WO2011143489A2

WO2011143489A2 - Variable compression stockings

Info

Publication number: WO2011143489A2
Application number: PCT/US2011/036333
Authority: WO
Inventors: Brad E. Vazales
Original assignee: Vazales Brad E
Priority date: 2010-05-13
Filing date: 2011-05-12
Publication date: 2011-11-17
Also published as: WO2011143489A3

Abstract

Variable compression stockings designed for use in subjects with one or more lower extremity venous ulcers are disclosed. The variable compression stockings can slide easily over a bulky compression boot (e.g., Unna boot) or other bandaging, dressing or wrap used to treat one or more venous ulcers. The variable compression stockings can provide a compression system or kit that can be used with the compression boot, bandaging, dressing or wrap (which may be treated with medication) during venous ulcer treatment and that can be used after the boot, bandaging, dressing or wrap has been removed.

Description

VARIABLE COMPRESSION STOCKINGS

FIELD

[0001] Embodiments of the invention relate generally to garments or wraps that exert a compressive force or pressure on at least a portion of a lower extremity when worn and, more particularly, to a compression stocking or compression hose for addressing (e.g., prevention and/or treatment of) medical complications of chronic venous insufficiency of the lower extremities, such as venous stasis ulcers and/or infection.

BACKGROUND

[0002] Therapeutic elastic stockings and wraps or bandages can be used to treat lower extremity chronic venous insufficiency and its complications, such as venous stasis ulcers, deep vein thrombosis, varicose veins, and/or other venous diseases. Therapeutic elastic stockings can be designed to provide sufficient external circumferential counterpressure to help overcome elevated internal pressures within the lower extremity caused by gravity or venous disease.

[0003] Venous stasis ulcers typically develop on the medial leg below the knee and above the inside ankle. Stasis ulceration of the legs is a particularly difficult condition to treat, and most often includes the use of medication-impregnated "boots" or compression wraps.

SUMMARY

[0004] In accordance with embodiments of the invention, a compression stocking for addressing (e.g., preventing and/or treating complications of chronic venous insufficiency (e.g., chronic venous reflux diseases) of a subject (e.g., a patient) with a therapeutic (e.g., compressive and/or medication-impregnated) boot (e.g., Unna boot) or compressive wrap over medication in place over a leg of the subject to treat one or more leg ulcers (e.g., venous stasis ulcers) is provided. In one embodiment, the compression stocking comprises a distal portion configured to provide a uniform first level of compression (e.g., compressive force or pressure) along an entire length of the distal portion. In one embodiment, the first level of compression is a non-therapeutic level of compression. In various embodiments, the first level of compression is substantially zero or less than 10 mmHg or less than 5 mmHg. In one embodiment, the first level of compression of the distal portion is variable along its length. The compression stocking can comprise a proximal portion configured to provide graduated compression along its length.

[0005] In one embodiment, the first level of compression of the distal portion is weaker or lower than a strength level of any compressive pressure or force provided by the graduated compression of the proximal portion. In one embodiment, the first level of compression is weak enough such that the distal portion can be pulled over the therapeutic boot or wrap with minimal effort (e.g., with little exertion or force by the person applying the boot or wrap) and such that the distal portion does not increase or add to, or does not significantly increase or add to (e.g., overcompress), the compression of the region of the leg covered by the therapeutic boot or wrap, which may already be providing compression. For example, a compression level less than 5 mmHg or less than 10 mmHg may not significantly increase or add to the compression already being provided.

[0006] Accordingly, the compression stockings disclosed herein can provide two or more levels of compression. In some embodiments, the compression stockings disclosed herein provide one, three, four, five or more levels of compression. In some embodiments, one or more levels provide therapeutic compression and one or more levels provide non- therapeutic compression. For example, a proximal portion of a compression stocking disclosed herein can provide a therapeutic compression level and a distal portion of the compression stocking can provide a non-therapeutic compression level. In some embodiments, varying portions of the compression stockings comprise varying degrees of stretchability (e.g., materials with varying stretch properties). In some embodiments, an entire compression stocking has uniform stretchability (non-varying stretchability). In some embodiments, portions of the compression stockings have varying thickness (e.g., padding).

[0006] In one embodiment, the proximal portion is sized and shaped to extend generally from the upper thigh to the upper calf below the knee and the distal portion is sized and shaped to extend from the upper calf below the knee to the ankle or to the toes of the wearer. In one embodiment, a transition zone separates the proximal portion from the distal portion. The transition zone can be adapted to be located or positioned at or adjacent a proximal or upper end of a medicated or therapeutic boot (e.g., Unna boot), wrap or dressing that has been placed around a lower leg (e.g., from the upper to mid-calf region to the ankle region) of the subject (e.g., to treat a venous ulcer). In some embodiments, the medicated or therapeutic boot, wrap or dressing provides compression. [0007] In one embodiment, the distal portion and the proximal portion comprise a single, unitary stocking. In another embodiment, the distal portion and the proximal portion comprise separate stocking members. In one embodiment, the distal portion and the proximal portion are removably coupled to each other (either permanently or temporarily). In one embodiment, the distal portion of the compression stocking comprises an adjustment mechanism to allow temporary separation of the material of the distal portion (e.g., hook-and- loop fasteners, zipper, buttons, snaps) while the compression stocking is being applied or put on over the boot, wrap or dressing.

[0008] The distal portion of the compression stocking can comprise a closed toe (e.g., closed distal end) or an open toe (e.g., open distal end). In one embodiment, a distal end of the distal portion comprises a mesh toe box or a toe opening. In one embodiment, the distal portion sized and configured to extend from the transition zone to the toes of the subject or wearer. In one embodiment, the distal portion is sized and configured to extend from the transition zone to the ankle region of the wearer. The graduated or variable compression provided can be Class I compression (e.g., light compression), Class II compression (e.g., medium compression) and/or Class III compression (e.g., high compression). The terms Class I, Class II, and Class III compression can be defined according to universally-accepted compression standards or as defined herein. The compression stockings described herein can be used to address (e.g., prevent and/or treat) complications of chronic venous insufficiency of a subject having a compressive medication- impregnated boot, wrap or dressing in place configured to treat one or more venous leg ulcers (e.g., venous stasis ulcers).

[0009] In accordance with embodiments of the invention, a compression system or kit of compression stockings for addressing (e.g., preventing and/or treating) complications of chronic venous insufficiency (e.g., venous reflux diseases) of a subject during and after application of a compressive therapeutic (e.g., medication-impregnated) boot or compressive wrap or compressive dressing around a lower leg of the subject (e.g., to address one or more venous leg ulcers) is provided. In one embodiment, the system or kit comprises a first compression stocking and a second compression stocking. The first compression stocking can have a proximal portion configured to provide variable compression along the length of the proximal portion. In one embodiment, the compression gradually increases from the proximal end of the proximal portion to the distal end of the proximal portion. The first compression stocking can have a distal portion configured to provide minimal to zero (e.g., non-therapeutic or non-significant) compression. In one embodiment, the distal portion configured to provide multiple compressive forces or pressure levels. In one embodiment, the compression provided by the distal portion is weaker than any compression level (e.g., compressive pressure) provided by the proximal portion. In one embodiment, the minimal to zero (e.g., non-therapeutic or non-significant) compression is uniform along an entire length of the distal portion of the first compression stocking. The second compression stocking can have variable compression along its length. In one embodiment, the variable compression increases from a proximal portion of the second compression stocking to a distal portion of the second compression stocking. The second compression stocking can be configured to be worn after removal of a compressive therapeutic boot (e.g., Unna boot), wrap or dressing.

[0010] In one embodiment, the first compression stocking is sized and shaped to extend generally from the upper thigh to the ankle and the second compression stocking is sized and shaped to extend from the upper calf below the knee to the toes of the wearer. In one embodiment, the proximal portion and the second portion of the first compression stocking are separated by a transition zone configured to be positioned at a location corresponding to an upper or proximal extent or end of a therapeutic boot (e.g., Unna boot), wrap or dressing on a leg of a subject. In one embodiment, the distal portion of the first compression stocking comprises an adjustment mechanism to allow temporary separation of the material of the distal portion (e.g., hook-and-loop fasteners, zipper, buttons, snaps) while the first compression stocking is being applied or put on over the boot, wrap or dressing.

[0011] In accordance with several embodiments, a non-invasive method of addressing (e.g., preventing and/or treating) complications of chronic venous insufficiency (e.g., venous reflux diseases) of a subject while a compressive medication-impregnated boot (e.g., Unna boot), wrap or dressing is being used to address one or more leg ulcers is provided. The method can comprise applying a first compression stocking over a compressive medication-impregnated boot or compressive wrap that has been applied (e.g., wrapped, formed, donned) around a lower leg of a subject having an ulcer (e.g., a venous stasis ulcer) on the lower leg. In one embodiment, the first compression stocking has an open proximal or upper end and an open distal or lower end.

[0012] In some embodiments, the method comprises positioning the first compression stocking such that the proximal end is located above the knee and the distal end is below the knee and overlaps at least a portion of the therapeutic or medication-impregnated boot or compressive wrap. In some embodiments, the method comprises removing the medication-impregnated boot, wrap or dressing from the lower leg of the subject. In some embodiments, the method comprises applying a second compression stocking over the lower leg of the subject to span at least a location of the ulcer (e.g., at least a portion of the region previously spanned by the boot, wrap or dressing).

[0013] In some embodiments, the first compression stocking can be used before and after removal of the medication-impregnated boot or wrap. In one embodiment, the first compression stocking and/or the second compression stocking comprises a variable compression stocking. In various embodiments, the second compression stocking is a closed- toe stocking or an open-toe stocking. The second compression stocking can be adapted for use after removal of the compressive medication-impregnated boot or compressive wrap or dressing.

[0014] In accordance with several embodiments, a non-invasive method of addressing (e.g., preventing and/or treating) chronic venous insufficiency while a compressive boot (e.g., medication-impregnated Unna boot), wrap or dressing is in place to address one or more leg ulcers (e.g., venous ulcers) is provided. In some embodiments, the method comprises applying a compression stocking over a medication-impregnated and/or compressive boot, wrap or dressing that has been applied on (e.g., wrapped around, formed on, molded over, placed on, covered over) a lower leg of a subject having an ulcer on the lower leg. In one embodiment, the compression stocking has a proximal portion and a distal portion separated by a transition zone. In one embodiment, the transition zone is adapted to be positioned at or adjacent a proximal or upper end of the boot, wrap or dressing that is applied (e.g., wrapped) around the lower leg of the subject.

[0015] In some embodiments, the proximal portion of the compression stocking is configured to provide variable compression (e.g., graduated therapeutic compression) along the length of the proximal portion. In some embodiments, the variable compression gradually increases from the proximal end of the proximal portion to the distal end of the proximal portion. In various embodiments, the variable compression of the proximal portion ranges from 10 to 20 mmHg, 15 to 30 mmHg, 20 to 30 mmHg, 25 to 40 mmHg, 30 to 40 mmHg, 35 to 50 mmHg, 40 to 50 mmHg, 45 to 60 mmHg, 50 to 60 mmHg, and/or overlapping ranges thereof.

[0016] In some embodiments, the distal portion of the compression stocking is configured to provide minimal to zero compression (e.g., non-therapeutic or non-significant) to allow the compression stocking to be pulled up over the boot, wrap or dressing. In some embodiments, the distal portion of the compression stocking is configured to provide weaker compression than any of the compressive forces or pressure levels provided by the proximal portion. In some embodiments, the weaker compression ranges from 0 mmHg to 10 mmHg, which may be non-therapeutic or minimally therapeutic. The loose, non-compressive or minimally compressive (e.g., non-therapeutic or providing insignificant compression) distal portion can prevent increased compression, significant compression, or overcompression of a region of the leg surrounded by the distal portion (or covered by a therapeutic and/or compressive boot, wrap or dressing).

[0017] In one embodiment, the minimal to zero (e.g., non-therapeutic compression of the distal portion of the compression stocking is uniform along an entire length of the distal portion of the compression stocking. In another embodiment, the minimal to zero (e.g., non-therapeutic) compression of the distal portion of the compression stocking is variable along the length of the distal portion of the compression stocking.

[0018] For purposes of summarizing the disclosure, certain aspects, advantages and novel features of the inventions have been described herein. It is to be understood that not necessarily all such advantages can be achieved in accordance with any particular embodiment of the inventions disclosed herein. Thus, the inventions disclosed herein can be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as can be taught or suggested herein.

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] These and other features, aspects and advantages of the present application are described with reference to drawings of certain embodiments, which are intended to illustrate, but not to limit, the various inventions disclosed herein. It is to be understood that the attached drawings are for the purpose of illustrating concepts and embodiments of the present application and may not be to scale.

[0020] Figure 1 illustrates an embodiment of a variable compression stocking.

[0021] Figures 2A-2C illustrate various embodiments of compression stockings.

DETAILED DESCRIPTION

[0022] A medication-impregnated boot (e.g., Unna boot) or medicated dressing with an overlying elastic wrap or compression bandage typically terminates in the proximal (or upper) calf and thereby only provides compression distally from the proximal calf to the foot. The medication-impregnated boot or the medicated dressing in combination with an overlying elastic wrap or compression bandage are relatively bulky and make application of current compression hose or stockings over the dressings extremely difficult (or even impossible) for the patient and/or caregiver because the current compression hose or stockings provide extremely strong compression along the distal portion of the hose or stockings (e.g., from the toes to the calf). The difficulty of placing thigh-high compression support hosiery or stockings over a boot, bandage, and/or wrap deters patients or caregivers from receiving more proximal compression therapy which could be provided by compression support hosiery or stockings in conjunction with the boot, bandage, and/or wrap.

[0023] In addition, even if the current compression stockings could be placed over the Unna boot (or other dressing/treatment combination as described above), the compression stockings may cause over-compression of the portion of the leg covered by the Unna boot because the compression stocking provides its own compressive force or pressure level in addition to the compression provided by the Unna boot. For example, if the Unna boot provided 20 mmHg compression and a current Class I compression stocking was placed over the Unna boot, the total compressive force or pressure applied to the portion of the leg covered by the Unna boot would be 35-40 mmHg, which may be an excessive amount of compression for the patient or wearer, thereby causing discomfort or hindering circulation. Patients could wrap an elastic wrap around the proximal (or upper) portion of the leg with a medication-impregnated boot or medicated dressing with an overlying elastic wrap or compression bandage in place but would not be able to determine the exact level of compression being exerted on the leg (which may result in a compression level that is too low or too high to treat the venous insufficiency). At least some of the compression stockings described herein can provide treatment of proximal venous reflux disease at known pressures or compression levels.

[0024] Stasis ulcer formation can result from chronic superficial and/or deep venous reflux disease starting all the way up at the groin level. Inability to easily and conveniently use full-length or thigh-high graduated compression hose or a full-length, thigh- high compression stocking concurrently or simultaneously with medication-impregnated boots, bandages, and/or wraps usually results in treatment of the ulcer with the boots, bandages, or wraps alone. Treatment with the boots, bandages, or wraps alone may inadequately treat the more proximal venous reflux disease and may result in delayed healing of the ulcer. Several embodiments disclosed herein are advantageously designed to allow ease of use of graduated thigh-high compression hose or of a graduated thigh-high compression stocking over an already-applied, medication-impregnated boot or compressive wrap dressing. The compression stockings and kits described herein can advantageously be used with or without medication-impregnated boots or compressive wraps.

[0025] In accordance with at least some embodiments disclosed herein, an integrated graduated thigh-high compression stocking is provided having a distal portion that provides minimal to no compression and a proximal portion that provides graduated or variable compression. In some embodiments, the distal portion is less compressive than any part of the proximal portion. The "loose" distal portion without significant compression (e.g., minimal to no compression) allows a user or caregiver to pull the compression stocking on over a boot, bandage, and/or wrap. In some embodiments, the distal portion comprises smooth, slick, elastic-like material to facilitate placement over the bulky boot, bandage, or wrap.

[0026] At least some embodiments described and/or illustrated herein allow specific treatment of ulcer or infection while simultaneously treating the proximal, underlying venous reflux that is the cause of the ulcer instead of merely treating the present manifestation of the disease. Further, according to some embodiments, the devices, systems and methods disclosed herein advantageously reduce the amount of time it takes for the ulcer to heal. In several embodiments, the inventions described herein comprise a thromboembolic deterrent (or compression) stocking that supports the venous and lymphatic systems of the leg or other body region. In several embodiments, the stocking aids in circulating blood and lymph fluid through the legs or other body regions.

[0027] Several embodiments of the invention allow for the aggressive local wound care of venous ulcers and/or infection with compressive medication-impregnated boots or bandage wraps, while at the same time allowing patients and/or caregivers to easily place graduated thigh-high compression hose, or stocking, over the boot, bandage, and/or dressing to treat the more proximal components of the underlying chronic venous reflux disease. Several embodiments of the invention make it easier for elderly, arthritic, or otherwise compromised patients and caregivers to put on, or apply, an overlying compression stocking or hose.

[0028] In accordance with some embodiments of the invention, the integrated graduated compression hose or stocking comprises a distal portion providing a low level of compression (e.g., 0 to 10 mmHg) and a proximal portion providing graduated, variable compression along its length. In some embodiments, the low level of compression provided by the distal portion is weaker (e.g., less compressive) than the weakest compression provided by the proximal portion. For example, the distal portion can provide minimal to no compression (e.g., 0 mmHg, less than 5 mm Hg, less than 8 mniHg, less than 10 mm Hg, less than 15 mmHg) and the proximal portion can provide graduated Class I (e.g., 15 to 20 mmHg), Class II (e.g., 20 to 30 mmHg), Class III (e.g., 30 to 40 mmHg), or Class IV (e.g., greater than 40 mmHg, 40 mmHg to 50 mmHg, 40 mmHg to 60 mmHg) compression. In other embodiments, the compression (e.g., pressure) provided by the proximal portion can be generally constant along its entire length. In still other embodiments, the compression provided by the proximal portion ranges from about 5 mmHg to about 65 mmHg, from about 8 mmHg to about 50 mmHg, from about 10 mmHg to about 40 mmHg, from about 15 mmHg to about 40 mmHg, from about 20 mmHg to about 50mmHg, from about 35 mmHg to about 60 mmHg, less than 5 mmHg, greater than 65 mmHg, and/or overlapping ranges thereof.

[0029] Figure 1 illustrates a thigh-high compression stocking 100 in accordance with an embodiment of the invention. The thigh-high compression stocking 100 comprises a distal portion 102 that generally extends from the toes of the wearer to a location corresponding to the proximal extent of a medication-impregnated or therapeutic boot (e.g., Unna boot), compressive wrap, or bandage 110 and a proximal portion 104 that generally extends from the location of the proximal extent of the medication-impregnated or therapeutic boot, compressive wrap, or bandage 110 to the groin area of the wearer.

[0030] In one embodiment, the distal portion 102 comprises a smooth, stretchy, and/or loose material that provides reduced (e.g., zero to minimal) compression of the region covered by the therapeutic boot, bandage, or wrap 110 (which may or may not be providing its own compressive force or pressure). In one embodiment, the distal portion 102 provides a weaker level of compressive force or pressure than any compressive forces or pressure levels provided by the proximal portion 104. In one embodiment, the distal portion 102 does not provide any measurably significant compression. In one embodiment, the proximal portion 104 comprises a compressive material that provides Class I, II, III or IV compression. In some embodiments, the proximal portion 104 comprises graduated compressive material that provides variable compression that gradually decreases from its distal end in the calf region to its proximal end near the groin area. In other embodiments, the proximal portion 104 provides generally constant compression along its entire length. [0031] In some embodiments, the compression stocking 100 comprises a transition zone 105 between the non-compressive or minimally compressive distal portion 102 and the compressive proximal portion 104. The transition zone 105 can be positioned so as to correspond to a location along the leg at which an upper end of a boot (e.g., Unna boot) or wrap 110 is typically positioned. In some embodiments, the transition zone 105 is configured to correspond to a location adjacent the knee, slightly above the knee in the lower thigh area, at the knee, slightly below the knee in the upper calf area, or at the mid-calf. In some embodiments, the transition zone 105 provides a level of compression between the compression provided by the distal portion 102 and the proximal portion 104. The compression of the transition zone can be graduated or uniform.

[0032] In one embodiment, the upper end of the compression stocking 100 ends at the upper portion of the thigh below the groin area and can be held in place with a proximal band 106 (e.g., elastic band) extending around the opening of the compression stocking 100 at the upper end of the proximal portion 104. In another embodiment, the upper end of the compression stocking 100 is held in place by an elastic tape. In yet other embodiments, the upper end of the compression stocking 100 is secured by one or more other methods or devices, such as body adhesive, a silicone band, and/or the like.

[0033] As shown in Figure 1, the upper end of the proximal portion 104 can optionally be connected to a belt or other waist support member or other means 108 (e.g., elastic waist band). The upper end of the proximal portion 104 can be connected directly to the belt 108 or can be connected to the waist support 108 via a connecting panel 109 (e.g., hip connecting panel) that extends between the waist support 108 and the upper end of the proximal portion 104 of the compression stocking 106 (e.g., as shown in Figure 1). The belt or other waist support means 108 can advantageously increase stability of proximal placement.

[0034] In some embodiments, the proximal portion and the distal portion of the compression stocking 100 are integrally connected and are not intended to be easily or typically separated (e.g., the proximal portion 104 and the distal portion 102 comprise a single unitary piece). In other embodiments, the distal portion 102 can be removably coupled to the proximal portion 104 (e.g., using Velcro® fasteners or other hook and loop fasteners, a zipper, snaps, buttons, adhesive, other suitable fastening methods or elements that allow for selective removal, etc.). In some embodiments, the distal portion 102 is configured to be selectively removable from the proximal portion at the transition zone 105. For example, the distal portion 102 could not be employed at all when the patient has an Unna boot or medicated dressing with compressive wrap 110 in place. In some embodiments, the distal portion 102 can be reattached or reconnected to the proximal portion 104 after removal. In other embodiments, the distal portion 102 cannot be reattached or reconnected after removal.

[0035] In embodiments where the distal portion 102 and the proximal portion 104 comprise separate pieces that are configured to be removably coupled to each other, the distal portion 102 can be replaced with a fresh, new distal portion after a specified period of time or as desired and/or required. Accordingly, the distal portion 102 can be interchangeable. In some embodiments, the same proximal portion 104 can be used with the medication- impregnated boot or compressive wrap in place during treatment of an ulcer and after the ulcer has healed and the medication-impregnated boot or compressive wrap has been removed (thereby providing cost savings to the patient).

[0036] After ulcer or infection healing, a less compressive distal portion can advantageously be removed and replaced by a distal portion having increased compressive force or pressure level(s), thereby effectively providing a full-length (e.g., toe-to-groin) graduated compression stocking without removing the proximal portion 104. In some embodiments, the replacement distal portion can be selected to match the class (e.g., Class I, II, or III) and/or other desired compression rating of the compressive proximal portion, thereby providing a full length toe-to-thigh compression stocking without requiring a whole new stocking to be applied. Embodiments where the distal portion 102 and proximal portion 104 comprise separate pieces can advantageously allow for the continued use of the proximal portion of the compression stocking after the medication-impregnated boots or compressed bandage wraps are no longer needed or after replacement of the distal portion 102 with a fresh, clean "loose" distal portion, thereby reducing costs and saving on materials.

[0037] The compression stocking 100 can comprise a closed toe stocking or an open toe stocking. As shown in Figure 1 , the distal end of the distal portion 102 can include a toe openmg 112, thereby providing air contact with the foot beyond the distal extent of the compressive wrap or boot 1 10. In another embodiment, a breathable mesh fabric is used for a toe box of a closed toe stocking. In some embodiments, multiple layers of fabric or other material are used. In some embodiments, the compression stocking does not have a toe opening or toe box. In some embodiments, the compression stocking 100 includes a contoured foot portion. [0038] In some embodiments, the distal portion 102 of the compression stocking 100 comprises a generally smooth, washable, easily stretchable, breathable material that easily slides over the medication-impregnated or therapeutic boot or compressive wrap dressing 110. Accordingly, the material used for the distal portion 102 can advantageously reduce the sliding friction between the stocking 100 and the underlying therapeutic boot, bandage or wrap 110. In some embodiments, one or more lubricants and/or similar substances or devices are impregnated, coated and/or otherwise disposed within or applied to the inner surface of the stocking. In one embodiment, the distal portion comprises a slip-fit coating on its inner surface. In one embodiment, the compression stocking 100 is a compression hose (e.g., panty hose that cover the entire groin area and buttocks and extend from the waist down to the toes of the wearer) having two compression stockings or leg portions having the variable compression features described herein. In some embodiments, separate compression stockings can be used on each leg (e.g., for patients requiring or desiring treatment of both legs).

[0039] With reference to Figures 2A-2C, in accordance with some embodiments, it may be desirable to have two separate compression stockings. For example, a first, or proximal, compression stocking 203 can be used that is configured to be worn over the upper leg (for example, to cover the leg region covered by the proximal portion 104 of the compression stocking 100 of Figure 1). Further, a second, or distal (e.g., below-the-knee), compression stocking 207 can be included that is configured to be worn over the lower leg (for example, to cover the leg region covered by the distal portion 102 of the compression stocking 100 of Figure 1) can be provided separately.

[0040] In some embodiments, the first, or proximal, compression stocking 203 is sized and shaped to extend generally from the groin area or upper thigh to the ankle. In some embodiments, the first, or proximal, compression stocking 203 is sized and shaped to extend to the upper calf, to the mid-calf, to the lower calf, to the knee, or one to five inches below the knee. The proximal compression stocking 203 can include a transition zone 205 located at a similar location as the transition zone 105 of the compression stocking 100 of Figure 1 (e.g., the upper calf, the mid-calf, the lower calf, the knee, or one to five inches below the knee). In general, the transition zone 205 is positioned along the length of the proximal compression stocking 203 so as to overlap the proximal, or upper, extent of a therapeutic boot (e.g., Unna boot) or wrap. [0041] The proximal compression stocking 203 can have variable compression along its length as described herein with reference to the proximal portion 104 of the compressive stocking 100 of Figure 1. For example, the proximal portion 204 (e.g., the portion above the transition zone 205) of the proximal compression stocking 203 can be more compressive than the distal portion 202 (e.g., the portion below the transition zone 205) of the proximal compression stocking 203. In some embodiments, the proximal portion 204 of the proximal compression stocking 203 has variable or graduated compression as described herein. The distal portion 202 of the proximal compression stocking 203 can have minimal to no compression. As shown in Figures 2A-2C, the distal portion 202 can comprise an adjustment feature or mechanism 214 to allow the proximal compression stocking 203 to be pulled over a therapeutic boot or wrap 210 more easily by providing separation of the material of the distal portion 202 along a vertical separation line. The adjustment feature or mechanism can include a zipper portion, a hook and loop (e.g., Velcro®) portion, one or more snaps or buckles, one or more hooks and loops, one or more buttons and holes, adhesives, lacing, and/or other suitable fastening methods or devices. In other embodiments, the distal end of the distal portion 202 can include an adjustable band or belt (e.g., elastic) configured to stretch or otherwise adjust to allow the wearer to more easily pull on the proximal compression stocking 203.

[0042] The second, or distal, compression stocking 207 can be sized and shaped to extend generally from the transition zone 205 to the toes of the wearer. In other embodiments, the distal compression stocking 207 is sized and shaped to extend from the transition zone 205 to the ankle, to the heel, or proximal to the toes of the wearer. In general, the distal compression stocking 207 can be sized and shaped so as to at least cover the region where the ulcer or ulcers were or are located.

[0043] With reference to Figure 2A, in some embodiments, the proximal compression stocking 203 is worn without the distal compression stocking 207. For example, the proximal compression stocking 203 may be used alone over an Unna boot or medicated dressing with bandage wrap 210. With reference to Figure 2B, patients or wearers may choose to wear a loose-fitting or perhaps oversized sock 215 (e.g., an athletic sock) over the therapeutic boot or wrap 210 such that improved comfort and/or cosmetic appearance is obtained. The loose-fitting sock 215 can be a standard athletic sock or a proprietary sock adapted to provide more aeration or a better fit than a standard athletic sock. In some embodiments, the loose-fitting sock 215 is applied, or donned, before the proximal compression stocking 203 or after the proximal compression stocking 203, but before the adjustable feature or mechanism is closed.

[0044] With reference to Figure 2C, the distal compression stocking 207 can be used after an ulcer or ulcers have been healed (e.g., after the therapeutic boot, medicated bandage, or dressing and wrap combination is removed). The distal compression stocking 207 can be donned before the proximal compression stocking 203. In one embodiment, the distal compression stocking 207 comprises a proximal band 216 at its proximal end to maintain a position of the proximal end of the distal compression stocking 207 on the leg of the wearer. The distal compression stocking 207 can have variable compression along its length similar to the proximal compression stocking 203. For example, the distal compression stocking 207 can gradually increase in compression from the proximal (e.g., upper) end to the distal (e.g., lower) end. The amount of compression and the variableness of the compression can vary as desired and/or required. For example, the compression provided by the proximal compression stocking 203 and the distal compression stocking 207 can range from about 5 mmHg to about 65 mmHg, from about 8 mmHg to about 50 mmHg, from about 10 mmHg to about 40 mmHg, from about 15 mmHg to about 40 mmHg, from about 20 mmHg to about 50mmHg, from about 35 mmHg to about 60 mmHg, less than 5 mmHg, greater than 65 mmHg, and/or overlapping ranges thereof. In some embodiments, the proximal compression stocking 203 provides a stronger level of compression than the distal compression stocking 207. In some embodiments, the distal compression stocking 207 provides a stronger level of compression than the proximal compression stocking 203. In some embodiments, the level of compression provided by the proximal compression stocking 203 and the distal compression stocking 207 is the same or substantially the same.

[0045] Providing two separate compression stockings can advantageously provide more adaptability and flexibility to the patient or wearer. The proximal compression stocking 203 and the distal compression stocking 207 can be provided together in a single package or in separate packages. Different types of distal compression stockings 207 can advantageously be used with a single proximal compression stocking 203. For example, the same proximal compression stocking 203 can be used with the medication-impregnated boot or compressive wrap in place during treatment of an ulcer and after the ulcer has healed and the medication- impregnated boot or compressive wrap has been removed (thereby providing cost savings to the patient). The loose-fitting sock 215 can also be provided together with the proximal compression stocking 203 and/or the distal compression stocking 207. The loose-fitting sock may also be provided with a matching regular-fit sock to provide a matching pair to the patient or wearer.

[0046] In some embodiments, the compression stockings described herein or equivalents thereof (e.g., compression stocking 100, proximal compression stocking 203, distal compression stocking 207, etc.) are adapted to provide light support (e.g., 8-15 mmHg), medium support (e.g., 15-20 mmHg), firm support (e.g., 20-30 mmHg), and/or extra- firm support (30-40 mmHg) along at least portions of their lengths. In some embodiments, portions of the compression stockings can provide varying levels of support.

[0047] The compression stockings can comprise mesh material, elastic material, Lycra material, nylon material, Spandex material, rubber or elastomeric material, other polymeric material, knitted material, jersey knit material, woven material, non-woven material, cotton material, silicone material, sheer material, opaque material, transparent material, machine-washable material, form-fitting material, stretchable material, medication- impregnated material, graduated compression material, compression material that provides a generally constant compressive force or pressure along its length, waterproof material, anti- odor material, and/or biodegradable material, or combinations thereof. The compression stockings can comprise one or more colors. Compression stockings according to some embodiments comprise one, two, three or more integral or removable layers or liners. In some embodiments, the compression stockings comprise anti-microbial treatment or provide natural anti-microbial protection by virtue of the materials selected. In some embodiments, the compression stocking comprises an inner layer that contacts the skin directly and functions like an Unna boot. For example, the inner layer can comprise a material (e.g., gauze bandage) that is impregnated, coated, or layered with therapeutics (e.g., antiinflammatory agents, wound cleansing agents, herbal agents, zinc oxide, glycerin and calamine). According to several embodiments, the entire compression stocking or selected portions or layers can be reusable (e.g., washable) or disposable.

[0048] Embodiments of the compression stockings or hose described herein can be used to prevent, treat or reduce the likelihood or occurrence of, without limitation, aching legs, varicose veins, spider veins, chronic venous insufficiency, edema, lymphedema, leg ulcers, burn scars, itching, swelling, inflammation, interstitial fluid accumulation, infection, and/or deep vein thrombosis.

[0049] In several embodiments, a thigh-high compression stocking is provided. In other embodiments, knee-length stockings, panty-hose stockings, or full-length stockings are provided. In some embodiments, the compression stockings are sized to extend just along the calf (e.g., from the upper calf below the knee to the lower calf above the ankle. Compression stockings or coverings that are used for other body regions (e.g., limbs) are provided according to some embodiments. For example, arms, hands and torso coverings are provided in several embodiments. Compression stockings include hose-type or sock-type stockings in several embodiments. For example, the compression stockings described herein can comprise panty hose that include the features of the compression stockings described herein for both legs. The compression hose can be used, for example, if both legs require treatment or for cosmetic purposes. In some embodiments, separate compression stockings can be used on each leg (e.g., for patients requiring or desiring treatment of both legs).

[0050] Compression stockings according to several embodiments are advantageously worn without the need for donning aids, lotions, or gloves.

[0051] To assist in the description of the disclosed embodiments, words such as upward, upper, lower, proximal, distal, vertical, and horizontal have been used above to describe different embodiments and/or the accompanying figures. It will be appreciated, however, that the different embodiments, whether illustrated or not, can be located and oriented in a variety of desired positions.

[0052] Although several embodiments and examples are disclosed herein, the present application extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the inventions and modifications and equivalents thereof. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the inventions. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combine with or substituted for one another in order to form varying modes of the disclosed inventions. Thus, it is intended that the scope of the present inventions herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.

Claims

WHAT IS CLAIMED IS:

1. A compression stocking for addressing complications · of chronic venous insufficiency of a subject having a compressive therapeutic boot or wrap applied to a leg of the subject to treat one or more leg ulcers, comprising:

a distal portion configured to provide a uniform first level of compression along an entire length of the distal portion;

a proximal portion configured to provide graduated compression along its length; and

a transition zone separating the proximal portion from the distal portion, wherein the transition zone is configured to be positioned at a location corresponding to a proximal end of a compressive therapeutic boot or wrap applied on a calf portion of a leg of a wearer;

wherein the first level of compression of the distal portion is weaker than a strength level of any compressive pressure provided by the graduated compression of the proximal portion, and

wherein the first level of compression is weak enough such that the distal portion can be pulled over the therapeutic boot or wrap with minimal effort and such that the distal portion does not significantly increase compression of the region of the leg covered by the therapeutic boot or wrap.

2. The compression stocking of claim 1, wherein the first level of compression is less than about 10 mmHg.

3. The compression stocking of claim 1, wherein the first level of compression is less than about 5 mmHg.

4. The compression stocking of claim 1, wherein the first level of compression is substantially zero.

5. The compression stocking of claim 1, wherein the transition zone provides graduated compression at a strength level between or inclusive of the first level of compression of the distal portion and the strength levels of the compressive forces or pressures provided by the graduated compression of the proximal portion.

6. The compression stocking of any of claims 1-5, wherein the distal portion and the proximal portion comprise a single, unitary stocking.

7. The compression stocking of any of claims 1-5, wherein the distal portion and the proximal portion comprise separate stocking members.

8. The compression stocking of any of claims 1-5, wherein the distal portion and the proximal portion are removably coupled to each other.

9. The compression stocking of any of claims 1-5, wherein the distal portion extends from the transition zone to the toes of the wearer.

10. The compression stocking of any of claims 1-5, wherein the distal portion extends from the transition zone to the ankle region of the wearer.

11. The compression stocking of any of claims 1-5, wherein the graduated compression provided by the proximal portion is therapeutic compression selected from the group consisting of: Class I compression, Class II compression, and Class III compression.

12. The compression stocking of any of claims 1-5, wherein the distal portion of the compression stocking comprises an adjustment mechanism to allow temporary separation of the material of the distal portion when applying the compression stocking over a leg of the subject.

13. A compression system for addressing complications of chronic venous insufficiency of a subject during and after application of a compressive therapeutic boot or wrap around a lower leg of the subject to address one or more leg ulcers, comprising:

a first compression stocking having a proximal portion configured to provide variable compression along the length of the proximal portion, wherein the compression gradually increases from the proximal end of the proximal portion to the distal end of the proximal portion;

the first compression stocking comprising a distal portion configured to provide weaker compression than any compressive force or pressure of the proximal portion, wherein the weaker compression is uniform along an entire length of the distal portion of the first compression stocking; and

a second compression stocking having variable compression along its length, wherein the variable compression increases from a proximal portion of the second compression stocking to a distal portion of the second compression stocking.

14. The system of claim 13, wherein the first compression stocking is sized and shaped to extend generally from the upper thigh to the ankle and the second compression stocking is sized and shaped to extend from the upper calf below the knee to the toes of the wearer.

15. The system of claim 13 or claim 14, wherein the proximal portion and the second portion of the first compression stocking are separated by a transition zone configured to be positioned at a location corresponding to an upper extent of a therapeutic boot or wrap on a leg of a subject.

16. The system of claim 13 or claim 14, wherein the distal portion of the first compression stocking comprises an adjustment mechanism to allow temporary separation of the material of the distal portion when applying the compression stocking over a leg of the subject.

17. A non-invasive method of addressing complications of chronic venous insufficiency of a subject while a compressive medication-impregnated boot or wrap is being used to address one or more leg ulcers, the method comprising:

applying a first compression stocking over a compressive medication- impregnated boot or wrap that has been applied around a lower leg of a subject having an ulcer on the lower leg, the first compression stocking having an open proximal end and an open distal end;

positioning the first compression stocking such that the proximal end is located above the subject's knee and the distal end is below the knee and overlaps at least a portion of the medication-impregnated boot or wrap;

removing the medication-impregnated boot or wrap from the lower leg of the subject; and

applying a second compression stocking over the lower leg of the subject to span at least a location of the ulcer.

18. The method of claim 17, wherein the first compression stocking can be used before and after removal of the medication-impregnated boot or wrap.

19. The method of claim 17, wherein the first compression stocking comprises a variable compression stocking.

20. The method of any of claims 17-19, wherein the second compression stocking comprises a variable compression stocking.

21. The method of claim 20, wherein the second compression stocking is a closed- toe stocking.

22. The method of claim 20, wherein the second compression stocking is an open- toe stocking.

23. A non-invasive method of addressing chronic venous insufficiency while a compressive boot or wrap is in place to address one or more leg ulcers, the method comprising: applying a compression stocking over a medication-impregnated boot or compressive wrap that is wrapped around a lower leg of a subject having an ulcer on the lower leg, the compression stocking having a proximal portion and a distal portion separated by a transition zone,

wherein the transition zone is adapted to be positioned at or adjacent a proximal or upper end of the medication-impregnated boot or compressive wrap that is wrapped around the lower leg of the subject,

wherein the proximal portion of the compression stocking is configured to provide variable compression along the length of the proximal portion,

wherein the variable compression gradually increases from the proximal end of the proximal portion to the distal end of the proximal portion, and

wherein the distal portion of the compression stocking is configured to provide weaker compression than any of the compressive forces or pressure levels provided by the proximal portion to allow the compression stocking to be pulled up over the medication-impregnated boot or compressive wrap without significantly increasing compression of a region of the leg surrounded by the distal portion.

24. The method of claim 23, wherein the weaker compression of the distal portion of the compression stocking is uniform along an entire length of the distal portion of the compression stocking.

25. The method of claim 23, wherein the weaker compression of the distal portion of the compression stocking varies along the length of the distal portion of the compression stocking.

26. The method of any of claims 23-25, wherein the weaker compression ranges from 0 mmHg to 10 mmHg.

27. The method of any of claims 23-25, wherein the variable compression of the proximal portion is selected from the group consisting of: 10 to 20 mmHg, 15 to 30 mmHg, 20 to 30 mmHg, 25 to 40 mmHg, 30 to 40 mmHg, 35 to 50 mmHg, 40 to 50 mmHg, 45 to 60 mmHg, and 50 to 60 mmHg.

28. The use of the compression stocking of claim 1 to prevent and/or treat complications of chronic venous insufficiency of a subject having a compressive medication- impregnated boot or wrap or dressing in place configured to treat one or more leg ulcers.

29. The use of the compression stocking of any of claims 1-12 to prevent and/or treat complications of chronic venous insufficiency of a subject having a compressive medication-impregnated boot or wrap or dressing in place configured to treat one or more leg ulcers.

30. The use of the compression system of claim 13 to prevent and/or treat complications of chronic venous insufficiency of a subject.

31. The use of the compression system of any of claims 13-16 to prevent and/or treat complications of chronic venous insufficiency of a subject.