Method to treat vascular dysfunction through enhanced vascular flow and hemodynamic activation of the autocrine and paracrine processes

• US 9,849,283 B2
• Filed: 01/29/2016
• Issued: 12/26/2017
• Est. Priority Date: 01/29/2016
• Status: Active Grant

• Current Assignee: Shear Stress Therapeutics LLC
• Original Assignee: Shear Stress Therapeutics LLC
• Inventors: Owen, John M.
• Primary Examiner(s): D ABREU, MICHAEL JOSEPH
• Application Number:
  US15/010,750
• Publication Number:
  US 20170216591A1
• Time in Patent Office: 697 Days
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters

Abstract

A method and system for creating shear stress and endothelial mechanotransduction through neuromuscular stimulation of the muscle pump. Chronic application a minimum of 30 days triggers the autocrine and paracrine processes which elevates production of vasoactive substances including nitric oxide, prostacyclin, superoxide dismutase, thrombomodulin, glutathion, Krupple-like factor 2 and many others. Chronic application also promotes angiogenesis and development of collateral circulation. This is a cost-effective, non-invasive, drug-free therapy to treat vascular dysfunction and ameliorate or reverse its effects on cardiovascular health.

Claims

1. A method for treating vascular dysfunction through neuromuscular stimulation and flow-mediated endothelial mechanotransduction, comprising the steps of:

providing a controller for the generation of electrical waveforms;

operably associating the controller to a plurality of treatment pads and a plurality of leads, the leads in electrical communication with the controller;

coupling the plurality of treatment pads and treatment leads to both the upper and lower extremities of a human body; and

initiating an electrical stimulation signal through the leads and into the tissue of the body, the controller regulating the electrical stimulation signal;

wherein the electrical stimulation signal is configured to contract skeletal muscle on the body to induce endothelium mechanotransduction in a blood vessel, the endothelium mechanotransduction resulting from induced frictional drag between blood cells and an endothelial layer of the blood vessel, the endothelium mechanotransduction activating both paracrine and autocrine process; and

wherein the electrical stimulation signal is regulated through the plurality of treatment pads and leads in a sequential manner with overlapping intervals of contractions from a distal end to a proximal end of each extremity.

2. The method of claim 1, wherein the waveforms are provided in a plurality of sequential treatment intervals from distal to proximal on each extremity.

3. The method of claim 2, wherein the treatment intervals vary in length between one half second to a plurality of seconds.

4. The method of claim 2, wherein each treatment interval commences before a preceding treatment interval ends, providing overlap of said treatment intervals.

5. The method of claim 1, wherein the plurality of pads are distributed along a route of at least one extremity of the human body.

6. The method of claim 5, wherein the plurality of pads are aligned in pairs and located in an opposed placement to one another.

7. The method of claim 1, wherein the controller is configured to regulate at least one of the duration, intensity, sequence, and form of the waveform.

8. The method of claim 1, wherein communication between the controller and the plurality of leads is performed through one or more wires.

9. The method of claim 1, wherein communication between the controller and the plurality of leads is performed through wireless signals.

10. The method of claim 1, wherein the pads are coupled to the dermal surface of the body by at least one of the following methods including an adhesive, a strap, a hook and loop fastener, an elastic member, and a garment.

11. The method of claim 1, further comprising:

adjusting intensities throughout each treatment and the entire series of treatments in response to changing conditions of the tissue being treated.

12. The method of claim 1, further comprising:

adjusting the waveform during the treatment for sufficient intensity to contract skeletal muscles and activate the venous muscle pump.

13. The method of claim 1, wherein the electrical stimulation signal is of sufficient intensity and sequentially provided, will activate a venous muscle pump and create elevated levels of blood flow delivering elevated levels of nutrients and oxygen to the skeletal muscle.

14. The method of claim 1, wherein the electrical stimulation signal is configured to selectively contract the skeletal muscle so as to elevate blood flow in the blood vessels, the elevated blood flow will increase laminar shear stresses on the endothelium of the blood vessel and thus induce or elevate endothelial mechanotransduction resulting in increased production of vasoactive substances including, but not limited to nitric oxide, prostacyclin, thrombomodulin, glutathione, Krupple-like factor 2, endothelial progenitor cells, C peptides, carbon monoxide, bradykinin, superoxide dismutase, adenosine, thioredoxin, adrenomedullin, heme oxygenase-1, and granulocyte-macrophage colony stimulating factor.

15. The method of claim 1, further comprising:

elevating the intensity of the electrical stimulation on the body to bring some discomfort.

16. The method of claim 1, wherein the waveform includes large inter-pulse spacing without ramping.

17. The method of claim 1, further comprising:

adjusting the electrical stimulation signal for each extremity individually and in sequential order.

18. The method of claim 1, further comprising:

adjusting the intensity of the electrical stimulation signal in response to nerve sensitivity during treatment.