Patent Application: US-201414894552-A

Abstract:
the invention provides the use of electrical pulses to reduce , improve , heal or prevent recurrence of a chronic ulcer , comprising administering to a need an effective amount of an electric stimulation in multiple treatment sessions , wherein the electric stimulation stimulates the lymphatic system .

Description:
an embodiment of the current invention will now be described , with reference to 2 examples of patients treated according to the invention . in both examples , the device for delivering the electrical stimulation is provided by the bodyflow ® models cx1 and p2ch , for in - hospital post - operative treatment and post - discharge , self - administered applications , respectively . both bodyflow units have been approved for use in australia by the therapeutic goods association ( tga ). the bodyflow ® units are marketed by bodyflow international pty ltd ( victoria , australia ; www . bodyflowinternational . com ). the characteristic electrical pulses produced by these units comprise short non - rectangular pulses in the millisecond range separated by gaps in the second range . these waveforms have previously been shown to reduce lymphoedema inpatients with lymphoedema of the legs [ piller 2010 ] and have other therapeutic benefits such as improved blood circulation . the bodyflow cx1 unit can work in two modes , called “ standard ”, which has a pulse width of 6 ms and a time between pulses of 658 ms ( 1 . 52 hz ), and “ light ”, which has a pulse width of 6 ms and a time between pulses of 580 ms ( 1 . 72 hz ). the bodyflow p2ch unit also can work in two modes , called “ standard ”, which has a pulse width of 2 ms and a time between pulses of 500 ms ( 2 . 0 hz ), and “ light ”, which has a pulse width of 2 ms and a time between pulses of 580 ms ( 1 . 72 hz ). early research on the range of useful pulse widths , frequencies and polarities for an earlier device , and adopted and adapted herein was reported in us patent application publication number 2006 / 0064129 . although the bodyflow units concentrate on stimulation with a dominant low frequency between 1 . 5 hz and 2 hz , the invention extends to any waveform which targets the lymphatic system . methods of targeting the lymphatic system are far from well established and alternative waveforms may in the future be identified that can be successfully used in the current invention . referring now to fig1 , the time profile of each pulse in the bodyflow units is shown , with pulse width w marked . referring to fig2 , an expanded time profile is shown of the pulse train , which appears in interspersed series of pulses with opposite polarities , each pulse separated by an interval i , 5 pulses in each series . the bodyflow units have an intensity control for the delivered maximum current which is adjustable from a delivered maximum current of 0 ma up to 75 ma . in practice , the appropriate level depends on the nature of the tissue , the distance between the electrodes and the desired effect . typically , in use , the intensity control is adjusted upwards until there is a slight visible muscular twitch in response to each pulse and either maintained at around this level or slightly below . for the application contemplated here , the maximum current is typically greater than 1 ma and is usually found to be around 5 to 15 ma . treatment sessions typically last around 20 minutes and may involve one or two pairs of electrodes . referring to fig3 , placement of the electrodes to optimise stimulation of the lymphatic drainage advantageously stimulates along the length of the lymphatic ducts in the limb concerned , but optimal placement will depend upon the needs of the patient and the areas of the lymphatic system which are compromised . the bodyflow unit comprises two sets of electrodes , coloured differently , shown in fig3 as white and black . each set of electrodes corresponds to an independent stimulation channel which can be separately adjusted . arrangement 1 corresponds to an optimum arrangement for stimulating the lymphatic system of a patient &# 39 ; s left leg , with one channel stimulating between the top of the foot and the quadriceps , and another channel stimulating between the inside calf and the torso or groin . arrangement 2 is appropriate for a stimulation attempting to stimulate both legs at once , and arrangement 3 is an example of stimulating the lymphatic system around one knee . in the examples that follow the bodyflow models p2ch were used , for in - home , self - administered applications , in standard mode . both bodyflow units have been approved for use in australia by the therapeutic goods association ( tga ). electrode placement depends on the particular location of the ulcer , but may not necessarily be directly adjacent to the ulcer , as described above , particularly where the skin is in poor condition . this female patient aged 62 years had a venous ulcer accompanied by some lymphoedema in existence for 5 months . the wound size was about 12 cm 2 located just above the ankle on the patient &# 39 ; s left leg . prior to treatment , the wound was not progressing well and had remained stagnant for four months . the patient was instructed in the use of the bodyflow unit , recommended to use four treatment sessions daily of 20 minutes each , and was instructed in the placement of the electrodes . in this case , placement of the electrodes was on the affected limb similar to arrangement 1 in fig3 . tubular compression bandages were also used . patient &# 39 ; s compliance was adequate , choosing to use the unit twice per day for one hour each session , but missed about one day per week . after eight weeks of treatment the wound was completely healed and treatment was stopped . her leg circumference had also reduced substantially in size , probably due to lymphatic drainage and appears much healthier . this female patient aged 58 years had two very large round ulcers , one on each leg near the back of her calf , of mixed aetiology , initially 62 cm 2 in area on the left leg and 90 cm 2 in area on the right leg . these wounds had been in existence for 5 - 6 years . the trial is still ongoing as of the date of writing . as with the previous example , this patient has been instructed in the use of the unit and recommended to use it for treatment sessions four times daily of 20 minutes each . electrode placement could not be practically achieved as in arrangement 1 of fig3 , instead the lowest connection for each channel was just below the knee , due to the poor condition of the skin in the ischaemic region . no compression bandages were used . the patient &# 39 ; s compliance is average to poor due to fragile emotional state , and she complains of some pain to parts of her legs during the treatments needing to find comfortable electrode placements . on average she misses two or three days per week for varying reasons . on days that she does use the unit , it is twice daily for 45 minutes per session . the patient is visited every second week to assist her to maintain compliance . assessment after four weeks showed a definite positive improvements with reduction in lymphoedema and general healthy appearance , as well as reduction in ulcer size . formal measurements were not made at the four week assessment . assessment after 20 weeks showed a reduced ulcer size of 15 cm 2 on the left leg and 13 cm 2 on the right leg , although not healed . this patient is an 84 - year - old woman having a venous leg ulcer of initial size about 21 cm 2 with a suspected arterial component which has been in existence for 3 to 4 years . the patient was instructed in the use of the unit and recommended to use it for treatment sessions twice daily of 20 minutes each . 2 - layer tubigrip compression bandages were also used . after 20 weeks , the wound was not healed and the wound size continued to fluctuate , being measured at 74 cm 2 at the 20 week point . although many more patients need to be treated to confirm the efficacy of the invention , these results are promising and suggest that the invention may provide an improved efficacy over previously investigated electrical stimulation modalities , at least in some patient groups and particularly where malfunctioning of the lymphatic system is a highly contributory factor . persons skilled in the art will appreciate that many variations may be made to the invention without departing from the scope of the invention . for example , the electrical stimulation of the invention may be augmented with one or several standard care approaches , including but not limited to compression bandages , elevation etc , or augmentation with a dc component of electrical stimulation as previously reported in the literature . in the claims which follow and in the preceding description of the invention , except where the context requires otherwise due to express language or necessary implication , the word “ comprise ” or variations such as “ comprises ” or “ comprising ” is used in an inclusive sense , i . e . to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention . the term “ stimulates the lymphatic system ” in the broadest aspect of the invention and the broadest claim encompasses any electrical stimulation modality which has been shown to specifically enhance performance of the lymphatic system , such as for example may be evidenced by reduction of lymphoedema in patients . the term includes electrical stimulation modalities that may stimulate the lymphatic system in addition to stimulating skeletal muscle or producing other biophysical or biochemical effects . as stated above , while the present embodiments of the invention focus on dominant low frequencies in the 1 . 5 hz to 2 . 5 hz range and particularly wave shapes comprising pulses separated by rests , the broadest aspect of the invention is the realisation that mobilisation of lymph using electrical stimulation is unexpectedly effective in healing ulcers , which has not been suggested by previous published investigations into the use of electrical currents in healing ulcers and has not been explored . accordingly , other waveforms that are found in the future or have been previously identified ( if any ) to stimulate the lymphatic system are also within the scope of the current invention . it is to be understood that , if any prior art publication is referred to herein , such reference does not constitute an admission that the publication forms a part of the common general knowledge in the art , in australia or any other country . 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