The subject disclosure relates to medical treatment garments, and more particularly to medical treatment garments worn by patients to treat symptoms of postural orthostatic tachycardia syndrome or other orthostatic hypotension, as well as other medical uses for hyperbaric or hyperoxic treatments.
Various medical garments have been utilized to treat patients. Often, patients will wear elastic mechanical counter pressure garments on the lower limbs and/or lower torso. This can include a garment designed to apply pressure to the lower torso and/or legs and/or arms of a user. In some cases, the pressure garment may cover more than just the lower body of the user, additionally covering the upper torso and arms collectively or individually. The pressure garment serves to mitigate blood pooling in the lower extremities, and thus reduce risk of presyncope (muscular weakness, feeling faint or lightheaded,) or syncope (fainting).
Additionally, hyperbaric chambers and hyperoxic chambers have been used to treat a wide variety of ailments such as wounds and inflammation, to improve physical performance, and to speed recovery.
While an elastic mechanical counterpressure lower body garment generally serves their desired purposes, this setup is imperfect for a number of reasons. First, the suit being multiple separate garments can create an ongoing source of discomfort because of the bulk, independent movement of the various garments, difficulty to don the garments, and the fact that the garments are always applying pressure, i.e., they cannot be activated or deactivated once donned. It can also be difficult to disperse heat through the bulk of the layers, particularly since the suit can inhibit evaporation of a user's natural perspiration. Solutions to this problem and others are limited, given that the user's perspiration must escape through separate garments. Therefore there is a need for a more comfortable, functional and easier to use garment. Additionally, hyperbaric chambers are prohibitively large, expensive, and overly engineered as compared to a lightweight garment that could provide an oxygen-rich environment, a hyperbaric environment, or both to improve and facilitate wound healing or treat other ailments. Therefore, there is a need for an improved hyperbaric medical garment.
In light of the needs described above, in at least one aspect, the subject technology relates to a medical garment which combines multiple layers securely in a single garment.
In at least one aspect, the subject technology relates to a garment configured to be worn by a user. A bladder layer is configured to retain a first pressurized fluid and apply pressure to the user, the bladder layer being a semi-permeable layer which is impermeable to both oxygen and nitrogen and permeable to water vapor. A first fluid tube is formed as part of the bladder layer and configured to deliver the first pressurized fluid to an interior of the bladder layer. A cover layer is formed from a lightweight, low-elongation fabric, the cover layer surrounding an exterior of the bladder layer, the cover layer sealed around the first fluid tube and allowing the first fluid tube to pass therethrough. Two thigh seals are configured to seal the bladder layer to the user such that the bladder layer forms a lower volume and an upper volume. The first fluid tube is configured to deliver the first pressurized fluid to the lower volume.
In some embodiments, the garment includes a second fluid tube formed as part of the bladder layer and configured to deliver a second pressurized fluid to the interior of the bladder layer at the upper volume. The cover layer is then sealed around the second fluid tube, allowing the second fluid tube to pass therethrough. In some cases, the upper volume is configured to be pressurized up to 50 mmHg and the lower volume is configured to be pressurized up to 100 mmHg. The bladder layer can be formed from a plurality of separate sections stitched together with nylon or polyester thread. The seams of the thread can be sealed with tape within the interior of the bladder layer.
In some embodiments, the bladder layer includes a boot region defined by an air and water-impermeable fabric in the shape of boots. The air and water impermeable fabric can be urethane-coated nylon which is ultrasonically sealed to the bladder layer. In some cases, the thigh seals are a laminated sponge fabric, the thigh seals cemented, or stitched and sealed, to the bladder layer around an outer perimeter or circumference of each seal. In some cases, the lightweight, low-elongation fabric of the cover layer is nylon or dacron. The cover layer can be formed from a plurality of separate sections stitched together with nylon or polyester thread.
In some embodiments, the cover layer includes a lower region proximate the lower volume and an upper region proximate the upper volume. In the upper region, the cover layer can include at least one attachment provision configured to allow an external component to be attached to an exterior of the cover layer. In some embodiments, the cover layer includes resizing areas. A first resizing area is located below the thigh seals, the first resizing area allowing the cover layer to be tightened above a knee region of the garment. A second resizing area is located below the first resizing area, the second resizing area allowing the cover layer to be tightened below the knee region.
In some embodiments, a liquid cooling layer is positioned on the interior of the bladder layer. A pass-through device then defines a first channel and a second channel through the cover layer and bladder layer. The pass-through device includes a first hose barb coupled to the first channel and a second hose barb coupled to the second channel, the hose barbs protruding from an exterior of the cover layer. The first channel is configured to receive a pressurized fluid and direct the pressurized fluid to the bladder layer, and the second channel is configured to receive a cooling fluid and direct the cooling fluid to the liquid cooling layer.
In some embodiments, the garment includes a urine evacuation pass-through providing a channel from the interior of the bladder layer proximate a groin region of the garment, through the bladder layer and cover layer, to an exterior of the garment. In some embodiments, the garment includes a urine evacuation device, the urine evacuation device including a tube and a waste container. The tube is configured to deliver urine from a groin region of the garment, through a urine evacuation pass through of the bladder layer, and to the waste container.
In some embodiments, the cover layer includes a plurality of adjustable seals configured to seal the bladder layer to the user. The adjustable seals include a neck seal and two wrist seals. In some embodiments, the garment has a neck region and a foot region. In some cases, the bladder layer and the cover layer extend an entire length of the garment between the foot region and the neck region. In other cases, the cover layer extends an entire length of the garment between the foot region and the neck region and the bladder layer terminates proximate a waist region of the garment. In other cases, the cover layer and the bladder layer terminate proximate a waist region of the garment.
In some embodiments, the cover layer includes a main entry closure operative to selectively open or seal the cover layer. The cover layer can be configured to enclose a removable urine collection device connected to the interior of the bladder layer in a groin region of the garment via a pass-through opening, the removable urine collection device being accessible through the main entry closure.
In some embodiments, the thigh seals are eliminated and the inner bladder layer forms one contiguous volume from the neck, to the wrists, to the feet.
So that those having ordinary skill in the art to which the disclosed system pertains will more readily understand how to make and use the same, reference may be had to the following drawings.
The subject technology overcomes many of the prior art problems associated with orthostatic intolerance garments. In brief summary, the subject technology provides a single garment which is safe, comfortable, and provides unique features not available (or possible) in prior garments. The advantages, and other features of the systems and methods disclosed herein will become more readily apparent to those having ordinary skill in the art from the following detailed description of certain preferred embodiments taken in conjunction with the drawings which set forth representative embodiments of the present invention. Like reference numerals are used herein to denote like parts. Further, words denoting orientation such as “upper”, “lower”, “distal”, and “proximate” are merely used to help describe the location of components with respect to one another. For example, an “upper” surface of a part is merely meant to describe a surface that is separate from the “lower” surface of that same part. No words denoting orientation are used to describe an absolute orientation (i.e. where an “upper” part must always at a higher elevation).
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The garment 100 includes the bladder layer 102 which is designed to retain a pressurized fluid, such as air, to apply a force against the user 106. Thigh seals 108 are integrated within the interior of the bladder layer 102 in a thigh region of the suit to seal the bladder layer 102 to the thighs of the user 106. The thigh seals 108 separate the bladder layer 102 into a lower portion 110 around the lower thighs and legs of a user 106, and an upper portion 112 which extends around the upper thighs and torso of the user 106. By sealing to the user 106, the thigh seals 108 create two distinct volumes, allowing the upper portion 112 to be pressurized to a different pressure than the lower portion 110. The thigh seals 108 can be a laminated sponge fabric, cemented or, alternatively, stitched and sealed, to the bladder layer 102 around the outer perimeter or circumference of each thigh seal 108 to provide the desired seal against the user's thighs. In general, the lower portion 110 can be pressurized up to 100 mmHg to provide a lower body hyperbaric environment. A lower pressure tube 114 is sealed to the bladder layer 102 to provide a channel for pressurized fluid to enter the interior of the bladder layer 102 from an external source (not shown distinctly). In general, the external source can be a pump system or the like configured to pressurize air for delivery to the bladder layer 102.
In the first embodiment of the garment 102a, where the upper portion 112 of the bladder 102a is full length and covers the torso of a user 106, the upper portion 112 can be pressurized up to 50 mmHg. A pressurized upper portion 112 can provide air cooling and torso counter pressure for a user 106, or it may provide an identical pressure as the lower volume, thus creating a full-body hyperbaric environment. Further, the garment 102 may include a urine evacuation device 116, as discussed in more detail below, and the pressurized upper portion 112 can then assist in urine evacuation. An upper pressure tube 118 is sealed to the bladder layer 102 in the upper portion 112 to provide a channel for the pressurized fluid to enter the interior of the bladder layer 102 in the upper portion 112. The upper tube 118 can connect to an external source, separate from the source connected to the lower pressure tube 114, to facilitate delivering lower pressure air to the upper portion 114. Notably, for environments where the pressurized upper portion 112 is unnecessary, the embodiment of the garment 100b shown in
The bladder layer 102 is formed from a lightweight, selectively permeable material which allows water vapor to pass through for the evaporation of perspiration from a user 106. The bladder layer 102 is impermeable to the pressurized fluid (which can be air including oxygen, nitrogen, etc., for example) to maintain the desired pressure within the lower and upper portions 110, 112 of the bladder layer 102. The fabric of the bladder layer 102 can be stitched together with nylon thread and the seams of the fabric can be taped internally to ensure there are no gaps in the sealed bladder layer 102. Boots 120 are integrally formed as part of the bladder layer 102 at a foot region (i.e. designed to conform to a user's foot). The boots 120 are both air and water tight to provide immersion protection. The boots 120 can be fabricated from a urethane-coated nylon fabric, ultrasonically sealed at the seams connecting the boots 120 to the bladder layer 102.
In the embodiment with the full length bladder layer 102a, the bladder layer 102a can also include seals 122, 124 for sealing to the extremities of the user 106. Wrist seals 122 provide a seal in the region of the garment 100a proximate the wrists of the user 106, allowing the user's hands to extend from the bladder layer 102a. The bladder layer 102a can also include a neck seal 124 to seal the bladder layer 102a to the user's upper torso and/or neck, allowing the user's head to extend from the top of the bladder layer 102a. A zipper 125 is positioned on the rear of the bladder layer 102a, the zipper 125 allowing the user to initially open and step into the bladder layer 102a when donning the garment 100a.
The garment 100 includes the urine evacuation device 116 which can be comprised of several different components that allow for a user to urinate directly into the urine evacuation device 116. First, an anatomy interface device is included (not shown distinctly herein) to couple to the user's anatomy to receive the urine. Such devices are known and used currently in fields outside of aviation, and can be particularly designed to interface with a male or female user. The bladder layer 140 then includes a pass-through opening 148 which seals around a tube 150 (see
In all embodiments, the garment 100 includes a cover layer 104 outside the bladder layer 102 which fits over the legs, and feet of the user 106. In some embodiments, the cover layer fits over the arms and torso as well. The cover layer 104 includes additional features, as will be discussed in more detail herein. The cover layer 104 is positioned over the bladder layer 102 to support the functionality of the bladder layer 102 and create a less bulky garment 100.
In general, the cover layer 104 serves some operational, comfort, and aesthetic purposes. To that end, the cover layer 104 includes provisions 126 for attaching external components in an upper half 138 of the garment 100 . . . . The attachment provisions 126 can be used for attaching pockets for storage, or for the attachment of a patch 130, insignia, name tags, or other aesthetic components. In the example shown, the provisions 126 include a number of Velcro strips integrated as part of the cover layer 104, to allow for Velcro components to be quickly and easily removed attached to the cover layer 104. The provisions 126 can also include an area of the suit that is designed to be punctured, allowing patches 130 or the like to be permanently sewn to the cover layer 104. It should be understood that the attachment provisions 126 shown are exemplary only, and other provisions 126 may be included depending on the intended use of the garment 100 and preferences of the user 106.
Upper and lower resizing areas 132, 134 are included above and below the user's knees, respectively. The resizing areas 132, 134 include a laced region (covered by standard cover layer 104 material) which can be tightened to shorten the leg length of the garment 100, if desired, for a better fit. The lower ankle region of the cover layer 104 also includes slide fasteners 136, running axially on inner side of the user's leg. When donning or removing the garment 100, the slide fasteners 136 can be opened to allow for an expansion in the leg region of the cover layer 104, making it easier to put on or take off the garment 100. Once the garment 100 is equipped by the user, the slide fasteners 136 can be closed. Similarly, a front zipper 146 extends from groin region to the neck region of the cover layer 104, allowing for the garment 100 to be easily put on or taken off, and securely closed thereafter.
The cover layer 104 includes lower and upper sleeves 142, 144 conforming around the lower and upper pressure tubes 114, 118, respectively, allowing the tubes 114, 118 to pass through the cover layer 104. The cover layer 104 can be formed from a lightweight, low-elongation fabric such as dacron or nylon and stitched together with nylon or polyester thread. This material in the lower half 140 also works together with the bladder layer 102 to help restrain the bladder layer 102 and bear the pressure loads felt in the lower half 140 (e.g. 100 mmHg in some cases) when the bladder layer 102 is pressurized. Thus, the bladder layer 102 relies on the cover layer 104 to help retain the pressure on the user.
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Overall, the garment 100 disclosed herein is a suit which performs all of the functions of multiple, separate garments that are typically worn together and on top of each other. Additionally, the garment 100 is functionally improved and provides features which are not present in traditional garments as disclosed herein, such as urine evacuation and air cooling. The garment 100 is able to adequately provide orthostatic intolerance treatment while eliminating some of the drawbacks of previous solutions. The garment 100 also provides breathability through internal fluid flow, and even can provide liquid and/or air cooling as desired.
All orientations and arrangements of the components shown herein are used by way of example only. Further, it will be appreciated by those of ordinary skill in the pertinent art that the functions of several elements may, in alternative embodiments, be carried out by fewer elements or a single element. Similarly, in some embodiments, any functional element may perform fewer, or different, operations than those described with respect to the illustrated embodiment. Also, functional elements shown as distinct for purposes of illustration may be incorporated within other functional elements in a particular implementation.
While the subject technology has been described with respect to preferred embodiments, those skilled in the art will readily appreciate that various changes and/or modifications can be made to the subject technology without departing from the spirit or scope of the subject technology. For example, each claim may depend from any or all claims in a multiple dependent manner even though such has not been originally claimed.
This application is a continuation-in-in part of U.S. application Ser. No. 18/385,738, filed Oct. 31, 2023, which is a continuation of U.S. application Ser. No. 17/155,341, filed Jan. 22, 2021, now U.S. Pat. No. 11,834,182, the contents of which are incorporated herein in their entirety by reference.
Number | Date | Country | |
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Parent | 17155341 | Jan 2021 | US |
Child | 18385738 | US |
Number | Date | Country | |
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Parent | 18385738 | Oct 2023 | US |
Child | 18677275 | US |