Method of treatment with low energy extracorporeal shockwaves

Abstract

The present invention relates to a method of treatment of the human or animal body with noninvasive low energy extracorporeal shockwaves and in particular, to such a method that is utilized for controlling a cascade of biomolecular activity involving a plurality of biomolecular factors, provided to improve function of the treatment portion of the human or animal body.

What is claimed is: 
     
         1 . A method for preventing an onset of formation of fibrosis in a human or animal body for individuals requiring a tissue removal procedure, the method comprising applying a low energy shockwave treatment protocol over at least a kidney of the human or animal body and a treatment area having or expected to undergo acute tissue trauma including a tissue removal procedure,
 a. the low energy shockwave treatment protocol having shockwave parameters including: an energy density from 0.02 and up to 0.2 milliJoules per millimeter squared (mJ/mm2), at a frequency of 1 to 6 Hertz (Hz);   b. wherein the low energy shockwave treatment protocol applies a number of low energy shockwaves, wherein the number of applied shockwaves is up to 5000 shockwaves, over at least a portion of the treatment area, and wherein the low energy shockwaves are delivered to the treatment area triggering a cascade of bio-molecular activity involving at least one bio-molecular factor selected from the group consisting of: Transforming Growth Factor beta (TGFbeta); Tissue Inhibitor of MetalloProteinases inhibitor1 (TIMP-1), Focal Adhesion Kinase (FAK), Stem Cell Factor (SCF), Hepatocyte Growth Factor (HGF), the cascade of bio-molecular activity operative to prevent or alleviate fibrosis in and around the treatment area wherein at least one of TGFbeta or TIMP-1 is reduced in expression or wherein of at least one of SCF, HFG or FAK is increased in expression; and   c. wherein said low energy shockwave treatment protocol is initiated within either a 48 hour window from an acute tissue trauma event or at least one week prior to a planned procedure that causes the acute tissue trauma.   
     
     
         2 . The method of  claim 1  wherein said tissue removal procedure is selected from at least one of: prostatectomy, transplant, hysterectomy, biopsy, mastectomy, or any combination thereof. 
     
     
         3 . The method of  claim 1  wherein said fibrosis is renal fibrosis. 
     
     
         4 . The method of  claim 1  wherein said treatment area is divided into a plurality of small treatment zones, wherein each treatment zone is provided with at least 100 shockwaves and up to 500 shockwaves. 
     
     
         5 . The method of  claim 1  wherein said low energy shockwave treatment protocol is provided in three week treatment phases wherein each week includes up to four treatment sessions. 
     
     
         6 . The method of  claim 1  wherein said low energy shockwave treatment is provided over a span of up to 9 weeks. 
     
     
         7 . The method of  claim 5  wherein the low energy shockwave treatment protocol includes up to four active treatment sessions per week. 
     
     
         8 . The method of  claim 6  wherein the low energy shockwave treatment protocol is configured according the number of active treatment sessions or the number of applied low energy shockwaves so as to cause an increased expression of Focal Adhesion Kinase (FAK) in and around said treatment area; and wherein said increased expression of FAK is proportional to the selected number of the active treatment sessions or the number of applied low energy shockwaves. 
     
     
         9 . The method of  claim 7  wherein the number of low energy shockwaves delivered in each session is gradually decreasing.