US20070260162A1 - Compression apparatus - Google Patents

Abstract

A compression apparatus is a foot cuff having an inner and outer layer with an inflatable member disposed therein. The inflatable member is attached to the inner or outer layer of the foot cuff by a variety of methods that leave it free to move with respect to the unattached layer.

Description

• This application is a continuation-in-part of U.S. Ser. No. 11/299,568, filed Dec. 12, 2005, now U.S. Pat. No. ______, the entire contents of which are incorporated herein by reference.
BACKGROUND
• The present disclosure relates generally to compression apparatus. In particular, the present disclosure relates to a compression apparatus configured for applying compressive forces to a portion of a patient's anatomy.
• Compression devices for applying compressive forces to a selected area of a person's anatomy are generally employed to improve blood flow in the selected area. Compression devices that provide intermittent pulses of a compressed fluid (i.e. air) to inflate at least one inflatable chamber in a cuff are particularly useful. This cyclic application of pressure provides a non-invasive method of prophylaxis to reduce the incidence of deep vein thrombosis (DVT), and the like. These compression devices find particular use during surgery on patients with high-risk conditions such as obesity, advanced age, malignancy, or prior thromboembolism. Patients who develop this condition often have swelling (edema) and tissue breakdown (venous stasis ulcer) in the lower leg. 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.
• Generally, these compression devices are fluidly coupled to a source of pressurized fluid by one or more air tubes. Additionally, each compression device includes a flexible shell having one or more inflatable members disposed therein. The compression device is placed around the patient's foot or other selected portion whereupon a pressurized fluid is delivered into the inflatable member creating pressure at the part or parts of the body in contact with the inflatable member.
• Compression cuffs adapted for use with a patient's foot may be combined with one or more additional compression cuffs that are disposed on portions of a patient's leg for improving the treatment regimen. In general, each of the additional compression cuffs includes a plurality of separate inflatable chambers that are progressively arranged along a longitudinal axis of the cuff from a lower portion to an upper portion of the limb. A pressure source, e.g. a controller, is provided for intermittently forming a pressure pulse within these inflatable chambers from a source of pressurized fluid during periodic compression cycles. The compression cuffs provide a pressure gradient along the patient's limbs during these compression cycles which progressively decreases from the lower portion to the upper portion of the limb (e.g. from the ankle to the thigh).
• Compression cuffs that are adapted for use with a patient's foot generally include a heel strap with a tab portion that is adapted to fit around a portion of the patient's heel. This arrangement allows the compression cuff to be releasably attached to the patient's foot.
• Examples of compression cuffs are disclosed in U.S. Pat. Nos. 4,013,069 and 4,030,488 to Hasty, U.S. Pat. Nos. 4,029,087 and 5,795,312 to Dye, and U.S. Pat. No. 5,626,556 to Tobler et al., all of which are currently owned by Tyco Healthcare Group LP and are incorporated by reference herein in their entireties. Other examples of compression cuffs are disclosed in U.S. Pat. Nos. 4,696,289 to Gardner et al. and 5,989,204 to Lina. An example of compression treatment method is disclosed in U.S. Pat. No. 6,231,532 to Watson et al., which is currently owned by Tyco Healthcare Group LP, the contents of which are hereby incorporated by reference herein in their entirety.
• Some prior art devices are bulky and may irritate portions of the limb undergoing treatment which may increase patient discomfort and may increase the possibility that the patient may not complete the treatment regimen.
SUMMARY
• In one aspect, a compression apparatus includes a first layer and a second layer. The first layer and second layer define a space between them. A single inflatable member is disposed in the space. The single inflatable member is freely movable in relation to at least one of the first and second layers when it is disposed on the body part of a patient for providing DVT prophylaxis therapy to a limb. An outer surface of the inflatable member is secured to an inner surface of the first or second layer by an adhesive layer. The adhesive layer is selected from the group consisting of at least one strip of adhesive tape, an adhesive fluid, a gel and combinations thereof.
• In another aspect, a compression apparatus includes a first layer and a second layer. The first layer and second layer define a space between them. A single inflatable member is disposed in the space. The single inflatable member is freely movable in relation to at least one of the first and second layers when it is disposed on the body part of a patient for providing DVT prophylaxis therapy to a limb. A fastener secures an outer surface of the inflatable member to an inner surface of the first or second layer. The fastener is selected from the group consisting of a button, a snap, a hook and eye fastener, a hook and loop fastener, a staple, a zip fastener, a magnetic fastener, a rivet and combinations thereof.
• In another aspect, a compression apparatus includes a first layer and a second layer. The first layer and second layer define a space between them. A single inflatable member is disposed in the space. The single inflatable member is freely movable in relation to at least one of the first and second layers when it is disposed on the body part of a patient for providing DVT prophylaxis therapy to a limb. Stitching joins an outer surface of the inflatable member to an inner surface of the first or second layer.
• In a further aspect, a compression apparatus includes a first layer and a second layer. The first layer and second layer define a space between them. A single inflatable member is disposed in the space. The single inflatable member is freely movable in relation to at least one of the first and second layers when it is disposed on the body part of a patient for providing DVT prophylaxis therapy to a limb. An outer surface of the inflatable member is secured to an inner surface of the first or second layer by fusion of the outer surface of the inflatable member with the inner surface of the first or second layer.
• In still a further aspect, a compression apparatus includes a first layer and a second layer. The first layer and second layer define a space between them. A single inflatable member is disposed in the space. The single inflatable member is freely movable in relation to at least one of the first and second layers when it is disposed on the body part of a patient for providing DVT prophylaxis therapy to a limb. A crimped element is located between the inflatable member and the first or second layer. The crimped element has folds capturing portions of the inflatable member and first or second layer for securing an outer surface of the inflatable member to an inner surface of the first or second layer.
• In another aspect, a compression apparatus includes a first layer and a second layer. The first layer and second layer define a space between them. A single inflatable member is disposed in the space. The single inflatable member is freely movable in relation to at least one of the first and second layers when it is disposed on the body part of a patient for providing DVT prophylaxis therapy to a limb. A material of an outer surface of the inflatable member and a material of an inner surface of the first or second layer are selected to produce an electrostatic connection of the outer surface of the inflatable member with the inner surface of the first or second layer.
• In yet another aspect a compression apparatus includes a first layer and a second layer. The first layer and second layer define a space between them. A single inflatable member is disposed in the space. The single inflatable member is freely movable in relation to at least one of the first and second layers when it is disposed on the body part of a patient for providing DVT prophylaxis therapy to a limb. Straps are attached to the inner surface of the first or second layer. The straps receive portions of the inflatable member for securing an outer surface of the inflatable member to an inner surface of the first or second layer.
• Other features will be in part apparent and in part pointed out hereinafter. Various refinements exist of the features noted in relation to the above-mentioned aspects of the present invention. Further features may also be incorporated in the above-mentioned aspects of the present invention as well. These refinements and additional features may exist individually or in any combination. For instance, various features discussed below in relation to any of the illustrated embodiments of the present invention may be incorporated into any of the above-described aspects.
BRIEF DESCRIPTION OF THE DRAWINGS
• The features of the presently disclosed compression apparatus will become more readily apparent by referring to the following detailed description of embodiments, which are described hereinbelow with reference to the drawings, wherein:
• FIG. 1 is an exploded perspective view, of a first embodiment of the compression apparatus in accordance with the present disclosure;
• FIG. 2 is a top plan view of the compression apparatus illustrated inFIG. 1;
• FIG. 3 is a top plan view of the compression apparatus ofFIG. 1, illustrating the outline of a foot of a patient disposed thereon;
• FIG. 4 is a bottom plan view of the compression apparatus ofFIG. 1;FIGS. 5-6 are bottom plan views of the compression apparatus ofFIG. 1 indicating inflatable member attachment points;
• FIG. 7 is a fragmentary cross-section view of the outer layer and inflatable member of the compression apparatus ofFIG. 1 illustrating attachment by use of an adhesive layer;
• FIG. 8 is a fragmentary cross-section view of the outer layer and inflatable member of the compression apparatus ofFIG. 1 illustrating attachment by use of magnetic strips;
• FIG. 9 is a fragmentary cross-section view of the outer layer and inflatable member of the compression apparatus ofFIG. 1 illustrating attachment by fusion;
• FIG. 10 is a fragmentary cross-section view of the outer layer and inflatable member of the compression apparatus ofFIG. 1 illustrating attachment by use of buttons;
• FIG. 11 is a fragmentary cross-section view of the outer layer and inflatable member of the compression apparatus ofFIG. 1 illustrating attachment by use of snaps;
• FIG. 12 is a fragmentary cross-section view of the outer layer and inflatable member of the compression apparatus ofFIG. 1 illustrating attachment by use of hook and eye fasteners;
• FIG. 13 is a fragmentary cross-section view of the outer layer and inflatable member of the compression apparatus ofFIG. 1 illustrating attachment by hook and loop fasteners;
• FIG. 14 is a fragmentary cross-section view of the outer layer and inflatable member of the compression apparatus ofFIG. 1 illustrating attachment by staples;
• FIG. 15 is a fragmentary cross-section view of the outer layer and inflatable member of the compression apparatus ofFIG. 1 illustrating attachment by rivets;
• FIG. 16 is a fragmentary cross-section view of the outer layer and inflatable member of the compression apparatus ofFIG. 1 illustrating attachment by stitching;
• FIG. 17 is a fragmentary cross-section view of the outer layer and inflatable member of the compression apparatus ofFIG. 1 illustrating attachment by electrostatic connection.
• FIG. 18 is a fragmentary cross-section view of the outer layer and inflatable member of the compression apparatus ofFIG. 1 illustrating attachment by use of zip fasteners;
• FIG. 19 is a perspective of the compression apparatus ofFIG. 1 with an inner layer removed therefrom, illustrating attachment of the inflatable member and outer layer by straps;
• FIG. 20 is a fragmentary cross-section view of the outer layer and inflatable member of the compression apparatus ofFIG. 1 illustrating attachment by use of a crimping element;
• FIGS. 21-24 are top plan views of further alternative embodiments of a compression apparatus, in accordance with the present disclosure;
• FIG. 25 is a top plan view of the compression apparatus ofFIG. 1 disposed about a foot of a patient;
• FIG. 26 is a side plan view of the compression apparatus ofFIG. 1 disposed about a foot of a patient;
• FIG. 27 is a perspective view of another embodiment of the compression apparatus, in accordance with the present disclosure; and
• FIG. 28 is a perspective view illustrating the compression apparatus ofFIG. 27 wrapped around a leg of a patient.
DETAILED DESCRIPTION
• With reference to the drawing figures, in which like references numerals identify identical or corresponding elements, various embodiments of the presently disclosed compression apparatus will now be described in detail.
• With initial reference toFIGS. 1-4, a first embodiment of a compression apparatus in accordance with the present disclosure is illustrated and is designated generally ascompression apparatus10.Compression apparatus10 is adapted for use in a system for applying compressive pressure to a portion of a body, such as, for example, a foot of a person.Compression apparatus10 generally includes afoot cuff12 configured for disposal about a foot and aninflatable member14 disposed withinfoot cuff12 and being freely movable or repositionable in relation tofoot cuff12. Moreover,foot cuff12 is configured and dimensioned for disposing about the right or left foot of the subject.
• Foot cuff12 includes an inner orcontact layer16 and anouter layer18 fixedly joined at seams adjacent corresponding perimeters thereof and defining a space for receivinginflatable member14 therein.Contact layer16 andouter layer18 may be joined by radio frequency (RF) welding, sewing, adhesives, etc.Contact layer16 andouter layer18 includestrap portions13aand13brespectively.Strap portions13a,13bhave a longitudinally projecting configuration for wrapping about a portion of the foot adjacent to the ankle.Contact layer16 is adapted for contacting the bottom portion of the foot and providing a fabric on fabric slide withinflatable member14, in accordance with the present disclosure.Strap portions13a,13bcan be sewn, RF welded, or sonic welded. However in the illustrated embodiments, thestrap portions13a,13bare formed as one piece with thecontact layer16 andouter layer18, respectively.Contact layer16 is fabricated from a chemically treated material, with wicking ability, for wicking away moisture from the skin. In one embodiment,contact layer16 includes a mesh-like fabric capable of wicking moisture away from the patient's skin. Furthermore, thecontact layer16 can be faced with a soft material toward the treatment surface of the patient. The material can be a thin layer of open celled porous foam, napped cloth, or a layer of vapor permeable cloth permeable.
• Outer layer18 includes anopening20 for permitting a pressurized fluid inlet passage therethrough, in a manner described herein below.Outer layer18 is configured for providing the attachment surface for a hook and loop feature ofcompression apparatus10, as will be described in detail hereinbelow. Moreover,outer layer18 provides a soft material for cushioning effect against the top portion of the feet and may be fabricated from similar materials ascontact layer16 and in similar dimensions therewith for corresponding geometry. Alternatively,outer layer18 may be fabricated from a laminated material, such as, for example, sontara fabric, open cell urethane foam, or loop fabric.
• With particular reference toFIG. 1,inflatable member14 is disposed within the space defined bycontact layer16 andouter layer18 and is configured for moving independently relative tofoot cuff12.Inflatable member14 is configured for positioning against the bottom portion of the foot and the ankle portion.Inflatable member14 is adapted for receiving and retaining a pressurized fluid (e.g. air) for exerting compressive pressure to the foot during successive pressure applying cycles.Inflatable member14 includes upper and lowerinflatable layers22,24 overlaid to form an inflatable portion. Upper andlower layers22,24 are fixedly joined via sealinglines26 along their perimeters to define the inflatable portion. Sealinglines26 may be formed by radio frequency (RF) welding. Alternatively, sealinglines26 may be sewn, formed by adhesive, heat sealing, etc.
• Afirst surface23 of upperinflatable layer22 is positioned just belowcontact layer16 for providing the largest compression effect on the foot. Upperinflatable layer22 includes material for wicking away moisture from the bottom of the feet. In one embodiment, upperinflatable layer22 includes a two-part laminated material that is formed from a chemically treated wicking fabric or non-woven material combined with a PVC or urethane sheet thereby allowinglayer22 to move with respect tocontact layer16. In another embodiment, upperinflatable layer22 is a PVC or urethanesheet allowing layer22 to move with respect tocontact layer16.
• Lowerinflatable layer24 includes a single material such as a polyvinyl chloride (PVC). It is envisioned that the material used to fabricate theinflatable member14 may include at least two different thicknesses for providing directional inflation ofinflatable member14. Thus, inflation ofinflatable member14 yields different shapes as determined by the thickness ofinflatable member14.
• Theinflatable member14 may be attached to thecontact layer16 or theouter layer18. It is preferred that theinflatable member14 be attached to theouter layer18 as this permits relative movement betweencontact layer16 and theinflatable member14. As a result, the skin does not become irritated or chaffed at locations where thecontact layer16 contacts the skin during the cyclical application of compression.
• Theinflatable member14 may be attached to theouter layer18 by a variety of methods. Attachment of the inflatable member to theouter layer18 may occur (for example) at all locations of contact between theinflatable member14, at discrete locations (FIG. 5; indicated by “X”), along attachment strips51 (FIG. 6) or along theinflatable member perimeter54. Various methods of attachment illustrated inFIGS. 7-20 will now be described. While attachment of theinflatable member14 to theouter layer18 is illustrated, it should be understood that the illustrated fastening methods are also suitable for attachment of theinflatable member14 to thecontact layer16.
• Referring toFIG. 7, a fragmentary cross-section of theinflatable member14 andouter layer18 is taken generally as indicated by line7-7 ofFIG. 4. All other components of thefoot cuff12 are removed for clarity of illustration. Theinflatable member14 is attached to theouter layer18 by a layer ofadhesive67. This layer of adhesive67 can be coextensive with the outer surface of theinflatable member14 or formed by discrete adhesive “strips”51 or “tape” as shown inFIG. 6. Theadhesive layer67 may be constructed of, for example, adhesive tape, adhesive fluids, gels or combinations thereof. Suitable adhesive fluids include, for example, glues, thermoplastic adhesives, thermosetting adhesives, rubber-resin blendsultraviolet curable adhesives and mixtures thereof. Suitable UV curable adhesives include, for example, acrylated urethanes, urethane oligomers and mixtures thereof. Suitable gels include, for example, silicone gels, hydrocolloidal gels, cyanoacrylate gels, thixotropic gels and mixtures thereof. Referring toFIG. 8, theinflatable member14 is attached to theouter layer18 by use of magnetic strips.FIG. 8 is similar toFIG. 7 but may be taken as indicated by line8-8 ofFIG. 6. Twomagnetic strips69 are attached to theinflatable member14 and twomagnetic strips70 are attached to theouter layer18. The magnetic strips can be attached to theinflatable member14 andouter layer18 in any suitable manner, for example, by adhesives. The magnetic strips should be configured so that the magnetic poles of each magnetic strip are aligned with the opposite magnetic pole of its mating magnetic strip. The arrangement of the strip or strips can be other than that shown within the scope of the present invention.
• Referring toFIG. 9, a cross section similar toFIG. 7, theinflatable member14 is secured to theouter layer18 by fusing theinflatable member14 to theouter layer18. This fusion creates an “intermingled”layer73 which comprises the fused portions of both layers. However, the material of only one of the inflatable member and contact layer may form the intermingled layer73 (i.e., only one of the layers may melt). Theinflatable member14 may be fused to theouter layer18 by, for example, heat lamination, radiofrequency welding or by solvent bonding.
• Referring toFIG. 10, theinflatable member14 is attached to theouter layer18 by twobuttons76. Eachbutton76 comprises acatch80 that is sewn to theinflatable member14 bythreads81. Theinflatable member14 is secured by fitting eachcatch80 through aslit78 formed in theouter layer18.
• Referring toFIG. 11, theinflatable member14 is secured to theouter layer18 by twosnaps82. Eachsnap82 comprises afirst snap element84 attached to theinflatable member14 and asecond snap element86 attached to theouter layer18. Thefirst snap element84 andsecond snap element86 are adapted for releasable, snap-in connection. Thefirst snap element84 andsecond snap element86 are attached to theinflatable member14 andouter layer18, respectively, by any suitable means including, for example, adhesion or by press-fitting the respective layer between metal flanges attached to the snap member.
• Referring now toFIG. 12, theinflatable member14 is attached to theouter layer18 by a hook andeye fastener88. The hook andeye fasteners88 include ahook90 attached to theinflatable member14 which extends through an opening or “eye”92 in theouter layer18. Thehook88 may be attached to the inflatable member by any suitable means including, for example stitching.
• Referring now toFIG. 13, theinflatable member14 is attached to theouter layer18 byhook elements90 andloop elements92. While thehook elements90 are shown attached to theinflatable member14 and theloop elements92 are shown attached to theouter layer18, the reverse arrangement is within the scope of the invention.
• Referring now toFIG. 14, theinflatable member14 is attached to theouter layer18 bystaples94.
• Referring now toFIG. 15, theinflatable member14 is attached to theouter layer18 byrivets96.
• Referring now toFIG. 16, theinflatable member14 is attached to theouter layer18 by stitching98 which joins an outer surface of the inflatable member to the inner surface of theouter layer18. Thestitching98 can be located along the periphery54 (FIG. 6), away from the periphery in any suitable pattern or at discrete points (FIG. 5).
• Referring now toFIG. 17, theinflatable member14 is attached to theouter layer18 by electrostatic connection. The material of the outer surface of theinflatable member14 and the inner surface of theouter layer18 are selected such that they contain opposite charges which causes an electrostatic attraction. Suitable materials which cause a positive charge, i.e., which tend to donate electrons, include, for example, leather, nylon and wool. Suitable materials which cause a negative charge, i.e., which readily accept electrons, include, for example polyurethane, polyethylene, polypropylene and polyvinyl chloride.
• Referring toFIG. 18, theinflatable member14 is attached to theouter layer18 by zip fasteners52 (e.g., like a ZIPLOC fastener). Thezip fasteners52 include agroove element58 formed within theouter layer18 and atongue56 which extends from theinflatable member14. At least a portion of thetongue56 is larger than the width of thegroove element58. The outer walls of thegroove element58 are resiliently deformable such that thetongue56 can be releasably captured within the groove upon mating of the tongue and groove element. Thezip fastener52 may extend around the perimeter or over shorter segments at or away from the perimeter of theinflatable member14. Thetongue56 may be integral with theinflatable member14 or may attached thereto by, for example, adhesive or RF welding.
• Referring toFIG. 19, thefoot cuff12 is shown with thecontact layer16 removed. Theinflatable member14 is secured to theouter layer18 by twostraps61 which receive portions of the inflatable member. The number and/or arrangement of the straps may be other than shown. Thestraps61 are attached to the inner surface of theouter layer18 by any suitable method including stitching, RF welding or heat lamination.
• Referring toFIG. 20, theinflatable member14 is secured to theouter layer18 by use of a crimpingelement65. The crimpingelement65 is either rounded or folded such that it captures portions of theinflatable member14 andouter layer18 to secure the outer surface of the inflatable member and inner surface of the outer layer together. The crimpingelement65 may be composed of any resilient material capable of retaining its shape after being rolled or crimped (broadly, “folded”) upon itself. Suitable materials include, for example, thin sheets of metal or resilient plastic. Thecrimpled member65 may extend continuously along the perimeter of theinflatable member14 or may extend along discrete tab portions (not shown) along the perimeter. Any discrete tab portions are typically defined by two slits formed through theinflatable member14 andouter layer18 and formed perpendicular to the cuff perimeter.
• Referring again toFIGS. 1-4, thecuff12 includes asole member39. Thesole member39 is generally shaped according to contours of the sole of the foot. Thesole member39 is made of a rigid material, for example, metal, polymers, ceramics or composite-type materials. The rigidity of thesole member39 helps to direct the compression supplied by theinflatable member14 toward the foot.
• Thesole member39 may be located between the upperinflatable layer22 of theinflatable bladder14 and thecontact layer16, however, it is preferred that thesole member39 be located between the lowerinflatable layer24 and theouter layer18 as illustrated inFIG. 1. This arrangement allows compression to be more directly applied to the foot.
• Thesole member39 is attached to theinflatable member14 by a strip ofadhesive tape45. Alternatively or in addition, the position of thesole member39 relative to thecontact layer16 andouter layer18 may be restricted by stitching55 (FIG. 4) which partially extends around the perimeter of the sole member. Thestitching55 also connects a wider portion of theinflatable member14 to theouter layer18. A narrower portion or “tongue” of theinflatable member14 could be free floating with respect to both thecontact layer16 and theouter layer18. [ESJ—is→could be provide a claim is not made indefinite]. Other methods of attaching and retaining the sole member are contemplated within the scope of the present invention, including, for example, stitching, RF welding, heat lamination and solvent bonding.
• In embodiments where thesole member39 is not included in thecuff12, theinflatable member14 can be fastened directed to the outer layer without the sole member being interposed therebetween. In embodiments where thesole member39 is included in thecuff12, the sole member may include one or more of the fastening/attachment elements describe above for attaching the sole member to theouter layer18.
• Referring now toFIGS. 1 and 4, a plurality ofhook fasteners42,44 are provided for attachingcompression apparatus10 to a foot F, and are positioned onouter layer18 offoot cuff12.Hook44 is mounted tostrap portion13bofouter layer18 offoot cuff12 whilehook42 is mounted on a surface ofouter layer18. In use, whenstrap portions13a,13bare wrapped about foot F,hook element44 engagesouter layer18 to facilitate mounting offoot cuff12 to foot F. In addition, inflatable strap portion21 ofinflatable member14 is disposed about foot F for compression therapy. An identification tab (not shown) may also be included for providing information such as the model number and manufacturer name.Hook fasteners42,44 may have tabs (one shown,44a) without fastening material thereon to provide convenient gripping locations on the hook fasteners to thereby allow the practitioner to easily removehooks42,44 from the surface ofouter layer18.
• With reference toFIGS. 21-24, alternative embodiments of thecompression apparatus10 ofFIGS. 1-4 are illustrated. These embodiments are similar to the embodiment illustrated inFIGS. 1-4 and will only be discussed in detail to the extent necessary to identify differences in construction and operation.
• With particular reference toFIG. 21,compression apparatus100 includesfoot cuff112 andinflatable member114, shown in phantom.Foot cuff112 includes first and second layers defining a space therebetween for receivinginflatable member114 therein, which are similar to upper and lowerinflatable layers22,24 (FIG. 1).Inflatable member114 is configured for independent movement relative to at least one of first or second layers.Foot cuff112 includesstrap portion113 extending longitudinally therethrough. Ahook element144aattached to a distal end ofstrap portion113, and ahook element142 is mounted to a portion of thefoot cuff112.Inflatable member114 is configured and dimensioned for substantial fit withinfoot cuff112, whereinfoot cuff112 is configured to be wrapped around the bottom portion of the foot. InFIG. 21, theheel portion121 of the inflatable of the foot cuff wraps around the ankle of the foot.
• With particular reference toFIG. 22,compression apparatus200 includesfoot cuff212 andinflatable member214, shown in phantom.Foot cuff212 includes first and second layers defining a space therebetween for receivinginflatable member214 therein, which are similar to upper and lowerinflatable layers22,24 (FIG. 1).Inflatable member214 is configured for independent movement relative to at least one of first or second layers.Inflatable member214 includes avalve connector216 for connectinginflatable member214 to a pressurized fluid source.Valve connector216 protrudes through an opening positioned on the outer cuff portion offoot cuff212, in a manner described hereinabove with respect tocompression apparatus10.Foot cuff212 includesstrap portion218 extending longitudinally therethrough. Ahook element220 attached to a distal end ofstrap portion218, and ahook element222 is mounted to a portion of thefoot cuff212.Inflatable member214 is configured and dimensioned for substantial fit withinfoot cuff212, whereinfoot cuff212 is configured to be wrapped around the bottom portion of the foot.
• With reference toFIG. 23,compression apparatus300 includesfoot cuff312 andinflatable member314, shown in phantom.Foot cuff312 includes first and second layers defining a space therebetween that receivesinflatable member314 therein, which are similar to upper and lowerinflatable layers22,24 (FIG. 1).Inflatable member314 is configured for independent movement relative to at least one of first or second layers.Foot cuff312 further includes anelongated strap316 extending longitudinally therethrough.Hook element318 is mounted toelongated strap316, whilehook element320 is mounted onfoot cuff312.Foot cuff312 further includes a plurality ofcurvatures322 for custom fitting about the foot.
• With reference toFIG. 24,compression apparatus400 includesfoot cuff412 andinflatable member414 shown in phantom.Foot cuff412 includes first and second layers defining a space therebetween that receivesinflatable member414 therein.Inflatable member414 is configured for independent movement relative to at least one of first or second layers.Foot cuff412 includes anelongated strap416 extending longitudinally therethrough.Hook element418 is mounted toelongated strap416, whilehook element420 is mounted onfoot cuff412.Foot cuff412 further includes a plurality ofcurvatures422 for custom fitting about the foot.Inflatable member414 includes inflatable elongatedstrap portion424 extending substantially alongstrap portion416.
• In use,compression apparatus10, in accordance with the present disclosure, is configured to apply compressive forces to a patient's foot. Referring now toFIGS. 3 and 25-26, thecuff12 is disposed about the foot F by wrapping thefirst flap49 about the medial aspect of the foot F over the instep. Thesecond flap47 is then wrapped over thefirst flap49 and instep and secures to theouter layer18 byhook fastener42. Thestrap portions13a,13bare then wrapped around the ankle A (FIG. 26) and thehook fastener44 engages the outer surface of theouter layer18. After placement offoot cuff12 about foot F and connecting movableinflatable member14 to pressurizedfluid source38 via inflation assembly32,controller40 may then be actuated for supply pressurized air tocompression apparatus10 and initiating compression therapy.Controller40 intermittently inflatesinflatable member14 during periodic compression cycles in a pressure gradient profile. As compression therapy is applied,contact layer16 andinflatable member14 move independently, whileouter layer18 remains fixed against the foot throughout the compression therapy. The wicking properties ofcontact layer16 will facilitate keeping feet F dry during prolonged periods of compression therapy. Deflation between successive inflation cycles occurs by return of air throughinflatable member14 tocontroller40, as known in the art
• With reference toFIGS. 27-28, another embodiment of a compression apparatus in accordance with the present disclosure is illustrated and is designated generally ascompression apparatus500.Compression apparatus500 is adapted for use in a system for applying compressive pressure to a portion of a patient's body, such as, for example, the legs.Compression apparatus500 is similar to the compression cuff disclosed in U.S. Pat. Nos. 5,626,556 to Tobler et al. and 5,795,312 to Dye that are currently owned by Tyco Healthcare Group LP and are incorporated herein by reference in their entirety.
• With particular reference toFIG. 27, thecompression apparatus500, in accordance with the present disclosure, includescuff510 having first orouter sheet512 and second orinner sheet514 connected by a plurality of laterally extending sealinglines516 and longitudinally extending sealinglines518 connecting the ends of lateral sealing lines516.Outer sheet512 is adapted as an outer gas-impervious sheet andsecond sheet514 is adapted as an inner gas-impervious sheet, for placement against the person's limbs. Sealinglines516,518 may be formed by radio frequency (RF) welding, etc. Anelongated opening521 is provided for extending through what would be the knee region.Opening521 is defined byperipheral edges523 extending aroundopening521.
• Sealinglines516,518 define a plurality of spaces orchambers520a,520b, and520cthat are adapted for receiving movableinflatable members522a,522band522c.Inflatable members522a,522b, and522care configured for moving independently relative tocuff510. Similar toinflatable member14 ofcompressive cuff10,inflatable members522a,522band522care adapted for receiving and retaining a pressurized fluid, such as, for example, air, for exerting compressive pressure to the leg of the patient during successive pressure applying cycles. A plurality oflumens524a,524b,524c, and524dhaving avalve connector525 is included for operably connectinginflatable members522a,522band522cto a controller (not shown) having a source of pressurized fluid, such as, air.
• First orouter sheet512 may, for example, comprise a suitable flexible polymeric material, such as, for example, polyvinyl chloride (PVC) on the order of 5-10 mils thick. Second orinner sheet514 will preferably comprise a similar polymeric material, e.g. 5-10 mil PVC having laminated to the inner surface to be placed against the limb a non-women material such as polyester for added comfort to the wearer.
• Compression apparatus500 further includes a plurality of hook fasteners for attaching the cuff about the patient's limb. Hook fasteners include a set of spaced strips, such as loop material, positioned on first orouter sheet512 and cooperating with a set of spacedhook material526a,526b, and526cdisposed on second orinner sheet514 for releasablyfastening compression apparatus500 encircling the limb.
• With particular reference toFIG. 27, in use, after placement ofcuff510 on the patient's leg and connection to the controller viaconnector525 and plurality oflumens524a,524b,524cand524d, the controller intermittently inflatesinflatable members522a,522band522csequentially during periodic compression cycles in a pressure gradient profile. As compression therapy is applied, first orouter sheet512 andinflatable members522a,522band522cmove independently, while second orinner sheet514 remains fixed against the leg throughout the compression therapy. Deflation between successive inflation cycles occurs by return of air throughinflatable members522a,522b, and522cto the controller, as known in the art.
• It will be understood that numerous modifications and changes in form and detail may be made to the embodiments of the present disclosure. It is contemplated that numerous other configuration of the compression apparatus and geometries and orientation of the inflatable member may be used, and the material of the cuff and/or inflatable member may be selected from numerous materials other than those specifically disclosed. Therefore, the above description should not be construed as limiting the disclosed compression apparatus but merely as exemplifications of embodiments thereof. Those skilled in the art will envision numerous modifications within the scope of the present disclosure as defined by the claims appended hereto.

Claims (50)

1. A compression apparatus comprising:

a first layer and a second layer defining a space therebetween; and

a single inflatable member disposed in the space, the single inflatable member being freely movable in relation to at least one of the first and second layers when disposed on the body part of a patient for providing DVT prophylaxis therapy to a limb of a patient, wherein an outer surface of the inflatable member is secured to an inner surface of the first or second layer by an adhesive layer selected from the group consisting of:

at least one strip of adhesive tape;

an adhesive fluid;

a gel; and

combinations thereof.

2. A compression apparatus as set forth inclaim 1 wherein the adhesive layer comprises plural, spaced apart strips of double-sided adhesive tape joining the bladder to the first or second layer.

3. A compression apparatus as set forth inclaim 1 wherein the adhesive fluid is selected from the group consisting of glue, a thermoplastic adhesive, a thermosetting adhesive, a rubber-resin blend, ultraviolet curable adhesives and mixtures thereof.

4. A compression apparatus as set forth inclaim 1 wherein the gel comprises silicone gels, hydrocolloidal gels, cyanoacrylate gels, thixotropic gels and mixtures thereof.

5. A compression apparatus as set forth inclaim 1 wherein the inflatable member has a body portion and a strap portion, the body portion adapted to engage a foot and the strap portion adapted to engage an ankle.

6. A compression apparatus as set forth inclaim 1 wherein the inflatable member has a body portion that is adapted to engage a foot.

7. A compression apparatus as set forth inclaim 1 further comprising a rigid sole element.

8. A compression apparatus comprising:

a first layer and a second layer defining a space therebetween; and

a single inflatable member disposed in the space, the single inflatable member being freely movable in relation to at least one of the first and second layers when disposed on the body part of a patient for providing DVT prophylaxis therapy to a limb of a patient;

a fastener securing an outer surface of the inflatable member to an inner surface of the first or second layer, the fastener selected from the group consisting of:

a button;

a snap;

a hook and eye fastener;

a hook and loop fastener;

a staple;

a zip fastener;

a magnetic fastener;

a rivet; and

combinations thereof.

9. A compression apparatus as set forth inclaim 8 comprising plural, spaced apart fasteners.

10. A compression apparatus as set forth inclaim 8 wherein the fastener comprises a first fastener element associated with the inflatable member and a second fastener element associated with the first or second layer.

11. A compression apparatus as set forth inclaim 10 wherein the fastener comprises a button, the first fastener element comprising one of a catch and a slit and the second fastener element comprising the other of the catch and the slit.

12. A compression apparatus as set forth inclaim 10 wherein the fastener comprises a snap, the first fastener element comprising a first snap element associated with the inflatable member and the second fastener element comprising a second snap element associated with one of the first and second layers adapted for releasable, snap connection to the first snap element.

13. A compression apparatus as set forth inclaim 10 wherein the fastener comprises a hook and eye fastener wherein the eye fastener comprises an opening associated with the first or second layer.

14. A compression apparatus as set forth inclaim 10 wherein the fastener comprises a hook and loop fastener, the first fastener element comprising one of a loop element and hook element and the second fastener element comprising the other of the loop element and hook element.

15. A compression apparatus as set forth inclaim 10 wherein the fastener comprises a zip fastener, the first fastener element comprising one of a tongue element and groove element and the second fastener element comprising the other of the tongue element and groove element, the groove element adapted to releasably receive the tongue element.

16. A compression apparatus as set forth inclaim 10 wherein the fastener comprises a magnetic fastener, the first fastener element comprising a first magnetic strip associated with the inflatable member and the second fastener element comprising a second magnetic strip associated with the first or second layer.

17. A compression apparatus as set forth inclaim 10 wherein the fastener comprises a rivet, the first fastener element comprising a first rivet element associated with the inflatable member and the second fastener element comprising a second rivet element associated with one of the first and second layers.

18. A compression apparatus as set forth inclaim 8 wherein the inflatable member has a body portion and a strap portion, the body portion adapted to engage a foot and the strap portion adapted to engage an ankle.

19. A compression apparatus as set forth inclaim 8 wherein the inflatable member has a body portion that is adapted to engage a foot.

20. A compression apparatus as set forth inclaim 8 further comprising a rigid sole element.

21. A compression apparatus comprising:

a first layer and a second layer defining a space therebetween; and

a single inflatable member disposed in the space, the single inflatable member being freely movable in relation to at least one of the first and second layers when disposed on the body part of a patient for providing DVT prophylaxis therapy to a limb of a patient;

stitching joining an outer surface of the inflatable member to an inner surface of the first or second layer.

22. A compression apparatus as set forth inclaim 21 wherein the stitching comprises plural, spaced apart stitches joining the inflatable member to the first or second layer.

23. A compression apparatus as set forth inclaim 22 wherein the plural spaced apart stitches are located away from the periphery of the inflatable member.

24. A compression apparatus as set forth inclaim 21 wherein the stitching extends along the periphery of the inflatable member.

25. A compression apparatus as set forth inclaim 24 wherein the stitching extends continuously around the periphery of the inflatable member.

26. A compression apparatus as set forth inclaim 21 wherein the inflatable member has a body portion and a strap portion, the body portion adapted to engage a foot and the strap portion adapted to engage an ankle.

27. A compression apparatus as set forth inclaim 21 wherein the inflatable member has a body portion that is adapted to engage a foot.

28. A compression apparatus as set forth inclaim 21 further comprising a rigid sole element.

29. A compression apparatus comprising:

a first layer and a second layer defining a space therebetween; and

a single inflatable member disposed in the space, the single inflatable member being freely movable in relation to at least one of the first and second layers when disposed on the body part of a patient for providing DVT prophylaxis therapy to a limb of a patient, wherein an outer surface of the inflatable member is secured to an inner surface of the first or second layer by fusion of the outer surface of the inflatable member with the inner surface of the first or second layer.

30. A compression apparatus as set forth inclaim 29 wherein the fusion is formed by plural, spaced apart spot welds.

31. A compression apparatus as set forth inclaim 29 wherein the fusion is formed by heat lamination of the outer surface of the inflatable member to the inner surface of the first or second layer.

32. A compression apparatus as set forth inclaim 29 wherein the fusion is formed by RF welding.

33. A compression apparatus as set forth inclaim 29 wherein the fusion is formed by solvent bonding.

34. A compression apparatus as set forth inclaim 29 wherein the inflatable member has a body portion and a strap portion, the body portion adapted to engage a foot and the strap portion adapted to engage an ankle.

35. A compression apparatus as set forth inclaim 29 wherein the inflatable member has a body portion that is adapted to engage a foot.

36. A compression apparatus as set forth inclaim 29 further comprising a rigid sole element.

37. A compression apparatus comprising:

a first layer and a second layer defining a space therebetween; and

a single inflatable member disposed in the space, the single inflatable member being freely movable in relation to at least one of the first and second layers when disposed on the body part of a patient for providing DVT prophylaxis therapy to a limb of a patient;

a crimped element between the inflatable member and the first or second layer having folds capturing portions of the inflatable member and first or second layer for securing an outer surface of the inflatable member to an inner surface of the first or second layer.

38. A compression apparatus as set forth inclaim 37 wherein the crimped element comprises a frame of plastic material extending generally along the periphery of the inflatable member.

39. A compression apparatus as set forth inclaim 38 wherein the crimped element extends continuously around the periphery of the inflatable member.

40. A compression apparatus as set forth inclaim 37 wherein the inflatable member has a body portion and a strap portion, the body portion adapted to engage a foot and the strap portion adapted to engage an ankle.

41. A compression apparatus as set forth inclaim 37 wherein the inflatable member has a body portion that is adapted to engage a foot.

42. A compression apparatus as set forth inclaim 37 further comprising a rigid sole element.

43. A compression apparatus comprising:

a first layer and a second layer defining a space therebetween; and

a single inflatable member disposed in the space, the single inflatable member being freely movable in relation to at least one of the first and second layers and free of overlap when disposed on the body part of a patient for providing DVT prophylaxis therapy to a limb of a patient, wherein a material of an outer surface of the inflatable member and a material of an inner surface of the first or second layer are selected to produce an electrostatic connection of the outer surface of the inflatable member with the inner surface of the first or second layer.

44. A compression apparatus as set forth inclaim 43 wherein the inflatable member has a body portion and a strap portion, the body portion adapted to engage a foot and the strap portion adapted to engage an ankle.

45. A compression apparatus as set forth inclaim 43 wherein the inflatable member has a body portion that is adapted to engage a foot.

46. A compression apparatus as set forth inclaim 43 further comprising a rigid sole element.

47. A compression apparatus comprising:

a first layer and a second layer defining a space therebetween; and

a single inflatable member disposed in the space, the single inflatable member being freely movable in relation to at least one of the first and second layers and free of overlap when disposed on the body part of a patient for providing DVT prophylaxis therapy to a limb of a patient;

straps attached to the inner surface of the first or second layer, the straps receiving portions of the inflatable member for securing an outer surface of the inflatable member to an inner surface of the first or second layer.

48. A compression apparatus as set forth inclaim 47 wherein the inflatable member has a body portion and a strap portion, the body portion adapted to engage a foot and the strap portion adapted to engage an ankle.

49. A compression apparatus as set forth inclaim 47 wherein the inflatable member has a body portion that is adapted to engage a foot.

50. A compression apparatus as set forth inclaim 47 further comprising a rigid sole element.

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