Method of treatment for and prevention of periodontal disease

• US 7,497,835 B2
• Filed: 09/29/2005
• Issued: 03/03/2009
• 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): Casler; Brian
• Assistant Examiner(s): RAMIREZ, JOHN FERNANDO
• Application Number:
  US11/238,730
• Publication Number:
  US 20060036194A1
• Time in Patent Office: 1,251 Days
• Field of Search: 600/437, 601/2
• US Class Current: 601/2
• CPC Class Codes: A61C 19/06 Implements for therapeutic treatment radiation therapy A61N5/00
• CPC Class Codes: A61C 8/0006 Periodontal tissue or bone regeneration support means for endoprosthetic bone substitute or bone graft implants A61F2/2846
• CPC Class Codes: A61H 13/00 Gum massage
• CPC Class Codes: A61H 2205/026 Mandible
• CPC Class Codes: A61H 23/008 using shock waves

Abstract

The method of treatment for a periodontal tissue exhibiting a periodontal disease or periodontal condition in a diagnosed patient is disclosed. The method has the steps of activating an acoustic shock wave generator or source to emit acoustic shock waves; and subjecting the periodontal tissue, or the entire periodontal region of the patient to the acoustic shock waves stimulating said tissue, wherein the tissue is positioned within a path of the emitted shock waves. The method of treatment may further have the steps of administering one or more medicaments prior, during or after subjecting the patient to acoustic shock waves or testing the bacterial count or viability of the treated tissue or region of the diagnosed patient after exposure to one or more acoustic shock wave treatments; or subjecting a tissue or organ to a surgical procedure to remove or repair some or all of any defects or degenerative tissues. The method of treatment is for prevention of periodontal disease and may be used with debridement. The treatment is particularly useful in eradicating and inhibiting periodontal biofilms.

Claims

1. The method of treatment for a periodontal tissue at risk for exhibiting a periodontal disease or periodontal condition in a diagnosed patient comprises the steps of:

receiving the diagnosed patient;

activating an acoustic shock wave or pressure pulse generator or source to emit pressure pulses or acoustic shock waves directed toward the periodontal tissue to impinge the periodontal tissue with shock waves or pressure pulses 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 periodontal tissue, or the entire periodontal region of the patient to convergent, divergent, planar or near planar acoustic shock waves or pressure pulses stimulating said tissue, wherein the 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 or pressure pulses 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 periodontal tissue or beyond the periodontal tissue thereby passing the emitted waves or pulses through the periodontal tissue while avoiding having any localized focal point within the periodontal 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 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 treatment of claim 1 wherein the emitted shock waves or pressure pulses are convergent having one or more geometric focal volumes of points at a distance of at least X from the generator or source, the method further comprising positioning the periodontal tissue at a distance at or less than the distance X from the source.

3. The method of treatment of claim 1 further comprises the step of:

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

4. The method of treatment of claim 1 further comprises the step of:

testing the bacterial count or viability of the treated tissue or region of the diagnosed patient after exposure to one or more acoustic shock wave or pressure pulse treatments.

5. The method of treatment of claim 1 further comprises the step of:

subjecting the periodontal tissue to a surgical procedure to remove or repair some or all of any defects or degenerative tissues.

6. The method of treatment of claim 1 wherein the treated periodontal tissue has an indication of one or more pathological conditions including:

a periodontal biofilm mass, periapical endodontic lesions, endo-perio lesions, gingivitis, inflammation of gingival tissue, periodontitis, progressive loss of ligament, cementum or alveolar bone support to teeth.

7. The method of claim 1 wherein the treated tissue has one or more conditions requiring treatment as follows:

ridge augmentation for cosmetic, prosthetic or implantation of teeth;

to assist osteoblastic and osteoclastic processes in orthodontia;

regeneration of alveolar bone surrounding loose teeth implants regeneration of structures supporting the teeth including regeneration of structures supporting teeth including gingival, periodontal ligament, cementum and alveolar bone.

8. The method of claim 1 wherein the treatment is for prevention of periodontal disease.

9. The method of claim 8 further comprises the step of:

debridement.

10. The method of claim 8 wherein the treatment further comprises the step of:

destroying biofilm in or on the treated tissue or region.

11. The method of claim 8 wherein the treated tissue or region activates or otherwise stimulates stem cells or release of cellular growth factors in the oral structure effecting a tissue repair or tissue regeneration.

12. The method of treatment for a periodontal tissue at risk of or exhibiting a periodontal disease or periodontal condition in a diagnosed patient comprises the steps of:

receiving the diagnosed patient;

activating an acoustic shock wave or pressure pulse generator or source to emit pressure pulses or acoustic shock waves directed toward the periodontal tissue to impinge the periodontal tissue with 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 periodontal tissue, or the entire periodontal region of the patient to convergent, divergent, planar or near planar acoustic shock waves or pressure pulses stimulating said tissue in the absence of creating cavitation bubbles in the treated periodontal tissue, wherein the 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 or pressure pulses 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 periodontal tissue or beyond the periodontal tissue thereby passing the emitted waves or pulses through the periodontal tissue while avoiding having any localized focal point within the periodontal 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 an energy density value ranging as low as 0.00001 mJ/mm² to a high end of below 1.0 mJ/mm²; and

wherein the periodontal tissue has cells and the shock waves or pressure pulses stimulate a cellular response in the tissue in the absence of cellular damage in the tissue caused by the shock waves or pressure pulses evidenced by the avoidance of localized hemorrhaging as a result of exposure to the emitted shock waves or pressure pulses.

13. The method of treatment of claim 12 wherein the tissue is gums.

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

15. The method of treatment of claim 12 further comprises the step of:

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

16. The method of treatment of claim 12 further comprises the step of:

testing the bacterial count or viability of the treated tissue or region of the diagnosed patient after exposure to one or more acoustic shock wave or pressure pulse treatments.

17. The method of treatment of claim 12 further comprises the step of:

subjecting the periodontal tissue to a surgical procedure to remove or repair some or all of any defects or degenerative tissues.

18. The method of treatment of claim 12 wherein the treated periodontal tissue has an indication of one or more pathological conditions including:

a periodontal biofilm mass, periapical endodontic lesions, endo-perio lesions, gingivitis, inflammation of gingival tissue, periodontitis, progressive loss of ligament, cementum or alveolar bone support to teeth.

19. The method of claim 12 wherein the treated tissue has one or more conditions requiring treatment as follows:

ridge augmentation for cosmetic, prosthetic or implantation of teeth;

to assist osteoblastic and osteoclastic processes in orthodontia;

regeneration of alveolar bone surrounding loose teeth implants regeneration of structures supporting the teeth including regeneration of structures supporting teeth including gingival, periodontal ligament, cementum and alveolar bone.

20. The method of claim 12 wherein the treatment is for prevention of periodontal disease.

21. The method of claim 12 further comprises the step of:

debridement.

22. The method of claim 12 wherein the treatment further comprises the step of:

destroying biofilm in or on the treated tissue or region.

23. The method of claim 12 wherein the treated tissue or region activates or otherwise stimulates stem cells or release of cellular growth factors in the oral structure effecting a tissue repair or tissue regeneration.