THERAPEUTIC COMPRESSION APPARATUS, SYSTEM AND METHODS OF USE
20220387249 · 2022-12-08
Assignee
Inventors
Cpc classification
International classification
Abstract
A therapeutic compression system for providing gradient compression to a limb or other body part, including at least one therapeutic compression apparatus having at least one elastic sock or sleeve integral and connected to at least one wrap having at least one bladder and a universal inflation port to connect to an inflation means to the at least one bladder. The connecting means connects the at least one elastic sock or sleeve in one embodiment by buttons inserted and connected into apertures on the at least one wrap. The inflation port has an open and closed mechanism so that when closed it maintains the level of inflation in the at least one bladder. The inflation means provides either constant or varying pressure within the bladder and a check valve is included in the inflation port and/or inflation means. The inflation means may be connected to a stabilization means configured to be attached to a body part of the user or a belt or bag or other means around for example, the shoulder, leg, waist or arm of the body. The inventive therapeutic compression apparatus and system is stabilized and secured on the user when the user moves the target body part.
Claims
1. A therapeutic compression system for applying pressure to at least one limb of the human body, comprising: at least one therapeutic compression apparatus including at least one elastic sleeve and at least one wrap configured to be worn on a limb of a user including at least one bladder connected to a universal inflation port configured to be capable of connection to a static or intermittent inflation means, and a connecting means configured to connect the at least one elastic sleeve to the at least one wrap; a static or intermittent inflation means connected to the at least one bladder via the universal inflation port wherein the inflation means includes a check valve; and wherein the universal inflation port includes a sealing means configured to include an open position and a closed position wherein the closed position maintains the at least one bladder in an inflated or deflated state and is in the open position when coupled to the inflation means so that the at least one bladder is the same inflation state as the inflation means.
2. The therapeutic compression system of claim 1 wherein the connecting means is selected from the group consisting of buttons, stud buttons, snaps, straps, adhesives, welds, zippers, hooks, buckles, hook and loop, or a combination thereof.
3. The therapeutic compression system of claim 1 further comprising a compression strap configured for the foot and wherein the at least one elastic sleeve is configured to be placed on a lower leg including a closed foot portion of the elastic sleeve.
4. The therapeutic compression system of claim 3 wherein the foot compression strap is configured to be placed around an arch and sole area of the foot over the elastic sleeve.
5. The therapeutic compression system of claim 3 wherein the at least one wrap includes an elastic portion configured to be placed on the ankle portion of a user.
6. The therapeutic compression system of claim 1 wherein the at least one wrap is configured to be placed on an arm of a user and includes an aperture configured to encircle a portion of an elbow portion of a user.
7. The therapeutic compression system of claim 6 wherein the at least one elastic sleeve is configured to be placed on an arm of a user and includes an aperture on a distal end of the elastic sleeve configured for insertion of a thumb of a user.
8. The therapeutic compression system of claim 1 wherein the at least one wrap is configured to be placed on a thigh of a user and includes an elastic portion configured to be placed on the groin area of a user.
9. The therapeutic compression system 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.
10. The therapeutic compression system of claim 1, wherein the inflation means includes a manual pump configured to provide static inflation.
11. The therapeutic compression system of claim 1, wherein the inflation means includes a powered pump configured to provide static and/or intermittent inflation.
12. The therapeutic compression system of claim 1, wherein the inflation means is connected to a securing means configured to worn on the body of the user.
13. The therapeutic compression system of claim 1, wherein the sealing means is selected from the group consisting of valves, caps, levers, switches, screws, stop taps, stopcocks, or combinations thereof.
14. The therapeutic compression system of claim 1, wherein the inflation port is a self-sealing inflation port configured to prevent deflation of the at least one bladder and includes a check valve.
15. The therapeutic compression system of claim 1 further comprising a pressure sensor operatively connected to the inflation means to protect from over inflation and wherein the check valve is set to open at a predetermined pressure or a user selectable pressure.
16. The therapeutic compression system of claim 1 further comprising a second wrap wherein the first wrap and the second wrap may each be configured to wrap around a limb of the user wherein the limb is selected from the group consisting of the foot, ankle, calf, lower leg, knee, thigh, upper leg, whole leg, waist, torso, chest, arm, shoulder, elbow, wrist, hand, neck or any combinations thereof.
17. The therapeutic compression system of claim 16 wherein the first wrap and second wrap are not connected to each other while connected to the same inflation means and wherein the second wrap has a different inflation pressure than the inflation pressure of the first wrap when both the first wrap and second wrap are inflated from the same inflation means.
18. The therapeutic compression system of claim 1 wherein the at least one wrap includes at least two bladders configured to be either separate or joined.
19. The therapeutic compression system of claim 18 wherein the second bladder has a different inflation pressure than the inflation pressure of the first bladder when both the first wrap and second wrap are inflated from the same inflation means.
20. The therapeutic compression system of claim 1, wherein the at least one bladder is an air bladder configured to have at least one chamber capable of sequential gradient pressure when connected to the inflation means.
21. The therapeutic compression system of claim 1, wherein the at least one bladder is configured to provide gradient compression profile when inflated by the inflation means.
22. The therapeutic compression system of claim 1, 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.
23. The therapeutic compression system of claim 1 wherein the inflation means includes areal-time pressure measurement mechanism.
24. A method for applying compression pressure to a portion of a human body, comprising: activating an at least one therapeutic compression apparatus by connecting at least one elastic sleeve to at least one wrap by a connecting means; affixing the at least one elastic sleeve on a body part of a user; closing the at least one wrap on a body part of a user, wherein the at least one wrap includes (a) at least one air bladder connected to an inflation means and (b) an universal inflation port having a sealing means configured to include an open position and a closed position wherein the closed position maintains the at least one bladder in an inflated or deflated state and is in the open position when coupled to the inflation means so that the at least one bladder is the same inflation state as the inflation means, and further including an elbow 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 inflation means to the same or different body part of a user; inflating the at least one air bladder; moving such that the at least one wrap is secure and stable on the body part; removing the inflation means from the universal inflation port; activating the sealing means on the universal inflation port; and deflating the inflated at least one bladder by opening the sealing means and releasing a pressure within the at least one bladder.
25. A therapeutic compression system comprising: at least one elastic sleeve configured to be located on an arm, hip, leg, groin, knee, or foot area of a user; at least one wrap having a proximal end configured to be located along a shoulder, hip, groin or knee area of a user and a distal end of the primary wrap configured to be located at a wrist, knee or ankle 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 optional inflation means connected to the bladder via a universal inflation port on the bladder wherein the inflation port includes a check valve and is configured to be capable of connection to a manual or powered pump; 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
[0064] 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:
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0077] 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, 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 including without limitation the arm, torso, etc.
[0078] 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 calf or thigh of a user, or an arm of a user, in a manner that is simpler, easier, more convenient and more secure 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.
[0079] The subject invention provides system for providing compression and preventing swelling of a limb such as for instance the calf, thigh or arm using an elastic sleeve connected to a wrap including a compression wrap having a non-elastic binder and bladder, which can be used for compression. The elastic sleeve or sock may have a compression element as well in addition to the compression wrap. 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.
[0080] 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.
[0081] 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.
[0082] 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.
[0083] 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.
[0084] Referring now to
[0085] The sock or sleeve 110 is elastic and can include compression throughout, or only a portion having a compression element, or be non-compression. The elastic sock or sleeve 110 may be comprised of materials such as nylon, wool, cotton or any other compatible elastic material. The elastic sock or sleeve 110 may have a feature of compression itself which is then another level of compression coupled with the wrap 120 and/or compression or pressure of the bladder 102 once inflated. In one embodiment as shown in
[0086] The elastic sock or sleeve 110 is connected via a connecting means to the wrap 120. In one embodiment shown in
[0087] Bladder 102 includes an inner sheet and outer sheet made out of a nylon laminated polyurethane sheet which are configured and adapted to be RF welded together as shown in
[0088] In this embodiment as shown in
[0089] Further, optional supports may be included to reduce tearing of the wrap 120 or hook 122 (222, 322) when pulling the hook portion 122 (222, 322) off the loop portion 124 (224, 324). As seen in
[0090] In this lower leg therapeutic compression apparatus embodiment 100 and in the arm and thigh embodiments (200, 300) inflation means may be a device such as a hand pump 400 (as shown in
[0091] It can be appreciated that a mechanical or automatic inflation pump 150 (as shown in
[0092] In this embodiment of the therapeutic compression apparatus 100 for application to a user's lower leg, the therapeutic compression apparatus 100 includes a panel 126 located along the distal end portion of the therapeutic compression apparatus 100 configured to conform to the ankle area of the leg. The panel 126 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 126 may be configured to prevent the occurrence of a pinch point and reduce pressure on a patient's ankle area when wearing therapeutic compression apparatus 100.
[0093] In another embodiment not shown, the therapeutic compression apparatus may include an optional knee pad which may be separate or connected to the therapeutic compression apparatus 100. The optional knee pad can be connected to the therapeutic compression apparatus 100 though a connecting means of located on the optional knee pad or an aperture of other married connecting means located on the therapeutic compression apparatus 100. 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 may be welded together or adhered or other connecting manner. The optional knee pad 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. Another optional pad could be a groin pad if the therapeutic compression apparatus 100 is applied to the user's thigh. Other optional pads may be employed for the comfort of the patient and to reduce slippage of the therapeutic compression apparatus 100 when in use and the user walks or moves about.
[0094] Bladder 102 (202, 302) can be integral within inner sheet and outer sheet, 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 therapeutic compression apparatus 100 (200, 300) of the subject invention such as those configurations described above. In another embodiment not shown the wrap 120 does not have any bladder(s).
[0095] It can be appreciated that depending on the location of the therapeutic compression apparatus, different pressure gradients may be utilized. Other possible gradient pressure profiles may be imagined based upon the geometric location of the spot welds 114, 214, 314, alone or in connection with the linear welds 116, 216, 316.
[0096] Referring now to
[0097] In accordance with another exemplary embodiment not shown, inner sheet further includes a layer that has a first elastic modulus, inner sheet 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, 200, 300 to wrap therapeutic compression apparatus 100, 200, 300 around the leg, calf, thigh or arm (or any other body part or limb) when the compression bladder 102, 202, 302 is inflated. In an exemplary embodiment, inner sheet includes a secondary sheet disposed on an inner surface thereof, to directly contact the calf, lower leg, thigh or arm (or any other body part or limb) 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, calf, thigh or arm (or any other body part or limb) when the compression bladder 102, 202, 302 is inflated.
[0098] In another exemplary embodiment, a hip strap (not shown) or a waist strap (not shown) is configured and adapted to improve wearability of therapeutic compression apparatus 100, 300 by locating a portion of bladder 102 above the widest portion of the thigh of a patient and provides stability of therapeutic compression apparatus 100, 300 by preventing therapeutic compression apparatus 100, 300 from slipping down the thigh of a patient towards the knee and increase stability and improving thigh compression.
[0099] It will be appreciated that the chambers of the bladder 102, 202, 302 may be filled by air, fluid or other known means of inflation. It will also be appreciated that the bladder 102, 202, 302 can be arranged to receive air and be inflated using a manual pumping bulb 420, or can be inflated by an electric air pump 150 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 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. As shown in
[0100] It will be appreciated that the chambers of the bladder 102, 202, 302 may be filled by air, fluid or other known means of inflation, It will also be appreciated that the bladder 102, 202, 302 can be arranged to receive air and be inflated via the inflation port 140, 240, 340 using a manual pumping bulb or can be inflated by an electric air pump which can use batteries or AC wall current to pump air into the chamber(s). The inflation port 140, 240, 340 of the therapeutic compression apparatus 100, 200, 300 is universal in that it can connect to many different types of inflation means.
[0101] As shown in
[0102] It can be appreciated that depending on the location of the therapeutic compression apparatus 100, 200, 300 being placed on the patient's body part or limb, different pressure gradients 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. Other examples of bladder pressure 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.
[0103] In order to improve comfort, through-holes 111, 211, 311 are incorporated into the spot welds 114, 214, 314 and within the non-bladder portions of the wrap 120, 220, 320 between the linear welds 116, 216, 316. The through holes 111, 211, 311 may be located throughout therapeutic compression apparatus 100, 200, 300 in order to allow for ventilation about a patient's leg, thigh, arm or other body part or limb during extended wear of therapeutic compression apparatus 100, 200, 300. For the sake of clarity, not all of the through-holes are identified with reference characters in the Figures.
[0104] Another embodiment of the present invention includes a therapeutic compression apparatus 200 capable of being secured on the arm 500 of a user. The arm therapeutic compression apparatus 200 according to the subject invention includes an elastic sleeve or elastic sock or sleeve 210 connected to a wrap 220 together integrally formed in the therapeutic compression apparatus 200. The therapeutic compression apparatus 200 is configured and adapted to wrap around a patient's limb such as in this instance as shown in
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[0106] In this embodiment of the therapeutic compression apparatus 200 for application to a user's arm 500, the apparatus 200 includes an opening or aperture 280 located to correspond with the user's elbow 500b. An option panel (not shown) may be included configured to conform to the shoulder area 500a, elbow area 500b or wrist area 500c. The optional panel(s) 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 optional panel(s) may be configured to prevent the occurrence of a pinch point and reduce pressure on a patient's shoulder area 500a, elbow area 500b or wrist area 500c when wearing the therapeutic compression apparatus 200. Other optional panels or pads may be employed for the comfort of the patient and to reduce slippage in a downward direction towards the wrist 500c or hand 500d of the therapeutic compression apparatus 200 when in use and the user walks or moves about.
[0107] The bladder 202 has a plurality of linear welds 216 and a plurality of spot welds 214 therein. Each of the linear welds 216 and spot welds 214 are strategically placed within bladder 202 in a predetermined pattern based on the desired gradient profile relative to the compression needed at the patient's treatment site. The geometric placement of linear welds 216 and spot welds 214 within bladder 202 allows increased inflation of certain portions of bladder 202, and can create one or more fluid chambers within bladder 202. This configuration is particularly useful when compression is needed to improve fluid movement (e.g., blood, lymph, etc.) within the body. This increased tension can generate a more effective compression in order to increase venous flow on the arm. Linear welds 216 may create a ribbed portion, which keeps the inflated profile of therapeutic compression apparatus 200 compact which can further increase ambulation and reduce interference with a patient's clothes. It can be appreciated that depending on the location of the therapeutic compression apparatus, different pressure gradients may be utilized. Other possible gradient pressure profiles may be imagined based upon the geometric location of the spot welds 214, alone or in connection with the linear welds 216. The gradient compression profile may be different depending on the treatment whether for lymphedema, dialysis, DVT or other uses of the therapeutic compression apparatus 200.
[0108] The arm therapeutic compression apparatus 200 may optionally include an expander 270 such as by way of example only a foam expander. The optional expander 270 may be employed in a longer arm therapeutic compression apparatus 200 such as on a taller individual with a longer arm 500. Any other type of expander may be employed for comfort of the user when the arm therapeutic compression apparatus 200 is secured on the user's arm 500 and the bladder 202 is inflated with a compression profile. Further, the expander 270 may enhance the user's comfort when bending his or her arm 500 at the elbow when the arm therapeutic compression apparatus 200 is secured on the user's arm 500 and the bladder 202 is inflated with a gradient or non-gradient compression profile. Other expanders may be included in the arm therapeutic compression apparatus 200 based on the length of the target limb such as the arm 500.
[0109] Referring now to
[0110] In another exemplary embodiment, a torso strap (not shown) chest strap (not shown), or a waist strap (not shown) is configured and adapted to improve wearability of therapeutic compression apparatus 200 by locating a portion of bladder 202 above the widest portion of the arm of a patient and provides stability of therapeutic compression apparatus 200 by preventing therapeutic compression apparatus 200 from slipping down the arm of a patient towards the elbow, wrist or hand, which would make the therapeutic compression apparatus 200 less effective in providing arm compression. The inflation means if an automatic pump 150 can be secured on the user via the belt system 180 shown in
[0111] Referring now to
[0112] In another embodiment not shown, the gap 303 in the lateral bladder 302B (which connects the flow of fluid between 302A and 302B) may be closed off and either the lateral bladder 302B 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 302B 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 302B is closed or sealed, the lateral bladder 302B may also have a separate inflation means 340′ so that the lateral bladder 302B has a different pressure level than the pressure within the medial bladder 302A. In other embodiments not shown, the lateral bladder 302B may be separately inflatable or inflatable through an inflation means 190 or 150 connected to or inserted within the inflation port 340, such as but not limited to a one-way valve or other desired inflation/deflation configuration. The lateral bladder 302B can also be configured and adapted to provide a differing pressure from the medial bladder 302A. The wrap 320 may not include any bladder in another embodiment not shown.
[0113] This embodiment of the present invention includes a therapeutic compression apparatus 300 capable of being secured on the thigh of a user. The thigh therapeutic compression apparatus 300 according to the subject invention includes an elastic sleeve or elastic sock 310 connected to a wrap 320 together integrally formed in the therapeutic compression apparatus 300. The therapeutic compression apparatus 300 is configured and adapted to wrap around a patient's limb such as in this instance as shown in
[0114] The elastic sleeve 310 is elastic and can be compression or non-compression. The elastic sleeve 310 may be comprised of materials such as nylon, wool, cotton or any other compatible elastic material. The elastic sleeve 310 may have a feature of compression itself which is then another level of compression coupled with the pressure of the bladder 302 (302A, 302B) once inflated. The elastic sleeve 310 is connected via a connecting means to the wrap 320. The connecting means may be via adhesion, sewing, welding, gluing, snaps, hooks, buttons, Velcro™ or any other known connecting means.
[0115] In this embodiment, hook fasteners 322 are provided along the edge of inner and outer sheets in order to ease adjustment and secure therapeutic compression apparatus 300 on a patient's limb such as for example a thigh by connecting to the loop portion 324. It is envisioned that the therapeutic compression apparatus 300 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 322 and loop closures 324 can be replaced by material such as a hip or waist stabilizer described below and be welded/sewn/attached to bladder 302 for improved comfort.
[0116] The thigh therapeutic compression apparatus 300 includes a panel 321 located along the proximal end portion of the thigh therapeutic compression apparatus 300 configured to conform to the groin area of the leg 600. The panel 321 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 321 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 300.
[0117] Referring now to
[0118] In this embodiment, a further stabilizing means or securing means 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 is connected to the wrap along the side closest to the lateral bladder portion 302B and from the proximal end to the distal end of the wrap. The stabilizing means or securing means is comprised of cotton, doe skin, leather, rubber, Spandex™ or any other material. The stabilizing means or securing means as shown in
[0119] While only one aperture 338 may be employed (not shown), the configuration including at least two apertures 338A, 338B 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 338. In the embodiment shown in
[0120] In this embodiment, the user connects the compression sleeve 310 to the wrap 320 via a connecting means such as for example inserting at least one button 313 into the opening or aperture 323 on the wrap 320. Once connected the user places the compression sleeve 310 onto the thigh by first placing it over the foot then pulling it up over the ankle, calf, knee 610 and up to the thigh area. The entire therapeutic compression apparatus is pulled up as the wrap 320 is connected via the connecting means, in this example the buttons 313 and openings or slits 323. Once the user is satisfied with the location of the compression sleeve 310 and connected wrap 320, the user then, with only one hand or using both hands, closes the wrap 320 via the hook and loop 322, 324, and inflates the bladder 302 so that the therapeutic compression apparatus 300 is not able to shift out of place, thus increasing comfort and reducing fitting issues on the patient. Further, 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 300 includes a securing means, so as to stabilize and secure the thigh therapeutic compression apparatus 300 to the thigh of the user and reduce slippage of the thigh therapeutic compression apparatus 300 down towards the knee. The belt system 180 is inserted into one of the apertures 338, 338A, 338B and the belt is placed on the user's waist. The user adjusts the belt by tightening or loosening the adjusters 182 and when satisfied, inserts the male portion 181A of the belt lock into the female portion 181B of the belt lock 181. If an automatic pump 150 is used and placed on the belt 180, an optional pump cover 170 may be placed over the pump 150.
[0121] The therapeutic compression apparatus 300 is easier for the patient to apply or place on the thigh, notably only using only one hand or both hands, as it is one integral apparatus in the embodiment comprised of the elastic sock or sleeve 310 and the wrap 320. The therapeutic compression apparatus 300 remains secure on the thigh and has decreased slippage down from the hip to the knee area 610 compared to conventional known compression sleeves or other known wraps, apparatus or garments.
[0122] The inflation means or mechanism for each of the various embodiments of the present invention may include a hand pump, electric pump, battery-operated pump, remote controlled pump, airpump, 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. 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, 202, 302, 302A, 302B 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 not shown there may be two separate bladders 102A and 102B with two separate inflation ports that are each connected to either the same or different inflation means, and the pressure levels of the bladder 102A and the 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 bladder 102A and set to 20 mm-Hg for the bladder 102B, or each could vary and the inflation means be set to inflate, deflate, inflate, etc. throughout the day as described above.
[0123] It is envisioned, that the inventive therapeutic compression apparatus 100, 200, 300 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 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. 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.
[0124] As an example, treatment options would include intermittent pneumatic compression (HPIPC) 60 minutes twice daily for 16 weeks. In this example, the inflation means would have a pressure level of 120 mm-HG and the bilateral pressures of 120 mm Hg in a cycle time to provide sequential compression for 4 seconds (+/−0.5 seconds) followed by a 16-second rest period (+/−3.0 seconds), resulting in a 20-second cycle or 3 cycles per minute. This treatment may help reduce vascular issues such as lymphedema, DVT, CVI and the like.
[0125] In another example, treatment options could include reducing DVT through applying pressure pre-operation, for instance for knee surgery, TKR, KRA, hip surgery, THR, HRA, shoulder surgery, rotator cuff surgery, SLAP surgery, breast cancer surgery, dialysis, or the like, to the target limb for a period of days or weeks or months prior to the surgical date. Prior to surgery the patient would apply compression via the therapeutic compression apparatus 100, 200, 300 and inflation means of the inventive system to reduce swelling of the target limb. During the actual operation and immediately after surgery while still in the hospital setting, the patient would use the same or a different therapeutic compression apparatus 100, 200, 300 connected to an inflation means within the hospital such as an intermittent compression pump accessible through the wall of the patient room or wheeled into the room, which may be considered mechanical DVT prophylaxis. Once discharged from the hospital setting, the patient can retain the same therapeutic compression apparatus 100, 200, 300 and use it at home by applying pressure via the inflation means of an electrical pump 150 configured to apply both constant static pressure and intermittent varying pressure based on the treatment plan. The method of use may reduce or prevent lymphedema, DVT, CVI and other vascular issues. The therapeutic compression apparatus has a universal inflation port configured so it can connect to a hand pump (410) and electric pump (150) and a hospital pump (not shown) and many other pumps. This method if use of the inventive system may reduce swelling pre-surgery and post-surgery and also reduce lymphedema, CVI, DVT and other post-surgical complications. As stated above, the patient is more mobile and ambulatory using the inventive system including the inflation means 150 attached to the retaining means 180 belt. This system is also less cumbersome than current post-operative compression systems which weigh many pounds on their own and other products on the market.
[0126] In another embodiment method of use of the inventive system the system us used both prior to, during and after a lower body surgery. Particularly with joint replacement (knee, shoulder and hip) surgery and breast cancer surgery, there is an increased risk of DVT along with the pre and post-op issues related to leg swelling and arm swelling. Due to the universal nature of the inflation port 140, 240, 340 (or valve) on the therapeutic compression apparatus 100, 200, 300, it can be coupled with a hand pump, a battery-operated pump, or the existing electrical intermittent pneumatic compression DVT systems that exist on the market. However, the sleeves to these existing DVT systems are not worn to reduce swelling, cannot apply compression in of a static nature, and cannot be used for mechanical DVT prophylaxis without the IPC DVT control unit. Thus, another method of use to improve the outcomes includes the steps of (a) at least 3 days pre-surgery, the patient is given the therapeutic compression apparatus 100, 200, 300 including the elastic compression stocking or sleeve 110, 210, 310 to reduce limb volume and leg swelling, which can be achieved with either static or intermittent compression pressure levels, then (b) during surgery and immediately post-operative the therapeutic compression apparatus 100, 200, 300 is connected to the IPC DVT control unit in the hospital or clinic or outpatient office setting, and the IPC cycles intermittently to provide standard DVT mechanical prophylaxis, and thereafter (c) as the patient is discharged, the patient is given the therapeutic compression apparatus 100, 200, 300 to bring home along with either or both the hand compression pump or battery operated (or electrical powered) inflation means, such as an automatic pump 150, to manage the risk of DVT along with preventing further swelling.
[0127] 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, 202, 302, 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, 202, 302 while a second umbrella valve would release a certain amount of air or fluid within the bladder 102, 202, 302, so as to release the pressure such as while the patient is walking (pressure increases on the leg 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, 202, 302 and thus release all pressure and deflate the therapeutic compression apparatus 100, 200, 300. 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, 202, 302 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, 202, 302 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 and thus release all pressure when activated by the patient so as to deflate the bladder 102, 202, 302 and the therapeutic compression apparatus 100, 200, 300. 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, 202, 302, 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, 202, 302, 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, 202, 302, to release pressure completely, one set to always close to maintain air or fluid in the bladder 102, 202, 302, 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.
[0128] Each of the embodiments of the therapeutic compression apparatus 100, 200, 300 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 therapeutic compression apparatus 100, 200, 300 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 therapeutic compression apparatus 100, 200, 300 so that the patient can walk or be transported away from the source of suction while pressure is still being applied to the wound orulcer.
[0129] The inventive therapeutic compression apparatus 100, 200, 300 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.
[0130] 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.
[0131] Another embedment 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 bladder 102A first and then filling up the 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 bladder 102A or 102B as chosen by the patient) inflates first, before the Second Bladder F (the opposite bladder of First Bladder Portion E, so either the bladder 102B or 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.
[0132] Another embodiment of the present invention includes 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. 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.
[0133] Post-operative treatment can also be effective with therapeutic compression apparatus 100, 200, 300 including without limitation knee replacements, hip replacements, shoulder replacements, rotator cuff surgery, breast cancer surgery, SLAP, sclerotherapy, dialysis and other procedures. Other treatments such as lymphedema may employ the therapeutic compression apparatus 100, 200, 300 so as to apply compression and pressure to the selected site on the patient's thigh or lower leg. In use the therapeutic compression apparatus 100, 200, 300 may be placed by the patient, practioner or care-giver on the chosen limb, such as for instance the lower leg, thigh, arm or other target body part or limb. The elastic sock or sleeve 110, 210, 310 is connected to the wrap 120, 220, 320 and then placed by the user on the foot and pulled towards the knee or placed on the hand and pulled towards the shoulder until reaching the satisfactory location on the body part. The therapeutic compression apparatus is thus located on the target body area and secured due to the compression of the elastic sock or sleeve 110, 210, 310 allowing the user to simultaneously now close the wrap 120, 220, 320 around the target body part by moving in an upward or downward position the patient, practitioner or care-giver fastens or secures the fastening tabs such as 122, 124 up or down to the knee and ankle or wrist to shoulder. 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 144, 244, 344 from the inflation port 140, 240, 340 on the therapeutic compression apparatus 100, 200, 300. 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, 202, 302) 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. At any point in use the patient, practioner or care-giver can deflate the bladder 102, 202, 302 by either inserting the valve cap 144, 244, 344 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 102, 202, 302 and decrease the pressure and/or compression until a deflated state is achieved for the bladder 102, 202, 302 and the therapeutic compression apparatus 100, 200, 300. The therapeutic compression apparatus 100, 200, 300 can be reinflated and deflated over and over again when in use.
[0134] 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.
[0135] 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.
[0136] The 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. It can be used to fulfill a long felt need while a patient is undergoing dialysis or after to reduce or prevent swelling of the arm or other body part as well as lymphedema, CVI or DVT. It can be used to fulfill a long felt need for a compression wrap, garment, apparatus or system to increase warm up before exercise, to remove lactic acid buildup during and after exercise and to reduce recovery time for the user.
[0137] The 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. The ease of use by the patient in applying the apparatus to the limb is an advantage over the known prior art. The inventive therapeutic compression apparatus 100 is capable of maintaining sufficient effective pressure without overpressure complications, maintaining compression and the like. The user can simultaneously locate the inventive therapeutic compression apparatus on the target body part while at the same time closing the wrap such as connecting fasteners or VELCRO™ straps and other connectors without the wrap moving off the target body part.
[0138] The 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 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.
[0139] The therapeutic compression apparatus of the instant invention also fulfills a long-felt need to reduce 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 therapeutic compression apparatus of the instant invention also fulfills a long-felt need and reduces the problem of slippage downward towards the knee or ankle of the patient when the apparatus is in use on the thigh or lower leg, especially when the patient is walking or moving about.
[0140] While in recent years various products have been created that include tight compression stockings or sleeves, these products have many problems as discussed above with being too tight to maintain location and non-slippage and then stretching out over time. Further, products which allow the user to apply a aster such as VELCRO™ to create compression with or without an inflation means, these products have problems in ease of location on the target body part while being closed at the same time by the user and then continued problems with slippage down to the knee, ankle or wrist. The inventive therapeutic compression apparatus and system do not have such problems and fulfill the long felt need for a compression apparatus which can be simultaneously placed on a location at a target body part and closed at the same time by the user himself or herself and when moving the user will see reduced or no slippage down to the knee, ankle or wrist. The inventive therapeutic compression apparatus 100, 200, 300 has the benefit of an elastic sock or sleeve without the problem of too high elasticity and the added benefit of compression (either from the hook and loop fasteners alone or with inflation of the bladder). These and other needs are met by the inventive therapeutic compression apparatus and system 100, 200, 300.
[0141] The inventive therapeutic compression apparatus 100, 200, 300 combined with the belt system 180 and other additions are a system and can be combined with other kits and products. The inventive therapeutic compression apparatus fulfill the need of a self-application by a user of a compression wrap, garment or apparatus even of the user has reduced strength or mobility in his or her hands, arms, legs or back. Once applied the inventive therapeutic compression apparatus and system 100, 200, 300 maintains stability securely on the target body part while maintaining sufficient compression levels on the target body part. The inventive therapeutic compression apparatus and system 100, 200, 300 may be used pre-surgery or post-surgery to reduce swelling and lymphedema as well as during dialysis as well as pre-exercise, during and post-exercise. Other uses of the inventive therapeutic compression apparatus and system 100, 200, 300 may be employed including without limitation treating or reducing CVI and/or DVT.
[0142] 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.