Methods for promoting nerve regeneration and neuronal growth and elongation

• US 7,544,171 B2
• Filed: 09/29/2005
• Issued: 06/09/2009
• Est. Priority Date: 10/22/2004
• Status: Active Grant

• Current Assignee: Softwave Tissue Regeneration Technologies, LLC
• Original Assignee: General Patent, LLC (Tissue Regeneration Technologies LLC)
• Inventors: Schmidhammer, Robert, Schaden, Wolfgang, Warlick, John, Schultheiss, Reiner
• Primary Examiner(s): Casler; Brian
• Assistant Examiner(s): RAMIREZ, JOHN FERNANDO
• Application Number:
  US11/238,499
• Publication Number:
  US 20070239080A1
• Time in Patent Office: 1,349 Days
• Field of Search: 601 2- 4, 600437-461, 600/427
• US Class Current: 601/2
• CPC Class Codes: A61H 23/008 using shock waves

Abstract

A method of enhancing the regeneration of injured nerves has the step of administering an effective exposure of pressure pulses or acoustic shock waves in a pulse or wave pattern to the zone of injury of the nerve during the regeneration process. The inventive method may include enhancing the stimulation of neuronal cell growth or regeneration by administering an effective exposure of pressure pulses or acoustic shock waves in a pulse or wave pattern to stimulate neuronal cell growth or regeneration, wherein the administering of the treatment is applied to a patient who has a pathological condition where neuronal repair can be facilitated including peripheral nerve damage caused by injury or disease such as diabetes, brain damage associated with stroke, and for the treatment of neurological disorders related to neurodegeneration, including Parkinson'"'"'s disease, Alzheimer'"'"'s disease and amyotrophic lateral, sclerosis multiple sclerosis and disseminated sclerosis. The treatment is ideally suited for neural regeneration after a degenerative condition due to any neurological infections or any other pathological condition.

Claims

1. A method of treating a patient having injured or otherwise diseased nerves to stimulate by accelerating or initiating the regeneration and repair of injured or diseased nerves which comprises the step of:

treating the patient with injured or damaged nerves;

activating an acoustic pressure pulse shock wave generator or source to emit a pressure pulse or acoustic shock waves from a shock wave head, 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 nerves to convergent, divergent, planar or near planar acoustic shock waves or pressure pulses in the absence of a focal point impinging the nerves stimulating a cellular response in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of hemorrhaging in the nerve caused by the emitted waves or pulses wherein the nerve is positioned within an unobstructed 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 nerve or beyond the nerve thereby passing the emitted waves or pulses through the nerve while avoiding having any localized focal point within the nerve 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; and

by

administering an effective exposure of pressure pulses or acoustic shock waves in a pulse or wave pattern having a low energy density less than 1.0 mJ/mm² per shock wave directly to a zone or treatment site of the injured or diseased nerves initiates or accelerates the regeneration and repair process wherein the zone or treatment site of the injured or diseased nerves is positioned directly in a path of the pulse or wave pattern in absence of any focal point or if a focal point exists, the zone or treatment site is positioned away from any focal point wherein the energy density is selected to avoid cell damage to the injured or otherwise diseased nerves within the treatment site or zone.

2. The method according to claim 1 wherein the nerve has been severed creating one or more ends of proximal stumps and distal stumps and a pulse or wave pattern is administered to the ends of the proximal and distal stumps.

3. The method according to claim 2 wherein fibrin containing collagenase is used as adhesive for the stumps.

4. The method according to claim 2 wherein the ends are sutured.

5. The method according to claim 4 wherein the sutured region is coated with a fibrin and collagenase mixture.

6. The method according to claim 2 wherein the stumps of individual severed fascicle groups are separately co-apted.

7. The method according to claim 2 wherein a nerve graft is interposed between the stumps.

8. The method according to claim 7 wherein interfascicular nerve grafts are employed.

9. The method according to claim 1 wherein injury has resulted in neuroma in continuity.

10. The method according to claim 1 wherein the injured nerves are subjected to surgical repair prior to administering the exposure to pressure pulse or acoustic shock waves.

11. The method according to claim 1 wherein the method further comprises the step of:

administering one or more nerve regenerating medicaments to the patient.

12. A method of treating a patient with a neurological disorder or injury to the brain by treating the neuronal cells of the brain tissue to stimulate by accelerating and increasing nerve or neurological brain tissue growth or regeneration or repair comprises the steps of:

treating a patient with a neurological disorder or injury to the brain by treating the neuronal cells of the brain tissue;

activating an acoustic shock wave or pressure pulse generator or source to emit a pressure pulses or acoustic shock waves, 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 neuronal cells to convergent, divergent, planar or near planar acoustic shock waves or pressure pulses in the absence of a focal point impinging the neuronal cells stimulating a cellular response in the absence of creating cavitation bubbles evidenced by not experiencing the sensation of hemorrhaging caused by the emitted waves or pulses in the neuronal cells wherein the neuronal cells are positioned within an unobstructed 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 neuronal cells or beyond the neuronal cells thereby passing the emitted waves or pulses through the neuronal cells while avoiding having any localized focal point within the neuronal cells of the brain 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; and

by

subjecting the neuronal cells of the neurological organ tissue or nerve tissue directly to the acoustic shock waves having a low energy density of less than 1.0 mJ/mm² per shock wave stimulates said neuronal cells or brain tissue wherein the neuronal cells or brain tissue is positioned directly within a path of the emitted pressure pulses or acoustic shock waves in the absence of any focal point or if a focal point exists, the neuronal cells or brain tissue being treated is positioned away from any focal point wherein the energy density is selected to avoid any cell damage to the neuronal cells or brain tissue.

13. The method of treating neuronal cells to stimulate by accelerating or increasing neuronal cell growth or regeneration according to claim 12 wherein the administering is applied to a patient who has a pathological condition where neuronal repair can be facilitated including peripheral nerve damage caused by injury or disease such as diabetes, brain damage associated with stroke, and for the treatment of neurological disorders related to neurodegeneration, including Parkinson'"'"'s disease, Alzheimer'"'"'s disease and amyotrophic lateral sclerosis, multiple sclerosis and disseminated sclerosis.

14. The method of treating neuronal cells to stimulate by accelerating and increasing nerve or neurological brain tissue growth or regeneration or repair according to claim 12 wherein the emitted shock waves or pressure pulses are convergent having one or more geometric focal volumes or points at a distance of at least X from the generator or source, the method further comprising positioning the nerve or neurological brain tissue at a distance less than the distance X from the source.

15. The method of treating neuronal cells to stimulate by accelerating and increasing neuronal cell neurological brain tissue growth or regeneration or repair according to claim 12 wherein the neuronal cell or neurological brain tissue is from a mammal which is a human or an animal.

16. The method of treating neuronal cells to stimulate by accelerating and increasing cell or neurological brain tissue growth or regeneration or repair according to claim 12 wherein the step of subjecting the cells or neurological brain tissue to acoustic shock waves or pressure pulses includes killing bacteria by stimulating a biological defense mechanism within said cells or neurological brain tissue by exposure to the acoustic shock waves or pressure pulses.

17. The method of treating neuronal cells to stimulate by accelerating and increasing cell or neurological brain tissue growth or regeneration or repair according to claim 12 further comprises a step of administering one or more antibiotics or other drugs to a blood stream feeding the nerve or neurological organ, the cell or neurological brain tissue being stimulated by the acoustic shock waves or pressure pulses.