WO2006033096A2

WO2006033096A2 - Massaging sleeve for body limb

Info

Publication number: WO2006033096A2
Application number: PCT/IL2005/000977
Authority: WO
Inventors: Adi Dagan; Jakob Barak
Original assignee: Medical Compression Systems (D.B.N.) Ltd.
Priority date: 2004-09-21
Filing date: 2005-09-14
Publication date: 2006-03-30
Also published as: WO2006033096A3

Abstract

An inflatable massaging sleeve (5) for massaging a body limb providing a pneumatic effect when being inflated, an elastic effect when deflated and muscles of the limb are not being used, and further providing an orthotic effect when deflated and the limb muscles are being used. The sleeve has one or more sections formed from a flexible inelastic material that are wrapped around the limb. Each section has an arcuate form when unrolled on a flat surface. With the sleeve is wrapped around a body limb, an elastic element (7b) is stretched and positioned in parallel to at least a portion of the inelastic material of the sleeve.

Description

MASSAGING SLEEVE FOR BODY LIMB

FIELD OF THE INVENTION

This invention relates to sleeves for massaging a body limb

BACKGROUND OF THE INVENTION

Among the physical methods for affecting deep vein flow patterns, intermittent pneumatic compression (IPC), the graduated compression stocking (GCS),and orthotic compression devices, are the most popular. In IPC, a massaging sleeve containing a number of individually inflatable, torroidal shaped cells is applied to a body limb, and the cells inflated and deflated in accordance with a desired temporo-spatially array of cell inflation. It has been confirmed that IPC maintains venous capacitance and venous outflow and creates high flow pulsatility. In addition, several studies show that IPC significantly improves resting flow velocity, volume flow rate, and shear stress, as well as blood clearance from the venous system. When used in accordance with their recommended protocols, these devices have been shown to be almost as good as anticoagulants in preventing DVT.

While the hemodynamic effects created by IPC devices are well established, the mechanisms by which the graduated compression stocking exerts its protective effect remain uncertain. It may be by promoting blood flow, or by preventing venous distention. The diameter of the veins under the stocking has been found to be reduced and it was therefore expected that the stocking would increase flow velocity in the veins. There have been measurements of changes in venous ejection fraction after tiptoe exercise and venous capacitance after pneumatic cuff compression. The evidence, when viewed together, suggests that a significant effect of the stockings may be to reduce pooling of blood in deep veins by mechanically preventing distension of the vessels. Operative venodilatation has been recorded and was shown to correlate with increased risk for postoperative DVT. While not necessarily as effective as IPC or anticoagulants, the GCS is readily available and would be recommended in the absence of other options, or in combination with the other more effective methods. The interest in the simultaneous use of the GCS and IPC boots has been stimulated by reports of a significant reduction in the incidence of DVT with this combination relative to the use of either device alone. One of the major disadvantages of currently available stationary IPCs is their poor patient compliance in the clinical environment, which limits their use and potentially reduces their efficacy in preventing DVT. It has been postulated that the addition of a GCS to these devices might provide some level of protection during the time the pneumatic sleeves of the IPC devices are not inflated.

An orthotic compression device is an inelastic sleeve consisting of multiple adjustable straps around the leg from the instep to the knee. This device provides sustained compression that enhances the muscle pump and occurs when limb muscles exert a pulsating effect on an adjacent blood or lymph vessel during repeated cycles of muscle contraction and stretching.

US Patent No. 4,153,050 discloses a massaging sleeve that incorporates elastic elements into the closed loop created around the treated limb by the inelastic air bladders, and therefore a significant portion of the energy expended during inflation is consumed by the stretching elastic elements.

An IPC system is disclosed in US Patent No. 6,478,757, which is incorporated herein in its entirety by reference. The system disclosed in this patent includes one or more massaging sleeves in which each of the torroidal shaped air cells is subdivided into several longitudinal compartments that are all inflated and deflated simultaneously, causing a constriction of the air cell circumference. As demonstrated in that patent, with this construction, the diameter of an inflated cell is theoretically 0.64 of the diameter of the same cell when deflated, irrespective of the number of compartments in the cell. Although in practice the shortening effect is less than 36% this way of creating pressure

01618438\6-01 around a body limb significantly decreases the amount of air that is needed in order to inflate each cell and create the needed pressure on the limb.

SUMMARY OF THE INVENTION

The present invention is based upon the finding that a massaging sleeve can provide an orthotic effect during the time that a cell is deflated if the deflated cell fits the underlying limb sufficiently snugly. The inventors have found that even minor muscle activity causes a significantly higher peak venous velocity (PW) than observed with the GCS.

In its first aspect, the present invention provides a massaging sleeve that delivers a pneumatic effect, an elastic effect, and an orthotic effect to a treated limb. The sleeve of the invention is made from an inelastic material and comprises one or more individually inflatable cells. In addition, the sleeve also includes one or more elastic elements that are positioned in parallel to overlap at least a portion of the inelastic material of the sleeve. When a cell is being inflated, the cell delivers a pneumatic effect to the portion of the limb contained in the cell. As explained in detail below, due to the presence of the elastic elements, a cell delivers an elastic effect when the cell is deflated and underlying limb muscles are not being used, and delivers an orthotic effect when the cell is deflated and the underlying muscles pulsate. Thus, when a cell is deflated, the cell acts as an elastic stocking when the limb muscles are not pulsating, and as an orthotic device when the limb muscles are pulsating.

One or more cells of the sleeve are preferably divided into confluent longitudinally extending compartments that are inflated and deflated essentially simultaneously, as disclosed in US Patent No. 6,478,757. The geometry of the calf can be described as composed of two or three frustums of circular cones: one frustum (the upper) oriented with its base (larger end) down and the other (the lower) oriented with its base up. In its second aspect, the invention provides a pneumatic sleeve for massaging a body limb that, when applied to the calf, conforms to this anatomy of the human calf. In its third aspect, the invention provides a fastener for a sleeve, such as a massaging sleeve, or an orthotic sleeve that allows control of the tension that is

01618438\6-01 - A -

developed in the sleeve cells during their application to a body limb. The fastener comprises an elastic element that, in use, overlaps at least a portion of the inelastic material of the sleeve. The fastener may be composed of two inelastic elements with a third elastic element connected serially in between the two. The fastener may be integral with the sleeve. Alternatively, the fastener may be separate from the sleeve and adapted to be attached to the sleeve. The elongation of the elastic element is directly proportional to the tension developed during sleeve application and therefore allows its semi-quantitative measurement and control. The fastener is preferably provided with an indicator showing when a predetermined desired tension has been achieved. The fastener of the invention ensures optimal tightening of the sleeve around the limb, and the development of a graduated pressure along the leg when the sleeve is deflated.

Thus, in its first aspect, the invention provides an inflatable massaging sleeve for massaging a body limb having at least one inflatable cell, the cell providing a pneumatic effect when being inflated, the cell providing an elastic effect when deflated and muscles of the limb are not being used, and further providing an orthotic effect when deflated and the limb muscles are being used.

In its second aspect, the invention provides a sleeve formed from a flexible inelastic material and configured to be wrapped around a body limb, comprising an elastic element configured to be affixed to the sleeve, the elastic element being attachable to the sleeve in a stretched state when the cell is wrapped around a body limb with the elastic element positioned in parallel to at least a portion of the inelastic material of the sleeve.

In its third aspect, the invention provides a sleeve having at least a first section configured to be wrapped around a -body limb and a second section configured to be wrapped around the limb, the first and second sections having an arcuate form when unrolled on a flat surface, the arcuate form of the first sectionl having an orientation opposite to the arcuate form of the second section when unrolled on flat surface. .

01618438\6-01 In its fourth aspect, the invention provides a fastener for a sleeve comprising an inelastic material , the fastener having a first end adapted for attachment to the sleeve at a first location and a second end adapted for attachment to the sleeve at a second location, the fastener comprising an elastic element attachable to the sleeve in a stretched state when the cell is wrapped around a body limb with the elastic element in parallel to at least a portion of the inelastic material.

In its fifth aspect, the invention provides a massaging sleeve comprising the fastener of the invention. In its sixth aspect, the invention provides a system for massaging a body limb comprising a massaging sleeve of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it may be carried out in practice, a preferred embodiment will now be described, by way of non- limiting example only, with reference to the accompanying drawings, in which:

Fig. 1 shows a massaging sleeve in accordance with one embodiment of the present invention.

Fig. 2 shows a fastener for use with a massaging sleeve; Fig. 3 shows a massaging sleeve of the invention in cross section;

Fig. 4 shows a massaging system comprising a sleeve of the invention; and

Fig. 5 compares the orthotic muscle pump effect obtained by the sleeve of the invention with the muscle pump effect obtained by a graduated compression stocking.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Figure 1 shows a sleeve 5 for massaging a body limb in accordance with one embodiment of the invention. The sleeve 5 is a calf sleeve, but this is by way of example only, and the sleeve of the invention may be adapted to accommodate any body limb, such as a thigh, arm, foot, ankle, wrist, and so on. The calf sleeve 5 is made from an inelastic flexible material and comprises three individually

01618438\6-01 inflatable arcuate cells 6a, 6b and 6c, when the sleeve 5 is unrolled onto a flat surface as shown in Fig. 1. The cell 6c is curved upwards, while the cells 6a and 6b are curved downwards. The calf sleeve 5 is shown from its outer side in Fig. Ia and from its inner side in Fig. Ib. A cell, that is arcuate when opened and unrolled onto a flat surface, forms a frustum of a cone when wrapped around a body limb. Thus, when wrapped around a body limb, the upper cell 6c assumes a shape of frustum of a circular cone that is oriented with its base (larger end) facing downward, while the lower two cells (6a and 6b) when wrapped around a body limb assume the shape of a frustum of a circular cone that are oriented with their bases faced upward. As shown in Fig. Ic, this geometry corresponds with the general geometry of the human calf and therefore provides a snugger fit in comparison with cylindrically shaped sleeves. The three cells may have different circumferences.

Each cell 6 in the sleeve 5 is divided into a plurality of compartments 8. The compartments 8 are oriented in the cell 6 so as to extend longitudinally along the limb to be treated when the cell 6 is applied to a body limb. The compartments are formed by means of incomplete seams 9. As explained in US Patent No. 6,478,757, with this construction, the diameter of a cell 6 when inflated is theoretically 0.64 of the diameter of the same cell when deflated, irrespective of the number of compartments 8 in the cell 6.

After wrapping a cell 6 around a body limb, each cell is secured by an elastic fastening element 11 that allows tightening of the massaging sleeve around the limb so as to provide a snug fit of the cell 6 around the limb. As shown in greater detail in Fig. 2, the fastener 11 is composed of three elements 7a, 7b, and 7c that are serially connected to each other. The elements 7a and 7c are made from an inelastic material and bear Velcro™-like hooks 21 on their inner side (Fig. 1) which are capable of being reversibly hooked to mated Velcro™-like loops 23 on the outer surface of the sleeve. The element 7b intervenes between the elements 7a and 7b. The elastic element 7b, is made from an elastic material, for example, an elastic bandage material. Element 7a is either integral with the edge of the cell 6,

01618438X6-01 as shown in Fig. 1, or is adapted to be attached to the cell before use. When the cell is wrapped around the limb, the user holds in his hand the element 7c and stretches the elastic element 7c with a certain force. The amount of the force that is used during the application of the sleeve will determine how tight it will be wrapped around the limb. The elongation of the elastic element 7b is, within a certain range, proportional to the applied force. A stretch indicator 12 is printed on, or embedded in, the elastic element 7b that provides an indication indicates when a predetermined elongation has been achieved. The predetermined elongation is achieved when the stretch indicator 12 assumes a predetermined shape. For example, Figs. 2A and 2B, show an elastic element 7b having a stretch indicator 12a in which, before stretching of the elastic element 7b (Fig. 2A), the stretch indicator 12a has a rectangular shape, and the predetermined stretch is obtained when the stretch indicator 12a has acquired a square shape (Fig. 2B). Figs. 2C and D show an elastic element 7b having a stretch indicator 12b in which, before stretching of the elastic element 7a (Fig. 2C), the stretch indicator 12b has an oval shape, and the predetermined stretch is obtained when the stretch indicator 12b has acquired a circular shape (Fig. 2D) The fastening mechanism enables semi-quantitative measurement of the tension used during its application, and thus enables simple, semi-quantitative control of the force used during sleeve application.

Fig. 3A shows a cross section of a cell 6 of the sleeve 5 in a deflated state after being applied to body limb 10. The two inelastic elements 7a and 7c bearing Velcro™ like hooks 21 are hooked to the looped surface of the Velcro™-like loops 23 on the outer surface of the cell 6 with the elastic element 7b stretched to its predetermined length, as indicated by the shape indicator 12, in order to endow the cell 6 with a snug fit around the limb 10. As shown in Fig. 3A, when the cell 6 is deflated the compartments 8 are collapsed. When fixed to the outer surface of the deflated cell 6, the inelastic element 7a determines the circumference of the cell 6 when deflated. Only the first inelastic element 7a is involved in determining the circumference, and neither of the elastic element 7b and the second inelastic element

01618438X6-01 7c affects the circumference. As a consequence, as long as the pressure created by the stretched elastic element on the inflated sleeve is lower then the pressure developed within the compartments 8 during cell inflation, the addition of elements 7b and 7c does not affect the sleeve pneumatic performance during inflation. When the cell 6 is deflated as shown in Fig. 3A, the elastic element 7b is attached through the inelastic elements 7a and 7c at two fixed lines 19a and 19b on the circumference of the closed loop formed by the cell 6, so as to create an elastic layer that overlaps at least a portion of the inelastic loop formed by the inelastic material of the cell 6. As demonstrated below, when the cell 6 is deflated, an orthotic effect is delivered to the limb when the limb muscles are being used, and an elastic effect is delivered when the limb muscles are not being used.

The cell 6 is inflated by delivering a pressurized fluid such as air from a source (not shown in Fig. 3) via a delivery tube 17. The compartments 8 of the cell 6 are inflated simultaneously. The cell 6 in the inflated state is shown in Fig. 3B. When inflated, the diameter of the cell 6 is theoretically 0.64 of its diameter when uninflated. Inflation of the cell 6 thus creates a pneumatic compression of the limb, as explained above.

When the cell 6 is subsequently deflated (Fig. 3A), the pressure that is created on the limb by the deflated cell 6 is directly proportional to the tension that was developed in the cell 6 during stretching of the elastic element 7b and application of inelastic elements 7a and 7c to the outer surface of the cell 6 and inversely proportional to its circumference (as is predicted by Laplace's law for a tube: T= PxR, where T is the tension, P is the pressure and R is the radius of the tube). The tension that is developed during application of the cell 6 to the body limb 10 is determined by the extent of stretching of the elastic element 7b. If the elastic elements in all three air cells 6 (Fig. 1) are identical, and all of them were stretched during application to the same length, (as determined by the indicator 12), then T is the same for all sleeve cells 6. Because the circumference of the calf increases gradually from the ankle towards the knee, the resting pressure that the deflated sleeve creates is graduated- it is highest at the level of the ankle and gradually

01618438\6-01 decreases towards the knee. This pressure distribution facilitates venous blood flow. However, the condition that the closed loop formed by a cell 6 snugly fits the surface of the limb is not always attainable with an inelastic sleeve of the prior art. The anatomy of the human calf is not that of an ideal cone, and further more, its geometry can actually change during the treatment itself (for example due to a reduction of edema or because the patient was initially sitting and subsequently lied down in a supine position, or because the patient changed the level of his muscle training). In these cases, the overlying elastic layer of the sleeve of the present invention can compensate for changes or irregularities in the shape of the limb being treated, so as to maintain a snug fit of the sleeve around the limb. The tension that is developed in the stretched elastic element 7b is identical to that developed in the inelastic material of the compartments. However, unlike the inelastic material that loses tension when the limb diameter is reduced, the overlying elastic layer is capable of restoring most of its original tension along a wide range of circumferences, if the elastic element 7b is not stretched beyond the linear range of the strain vs. stretch relation of the elastic material. Thus, the elastic element 7b may initially be stretched to a length near the center of the clinically relevant linear range of the strain vs. stretch relation of the elastic material in order to minimize the chances that the elastic element 7b should subsequently become stretched beyond this relevant linear range. By positioning the elastic element in parallel with the inelastic closed loop, and not in series with the inelastic sleeve material, it is possible to compensate for a reduction in limb diameter without compromising the pneumatic effect. Whenever there is some level of fit redundancies, which is practically most of the time due to the irregular shape of the body limbs, the cell 6 behaves to a certain limited range as an elastic cell (when deflated and the limb muscles are not being used). When the limb circumference is increased locally, as during limb muscle exercise, the small redundancies disappear and the sleeve behaves like an inelastic orthotic device and effectively augments the muscle pump. When the sleeve is actively inflated, a very small amount of energy is used to

01618438\6-01 compensate for any minor redundancies in sleeve, so as to provide a pneumatic effect that is not significantly affected by the elastic component.

Figure 4 shows a pneumatic massaging system comprising a massaging calf sleeve 5. The system further comprises a foot sleeve 4 and a pneumatic actuating and control system 1 that is connected to the sleeves for coordinated inflation and deflation of the cells 6 in sleeves in accordance with a predetermined temporo-spatial array. The console system is connected to the sleeves through connecting tubes 3 that terminate in special pneumatic connectors 2. The consol system 1 is disclosed in US Patent No. 6,478,757. The orthotic effect of the sleeve 5 was investigated in a hemodynamic duplex study. Peak Venous Velocity (PVV) was measured in the popliteal vein of ten healthy volunteers after ten tiptoe exercises. Measurements were taken with the subject wearing the calf sleeve 5, a GCS calf sleeve, or no sleeve. The pneumatic sleeves were kept deflated during the study so that their effect, if any, was completely passive. The percent of improvement in PW during the tiptoe exercises, in comparison to no tiptoe exercise was calculated at various times after application of the sleeve or stocking. As shown in Table 1 and Fig. 5, application of the deflated sleeve caused an augmentation of the effect of exercise on the popliteal PW. Such an augmentation was not achieved when GCS were applied to the legs.

01618438X6-01

Claims

CLAIMS:

1. An inflatable massaging sleeve for massaging a body limb having at least one inflatable cell, the cell providing a pneumatic effect when being inflated, the cell providing an elastic effect when deflated and muscles of the limb are not being used, and further providing an orthotic effect when deflated and the limb muscles are being used.

2. A sleeve formed from a flexible inelastic material and configured to be wrapped around a body limb, comprising an elastic element configured to be affixed to the sleeve, the elastic element being attachable to the sleeve in a stretched state when the cell is wrapped around a body limb with the elastic element positioned in parallel to at least a portion of the inelastic material of the sleeve.

3. The sleeve according to Claim 2 wherein the elastic element is attached at a first end to a first inelastic element and is attached at a second end to a second inelastic element.

4. The sleeve according to Claim 2 or 3 wherein the elastic element is provided with a stretch indicator.

5. The sleeve according to Claim 4 wherein the stretch indicator is printed or embedded in the elastic element, the stretch indicator having a first conformation when the elastic element is in an unstretched state and having a second conformation when the elastic element has a predetermined stretched state.

6. The sleeve according to Claim 5 wherein the predetermined stretched state is a state at which a stretch vs. strain relationship of the elastic element is in the middle of a linear range.

7. The sleeve according to any one of the previous claims comprising a section having an arcuate form when unrolled on a flat surface.

8. The sleeve according to Claim 7 comprising two sections having an arcuate form of opposite orientations when the sleeve is unrolled on a flat surface.

01618438\6-01

9. The sleeve according to Claim 8 further comprising a third section having an arcuate form.

10. The sleeve according to Claim 9 adapted for application to a calf.

11. The sleeve according to any one of Claims 2 to 10 being a pneumatic massaging sleeve.

12. The sleeve according to Claim 11 comprising one or more cells divided into longitudinally extending compartments that are inflated and deflated essentially simultaneously.

13. A sleeve having at least a first section configured to be wrapped around a body limb and a second section configured to be wrapped around the limb, the first and second sections having an arcuate form when unrolled on a flat surface, the arcuate form of the first sectionl having an orientation opposite to the arcuate form of the second section when unrolled on flat surface. .

14. The sleeve according to Claim 13 further comprising a third cell having an arcuate form.

15. The sleeve according to Claim 14 adapted for applying pressure to a calf.

16. The sleeve according to any one of Claims 13 to 15 being a pneumatic massaging sleeve.

17. The sleeve according to Claim 16 having one or more cells divided into longitudinally extending compartments that are inflated and deflated essentially simultaneously.

18. A fastener for a sleeve comprising an inelastic material , the fastener having a first end adapted for attachment to the sleeve at a first location and a second end adapted for attachment to the sleeve at a second location, the fastener comprising an elastic element attachable to the sleeve in a stretched state when the cell is wrapped around a body limb with the elastic element in parallel to at least a portion of the inelastic material.

01618438\6-01

19. The fastener according to Claim 18 wherein the elastic element is attached at a first end to a first inelastic element of the fastener and is attached at a second end to a second inelastic element of the fastener.

20. The fastener according to Claim 18 or 19 wherein the elastic element is provided with a stretch indicator.

21. The fastener according to Claim 20 wherein the stretch indicator is printed or embedded in the elastic element, the stretch indicator having a first conformation when the inelastic element is in an unstretched state and having a second conformation when the elastic element has a predetermined stretched state.

22. The fastener according to Claim 21 wherein the predetermined stretched state is a state at which a stretch vs. strain relationship of the elastic element is in the middle of a linear range.

23. A massaging sleeve comprising the fastener according to any one of Claims 18 to 23.

24. A system for massaging a body limb comprising a massaging sleeve according to any one of Claims 11, 12, 16, or 17. .

25. The system according to Claim 24 further comprising a pneumatic actuating and control system.

26. An inflatable massaging sleeve for massaging a body limb having at least one inflatable cell, the cell providing a pneumatic effect when being inflated, the cell providing an elastic effect when deflated and muscles of the limb are not being used, and further providing an orthotic effect when deflated and the limb muscles are being used.

01618438\6-01