Patent Application: US-201414157822-A

Abstract:
a wound therapy method that results in improved wound healing for conditions including diabetic foot ulcers , pressure ulcers , and arterial and venous ulcers is described . the wound therapy method uses local anesthetic injections in an area surrounding the wound combined with electrical stimulation causing local and deep muscle contraction in the same area . the method leads to increased vasodilation , increased tissue oxygen levels at the target site , and increased blood flow to the target site . this causes local angiogenesis and tissue perfusion that increases wound healing rates and decreases future wound occurrences .

Description:
the wound therapy method of the present disclosure involves a combination of injections of anesthetic and electrical stimulation . in particular , a solution of 0 . 25 % bupivacaine hydrochloride is prepared and injected in amounts ranging from about 1 cc to about 2 cc at a plurality of nerve locations in proximity to the wound being treated . as an example , when the wound is in close proximity to the mortise joint , 2 cc of the solution is injected in the deep peroneal nerve . then the superficial peroneal nerve is injected with 1 . 5 cc solution , the saphenous nerve is injected with 1 . 5 cc solution , the sural nerve is injected with 1 . 5 cc solution , and the posterior tibial nerve is injected with 2cc solution , in a like manner . another example would be the treatment of a wound occurring along the inner thigh . the wound therapy method remains the same save the exception of the injection locations , which in this case would be the closest neurovasculature branch both distal and proximal to the wound margins with the number of injections determined by local anatomy . in this case the preferable nerves injected would be the ilioinguinal nerve , genitofemoral nerve , obturator nerve , and most obvious the anterior cutaneous femoral nerve . electrostimulation therapy is then performed by placing contact pads in four locations in proximity to the wound . electrostimulation is applied for about 15 minutes via an alternating current neuromuscular electrostimulation device delivering a high voltage ( about a maximum of 440 v ) and very low amperage ( about 0 . 1 to about 4 . 4 milliamps ). the stimulator uses a biphasic pyramidal wave with a frequency of about 47 hz . duty cycles may be fixed at about 1 . 5 seconds on and 1 . 8 seconds off . there is no ramp time . the intensity is the only variable . the intensity is controlled via a dial that is turned clockwise to increase intensity and counterclockwise to decrease intensity . the dial also has an off position at the its most extreme counterclockwise position . when the dial is turned in the clockwise direction it may be positioned anywhere along an incremental gradient beginning from zero and increasing to a maximum of one hundred at the farthest clockwise position . the intensity is determined by the patient &# 39 ; s tolerance to the stimulation and at the minimum must produce involuntary muscle contraction . the therapy is repeated based on patient need and resolution of the wound . muscle contractions are generally stimulated with voltage and as a general rule the higher the amperage the greater the patient discomfort . in fact , most patients can only tolerate around 30 milliamps from a direct current device although these devices are capable of delivering around 90 milliamps at a maximum output of 125 volt . therefore , an alternating current can achieve much higher voltage and correspondingly much lower amperage creating a distinct therapeutic benefit over direct current devices . the wound therapy method is shown to lead to an increase in wound healing caused by multiple conditions including but not limited to diabetic foot ulcers , pressure ulcers , arterial , and venous ulcers . the wound therapy method also improves peripheral neuropathy and related syndromes , peripheral vascular disease , chronic lymphedema states , venous and arterial insufficiency , and pain caused by varicose veins or peripheral arterial occlusion . the patients were given a full informed consent of the benefits and risks of the procedure . due to the persistence of lower extremity pain refractory to all other treatments , the patients were determined to be candidates for a series of 5 nerve injections to the ankle followed by specific parameter electroanalgesia treatments utilizing the present wound therapy method . without being limited by theory , it is anticipated that the nature of the interaction of the specific parameter electrical signaling with the local anesthetic will have additional beneficial effects on the spinal nerve , dorsal horn , and sympathetic chain , and therefore serve to improve any co - existing pathology . after stable vital signs were recorded , the patients were placed in a seated position . using sterile technique , the skin over ankle was prepped with a disinfectant ( such as betadine × 3 , purdue products l . p . stamford , conn . ), in the usual sterile manner . a mixture of 0 . 25 % preservative free marcaine was prepared in a sterile manner with a 5 cc syringe . areas of anesthetization completed for the procedure include a line along the anterior ankle . the deep peroneal nerve was injected after passage of a 30 g 1 - inch needle , with 2 cc of the solution being injected after aspiration . then the superficial peroneal nerve was injected with 1 . 5 cc solution , the saphenous nerve was injected with 1 . 5 cc solution . the sural nerve was injected with 1 . 5 cc solution , and the posterior tibial nerve was injected with 2 cc solution , in a like manner . the patients tolerated the procedure well . the patients then underwent a 15 - minute electro analgesia treatment using a high voltage ( max . 440 v ) and very low amperage ( 0 . 1 - 4 . 4 milliamps ), ac output neuromuscular electrical stimulator . the technology uses a biphasic pyramidal wave with a frequency of 47 hz . duty cycles are fixed at 1 . 5 seconds on and 1 . 8 seconds off there is no ramp time . these settings are preset with the intensity being the only variable . a neuropathic pain assessment questionnaire was given to each patient prior to initiation of therapy and at the conclusion of therapy . the neuropathic pain assessment asks each patient to rank the perception of pain from 1 ( little pain ) to 10 ( extreme pain ). before and after pictures were taken in each patient that presented with non - healing ulcers as well as those with significant impairment in local circulation . patients were asked to return as directed for repeat treatments and follow up evaluation . patient 1 was a 68 year old female with a past medical history of atrial fibrillation , diastolic congestive heart failure , hypertension , diabetes mellitus with associated chronic renal insufficiency and neuropathy , peripheral vascular disease , and dependent edema . patient 1 complained of significant lower extremity parasthesia and pain and was referred for treatment with the present wound therapy method . upon physical examination of bilateral lower extremities the patient had significant gross edema to her mid thigh . the legs contained multiple stage 1 ulcerations . serous fluid weeped from the open wounds with erythematous changes consistent with peripheral venous disease . pulses were palpable in both lower extremities . 10 g monofilament test was performed and was positive for the presence of diabetic neuropathy . treatment was administered as described above . after two weeks of treatment , the skin in the affected lower extremity appeared visibly healed . fig1 shows photographs of patient 1 taken ( a ) at the early stages of treatment and ( b ) further into treatment , showing visibly healed skin . patient 2 was a 76 year old male with a past medical history significant for peripheral vascular disease , hypertension , coronary artery disease , and tobacco use . patient 2 complained of pain to a lower extremity . he was referred for vein ablation surgery but declined and was referred for treatment with the present wound therapy method . physical examination of bilateral lower extremities revealed erythematous legs with absent peripheral pulses . stage 1 to 2 ulcerations were seen measuring approximately 1 × 2 cm in diameter . absence of blanching of the skin was noted indicating diminished vascular blood supply to the lower extremities . 10 g monofilament test was positive for the presence of peripheral vascular neuropathy . treatment was administered as described above . treatment was initiated and revealed improved circulation verified by restitution of pedal pulses as well as complete healing of multiple wounds within 2 weeks of therapy . fig2 shows ( a ) a photograph taken in the early stages treatment and ( b ) a photograph taken after further treatment , showing skin in the affected lower extremity appearing much healthier . patient 3 was a 71 year old white female with a history of hypertension , hyperlipidemia , waldenstrom macroglobulinemia , peripheral vascular disease , and prior below the knee amputation who was referred for the treatment of a stage four ulcer to the right medial upper thigh . she was discharged from the hospital two weeks prior , where she was admitted for wound debridement and iv antibiotic treatment . she had a history of previous wound infections and had undergone previous hyperbaric oxygen therapy . the medial thigh wound measured 6 × 8 cm in diameter and with gentle probing the underlying tendon was involved . this was a stage iv wound with significant wet gangrene and foul smelling odor in spite of chronic antibiotic therapy . the treatment was initiated and within the first few treatments , healthy granulation tissue began to form around the periphery . she had significant improvement with complete healing of the wound at day 30 of treatment . fig3 shows ( a ) a photograph taken in the early stages of treatment and ( b ) a photograph taken further into treatment , showing a visibly healed wound . patient 4 was a 62 year old male with history significant for ischemic cardiomyopathy hypertension peripheral vascular disease with significant and painful diabetic peripheral neurapothyy . he presented with stage 1 ulceration . bilateral lower extremity examination was performed and indicated gross edema to mid thigh with significantly diminished peripheral pulses . the patient had stage 1 ulcerations to the lower tibial aspect of both legs with induration around the periphery , purulent discharge and foul odor . the wounds measured approximately 1 × 2 cm in diameter . upon 10 g monofilament examination there was absent fine touch and proprioception indicating significant neuropathy . treatment was initiated and within 10 treatments reevaluation of the wounds showed dry , well healed eschar with improved pain and sensation . these ulcerations remained healed and in follow up of over 1 year the patient has continued to show improvement . additionally , four other patients were referred for evaluation and examination . all four patients presented with history of diabetic peripheral neuropathy with loss of protective sensation but did not have open persistent wounds . all four patients complained of neuropathic pain and exhibited classical signs of advanced tissue degradation as a result of their neuropathy . these patients were deemed to be at high risk for developing a diabetic foot ulcer and the decision was made to treat these patients with the same method described above as a preventative measure from the development of a lesion . outcomes for these patients were consistent with results experienced by patients in the previous examples . all of the patients reported significant improvement in regards to pain , edema , circulation , walking distance , and quality of life . king h , aubert r e , herman w h . global burden of diabetes , 1995 - 2025 : prevalence , numerical estimates , and projections . diabetes care . 1998 ; 21 : 1414 - 1431 . boulton a j m , kirsner r s , vileikyte l . clinical practice . neuropathic diabetic foot ulcers . n engl j med . 2004 ; 351 : 48 - 55 . boulton a j , vileikyte l , ragnarson - tennvall g , apelqvist j . the global burden of diabetic foot disease . lancet . 2005 ; 366 : 1719 - 1724 . apelqvist j , larsson j . what is the most effective way to reduce incidence of amputation in the diabetic foot ? diabetes metab res rev . 2000 : 16 ( suppl 1 ): s75 - s83 . ramsey s d , newton k , blough d , et al . incidence , outcomes , and cost of foot ulcers in 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