COMPRESSION APPARATUS
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.
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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.
BACKGROUNDThe 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.
SUMMARYIn 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 DRAWINGSThe 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:
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 to
Foot cuff 12 includes an inner or contact layer 16 and an outer layer 18 fixedly joined at seams adjacent corresponding perimeters thereof and defining a space for receiving inflatable member 14 therein. Contact layer 16 and outer layer 18 may be joined by radio frequency (RF) welding, sewing, adhesives, etc. Contact layer 16 and outer layer 18 include strap portions 13a and 13b respectively. Strap portions 13a, 13b have a longitudinally projecting configuration for wrapping about a portion of the foot adjacent to the ankle. Contact layer 16 is adapted for contacting the bottom portion of the foot and providing a fabric on fabric slide with inflatable member 14, in accordance with the present disclosure. Strap portions 13a, 13b can be sewn, RF welded, or sonic welded. However in the illustrated embodiments, the strap portions 13a, 13b are formed as one piece with the contact layer 16 and outer layer 18, respectively. Contact layer 16 is fabricated from a chemically treated material, with wicking ability, for wicking away moisture from the skin. In one embodiment, contact layer 16 includes a mesh-like fabric capable of wicking moisture away from the patient's skin. Furthermore, the contact layer 16 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 layer 18 includes an opening 20 for permitting a pressurized fluid inlet passage therethrough, in a manner described herein below. Outer layer 18 is configured for providing the attachment surface for a hook and loop feature of compression apparatus 10, as will be described in detail hereinbelow. Moreover, outer layer 18 provides a soft material for cushioning effect against the top portion of the feet and may be fabricated from similar materials as contact layer 16 and in similar dimensions therewith for corresponding geometry. Alternatively, outer layer 18 may be fabricated from a laminated material, such as, for example, sontara fabric, open cell urethane foam, or loop fabric.
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A first surface 23 of upper inflatable layer 22 is positioned just below contact layer 16 for providing the largest compression effect on the foot. Upper inflatable layer 22 includes material for wicking away moisture from the bottom of the feet. In one embodiment, upper inflatable layer 22 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 allowing layer 22 to move with respect to contact layer 16. In another embodiment, upper inflatable layer 22 is a PVC or urethane sheet allowing layer 22 to move with respect to contact layer 16.
Lower inflatable layer 24 includes a single material such as a polyvinyl chloride (PVC). It is envisioned that the material used to fabricate the inflatable member 14 may include at least two different thicknesses for providing directional inflation of inflatable member 14. Thus, inflation of inflatable member 14 yields different shapes as determined by the thickness of inflatable member 14.
The inflatable member 14 may be attached to the contact layer 16 or the outer layer 18. It is preferred that the inflatable member 14 be attached to the outer layer 18 as this permits relative movement between contact layer 16 and the inflatable member 14. As a result, the skin does not become irritated or chaffed at locations where the contact layer 16 contacts the skin during the cyclical application of compression.
The inflatable member 14 may be attached to the outer layer 18 by a variety of methods. Attachment of the inflatable member to the outer layer 18 may occur (for example) at all locations of contact between the inflatable member 14, at discrete locations (
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The sole member 39 may be located between the upper inflatable layer 22 of the inflatable bladder 14 and the contact layer 16, however, it is preferred that the sole member 39 be located between the lower inflatable layer 24 and the outer layer 18 as illustrated in
The sole member 39 is attached to the inflatable member 14 by a strip of adhesive tape 45. Alternatively or in addition, the position of the sole member 39 relative to the contact layer 16 and outer layer 18 may be restricted by stitching 55 (
In embodiments where the sole member 39 is not included in the cuff 12, the inflatable member 14 can be fastened directed to the outer layer without the sole member being interposed therebetween. In embodiments where the sole member 39 is included in the cuff 12, the sole member may include one or more of the fastening/attachment elements describe above for attaching the sole member to the outer layer 18.
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In use, compression apparatus 10, in accordance with the present disclosure, is configured to apply compressive forces to a patient's foot. Referring now to
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Sealing lines 516, 518 define a plurality of spaces or chambers 520a, 520b, and 520c that are adapted for receiving movable inflatable members 522a, 522b and 522c. Inflatable members 522a, 522b, and 522c are configured for moving independently relative to cuff 510. Similar to inflatable member 14 of compressive cuff 10, inflatable members 522a, 522b and 522c are 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 of lumens 524a, 524b, 524c, and 524d having a valve connector 525 is included for operably connecting inflatable members 522a, 522b and 522c to a controller (not shown) having a source of pressurized fluid, such as, air.
First or outer sheet 512 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 or inner sheet 514 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 apparatus 500 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 or outer sheet 512 and cooperating with a set of spaced hook material 526a, 526b, and 526c disposed on second or inner sheet 514 for releasably fastening compression apparatus 500 encircling the limb.
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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
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 in claim 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 in claim 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 in claim 1 wherein the gel comprises silicone gels, hydrocolloidal gels, cyanoacrylate gels, thixotropic gels and mixtures thereof.
5. A compression apparatus as set forth in claim 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 in claim 1 wherein the inflatable member has a body portion that is adapted to engage a foot.
7. A compression apparatus as set forth in claim 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 in claim 8 comprising plural, spaced apart fasteners.
10. A compression apparatus as set forth in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 8 wherein the inflatable member has a body portion that is adapted to engage a foot.
20. A compression apparatus as set forth in claim 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 in claim 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 in claim 22 wherein the plural spaced apart stitches are located away from the periphery of the inflatable member.
24. A compression apparatus as set forth in claim 21 wherein the stitching extends along the periphery of the inflatable member.
25. A compression apparatus as set forth in claim 24 wherein the stitching extends continuously around the periphery of the inflatable member.
26. A compression apparatus as set forth in claim 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 in claim 21 wherein the inflatable member has a body portion that is adapted to engage a foot.
28. A compression apparatus as set forth in claim 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 in claim 29 wherein the fusion is formed by plural, spaced apart spot welds.
31. A compression apparatus as set forth in claim 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 in claim 29 wherein the fusion is formed by RF welding.
33. A compression apparatus as set forth in claim 29 wherein the fusion is formed by solvent bonding.
34. A compression apparatus as set forth in claim 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 in claim 29 wherein the inflatable member has a body portion that is adapted to engage a foot.
36. A compression apparatus as set forth in claim 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 in claim 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 in claim 38 wherein the crimped element extends continuously around the periphery of the inflatable member.
40. A compression apparatus as set forth in claim 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 in claim 37 wherein the inflatable member has a body portion that is adapted to engage a foot.
42. A compression apparatus as set forth in claim 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 in claim 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 in claim 43 wherein the inflatable member has a body portion that is adapted to engage a foot.
46. A compression apparatus as set forth in claim 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 in claim 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 in claim 47 wherein the inflatable member has a body portion that is adapted to engage a foot.
50. A compression apparatus as set forth in claim 47 further comprising a rigid sole element.
Type: Application
Filed: Jun 8, 2007
Publication Date: Nov 8, 2007
Applicant: TYCO HEALTHCARE GROUP LP (Mansfield, MA)
Inventors: Ann Meyer (Shrewsbury, MA), Kristin Watson (North Attleboro, MA), Heather Gillis (Sharon, MA), Mark Vess (Hanson, MA), Malcolm Bock (Medfield, MA)
Application Number: 11/760,321
International Classification: A61H 7/00 (20060101); A61F 5/00 (20060101);