Wound care vacuum bandaging in combination with acoustic shock wave applications

• US 8,057,411 B2
• Filed: 04/25/2007
• Issued: 11/15/2011
• Est. Priority Date: 04/25/2007
• Status: Active Grant

• Current Assignee: Softwave Tissue Regeneration Technologies, LLC
• Original Assignee: General Patent, LLC (Tissue Regeneration Technologies LLC)
• Inventors: Rozmajzl, Michael F, Warlick, John
• Primary Examiner(s): Thanh; Quang D
• Application Number:
  US11/739,715
• Publication Number:
  US 20080269651A1
• Time in Patent Office: 1,665 Days
• Field of Search: 601/2, 601/6, 601/7, 601/9, 601/10, 601/11, 601/46, 601/47, 601/48, 601/84, 602/41, 602/42, 602/43, 602/46, 602/48, 604/289, 604/304, 604/305, 604/307, 604/308, 604313-316
• US Class Current: 601/6
• CPC Class Codes: A61H 23/008 using shock waves
• CPC Class Codes: A61H 23/0236 using sonic waves, e.g. using loudspeakers
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/772 operating alternately
• CPC Class Codes: A61M 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208
• CPC Class Codes: A61M 1/916 specially adapted for deep wounds
• CPC Class Codes: A61M 1/92 with liquid supply means
• CPC Class Codes: A61M 2205/05 combined with other kinds of therapy

Abstract

A method and device for treating wounds 10 of tissue 11 is disclosed. The method has the steps of applying a porous pad 12 upon the treatment surface of the tissue 11; covering the treatment surface and the porous pad 12 with a foil or sealing cover 14 for isolating the treatment surface and the porous pad 12 from the atmosphere; filling the volume under the foil or sealing cover 14 with fluid 100 and purging air from the volume under the foil or sealing cover 14 thereby fluid 100 saturating said porous pad 12: applying an acoustic shock wave treatment through the foil or sealing cover 14 or surrounding tissue 11 or a combination thereof sending acoustic shock waves 200 through the volume to the treatment surface and underlying tissue 11 and thereafter pulling a vacuum to create a sub-atmospheric pressure under the foil or sealing cover 14 wherein the combination of the applied acoustic shock waves 200 and sub-atmospheric conditions stimulates healing of the treatment surface and underlying tissue 11. Preferably the acoustic shock waves 200 are unfocused or a wide area focused shock wave pattern. More preferably the shock waves 200 are sufficiently low energy or amplitude to avoid the sensation of pain during the treatment process thereby eliminating the need for anesthesia or localized numbing of the treatment area.

Claims

1. An acoustic shock wave and vacuum wound treatment device for application to tissue, the device comprising:

a porous padding for application upon a treatment surface of the tissue;

an air tight water vapor permeable foil or sealing cover for covering the treatment surface and the porous padding which seals the treatment surface from air;

at least one fluid supply line for supplying fluid to the treatment surface and the porous pad;

at least one fluid removal line for removing fluid from the treatment surface and the porous padding, the removal line being to a vacuum line, wherein the introduction of fluids through the supply line in combination with the removal of fluids and entrapped air through the removal line thereby fluid saturates the porous pad and treatment surface; and

wherein

an acoustic shock wave applicator head device being acoustically coupled to either the foil or sealing cover, the foil or sealing cover and adjacent tissue or the adjacent tissue for transmission of acoustic shock waves to the treatment surface through the fluid saturated porous padding, and wherein the transmission of acoustic shock waves are emitted from the shock wave applicator as pressure pulses or acoustic shock waves in a transmission dosage directed toward the treatment surface of the tissue to impinge the tissue of a wound 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 above 0.1 MPa and the time duration of the pressure pulse is from below a microsecond to a second, rise times of the positive part of the first pressure cycle being 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;

wherein the transmission dosage subjects the tissue of the wound 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 increased cellular hemorrhaging in the tissue of the wound caused by the emitted waves or pulses in the tissue of the wound wherein the tissue of the wound 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 wound or beyond the tissue of the wound thereby passing the emitted waves through the tissue of the wound while avoiding having any localized focal point within the tissue of the wound and wherein the emitted pressure pulses or shock waves are convergent, divergent, planar or near planar and the pressure pulse shock wave 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 acoustic shock wave and vacuum wound treatment device of claim 1 wherein the acoustic shock wave device transmits one of convergent, divergent, near planar or unfocused acoustic shock waves to the treatment surface and underlying tissue.

3. The acoustic shock wave and vacuum wound treatment device of claim 1 wherein said porous padding is comprised of an elastic compressible porous material.

4. The acoustic shock wave and vacuum wound treatment device of claim 3 wherein the porous padding is comprised of an open pored polyvinyl alcohol-sponge foam material.

5. The acoustic shock wave and vacuum wound treatment device of claim 1 further comprises:

a controller;

a supply side valve;

a return side valve;

a vacuum line connected to the return side valve;

a supply side fluid pressure infusion line connected to the supply side valve; and

wherein the controller can actuate the supply side valve, the return side valve, the vacuum line or the pressure infusion line to provide a fluid filled infusion of said porous pad or a drainage of said porous pad and treatment surface or a combination thereof for simultaneous fluid infusion and vacuum drainage.

6. The acoustic shock wave and vacuum wound treatment device of claim 5 wherein after a fluid infusion wherein the return side valve is either closed or restricted there is created a fluid filled reservoir directly under the foil or sealing cover void of air;

and wherein an acoustic shock wave treatment is applied through the foil or sealing cover, the tissue adjacent the sealing cover or a combination of the two passing through the fluid saturated porous padding to the treatment tissue and underlying tissue.

7. The acoustic shock wave and vacuum wound treatment device of claim 6 wherein the return side valve can be closed and vacuum applied through the vacuum line to create a sub atmospheric pressure to the treatment tissue which in combination with the administered acoustic shock waves stimulates the tissue to accelerate a rate of healing of the tissue of the wound.

8. A method of treating wounds of tissue comprises the step of:

applying a porous pad upon a treatment surface of the tissue, covering the treatment surface and porous pad with a sealing cover for isolating the treatment surface and the porous pad from the atmosphere, a space between the sealing cover and treatment surface form a volume;

filling the volume under the sealing cover with fluid and purging air from the volume under the sealing cover thereby fluid saturating said porous pad;

applying an acoustic shock wave treatment through the sealing cover or surrounding tissue or a combination thereof sending acoustic shock waves through the volume to the treatment surface and underlying tissue and wherein the transmission of acoustic shock waves are emitted from the shock wave applicator as pressure pulses or acoustic shock waves in a transmission dosage directed toward the treatment surface of the tissue to impinge the tissue of a wound 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 above 0.1 MPa and the time duration of the pressure pulse is from below a microsecond to a second, rise times of the positive part of the first pressure cycle being 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;

wherein the transmission dosage subjects the tissue of the wound 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 increased cellular hemorrhaging in the tissue of the wound caused by the emitted waves or pulses in the tissue of the wound wherein the tissue of the wound 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 wound or beyond the tissue of the wound thereby passing the emitted waves through the tissue of the wound while avoiding having any localized focal point within the tissue of the wound and wherein the emitted pressure pulses or shock waves are convergent, divergent, planar or near planar and the pressure pulse shock wave 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 pulling a vacuum to create a sub-atmospheric pressure under the sealing cover, wherein the combination of applied acoustic waves and the sub-atmospheric conditions stimulate healing of the treatment surface and underlying tissue.

9. The method of treatment of claim 8 wherein the acoustic shock waves are unfocused or wide area focused shock wave pattern.

10. The method of treatment of claim 9 wherein the shock waves are of a sufficiently low energy or amplitude to avoid the sensation of pain.

11. The method of treatment of claim 9 wherein the treatment of the acoustic shock waves creates a germicidal effect on the porous pad and the treatment surface of the tissue, and a fluid drainage within the volume under the cover removes tissue toxins and other decomposition products.

12. The method of treatment of claim 8 further comprises the step of introducing a medicament antiseptic or antibiotic into the volume under the sealing cover prior to activation of the shock waves to stimulate absorption or covering of the treatment surface tissue during and after the shock wave treatment.