Pancreas regeneration treatment for diabetics using extracorporeal acoustic shock waves

• US 7,988,648 B2
• Filed: 02/20/2007
• Issued: 08/02/2011
• Est. Priority Date: 03/04/2005
• Status: Active Grant

• Current Assignee: Softwave Tissue Regeneration Technologies, LLC
• Original Assignee: General Patent, LLC (Tissue Regeneration Technologies LLC)
• Inventors: Schaden, Wolfgang, Warlick, John, Schultheiss, Reiner
• Primary Examiner(s): Chen; Tse
• Assistant Examiner(s): RAMIREZ, JOHN FERNANDO
• Application Number:
  US11/676,761
• Publication Number:
  US 20070142753A1
• Time in Patent Office: 1,624 Days
• Field of Search: 601/2, 601/4, 600/437, 600/427
• US Class Current: 601/2
• CPC Class Codes: A61H 23/008 using shock waves
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

The method of stimulating a tissue of a subsurface organ is disclosed. The method has the steps of activating an acoustic shock wave generator or source to emit acoustic shock waves; and subjecting the tissue to the acoustic shock waves stimulating said tissue wherein the tissue is positioned within a path of the emitted shock waves and away from a geometric focal volume or point of the emitted shock waves. In one embodiment the emitted shock waves are divergent or near planar. In another embodiment the emitted shock waves are convergent having a geometric focal volume of point at a distance of at least X from the source, the method further comprising positioning the tissue at a distance less than the distance X from the source. The subsurface organ is a tissue having cells. The tissue is a part of the incretin system. The subsurface organ is preferably the pancreas of a diabetic or at risk diabetic patient. The treatment stimulates the pancreatic tissue by an analgesic effect on the nerves and a stimulation of the insulin producing islets.

Claims

1. The method of stimulating a tissue of a subsurface organ comprises the steps of:

treating the tissue of the subsurface organ;

activating an acoustic shock wave generator or source to emit pressure pulses or acoustic shock waves directed toward the tissue of the subsurface organ to impinge the tissue of the subsurface organ with pressure pulses or shock waves having a low energy density in the range of 0.00001 mJ/mm² to 1.0 mJ/mm²;

the pressure pulse being an acoustic pulse which includes several cycles of positive and negative pressure, wherein the pressure pulse has an amplitude of the positive part of such a cycle should be above 0.1 MPa and the time duration of the pressure pulse is from below a microsecond to about a second, rise times of the positive part of the first pressure cycle in the range of nano-seconds (ns) up to some milli-seconds (ms), the acoustic shock waves being very fast pressure pulses having amplitudes above 0.1 MPa and rise times of the amplitude being below 100'"'"'s of ns, the duration of the shock wave is typically below 1-3 micro-seconds (μ

s) for the positive part of a cycle and typically above some micro-seconds for the negative part of a cycle;

subjecting the tissue of the subsurface organ to convergent, divergent, planar or near planar acoustic shock waves or pressure pulses in the absence of a focal point impinging the substance stimulating a cellular response in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of cellular hemorrhaging caused by the emitted waves or pulses in the tissue of the subsurface organ wherein the tissue of the subsurface organ is positioned within a path of the emitted shock waves or pressure pulses and away from any localized geometric focal volume or point of the emitted shock waves wherein the emitted shock waves or pressure pulses either have no geometric focal volume or point or have a focal volume or point ahead of the tissue of the subsurface organ or beyond the tissue of the subsurface organ thereby passing the emitted waves through the tissue of the subsurface organ while avoiding having any localized focal point within the tissue of the subsurface organ wherein the emitted pressure pulses or shock waves are convergent, divergent, planar or near planar and the pressure pulse shock wave generator or source is based on electro-hydraulic, electromagnetic, piezoceramic or ballistic wave generation having an energy density value ranging as low as 0.00001 mJ/mm² to a high end of below 1.0 mJ/mm².

2. The method of stimulating a tissue of a subsurface organ of claim 1 wherein the emitted shock waves are divergent or near planar.

3. The method of stimulating a tissue of a subsurface organ of claim 1 wherein the emitted shock waves are convergent having a geometric focal volume or point at a distance of at least X from the generator or source, the method further comprising positioning the tissue at a distance less than the distance X from the source.

4. The method of stimulating a tissue of a subsurface organ of claim 1 wherein the tissue is a tissue having cells.

5. The method of stimulating a tissue of a subsurface organ of claim 4 wherein the tissue is an organ of a mammal.

6. The method of stimulating a tissue of a subsurface organ of claim 5 wherein the mammal is a human or an animal exhibiting type 1 or type 2 diabetes condition.

7. The method of stimulating a tissue of a subsurface organ of claim 6 wherein the organ is a pancreas.

8. The method of stimulating a tissue of a subsurface organ of claim 6 wherein the organ is a liver.

9. The method of stimulating a tissue of a subsurface organ of claim 6 wherein the organ is a kidney.

10. The method of stimulating a tissue of a subsurface organ of claim 4 wherein the tissue is a part of the incretin system.

11. The method of stimulating a tissue of a subsurface organ of claim 10 wherein the tissue is a part of the incretin system, including alpha cells, beta cells, neural cells, nerve cells and islets for the production of insulin.

12. The method of stimulating a tissue of a subsurface organ of claim 11 wherein the tissue is a part of the pancreas.

13. The method of stimulating a tissue of a subsurface organ of claim 12 wherein the step of subjecting the tissue to acoustic shock waves creates an analgesic effect on the nerve cells sufficient to deactivate the pancreatic sensory nerves and to thereby stimulate the islets to begin producing insulin normally.

14. The method of stimulating a tissue of a subsurface organ of claim 12 wherein the step of subjecting the tissue to acoustic shock waves reduces the chronic inflammation of islets of the pancreas.

15. The method of stimulating a tissue of a subsurface organ of claim 12 wherein the step of subjecting tissue to acoustic shock waves stimulates the nerve cells of the pancreas to secrete neuropeptides.

16. The method of stimulating a tissue of a subsurface organ of claim 12 wherein the step of subjecting the substance to acoustic shock waves stimulates at least some of said cells within said substance to release or produce one or more of nitric oxygen (NO), vessel endothelial growth factor (VEGF), bone morphogenetic protein (BMP) or other growth factors.

17. The method of stimulating a substance of claim 4 wherein the substance tissue has a pathological condition.

18. The method of stimulating a tissue of a subsurface organ of claim 12 wherein the organ is in a degenerative condition.

19. The method of stimulating a tissue of a subsurface organ of claim 12 further comprises the step of injecting neuropeptide substance P into the pancreas to stimulate the nerve cells and allow islets to produce insulin properly.

20. The method of preventive shock wave therapy comprises the steps of:

identifying a diabetic at risk patient, the patient having an at risk tissue;

treating the at risk tissue;

subjecting the at risk tissue to shock waves to stimulate tissue repair;

activating an acoustic shock wave generator or source to emit pressure pulses or acoustic shock waves directed toward the at risk tissue to impinge the at risk tissue with pressure pulses or shock waves having a low energy density in the range of 0.00001 mJ/mm² to 1.0 mJ/mm²;

the pressure pulse being an acoustic pulse which includes several cycles of positive and negative pressure, wherein the pressure pulse has an amplitude of the positive part of such a cycle should be above 0.1 MPa and the time duration of the pressure pulse is from below a microsecond to about a second, rise times of the positive part of the first pressure cycle in the range of nano-seconds (ns) up to some milli-seconds (ms), the acoustic shock waves being very fast pressure pulses having amplitudes above 0.1 MPa and rise times of the amplitude being below 100'"'"'s of ns, the duration of the shock wave is typically below 1-3 micro-seconds (μ

s) for the positive part of a cycle and typically above some micro-seconds for the negative part of a cycle; and

subjecting the at risk tissue to convergent, divergent, planar or near planar acoustic shock waves or pressure pulses in the absence of a focal point impinging the at risk tissue stimulating a cellular response in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of cellular hemorrhaging caused by the emitted waves or pulses in the at risk tissue wherein the at risk tissue is positioned within a path of the emitted shock waves or pressure pulses and away from any localized geometric focal volume or point of the emitted shock waves wherein the emitted shock waves or pressure pulses either have no geometric focal volume or point or have a focal volume or point ahead of the at risk tissue or beyond the at risk tissue thereby passing the emitted waves through the at risk tissue while avoiding having any localized focal point within the at risk tissue wherein the emitted pressure pulses or shock waves are convergent, divergent, planar or near planar and the pressure pulse shock wave generator or source is based on electro-hydraulic, electromagnetic, piezoceramic or ballistic wave generation having anenergy density value ranging as low as 0.00001 mJ/mm² to a high end of below 1.0 mJ/mm².

21. The method of preventive shock wave therapy of claim 20 wherein the step of identifying an at risk patient includes one or more indications of risk based on family history, genetic disposition, physical condition, or blood or tissue analysis.

22. The method of preventive shock wave therapy of claim 20 further comprises the step of testing the at risk tissue to establish measured baseline condition pre shock wave therapy.

23. The method of preventive shock wave therapy of claim 22 further comprises the step of post shockwave therapy testing the treated tissue for comparison to the baseline condition.