WO2017015715A1

WO2017015715A1 - Reduction or prevention of swelling after surgery

Info

Publication number: WO2017015715A1
Application number: PCT/AU2016/050670
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 (I,W) for use in a method of reducing or preventing occurrence of a region of swelling in a patient after surgery, 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 to deliver the electrical current to a lymphatic system of the patient associated with the region of swelling, configuring the electrical current with a time profile (I,W) adapted to stimulate the lymphatic system of the patient, and delivering the electrical current through the electrical contacts; the method further comprising scheduling the treatment sessions to occur at least once per day over most days in a period of at least 2 weeks.

Description

TITLE: REDUCTION OR PREVENTION OF SWELLING AFTER SURGERY

FIELD

[0001] The present invention relates to surgery, in particular but not limited to orthopaedic surgery, and to an application of electrical current to resolve or prevent residual swelling occurring post-operatively .

BACKGROUND

[0002] Following surgery including but not limited to

orthopaedic surgery such as hip and knee surgery, there is an initial period of swelling occurring post operatively which typically resolves over a few days mostly during a recovery period in hospital and this initial period of swelling is mitigated by the use of compression bandages in the case of knees. As the patient gradually regains mobility, there can be an extended period of residual swelling lasting many weeks or months which causes a delay in recovery. This period of residual swelling may in part be caused by the increased trauma

associated with increased mobilisation of the joint as the patient returns to a normal level of activity, or other unknown factors. Often, residual swelling is resistant to antiinflammatory drugs or compression and ice strategies.

[0003] There is therefore a need for alternative or improved methods of reducing residual swelling occurring post

operatively.

[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.

[0005] 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. As the applicants have built experience in the use of the portable units which enable sel -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 chronic or persistent swelling which often occurs after orthopaedic surgery may be successfully treated or prevented using electrical stimulation devices which stimulate the lymphatic system, using frequent and persistent treatment sessions. Swelling occurring after orthopaedic surgery may be caused by inflammation,

accumulation of lymph or a combination thereof and the invention is not restricted to any particular type of swelling in this context, not the least because the reasons behind efficacy of these electrical stimulation devices are incompletely understood and may not be confined to direct effects of stimulation of the lymphatic system.

SUMMARY OF THE INVENTION

[0007] In accordance with a first broad aspect of the invention there is provided a method of reducing or preventing occurrence of a region of swelling in a patient after surgery, 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 the region of swelling,

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 once per day over most days in a period of at least 2 weeks.

[0008] In one embodiment, the surgery is an orthopaedic surgery performed on a limb of the patient and the step of configuring the positions further comprises configuring the positions to deliver the electrical current to a lymphatic system of the limb of the patient associated with the area of swelling.

[0009] In one embodiment, the method is applied to the

prevention of the region of swelling after surgery, and the step of scheduling the treatment sessions further comprises

commencing the treatment sessions as soon as practicable after the surgery, which may be at least 48 hours after resolution of bleeding. The treatment sessions may be scheduled to occur at least once per day over most days in a period of at least 6 weeks after the surgery. The treatment sessions may be scheduled to occur at least 3 times per day over most days in a period of at least 2 weeks or at least 6 weeks after the surgery.

[0010] In one embodiment, the step of scheduling the treatment sessions further comprises commencing the treatment sessions after an identification of chronic swelling occurring after the surgery. The treatment sessions may be scheduled to occur at least once per day or at least 3 times per day over most days at least until the chronic swelling is acceptably reduced. The treatment sessions may be scheduled to continue after the chronic swelling is acceptably reduced at a reduced frequency.

[0011] 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.

[0012] 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 .

[0013] In accordance with a 2nd broad aspect of the invention there is provided electrical current, for use in reducing or preventing occurrence of a region of swelling in a patient after surgery, 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,

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

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 ; and wherein the treatment sessions are configured to occur at least once per day over most days in a period of at least 2 weeks .

BRIEF DESCRIPTION OF DRAWINGS

[0014] Figure 1 is a time profile of each pulse used in one embodiment of the invention;

[0015] Figure 2 is a time profile showing series of pulses used in one embodiment of the invention .

[0016] Figure 3 is a diagram showing alternative placement of electrodes in one embodiment of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

[0017] An embodiment of the current invention will now be described.

[0018] 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 .

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. These waveforms have previously been shown to reduce lymphoedema in patients with 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] and have other therapeutic benefits such as improved blood circulation.

[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 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 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 swelling. 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] In the case studies that follow the Bodyflow model P2Ch was used, for in-home, self-administered applications, 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 location of the swelling and assists lymphatic drainage from that area.

Case study 1

[0022] This was a 72 Year old very fit and active female patient that underwent a Left 1st MTP Fusion + Right Scarf and Akin. She had an uneventful recovery however she continued to have

residual swelling which after many months was impacting on her activities. All other methods to reduce swelling failed. For 8 weeks this patient used 3-4 treatment sessions per day with the Bodyflow each session administering the current for a total period of 20 min. The black channel was placed on the top of foot and outer aspect of the quadricep, and the red channel was placed on the inner aspect calf and groin. The patient's chronic swelling reduced slowly over the 8 week period. Case study 2

[0023] This 63 year old ex elite footballer underwent a Bone Graft to his ankle and an External Fixator was applied for 6 weeks which was then removed. He previously had an ankle fusion which was unsuccessful. He presented with an extremely swollen ankle prior to the bone graft operation. He used the Body Flow for 6 weeks immediately post operation, commencing 48 hours after the surgery and 4 treatment sessions with the device daily. He had virtually no swelling after the operation and given the amount he had prior to the operation we felt this was an excellent outcome.

Case study 3

[0024] This female patient underwent total knee replacement surgery and used the Bodyflow Therapy according to the invention for at least 4 weeks post-surgery at least 4 times per day (20 minute treatments) . By the 4 week point, the surgeon noted that the knee showed very little swelling with a range of movement of 0 to 110° , more characteristic of typical progress 8-12 weeks after surgery.

[0025] The case studies set out above provides support for the hypothesis that frequent and extended use delivers substantial and unexpected benefits, and further studies are underway.

[0026] 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 .

[0027] For example, in the case where swelling exists before an operation, scheduling of additional treatment sessions before the operation in addition to after the operation is within the broadest scope of the invention. Further, although the invention finds its most likely application to surgery occurring on limbs, surgery performed on any part of the body is within the broadest scope. Further also, descriptions of the invention above

comprise characteristics described to occur on "most" days in a particular period or "most" treatment sessions, which

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

[0028] 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.

[0029] 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 or preventing occurrence of a region of swelling in a patient after surgery, the method comprising multiple treatment sessions, each treatment session comprising: applying electrical contacts in positions on skin of the patient,

the method further comprising scheduling the treatment sessions to occur at least once per day over most days in a period of at least 2 weeks.

2. The method of claim 1, wherein the surgery is an

orthopaedic surgery performed on a limb of the patient and the step of configuring the positions further comprises configuring the positions to deliver the electrical current to a lymphatic system of the limb of the patient associated with the area of swelling .

3. The method of claim 1, applied to the prevention of the region of swelling after surgery, and the step of scheduling the treatment sessions further comprises commencing the treatment sessions as soon as practicable after the surgery.

4. The method of claim 3, wherein the step of scheduling the treatment sessions further comprises commencing the treatment sessions at least 48 hours after resolution of bleeding.

5. The method of claim 3, wherein the step of scheduling the treatment sessions further comprises scheduling the treatment sessions to occur at least once per day over most days in a period of at least 6 weeks after the surgery.

6. The method of claim 3 wherein the step of scheduling the treatment sessions further comprises scheduling the treatment sessions to occur at least 3 times per day over most days in a period of at least 2 weeks after the surgery.

7. The method of claim 3 wherein the step of scheduling the treatment sessions further comprises scheduling the treatment sessions to occur at least 3 times per day over most days in a period of at least 6 weeks after the surgery.

8. The method of claim 1, wherein the step of scheduling the treatment sessions further comprises commencing the treatment sessions after an identification of chronic swelling occurring after the surgery.

9. The method of claim 8, wherein the step of scheduling the treatment sessions further comprises scheduling the treatment sessions to occur at least once per day over most days at least until the chronic swelling is acceptably reduced.

10. The method of claim 9, wherein the step of scheduling the treatment sessions further comprises scheduling the treatment sessions to occur at least 3 times per day over most days at least until the chronic swelling is acceptably reduced.

11. The method of claim 10, wherein the step of scheduling the treatment sessions further comprises scheduling the treatment sessions to continue after the chronic swelling is acceptably reduced at a reduced frequency.

12. 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 .

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

14. The method of claim 12, 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 .

15. The method of claim 12, 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 .

16. The method of claim 12, 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.

17. The method of claim 1, 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.

18. Electrical current, for use in reducing or preventing occurrence of a region of swelling in a patient after surgery, wherein :

the electrical current is delivered to the patient in

and wherein the treatment sessions are configured to occur at least once per day over most days in a period of at least 2 weeks .