WO2017015714A1

WO2017015714A1 - Treatment of primary or secondary lymphoedema

Info

Publication number: WO2017015714A1
Application number: PCT/AU2016/050669
Authority: WO
Inventors: Joe DI SANTO
Original assignee: Bodyflow International Pty Ltd
Priority date: 2015-07-27
Filing date: 2016-07-27
Publication date: 2017-02-02

Abstract

The invention provides electrical current used in a method of reducing lymphoedema in a patient, the method comprising multiple treatment sessions, each treatment session comprising: applying electrical contacts in positions on skin of the patient (1,2,3), configuring the positions (1,2,3)to deliver the electrical current to a lymphatic system of the patient associated with a lymphoedema affected region in the patient, configuring the electrical current with a time profile (I,W) adapted to stimulate the lymphatic system of the patient, and delivering the electrical current (I,W) through the lectrical contacts; the method further comprising scheduling the treatment sessions to occur at least twice per day over most days in each week at least until the lymphoedema is acceptably reduced.

Description

TREATMENT OF PRIMARY OR SECONDARY LYMPHOEDEMA FIELD

[0001] The present invention relates to primary or secondary lymphoedema, and to an application of electrical current to resolve or improve the condition and in embodiments to maintain the resolution or improvement over the long term.

BACKGROUND

[0002] Lymphoedema is a condition of localized fluid retention and tissue swelling in a limb caused by a compromised lymphatic system, which normally returns interstitial fluid to the

thoracic duct and then the bloodstream. Lymphoedema may be primary or secondary. Primary lymphoedema is caused by a genetic defect in the lymphatic system draining of lymph from the affected site. Secondary lymphoedema is caused by a traumatic event suffered by the lymphatic system affecting drainage of the effective site, such as may be occasioned by removal of a lymph node during surgery when treating cancer, as a result of a hysterectomy or other medical intervention, or as a result of severe bacterial infection. Lymphedema is painful and

disfiguring and causes difficulties in daily living. It can lead to the sufferer's lifestyle becoming severely limited, it may also result in psychological distress.

[0003] Absent attempted surgical correction, lymphoedema is managed by careful treatment of the affected limb. Regular physical massage, compression garments and bandages are known strategies to help ameliorate the condition. [0004] The inventors have experience in the use of a form of electrical stimulation therapy which has a waveform tuned to stimulate the lymphatic system, previously described in US

Patent application publication number 2006/0064129, disclosures of which are hereby incorporated by reference. The applicant currently markets a portable device under the designation

Bodyflow® model P2Ch which reproduces the same waveforms, being two alternative modes called "Standard", which has a pulse width of 6 ms and a time between pulses of 650 ms (1.53 Hz) , and

"light", which has a pulse width of 2 ms and a time between pulses of 500 ms (2.00 Hz) . At maximum intensity, the peak current delivered is 40 mA. A tabletop device also marketed by the company is capable of delivering a maximum current of 75 mA which can be tolerated in some patients and would also be useful in the current invention. Further features of the pulses are described below. The "light" mode is less intrusive to the patient and is currently recommended to be used when initially commencing treatment with progression to the "standard" mode normally achievable soon thereafter without patient discomfort. Although the Bodyflow units concentrate on stimulation with a dominant low frequencies around 1.5 Hz and 2 Hz (corresponding to interval between pulses of 650 ms to 500 ms) , intervals between 900 ms and 300 ms are potentially useful and moreover the invention extends to uses of 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 stimulation of the lymphatic system.

Initial experience with the lymphatic stimulation devices concentrated on treatment protocols which were practically achievable with the use of the early nonportable units which were necessarily located outside the home of the patient. Typically, treatments were applied at a frequency of less than daily, typically a few times per week at most. The Bodyflow device have previously been shown to have some beneficial effect on lymphoedema of the legs using a total of 13 treatment

sessions over 4 weeks [N.Piller et al , Journal of Lymphoedema, 2010, Vol 5, No 1:15-35].

[0005] As the applicants have built experience in the use of the portable units which enable self-administration in the home, the significance of a combination of treatment frequency and

duration in the efficacy of units is gradually becoming apparent and this has led conception of a number of new inventions in the method of its use. The first published example of this is to be found in the treatment of chronic leg ulcers as described in international patent application publication WO2014201493 , where multiple treatment sessions per day with the device for many weeks or months have been used to very good effect in healing chronic leg ulcers which have hitherto been refractory to other treatments .

[0006] The inventors have now conceived the idea that

lymphoedema may be more successfully treated or prevented using electrical stimulation devices which stimulate the lymphatic system, using frequent and persistent treatment sessions.

SUMMARY OF THE INVENTION

[0007] In accordance with a first broad aspect of the invention there is provided a method of reducing lymphoedema in a patient, the method comprising multiple treatment sessions, each

treatment session comprising:

applying electrical contacts in positions on skin of the patient ,

configuring the positions to deliver the electrical current to a lymphatic system of the patient associated with a

lymphoedema affected region in the patient,

configuring the electrical current with a time profile adapted to stimulate the lymphatic system of the patient, and delivering the electrical current through the electrical contacts ;

the method further comprising the step of scheduling the

treatment sessions to occur at least twice per day over most days in each week until the lymphoedema is acceptably reduced. Preferably, the treatment sessions are scheduled to occur at least 3 or 4 times per day.

[0008] In one embodiment, the method further comprises

scheduling continuing treatment sessions to occur at least 3 times per week once the lymphoedema is acceptably reduced, to prevent recurrence .

[0009] In one embodiment, the step of configuring the electrical current includes configuring the electrical current with a time profile comprising short pulses of current having a pulse width substantially shorter than an interval between the pulses. The electrical current pulse width may be configured as less than 12 milliseconds. The interval between the pulses may be configured as greater than 40 ms and less than 1000 ms , or greater than 400 ms and less than 700 ms . The pulses may be configured as a first series of multiple pulses of a first polarity interspersed with a second series of multiple pulses of an opposite second

polarity.

[0010] In one embodiment, most of the treatment sessions comprise a total period of administration of the current of less than 2 hours and greater than 5 minutes .

[0011] In one embodiment, the method is performed over a period of at least four weeks, eight weeks or 12 weeks.

[0012] In accordance with a 2nd broad aspect of the invention there is provided electrical current, for use in reducing lymphoedema in a patient, wherein:

the electrical current is delivered to the patient during multiple treatment sessions, each treatment session comprising: applying electrical contacts in positions on skin of the patient,

lymphoedema affected region of the patient,

configuring the electrical current with a time profile adapted to stimulate the lymphatic system, and

delivering the electrical current through the electrical contacts ;

and wherein the treatment sessions are configured to occur at least twice per day over most days in each week until the lymphoedema is acceptably reduced.

BRIEF DESCRIPTION OF DRAWINGS

[0013] Figure 1 is a time profile of each pulse used in one embodiment of the invention;

[0014] Figure 2 is a time profile showing series of pulses used in one embodiment of the invention . [0015] Figure 3 is a diagram showing alternative placement of electrodes in one embodiment of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

[0016] An embodiment of the current invention will now be described.

[0017] In both examples, the device for delivering the

electrical stimulation is provided by the Bodyflow® model P2Ch, a portable unit suitable for both in-hospital post-operative treatment and post-discharge, self-administered applications. Bodyflow® model P2Ch has been approved for use in Australia by the Therapeutic Goods Association (TGA) , in the US by the Food and Drug Administration (FDA) and has CE certification in

Europe .

[0018] The Bodyflow® unit 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.

[0019] Referring now to Figure 1, the time profile of each pulse in the Bodyflow unit is shown, with pulse width W marked.

Referring to Figure 2, 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 unit has an intensity

control for the delivered maximum current which is adjustable from a delivered maximum current of 0 mA up to 40 mA. In

practice, the appropriate level depends on the nature of the tissue, the distance between the electrodes and the desired e ect. 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 40 mA. Treatment sessions typically last around 20 minutes and may involve one or two pairs of electrodes.

[0020] Referring to figure 3, 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 figure 3 as white and black. Each set of electrodes corresponds to an independent stimulation channel which can be separately intensity adjusted. Arrangement 1 corresponds to an optimum arrangement for stimulating the lymphatic system of a patient'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.

[0021] The Bodyflow model P2Ch is contemplated to be used for in-home, self-administered applications, mostly in standard mode. Electrode placement depends on the particular location of the swelling, but may not necessarily be directly adjacent to the swelling, as described above, and can be effective wherever the electrical current is stimulating the lymphatic system which is associated with the lymphoedema affected region the patient and assists lymphatic drainage from that region.

[0022] A typical example application would involve a patient with primary or secondary lymphoedema in a leg. The treatment involves positioning the electrical contacts appropriately as described above and self administering the electrical current at least twice per day, preferably 3 times per day and more

preferably 4 or more times per day. This may proceed for a period of several months, during which time progressive

improvement in the lymphoedema is expected to be seen as

evidenced by reduced volume. After at least four weeks and possibly eight weeks, 12 weeks or several months, the

lymphoedema may be reduced to an acceptable level. Thereafter, to prevent recurrence the patient may reduce the frequency of treatment sessions to once per day for at least 3 days in the week and continue that protocol indefinitely, increasing the number of treatments per day if symptoms worsen again.

Case study

[0023] A 52-year-old woman who underwent an aggressive auxiliary clearance of lymph nodes in her left arm as a result of breast cancer treatment suffered a lymphatic system insufficiency which necessitated constant use of compression garments. She then commenced use of a Bodyflow machine at home and has found that she is able to keep the lymphoedema under control without the compression garments and with very little specialist

intervention, by applying the therapy for 1-2 hours daily particularly after each working day during periods of

sensitivity.

[0024] It is planned to conduct formal case studies to

investigate the efficacy of the invention further. [0025] Persons skilled in the art will also appreciate that many variations may be made to the invention without departing from the scope of the invention, which is determined from the

broadest scope and claims .

[0026] For example, descriptions of the invention above comprise characteristics described to occur on "most" days in a

particular period, which encompasses any proportion greater than 50% such as 60%, 70%, 80%, 90% and 100%.

[0027] 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. Further, any method steps recited in the claims are not necessarily intended to be performed temporally in the sequence written, or to be performed without pause once started, unless the context requires it.

[0028] 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.

Claims

1. A method of reducing lymphoedema in a patient, the method comprising multiple treatment sessions, each treatment session comprising :

applying electrical contacts in positions on skin of the patient,

lymphoedema affected region in the patient,

the method further comprising scheduling the treatment sessions to occur at least twice per day over most days in each week at least until the lymphoedema is acceptably reduced.

2. The method of claim 1, the method further comprising scheduling the treatment sessions to occur at least 3 times per day over most days in each week at least until the lymphoedema is acceptably reduced.

3. The method of claim 1 or claim 2 , the method further comprising scheduling continuing treatment sessions to occur at least 3 times per week once the lymphoedema is acceptably

reduced, to prevent recurrence.

4. The method of claim 1, wherein the step of configuring the electrical current includes configuring the electrical current with a time profile comprising short pulses of current having a pulse width substantially shorter than an interval between the pulses .

5. The method of claim 4, wherein the step of configuring the electrical current includes configuring the electrical current pulse width as less than 12 milliseconds.

6. The method of claim 4, wherein the step of configuring the electrical current includes configuring the interval between the pulses as greater than 40 ms and less than 1000 ms .

7. The method of claim 4, wherein the step of configuring the electrical current includes configuring the interval between the pulses as greater than 400 ms and less than 700 ms .

8. The method of claim 4, wherein step of configuring the electrical current includes configuring the pulses as a first series of multiple pulses of a first polarity interspersed with a second series of multiple pulses of an opposite second

polarity.

9. The method of claim 4, wherein most of the treatment sessions comprise a total period of administration of the current of less than 2 hours and greater than 5 minutes.

10. The method of any one of claims 1 to 9, performed over a period of at least four weeks.

11. The method of claim 10, performed over a period of at least eight weeks.

12. The method of claim 10, performed over a period of at least 12 weeks.

13. Electrical current, for use in reducing lymphoedema in a patient, wherein:

the electrical current is delivered to the patient in

multiple treatment sessions, each treatment session comprising: applying electrical contacts in positions on skin of the patient,

lymphoedema affected region of the patient,

delivering the electrical current through the electrical contacts ;