Method and device for treating osteoarthritis noninvasively

Abstract

Methods and devices are provided for OA treatment of an affected area or joint. In one embodiment, the method may involve identifying a treatment site of the joint, and providing at least one transducer module at the treatment site. The at least one transducer module may be in operative communication with a signal generator module, and may include transducer(s) for delivering stimulative signals (e.g., electromagnetic signals and/or ultrasound signals). The method may also involve stimulating (a) bone remodeling, (b) bone cells and associated precursors, and/or (c) pericytes with the stimulative signals delivered to the treatment site.

1 - 24 . (canceled) 
     
     
         25 . A noninvasive method for treating osteoarthritis (OA) of an OA affected joint at the site of a junction between hones, comprising:
 identifying a treatment site of the OA affected joint;   providing at least one transducer module at the treatment site, the at least one transducer module being in operative communication with a signal generator module and comprising at least one transducer for delivering stimulative signals, the stimulative signals comprising at least ultrasound signals with a maximum intensity of about 100 milliwatts/cm 2 ;   stimulating bone remodeling at the joint with the stimulative signals delivered to the treatment site at a user-selected intensity for a user-selected time period by exciting the at least one transducer module with the signal generator module;   repeating the providing and stimulating over time consistent with a treatment protocol; and   alleviating, in response to the repeating, OA conditions at the OA affected joint;   wherein the alleviating comprises alleviating subchondral sclerosis of cancellous bone at the affected joint.   
     
     
         26 . The method of  claim 25 , wherein the affected joint comprises one of a knee, hip, and vertebra. 
     
     
         27 . The method of  claim 25 , wherein providing the at least one transducer module comprises placing at least one electrode at the treatment site. 
     
     
         28 . The method of  claim 25 , wherein the stimulative signals further comprise at least electromagnetic signals, and wherein stimulating the bone remodeling comprises delivering the electromagnetic signals via at least one of direct current (DC), pulsed electromagnetic fields (PEMFs), combined magnetic fields (CMFs), and capacitively coupled electric fields (CCEFs). 
     
     
         29 . The method of  claim 28 , wherein the user-selected intensity of the electromagnetic signals comprises: (a) a current of between about 5 milliamps and about 10 milliamps; and (b) a driving force voltage of between about 3.0 V and about 6.3 V. 
     
     
         30 . The method of  claim 28 , wherein the electromagnetic signals comprises frequencies in the range of about 0 to about 150 hertz, and wherein the user-selected time period comprises about 6 hours to about 8 hours per day, for about 3 to about 9 months. 
     
     
         31 . The method of  claim 25 , wherein stimulating the bone remodeling comprises delivering the ultrasound signals with alternate signaling characteristics including a nominal frequency of about 1.5 MHz, a width of each pulse varied between about 10 microseconds and about 2,000 microseconds, and a pulse repetition rate varied between about 100 Hz and about 1,000 Hz. 
     
     
         32 . The method of  claim 25 , wherein stimulating the bone remodeling comprises delivering the ultrasound signals for about twenty minutes per day for a defined period, using dual frequency treatment heads of about 1 MHz and 3 MHz, and a tow beam nonuniformity ratio of about 3.1 to about 3.5. 
     
     
         33 . A noninvasive method for treating osteoarthritis (OA) of an affected joint, comprising:
 identifying a treatment site of the joint;   providing at least one transducer module at the treatment site, the at least one transducer module being in operative communication with a signal generator module and comprising at least one transducer for delivering a combination of electromagnetic signals and ultrasound signals, the ultrasound signals having a maximum intensity of about 100 milliwatts/cm 2 ;   stimulating bone remodeling at the joint with the electromagnetic signals and the ultrasound signals delivered to the treatment site by exciting the at least one transducer module with the signal generator module;   repeating the providing and stimulating over time consistent with a treatment protocol; and   alleviating, in response to the repeating, OA conditions at the OA affected joint;   wherein the alleviating comprises alleviating subchondral sclerosis of cancellous bone at the affected joint.   
     
     
         34 . The method of  claim 33 , wherein stimulating the bone remodeling comprises delivering the electromagnetic signals via at least one of direct current (DC), pulsed electromagnetic fields (PEMFs), combined magnetic fields (CMFs), and capacitively coupled electric fields (CCEFs). 
     
     
         35 . The method of  claim 34 , the electromagnetic signals comprise: (a) a current of between about 5 milliamps and between about 110 milliamps; and (b) a driving force voltage of about 3.0 V and about 6.3 V. 
     
     
         36 . The method of  claim 33 , wherein stimulating the bone remodeling comprises delivering the ultrasound signals with alternate signaling characteristics including a nominal frequency of about 1.5 MHz, a width of each pulse varied between about 10 microseconds and about 2,000 microseconds, and a pulse repetition rate varied between about 100 Hz and about 1,000 Hz. 
     
     
         37 . A noninvasive method for treating osteoarthritis (OA) of an affected joint, comprising:
 identifying a treatment site of the joint;   providing at least one transducer module at the treatment site, the at least one transducer module being in operative communication with a signal generator module and comprising at least one transducer for delivering stimulative signals, the stimulative signals comprising at least ultrasound signals having a maximum intensity of about 100 milliwatts/cm 2 ;   stimulating at least one of (a) bone cells and associated precursors and (b) pericytes at the joint with the stimulative signals delivered to the treatment site at a user-selected intensity for a user-selected time period by exciting the at least one transducer module with the signal generator module;   repeating the providing and stimulating over time consistent with a treatment protocol; and   alleviating, in response to the repeating, OA conditions at the OA affected joint   wherein the alleviating comprises alleviating subchondral sclerosis of cancellous bone at the affected joint.   
     
     
         38 . The method of  claim 37 , wherein stimulating the at least one of (a) the bone cells and the associated precursors and (b) the pericytes comprises additionally delivering electromagnetic signals via at least one of direct current (DC), pulsed electromagnetic fields (PEMFs), combined magnetic fields (CMFs), and capacitively coupled electric fields (CCEFs). 
     
     
         39 . The apparatus of  claim 37 , wherein stimulating comprises delivering the ultrasound signals with alternate signaling characteristics including a nominal frequency of about 1.5 MHz, a width of each pulse varied between about 10 microseconds and about 2,000 microseconds, and a pulse repetition rate varied between about 100 Hz and about 1,000 Hz. 
     
     
         40 . (Nov) The method of  claim 37 , wherein stimulating comprises delivering the ultrasound signals for about twenty minutes per day for a defined period, using dual frequency treatment heads of about 1 MHz and 3 MHz, and a low beam nonuniformity ratio of about 3.1 to about 3.5. 
     
     
         41 . A noninvasive method for treating osteoarthritis (OA) of an OA affected joint at the site of a junction between bones, comprising:
 identifying a treatment site of the OA affected joint;   providing at least one transducer module at the treatment site, the at least one transducer module being in operative communication with a signal generator module and comprising at least one transducer for delivering stimulative signals, the stimulative signals comprising at least ultrasound signals with a maximum intensity of about 100 milliwatts/cm 2 ;   stimulating bone remodeling at the joint with the stimulative signals delivered to the treatment site at a user-selected intensity for a user-selected time period by exciting the at least one transducer module with the signal generator module;   repeating the providing and stimulating over time consistent with a treatment protocol; and   alleviating, in response to the repeating, OA conditions at the OA affected joint;   wherein the alleviating comprises alleviating intertrabecular fibrosis of cancellous bone at the affected joint.   
     
     
         42 . The method of  claim 41 , wherein the affected joint comprises one of a knee, hip, and vertebra. 
     
     
         43 . The method of  claim 41 , wherein providing the at least one transducer module comprises placing at least one electrode at the treatment site. 
     
     
         44 . The method of  claim 41 , wherein the stimulative signals further comprise at least electromagnetic signals, and wherein stimulating the bone remodeling comprises delivering the electromagnetic signals via at least one of direct current (DC), pulsed electromagnetic fields (PEMFs), combined magnetic fields (CMFs), and capacitively coupled electric fields (CCEFs). 
     
     
         45 . The method of  claim 44 , wherein the user-selected intensity of the electromagnetic signals comprises: (a) a current of between about 5 milliamps and about 10 milliamps; and (b) a driving force voltage of between about 3.0 V and about 6.3 V. 
     
     
         46 . The method of  claim 45 , wherein the electromagnetic signals comprises frequencies in the range of about 0 to about 150 hertz, and wherein the user-selected time period comprises about 6 hours to about 8 hours per day, for about 3 to about 9 months. 
     
     
         47 . The method of  claim 41 , wherein stimulating the bone remodeling comprises delivering the ultrasound signals with alternate signaling characteristics including a nominal frequency of about 1.5 MHz, a width of each pulse varied between about 10 microseconds and about 2,000 microseconds, and a pulse repetition rate varied between about 100 Hz and about 1,000 Hz. 
     
     
         48 . The method of  claim 41 , wherein stimulating the bone remodeling comprises delivering the ultrasound signals for about twenty minutes per day for a defined period, using dual frequency treatment heads of about 1 MHz and 3 MHz, and a tow beam nonuniformity ratio of about 3.1 to about 3.5. 
     
     
         49 . A noninvasive method for treating osteoarthritis (OA) of an affected joint, comprising:
 identifying a treatment site of the joint;   providing at least one transducer module at the treatment site, the at least one transducer module being in operative communication with a signal generator module and comprising at least one transducer for delivering a combination of electromagnetic signals and ultrasound signals, the ultrasound signals having a maximum intensity of about 100 miliiwatts/cm 2 ;   stimulating bone remodeling at the joint with the electromagnetic signals and the ultrasound signals delivered to the treatment site by exciting the at least one transducer module with the signal generator module;   repeating the providing and stimulating over time consistent with a treatment protocol; and   alleviating, in response to the repeating, OA conditions at the OA affected joint;   wherein the alleviating comprises alleviating intertrabecular fibrosis of cancellous bone at the affected joint.   
     
     
         50 . The method of  claim 49 , wherein stimulating the bone remodeling comprises delivering the electromagnetic signals via at least one of direct current (DC), pulsed electromagnetic fields (PEMFs), combined magnetic fields (CMFs), and capacitively coupled. electric fields (CCEFs). 
     
     
         51 . The method of  claim 50 , the electromagnetic signals comprise: (a) a current of between about 5 milliamps and between about 10 milliamps; and (b) a driving force voltage of about 3.0 V and about 6.3 V. 
     
     
         52 . The method of  claim 49 , wherein stimulating the bone remodeling comprises delivering the ultrasound signals with alternate signaling characteristics including a nominal frequency of about 1.5 MHz, a width of each pulse varied between about 10 microseconds and about 2,000 microseconds, and a pulse repetition rate varied between about 100 Hz and about 1,000 Hz. 
     
     
         53 . A noninvasive method for treating osteoarthritis (OA) of an affected joint, comprising:
 identifying a treatment site of the joint;   providing at least one transducer module at the treatment site, the at least one transducer module being in operative communication with a signal generator module and comprising at least one transducer for delivering stimulative signals, the stimulative signals comprising at least ultrasound signals having a maximum intensity of about 100 milliwatts/cm 2 ;   stimulating at least one of (a) bone cells and associated precursors and (b) pericytes at the joint with the stimulative signals delivered to the treatment site at a user-selected intensity for a user-selected time period by exciting the at least one transducer module with the signal generator module;   repeating the providing and stimulating over time consistent with a treatment protocol; and   alleviating, in response to the repeating, OA conditions at the OA affected joint   wherein the alleviating comprises alleviating intertrabecular fibrosis of cancellous bone at the affected joint.   
     
     
         54 . The method of claim  58 , wherein stimulating the at least one of (a) the bone cells and the associated precursors and (b) the pericytes comprises additionally delivering electromagnetic signals via at least one of direct current (DC), pulsed electromagnetic fields (PEMFs), combined magnetic fields (CMFs), and capacitively coupled electric fields (CCEFs). 
     
     
         55 . The apparatus of  claim 53 , wherein stimulating comprises delivering the ultrasound signals with alternate signaling characteristics including a nominal frequency of about 1.5 MHz, a width of each pulse varied between about 10 microseconds and about 2,000 microseconds, and a pulse repetition rate varied between about 100 Hz and about 1,000 Hz. 
     
     
         56 . The method of  claim 53 , wherein stimulating comprises delivering the ultrasound signals for about twenty minutes per day for a defined period, using dual frequency treatment heads of about 1 MHz and 3 MHz, and a low beam nonuniformity ratio of about 3.1 to about 3.5.