THIGH THERAPEUTIC COMPRESSION APPARATUS, SYSTEM, AND METHODS OF USE

Abstract

A thigh therapeutic compression apparatus for providing pressure to a limb or other body part namely a thigh, including a bladder assembly having at least one bladder within a primary wrap and/or a secondary wrap. The primary wrap includes an inflation port to connect to an inflation means which provides either constant or varying pressure within the bladder and a check valve is included in the inflation port and/or inflation means. The primary wrap is connected to a stabilization means configured to be attached to a belt or other means around the waist of the body.

Claims

1. A therapeutic compression apparatus for applying pressure to a thigh of the human body, comprising: a wrap including at least one bladder configured to be located along the medial area of the thigh and the at least one bladder having a number of welds forming a predetermined compression gradient when inflated; a first means for locating the at least one bladder along the medial area of the thigh above a knee of the human body when in use; a second means for locating the wrap along a groin and hip area of the human body when in use; an inflation means connected to the at least one bladder via an inflation port wherein the inflation means includes a check valve; and wherein the inflation port is configured to be universally capable of connection to a variety of inflation means.

2. The therapeutic compression apparatus of claim 1, wherein the first means for locating is a first attachment member wrapping around the thigh to secure the wrap to the thigh.

3. The therapeutic compression apparatus of claim 2, wherein the first attachment member is a plurality of straps attached to the wrap.

4. The therapeutic compression apparatus of claim 1, wherein the second means for locating is a second attachment member wrapping around the groin and hip and attached to a securing means around a waist of the human body when in use.

5. The therapeutic compression apparatus of claim 4 wherein the second attachment member is a panel attached to the wrap and extending above a proximal end of the wrap, including at least one aperture on a proximal end of the panel configured to be capable of insertion of the securing means around the waist.

6. The therapeutic compression apparatus of claim 4, wherein the securing means includes a belt or straps for securing around the waist.

7. The therapeutic compression apparatus of claim 1 wherein the at least one bladder has at extend below the knee joint level and apply compression around the patella of the knee area. It may also have suspender hooks or slots (not shown) that allow for suspenders to be mated thereto in order to support the apparatus by a waist band when in use. The suspenders limit downward travel of the apparatus when in use such that it maintains its desired position. While the subject invention of the present disclosure has been described with respect to preferred and exemplary embodiments, those skilled in the art will readily appreciate that various changes and/or modifications can be made to the invention without departing from the spirit or scope of the invention as described herein. There have been described and illustrated herein several embodiments of an intermittent pressure apparatus and a method of installing and operating same. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. Thus, while particular shapes and sizes of inflatable bladders and straps have been disclosed, it will be appreciated that other shapes, sizes, and attachment means may be used as well. It will also be understood that while Velcro and adhesive means have been disclosed for helping to secure the bladders to the leg and foot, other types of attachments such as hooks, snaps, or wraps may be used. In addition, it will be appreciated that while the fluid conduit may be detachably connected to the bladders using mating threaded portions or bayonet locks, other means of attachment known in the art may be used. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed. least two chambers configured wherein one chamber is located along the medial area of the thigh and a second chamber is located along a lateral area of the thigh.

8. The therapeutic compression apparatus of claim 7, wherein the at least two chambers of the at least one bladder are configured such that when the fluid is forced out of one chamber is applies an extra pressure to the other chamber and wherein the predetermined compression profiles are difference in each chamber.

9. The therapeutic compression apparatus of claim 8, wherein the extra pressure is between 10 and 20 mm Hg extra pressure.

10. The therapeutic compression apparatus of claim 1 wherein the inflation means is selected from the group consisting of manual pumps, static pumps, intermittent pumps, electrical inflation pumps, battery inflation pumps, gas powered inflation pumps, static pneumatic compression pumps, intermittent pneumatic pressure pumps, and the combination thereof and the inflation means for the at least one bladder is selected from the group consisting of air, gas, fluid or combinations thereof.

11. The therapeutic compression apparatus of claim 1 further comprising a face connector, a check valve and a valve cap wherein the valve cap is capable of releasing a pressure created by the inflation means within the at least one bladder.

12. The therapeutic compression apparatus of claim 11 further comprising a check valve operatively connected to the primary bladder to protect from over inflation and wherein the check valve is set to open at a predetermined pressure or a user selectable pressure.

13. The therapeutic compression apparatus of claim 1 further comprising a second bladder not connected to the first bladder, wherein the second bladder has a second inflation means and each of the first and second bladders may have different predetermined compression profiles when inflated.

14. A method for applying pressure to a portion of a human body, comprising: affixing a wrap to a thigh, wherein the thigh wrap includes (a) at least one air bladder connected to an inflation means and wherein the at least one air bladder has a plurality of welds configured to create a predetermined compression profile when inflated and (b) an inflation port having a face connector, a check valve and a valve cap wherein the valve cap is capable of releasing a pressure created by the inflation means within the at least one air bladder; securing the thigh wrap to the thigh with a securing means attached to the thigh wrap so that the at least one air bladder is located in the medial area of the thigh; stabilizing the thigh wrap along a waist or hip using a stabilizing means; inflating the at least one air bladder; closing the valve cap on the inflation port; and walking such that the thigh wrap is secure and stabilize on the thigh.

15. The method of claim 14, wherein the securing means includes a plurality of straps or hook and loop means.

16. The method of claim 15, wherein the inflation means is selected from the group consisting of manual pumps, static pumps, intermittent pumps, electrical inflation pumps, battery inflation pumps, gas powered inflation pumps, static pneumatic compression pumps, intermittent pneumatic pressure pumps, and the combination thereof.

17. The method of claim 15 wherein the at least one air bladder is configured to have one chamber capable of sequential gradient pressure when connected to the inflation means.

18. The method of claim 15 wherein the inflation means includes a three-way switch configured to be capable of holding a pressure created by the inflation means within the at least one bladder creating an inflated state of the bladder, capable of releasing a set amount of pressure within the at least one bladder creating a partially deflated state of the bladder, and capable of releasing all the pressure within the at least one bladder so as to create a fully deflated state of the bladder.

19. The therapeutic compression apparatus of claim 1 wherein the inflation means includes a real-time pressure measurement mechanism.

20. A thigh therapeutic compression apparatus comprising: a primary wrap having a proximal end configured to be located along a hip or groin area of a user and a distal end of the primary wrap configured to be located at a knee of a user, the primary wrap including at least one bladder; a secondary wrap having a proximal end and a distal end wherein the proximal end of the secondary wrap is connected to the distal end of the primary wrap; an inflation means connected to the bladder via an inflation port on the bladder wherein the inflation port includes a check valve; and an assembly comprising: a) a pressure mechanism having a flexible member for attachment around a limb and an air chamber which assumes a first depressurized state and a second pressurized state, said air chamber having a length and a width, said width being less than half the width of the flexible member; b) a pre-filled air bladder having a length and a width smaller than the width of the air chamber; c) an absorbent foam, sponge or dressing coupled to the pre-filled air bladder; and d) a suction conduit in fluid communication with the absorbent foam, sponge or dressing and adapted for coupling to a source of negative pressure.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0059] So that those having ordinary skill in the art to which the subject invention pertains will more readily understand how to make and use the apparatuses of the subject invention, preferred embodiments thereof will be described in detail herein below with reference to the drawings, wherein:

[0060] FIG. 1 is a view of one embodiment of the present invention including a thigh therapeutic compression apparatus for the left leg of a user, constructed in accordance with the present invention, including one air bladder having a medial bladder portion joined to a lateral bladder portion and including a stabilization means having a belt located at the user's waist and connected to the thigh therapeutic compression apparatus via an aperture on the proximal end of the apparatus;

[0061] FIG. 2 is an exploded view of the embodiment of the present invention of FIG. 1

[0062] FIG. 3 is a view of the present invention of FIG. 1 in use on the left thigh of an individual and a manual pump connected to the universal port illustrating the lateral and medial bladders both in an inflated state;

[0063] FIG. 4 is another embodiment of the present invention including a thigh therapeutic compression apparatus for the left leg of a user constructed in accordance with the present invention, including two separate air bladders of a medial bladder portion and a lateral bladder portion and including a stabilization means having a belt located at the user's waist and connected to the thigh therapeutic compression apparatus via an aperture on the proximal end of the apparatus;

[0064] FIG. 5 is another embodiment of the present invention including a thigh therapeutic compression apparatus for the left leg of a user, constructed in accordance with the present invention, including one medial air bladder and including a stabilization means having a belt located at the user's waist and connected to the thigh therapeutic compression apparatus via an aperture on the proximal end of the apparatus;

[0065] FIG. 6 is another embodiment of the present invention including a thigh therapeutic compression apparatus for either leg of the user (left or right) constructed in accordance with the present invention, showing the layout of through-holes throughout the compression garment as viewed from the interior of the garment and an optional knee pad and stabilization means includes a series of apertures configured to connect to a connecting means;

[0066] FIG. 7 is another embodiment of a belt system for use with the embodiment of the present invention of FIG. 6; and

[0067] FIGS. 8A-8F is a flow representation of the method of use of the thigh therapeutic compression apparatus of FIG. 1.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0068] Preferred embodiments of the subject invention are described below with reference to the accompanying drawings, in which like reference numerals represent the same or similar elements. One of ordinary skill in the art would appreciate that while the apparatuses discussed herein relate to compression therapy of the leg and foot, the scope of the invention is not limited to those exemplary applications and may be sized and shaped for the anatomical portion for which compression therapy is needed.

[0069] The subject invention provides compression to a patient's limbs, including the extremities, including for example, the leg of a user and more specifically the thigh of a user, in a manner that is simpler and more convenient than current systems. Any limb or body part may be compressed by the instant therapeutic compression apparatus such as for instance a foot, calf, thigh, knee, leg, hip, buttocks, waist, torso, ribs, shoulder, arm, hand, fingers, neck, head or the like.

[0070] The subject invention provides system for providing compression and preventing swelling of a limb such as for instance the thigh using a non-elastic binder and bladder which can be used for compression. The bladder is provided within a non-elastic wrap and creates compression in a manner that allows for consistent measuring of the pressure supplied, as well as safe, comfortable, convenient, effective, self-application by the patient.

[0071] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either both of those included limits are also included in the invention.

[0072] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, exemplary methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.

[0073] It must be noted that as used herein and in the appended claims, the singular forms “a”, “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a stimulus” would include a plurality of such stimuli and reference to “the signal” would include reference to one or more signals and equivalents thereof known to those skilled in the art, and so forth.

[0074] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may differ from the actual publication dates which may need to be independently confirmed.

[0075] Referring now to FIG. 1, there is illustrated an exemplary embodiment of a thigh therapeutic compression apparatus 100 according to the subject invention showing compression bladder 102 integrally formed in the thigh therapeutic compression apparatus 100. The compression bladder 102 includes a medial bladder portion 102A and a lateral bladder portion 102B. The medial bladder portion 102A when in use is located along the medial saphenous vein of the individual on the inner thigh and the lateral bladder portion 102b when in use is located along the lateral saphenous vein of the individual on the back thigh. The thigh therapeutic compression apparatus 100 as shown in FIGS. 1-5 is configured and adapted to wrap around a patient's limb such as in this instance a left thigh, though it could be used in other limbs. An embodiment not shown of the thigh therapeutic compression apparatus 100 is configured and adapted to wrap around a patient's limb such as in this instance a right thigh and would be the mirror image of the inventive thigh therapeutic compression apparatus as shown in FIGS. 1-5 so that the medial bladder 102A would be located on the inner thigh area of the right leg and the lateral bladder portion 102B (if included) would be located on the back thigh of the user. The thigh therapeutic compression apparatus 100 is formed out of continuous outer sheet 108 and inner sheet 106. The thigh therapeutic compression apparatus 100 is a wrap member with a proximal end portion (top as oriented in FIGS. 1 and 2) and opposed distal end portion (bottom as oriented in FIGS. 1 and 2) which is configured and adapted to conform around a patient's thigh and provide compression through the inflation of bladder 102. Inner sheet 106 and outer sheet 108 are made out of a nylon laminated polyurethane sheet which are configured and adapted to be RF welded together. However, any other suitable materials which are weldable or otherwise joined while being airtight can be used. Continuous peripheral weld line 110 forms an airtight boundary of integrally formed bladder 102. In this exemplary embodiment, bladder 102 is a single continuous bladder throughout however, it is envisioned that the thigh therapeutic compression apparatus 100 could have an independent bladder either separately inflatable or inflatable through a one-way valve or other desired inflation/deflation configuration.

[0076] In this embodiment, hook and loop fasteners 124 are provided along the edge of inner and outer sheets in order to ease adjustment and secure therapeutic compression apparatus 100 on a patient's limb such as for example a thigh. It is envisioned that the therapeutic compression apparatus 100 can also be secured to a patient's thigh by other means, such as zippered, buttoned, or be cuff shaped by other such suitable means. Further, it is also envisioned that hook and loop closures 124 can be replaced by material similar to that of stabilization means 140 (such as a hip or waist stabilizer) described below and be welded/sewn/attached to bladder 102 for improved comfort.

[0077] In this embodiment inflation means is a device 130 which is a hand pump 200 (as shown in FIG. 3) capable of attaching to inflation port 112 to inflate bladder 102 (102A, 102B, 402). It can be appreciated that a mechanical or automatic inflation pump (not shown) can also be attached to inflation port 112 to inflate and deflate bladder 102 (102A, 102B, 402) to provide pulsating pressure to a user's thigh. A number or variety of inflation means can be employed such as a manual pump, hand pump, foot pump, mechanical pump, electrical pump, battery-operated pump, static pump, intermittent pump, varying pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulsing pump, or any other known or developed source of inflation so as to provide a certain pressure within the bladder so to provide compression in use by the patient. A vent valve (not shown) can also be incorporated into thigh therapeutic compression apparatus 100 or with inflation means 130 to allow a user to selectively deflate bladder 102 (102A, 102B, 402). Further, a check valve or relief valve is incorporated with either inflation means 130 or bladder 102 (102A, 102B, 402)to prevent over-inflation once a maximum pressure is detected. Examples of relief valves are described in U.S. Pat. Nos. 7,276,037 and 7,850,629, the disclosures of which are incorporated by reference in their entirety.

[0078] The thigh therapeutic compression apparatus 100 includes a panel 118 located along the proximal end portion of the thigh therapeutic compression apparatus configured to conform to the groin area of the leg. The panel 118 may be comprised of a flexible material such as but not limited to nylon, polyurethane, cotton, or other suitable material, or a material such as Spandex. The panel 118 may be configured to prevent the occurrence of a pinch point and reduce pressure on a patient's groin area when wearing the thigh therapeutic compression apparatus 100.

[0079] Referring now to FIGS. 1-2, by forming bladder 102 (102A and 102B) to be integral within inner sheet 106 and outer sheet 108, the location and desired preconfigured compression gradient profile can be obtained cost-effectively. A number of different embodiments of bladder configurations can be used in the thigh therapeutic compression apparatus 100 of the subject invention such as those configurations described above. FIGS. 1 and 2 show therapeutic compression apparatus 100 having bladder 102A, 102B with a plurality of spot welds 114 therein. Spot welds 114 are strategically placed within bladder 102 (102A and 102B) in a predetermined pattern based on the desired gradient profile relative to the compression needed at the patient's treatment site. Spot welds 114 enable bladder 102 (102A and 102B) to define the gradient profile when inflated through inflation port 112. The geometric placement of spot welds 114 within bladder 102 allows increased inflation of certain portions of bladder 102 (102A and 102B), and can create one or more fluid chambers within bladder 102. In this embodiment fluid chambers the bladder 102 is comprised of two bladders with air flowing between each bladder, for example the medial bladder 102A located in use along the inner portion of the patient's thigh and the lateral bladder 102B located in use along the patient's back and/or outer thigh. In this exemplary embodiment, bladder 102 is a single continuous bladder comprised of two portions of a bladder such as the medial bladder 102A and lateral bladder 102B. This configuration is particularly useful when compression is needed to improve fluid movement (e.g., blood, lymph, etc.) within the body. Further, linear weld lines 116 allow for better compression along the inner though and outer thigh of a patient's thigh by increasing tension applied to the medial portion of the thigh of a patient and thus further forming the predetermined gradient compression profile. This increased tension can generate a more effective thigh compression in order to increase venous flow. Linear weld lines 116 located horizontally along the medial portion of the thigh create a ribbed portion, which keeps the inflated profile of therapeutic compression apparatus 100 compact which can further increase ambulation and reduce interference with a patient's clothes. While not shown, the linear weld lines 116 could also be located vertically along the medial bladder portion 102A and/or the lateral bladder portion 102B, such as the vertical linear weld lines 416 as seen in FIGS. 6 and 7. Other combinations of linear weld lines 116, 416 and spot welds 114, 414 may be used to create a predetermined gradient compression profile for the bladders 102, 102A, 102B, 402 and thus apply gradient compression onto the leg or other limb, body part when in use.

[0080] It can be appreciated that depending on the location of the thigh therapeutic compression apparatus, different pressure gradients or compression gradients may be utilized. Looking at FIGS. 4, 5 and 6 other examples of other bladder pressure gradient profiles are described herein. Other possible gradient pressure profiles or compression gradient profiles may be imagined based upon the geometric location of the spot welds 114, 414 alone or in connection with the linear welds 116, 416.

[0081] In order to improve comfort, through-holes 113, as seen in FIGS. 1-2, and 4-7, (through-holes 413 as seen in FIGS. 6 and 7) are located throughout thigh therapeutic compression apparatus 100 (400) in order to allow for ventilation about a patient's thigh during extended wear of thigh therapeutic compression apparatus 100 (400). For the sake of clarity, not all of the through-holes 113 (and 413) are identified with reference characters in the Figures.

[0082] Referring now to FIGS. 1-5, once thigh therapeutic compression apparatus 100 is secured around a patient's thigh, bladder 102, 102A, 10213 is inflated and not able to shift out of place, thus increasing comfort and reducing fitting issues on the patient. In order to increase the ease of ambulation by a patient, in this exemplary embodiment, the proximal portion (upper edge located closer to the hip and pelvis) of the thigh therapeutic compression apparatus 100 includes a securing means, which is shown in FIGS. 1-5 as a stabilizer 140 so as to stabilize and secure the thigh therapeutic compression apparatus 100 to the thigh of the user and reduce slippage of the thigh therapeutic compression apparatus 100 down towards the knee. Any stabilizing or securing means may be employed such as for instance, and not show, a hip or waist strap can be used. If a strap is used, the strap may be pulled tight against a patient's leg and hip so as to reduce slippage of the thigh therapeutic compression apparatus 100 down the knee and may also improve compression near the hip area of a patient. In this embodiment, the stabilizing means or securing means 140 is comprised of a material that is comfortable to the user, and possibly thin so as to worn either under pants or over pants. The stabilizing mean or securing means 140 is connected to the wrap along the side closest to the lateral bladder portion 102B and from the proximal end to the distal end of the wrap. The stabilizing means or securing means 140 is comprised of cotton, doe skin, leather, rubber, Spandex™ or any other material. The stabilizing means or securing means 140 as shown in FIGS. 1-5 includes a panel 140 and at least two apertures 144A, 144B on the proximal end configured wherein a belt 300 or other securing means can be inserted and then secured around the waist of the individual when in use. In this embodiment of the thigh therapeutic compression apparatus 100, the securing means is a panel 140 which includes at least one aperture 144 or two 144A, 144B, created by a linear 142 weld(s) or other sealing means such as a linear stitch, linear adhesion, linear fold, or the like. The apertures 144A, 14413 are configured, in this embodiment, to allow a belt system 300 to be inserted within one of the apertures 144A, 144B so as to secure the thigh therapeutic compression apparatus 100 to the waist of a patient and to reduce slippage of the thigh therapeutic compression apparatus 100 downward towards the knee.

[0083] While only one aperture 144 may be employed (not shown), the configuration including at least two apertures 144A, 14413 is suggested so that each user can adjust the placement of the wrap and inventive thigh therapeutic compression apparatus along the user's thigh given the user's height, length of leg, waist, and the like. Other configurations may also be employed having three or more apertures 144.

[0084] In the embodiment shown in FIGS. 1-5, there are two apertures 144A, 144B so that the patient can adjust the location of the thigh therapeutic compression apparatus 100 on the patient's thigh depending on the height of the patient, the length of the patient's waist (for example, does the patient have a long torso or high or low waist), the length of the patient's thigh (for example, does the patient have long or short legs, including a long or short thigh), the width of the patient's waist (for example, is the patient thinner or thicker at the waist), the anatomy of the patient's hips and buttocks (for example, does the patient have a flat buttock or not), and any other anatomical configuration which may affect how the thigh therapeutic compression apparatus 100 would lie on the patient's thigh when in use and inflated. The securing means of the panel 140 of FIGS. 1-5 are shown in use on a user in FIG. 3 including the belt system 300. In use, the patient inserts the belt system 300 into the aperture 144 chosen, either 144A or 144B (or in other embodiments not shown there may be three or more apertures), and loops the belt around the patient's waist, adjusts the length of the belt system 300 via the adjusting means 305, and then cinches or closes the belt such as via a belt buckle 320 and the inserting are 325, as shown in FIG. 3. Again, other securing means may be employed which are not shown such as a waist strap or a hip strap, so as to reduce slippage of the thigh therapeutic compression apparatus 100 downward towards the patient's knee when in use.

[0085] The panel 140 as shown in FIGS. 105 may be comprised of a flexible material such as but not limited to nylon, polyurethane, cotton, or other suitable material, or a material such as Spandex. The panel 140 may be connected to the thigh therapeutic compression apparatus 100 by a RF weld, adhesive, glue or any other known connecting means.

[0086] While a strap, rope of other securing means may be inserted into the apertures 144A, 144B, in the embodiments shown in FIGS. 1-5, by way of example only and non-limiting, a belt 300 is shown including the belt portion 310, adjusting means 305 to shorten or length then overall belt 300, and a belt closure such as a buckle 320 and inserting portion 315, which belt system 300 is worn by the user at the waist. The belt system 300 may be employed as shown in FIGS. 105, but other securing means or belt systems may be employed such as for example and not limited to hook and loop closure or VELCRO™ or any other known connecting means such as buckles, straps, buttons, snaps, zippers, hooks and other combinations.

[0087] In another exemplary embodiment, a hip strap (not shown) or a waist strap (not shown) is configured and adapted to improve wearability of the thigh therapeutic compression apparatus 100 by locating a portion of bladder 102, 102A, 102B, 402 above the widest portion of the thigh of a patient and provides stability of thigh therapeutic compression apparatus 100 by preventing thigh therapeutic compression apparatus 100 from slipping down the thigh of a patient towards the knee, which would make the thigh therapeutic compression apparatus 100 less effective in providing thigh compression.

[0088] In accordance with another exemplary embodiment, inner sheet 106, 406 further includes a layer (not shown) that has a first elastic modulus, inner sheet 106, 406 has a second elastic modulus. The first elastic modulus is less than the second elastic modulus in a transverse direction relative to the proximal and distal end portions of therapeutic compression apparatus 100, 400 to wrap thigh therapeutic compression apparatus 100 around the thigh when the air bladder 102, 102A, 102B, 402 is inflated. In an exemplary embodiment, inner sheet 106, 406 includes a secondary sheet (not shown) disposed on an inner surface thereof, to directly contact the thigh in use. The secondary sheet can be a fabric layer, which is elastic in a first direction and inelastic in a second direction to curl the wrap member around the leg when the leg compression bladder is inflated.

[0089] It will be appreciated that the chambers of the bladder 102 (102A and 102B) may be filled by air, fluid or other known means of inflation, It will also be appreciated that the bladder 102 (102A and 102B) can be arranged to receive air and be inflated using a manual pumping bulb (as shown in FIG. 3 as 200), or can be inflated by an electric air pump (not shown) which can use batteries or AC wall current to pump air into the chamber(s). Any known source of air or fluid may be employed whether manual, mechanical, electrical, battery-operated or any other power sourced pump or pressure creator. The inflation means 130 may be a manual pump, hand pump, foot pump, mechanical pump, electrical pump, battery-operated pump, static pump, intermittent pump, varying pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulsing pump, or any other known or developed source of inflation so as to provide a certain pressure within the bladder so to provide compression in use by the patient.

[0090] The embodiment of the thigh therapeutic compression apparatus 100 may further (not shown) include an absorbent foam, sponge or dressing to be used alone or with a suction conduit coupled to a suction apparatus. Other embodiments of the compression mechanism are possible such as a combination of a sealed fluid-filled bladder, an absorbent foam, sponge or dressing, and a suction conduit for use with venous ulcers or other open wounds. The absorbent foam, sponge or dressing (not shown and hereinafter referred to as “the sponge”) may have the ability to absorb exudate from the wound or ulcer. In addition, the sponge preferably has an open-cell structure which aids in wicking the exudate from the wound or ulcer. The sponge may be lightly affixed to the patient's skin by an adhesive film such that the sponge may be peeled off and replaced. Some embodiments may include a suction conduit for example provided in between the thigh therapeutic compression apparatus 100 and the sponge. More particularly, the suction conduit may be oriented downwardly towards the sponge so that when a source of negative pressure is applied to the suction conduit, that negative pressure is applied to the wound or ulcer via the sponge. As a result, exudate can be wicked and suctioned away from the wound or ulcer via the sponge and into the conduit (such as a tube and other devices). In one embodiment, the conduit may be easily detached from the thigh therapeutic compression apparatus 100 so that the patient can walk or be transported away from the source of suction while pressure is still being applied to the wound or ulcer.

[0091] In another embodiment as seen in FIG. 4, the gap 103 in the lateral bladder 102B (which connects the flow of fluid between 102A and 102B) may be closed off and either the lateral bladder 102B inflated at manufacture to a set pressure level or not inflated and remain in an uninflated state when in use. Also not shown, in another embodiment, the lateral bladder 102B may be closed via a closing means (not shown) such as snap, hook, zipper, or other closing means. In such embodiment, if the lateral bladder 102B is closed or sealed, the lateral bladder 102B may also have a separate inflation means 130′ so that the lateral bladder 102B has a different pressure level than the pressure within the medial bladder 102A. As shown in FIG. 4, the lateral bladder 102B can be separately inflatable or inflatable through a n inflation means 112B including 109A, 111B, such as but not limited to a one-way valve or other desired inflation/deflation configuration. The lateral bladder 102B can also be configured and adapted to provide a differing pressure from the medial bladder 102A.

[0092] Hook and loop fasteners 124, 424 are provided along the edge of inner and outer sheets 106, 108 in order to ease adjustment in the embodiments shown in FIGS. 1-5, close up and secure the thigh therapeutic compression apparatus 100 (400) on a patient's thigh. A connector 115 may be used to strengthen the area between then hook and loop fastened 124 to prevent tearing of the material when in constant use by the individual. It is envisioned that thigh therapeutic compression apparatus 100, 400 can also be secured to a patient's thigh by other means, such as zippered, buttoned, or be cuff shaped by other such suitable means. Further, it is also envisioned that hook and loop closures 124 can be replaced by material similar to that of a strap described below and be welded/sewn/attached to bladder 102, 102A (or even 102B) for improved comfort. As shown in FIGS. 1-5, the hook and loop closures 124 can connect to the panel 140 and thus close around the thigh of the individual when in use. Other configurations for closure may be employed.

[0093] In one embodiment of the present invention inflation means 130 is a hand pump 200 which can attach to inflation port 112, 412 to inflate bladder 102, 102A, 102B, 402. It can be appreciated that a mechanical or automatic inflation pump (not shown) can also be attached to inflation port 112, 412 to inflate and deflate bladder 102, 102A, 102B, 402 to provide pulsating pressure to a user's thigh. A number or variety of inflation means can be employed not limited to a manual pump, hand pump, foot pump, mechanical pump, electrical pump, battery-operated pump, static pump, intermittent pump, varying pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulsing pump, or any other known or developed source of inflation so as to provide a certain pressure within the bladder so to provide compression in use by the patient. A vent valve is also be incorporated into thigh therapeutic compression apparatus 100, 400 or with inflation means 130 to allow a user to selectively deflate bladder 102, 102A, 102B, 402. Further, a relief valve is also incorporated with either inflation means 130 or bladder 102, 102A, 102B, 402 to prevent over inflation once a maximum pressure is detected. Examples of relief valves are described in U.S. Pat. Nos. 7,276,037 and 7,850,629, the disclosures of which are incorporated by reference in their entirety.

[0094] In another embodiment of the present invention the therapeutic compression apparatus 100, 400 can be formed by first forming bladder 102, 102A, 102B, 402 to be integral within inner sheet 106, 406 and outer sheet 108, 408, the location and desired preconfigured compression gradient profile can be obtained cost-effectively. A number of different embodiments of bladder configurations can be used in the thigh therapeutic compression apparatus 100, 400 of the subject invention such as those configurations described above. In another embodiment thigh therapeutic compression apparatus 100, 400 may have a bladder 102, 102A, 102B, 402 with a plurality of spot welds 114, 414 therein. Spot welds 114, 414 may be strategically placed within bladder 102, 102A, 102B, 402 in a predetermined pattern based on the desired gradient profile relative to the compression needed at the patient's treatment site. Spot welds 114, 414 enable bladder 102, 102A, 102B, 402 to define the gradient profile when inflated through inflation port 112, 412. The geometric placement of spot welds 114, 414 within bladder 102, 102A, 102B, 402 allows increased inflation of certain portions of bladder 102, 102A, 102B, 402, and can create one or more fluid chambers within bladder 102, 102A, 102B, 402. This configuration is particularly useful when compression is needed to improve fluid movement (e.g., blood, lymph, etc.) within the body. Further, linear weld lines 116, 416 allow for better compression along the thigh of the patient calf by increasing tension applied to a certain portion of the thigh of the patient, such as the inner thigh or the outer thigh, depending on the treatment considered for such patient. This increased tension can generate a more effective thigh compression in order to increase venous flow. For instance, in the exemplified and embodiments shown in FIGS. 1-2, and 4-5, the linear weld lines 116 are only within the medial bladder 102A and thus, their geometric pattern together with the geometric pattern of the spot welds 114 form a gradient pressure profile or gradient compression profile for the inner thigh area of the patient when inflated. Other configurations may be employed, whereas the spot welds 114 are in other geometric shapes or patterns and therefore create other gradient compression profiles for the bladder 102 when inflated and in use. As shown in FIGS. 1-2 and 4-5, the spot welds 114 of the lateral bladder 102B are in a geometric shape or pattern create a different or the same gradient pressure within the lateral bladder 102B compared with the medial bladder 102A. Any geometric pattern may be employed to create the set gradient compression profile and level within the bladder 102 when inflated and in use. As shown in FIGS. 1-2 and 4-5, one gradient compression profile is shown including linear weld lines 116 are located along the inner thigh and further create a ribbed portion, which keeps the inflated profile of therapeutic compression apparatus 100 compact which can further increase ambulation and reduce interference with a patient's clothes.

[0095] It can be appreciated that depending on the location of the therapeutic compression apparatus being placed on the patient's body part or limb, different compression gradient profiles may be utilized. Further, different pressure gradients may be employed depending on the treatment (general swelling, lactic acid build up, lymphedema, post-sclerotherapy, CVT, DVT, etc.) and the treatment site. Examples of other bladder compression gradient profiles are described in FIGS. 6-7. Other examples of bladder compression gradient profiles are described in U.S. patent application Ser. No. 12/911,563 and U.S. patent application Ser. No. 12/855,185, the disclosures of which are incorporated by reference in their entirety.

[0096] A number or variety of inflation means can be employed such as a manual pump, hand pump, foot pump, mechanical pump, electrical pump, battery-operated pump, static pump, intermittent pump, varying pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulsing pump, or any other known or developed source of inflation so as to provide a certain pressure within the bladder so to provide compression in use by the patient. Further, the inflation means could include a means to monitor or regulate the inflation. The inflation means could include programming such that the bladder 102, 102A, 102B, 402 is inflated and deflated to a set pressure at intervals or at set times throughout the day or night when the compression apparatus is in use worn on the patient. For instance, by way of example only, the inflation means could be set to 40 mm-Hg at 9 am and then set to deflate to 20 mm-Hg at 11 am and then set to inflate to 30 mm-Hg at 12 pm and so on throughout the day and night for each patient individually. In another embodiment of the present invention, if the lateral bladder 102B is sealed and separate from the medial bladder 102A, then there may be two separate inflation ports 112 (e.g. 112 A and 112B) that are each connected to either the same or different inflation means, and the pressure levels of the medial bladder 102A and the lateral bladder 102B could be the same or have different pressure levels. For instance, by way of example only, the inflation means could be set to 40 mm-Hg for the medial bladder and set to 20 mm-Hg for the lateral bladder, or each could vary and the inflation means be set to inflate, deflate, inflate, etc. throughout the day as described above.

[0097] It is envisioned, that the inventive thigh therapeutic compression apparatus (either 100 or 400) could be used in conjunction with a lower leg compression apparatus (such as those described in U.S. Pat. Nos. 9,033,906 and 7,967,766 and 7,559,908 and 7,276,037 and U.S. Ser. No. 13,444,600), and one inflation means could be connected to each of the two compression apparatus. The inflation means could include programming such that the bladders of both the thigh therapeutic compression apparatus and the bladder or bladders of the lower leg compression apparatus are each(or together at the same time) inflated and deflated to a set pressure at intervals or at set times throughout the day or night when the compression apparatus is in use worn on the patient. For instance, by way of example only, the inflation means could be set to 40 mm-Hg at 9 am and then set to deflate to 20 mm-Hg at 11 am and then set to inflate to 30 mm-Hg at 12 pm and so on throughout the day and night for each patient individually. In another embodiment of the present invention, for instance, by way of example only, the inflation means could be set to 40 mm-Hg for the thigh bladder and set to 20 mm-Hg for the lower leg bladder (or calf bladder or foot bladder, etc.), or each could vary and the inflation means be set to inflate, deflate, inflate, etc. throughout the day as described above. Depending on the treatment plan for the patient and depending on the specific patient, each of the bladders could be set to the same or different pressure levels though out the day and night.

[0098] In one embodiment of the invention, the inflation means includes a manual hand pump 200 (as shown in FIG. 3) and the dial includes graphics of pressure amount such as “35, “45′, “55′ and “65” or lettering such as “A”, “B”, “C”, “D” which each would correspond to a certain pressure such as 25 mm-Hg, 35 mm-Hg, 45 mm-Hg and 55 mm-Hg. The specific pre-determined pressure to correspond with the graphic is endless and not limited by the examples herein.

[0099] Further, the therapeutic compression apparatus may be deflated by a valve cap or in another embodiment has a button or a switch to deflate the bladder 102, 102A, 102B, 402 and thus release the pressure. In another embodiment (not shown), the switch may have a plurality of integrated umbrella valves so that one umbrella valve is set and closed to maintain the pressure within the bladder 102, 102A, 102B, 402, while a second umbrella valve would release a certain amount of air or fluid within the bladder 102, 102A, 102B, 402, so as to release the pressure such as while the patient is walking (pressure increases on the thigh with each step) or flying (pressure increases based on altitude), and a thirds umbrella valve which would release all the air or fluid in the bladder 102, 102A, 102B, 402 and thus release all pressure and deflate the thigh therapeutic compression apparatus 100 or 400. For instance by way of example only, the first umbrella valve is set in a closed position so that when activated this umbrella valve maintains the amount of air or fluid in the bladder 102, 102A, 102B, 402 and thus maintains the set pressure, say for instance at 45 mm-Hg, the second umbrella valve is set to release the air or fluid within the bladder 102, 102A, 102B, 402 if the pressure within exceeds 45 mm-Hg and bring the pressure down to 45 mm-Hg (such as when in high altitude or other increases in pressure) and then maintain the pressure at 45 mm-Hg, and a third umbrella valve is set to open and release all the air or fluid within the bladder 102, 102A, 102B, 402 and thus release all pressure when activated by the patient so as to deflate the bladder 102, 102A, 102B, 402 and the therapeutic compression apparatus 100, 400. By way of another example, the dial may include graphics such as (A) “Walk” wherein the set pressure amount is maintained while the patient walks and the pressure spikes and returns over and over in time as the umbrella valve remains in the closed position, (B) then a graphic of “Air” wherein the set pressure amount will be maintained by this umbrella vale occasionally releasing pressure as the pressure increases over the set amount or value so that the umbrella valve is activated to release air or fluid within the bladder 102, 102A, 102B, 402 and release the pressure yet then close and stay closed to maintain the set pressure amount, and (C) “Release” or “Deflate” wherein the pressure will be released and the air or fluid within the bladder 102, 102A, 102B, 402 released to deflate and this umbrella valve is always in the open position. In this embodiment (not shown) there are three umbrella valves with one set to always open the bladder 102, 102A, 102B, 402 to release pressure completely, one set to always close to maintain air or fluid in the bladder 102, 102A, 102B, 402 to maintain pressure, and a third set to open or release at a predetermined or set pressure point. In all of the embodiments referring to umbrella valve the umbrella valve may also be a switch (manual or otherwise) or a digital switch or any other known means to open, close or partial release air or fluid within a bladder and thereby maintain, change or release pressure therein.

[0100] The inflation means and valves shown in FIGS. 1-7 include an inflation port 112 or 412 having an elbow connector 109, 409 which is welded to the thigh therapeutic compression apparatus 100, 400 to allow air to flow into it. A check valve or relief valve is inserted into the elbow connector 109, 409. A dust cap or valve cap 111, 411 is included to prevent dust clogging the check valve and if inserted in a reverse configuration the inflated bladder is deflated manually. This is spring loaded so that the inflation means can inflate the bladder 102, 102A, 102B, 402 and once the inflation means is removed the spring seals the bladder 102, 102A, 102B, 402 such that the pressure is not released until manually or automatically decreased or deflated. The check valve may also be non-spring activated and activated by any other known means. The inflation means may include a bulb, motorized, batter-operated or electric means. The inflation means may include the dials shown or a simpler dial or one valve. Further embodiment are envisioned but not shown.

[0101] The inflation means 130 shown in FIG. 3 includes a hand pump 200 including a tube connected to a pump assembly including a valve dial and in this embodiment three umbrella valves, as well as a label which the user can use to see the various pressure amounts for the thigh therapeutic compression apparatus 100. The hand pump bulb 200 may be a squeeze bulb or any other known hand pump or ball.

[0102] In another embodiment of the present invention the compression apparatus may be a stand-alone thigh compression or thigh compression portion added to the leg and foot compression apparatus of the various other disclosed embodiments. The thigh compression apparatus includes an inner layer and an outer layer. The outer layer has joined to it an inflation port which is capable of connecting or joining to an inflation means. The inner layer includes a plurality of fasteners. In one embodiment the thigh compression apparatus includes, by way of example only, hook and loop fasteners along the edge to ease adjustment and secure therapeutic compression apparatus on a patient's thigh. Other uses of the thigh compression apparatus may be used such as on the back, calf, arm, stomach, torso, shoulder and other body parts, such that the designation as the “thigh” compression apparatus is not limited to only use of such apparatus on the thigh of a patient. It is envisioned that compression apparatus can also be secured to a patient's thigh or other body part by other means, such as zippered, buttoned, or be cuff shaped by other such suitable means.

[0103] Post-operative sclerotherapy treatment can also be effective with thigh therapeutic compression apparatus 100 wherein the lateral bladder 102B is closed via a closing means (not shown) over the gap 103 and either remains in a non-inflated state or may be slightly inflated to a lower pressure level, or could be inflated to any pressure level desire by the patient. As shown in FIGS. 4, the lateral bladder 102B is separate and not connected to the medial bladder and thus in this embodiment, the medial bladder 102A is inflated as part of the post-operative treatment plan to apply a certain predetermined gradient compression profile and pressure to the treatment site while a different predetermined gradient compression profile and pressure may be applied to the back or lateral portion of the user's thigh. Looking at the embodiment shown in FIG. 5 including only one bladder which is the medial bladder 102A, the predetermined gradient compression profile and pressure would be applied via the medial bladder 102A and the only compression applied to the remainder of the thigh would be the wrap itself closed on the thigh as the thigh therapeutic compression apparatus would not include a lateral bladder 102B. In another embodiment of the present invention, the thigh therapeutic compression apparatus 100 as shown in FIG. 5, only one bladder 102A is shown and configured to be compressed against the medial portion of the patient's leg on the inner thigh area. No lateral bladder (102B) in included in this embodiment of the present invention. This embodiment may be used in post-operative sclerotherapy treatment along with other treatments and post-operative treatments, Typically varicose veins are located on the inner thighs of an individual patient and for post-operative sclerotherapy treatment, compression is needed on the surgical site along the inner thigh. The embodiment of the inventive thigh therapeutic compression apparatus 100 as shown in FIG. 5 can be used for specific compression only along the inner thigh of the patient's leg, such as post-operative sclerotherapy procedures. Other post-operative procedures may employ the same method.

[0104] Other treatments such as lymphedema may employ both the medial bladder 102A and the lateral bladder 102B in an inflated state so as to apply compression and pressure to the selected site on the patient's thigh. As described above, the bladders 102A, 1022B could have the same pressure level, or if closed and separated with separate inflation ports 112 (112A and 112B respectively as shown in FIG. 4) have different pressure levels.

[0105] Referring now to FIGS. 6-7, another embodiment of the inventive thigh therapeutic apparatus 400 is shown, including bladder 402 (102A and 102B) integral within inner sheet 406 and outer sheet 408, the location and desired preconfigured compression gradient profile can be obtained cost-effectively. Continuous peripheral weld line 410 forms an airtight boundary of integrally formed bladder 4 02.A number of different embodiments of bladder configurations can be used in the thigh therapeutic compression apparatus 400 of the subject invention and which include a plurality of spot welds 414 and linear weld lines 116therein. Spot welds 414 are strategically placed within bladder 402 in a predetermined pattern based on the desired gradient compression profile relative to the compression needed at the patient's treatment site. Spot welds 414 enable bladder 402 to define the gradient profile when inflated through inflation port 412. The geometric placement of spot welds 414 within bladder 402 allows increased inflation of certain portions of bladder 402, and can create one or more fluid chambers within bladder 402, in this embodiment fluid chambers are further defined by the vertical linear weld lines 416. This configuration is particularly useful when compression is needed to improve fluid movement (e.g., blood, lymph, etc.) within the body. Further, linear weld lines 416 allow for better compression along the inner though and outer thigh of a patient's thigh by increasing tension applied to the medial portion of the thigh of a patient and thus further forming the predetermined S gradient compression profile. This increased tension can generate a more effective thigh compression in order to increase venous flow. Linear weld lines 416 located vertically along the medial portion of the thigh create a ribbed portion, which keeps the inflated profile of therapeutic compression apparatus 400 compact which can further increase ambulation and reduce interference with a patient's clothes whether worn under or on top of the patient's clothes such as pants.

[0106] Referring now to FIGS. 6-7, once thigh therapeutic compression apparatus 100 is secured around a patient's thigh, bladder 402 is inflated and not able to shift out of place, thus increasing comfort and reducing fitting issues on the patient. In order to increase the ease of ambulation by a patient, in this exemplary embodiment, the proximal portion (upper edge located closer to the hip and pelvis) of the thigh therapeutic compression apparatus 400 includes a securing means, which is shown in FIGS. 6 and 7 as a series of apertures 425 on the proximal end which are configured to allow a hook, snap, strap, or other material to be placed therein so as to secure the thigh therapeutic compression apparatus 400 to the thigh of the user and reduce slippage of the thigh therapeutic compression apparatus 400 down towards the knee. Any securing means may be employed such as for instance, and not show, a hip or waist strap can be used. If a strap is used, the strap may be pulled tight against a patient's leg and hip so as to reduce slippage of the thigh therapeutic compression apparatus 400 down the knee and may also improve compression near the hip area of a patient. In this embodiment, the securing means may include the apertures 425 which are connected to a strap 523 having a hook 519, which strap and hook are inserted within an aperture 425 and then snapped together. In this embodiment as shown in FIG. 7, a garter belt system 300, by way of example only and non-limiting, has a belt 310 and a belt closure such as a buckle 320 which belt system 300 is worn by the user at the waist. The belt system 300 includes the strap 523 and other connecting means such as a hook 519, though other connecting means may be employed such as for example and not limited to hook and loop closure or VELCRO™ or any other known connecting means such as buckles, straps, buttons, snaps, zippers, hooks and other combinations.

[0107] The thigh therapeutic compression apparatus 400 includes a panel 418 located along the proximal end portion of the thigh therapeutic compression apparatus configured to conform to the groin area of the leg. The panel 418 may be comprised of a flexible material such as but not limited to nylon, polyurethane, cotton, or other suitable material, or a material such as Spandex. The panel 418 may be configured to prevent the occurrence of a pinch point and reduce pressure on a patient's groin area when wearing the thigh therapeutic compression apparatus 400.

[0108] The thigh therapeutic compression apparatus may include an optional knee pad 420 which may be separate or connected to the thigh therapeutic compression apparatus 400. As shown in FIGS. 6-7, the optional knee pad 420 is connected to the thigh therapeutic compression apparatus 400 though a connecting means of 421A located on the optional knee pad 420 to an aperture of other married connecting means 421B located on the thigh therapeutic compression apparatus 400. Any other connecting means may be employed such as but not limited to hook and loop closure or VELCRO™ or any other known connecting means such as buckles, straps, buttons, snaps, zippers and other combination. In the alternative the connecting means 421A and 421B may be welded together or adhered or other connecting manner. The optional knee pad 420 may be comprised of a flexible material such as but not limited to nylon, polyurethane, cotton, or other suitable material, or a material such as Spandex.

[0109] In accordance with another exemplary embodiment of the thigh therapeutic compression apparatus 400 of FIGS. 6-7, inner sheet 406 further includes a layer (not shown) that has a first elastic modulus, inner sheet 406 has a second elastic modulus. The first elastic modulus is less than the second elastic modulus in a transverse direction relative to the proximal and distal end portions of therapeutic compression apparatus 400 to wrap therapeutic compression apparatus 100 around the leg when the leg compression bladder is inflated. In an exemplary embodiment, inner sheet 406 includes a secondary sheet (not shown) disposed on an inner surface thereof, to directly contact the lower leg in use. The secondary sheet can be a fabric layer, which is elastic in a first direction and inelastic in a second direction to curl the wrap member around the leg when the leg compression bladder is inflated.

[0110] In another exemplary embodiment of the thigh therapeutic compression apparatus 400 of FIGS. 6-7, a hip strap (not shown) or a waist strap (not shown) is configured and adapted to improve wearability of therapeutic compression apparatus 400 by locating a portion of bladder 402 above the widest portion of the thigh of a patient and provides stability of thigh therapeutic compression apparatus 400 by preventing thigh therapeutic compression apparatus 100 from slipping down the thigh of a patient towards the knee, which would make the thigh therapeutic compression apparatus 400 less effective in providing thigh compression.

[0111] The embodiment of the thigh therapeutic compression apparatus 400 in FIGS. 6-7 may further (now shown) include an absorbent foam, sponge or dressing to be used alone or with a suction conduit coupled to a suction apparatus. Other embodiments of the compression mechanism are possible such as a combination of a sealed fluid-filled bladder, an absorbent foam, sponge or dressing, and a suction conduit for use with venous ulcers or other open wounds. The absorbent foam, sponge or dressing (not shown and hereinafter referred to as “the sponge”) may have the ability to absorb exudate from the wound or ulcer. In addition, the sponge preferably has an open-cell structure which aids in wicking the exudate from the wound or ulcer. The sponge may be lightly affixed to the patient's skin by an adhesive film such that the sponge may be peeled off and replaced. Some embodiments may include a suction conduit for example provided in between the thigh therapeutic compression apparatus 400 and the sponge. More particularly, the suction conduit may be oriented downwardly towards the sponge so that when a source of negative pressure is applied to the suction conduit, that negative pressure is applied to the wound or ulcer via the sponge. As a result, exudate can be wicked and suctioned away from the wound or ulcer via the sponge and into the conduit (such as a tube and other devices). In one embodiment, the conduit may be easily detached from the thigh therapeutic compression apparatus 400 so that the patient can walk or be transported away from the source of suction while pressure is still being applied to the wound or ulcer.

[0112] The inventive thigh therapeutic compression apparatus 100, 400 may be included in a kit having various wound dressings and/or bandages. The wound dressings and/or bandages may be disposed of on a more frequent basis and the inventive therapeutic compression apparatus is applied in conjunction or combination with the wound dressings and/or bandages. In one embodiment the therapeutic compression apparatus is used over or on top of the wound dressing applied to the skin.

[0113] Another embodiment of the present invention includes a method of applying a measured compression amount with feedback. In this embodiment (not shown), Compression Bladder A is inflated by Inflation Source C—the nature of Compression Bladder A is such that the amount of compression is determined by the amount of inflation medium (typically air) pumped into A from C. In this design, Inflation Source C is also coupled with Bladder B, which has a fixed volume of air. When Compression Bladder A inflates, it will squeeze Bladder B as it compresses Compressed Item F. Inflation Source C is able to read the line pressure from the Coupling Line E to determine the interface pressure from Bladder B—in this design, Inflation Source C can be calibrated to provide only the amount of inflation medium necessary into Compression Bladder A as determined by matching the desired interface pressure from Bladder B. Other configurations may be employed so that feedback may be obtained from the inflation means and compression apparatus.

[0114] Another embodiment of the present invention includes a Sequential Gradient Compression with Single Chamber. In such embodiment (not shown), the compression apparatus includes an inflation bladder to apply not only gradient compression but sequential (filling up either the medial bladder 102A first and then filling up the lateral bladder 102B second, or the opposite) compression. In this embodiment (not shown), Inflation Device A is coupled to the device in two places (Intake Port C and Exhaust Port D). By inflating and providing air that goes directly into Channel B, the First Bladder Portion E (either the medial bladder 102A or the lateral bladder 102B as chosen by the patient) inflates first, before the Second Bladder F (the opposite bladder of First Bladder Portion E, so either the lateral bladder 102B or the medial bladder 102A). Air Then exits out of Exhaust Port D. In this design, the inflation can be intermittently provided for gradient and sequential compression or inflation can be held at a constant level to provide just the gradient profile.

[0115] Another embodiment of the present invention include an electric or other automated inflation means such that the bladder is inflated to a set volume or by reading the back pressure of which is being filled in. A pressure cycling function may be included. Further, an embodiment may have an inflation means such that the inflation maintains in the bladder(s) even after the inflation means is removed. Such inflation means may be integral to the compression apparatus itself or may be removable. Such inflation means may include an integrated circuit and/or wireless capability for tracking of usage, pressure, compliance by the patient in regard to maintaining certain pressures recommend by a physician or part of such patient's treatment plan, and other health data such as standing pressure and moving or working pressure, pedometer (number of steps), heartbeat, blood pressure and any other possible monitoring of the patient. Depending on the feedback obtained the inflation means may be programmed to increase or decrease the pressure without manual changing by the patient. Further, the inflation means may be configured so that the physician or other treatment professional may increase or decrease the pressure remotely based on the feedback. Other combinations may be included such as manual changing of the dial or inflation means in combination with automated means or electric means or digital means.

[0116] The dials shown are non-digital by way of non-limiting example only but a digital means may also be employed. A motorized pump and digital display may be used. The valve may include digital or electric means to change or modify pressure at a set rate or intervals or based on feedback from the monitoring means. The apparatus may include various sensors and monitors

[0117] In use the therapeutic compression apparatus 100 or 400 may be placed by the patient, practioner or care-giver on the chosen limb, such as for instance the thigh and fastened around the thigh of the patient. FIGS. 8A-8F shows one flow representations of the method of use of the thigh therapeutic compression apparatus 100 though other methods may be envisioned but not shown here. The user places the belt system 300 through the aperture either 144A or 144B depending on the individual's height and thigh location, then adjusts the belt 310 via the adjusting means 305 and buckles snaps or otherwise stabilizes and secures the thigh compression apparatus 100 to the waist and hip area of the individual. As seen in FIG. 8B, the user then places the lateral bladder 102B behind the thigh area such the medial bladder 102A is located on the inner thigh area and the hook and loop fasteners 124 are located on the outer thigh area, with the distal end of the therapeutic thigh compression apparatus 100 located above the knee 610 on the thigh 600. The user then closes or secures or fastens the therapeutic thigh compression apparatus 100 on the thigh 600 and locates the panel 118 and places it along the groin are of the upper thigh 600. The user then adjusts the therapeutic thigh compression apparatus 100 upward on the thigh 600 as seen in FIG. 8D. Moving in an upward or downward position from the knee 610 and/or hip then the patient, practioner or care-giver fastens or secures the fastening tabs (such as 124 or 424) up or down to the knee as seen in FIG. 8E. If there are additional optional straps located on the proximal end of the apparatus the first strap should be closed or secured in a tight fashion so that the therapeutic compression apparatus fits snugly but not too tight and the second strap should be closed or secured in a tight fashion so that the therapeutic compression apparatus fits snugly but not too tight. The patient, practioner or care-giver then removes the valve cap 111 from the valve located on the therapeutic compression apparatus. The patient, practioner or care-giver then selects a pressure amount of value on the dial of the inflation means depending on the treatment and whether the patient will be walking, sitting, lying down or traveling in a vehicle, train or airplane. Once the pressure amount or value is chosen on the dial (such as a given pressure amount such as “35” mm-Hg or a text such as “Walk” or “Air” or “Travel” or “Low” or “Medium” or “High”), the corresponding umbrella valve or switch is activated such that the pressure is thereafter maintained (closed position) or modified so as to maintain the pressure as it changes with the activity or altitude when in use). The patient, practioner or care-giver then inserts an end of the inflation means into the valve on the therapeutic compression apparatus and the air or fluid is increased to inflate the bladder (102, 102A, 102B, 402) and thus achieve a desired pressure amount or valve. Again this inflation means may be a hand pump, electric pump, battery-operated pump, remote controlled pump, air pump, gas pump, or any other known inflation means. A number or variety of inflation means can be employed such as a manual pump, hand pump, foot pump, mechanical pump, electrical pump, battery-operated pump, static pump, intermittent pump, varying pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulsing pump, or any other known or developed source of inflation so as to provide a certain pressure within the bladder so to provide compression in use by the patient. The valve cap 111 is then placed in the elbow connector 109 of the inflation port 112. Depending on the inflation means employed such inflation means may be removed and the valve cap replaced and the pressure will not decrease except as noted in the “Air” or “Walk” position. At any point in use the patient, practioner or care-giver can deflate the bladder by either inserting the valve cap so it depresses the valve spring and thus release the air or fluid in the bladder and decrease the pressure, or the patient, practioner or care-giver can reinsert the inflation means and select the “Deflate” or “Release” and the corresponding umbrella valve will be in the open position so as to release the air or fluid in the bladder and decrease the pressure until a deflated state is achieved for the bladder and the therapeutic compression apparatus. The therapeutic compression apparatus can be reinflated and deflated over and over again when in use.

[0118] The present invention has been illustrated and described with respect to specific embodiments thereof, which embodiments are exemplary and illustrative of the principles of the invention and are not intended to be exclusive or otherwise limiting embodiments. For instance, while in the foregoing embodiments the therapeutic compression apparatus are described as having inflatable bladders, the therapeutic compression apparatus may additionally include integrally formed or attached (e.g., by adhesive, radio-frequency welding, etc.) compression members that are not configured for inflation and/or deflation. For instance, additional compression members may be implemented using any of a variety of preformed and/or prefilled cushioning materials such as foam cushions and/or air, gel, or other fluid filled non-inflatable cushions, provided such compression members generate sufficient compression in combination with integral compression bladders. Further, while particular shapes, sizes, and materials have been described for purposes of illustration, it will be recognized that any of a variety of shape or size can be used, and the materials described are not exclusive but merely illustrative. Also, as noted above, while the bladder shown is inflated with air, it will be appreciated that any other fluid or medium such as liquid or gel can be used. Moreover, as also noted, it will be understood that bladders may be configured to have multiple pneumatically independent and/or pneumatically coupled bladder sections, and may also be configured to have various contours or lobulations.

[0119] The thigh therapeutic compression apparatus described herein can be used for any suitable condition treatable by compression therapy and the like. For example, therapeutic compression apparatus in accordance with the present invention can be used for compression of the venous system for the treatment of venous ulcers, CVI, DVT, for the treatment of lymphedema (where it is circulation of fluids in the lymph system rather than in the venous system that is promoted), and the like.

[0120] The thigh therapeutic compression apparatus of the instant invention described herein solves many problems with the prior art and in the industry and treatment of patients. The therapeutic compression apparatus may be applied on the patient's body part by the patient without the need or requirement of a skilled care-giver as required by current devices and apparatus. It further is capable of maintaining sufficient effective pressure without overpressure complications, maintaining compression and the like.

[0121] The thigh therapeutic compression apparatus of the instant invention includes a universal inflation port which is configured to be capable of connecting to more than one source of compression or inflation means such that the patient could vary treatment through varying the inflation source and inflation means for the treatment apparatus or device. For instance, a patient using the thigh therapeutic compression apparatus of the instant invention can alternate between a manual or mechanical or electrical inflation means or source of inflation and pressure. Further, the patient can alternate between static or intermittent inflation and pressure when using the inventive therapeutic compression apparatus

[0122] The thigh therapeutic compression apparatus of the instant invention also reduces the problem is leakage of set compression within the treatment apparatus and devices, bandages, stockings and hosiery and instead promotes a more effective treatment for CVI, DVT and/or lymphedema and other treatments. The thigh therapeutic compression apparatus of the instant invention also reduces the problem of slippage downward towards the knee of the patient when the apparatus is in use, especially when the patient is walking or moving about.

[0123] The present invention may assist in treatments wherein compression on the long saphenous vein may be recommended in treatment of certain conditions. Other embodiments of the present invention may assist in treatments for other conditions there may be less compression recommendation on the long saphenous vein on the medial side of the leg and more compression recommended on the short saphenous vein of the leg which runs on the back portion of the leg, including the thigh. In other embodiments of the present invention with only one lateral bladder and no medial bladder, the inventive therapeutic compression apparatus may assist in treatment of conditions where compression is recommended only on the short saphenous vein of the leg. These and other needs are met by the inventive thigh therapeutic compression apparatus 100, 400.

[0124] Another embodiment (not shown) may be a full leg compression apparatus including a thigh bladder, a calf bladder, an optional foot bladder, and a knee opening (or an optional knee pad) and an optional heel opening and foot strap. In this configuration, the thigh bladder may extend below the knee joint level and apply compression around the patella of the knee area. It may also have suspender hooks or slots (not shown) that allow for suspenders to be mated thereto in order to support the apparatus by a waist band when in use. The suspenders limit downward travel of the apparatus when in use such that it maintains its desired position.

[0125] While the subject invention of the present disclosure has been described with respect to preferred and exemplary embodiments, those skilled in the art will readily appreciate that various changes and/or modifications can be made to the invention without departing from the spirit or scope of the invention as described herein. There have been described and illustrated herein several embodiments of an intermittent pressure apparatus and a method of installing and operating same. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. Thus, while particular shapes and sizes of inflatable bladders and straps have been disclosed, it will be appreciated that other shapes, sizes, and attachment means may be used as well. It will also be understood that while Velcro and adhesive means have been disclosed for helping to secure the bladders to the leg and foot, other types of attachments such as hooks, snaps, or wraps may be used. In addition, it will be appreciated that while the fluid conduit may be detachably connected to the bladders using mating threaded portions or bayonet locks, other means of attachment known in the art may be used. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed.