AU718973B2 - Method and apparatus for treating edema and other swelling disorders - Google Patents

Description

r S F Ref: 388255D1

AUSTRALIA

PATENTS ACT 1990 COMPLETE SPECIRCATION FOR A STANDARD PATENT

ORIGINAL

A

a a a a a a. Name and Address of Applicant: Actual Inventor(s): Address for Service: Tony Reid 3030 Pleasure Point Drive Santa Cruz California 95062 UNITED STATES OF AMERICA Tony Reid Spruson Ferguson, Patent Attorneys Level 33 St Martins Tower, 31 Market Street Sydney, New South Wales, 2000, Australia Method and Apparatus for Treating Edema and Other Swelling Disorders Invention Title: The following statement is a full description of this invention, including the best method of performing it known to me/us:- 5845 METHOD AND APPARATUS FOR TREATING EDEMA

AND

OTHER SWELLING

DISORDERS

This application is a continuation-in-part of application serial no. 08/390,866 filed on February 17 1995 the full disclosure of which is incorporated herein by reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to medical 0 devices and methods, and in particular to a device and method for removing edema fluids from a body trunk and/or extremity such as an arm or a leg.

Breast cancer is a serious disease in women, and a variety of modalities are employed in its treatment. Many of these treatments result in damage to the lymphatic and/or 15 venous system which, in turn, can cause a condition referred to as "lymphedema." Lymphedema is the accumulation of excessive lymph fluid and swelling of subcutaneous tissues due to the obstruction or destruction of lymph vessels. In breast cancer patients, lymphedema occurs, in the arm and results in 20 painful swelling. Excessive fluid accumulation, referred to as edema, can also arise in the arms, legs and, trunk from a variety of other causes, including infection, radiation therapy, and other conditions which result in damage to or destruction of portions of the lymphatic and/or venous system.

2. Description of the Background Art A variety of devices and methods have been proposed for the treatment of lymphedema in the arms and elsewhere.

Many such devices utilize a sequential pump which works like a multiplicity of blood pressure cuffs extending from the shoulder to the hand, which contract and expand individually.

When pressure is exerted by any one chamber or cuff, it applies a 'blanket pressure' an annular pressure which completely circumscribes the limb or other body portion) to the skin directly underneath the area of that chamber. When the pressure upon that area is released, a similar blanket pressure is then applied to the portion of the arm covered by the next adjacent chamber, and so on up the arm. Such blanket pressures are applied sequentially from the distal to the proximal ends of the arm, with the intention of forcing the fluids-up the arm and into the trunk of the body, where existing lymph nodes can process them.

Another prior mode of treatment has been a double walled sheath or stocking in which air pressure is introduced between the walls to squeeze the limb. It has been found that this and other similar systems, which rely on uniform blanket S 15 pressure application through the length of the afflicted limb "or portions thereof, do not perform very well and in fact may interfere with the desired distal-to-proximal flow of ooo lymphatic fluid.

S•We have found that when a uniform and/or excessive pressure is applied to an area for the purpose of moving fluid, the opposite effect may result. In particular, the application of pressure may: 1) compress the veins and lymph ducts, resulting in blockage; 2) augment capillary leak; and 3) prevent the lymphatic fluids from mobilizing.

Other approaches to treatment have included employment of a sheath that is separated into a number of longitudinally spaced inflatable air cells encircling the limb to be treated. These cells are successively inflated with uniform air pressure from the distal end to the proximal end of the sheath with the intent of promoting fluid flow in the desired direction. Such systems have been largely ineffectual, as they rely on air pressure being maintained at the same level or magnitude in any one of, or all, of the pressurized cells, producing a blanket effect. U.S. Patent Nos. 2,533,504 and 2,781,041 disclose examples of such systems.

Prior U.S. Patent No. 4,370,975 discloses an apparatus for treating lymphedema and similar fluid retention afflictions through the use of a multi-cell inflatable sheath which encompasses the swollen limb. Pressure is applied in the cells of the sheath in timed sequence from the distal cell to the proximal cell, the sequence of pressure applied also defining a decreasing gradient pressure from a maximum pressure applied in the distal cell to a minimum pressure applied in the proximal cell when all of the cells are pressurized. Generally, for each of the adjacent cells the more distal has applied a higher pressure than the more proximal. This application of gradient pressure from distal to proximal cells in time sequence comprises a cycle, and such cycle may be repeated indefinitely to promote the flow of lymphatic fluid from the afflicted limb in a proximal direction.

15 The problem with the above methods is that any form of blanket pressure such as that applied by pneumatic or hydraulic pressure to large afflicted areas will have at best a minimal result.

Carter, 5,063,910 shows an apparatus for treating vascular, metabolic and functional imbalance of a limb by variations in pressure of a high-density fluid, such as a e mercury bath, around the limb.

The problem with this device is that the pressure applied by this means is, in fact, a blanket-pressure, which increases with the depth of the limb portion within the fluid bath, resulting in the disadvantages described above for al other pressure systems. Another disadvantage is that the patient must remain immobilized during treatment.

R.W. Lilligren et al, 3,454,010, shows a hollow tube-like bandage for wrapping in a spiral-like manner around the limb of a patient, into which is then applied a pneumatic pressure, which is intended to drive out excess fluids prior to surgery.

Once again the pressure applied is a uniform or blanket pressure to the skin, and so is relatively ineffective to reduce swelling.

Ewen, 5,257,956, shows a garment for use by postmastectomy patients which alleviates post-operative pain and discomfort and facilitates normal activity during the recovery period. A padded vest-like garment is adapted for applying comforting pressure to the sites of removal of breast and other tissues and for holding pain relieving packages.

Again, the problem with this garment is that it applies a blanket pressure, resulting in little reduction in swelling.

Fregealle, 3,975,929, shows a stocking knit on a circular knitting machine which provides a gradually decreasing compressive force on the leg of the of the wearer from the ankle upwardly to the top of the stocking. Again, we believe that a uniform or blanket-pressure such as is applied by this device, is not the best method for forcing out excess lymphedema fluids.

15 In all of these pressure-applied methods, the Spatient is immobilized up to 4 hours per day, and sometimes several days in succession, suffering following treatment and soreness of the arm for many days afterwards.

It is a well established fact that special exercises following mastectomy help to mobilize lymphedema fluids; yet prior art devices contribute toward immobilizing the patient, making exercising difficult or impossible. Thus resulting in a counter-producing effect.

The cost of sequential pumps including necessary limb compression apparatus range from $500 to over $8,000. In addition, skilled technicians are necessary to operate it, thereby making treatment for lymphedema patients extremely expensive.

The following cited prior art references are relevant but distinguished from the present invention: 2,533,504, 2,699,165, 2,781,041, 2,943,859, 3,173,420, 3,454,010, 6,548,819, 3,561,435, 3,728,875, 3,845,769, 3,862,629, 3,885,554, 3,942,518, 3,975,929, 4,013,069, 4,030,488, 4,180,065, 4,320,746, 4,370,975, 4,374,518, 4,402,312, 4,552,133, 4,583,522, 4,773,397, 4,922,893, 4,938,208, 4,961,418, 5,108,426, 5,109,832, 5,117,812, 5,171,211, 5,172,689, 5,228,142, 5,233,974, 5,257,956 and 5,310,400.

Summary of the Invention It is the object of the present invention to overcome or substantially ameliorate the above disadvantages.

Accordingly, in a first aspect the invention provides a method for treating edema in a body part of a patient comprising applying pressure to an entire surface of a body part simultaneously at a multiplicity of spaced-apart pressure points extending over the entire surface of the body part in a grid-like pattern thereby increasing drainage of fluids from within said body part.

In a second aspect, the invention provides a method of treating edema in a body part of a patient, said method comprising applying pressure in a grid-like pattern onto a surface in the body part in the range from 5 mmHlg to 60 mmHflg and below venous and lymphatic outflow pressure for a time sufficient to reduce swelling.

i. Preferably, said multiplicity of pressure applying protrusions are spaced apart to provide a multiplicity of high pressure points or lines within said body part.

15 Preferably, the protrusions have a height from a base to a tip in the range from cm to 15 cm.

Preferably, the protrusions comprise fingers arranged in a generally cylindrical envelope with individual fingers being aligned radially with respect to the axis of the S•cylindrical envelope.

Preferably, the apparatus applies pressure to an arm wherein the length of the cylinder is in the range from 3 cm to 200 cm, the bases of the fingers are distributed over a generally cylindrical surface having a diameter in the range from 7.5 cm to cm, and the tips of the fingers are distributed over a generally cylindrical surface g having a diameter in the range from 2 cm to 25 cm.

25 Preferably, the outer sleeve secures the bases of the finger over a generally cylindrical surface.

0@: 00 [I:\DayLib\L1BLL102693. doc: KEH Preferably, the outer sleeve is formed from a non-distensible fabric which can be rolled to form the cylindrical surface.

Preferably, the apparatus further comprises an axial fastener which allows the rolled fabric to be opened and closed.

Preferably, the structure for radially compressing the resilient protrusions comprises a plurality of straps which allow the rolled fabric to be adjustably radially inwardly compressed.

Preferably, the apparatus further comprises an inner sleeve which covers the tips of the fingers over a generally cylindrical surface.

1o Preferably, said multiplicity of protuberances comprises a sheet of convoluted plastic foam.

Preferably, said multiplicity of pressure applying protrusions are configured to apply pressure in a pattern encircling a limb of a patient to provide a multiplicity of high pressure points or lines within said limb of said patient.

Preferably, said outer sleeve is configured to encircle an arm of said patient.

o. Preferably, said outer sleeve is configured to encircle a leg of said patient.

Preferably, said outer sleeve is configured to encircle a torso of said patient.

Preferably, the apparatus further comprises an inner sleeve interposed between said multiplicity of pressure applying fingers and said limb of said patient.

me~o q".

[N:\LIBLL02693:KEH 7 Preferably, the apparatus further comprises a pair of opposed plates arranged to engage opposite sides of a patient's hand when the cylindrical envelope is disposed over an arm.

There is further disclosed herein an apparatus for treating lymphedema in a limb of a patient comprising: an outer sleeve configured to encircle and extend along the entire length of said limb of said patient, a sheet of convoluted plastic foam within said outer sleeve having a multiplicity of protuberances defining a multiplicity of inwardly directed pressure applying fingers configured to apply pressure in a grid-like pattern to a surface of said limb of said patient, said pressure applying fingers being spaced apart to provide a multiplicity of high pressure points within said limb of said patient and a multiplicity of lower pressure channels between said multiplicity of high pressure points, an inner sleeve interposed between said multiplicity of pressure applying S 15 fingers and said limb of said patient, and :a plurality of strap means configured to tighten said outer sleeve about said pressure applying fingers upon said limb of said patient.

Preferably, wherein said outer sleeve is configured to encircle an arm of said patient.

20 Preferably, wherein said outer sleeve is configured to encircle a leg of said patient.

There is further disclosed herein a method for treating edema in a body part of *patient comprising applying pressure to a surface of a body part simultaneously at a multiplicity of spaced-apart pressure points in a grid-like pattern thereby increasing drainage of fluids from within said body part.

[N:\LIBLL]02693:KEH 8 Preferably, the body part is a limb and pressure is applied by encircling the entire length of the limb with a plurality of resilient protuberances within an outer sleeve which are arranged to engage the limb in a radially inward pattern.

Preferably, the protuberances are arranged so that radially inward tips thereof are spaced-apart by a distance in the range from 0.5 cm to 2 cm when engaged against the body part surface.

Preferably, the pressure is applied at from 5 mmHg to 60 mmHg.

There is further disclosed herein a method of treating edema in a body part of a patient, said method comprising applying pressure in a grid-like pattern onto a surface in the body part in the range from 5 mmHg to 60 mmHg and below venous and lymphatic outflow pressure for a time sufficient to reduce swelling.

Brief Description of the Drawings A preferred form of the present invention will now be described by way of example with reference to the accompanying drawings, wherein: Fig. 1 is a perspective view of the sleeve of the present invention fitted to a patient.

.pe Fig. 2 is a detailed perspective view of the sleeve.

Fig. 3 is a detailed perspective view of a piece of convolute plastic foam material used in the construction of the present invention.

20 Fig. 4 is a sectional view taken along the line 4-4 of Fig. 2.

Fig. 5 is the sectional view shown in Fig. 4 when a limb is placed inside the sleeve showing compression of the pressure fingers against the limb.

Fig. 6 is an end view of Fig. 2.

Fig. 7 is an opposite end view of Fig. 2.

Fig. 8 is a perspective side view of the sleeve showing VELCRO bands arrangement attached to the sleeve.

i 9.° [N:\LIBLLO2693:KEH Fig. 9 is a side view of a short sleeve for enclosing a portion of a limb.

Fig. 10 is a side view of a sleeve for enclosing a lower limb including the foot.

Fig. 11 is a perspective view of a second embodiment of a sleeve constructed in accordance with the principles of the present invention fitted to an arm of a patient.

Fig. 12 is a detailed view of the distal end of the sleeve of Fig. 11.

Fig. 13 is a detailed view, similar to Fig. 12, shown in partial section.

DESCRIPTION OF THE SPECIFIC

EMBODIMENTS

Accordingly, Fig. 1 shows a therapeutic sleeve 15 apparatus 18 of the present invention fitted to a patient for treating lymphedema.

Fig. 2 is a detailed perspective view of sleeve 18, which is made from a quadrangle of convoluted foam material (Fig. Convoluted foam material is widely used as an under-sheet lining on mattresses. Tapered quadrangle 20 of convoluted foam is cut as shown in Fig. 3, the-sides 21 can be angle-cut so that the edges meet flush when the foam is rolled to form a tapered sleeve. The foam comprises a base portion 22 having a multiplicity of convolutes or upwardstanding fingers 24. Fingers 24 are arranged in a grid pattern formation as shown in Fig. 3, having space 26 around each finger end 28. Since the fingers are arranged in rows, avenues or channels of space 30 exist in four different directions between and through these rows as indicated by arrows A,B,C, and D, which lie longitudinally, transversely, diagonally to the right and diagonally to the left.

Convoluted foam quadrangle 20 is rolled longitudinally, to form a slow-tapering funnel-shaped sleeve 18 (Figs. 2, 6-9 with the fingers facing inwardly.

Inwardly facing fingers -24 are best seen in cross section view Figs. 4 and 5. Sleeve 18 is encased in fabric comprising an inner lining 32 of SPANDEX material, and an outer lining 34 of NYLON (Figs. 2, Any other suitable materials can also be used. Inner lining 32 and outer lining 34 are sewn together at each end, indicated by numeral 36 (Fig. 4-6).

Each sleeve's outer lining 34 is encircled by a plurality of adjustable VELCRO straps or bands 38. Each band comprises a length of 50 mm wide loop-side

VELCRO

band 38, having a first end 40 and a second end 42, (Fig. 8).

First end 40 is fitted with a single loop ring 44, and is then sewn at 45 (Figs. 4 and 5) to outer lining 34. Second end is fitted with a 50 mm X 50 mm x square 46 of hook-side VELCRO, which is sewn or adhesively attached near end 42.

Second end 42 is then passed underneath and around sleeve 18 and through single loop ring 44, then doubled back so as to attach hook-side square 46 to loop-side band 38. A ring 48, or a self-separating pad, (not shown) is attached 15 to end 42).

Each webbing strap or band 38 can be adjusted tighter or looser to increase or decrease inward pressure of fingers 24 against the patient's limb. The adjustment can then be secured by attaching hook-side square 46 at end 42 to loop-side band 38.

In like manner, an additional number of encircling webbing bands 38 are progressively attached along the remainder of the sleeve's outer lining 34, keeping them 12.5 mm apart (Figs. 2 and 8).

A short sleeve 50 (Fig. which is about 225 mm long, will require three 50 mm wide bands. A 400 mm long sleeve 18, Fig. 2, will require 6 bands, while a 76 cm to 99 cm (30" to 39") long sleeve 52, (Fig. 10), for a lower limb, would require about 12 to 16 bands.

In addition, to sewing end 40 to the sleeve's outer lining 34 along one side of sleeve 18, a series of loops 54 (Fig. 7) are sewn at 56 to the opposite side of the sleeve, so as to slidably locate bands 38 in a regular spaced-apart relationship along the sleeve. Each band 38 is free to slip endwise through loops 54 during tightening or loosening of the bands.

Convoluted foam material can be made in a variety of material density, resulting in harder or softer pressure fingers. Soft for patients requiring a lower level of applied pressure while more dense fingers are used for patients requiring high levels of applied pressure, as described more fully below.

Fig. 10 shows a sleeve 52 for a lower limb, which also includes patient's foot. These can be made in various lengths to accommodate longer and shorter limbs.

When a plane of convoluted foam material shown in Fig. 2, is rolled into a sleeve with the fingers facing inwardly, the fingers and the finger ends 28 are then located closer together as seen in Fig. 4 and 5. However, the fingers still maintain the original grid formation, and also a space between the fingers, and between the rows of fingers still exist in the four directions mentioned above.

15 When a limb, such as arm 25 (Fig. 1 and 5) is placed l pinside the sleeve, and tightening adjustments made with VELCRO bands 38, the elastomeric pressure fingers 24 press against skin 29 around and along the full length of the arm. Each pressure finger is separated from the adjacent pressure finger by channel 30 against which no pressure is applied. Shaded areas 31 (Fig. 5) indicate the areas not under pressure, which form the channels for conveying lymphedema fluids.

It is believed that each small area under pressure changes the interstitial pressure in the tissues, moving lymphatic fluids into and along these channels to the lymphatic and venous drainage system.

An alternative construction of the sleeve of the present invention is illustrated in Figs. 11-13. The sleeve 100 is generally similar to the sleeve illustrated in Fig. i, except that an outer sleeve 102 comprises an axial fastener in the form of a zipper 104 which permits the entire length of the sleeve to be opened and closed to facilitate inserting and withdrawing the arm A from the sleeve. In some cases, it may be sufficient to employ only the zipper 104 to apply a preselected level of pressure onto the arm. Usually, however, it will still be desirable to provide a plurality of separate straps 106 which may be constructed as generally described above.

further difference in the sleeve 100 is the inclusion of a pair of opposed plates 110 and 112, as best observed in Figs. 12 and 13. The plates 110 and 112 help apply pressure to the convoluted foam which engage the hand to the inner sleeve material 120.

In using the devices of Figs. 1 and 11, it is important to apply pressure at the spaced-apart locations on the body surface in a uniform manner. The pressure applied should be relatively high, but should always be maintained below venous pressure in order to permit continued blood flow and allow lymphatic and other fluid drainage. The applied pressure may be measured by interposing a fluid-filled bladder between the body surface and the inner radial tips of the pressure-applying fingers. The outer sleeve of the device can 15 then be tightened sufficiently so that the pressure applied by the fingers to the bladder is in the range from 5 mmHg to *i 60 mmHg, preferably from 10 mmHg to 45 mmHg. The pressure should be applied for a time sufficient to reduce swelling, typically being employed overnight. Often, initial treatment will involve daily (or nightly) treatments, with maintenance treatments occurring once or twice a week.

The devices illustrated in Figs. 1 and 11 have been successfully employed in a number of test cases. In one case, an arm which had been swollen of excess lymphatic fluids was reduced in circumference by 50 mm in 2 hours, whereas other prior art pressure devices which had been used over several days had produced no appreciable reduction. Similar results were obtained with other patients. Another patient who had been using prior art pressure devices without success and who also had suffered frequent infections to her arm, was fitted with the present invention on a 12 month trial basis; the swelling was soon reduced and no further infections.

Although the present invention is especially directed toward the treatment of lymphedema, it is envisioned as also being applicable for prevention and/or treatment-of embolism or thrombosis, as well as for treatment of swollen limbs resulting from venous insufficiency.

Those skilled in the art will envision that many other possible variations are within its scope. For example skilled artisans will readily be able to change the thickness or density of the foam, or length of convolutes, or assembly different combinations of foam, or design a different configuration of pressure points and channels. It is possible to change the arrangement, or widths of the VELCRO bands or use different grades of VELCRO. It is possible to fit other forms of loops, or means to grasp the VELCRO bands when making adjustments. Any suitable material can be sued to cover the elastomeric pressure material, including fabric printed with patterns. Other types of foam material such as rubber, plastic air bubbles, foam air bubbles or non-convolute foam and the like can be used. Different means of installation can 15 be used. Various heights of convolutes can be used to conform to limb shape, and various number of convolutes per square i* foot can be used.

Accordingly, the reader is requested to determine the scope of the invention by the appended claims and their legal equivalents, and not by the examples which have been given.

a0 0 S.

Claims (6)

1. A method for treating edema in a body part of a patient comprising applying pressure to an entire surface of a body part simultaneously at a multiplicity of spaced-apart pressure points extending over the entire surface of the body part in a grid-like pattern thereby increasing drainage of fluids from within said body part.

2. The method as in claim 1, wherein the body part is a limb and pressure is applied by encircling the entire length of the limb with a plurality of resilient protuberances within an outer sleeve which are arranged to engage the limb in a radially inward pattern.

3. The method as in claim 2, wherein the protuberances are arranged so that radially inward tips thereof are spaced-apart by a distance in the range from 0.5 cm to 2 cm when engaged against the body part surface.

4. The method as in claim 1, wherein the pressure is applied at from mmHg to 60 mmng.

5. A method of treating edema in a body part of a patient, said method comprising applying pressure in a grid-like pattern onto a surface in the body part in the range from 5 mmHg to 60 mmHg and below venous and lymphatic outflow pressure for a time sufficient to reduce swelling.

6. A method of treating edema in a body part of a patient, substantially 20 as described herein with reference to the accompanying drawings. Dated 23 February, 2000 Tony Reid Patent Attorneys for the Applicant/Nominated Person •°SPRUSON FERGUSON 00•0 o• [I :\DayLib\L1BLL102693.doc:KEH