Therapeutic stimulation of genital tissue or reproductive organ of an infertility or impotence diagnosed patient

• US 7,601,127 B2
• Filed: 09/29/2005
• Issued: 10/13/2009
• 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: Schaden, Wolfgang, Warlick, John, Schultheiss, Reiner
• Primary Examiner(s): Le; Long V
• Assistant Examiner(s): Abraham; Salieu M
• Application Number:
  US11/239,251
• Publication Number:
  US 20060100552A1
• Time in Patent Office: 1,475 Days
• Field of Search: 600/427, 600/439, 601 2- 4, 606/128
• US Class Current: 601/2
• CPC Class Codes: A61H 2205/086 Buttocks
• CPC Class Codes: A61H 2205/087 Genitals
• CPC Class Codes: A61H 23/008 using shock waves

Abstract

The method of stimulation for a genital tissue or reproductive organ of an infertility or impotence diagnosed patient is disclosed. The stimulation has the steps of activating an acoustic shock wave generator or source to emit acoustic shock waves; and subjecting the genital tissue, reproductive organ or the entire reproductive region of the body to the acoustic shock waves stimulating said tissue, organ or body wherein the tissue, organ or body is positioned within a path of the emitted shock waves. The emitted shock waves can be convergent, divergent, planar or near planar.

Claims

1. The method of stimulation of a genital tissue or reproductive organ of an infertility or impotence diagnosed patient comprising the steps of:

activating an acoustic shock wave generator or source to emit pressure pulses including but not limited to very fast pressure pulses called acoustic shock waves directed toward the genital tissue or reproductive organ to impinge the genital tissue or reproductive organ with pressure pulses or shock waves having a low energy density in the range of 0.000001 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 above 0.1 MPa and the time duration of the pressure pulse cycle is from a microsecond to about a second, rise times to the peak pressure of the positive part of the first pressure cycle being in the range of nano-seconds (ns) up to milli-seconds (ms), the acoustic shock waves being very fast pressure pulses having amplitudes of the positive part of the cycle similarly above 0.1 MPa but with rise times to a peak positive pressure of the positive part of the amplitude being below 100 ns, the duration of the shock wave is below 3 micro-seconds (μ

s) for the positive part of a cycle and above 3 micro-seconds for the negative part of a cycle;

subjecting the genital tissue, reproductive organ or the entire reproductive region of the body to the convergent, divergent, planar or near planar acoustic shock waves or pressure pulses in the absence of a focal point impinging the genital tissue or reproductive organ 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 genital tissue or reproductive organ wherein the genital tissue or reproductive 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 genital tissue or reproductive organ or beyond the genital tissue or reproductive organ thereby passing the emitted waves through the genital tissue or reproductive organ while avoiding having any localized focal point within the genital tissue or reproductive 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; and

stimulating said tissue, organ or body wherein the tissue, organ or body is positioned within a path of the emitted shock waves removed from any focal point of the emitted acoustic shock wave.

2. The method of stimulation of claim 1 wherein the emitted shock waves are convergent having one or more geometric focal points at a distance of at least X from the generator or source, the method further comprising positioning the genital tissue or reproductive organ at a distance less than the distance X from the source to position the one or more focal points beyond the treatment site of the genital tissue or reproductive organ.

3. The method of stimulation of claim 1 further comprising the step of:

administering one or more medicaments prior, during or after subjecting the patient to acoustic shock waves.

4. The method of stimulation of claim 1 further comprising the step of:

testing the sperm count or viability of the male infertility or impotence diagnosed patient after exposure to one or more acoustic shock wave stimulations.

5. The method of stimulation of claim 1 further comprising the step of:

testing the oocyte viability or count of the female infertility or impotence diagnosed patient after one or more acoustic shock wave stimulations.

6. The method of stimulation of claim 1 further comprising the step of:

subjecting a genital tissue or reproductive organ to a surgical procedure to remove or repair some or all of any defects or degenerative genital tissues or reproductive organs.

7. The method of stimulation of claim 1 wherein the treated genital tissue or reproductive organ has an indication of one or more pathological conditions including:

infertility of oocyte or sperm, impotency, premenstrual syndrome, PMDD, stress urinary incontinence, polycystic ovarian disease, endometriosis, endometrial cancer, infertility, hormone imbalance, and tissue subjected to a variety of perturbations including hormone replacement therapy or chemical contraception.

8. The method of stimulation for a genital tissue or reproductive organ of an infertility or impotence diagnosed patient of claim 1 where the emitted shock waves have an energy density of less than 0.2 mJ/mm².

9. The method of stimulation for a genital tissue or reproductive organ of an infertility or impotence diagnosed patient of claim 1 where the emitted shock waves have an energy density in the range of 0.0001 to 0.1 mJ/mm².

10. The method of stimulation of a genital tissue or reproductive organ of an infertility or impotence diagnosed patient comprising the steps of:

activating an acoustic shock wave generator or source to emit pressure pulses including but not limited to very fast pressure pulses called acoustic shock waves directed toward the genital tissue or reproductive organ to impinge the genital tissue or reproductive organ with pressure pulses or shock waves having a low energy density in the range of 0.000001 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 above 0.1 MPa and the time duration of the pressure pulse cycle is from a microsecond to about a second, rise times to the peak pressure of the positive part of the first pressure cycle being in the range of nano-seconds (ns) up to milli-seconds (ms), the acoustic shock waves being very fast pressure pulses having amplitudes of the positive part of the cycle similarly above 0.1 MPa but with rise times to a peak positive pressure of the positive part of the amplitude being below 100 ns, the duration of the shock wave is below 3 micro-seconds (μ

s) for the positive part of a cycle and above 3 micro-seconds for the negative part of a cycle;

subjecting the genital tissue, reproductive organ or the entire reproductive region of the body to the convergent, divergent, planar or near planar acoustic shock waves or pressure pulses in the absence of a focal point impinging the genital tissue or reproductive organ stimulating a cellular response in the absence of cellular damage evidenced by not experiencing the sensation of cellular hemorrhaging caused by the emitted waves or pulses in the genital tissue or reproductive organ wherein the genital tissue or reproductive 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 genital tissue or reproductive organ or beyond the genital tissue or reproductive organ thereby passing the emitted waves through the genital tissue or reproductive organ while avoiding having any localized focal point within the genital tissue or reproductive 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; and

stimulating said tissue, organ or body wherein the tissue, organ or body is positioned within a path of the emitted shock waves removed from any focal point of the emitted acoustic shock wave.

11. The method of stimulation of claim 10 wherein the emitted shock waves are convergent having one or more geometric focal points at a distance of at least X from the generator or source, the method further comprising positioning the genital tissue or reproductive organ at a distance less than the distance X from the source to position the one or more focal points beyond the treatment site of the genital tissue or reproductive organ.

12. The method of stimulation of claim 10 further comprising the step of:

administering one or more medicaments prior, during or after subjecting the patient to acoustic shock waves.

13. The method of stimulation of claim 10 further comprising the step of:

testing the sperm count or viability of the male infertility or impotence diagnosed patient after exposure to one or more acoustic shock wave stimulations.

14. The method of stimulation of claim 10 further comprising the step of:

testing the oocyte viability or count of the female infertility or impotence diagnosed patient after one or more acoustic shock wave stimulations.

15. The method of stimulation of claim 10 further comprising the step of:

subjecting a genital tissue or reproductive organ to a surgical procedure to remove or repair some or all of any defects or degenerative genital tissues or reproductive organs.

16. The method of stimulation of claim 10 wherein the stimulated genital tissue or reproductive organ has an indication of one or more pathological conditions including:

infertility of oocyte or sperm, impotency, premenstrual syndrome, PMDD, stress urinary incontinence, polycystic ovarian disease, endometriosis, endometrial cancer, infertility, hormone imbalance, and tissue subjected to a variety of perturbations including hormone replacement therapy or chemical contraception.

17. The method of stimulation for a genital tissue or reproductive organ of an infertility or impotence diagnosed patient of claim 10 where the emitted shock waves have an energy density of less than 0.2 mJ/mm².

18. The method of stimulation for a genital tissue or reproductive organ of an infertility or impotence diagnosed patient of claim 10 where the emitted shock waves have an energy density in the range of 0.00001 to 0.1 mJ/mm².