The autonomic nervous system controls blood pressure, heart rate, digestion, and breathing and is thus vitally important to one's health. Postural orthostatic tachycardia syndrome (POTS), orthostatic hypotension (OH) and neurogenic orthostatic hypotension (NOH) are types of dysautonomia that affect the body's nervous system. Patients with these conditions may experience fainting, dizziness, blurred vision, nausea, mental fogginess, and tingling, due to a lack of blood flow to the brain and upper body when standing or sitting up. The blood vessels in the lower body of affected patients do not properly constrict, which results in a drop in blood pressure and a lack of blood flow to the brain and upper body. As the heart fails to fight against gravity and force blood to the brain, blood pools in the abdominal blood vessels until the patient lies down again. Many patients with POTS, OH or NOH are unable to stand up and walk for a length of time which prohibits many POTS, OH or NOH patients from living normal lives. In serious cases, POTS or NOH may lead to hospice care and death.
POTS is a disorder in which a reduced volume of blood is pumped back into the heart after sitting up or standing up from a lying position. This lack of blood flow can cause lightheadedness or fainting and an increase in heart rate of over 30 bpm. POTS may be treated by some existing drugs, but these only alleviate POTS symptoms and are not always effective. POTS is a common condition affecting an estimated one to three million Americans. POTS is more common in women than men and is more likely to develop in adolescents and young adults. Many cases, approximately 70% to 80%, are diagnosed in women between the ages of 15 and 50.
OH is a common cause of syncope and is highly prevalent in patients with heart failure. OH is diagnosed in 5% to 11% of middle-aged adults and in approximately 20% to 30% of people age 65 years and older. Many of the medications used to treat heart failure decrease blood pressure and blunt the body's compensatory response to a drop in blood pressure contributing to OH making OH in heart failure patients a particularly challenging problem.
The present disclosure provides systems and devices for providing compression pressure to a subject's abdomen to treat and relieve symptoms associated with POTS, OH, NOH or other similar conditions. Advantageously, the disclosed systems and devices provide a general, precise, focused, or select pressure to the abdomen to stimulate the autonomic nervous system, reduce decreases in blood pressure and venous pooling, maintain blood pressure while standing, walking, or sitting, and/or reduce increases in heart rate within a first minute of standing up from a supine position, thus allowing affected subjects to improve their health or mobility. The disclosed systems and devices are easy to use and allow a subject to select the amount of pressure provided.
A compression device as described herein is a wearable device including at least one support; a pressure applicator connected to the at least one support, the pressure applicator configured to apply compressive pressure to a treatment zone on an abdomen of a wearer; and a regulator for controlling the amount of compressive pressure applied to the wearer by the pressure applicator, the regulator for controlling an amount of the compressive pressure from a minimum pressure to a maximum pressure as selected by the wearer.
This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.
The figures depict various embodiments for purposes of illustration only. One skilled in the art will readily recognize from the following discussion that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles described herein.
The present disclosure provides systems and devices for providing compression pressure to a subject's abdomen to treat and relieve symptoms associated with POTS, OH, NOH or other similar conditions. POTS, OH and NOH may be treated by wearable medical devices, such as compression garments, that provide abdominal compression. However, available wearable medical devices provide constant abdominal compression when worn by the patient and consequently, do not allow patients to modulate the amount of abdominal pressure or selectively engage and disengage the abdominal pressure while wearing the garment.
Advantageously, the disclosed systems and devices provide a precise, focused, or select pressure to the abdomen to stimulate the autonomic nervous system, reduce decreases in blood pressure and venous pooling, maintain blood pressure while standing, walking, or sitting, and/or reduce increases in heart rate within a first minute of standing up from a supine position, thus allowing affected subjects to improve their health or mobility. The disclosed systems and devices are easy to use and allow a wearer to select an amount of pressure as desired to accommodate their symptoms and/or lifestyle, for example.
As described herein, compression devices for treating orthostatic syncope include a waist garment such as a belt, strap or support that is configured to be attached around a subject's abdominal region and a pressure component for generating and maintaining directed abdominal pressure to the subject's abdomen. Specifically, the pressure component applies a selected and/or prescribed therapeutic pressure to a portion of the abdomen.
The present inventors have shown that when the belt, strap or support is secured or tightened around the abdomen, the compression device can maintain a therapeutic pressure of, for example, 40 mmHg in some implementations and a therapeutic pressure of 95 to 150 mmHg in other implementations. This pressure improves blood flow to the upper half of the body, especially to the brain and reduces symptoms associated with POTS, OH and NOH such as lightheadedness and fainting following standing or sitting up from a lying down position. Improved blood flow to the brain may alleviate major hypotension symptoms for POTS, OH and NOH patients. The wearer may decrease the amount of pressure applied by loosening the belt, strap or support and/or deactivating the pressure component.
Certain implementations of the presently described approaches have several advantages over conventional abdominal binders because the certain implementations of the described compression devices are able to sustain abdominal compression pressure, are easy to assemble, are easy to take on and off, are easy to clean, are anti-bacterial or washable, are concealable or discreet under clothing, and can be adjusted to accommodate wide variety of body habitus. Certain implementations of the described devices fill an unmet market need by allowing patients to engage or disengage the pressure mechanism at will, allowing greater quality of treatment without additional cost.
As illustrated in
Waist strap 32 connects to pressure applicator 40 on lateral ends of baseplate 42 and extends circumferentially around abdomen 12 of subject 10. Waist strap 32 may vary in width and thickness and may be adjustable to accommodate various sized wearers. In the embodiment shown in
Baseplate 42 includes an opening 50 extending from a front side 36 of baseplate 42 to a back side 38 of baseplate 42. A threaded portion 43 of dial 44 extends into opening 50 toward back side 38 while a face 45 of dial 44 remains adjacent front surface 36 during operation of compression device 30. Opening 50 includes a threaded portion 52. Threaded portion 43 and threaded portion 52 have complementary threads for coupling together.
During operation, dial 44 is turned to move a head 47 of piston 46 away from back side 38 of baseplate 42 and toward subject 10. Dial 44 is turned until piston 46 applies the desired compression pressure to treatment zone 14 of subject 10. Once compression device 30 is securely fit to subject 10, the amount of pressure applied by piston 46 is controlled by dial 44 and subject 10 since straps 32 do not stretch or yield by a measurable significance. The dial 44 can be configured to be manually adjusted by the subject 10. Subject 10 selects and controls an amount of pressure applied by piston 46 by turning dial 44 in either direction. In various implementations, pressure applicator 40 is pneumatic and dial 44 and piston 46 are pneumatically operated.
In the disengaged position illustrated in
In an engaged position illustrated in
In this manner, subject 10 can regulate the amount of pressure applied to the treatment zone 14 (above or at the umbilicus region) of their abdomen 12 by pressure applicator 40 with minimal effort by turning dial 44. When pressure is needed, for example, upon standing, the subject can increase pressure by turning dial 44 in a first direction and when pressure is no longer needed, for example, upon sitting or lying down, the subject can decrease the pressure by turning dial 44 in a second direction. Implementations of the compression device according to the present disclosure differ from typical abdominal binders because the pressure is focused to a smaller area in the treatment zone 14, unlike traditional abdominal binders that compress the entire midsection. Specifically, piston head 47 may apply pressure to a one square inch area in the treatment zone of the subject. Pressure applied to the one square inch arca may range from 95 to 150 mmHg.
Waist strap 132 connects to pressure applicator 140 on lateral ends of baseplate 142 and extends circumferentially around abdomen 112 of subject 110. Waist strap 132 may be adjustable to accommodate various sized wearers. In the embodiment shown in
Shoulder strap 134 extends from pressure applicator 140 over the shoulders of subject 110 and secures to waist strap 132 on a dorsal side of subject 110. Shoulder strap 134 may be adjustable to accommodate various sized wearers. As shown in
In the embodiment shown in
Waist strap 132 and shoulder strap 134 may vary in width and thickness and may be designed to provide comfort when worn by subject 110. Straps 132, 134 may be casy to clean and/or made of a washable material. In some embodiments, a single waist strap 132 may sufficiently support pressure applicator 140. In other embodiments, a single shoulder strap 134 may sufficiently support pressure applicator 140. In further embodiments, at least one strap may be used with another support to position pressure applicator 140 adjacent treatment zone 114. Straps 132, 134 may be made of an inelastic material so the straps 132, 134 do not stretch out when pressure is applied.
Referring now to
During operation, dial 150 is turned to thread bolt 152 through nut 154 so pressure pad 144 moves toward subject 110 and applies compression pressure to treatment zone 114 of subject 110. Once compression device 130 is securely fit to subject 110, the amount of pressure applied by pressure pad 144 is controlled by dial 150 and subject 110 since the straps 132, 134 do not stretch or yield by a measurable significance. The dial 150 can be configured to be manually adjusted by the subject 110. The subject 110 selects and controls the amount of pressure applied by pressure pad 144 by turning dial 150 in either direction.
In the disengaged position illustrated in
In an engaged position, dial 150 is less than a distance d away from front side 141 of baseplate 142 and pressure pad 144 exerts an amount of pressure on subject 110.
In a second engaged position illustrated in
In this manner, subject 10 can regulate the amount of pressure applied to the abdomen by pressure applicator 140 with minimal effort by turning dial 150. When pressure is needed, for example, upon standing, the subject can increase pressure by turning dial 150 in a first direction and when pressure is no longer needed, for example, upon sitting or lying down, the subject can decrease the pressure by turning dial 150 in a second direction. Implementations of the compression device according to the present disclosure differ from typical abdominal binders because the pressure is focused just below the diaphragm, unlike abdominal binders that compress the entire midsection.
Compression devices 30, 130 are abdominal compression belts that apply pressure above, at or below the umbilicus region of the abdomen to relieve symptoms of subjects with POTS, OH and NOH. Compression devices 30, 130 are lower profile than conventional devices and advantageously also allows the subject to adjust the pressure being applied. Compression devices 30, 130 are also adaptable to a broader range of body habitus given the harness design. These features allow the subjects to keep the compression devices 30, 130 on during the day and to apply pressure as needed. Components of compression devices 30, 130 including pressure applicator 140 may be 3D printed. It should be understood that the thickness of pressure applicator 140 can be selected for desired garment profile and/or constraints of the materials used.
In addition to or as alternative to straps, pressure applicators may be securable to garments or undergarments. In some implementations, pressure applicators may connect to a brassiere for placement adjacent treatment zone. In other implementations pressure applicators may be incorporated into garments or undergarments or be worn over or under garments or undergarments.
In some implementations, baseplate 642 is supported inside pocket 636 of compression garment 632. Dial 644 remains adjacent an exterior side 631 of garment 132 and piston head 647 remains adjacent an interior side 633 of garment 632, dial 144 extends through an opening in the exterior side 631 of garment through pocket 636 and piston 646 extends out an opening in the interior side 633 of garment 632. Subject 610 controls the amount of pressure being applied to their abdomen 612 by pressure applicator 640 by turning dial 644. When subject 610 turns dial 644 in a first direction, dial 644 moves toward subject 610 so piston 646 applies a compression pressure to the treatment zone 614. When the subject turns dial 644 in the opposite direction, piston 644 moves away from subject 610 so pressure applied to abdomen 612 decreases. In some implementations, the amount of pressure applied to subject 610 is from 20 to 40 mmHg. In various implementations, a maximum amount of pressure applied can be from 95 to 150 mmHg when the size of treatment zone 614 is small, for example, approximately one square inch.
Compression garment 632 may be made of a washable material and a compression material. Compression garment 632 may be made of materials known to make shapewear, undergarments, compression stockings, compression socks, for example. Compression garment 632 may have a compression pressure of 5 to 20 mmHg from which additional pressure is able to be applied using the pressure applicator and pressure regulator. Designs of compression garment 132 may include a variety of styles and include, for example, underwear, briefs, bicycle shorts, thigh shorts, briefs, a wide band, tank tops, camisoles, tube tops, shirts or tops, or hosiery. In various implementations, compression garment 632 may have a gripping material, e.g. silicone or silicone rubber, on the interior side 633 so the garment 632 remains in a desired position despite movement of subject 610.
Referring now to
Straps 932 may be coupled to baseplate 942 via buckles 933. Straps may include one strap 932 on lateral sides of baseplate 942 for securing compression device 930 to subject 910. As illustrated in
In an embodiment of compression device 930, straps 932 include markings or demarcations 934 and an indicator slide or clip 936 to regulate the amount of pressure applied to the subject. The markings 934 are calibrated so subject 910 can adjust straps 932 to achieve a desired and/or therapeutic abdominal pressure. Subject 910 moves indicator clip 936 to the desired marking 934 that corresponds to the desired pressure and secures straps 932 in this position. The fit of straps 932 together with pressure pad 944 applies the selected pressure to the abdomen 912 of subject 910. In order to change the pressure (increase or decrease), subject 910 can release the straps 932 and/or move the indicator clip 936 to a second marking 934 and secure straps 932 at second marking 934. Straps 932 are made of an inelastic material so the straps do not stretch or give when pressure is applied by pressure pad 944.
In some implementations, the demarcation or markings 934 are different colors. As shown in
In some examples, straps 932 may be calibrated to indicate a therapeutic pressure, for example, 40 mmHg for various body habitus including a range of waist sizes or waist circumferences, for example, 26 to 32 inches. Table 1, shown below, provides examples of markings 934 that are calibrated to provide a therapeutic pressure of 40 mmHg for a given waist size for compression device 930. Subjects may use compression device 930 with ease by looking up their waist size on Table 1 to determine which color demarcation 934a, 934b, 934c, 934d to align with indicator clip 936. As a result, subjects of varying body habitus can achieve the desired 40 mmHg of therapeutic pressure with ease. In other examples, straps 932 may be calibrated to indicate a range of pressures, for example, from 20 mmHg to 40 mmHg, for a single waist circumference, for example, 30 inches. In these examples, subjects can select a desired pressure from markings 934 with respect to their waist circumference. Table 2, shown below, provides examples of markings for a given waist size (circumference). In further examples, a combination of the former and latter examples may be employed.
Referring to
As illustrated in
Compression device 930 can support patients with POTS because compression device 930 applies sufficient pressure to abdomen 912 to keep subject 910 standing without symptoms. In addition to compression device 930, a pressure measuring device or pressure gauge may be used to measure the pressure being applied by pressure applicator 940 at abdomen 912 and/or to ensure a desired pressure is being maintained. In various implementations, a pressure gauge and/or electronic sensors or gauges may work together with an application on a smartphone, watch or personal device to provide feedback to the subject regarding pressure applied to the subject and the subject's blood pressure.
Compression device 1030 also includes a dorsal baseplate 1052 having a dorsal pad 1054 removably coupled thereto. Dorsal pad 1054 may be ergonomically designed for optimal back support of a subject. Pressure pad 1044 and dorsal pad 1054 work together to relieve stress towards the medial direction while ensuring the desired amount of compression is exerted towards the posterior direction. Dorsal pad 1054 may be removably coupled to dorsal baseplate 1052 via hook and loop fasteners, other couplers or other fasteners.
Pressure pad 1044 and dorsal pad 1054 may be replaced with pads of various shapes, sizes, rigidities, and densities/firmness for variations and customizations in applying pressure to subjects. In some examples, a firmer, more rigid, or thicker pad may be used to apply more pressure given the same amount of force has been pulled on straps. In other examples, a thinner, less rigid, or softer pad may be used to apply less pressure given the same amount of force has been pulled on straps. In further examples, the pads may have a smaller size to target a specific area of the subject. In some examples, pads and straps are made of washable material. Advantageously, compression device 1030 is configured so the components including straps 1032, buckles 1033 and pressure applicator 1040 including dorsal pad 1054 and dorsal baseplate 1052 can be easily removed and replaced when a single component fails or is no longer suitable for its intended purpose.
When lacing 1142 is tightened, ends 1131, 1133 are pulled closer to one another and pressure is applied to abdomen 1112 of subject 1110. The treatment zone of the pressure can be between 10 to 20 square inches or higher, depending on area covered by lacing 1142. When lacing 1142 is loosened or released, pressure on the abdomen decreases. In this implementation, pressure applicator 1140 is configured to apply pressure to abdomen 1112 by tightening or cinching garment 1132. As a result, pressure is applied circumferentially around the abdomen by garment 1132. Garment 1132 may vary in width and thickness. Garment 1132 may be made of an inelastic material that does not give or stretch out such that pressure applicator 1140 can control the amount of pressure applied to subject 1110 by controlling how tightly or loosely garment 1132 is worn by subject 1110. Therapeutic ranges of pressure may go up to 40 mm Hg, for example, or up to 60 mm Hg, for example.
An inflatable bladder 1244 of pressure applicator 1240 is adjacent a treatment zone of subject 1210 when belt 1232 is secured on subject 1210 as illustrated in
The subject 1310 can use actuator 1344 to reduce the pressure to a lower desired amount and/or to empty inflatable bladder. Thus, compression device 1330 is easy for a subject to take on and off and position properly. Compression device 1330 is also easy for a subject to operate. Actuator 1344 can be used to increase and decrease the pressure applied by pressure applicator 1340 as desired with case. An optional barometer or a pressure gauge may be provided so the subject can see the amount of pressure in inflatable bladder and inflate or deflate bladder accordingly. Belt 1332 may be adaptable to various waist circumferences due to the adjustability of pressure in bladder 1244. Various implementations of the systems and devices of the present disclosure allow a subject to control the amount of pressure being applied and provide the subject with the power to adjust the pressure. Therapeutic ranges of pressure may go up to 40 mm Hg, for example, or up to 60 mm Hg, for example. If a subject wants less pressure, the present disclosure advantageously gives subjects the freedom and ability to control or adjust the pressure from amounts in recommended ranges to lower amounts.
Various implementations of the systems and devices of the present disclosure can further comprise optional features, for example, feedback loops, that provide enhanced control of abdominal compression and pressure. For example, the support, belt, straps or garments can include features or “smart” features that monitor patient status, automatically adjust the pressure accordingly and limit the amount of maximum pressure provided. Sensors may be employed to monitor the patient directly or indirectly and communicate with an on-board controller to change or suggest changes to the applied pressure. Some examples of patient status include, but are not limited to, changes in postural position, patient movement, user feedback, heart rate, blood pressure, and the like. Sensors can be incorporated into the devices, and/or the devices can be electronically connected to other health-monitoring devices, such as smart watches, smart phones, activity monitors, personal devices, and the like.
Non-limiting example embodiments of belts, straps, supports and garments can include an inelastic (i.e., not stretchable) fabric that is comfortable to the subject yet provides strong docking forces when locked in place. The belts, straps, supports and garments can also include fabric, leather, non-woven material, or a combination thereof. In some embodiments, the belts, straps, supports and garments comprise an optional stiffener disposed on anterior and/or posterior portions. In general, the belts, straps, supports and garments are configured to be adjustable to a specific circumference so as to apply a prescribed pressure in the treatment zone of the subject. The adjustment can be accomplished by any suitable method, such as laces, cinches, buckles, clips, hook and loop fasteners, etc. In an example, a belt is tightened by cinching lateral straps. In another example, a belt comprises one or more straps with indicators/markings for tightening guidance, such as length markers, detents, etc. Other means of adjustment will be evident to a person of skill in the art and are within the scope of the invention. The belts, straps, supports and garments lengths can be configured such that it is specific to a particular abdomen size, or it can be provided with features that allow a single item to accommodate a range of abdomen sizes.
For any of the above-mentioned configurations, the belt is designed to provide a prescribed and measurable pressure to the abdomen. In some configurations localized and focused pressure is applied to a small area (approximately one square inch) at or above the umbilical region. In other configurations, pressure is applied to a larger area (approximately 10 square inches) at, above or below the umbilical region. In yet other configurations, pressure is applied to an even larger area (up to 30 square inches or higher). Initial testing suggests that compressing an approximately 10 square inch area at a pressure of about 40 mm Hg provides relief to patients. By compressing approximately a 10 square inch area just below the diaphragm at a therapeutic pressure from 20 mmHg to 50 mmHg, for example, at 40 mmHg, multiple studies and the inventors' own testing has shown to relieve these symptoms. In other implementations, pressure is applied to a smaller, focused area that may be approximately 1 square inch with therapeutic pressures ranging from 95 to 150 mmHg.
The materials used in this design are easily mass produced, modular and low cost, making the pricing of this device quite competitive. This is a novel medical device that fills quite a large unmet need because the design fulfills several consumer requirements and effectively delivers therapeutic pressure.
No admission is made that any reference, including any non-patent or patent document cited in this specification, constitutes prior art. In particular, it will be understood that, unless otherwise stated, reference to any document herein does not constitute an admission that any of these documents forms part of the common general knowledge in the art in the United States or in any other country. Any discussion of the references states what their authors assert, and the applicant reserves the right to challenge the accuracy and pertinence of any of the documents cited herein. All references cited herein are fully incorporated by reference, unless explicitly indicated otherwise. The present disclosure shall control in the event there are any disparities between any definitions and/or description found in the cited references.
One skilled in the art will readily appreciate that the present disclosure is well adapted to carry out the objects and obtain the ends and advantages mentioned, as well as those inherent therein. The present disclosure described herein are presently representative of preferred embodiments, are exemplary, and are not intended as limitations on the scope of the present disclosure. It is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as examples of implementing the claims and other equivalent features and acts are intended to be within the scope of the claims.
The present invention claims the benefit of U.S. Provisional Application Ser. No. 63/454,987, filed Mar. 28, 2023, which is hereby incorporated by reference in its entirety, including any figures, tables, and drawings.
Number | Date | Country | |
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63454987 | Mar 2023 | US |