EP0388200B1

EP0388200B1 - Full length compressible sleeve

Info

Publication number: EP0388200B1
Application number: EP90302781A
Authority: EP
Inventors: John F. Dye
Original assignee: Kendall Co
Current assignee: Kendall Co
Priority date: 1989-03-16
Filing date: 1990-03-15
Publication date: 1994-09-14
Anticipated expiration: 2010-03-15
Also published as: ATE111337T1; EP0388200A2; EP0388200A3; DK0388200T3; ES2060024T3; DE69012381T2; DE69012381D1

Abstract

A sleeve for applying compressive pressures against a patient's limb from a source of pressurized fluid, wherein the sleeve comprises a multi-layered sheath (10), having a proximal (60) and a distal end. Generally parallel side edges (52, 54) extend between the proximal (60) and distal ends, which side edges (52, 54), on the proximal half of the sheath, are adjustably wrappable about the patient's limb, once it is inserted in the sleeve (10).

Description

This invention relates to pressurizable, multi-chambered, therapeutic devices, and more particularly to sleeves for applying compressive pressures against a patient's leg.
Blood flow in patient's extremities, particularly the legs, markedly decrease during extended terms of confinement. Such pooling or stasis, is particularly acute in surgery and during recovery periods immediately thereafter.
Blood flow compressive devices, such as shown in U.S. Patents 4,013,069 and 4,030,488, develop and facilitate the application of compressive pressures against a patient's limbs and in so doing promoting venous return. The devices comprise a pair of sleeves which are wrapped about the patient's limbs, with a controller for supplying the pressurized fluid to the sleeves.
These sleeve devices may be seen in U.S. Patents 4,402,312 and 4,320,746.
US-A-4029087 shows another form of such device in which a sleeve having chambers for pressure fluid is wrapped around a patients leg and secured at one side by a multiplicity of tapes all of which have to be secured individually.
EP-A-168085 shows a boot having means for pressurizing its interior. The boot is secured on the leg by a zipper or boot laces, the location of which not shown.
One use for the above mentioned sleeves is the prevention of deep vein thrombosis (DVT) which sometimes occurs in surgical patients who are confined to bed. When a DVT occurs, the valves that are located within the veins of the leg can be damaged which in turn can cause stasis and high pressure in the veins of the lower leg. Patients who have this condition often have leg swelling (edema) and tissue breakdown (venous stasis ulcer) in the lower leg.
It has been shown that pneumatic compression can be highly effective in the treatment of such edema and venous ulcers. This treatment is usually performed by the patient themselves at home on a daily basis and requires that the patient be able to put on and remove the sleeves unassisted. The sleeve devices which are wrappable from a flat configuration as shown in the aforementioned patents, are difficult to apply by the patients themselves.
It is therefore an object of the present invention, to provide a compressible sleeve device which is easily utilizable at home by the patient himself.
A further object of the present invention is to optimize therapy for venous ulcers and edema associated with poor venous return.
According to the present invention a sleeve for applying compressive pressures against a patient's limb from a source of pressurized fluid comprises an elongated sheath preferably multi layered defining a plurality of compressive chambers which may be generally limb encircling, the said sheath having an open proximal end and a closed distal end, the said sheath being adapted to receive a patient's limb through its open proximal end; the said sheath having a front portion for juxtaposition with the front surface of a patient's limb, and a back portion for juxtaposition with the back surface of a patient's limb; the said front and back portions of the said sheath having transversely extending side elements, the said side elements having an outer gripping edge thereon, the said front portion having gripping means thereon being adapted to be wrapped over the said side elements and secured on to the said gripping means of the said front portion to permit girthwise adjustment of the said sleeve about a patient's limb, for example the front and back portions of the sheath having transversely extending side elements, the said side elements having a gripping edge thereon and the said front portion having gripping means thereon, preferably on an outer lateral central surface thereof, the said side elements being wrappable over and securable to the said front portion of the sheath.
The said front portion and the said back portion of the said sheath are preferably joined along their common edges coinciding between the said proximal end and the said distal end, to define the said sheath.
The said front portion and the said rear portion preferably have a common coinciding edge only partway along the length of the side of the said sheath from the said proximal end to the said distal end, to permit openability of the said sheath, thus facilitating entry of a patient's limb into the sheath.
The said back preferably includes a cushion pad for the juxtaposition of a patient's foot thereagainst.
A compressive chamber is preferably disposed in the said back portion of the said sheath, about the said foot cushion pad.
A compressive chamber is preferably longitudinally disposed in the said front portion of the said sheath, extending from the distal end thereof, to or towards the proximal end thereof, said compressive chamber about the said foot cushion pad and the said longitudinally disposed compressive chamber in the said front portion are preferably in fluid communication with one another.
The sleeve preferably includes a plurality of compressive chambers extending transversely across the said back portion of the said sheath so as to extend only around the fleshy portions of a leg when the sheath is wrapped therearound.
The chambers preferably extend across the back portion of the said sheath including the said side elements. Thus these chambers and the longitudinally extending chambers at the front together generally encircle a limb placed in the said sheath.
Indicia, e.g. a centre line, are preferably disposed longitudinally along, e.g. the middle of said gripping means, the front portion to assist a patient in properly aligning the said sleeve on his limb. The sheath is preferably a multi-layered sheath and comprises an innermost film of flexible extensible plastic, and an outermost sheet of flexible material, preferably less extensible, which between them define the said compressive chambers. The sleeve preferably includes a plurality of conduits to duct pressure fluid e.g. air from a pressure source to the said compressive chambers, at least one of the said conduits preferably ducting the said air to more than one of the said compressive chambers. The sheath preferably comprises an outer sheet which is relatively stiff and inelastic so that it remains relatively flat upon inflation on introduction of pressure fluid within the said compressive chambers; and an inner sheet which is soft and compliant, so that upon inflation the said inner sheet conforms substantially to the shape of the said limb.
In a preferred form of the invention the said front portion is adapted for placement against the bony front of a patient's leg, the said front portion being substantially inelastic, whereby when compression occurs by introducing the said fluid within the said chambers, tension is applied across the curvature of the said front portion, which tension translates into a pressure over the radius of curvature along the front of the said leg.
In this preferred form of the invention the said inelastic front portion and the said back portion of the said sheath when secured to enclose a patient's leg provide pressure chamber means for filling the hollow portions at either side of the said bony portion of the leg, whereby tension on the said inelastic front portion will result in compression at that portion of the leg.
The said pressure chamber means in the said front portion is preferably partially bifurcated. The bifurcation of the front portion chamber has the advantage of avoiding any pressurizable chamber along the mid portion of the front portion of said proximal end of the said sheath.
Desirably the sleeve is provided with a portion adapted to enclose a patient's foot when the said front and back portions are wrapped over and secured together, the said foot portion in juxtaposition with the bottom of the said patient's foot containing no compressive chamber and thereby being non-inflatable.
Preferably the said portion enclosing the said foot contains cushion means for the bottom of the said foot.
The present invention provides an elongated compressible sleeve device for enclosing a length of a patient's limb, the sleeve having a plurality of sets of adjoining laterally extending fluid pressure chambers.
The sleeve is preferably comprised of a single elongated outermost sheet of flexible fluid-impervious material such as urethane-coated nylon.
An "inner" film of a suitable flexible fluid-impervious material such as urethane is preferably disposed against the upper side of the "outer" elongated sheet, having common sealed peripheral margins. The film is preferably sealed with respect to the outer sheet to define a plurality of pressurizable chambers. The outer sheet is most preferably stiffer and inelastic or less elastic relative to the inner film, thereby permitting the inner layer to conform appreciably better to the shape of the leg. Thus, the outer sheet will remain relatively flat upon inflation while the inner film inflates and the areas of the film defining adjacent chambers press together, which in turn substantially inhibits zero pressure areas. The elongated sheet and attached film is preferably folded upon itself along a transverse fold near its longitudinal mid-point. The sheet is then preferably joined along all of one and a portion of its other longitudinal edges when folded upon itself to leave one side open from the midpoint upwardly for ease of inserting the limb, thereby forming a two-layered sheath-like structure, open at its proximal end to define an inner film and outer sheet arrangement. A plurality of conduits are preferably arranged in fluid communication with their respective chambers, each conduit preferably terminating in a connector adjacent the open end of the sleeve.
The sleeve has a distal end which is preferably closed by its transverse fold, for the enclosed emplacement of a patient's foot. An oblong or generally oval non-inflatable pad is preferably enclosed between the inner and outer sheets at the distal end of the sleeve, on top of the film, to provide a cushion base for the patient's foot.
The outer film of the topmost layer is arranged to be positionable over the front side of a patient's limb. An adhering or securement means is preferably disposed along the front of the topmost layer.
The side edges of the topmost layer, from the proximal end of the foot chamber, to the uppermost end of the sleeve, preferably have an adhering strip attached therealong. The longitudinal side portions of the sleeve preferably include margins or flap portions which are foldable onto the adhering means, so as to adjustably encase the wearer's limb in the sleeve.
The topmost layer preferably comprises a pair of longitudinally directed pressurizable chambers which are in fluid communication with the pressurizable chamber above and alongside the patient's foot.
A longitudinally directed centrally disposed sight line may be arranged along the middle of the adhering means to permit the patient to line up the sleeve, so that the sight line is aligned up the middle of the limb, permitting most effective utilization and location of the compressive chambers on the limb.
When the sleeve fully encloses a patient's limb, and the marginal side flaps of the sleeve are wrapped over and adhered to their respective sides of the adhering means, the patient's limb is almost completely surrounded by inflatable chambers, awaiting sequential pressurization. However, the front of a patient's leg is bony and hence requires no pressurizable chambers. The important area is the muscular area on the sides and back of a patient's leg, which contains the veins to which compressive pressure needs to be applied in accordance with this invention. The front side of the sleeve, which comprises the tongue portion thereof, is preferably inelastic, so that when compression occurs in the remainder of the sleeve and onto the leg, tension is applied across the curvature of the tonge which in effect translates into pressure over the radius of curvature along the front of a patient's leg.
The invention may be put into practice in various ways and one specific embodiment will be described by way of example to illustrate the invention with reference to the accompanying drawings, in which:

Figure 1 is a perspective view of a full limb length compressible sleeve constructed according to the principles of the present invention;
Figure 2 is another perspective view of the sleeve shown in Figure 1, with a patient's limb depicted therein;
Figure 3 is a plan view of the elongated outer sheet, which when folded generally along its transverse mid-point, comprises the outer layer of the sleeve;
Figure 4 is a plan view of an inner film disposed upon the outer sheet having the chambers defined by seal margins between the inner film and the outer sheet; and
Figure 5 is a plan view on an enlarged scale of the sleeve, with the inner and the outer sheet joined at their appropriate peripheral locations.

The present invention comprises an elongated compressible sleeve 10 for enclosing a patient's limb, and is of a form and shape appropriate for a leg. The sleeve 10, shown in perspective view in Figure 1, includes a plurality of adjoining generally transversely extending fluid pressurizable chambers 12, which are shown more clearly in Figure 4.
The sleeve 10 is comprised of an outermost flexible fluid-impervious sheet 14, made of urethane-coated nylon, or the like, in an elongated form, as shown in Figure 3. The outermost sheet 14 has a first end 16 and a second or opposed end 18, each of which has a transverse dimension that narrows (tapers) slightly to a general mid-point of the sheet 14, defined by a transverse fold line 20.
The sleeve 10 is also comprised of an innermost flexible fluid-impervious film 22, made of plastic material such as urethane, having a peripheral outline, as shown in Figure 4, which is generally similar to the configuration of the outermost sheet 14. As previously stated, the outermost sheet is stiffer and less elastic or inelastic relative to the innermost film so that the latter conforms well to the shape of the leg while the former remains relatively flat upon inflation.
The film 22 has a first end 24 and a second end 26, each of which has a transverse dimension that narrows slightly to a general mid-point of the film 22 defined by the common transverse "fold" line 20. The peripheral outline of the innermost film 22 is substantially the same as the periphery of the outermost sheet 14. Preferably, however, the length of the film 22, to the right of the common "fold" line 20 as shown in Figure 4, is shorter than the corresponding length of the outer sheet 14, e.g. of the order of 20% shorter.
In both the outermost sheet 14, and the innermost film 22, the longer portion of each to one side of their common fold line 20, comprises the backside portion 17 of the sleeve 10 having elongated side marginal portions 70 which wrap about the patient's limb from the backside thereat, which portions are to the left of the fold line 20, viewing Figure 2.
The innermost film 22 is placed over the outermost sheet 14, with their common fold line 20, and their first ends 24 and 16 also contiguous, as shown in Figure 4. The section of the sleeve 10, to the right of the fold line 20, as shown in Figure 4, will comprise the frontside portion 19, of the sleeve 10, when the film 22 and sheet 14 are folded along the fold line 20, onto themselves, to form the sleeve.
The innermost film 22 may then be sealed to the outermost sheet 14 generally at the periphery 23 of the film 22 and at seal lines 32 which also define a plurality of longitudinally spaced transversely directed pressurizable chambers 12 between the innermost film 22 and the outermost sheet 14. The seal lines 32 and the chambers 12 are shown in Figure 4 prior to the folding of the elongated sheet 14 and the film 22 and subsequent peripheral joining. Suitable sealing means, e.g. radio frequency (RF) sealing means, will be readily suggested to those skilled in the art.
A foot pad 36, of generally oval shape, is non-pressurizably disposed between the sheet 14 and the film 22, to form a cushion against which a patient's foot is placed, as may be seen in Figure 2. A front pressurizable chamber 34, partially bifurcated, is disposed to the right of the fold line 20 of Figure 4. The front chamber 34 is in fluid communication with a chamber 35 which extends around the side portions of the foot pad 36. The bifurcated chamber 34 eliminates any pressure chamber juxtaposed against the very forwardmost bony part of a patient's leg, when it is enclosed in the sleeve 10. This in turn applies compression to the flat leg sections on either side of the forwardmost bony portion of the lower leg. Since these flat leg sections are the sites of many ulcers, it follows that they are important areas for applying compressive pressure in accordance with this invention. The backside portion 17 of the sleeve 10 includes a lowermost pressurizable ankle chamber 38, an intermediate calf chamber 40, a first thigh chamber 42 and an upper thigh chamber 44. Each chamber 38, 40, 42 and 44 has an orifice 46 for the supply of pressure fluid e.g. for the sequential pressurization and depressurization of those chambers, through a plurality of conduits 50, through a coupling adapter 51, which is in fluid communication through further conduits 53 with a compression generator. This arrangement may be as identified in various patents including those previously incorporated by reference herein. The chamber 35, disposed about the sides and forepart of the pad 36, as well as the pressurizable chamber 34 in the frontside of the sleeve 10, including the top of the foot, is preferably maintained at a constant base pressure of about 10 pounds pressure, from a pressure generating source as aforementioned.
During assembly of the sleeve 10, the frontside 19 of the sleeve 10 is folded over onto the backside portion 17 of the sleeve 10, along their common fold line 20, and are joined, as by stitching or the like, along their common peripheral points, as indicated by "P", shown in Figure 5. The common peripheral points P may be recited as one generally longitudinally common side edge 52, and another side edge 54, only a portion of which is common to the frontside 19 and the backside 17. A longitudinal opening 56 extends almost half-way along one longitudinal side, and the sleeve 10 is open at its proximalmost end 60, to permit, in conjunction with the side opening 56, a patient to easily slide his leg "L" into the sheath-like arrangement of the sleeve 10.
A generally rectangular (slightly truncated) patch of receiving cloth 62 is secured to the outside upper portion of the frontside 19, of the sleeve, as shown in Figures 1, 2, 3, and 5. A narrow strip 64 of hook means, such as the trademarked "Velcro" material, is attached adjacent the elongated marginal side elements 70 or edges, as shown in Figures 1, 2, and 5.
After a patient has placed his leg or limb in the sheath-like sleeve 10, the longitudinal side portions along the proximal segment of the sleeve 10, may be wrapped about the patient's limb "L" as shown in Figure 2, so that the narrow strip 64 of hook means engages the receiving cloth 62 to encircle the patient's limb and hold the sleeve closely around the leg. A marker (or sight) line "M" as shown in Figure 1, may be disposed on the topside of the receiving cloth 62, to facilitate alignment of the sleeve with the front mid-portion of the patient's limb (leg). The sheath shown in Figure 5 is of a size such as to reach just above the knee. Longer sheaths may be used.
Air or other pressurizable fluid may then be directed through the conduits 46 into the chambers 34, 38, 40, 42 and 44 in the manner, e.g. of sequence and pressure profile, created by the pressure generator aforementioned.
In view of the foregoing description and illustrative drawings, it will thus be appreciated that the present invention provides a therapeutic device for applying compressive pressure against the leg, which device is easily applied and removed by the patient and is accordingly particularly suitable for home care.
Apart from this advantage, the construction and arrangement of elements of the therapeutic device of this invention provides further significant advantages which can best be described by reference to the physiology of the patient's leg.
As was previously stated, the important area to be subjected to compression is the muscular area on the sides and particularly on the back of the leg. The front of the leg is bony and hence does not require this treatment. Accordingly, the front side of the sleeve, which we can call the tongue portion thereof is not provided with sequential compression chambers. Moreover, the tongue portion is inelastic so that compression occurring at the back of the leg causes tension to be applied to the inelastic tongue portion which is in turn translated to pressure over the radius of curvature at the front of the leg.
It will also be seen from the foregoing description that there is no compression applied to the bottom of the foot. Since blood does not pool there, edema does not occur and consequently there is no need to apply compression. On the other hand, if the bottom of the foot portion were inflated to apply compression, the resulting pressure patterns would be changed if the patient stood on his feet, which the patient is indeed permitted to do when wearing the therapeutic device of this invention.
Yet another important advantage is obtained from the use of an outer sheet which is relatively stiff and inelastic and an inner film which is soft and compliant. Apart from the fact that it is desirable to have an abrasion resistant outer surface, this combination of outer sheet and inner film permits the inner film to conform substantially to the shape of the individual leg. Accordingly, zero pressure points are substantially precluded, thus avoiding or lessening the so-called corrugation effect typically seen when prior hospital compressible sleeve devices are used on edematous legs.

Claims

A sleeve for applying compressive pressures against a patient's limb from a source of pressurized fluid, comprising an elongated sheath (10) defining a plurality of compressive chambers (12), the said sheath having an open proximal end (60) and a closed distal end, the said sheath being adapted to receive a patient's limb through its open proximal end; the said sheath having a front portion (19) for juxtaposition with the front surface of a patient's limb, and a back portion (17) for juxtaposition with the back surface of a patient's limb; characterised in that the said front and back portions of the said sheath having transversely extending side elements (70), the said side elements having an outer gripping edge (64) thereon, the said front portion having gripping means (62) thereon, the said side elements (70) being adapted to be wrapped over and secured on to the said gripping means (62) of the said front portion to permit girthwise adjustment of the said sleeve about a patient's limb.
A sleeve for applying compressive pressures about a patient's limb as claimed in Claim 1 characterized in that the said front portion and the said rear portion have a common coinciding edge (54) only partway along the length of the side of the said sheath from the said proximal end to the said distal end, to permit openability of the said sheath, thus facilitating entry of a patient's limb into the sheath.
A sleeve for applying compressive pressures about a patient's limb as claimed in Claim 1 or Claim 2 characterized in that the said back portion includes a cushion pad (36) for the juxtaposition of a patient's foot thereagainst.
A sleeve for applying compressive pressures about a patient's limb as claimed in any one of Claims 1 to 3 characterized in that a compressive chamber (34) is longitudinally disposed in the said front portion of the said sheath, extending from the distal end thereof, to or towards the proximal end thereof.
A sleeve for applying compressive pressures about a patient's limb as claimed in any one of Claims 1 to 4 characterized in that it includes a plurality of compressive chambers (38,40,42,44) extending transversely across the said back portion (17) of the said sheath so as to extend only around the fleshy portions of a leg when the sheath is wrapped therearound.
A sleeve as claimed in any one of Claims 1 to 5 characterized in that the sheath comprises an outer sheet (14) which is stiff and inelastic so that it remains flat upon inflation on introduction of pressure fluid within the said compressive chambers; and an inner sheet (22) which is soft and compliant, so that upon inflation the said inner sheet conforms substantially to the shape of the said limb.
A sleeve as claimed in any one of Claims 1 to 6 characterized in that the said front portion is adapted for placement against the bony front of a patient's leg, the said front portion being substantially inelastic, whereby when compression occurs by introducing the said fluid within the said chambers, tension is applied across the curvature of the said front portion, which tension translates into a pressure over the radius of curvature along the front of the said leg.
A sleeve as claimed in Claim 7 characterized in that the said inelastic front portion and the said back portion of the said sheath when secured to enclose a patient's leg provide pressure chamber means (34) for filling the hollow portions at either side of the said bony portion of the leg, whereby tension on the said inelastic front portion will result in compression at that portion of the leg.
A sleeve as claimed in Claim 8 characterized in that the said pressure chamber means (34) in the said front portion is partially bifurcated.
A sleeve as claimed in any one of Claims 1 to 9 characterized in that it includes a portion adapted to enclose a patient's foot when the said front and back portions are wrapped over and secured together, the said foot portion in juxtaposition with the bottom of the said patient's foot containing no compressive chamber and thereby being non-inflatable.