiments, electrical stimulation may provide other health benefits as well.

[0071] Now that embodiments of the present invention have been shown and described in detail, various modifications and improvements thereon can become readily apparent to those skilled in the art. Accordingly, the exemplary embodiments of the present invention, as set forth above, are intended to be illustrative, not limiting. The spirit and scope of the present invention is to be construed broadly.104915-1390-8123v.l

Claims

Atty. Dkt. No. 00876-5What is claimed is:

1. A wearable bioelectric stimulation device configured for placement adjacent to biological tissue, comprising:a flexible support structure;an energy-harvesting element disposed within the support structure and configured to generate an electrical charge based on one or more of mechanical, thermal, acoustic, or vibrational inputs; anda conductive interface electrically connected to the energy harvesting element and in contact with the biological tissue to transmit the generated electrical charge to the biological tissue.

2. The device of claim 1, comprising an outer protective layer, wherein the energyharvesting element is positioned between the outer protective layer and the conductive interface.

3. The device of claim 2, wherein the protective outer layer, support structure and the conductive interface are formed in a multilayer configuration.

4. The device of claim 1, wherein the flexible support structure comprises a biocompatible material.

5. The device of claim 4, wherein the biocompatible material is selected from the group consisting of textile materials, polymer films, elastomeric materials, and combinations thereof.114915-1390-8123v.lAtty. Dkt. No. 00876-56. The device of claim 1 , wherein the conductive interface comprises one of the group consisting of conductive fabric, conductive polymer, conductive thread, metallic elements, and conductive hydrogel.

7. The device of claim 1, wherein the electrical charge is provided to the biological tissue through a conductive medium.

8. The device of claim 1, wherein the energy-harvesting element isconfigured to generate electrical energy in response to mechanical pressure.

9. The device of claim 8, wherein the mechanical pressure is the result of movement of a user associated with the biological tissue.

10. The device of claim 1, wherein the energy-harvesting element generates the electrical charge in response to thermal variation.

11. The device of claim 1, wherein the energy-harvesting element generates the electrical charge in response to an acoustic input.

12. The device of claim 1, wherein the energy-harvesting element generates the electrical charge in response to a vibrational input.

13. The device of claim 1, wherein the energy-harvesting element generates the electrical charge in response to deformation of the device during use.124915-139C)-8123v.lAtty. Dkt. No. 00876-514. The device of claim 1 , wherein the energy-harvesting element generates the electrical charge based on more than one of a mechanical, a thermal, an acoustic, and a vibrational input.

15. The device of claim 1, wherein the energy-harvesting element includes a piezoelectric material.

16. The device of claim 1, wherein the energy-harvesting element includes a pyroelectric material.

17. The device of claim 1, wherein the energy-harvesting element comprises crystalline material arranged within the flexible support structure and responsive to at least one of mechanical pressure, thermal variation, acoustic stimulation, or vibrational input, such that electrical energy is generated and transmitted to biological tissue through the conductive interface.

18. The device of claim 17, wherein the crystalline materials include at least one of the group comprising quartz, tourmaline, Rochelle salt, topaz, zincite and selenite.

19. The device of claim 1, wherein the energy-harvesting element comprises particles, fibers, powders, plates, or embedded structures within the support structure.

20. The device of claim 1, wherein the energy-harvesting element comprises a combination of crystalline materials and synthetic piezoelectric materials.134915-139C)-8123v.lAtty. Dkt. No. 00876-521. The device of claim 1 , wherein the device operates without external activation.

22. The device of claim 1, wherein the electrical charge is provided based on natural body movement and environmental interaction.

23. The device of claim 1, wherein the device is configured as one of a group consisting of a bandage, a patch, a wrap, a compression sleeve, a garment, and a wearable textile.

24. The device of claim 1, comprising a sensor configured to monitor conditions of the biological tissue.

25. A method for stimulating biological tissue, comprising:placing a wearable device adjacent to the biological tissue, the device including an energy-harvesting element;generating, by the energy-harvesting element, an electrical charge from a mechanical input, a thermal input, an acoustic input, or a vibrational input; andtransmitting the generated electrical charge to the biological tissue through a conductive interface.

26. The method of claim 25, wherein the electrical charge has a voltage inthe range of approximately 1 mV to 10 V.144915-139C)-8123v.lAtty. Dkt. No. 00876-527. The method of claim 25, wherein the electrical charge provides acurrent in the range of approximately 0.1 pA to 1000 pA.

28. The method of claim 25, wherein the generating and transmittingsteps provide electrical stimulation continuously or intermittently over a period oftime ranging from minutes to multiple days.

29. The method of claim 25, wherein the conductive interface isconfigured to contact both healthy tissue and affected tissue to facilitate electricalgradients across a treatment area.

30. The method of claim 25, wherein electrical charge varies based on orientation of the wearable device relative to applied mechanical forces.

31. The method of claim 25, wherein electrical charge generationincreases in response to temperature variation across the device.

32. A wearable bioelectric stimulation device configured for placement adjacent to biological tissue, comprising:a flexible support structure;an energy-harvesting element disposed within the support structure,the energy-harvesting element comprising one or more crystalline materials configured to generate electrical energy in response to a mechanical input, a thermal input, an acoustic input, or a vibrational input; and154915-1390-8123v.lAtty. Dkt. No. 00876-5a conductive interface electrically connected to the energy-harvesting element configured to transmit the generated electrical charge to the biological tissue.

33. The device of claim 32, wherein the crystalline materials are arranged within the support structure in a selected configuration to influence electrical generation characteristics.

34. The device of claim 32, wherein the crystalline materials are arrangedwith a defined spatial distribution, orientation, density, or alignment within the support structure.

35. The device of claim 32, wherein a configuration of the crystallinematerial enhances responsiveness to one or more of a mechanical input, a thermal input, or a vibrational input.

36. The device of claim 32, wherein different configurations of thecrystalline material produce different electrical output profiles.

37. The device of claim 32, wherein the crystalline material is arranged in a repeating geometric lattice configuration.164915-1390-8123v.l

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