# Patent

## Title
Compression sleeve having air conduits formed by a textured surface

## Abstract

A compression sleeve is described as having a first sheet and a second sheet attached to the first sheet. The first and second sheets define at least one inflatable section. At least one conduit including a textured inner surface on each of the first and second sheets is disposed within the inflatable section.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. Ser. No. 12/251,004, filed Oct. 14, 2008, which is a continuation-in-part of U.S. Pat. No. 7,442,175, issued Oct. 28, 2008, the entireties of which are incorporated herein by reference.


FIELD OF THE INVENTION
The present disclosure relates generally to a compression sleeve for use in a system for applying compressive forces or pressure to a patient's limb, such as the leg. In particular, the present disclosure relates to a compression sleeve that maintains air flow in the entire sleeve during compression therapy when wrapped around the limb of an individual.
BACKGROUND OF THE INVENTION
Compression devices for applying compressive forces to a selected area of a person's anatomy are generally employed to improve blood flow in the selected area. Compression devices that provide intermittent pulses of a compressed fluid (e.g. air) to inflate at least one inflatable chamber in a sleeve are particularly useful. This cyclic application of pressure provides a non-invasive method of prophylaxis to reduce the incidence of deep vein thrombosis (DVT), and the like. These compression devices find particular use during surgery on patients with high-risk conditions such as obesity, advanced age, malignancy, or prior thromboembolism. Patients who have this condition often have swelling (i.e. edema) and tissue breakdown (i.e. venous stasis ulcer) in the lower leg.
In general, compression devices include a sleeve having at least one fluid inflatable pressure chamber progressively arranged longitudinally along the sleeve. A pressure source (e.g. a pump) is provided for intermittently forming a pressure pulse within these inflatable chambers from a source of pressurized fluid during periodic compression cycles. The compression sleeves provide a pressure gradient along the patient's limbs during these compression cycles, which progressively decreases from the lower portion to the upper portion of the limb (i.e. from the ankle to the thigh).
Examples of compression sleeves are disclosed in U.S. Pat. Nos. 4,013,069 and 4,030,488 to Hasty, U.S. Pat. Nos. 4,029,087 and 5,795,312 to Dye, and U.S. Pat. No. 5,626,556 to Tobler et al., all of which are currently owned by Tyco Healthcare Group, LP and are incorporated by reference herein in their entirety. Other examples of compression sleeves are disclosed in U.S. Pat. Nos. 4,696,289 to Gardner et al. and 5,989,204 to Lina.
When compression therapy is administered to a patient, the inflatable pressure chambers of the compression sleeves of the foregoing description may include trapped air. Trapped air changes the volume of a chamber, thus reducing the pressure gradient along the patient's limb during treatment. The shape, weight, and position of a patient's limb will contribute to the size and number of pockets of air formed. An example of compression treatment method is disclosed in U.S. Pat. No. 6,231,532 to Watson et al., which is currently owned by Tyco Healthcare Group, LP, the contents of which we hereby incorporated by reference herein in their entirety.
SUMMARY OF THE INVENTION
In one aspect of the invention, a compression sleeve generally comprises a first sheet and a second sheet attached to said first sheet. The first and second sheets define at least one inflatable section. At least one conduit within the inflatable section extends along at least one dimension of the inflatable section. A lumen partially disposed between the first and second sheets is adapted for connection to a source of pressurized fluid. The at least one conduit comprises a textured inner surface on at least one of the first and second sheets. The textured inner surface is shaped and arranged to form channels across the first and second sheets for channeling the pressurized fluid to and from the lumen.
In another aspect of the invention, a method for making a compression bladder generally comprises the step of providing at least one sheet of air impermeable material having a textured inner surface shaped and arranged for forming channels across the one sheet for channeling air within the bladder. The one sheet is sealed to form an inflatable chamber so that the textured inner surface faces an opposing surface. The textured inner surface prevents collapse of the opposing surface and maintains the channels for flow of air. A port is formed in the inflatable chamber. The channels of the textured inner surface are arranged to pass air to the channels to the port when the opposing surface engages the textured inner surface.
Other objects and features will be in part apparent and in part pointed out hereinafter.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a plan view of a compression sleeve, in accordance with the present disclosure;
FIG. 2A-2B are plan and cross-sectional views, respectively, of a first embodiment of an air conduit in accordance with the present disclosure;
FIG. 2C is a cross-sectional view taken along line 2-2 in FIG. 1, illustrating the air conduit of FIG. 2A positioned within the inflatable sections of the compression sleeve;
FIG. 3A-3B are plan and cross-sectional views, respectively, of a second embodiment of the air conduit in accordance with the present disclosure;
FIG. 3C is a cross-sectional view taken along line 2-2 in FIG. 1, illustrating the air conduit of FIG. 3A positioned within the inflatable sections of the compression sleeve;
FIG. 4A-4B are plan and cross-sectional views, respectively, of yet another embodiment of the air conduit in accordance with the present disclosure;
FIG. 4C is a cross-sectional view taken along line 2-2 in FIG. 1, illustrating the air conduit of FIG. 4A positioned within the inflatable sections of the compression sleeve;
FIG. 5A-5B are plan and cross-sectional views, respectively, of yet another embodiment of the air conduit in accordance with the present disclosure;
FIG. 5C is a cross-sectional view taken along line 2-2 in FIG. 1, illustrating the air conduit of FIG. 5A positioned within the inflatable sections of the compression sleeve;
FIG. 6A-6B are plan and cross-sectional views, respectively, of yet another embodiment of the air conduit in accordance with the present disclosure;
FIG. 6C is a cross-sectional view taken along line 2-2 in FIG. 1, illustrating the air conduit of FIG. 6A positioned within the inflatable sections of the compression sleeve;
FIG. 7A-7B are plan and cross-sectional views, respectively, of yet another embodiment of the air conduit in accordance with the present disclosure;
FIG. 7C is a cross-sectional view taken along line 2-2 in FIG. 1, illustrating the air conduit of FIG. 7A positioned within the inflatable sections of the compression sleeve;
FIG. 7D is a front elevational view of the compressive sleeve showing a linear void across the sleeve;
FIG. 8A-8B are plan and cross-sectional views, respectively, of yet another embodiment of the air conduit in accordance with the present disclosure;
FIG. 8C is a cross-sectional view taken along line 2-2 in FIG. 1, illustrating the air conduit of FIG. 8A positioned within the inflatable sections of the compression sleeve;
FIG. 9 is a plan view of the compression sleeve illustrating yet another embodiment of the air conduit in accordance with the present disclosure;
FIG. 10A-B are cross-sectional views of another embodiment of the compression sleeve illustrating various textures of an inner surface of first and second sheets in accordance with the present disclosure;
FIG. 11A is a cross-sectional view of a prior art bladder under the weight of a patient's limb without an air conduit according to one of the embodiments of this invention;
FIG. 11B is a cross-sectional view of a bladder incorporating one of the air conduit embodiments, at A, of this invention;
FIG. 12A is a graphical representation of a pressure profile of the bladder shown in FIG. 11A;
FIG. 12B is a graphical representation of a pressure profile of the bladder shown in FIG. 11B;
FIG. 13 is a plan view of a foot cuff bladder with air conduits; and
FIG. 14 is a plan view of an inflatable section with a flush mounted or formed lumen.



Corresponding reference characters indicate corresponding parts throughout the drawings.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to the drawing figures, in which like reference numerals identify identical or corresponding elements, various embodiments of the presently disclosed compression sleeve will now be described in detail. The compression sleeve of the present disclosure is similar to the compression sleeve disclosed in U.S. Pat. Nos. 5,626,556 to Tobler et al. and 5,795,312 to Dye, both of which are currently owned by Tyco Healthcare Group, LP and are incorporated by reference herein in their entirety.
With initial reference to FIG. 1, a compression sleeve in accordance with the present disclosure is illustrated and is designated generally as compression sleeve 10. Compression sleeve 10 is adapted for use in a system for applying compressive forces or pressure to a portion of a patient's limbs such as, for example, the legs. Compression sleeve 10 includes first or outer sheet 12 and second or inner sheet 14 connected by a plurality of laterally extending sealing lines 16 and longitudinally extending sealing lines 18 connecting the ends of lateral sealing lines 16. First and second sheets 12, 14 are adapted as inner gas-impervious sheets, for placement against the person's limbs. Sealing lines 16, 18 may be formed by radio frequency (RF) welding, etc. Moreover, sealing lines 16, 18 define a plurality of longitudinally disposed inflatable sections or chambers 20a, 20b, and 20c which are capable of retaining a pressurized fluid such as, for example, air, in order to exert compressive forces to the patient's limbs during successive pressure-applying cycles.
First sheet 12 may, for example, comprise a suitable flexible polymeric material such as, for example, polyvinyl chloride (PVC) on the order of 5-10 mils thick. Second sheet 14 will preferably comprise a similar polymeric material (i.e. 5-10 mil PVC) having a non-woven material, such as polyester, laminated to the inner surface that is placed against the limb, thereby increasing the comfort of the wearer. Each inflatable section 20a, 20b, and 20c may include at least one wave-shaped border 22. When inflatable sections 20a, 20b, and 20c abut one another, wave-shaped border 22 defines a plurality of un-inflatable “eyes”, as illustrated in FIG. 1.
In addition, compression sleeve 10 includes a plurality of hook and loop fasteners for attaching the sleeve about the patient's limb. Hook and loop fasteners include a set of spaced strips 24a, 24b, and 24c, such as loop material positioned on first sheet 12. Strips 24a, 24b, and 24c extend laterally at the inflatable sections 20a, 20b, and 20c, and cooperate with a set of spaced hook materials 26a, 26b, and 26c disposed on second sheet 14 for releasably fastening sleeve 10 to the leg.
When compression sleeve 10 is attached to the patient's limbs, each inflatable section 20a, 20b, and 20c is oriented in a direction that is substantially transverse to a longitudinal axis of the patient's limb. That is, compression sleeve 10 encircles the leg.
Compression sleeve 10 includes an elongated opening 28 extending through what would be the knee region 30 when the sleeve is employed to apply compressive forces or pressure to the limb, opening 28 being defined by peripheral edges 32 extending around the opening. In addition, the knee region 30 has elongated cut-outs or openings 31a and 31b being defined by peripheral side edges 33a and 33b, respectively. Compression sleeve 10 is provided with a set of lumens 34a, 34b and 34c having a connector 36 for operably connecting lumens 34a, 34b and 34c to a controller (not shown) having a source of pressurized fluid (e.g. air).
With continued reference to FIG. 1, compression sleeve 10 further includes a plurality of air conduits 38 disposed within at least one of inflatable sections 20a, 20b, or 20c. Air conduit 38 is adapted for creating a passage for facilitating the flow of the pressurized air in the at least one inflatable section 20a, 20b, or 20c when compression therapy is being administered. Each air conduit 38 facilitates the flow of the pressurized air within inflatable sections 20a, 20b, or 20c by separating first and second sheets 12 and 14 when compression sleeve 10 is in a deflated state. Although air conduit 38 is shown as a linear structure in the various figures, air conduit 38 may be shaped to follow an arc that substantially corresponds to the arc defined by inflatable sections 20a, 20b, or 20c (see FIG. 1). Air conduit 38 may be formed from extruded PVC. It is envisioned that each air conduit 38 may be constructed to fit the shape of other flexible sleeves and foot cuffs such as those available from Kendall's product catalog H-4693VT “Vascular Therapy Products.”
In use, compression sleeve 10, in accordance with the present disclosure, is configured to apply compressive forces to a patient's leg. Compression sleeve 10 is positioned about the leg of a patient, wherein hook materials 26a, 26b, and 26c are configured for engaging loop materials 24a, 24b, and 24c. After placement of compression sleeve 10 about a leg of the patient and connecting compression sleeve 10 to pressurized fluid source via connector 36, the controller (not shown) may then be actuated for supplying pressurized air to compression sleeve 10 and initiating compression therapy. Thus, the controller intermittently inflates inflatable sections 20a, 20b, and 20c sequentially during periodic compression cycles and defines a pressure gradient profile.
Air conduit 38 inhibits the formation of random pockets of air in each of the inflatable sections. When the pressurized air is introduced into each inflatable section 20a, 20b, and 20c, the passage created by the at least one air conduit 38 located between first and second sheets 12, 14, improves the inflation characteristics of each inflatable section. In devices that do not include at least one air conduit 38, as inflatable sections 20a, 20b, or 20c deflate, first and second sheets 12, 14 collapse and may form random pockets of pressurized air. These pockets randomly redirect and/or restrict the flow of the pressurized fluid through the inflatable sections 20a, 20b, or 20c, thereby obstructing the removal of the pressurized fluid.
By positioning air conduit 38 within inflatable sections 20a, 20b, or 20c, a passage is created for facilitating the flow of pressurized fluid in each of the inflatable sections 20a, 20b, or 20c. Deflation between successive inflation cycles occurs by returning the air in inflatable sections 20a, 20b, and 20c to the controller or to another vent (not shown), as is known in the art. Air conduit 38 effectively channels the pressurized air towards lumen 34a, 34b, or 34c, thus minimizing the formation of random pockets of pressurized air in each inflatable section 20a, 20b, or 20c. In addition, air conduit 38 channels the pressurized air towards lumens 34a, 34b, or 34c thereby improving the removal rate of the pressurized air and minimizing the formation of random pockets of pressurized air throughout compression sleeve 10.
With reference to FIGS. 2A-2C, one embodiment of air conduit 38 is illustrated and is designated generally as air conduit 38A. Air conduit 38A includes a plurality of ridges or ribs 40 extruding upwards from a base member 42. Base member 42 is adhesively fastened to second sheet 14 or first sheet 12 of inflatable sections 20a, 20b, or 20c, and ribs 40 are in releasable contact with the first sheet 12 or second sheet 14 of the inflatable section 20a, as illustrated in FIG. 2C. The plurality of ribs 40 includes a center rib 40a, middle ribs, 40b, and outer ribs 40c that will be discussed in detail hereinbelow.
With particular reference to FIG. 2B, the height of ribs 40 is at a minimum at the outer edges of base member 42 and progressively increases towards the center of the base member 42 such that center rib 40a has the greatest height of ribs 40. Base member has a thickness from about 19 mils to about 39 mils. In one embodiment, center rib has a height from about 65 mils to about 85 mils, middle ribs 40b have a height from about 43 mils to about 63 mils, and outer ribs have a height from about 29 mils to about 49 mils. Further still, center rib has a width from about 50 mils to about 70 mils, while middle and outer ribs 40b and 40c have a width of about 40 mils to about 60 mils. Therefore, air conduit 38 has a low profile and, in combination with first and second sheets 12, 14, defines a low profile compression sleeve 10. Moreover, adjacent middle and outer ribs 40b and 40c, respectively, are spaced apart defining troughs 44 therebetween. Troughs 44 fluidly couple the opposing ends of air conduit 38A and are configured for channeling the pressurized air within inflatable sections 20a, 20b, or 20c towards lumens 34a, 34b, or 34c. In use, when the pressurized air is introduced into inflatable sections 20a, 20b, and 20c, the passage created by ribs 40 in air conduit 38A improves the inflation characteristics of inflatable sections 20a, 20b, or 20c. During deflation, troughs 44 channel the pressurized air towards lumens 34a, 34b, or 34c, effectively improving the removal of the pressurized air and minimizing the formation of random pockets of pressurized air.
With reference to FIGS. 3A, 3B and 3C, a second embodiment of air conduit 38, in accordance with the present disclosure, is illustrated and is designated generally as air conduit 38B. As best illustrated in FIG. 3B, air conduit 38B includes a plurality of randomly placed pins or knobs 46 extending upward from a base member 48. Base member 48 is fastened to second sheet 14 or first sheet 12 of inflatable sections 20a 20b, or 20c and pins 46 are in releasable contact with first sheet 12 or second sheet 14 of at least one of inflatable sections 20a, 20b, or 20c, as illustrated in FIG. 3C. Thus, air conduit 38B effectively separates first and second sheets 12 and 14 when compression sleeve 10 is in a deflated state. The passage created by the plurality of pins 46 improves the inflation characteristics of inflatable sections 20a, 20b, or 20c. During deflation, pins 46 channel the pressurized air towards lumens 34a, 34b, or 34c, effectively improving the removal of the pressurized air and minimizing the formation of random pockets of pressurized air.
With reference to FIG. 4A-4C, another embodiment of air conduit 38 is illustrated and is designated generally as air conduit 38C. Air conduit 38C includes at least one inflatable elongated sheath 49 positioned within at least one of inflatable sections 20a, 20b, or 20c. The at least one elongated sheath 49 is adhesively fastened to second sheet 14 or first sheet 12 and is in releasable contact with first sheet 12 or second sheet 14, as illustrated by FIG. 4C. In an alternative embodiment, the sheath may be RF welded to an inside surface of second sheet 14 or first sheet 12. In this particular embodiment, air conduit 38C forms a circumferential bubble passageway, as illustrated in FIG. 4C. The at least one elongated sheath 49 may be formed from a foam material wherein the foam material does not collapse under the load of the leg, thus maintaining a separation between first and second sheets 12 and 14. In use, when the pressurized air is introduced into inflatable sections 20a, 20b, and 20c, the circumferential bubble passageway formed by air conduit 38C improves the inflation characteristics of inflatable sections 20a, 20b, or 20c. During deflation, the at least one elongated sheath 49 channels the pressurized air towards lumens 34a, 34b, or 34c, effectively improving the removal of the pressurized air and minimizing the formation of random pockets of pressurized air. In addition, elongated sheath 49 may also be positioned on the outer surface of first and second sheets 12 and 14 for providing a rigid support structure of the sleeve for receiving the leg. Alternatively, a separate leg support may be provided to keep the limb raised off the bed surface.
With reference to FIGS. 5A, 5B and 5C, yet another embodiment of air conduit 38 is illustrated and is designated generally as air conduit 38D. Air conduit 38D is similar to air conduit 38A and will only be discussed in detail to the extent necessary to identify differences in construction and operation. Air conduit 38D includes a semi-rigid “I” beam having a web 50 and two flange portions 52 disposed on either end of web 50. Air conduit 38D is positioned within at least one of inflatable sections 20a, 20b, or 20c in a manner illustrated in FIG. 5C for separating first and second sheets 12 and 14, thus preventing sleeve 10 from collapsing under the weight of the patient's leg. In addition, a plurality of openings 54 is disposed on web 50 for facilitating communication throughout inflatable sections 20a, 20b, or 20c. In use, when the pressurized air is introduced into inflatable sections 20a, 20b, or 20c, the plurality of openings 54 disposed on web 50 improves the inflation characteristics of inflatable sections 20a, 20b, or 20c. During deflation, the semi-rigid “I” beam of air conduit 38D channels the pressurized air towards lumens 34a, 34b, or 34c, effectively improving the removal of the pressurized air and minimizing the formation of random pockets of pressurized air.
With reference to FIG. 6A-6C, yet another embodiment of air conduit 38 is illustrated and is designated generally as air conduit 38E. Air conduit 38E is similar to air conduit 38A and will only be discussed in detail to the extent necessary to identify differences in construction and operation. Air conduit 38E includes a plurality of longitudinal corrugated extrusions 56 attached to base 58. Corrugated extrusions 56 form a passageway for air to pass therethrough. It is envisioned that corrugated extrusions 56 will permit air to infiltrate into inflatable sections 20a, 20b, or 20c. In use, when the pressurized air is introduced into inflatable sections 20a, 20b and 20c, the corrugated extrusions 56 improves the inflation characteristics of inflatable sections 20a, 20b, or 20c. During deflation, the corrugated extrusions channel the pressurized air towards lumens 34a, 34b, or 34c, effectively improving the removal of the pressurized air and minimizing the formation of random pockets of pressurized air.
With reference to FIG. 7A-7C, yet another embodiment of air conduit 38 is illustrated and is designated generally as air conduit 38F. Air conduit 38F is similar to air conduit 38A and will only be discussed in detail to the extent necessary to identify differences in construction and operation. Air conduit 38F includes a base portion 60 having a central longitudinal channel 62, as illustrated in FIG. 7B. In this particular embodiment, air conduit 38F is installed within inflatable sections 20a, 20b, or 20c such that channel 62 forms a passageway therethrough. Base portion 60 and channel 62 may be inflatable or, alternatively, may be RF welded onto first and second sheets 12, 14. They may also be reinforced with an additional layer of PVC sheet to form a more rigid conduit. In use, when the pressurized air is introduced into inflatable sections 20a, 20b, and 20c, central longitudinal channel 62 improves the inflation characteristics of inflatable sections 20a, 20b, or 20c. During deflation, longitudinal channel 62 directs the pressurized air towards lumens 34a, 34b, or 34c, effectively improving the removal of the pressurized air and minimizing the formation of random pockets of pressurized air.
Alternatively, first and second sheets 12, 14 may be RF welded, having a pre-fabricated feature, wherein a linear void 64 across the sleeve is formed, as illustrated in FIG. 7D. In this particular embodiment, linear void 64 directs the pressurized air towards lumen 34a, 34b, and 34c for improving the removal of the pressurized air and minimizing the formation of random pockets of pressurized air.
With reference to FIGS. 8A, 8B and 8C, yet another embodiment of air conduit 38 is illustrated and is designated generally as air conduit 38G. Air conduit 38G is similar to air conduit 38C (FIGS. 4A, 4B and 4C) and will only be discussed in detail to the extent necessary to identify differences in construction and operation. Air conduit 38G includes at least one elongated sheath 49A having an axial aperture 66 (FIG. 8B) and a plurality of transverse openings 68 (FIG. 8A). Axial aperture 66 and transverse openings 68 permit air to disperse across the full length of compression sleeve 10. The at least one elongated sheath 49A may be positioned within inflatable sections 20a, 20b, or 20c, adhesively fastened to second sheet 14 or the first sheet 12 and in releasable contact with first sheet 12 or second sheet 14, as illustrated in FIG. 8C. In use, when the pressurized air is introduced into inflatable sections 20a, 20b, and 20c, axial aperture 66 and transverse openings 68 of the at least one elongated sheath 49A improves the inflation characteristics of inflatable sections 20a, 20b, or 20c. During deflation, axial aperture 66 channels the pressurized air towards lumens 34a, 34b, or 34c, effectively improving the removal of the pressurized air and minimizing the formation of random pockets of pressurized air.
Other methods of facilitating the flow of pressurized air within inflatable sections 20a, 20b, and 20c are envisioned. For example, compression sleeve 10 may be manufactured to include a channel 70 for sliding a support member 72 therethrough, as illustrated in FIG. 9, for providing a rigid support structure to compression sleeve 10. Thus, support member 72 will rigidly support the weight of the leg. Alternatively, sealing lines 16 (FIG. 1) may be strategically placed along first and second sheets 12, 14 for facilitating the passage of air. Moreover, inflatable sections 20a, 20b, and 20c may be filled with styrene foam pellets for adding structural rigidity and still permitting the flow of pressurized air throughout inflatable sections 20a, 20b, and 20c. In addition, a plurality of connectors 36 may be strategically installed throughout the compression sleeve for supplying inflatable sections 20a, 20b, and 20c with pressurized air from a plurality of points. Likewise, the plurality of connectors 36 can be actuated to deflate a chamber to minimize air pockets. Moreover, the strength of the sleeve material may be increased in order to allow for increased burst strength, permitting more pressure and volume to raise the large limb. For example, first and second sheets 12, 14 may be formed from a rigid material to prevent inflatable sections 20a, 20b, and 20c from collapsing under the weight of a large limb. Moreover, during manufacture of compression sleeve 10, a plurality of passageways may be embossed along the surface of first and second sheets 12, 14.
With reference to FIGS. 10A and 10B, first and second sheets 12, 14 may include a design or feature wherein the texture of the sleeve improves the flow of air. For example, particular textures may be provided on an inside surface of first and second sheets 12, 14, as shown in FIGS. 10A and 10B, such that they never collapse fully, thus facilitating the passage of the pressurized air. The texture may be laminated or may form part of first and second sheets 12 and 14. In use, when the pressurized air is introduced into inflatable sections 20a, 20b, and 20c, the texture on the inside surface of first and second sheets 12 and 14 improves the inflation characteristics of inflatable sections 20a, 20b, and 20c. During deflation, the textures on the inside surface of first and second sheets 12 and 14 assist in channeling the pressurized air towards lumens 34a, 34b, and 34c, effectively improving the removal of the pressurized air and minimizing the formation of random pockets of pressurized air. One skilled in the art will recognize other fluids besides air can be used without departing from the scope of the invention.
With reference to FIGS. 11A and 11B, a patient's limb 76 can, unfortunately, weight as much as 50 lbs. The leg is typically heavy and broad for those patients with medical conditions related to obesity. An obese leg resting on a leg sleeve bladder is generally shown at FIG. 11A, without the air conduit of the present invention. This prior art configuration 74, shows the sleeve laying flat, as opposed to being circumferentially wrapped about the limb. Opposing tabs (not shown) are positioned along the longitudinal edge, that when the sleeve is wrapped around the limb, the opposing tabs are connected by various means—snaps, belt and buckle, or loop and hook material.
One can see that the therapy pressure 78A, 78B is not evenly distributed around the limb, because the weight “W”, of a patient's limb, causes sheets 12, 14 of the bladder to become compressed, constricting or cutting off air flow. As a result of this restriction, the pressure on the port side of the bladder 78A is much higher than its opposite side 78B. This reduces, if not eliminates, therapy, to one side of the limb. Blood will tend to pool in the lower pressure side of the limb. The impact of these devices is to help move blood toward the heart in an effort, among other things, to help remove fluid build up in the limbs.
The therapy provided is in the form of repeated inflation and deflation of the bladder, generally called a compression cycle. A compression cycle is shown at FIG. 12A, for the prior art device with a heavy limb. The pressure measurement rises to above 50 mmHg The pressure in a bladder is not fully decayed or removed until sometime after 10 sec. By contrast, FIG. 12B (illustrating the present invention), shows a more rapid inflation and, a more fully decayed bladder in about 6 sec. This allows for a more complete compression cycle, because of a more fully evacuated bladder in a cycle. Also, more therapy cycles are provided for each minute of treatment, in addition to a more complete evacuation of air within the chambers of a bladder. The more complete the cycle of inflation and deflation and a more even distribution of pressure around the limb during a cycle, the more evenly the blood and fluids therein are moved toward the heart. By analogy, the squeezing a tube of toothpaste unevenly along its length, results in pockets of paste. The user then must apply a fairly even force to move the trapped paste toward the opening, by pressing two fingers together along the length of the tube. Other techniques are possible, but the uneven trapping of the paste is analogous to uneven trapped air in the bladder. The folds created by the limb weight, prevent air from being evenly distributed and then evenly evacuated during deflation. This unevenness results in less treatment for larger patients. As with the toothpaste analogy, material, in this case air, is left behind, interfering with the treatment. Large amounts of trapped air must be moved by next inflation cycle resulting in lost energy to move blood.
FIG. 11B shows an even distribution of air pressure 78A′ and 78B′ around the limb when the air conduits depicted in FIGS. 2-8 and 10, are used at “A” in FIG. 11A. The air conduit maintains separation of the sheets 12, 14 during a cycle, so pressurized air can flow around the limb. A more even distribution of circumferential pressure around the limb causes more blood to be pushed from the blood vessels nearer the surface of the skin, toward the main vessels within the limb; toward the heart. The more even the pressure about the limb, the more effective the treatment. FIG. 13 shows a plan view of an air conduit within the boundary of a foot cuff bladder 86.
The foot cuff bladder 86 has a pair of air conduits 90, 92 disposed within a boundary 94 formed at a perimeter of the bladder 100 (FIG. 14). A flush-mounted port 88 provides pressurized air to the bladder 100 (sometimes called an inflatable section). The conduits 90, 92 also help channel the air throughout the bladder 100, and likewise, assist in air evacuating from the bladder 100 during the deflation cycle. The conduit 90, 92 is placed substantially along a dimension of the sheet that forms the inflatable bladder. The conduit 90, 92 is secured to the first or second sheet. The conduit is completely within the boundary of inflatable section and does not extend through the boundary or the surface of the sheet. A foot cuff 86 is similar to a sleeve, except, a foot cuff typically has a one chamber bladder, whereas, a sleeve has one or more bladders along its longitudinal length, and the bladder may have more than one chamber. A chamber is formed using a welding die that clamps together with a pair of sheets therebetween and, with RF energy, causes the first and second sheets of the bladder to melt together to form the air-tight boundary. Within one or more of the chambers may be disposed one or more air conduits, within the boundary of a chamber.
FIG. 14 illustrates a single-chamber bladder 100, with a lumen 80 mounted flush 88 with the first sheet or second sheet 12, 14. The lumen 80, at a first end 98, is mounted flush with an outside surface of the sheet 12, 14. As shown at FIG. 14, the lumen 80 does not extend beyond the surface into the inflatable area 100 formed by the sheets 12, 14. A flange 102, formed as part of the first sheet, provides fluid communication to a pressure source 104 to a first end 98 of the lumen. The pressurized fluid source 104 is capable of inflating and deflating the bladder. This non-limiting embodiment shows one way to flush mount the lumen securely without the lumen extending into the inflatable section.
It will be understood that numerous modifications and changes in form and detail may be made to the embodiments of the present disclosure. For example, it is contemplated that numerous other configurations of the conduit may be used, and the material of the sleeve and/or conduit may be selected from numerous materials, other than those specifically disclosed. Therefore, the above description should not be construed as limiting, but merely as exemplifications of the various embodiments.

## Claims

1. A compression sleeve, comprising:
a first sheet;
a second sheet attached to said first sheet, the first and second sheets defining at least one inflatable section;
at least one conduit within the inflatable section and extending along at least one dimension of the inflatable section; and
a lumen partially disposed between the first and second sheets and adapted for connect to a source of pressurized fluid;
the at least one conduit comprising a textured inner surface on at least one of the first and second sheets, the textured inner surface being shaped and arranged to form channels across the first and second sheets for channeling the pressurized fluid to and from the lumen.

2. A compression sleeve as recited in claim 1 wherein the textured inner surface is configured such that the first and second sheets never fully collapse.

3. A compression sleeve as recited in claim 2 wherein the textured inner surface is laminated on the first and second sheets.

4. A compression sleeve as recited in claim 1 wherein the at least one conduit comprises textured inner surfaces on both of the first and second sheets, the textured inner surfaces being engageable upon collapse of the first and second sheets toward each other to form the channels.

5. A compression sleeve as recited in claim 4 wherein the textured inner surfaces are laminated on the first and second sheets.

6. The compression sleeve as recited in claim 1 wherein the sleeve comprises a plurality of fasteners comprising hook and loop fastener components adapted for securing the sleeve about a portion of a patient's body.

7. A method for making a compression bladder comprising the steps of:
providing at least one sheet of air impermeable material having a textured inner surface shaped and arranged for forming channels across the one sheet for channeling air within the bladder;
sealing the one sheet to form an inflatable chamber so that the textured inner surface faces an opposing surface, the textured inner surface preventing collapse of the opposing surface and maintain the channels for flow of air;
forming a port in the inflatable chamber, the channels of the textured inner surface being arranged to pass air to the channels to the port when the opposing surface engages the textured inner surface.

8. A method as recited in claim 7 further comprising providing a second sheet of air impermeable material.

9. A method as recited in claim 8 wherein sealing the one sheet includes joining the one sheet to the second sheet, the second sheet including the opposing surface.

10. A method as recited in claim 9 wherein providing a second sheet comprises providing the second sheet with a textured inner surface shaped and arranged for engaging the textured inner surface of the one sheet and forming the channels.

11. A method as recited in claim 10 wherein providing the one sheet and providing the second sheet each include laminating a textured surface onto an inner surface of the one and second sheets.

12. A method as recited in claim 8 wherein forming a port in the inflatable chamber comprises inserting a lumen between the first and second sheets.