Blood Flow Restriction Systems Having Wireless Monitoring and Control
20210228099 · 2021-07-29
Inventors
Cpc classification
A61B5/022
HUMAN NECESSITIES
A61B5/02141
HUMAN NECESSITIES
A61B2090/064
HUMAN NECESSITIES
A61B5/0015
HUMAN NECESSITIES
International classification
A61B5/00
HUMAN NECESSITIES
Abstract
A BFRT cuff and motor/pump unit and a method for exercising using said cuff. The method incudes providing a BFRT cuff and a motor/pump unit, placing the BFRT cuff on a user's limb, connecting the BFRT cuff to the motor/pump unit, selecting a pressure value or percent of limb occlusion pressure (LOP), causing the motor/pump unit to supply air to the BFRT cuff until the LOP of said limb is obtained, terminating air flow to the BFRT cuff and then reducing the pressure in the BFRT cuff, and exercising the user's limb while the BFRT cuff is at a selected pressure or a selected percent of LOP.
Claims
1. A method for exercising using a blood flow restriction training (BFRT) system comprising: a. providing a BFRT cuff, said BFRT cuff including i) a flexible outer material, ii) an air chamber at least partially encapsulated by said flexible outer material, and iii) a connection arrangement configured to secure said BFRT cuff to a limb of a user, said flexible outer material having a length of at least 20 cm and a width of least 5 cm; b. providing a motor/pump unit, said motor/pump unit configured to at least partially inflate said BFRT cuff, said motor/pump unit including a housing and an air connection arrangement that fluidly connects said housing to said BFRT cuff to enable pumped air from said motor/pump unit to flow to and at least partially inflate said air chamber, said housing having a size less than 400 cubic inches and a weight less than 4 lbs., said housing at least partially containing i) an air pump, ii) a power source, and iii) a pressure sensor; c. placing said BFRT cuff on a user's limb; d. connecting said BFRT cuff to said motor/pump unit to enable air flow between said BFRT cuff and said motor/pump unit; e. manually or automatically selecting a select pressure value or percent of limb occlusion pressure (LOP), said pressure value less than said LOP, said percent no more than 90%; f. causing said motor/pump unit to supply air to said BFRT cuff to thereby cause said BFRT cuff to inflate until said LOP of said limb is obtained; g. terminating air flow from said motor/pump unit to said BFRT cuff after said LOP has been obtained for the limb; h. reducing pressure in said BFRT cuff within 0.001-30 seconds after said LOP is obtained in said BFRT cuff until said pressure value is said select pressure value or said percent of LOP; and, i. exercising the user's limb While said BFRT cuff is positioned on said limb of said user; and wherein A) said motor/pump unit activates said air pump when said pressure in said air chamber falls below said selected pressure value, falls below said percent of said LOP, falls to or below a preset minimum pressure value, or falls to or below a preset minimum percent LOP value during said step of exercising to increase said pressure in said air chamber, and/or B) said motor/pump unit or said BFRT cuff causes said pressure in said air chamber to be reduced when said pressure in said air chamber exceeds below said selected pressure value, exceeds said percent of said LOP, obtains or exceeds a preset maximum pressure value, or obtains or exceed a preset maximum percent LOP value during said step of exercising so as to decrease said pressure in said air chamber.
2. The method as defined in claim 1, wherein said step of reducing is at least partially accomplished by causing said motor/pump unit to remove air from said BFRT cuff.
3. The method as defined in claim 1, further including the step of removing said BFRT cuff from said limb after said step of exercising said user's limb.
4. The method as defined in claim 2, further including the step of removing said BFRT cuff from said limb after said step of exercising said user's limb.
5. The method as defined in claim 1, wherein said housing of said motor/pump unit provides three or more types of information selected from the group consisting of a) measured pressure, b) power or charge level of said power source, c) a warning symbol when some type of warning event has occurred, d) selected % LOP, e) selected pressure, fe) instructional information as to how to use said motor/pump unit and/or BFRT cuff, and g) arm or leg selection options for BFRT cuff.
6. The method as defined in claim 4, wherein said housing of said motor/pump unit provides three or more types of information selected from the group consisting of a) measured pressure, b) power or charge level of said power source, c) a warning symbol when some type of warning event has occurred, d) selected % LOP, e) selected pressure, f) instructional information as to how to use said motor/pump unit and/or BFRT cuff, and g) arm or leg selection options for BFRT cuff.
7. The method as defined in claim 1, further including the step of turning on or powering up said motor/pump unit, said motor/pump unit configured to calibrate with ambient pressure after said motor/pump unit is turned on or powered up.
8. The method as defined in claim 6, further including the step of turning on or powering up said motor/pump unit, said motor/pump unit configured to calibrate with ambient pressure after said motor/pump unit is turned on or powered up.
9. The method as defined in claim 1, further including the step of selecting the limb upon which said motor/pump unit that said BFRT cuff is to be placed.
10. The method as defined in claim 8, further including the step of selecting the limb upon which said motor/pump unit that said BFRT cuff is to be placed.
11. A method for exercising using a blood flow restriction training (BFRT) system comprising: providing a BFRT cuff, said BFRT cuff including i) an air chamber at least partially encapsulated by said flexible outer material, and ii) a connection arrangement configured to secure said BFRT cuff to a user's limb; b. providing a motor/pump unit, said motor/pump unit configured to at least partially inflate said BFRT cuff, said motor/pump unit including a housing and an air connection arrangement that fluidly connects said housing to said BFRT cuff to enable pumped air from said motor/pump unit to flow to and at least partially inflate said air chamber, said housing at least partially containing i) an air pump, and ii) a power source; c. placing said BFRT cuff on a user's limb; d. connecting said BFRT cuff to said motor/pump unit to enable air flow between said BFRT cuff and said motor/pump unit; e. manually or automatically selecting a pressure value or percent of limb occlusion pressure (LOP), said pressure value less than said LOP; f. causing said motor/pump unit to supply air to said BFRT cuff to thereby cause said BFRT cuff to inflate until said LOP of said limb is obtained; g. terminating air flow from said motor/pump unit to said BFRT cuff after said LOP has been obtained for the limb; h. reducing pressure in said BFRT cuff after said LOP is obtained in said BFRT cuff until said pressure value is said selected pressure value or said percent of said LOP; and, i. exercising the limb of said user while said BFRT cuff is positioned on said limb of said user; and wherein A) said motor/pump unit activates said air pump when said pressure in said air chamber falls below said selected pressure value, falls below said percent of said LOP, falls to or below a preset minimum pressure value, or falls to or below a preset minimum percent LOP value during said step of exercising so as to increase said pressure in said air chamber to be within certain pressure range or within a certain range of percent LOP, and/or B) said motor/pump unit or said BFRT cuff causes said pressure in said air chamber to be reduced when said pressure in said air chamber exceeds said selected pressure value, exceeds said percent of said LOP, obtains or exceeds a preset maximum pressure value, or obtains or exceed a preset maximum percent LOP value during said step of exercising to decrease said pressure in said air chamber to be within certain pressure range or within a certain range of percent LOP; and wherein I) said motor/pump unit or said BFRT cuff causes said pressure in said air chamber to be reduced below said selected pressure value or said percent of said LOP when said motor/pump unit or said BFRT cuff detects inactivity of use of said BFRT cuff by said user after a preselect period of time, or II) said motor/pump unit or said BFRT cuff causes said pressure in said air chamber to be reduced below said selected pressure value or said percent of said LOP after said motor/pump unit or said BFRT cuff detects that a certain number of repetitions have been completed or a selected exercise has been completed.
12. The method as defined in claim 11, including the step of wirelessly controlling said motor/pump unit.
13. A blood flow restriction training (BFRT) system comprising: a. a BFRT cuff, said BFRT cuff including i) an air chamber at least partially encapsulated by a flexible outer material, and ii) a connection arrangement configured to secure said BFRT cuff to a user's limb; and b. a motor/pump unit, said motor/pump unit configured to at least partially inflate said BFRT cuff, said motor/pump unit including a housing, and an air connection arrangement that fluidly connects said housing to said BFRT cuff to enable pumped air from said motor/pump unit to flow to and at least partially inflate said air chamber, said housing at least partially containing i) an air pump, ii) a power source, and iii) a controller; said housing having a size less than 400 cubic inches and a weight less than 4 lbs.; and wherein said controller is configured to a) cause said motor/pump unit to supply air to said BFRT cuff to thereby cause said BFRT cuff to inflate until said LOP of said limb is obtained; b) terminate air flow from said motor/pump unit to said BFRT cuff after said LOP has been obtained for the limb, c) reduce pressure in said BFRT cuff after said LOP is obtained in said BFRT cuff until a pressure value in said air chamber is at a selected pressure value or a selected percent of said LOP; and wherein said controller is configured to A) activate said motor/pump unit when said pressure in said air chamber falls below said selected pressure value, falls below said selected percent of said LOP, falls to or below a preset minimum pressure value, or falls to or below a preset minimum percent LOP value so as to increase said pressure in said air chamber to be within a certain pressure range or within a certain range of percent LOP, and/or B) activates said motor/pump unit to cause said pressure in said air chamber to be reduced when said pressure in said air chamber exceeds said selected pressure value, exceeds said percent of said LOP, obtains or exceeds a preset maximum pressure value, or obtains or exceed a preset maximum percent LOP value so as to decrease said pressure in said air chamber to be within certain pressure range or within a certain range of percent LOP.
14. The BFRT system as defined in claim 13, wherein said controller is configured to I) cause said motor/pump unit to reduce said pressure in said air chamber below said selected pressure value or said percent of said LOP when said motor/pump unit or said BFRT cuff detects inactivity of use of said BFRT cuff after a preselect period of time, or II) cause said motor/pump unit to reduce said pressure in said air chamber below said selected pressure value or said percent of said LOP when said motor/pump unit or said BFRT cuff detects that a certain number of repetitions have been completed or a selected exercise has been completed.
Description
BRIEF DESCRIPTION OF DRAWINGS
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DETAILED DESCRIPTION
[0087] A more complete understanding of the articles/devices, processes and components disclosed herein can be obtained by reference to the accompanying drawings. These figures are merely schematic representations based on convenience and the ease of demonstrating the present disclosure, and are, therefore, not intended to indicate relative size and dimensions of the devices or components thereof and/or to define or limit the scope of the exemplary embodiments.
[0088] Although specific terms are used in the following description for the sake of clarity, these terms are intended to refer only to the particular structure of the embodiments selected for illustration in the drawings and are not intended to define or limit the scope of the disclosure. In the drawings and the following description below, it is to be understood that like numeric designations refer to components of like function.
[0089] The singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.
[0090] As used in the specification and in the claims, the term “comprising” may include the embodiments “consisting of” and “consisting essentially of.” The terms “comprise(s),” “include(s),” “having,” “has,” “can,” “contain(s),” and variants thereof, as used herein, are intended to be open-ended transitional phrases, terms, or words that require the presence of the named ingredients/steps and permit the presence of other ingredients/steps. However, such description should be construed as also describing compositions or processes as “consisting of” and “consisting essentially of” the enumerated ingredients/steps, which allows the presence of only the named ingredients/steps, along with any unavoidable impurities that might result therefrom, and excludes other ingredients/steps.
[0091] Numerical values in the specification and claims of this application should be understood to include numerical values which are the same when reduced to the same number of significant figures and numerical values which differ from the stated value by less than the experimental error of conventional measurement technique of the type described in the present application to determine the value.
[0092] All ranges disclosed herein are inclusive of the recited endpoint and independently combinable (for example, the range of “from 2 inches to 10 inches” is inclusive of the endpoints, 2 inches and 10 inches, and all the intermediate values).
[0093] The terms “about” and “approximately” can be used to include any numerical value that can vary without changing the basic function of that value. When used with a range, “about” and “approximately” also disclose the range defined by the absolute values of the two endpoints, e.g. “about 2 to about 4” also discloses the range “from 2 to 4.” Generally, the terms “about” and “approximately” may refer to plus or minus 10% of the indicated number.
[0094] In accordance with the present disclosure, there is provided a BFRT system 20 that includes a BFRT cuff 100 and motor/pump unit 200.
[0095] BFRT 100 cuff includes an inflatable air system formed of one or more two layers of material. In one non-limiting embodiment, the inflatable air system includes two layers of material coupled together to create one or more air chambers to be inflated with air and/or some other gas. In one non-limiting configuration, BFRT cuff 100 is a single air chamber inflatable cuff. In another non-limiting configuration, BFRT cuff 100 includes two or more air chambers. The configuration and shape of the one or more air chambers is non-limiting. The inflatable air system is configured in BFRT cuff 100 such that inflation of the inflatable air system produces compression on a target compression zone that in turn produces a restriction of blood flow in the venous system of a user. BFRT cuff 100 includes an outer material cover 102 having a cavity (not shown) for containing the inflatable air system to partially or fully isolate the inflatable air system from the skin of the user and/or to provide protection to the inflatable air system, and/or to provide structural strength to BFRT cuff 100. The inflatable air system can optionally be secured in the cavity to one or more inner surface of outer material cover 102 (e.g., stitching, adhesive, melted connection, etc.). titer material cover 102 is generally made of a flexible and durable material (e.g., nylon, Kevlar™, etc.). In one non-limiting embodiment, outer material cover 102 is formed of an inelastic or non-stretch material. Outer material cover 102 is configured to a) facilitate in distributing the force applied by the inflatable air system to the limb of a user, b) reduce pinching of the user's skin during the inflation of the inflatable air system, and/or c) provide friction between BFRT cuff 100 and the user's skin to inhibit or prevent rotation of BFRT cuff 100 on the user during use.
[0096] BFRT cuff 100 generally includes a connection arrangement to facilitate in the securing of BFRT cuff 100 to a user's limb. As illustrated in 1, BFRT cuff 100 includes a loop/loop like material 110 on the outer surface that is configured to releasably connect to a hook/loop material on a strap 120.
[0097] BFRT cuff 100 includes one or more input ports 130 (e.g., air input port, data/communication input port, power input port, etc.). The one or more input ports can be in fluid communication with the inflatable air system to allow a fluid (e.g., air) to flow into and out of the inflatable air system. Input port 130 generally includes a valve component (not shown). The location of the one or more input ports 130 on the BFRT is non-limiting. Generally, at least one input port 130 is located on an outwardly facing surface of the outer material cover 102. One or more of the input ports 130 is configured to be connected to a motor/pump unit 200 (e.g., portable motor/pump, non-portable motor/pump, permanently connected motor/pump, detachably connected motor/pump, etc.). The one or more input ports 130 can optionally include a one-way valve (not shown) to prevent undesired deflation of the air inflatable system. The one or more input ports 130 can optionally be configured to allow for manual deflation of the air inflatable system.
[0098] As illustrated in
[0099] Motor/pump unit 200 includes a housing 210 that at least partially contains a) a motor (not shown); b) a pump (not shown); c) optionally a power source (not shown); d) one or more pressure sensors (not shown); e) circuit board and other electronics (not shown); f) one or more processors (e.g., controller, etc.); g) one or more pressure gauge(s) (not shown); h) software (not shown); i) one or more display(s) 230 (e.g., LED screen, OLED screen, etc.); j) optionally a power port (not shown); k) optionally a data port 220 (e.g., micro USB port, etc.); l) optional GPS system (not shown); m) optional wireless electronics (e.g., transmitter and/or receiver, etc.) to send/receive wireless signals (not shown); n) one or more buttons 240, 241 (e.g., power button, home button, power off button, etc.); o) one or more selection or scroll buttons 250, 260 to enable manual operation/control of motor/pump emit 200; p) one or more switch(es) (not shown) to enable manual operation/control of motor/pump unit 220; q) connection arrangement 280 to permanently or releasably connect motor/pump unit 220 to the outer material cover 110; r) air hose port 290; and/or s) optional lights and/or other indicators (not shown) to indicate a mode and/or operation and/or status of motor/pump unit 200. The shape and size of housing 210 is non-limiting. The material used to form housing 210 is generally a durable material (e.g., plastic, metal, composite, etc.), Motor/pump unit 200 is generally a portable motor/pump unit 200 that can be easily handled by a user, Generally, the volume of housing 210 of motor/pump unit 200 is no more than 500 cubic inches, typically 0.5-500 cubic inches (and all values and ranges therebetween), and more typically 1-50 cubic inches. Generally, the weight of motor/pump unit 200, including housing 210 and air hose 270, is no more than 10 lbs., typically 0.05-10 lbs. (and all values and ranges therebetween), and more typically 0.2-3 lbs.
[0100] As illustrated in
[0101] As illustrated in
[0102] As illustrated in
[0103] As illustrated in
[0104] As illustrated in
Operation of BFRT System
[0105] The operation of BFRT system 20 illustrated in
[0106] Step 1—Turning on or powering up motor/pump unit 200 (if not already turned on). The turning on or powering up of th motor/pump unit 200 can be accomplished by pressing power button 240 on housing 210. If motor/pump unit 200 has been turned off or powered down, motor/pump unit 200 can optionally be configured to calibrate with the ambient pressure when motor/pump unit 200 is tuned on or powered up. Generally, motor/pump unit 200 turning on or powering up of motor/pump unit 200 will cause the display 230 to be turned on.
[0107] Step 2—Optionally charge battery in housing 210 of motor/pump unit 200 (if not already sufficiently charged). Generally, the battery in housing 210 should be charged at least 30-50% (and all values and ranges therebetween) of a full charge prior to operation of motor/pump unit 200 to inflate BFRT cuff 100. The battery charge level 292 can be optionally displayed on display 230 of housing 210. In one non-limiting embodiment, the battery in housing 210 should be charged at least 50-100% (and all values and ranges therebetween) of a full charge prior to operation of motor/pump unit 200 to inflate BFRT cuff 100. Motor/pump unit 200 can optionally be configured to cause a warning 294 to be displayed on display 230 of housing 210 when 1) the battery charge level is too low, and/or 2) occlusion has been detected when occlusion was not being tested thereby causing an auto-vent protocol to engage. As can be appreciated, motor/pump unit 200 can be configured such that other or alternative events can cause warning 294 to be displayed on display 230. Motor/pump unit 200 can optionally be configured to prevent operation of the air pump when the battery charge level is too low.
[0108] Step 3—Optionally select the limb (e.g., arm or leg) upon which BFRT cuff 100 is to be placed. Motor/pump unit 200 can be optionally programmed such that display 230 on housing 210 requests the user to select using one or both of two arrow or scroll buttons 250, 260 or by touching the display (if the display is a touch screen display) on the limb upon which that BFRT cuff 100 is to be attached during the inflation of BFRT cuff 100. This step and feature of portable motor/pump unit 200 is optional.
[0109] Step 4—Place EMU cuff 100 on the desired limb of the user. The step of placing BFRT cuff 100 on the desired limb of the user can occur at any time prior to motor/pump unit 200 causing BFRT cuff 100 to be inflated. During the step of placing BFRT cuff 100 on the desired limb of the user, proper size BFRT 100 cuff is selected (generally there are different BFRT cuff sizes for the arms and legs), and then BFRT cuff 100 is fitted about the user's limb, and connection strap (e.g., hook and loop fastener strap, etc.) removably secures BFRT cuff 100 to the limb.
[0110] Step 5—Select % LOP. Motor/pump unit 200 can be is configured to allow the user to select the desired % LOP to be used during the exercise of the limb. The % LOP can be selected by the user using one or both of two arrow or scroll buttons 250, 260 or by touching the display (if the display is a touch screen display). Motor/pump unit 200 can optionally be configured to not permit a selected % LOP greater than 90%. In one non-limiting embodiment, motor/pump unit 200 allows the user to only select a % LOP from 20-85% and all values and ranges therebetween. Motor/pump unit 200 can optionally provide a suggested % LOP based on the input by the user of the limb upon which BFRT cuff 100 is to be connected. Motor/pump unit 200 can optionally have preprogrammed maximum and/or minimum % LOP values so that a user is optionally unable to selected a % LOP that is greater than the maximum preprogrammed % LOP value and/or the user is optionally unable to selected a % LOP that is less than the minimum preprogrammed % LOP value.
[0111] Step 6—Connect motor/pump unit 200 to BFRT cuff 100 prior to activating the pump of the motor/pump unit 200. The step of connecting motor/pump unit 200 to BFRT cuff 100 can occur at any time prior to motor/pump unit 200 causing BFRT cuff 100 to be inflated. As illustrated in
[0112] Step 7—Cause air pump of motor/pump unit 200 to activate to cause BFRT cuff 100 to be inflated to the LOP of the limb upon which BFRT cuff 100 is attached. Motor/pump unit 200 can be caused to be activated by the user using one or both of the two arrow or scroll buttons 250, 260 or by touching the display (if the display is a touch screen display), or automatically after the % LOP or selected pressure is selected by the user. Motor/pump unit 200 can optionally be configured to allow the air pump to continue to pump air into BFRT cuff 100 until a maximum preset air pressure is reached in BFRT Cuff 100. Motor/pump unit 200 can optionally be configured to stop the operation of the air pump once the maximum preset air pressure is reached in BFRT cuff 100, and thereafter optionally cause BFRT cuff 100 to be partially or fully deflated. Such a feature can be used to reduce or prevent damage to BFRT cuff 100 and/or reduce or prevent harm to the user. Motor/pump unit 200 is configured to terminate the flow of air to BFRT cuff 100 once the LOP in the limb has been detected. The LOP can be measured by use of the oscillometric method by inflating up the BFRT cuff 100 until it senses full occlusion (no arterial pulse) then taking an array average/mean pressure. Motor/pump unit 200 can be configured to sense full occlusion as fast as a half a millisecond such that motor/pump unit 200 can take an average pressure in the span of full occlusion. Thereafter, motor/pump unit 200 is configured to allow or cause air to be removed BFRT cuff 100 until the selected % LOP is reached in BFRT cuff 100. Generally, motor/pump unit 200 is configured to allow or cause air to be removed from BFRT cuff 100 in no more than 10 seconds (e.g., 0.001-140 seconds and all values and ranges therebetween) of motor/pump unit 200 determining or sensing that the LOP has been obtained, and typically motor/pump unit 200 is configured to allow or cause air to be removed from BFRT cuff 100 in no more than 5 seconds of motor/pump unit 200 determining or sensing that the LOP has been obtained, and more typically motor/pump unit 200 is configured to allow or cause air to be removed from BFRT cuff 100 in more than 2 seconds of motor/pump unit 200 determining or sensing that the LOP has been obtained.
[0113] The removal of air from BFRT cuff 100 can be by use of a valve in the motor/pump unit 200 that is activated to allow release of air that is flowing from BFRT cuff 100 through air tube 270 and to motor/pump unit 200, and/or the air pump in motor/pump unit 200 can be configured to draw air from BFRT cuff 100 via air tube 270.
[0114] Once the % LOP or selected pressure has been obtained in BFRT cuff 100, the air pump terminates operation (if operating) and/or the air release valve in motor/pump unit 200 closes so that no further air is allowed to escape from BFRT cuff 100 after % LOP or selected pressure has been obtained in BFRT cuff 100. Motor/pump unit 200 can optionally be configured to provide a visual signal via display 230 on housing 210 and/or provide an audible sound once the user selected % LOP or selected pressure in BFRT cuff 100 has been obtained.
[0115] Step 8—Optionally detach motor/pump unit 200 from BFRT cuff 100 after the % LOP has been obtained in BFRT cuff 100. The detachment of motor/pump unit 200 from BFRT cuff 100 can be accomplished by disconnecting hose connector 280 of air hose 270 from air input port 130 of BFRT cuff 100. As can be appreciated, motor/pump unit 200 can be disconnected from BFRT cuff 100 in other manners. The disconnecting of motor/pump unit 200 from BFRT cuff 100 results in motor/pump unit 200 not regulating the pressure in BFRT 100 cuff while the user exercises a limb while BFRT cuff 100 is connected and partially inflated on the limb.
[0116] Step 9—Optionally Auto Regulate pressure in BFRT cuff 100 during use of BFRT cuff 100 by the user. If Auto Regulation is used, motor/pump unit 200 is connected to BFRT cuff 100 during use of BFRT cuff 100 by the user. The Auto Regulation of the pressure of BFRT cuff 100 is used to ensure that proper inflation pressure of BFRT cuff 100 is maintained during the use of BFRT cuff 100.
[0117] Step 10—Deflate BFRT cuff 100. The partial or full deflation of BFRT cuff 100 can be accomplished by 1) opening an air release valve on BFRT cuff 100, 2) reconnecting motor/pump unit 200 to BFRT cuff 100 (if not already connected—reconnecting is not required When motor/pump unit 200 remains on BFRT cuff 100 during the use of BFRT cuff 100) and then causing motor/pump unit 200 to cause air to be removed from BFRT cuff 100 (e.g., activating the air pump to cause the air pump to draw air from BFRT cuff 100, and through air tube 270 and then out from housing 210, causing a valve in motor/pump unit 200 to open to allow air to flow from BFRT cuff 100, through air tube 270 and out through the open valve, etc.). The deflation Step includes the optional Intermittent Regulation feature of the BFRT system.
[0118] Step 11—Remove BFRT cuff 100 from the user's limb. After the user has completed the exercises for the limb using BFRT cuff 100, the user can remove BFRT cuff 100 from the limb after BFRT cuff 100 has been partially or fully deflated.
[0119] The above steps can be modified if the user wishes to perform multiple exercises of the limb using different % LOP. For example, if a user after an exercise wants to continue exercise of the limb but using a different LOP, then after Step 9, the user repeats one or more or Steps 1-3 and 5-10.
[0120] Motor/pump unit 200 can optionally be configured to allow a user to select the same % LOP or pressure used on one limb for use on another limb. For example, if a user uses BFRT cuff 100 on his right arm and selected a % LOP of 50% (which was a pressure of 190 mmHg), motor/pump unit 200 can optionally be configured to allow the user to use same BFRT cuff pressure when BFRT cuff 100 is connected to the left arm without having motor/pump unit 200 having to determine the LOP of the left arm. In such an arrangement, motor/pump unit 200 will merely cause BFRT cuff 100 on the left arm to inflate to the same pressure as was used on the right arm. When such a configuration is available on motor/pump unit 200, such option will typically be displayed on display 230 of housing 210.
[0121] Referring now to
[0122] Referring again to
[0123] After the optional Welcome Screen, an optional Warning Screen and/or Terms Of Use Screen can be displayed. One or more buttons 250, 260 may optionally be required to be pressed or display screen 230 touched (when display is a touch screen display) to indicate acknowledgement of the warnings and/or Terms of Use.
[0124] After the optional Warning Screen and/or Terms Of Use Screen, if motor/pump unit 200 has more than one mode, then the two or more modes of operation of motor/pump unit 200 can be displayed so that the user can select the mode of operation by use of one or more buttons 250, 260 or by touching display screen 230 (when display is a touch screen display). As illustrated in
[0125] When the Manual Pressure mode is selected by the user, the operation of BFRT cuff 100 and motor/pump unit 200 will follow the operation illustrated in
[0126]
[0127] When BFRT cuff 100 and motor/pump unit 200 have an Automatic LOP mode,
[0128]
[0129] Referring now to
[0130] BFRT cuff 310 includes an inflatable air system formed of at least two layers of material coupled together to create one or more air chambers to be inflated with air and/or some other gas. The inflatable air system is configured in BFRT cuff 310 such that inflation of the inflatable air system produces compression on a target compression zone that in turn produces a restriction of blood flow in the venous system of a user. The BFRT cuff 310 includes an outer material cover 312 having a cavity for containing the inflatable air system so as to isolate the inflatable air system from the skin of the user. The inflatable air system can optionally be secured in the cavity to one or more inner surface of the outer material cover (e.g., stitching, adhesive, melted connection, etc.). The outer material cover 312 is generally made of a flexible and durable material (e.g., nylon, Kevlar™, etc.). In one non-limiting embodiment, outer material cover 312 is formed of an inelastic or non-stretch material. Outer material cover 312 is configured to a) facilitate in distributing the force applied by the inflatable air system to the limb of a user, b) reduce pinching of the user's skin during the inflation of the inflatable air system, and/or c) provide friction between the BFRT and the user's skin to inhibit or prevent rotation of BFRT cuff 310 on the user during use.
[0131] BFRT cuff 310 includes one or more air input ports 318 in fluid communication with the inflatable air system to allow a fluid (e.g., air) to flow into and out of motor/pump unit 320. Input port 318 generally includes a valve component. The location of the one or more input ports 318 on BFRT cuff 310 is non-limiting. Generally, at least one input port 318 is located on an outwardly facing surface of outer material cover 312. One or more of input ports 318 is configured to be connected to a motor/pump unit 320. One or more input ports 318 can optionally include a one-way valve (not shown) to prevent undesired deflation of the air inflatable system. The one or more input ports 318 can optionally be configured to allow for manual deflation of the air inflatable system.
[0132] As illustrated in
[0133] Motor/pump unit 320 includes a) a housing 322; b) a motor (riot shown); c) a pump (not shown); d) one or more displays 324 (e.g., LED screen, OLED screen, etc.) to display measured pressure and/or to display other information; e) optional one or more processors (not shown); f) optional wireless electronics (not shown) that can be used to send/receive wireless signals between the motor/pump unit and a computer, server, data hub, cloud, tablet, smart phone and/or other type of smart device; g) one or more pressure gauges and/or sensors (not shown) used to measure a gas pressure in the air inflatable system; h) optional power source (not shown) to power one or more components of motor/pump unit 320 (e.g., motor, pump, pressure sensor/gauge; electronics, display, etc.); i) optional one or more power ports (not shown) to charge the power source; j) optional connection arrangement 330 to permanently or releasably connect motor/pump unit 320 to outer material cover 310; k) optional one or more fluid connectors 330 to fluidly connect motor/pump unit 320 to the air inflatable system; l) optional UPS system (not shown); m) optional circuit board and other electronics (not shown); n) optional software (not shown); o) optional one or more data ports (e.g., micro USB port, etc.) (not shown) to enable wired transfer of data between motor/pump unit 320 and a computer, server, data hub, cloud, tablet, smart phone and/or other type of smart device; p) optional one or more buttons (e.g., power button, etc.) (not shown), r) optional one or more selection or scroll buttons (not shown) to enable manual operation/control of motor/pump unit 320 and/or to select certain information to be displayed on motor/pump unit 320; s) optional one or more switch(es) (not shown), to enable manual operation/control of motor/pump unit 320; r) optional air hose port (not shown); t) optional one or more lights and/or other indicators (not shown) to indicate a mode and/or operation and/or status of motor/pump unit 320; and u) optional memory (not shown). The shape, size and weight of housing 322 is non-limiting. The material used to form the housing is generally a durable material (e.g., plastic, metal, composite, etc.). The size and weight of motor/pump unit 320 can be the same or similar to motor/pump unit 200 as described above.
[0134] As can be appreciated, motor/pump unit 320 can be partially of fully contained within BFRT cuff 310 and/or partially or fully contained within the air inflatable system of BFRT cuff 310. In such an arrangement, motor/pump unit 320 can be partially or fully hidden within BFRT cuff 310. In such an arrangement, outer surface 313 of outer material cover 312 can optionally include one or more displays and/or buttons to display information regarding motor/pump unit 320, display information regarding pressure of the air inflation system, and/or to manually control motor/pump unit 320. As can be appreciated, the one or more displays and/or buttons can be used to display information and/or control motor/pump unit 320 as described above with regard to motor/pump unit 200. In such an arrangement, housing 320 of
[0135] As illustrated in
[0136] Referring now to
[0137] BFRT cuff 310 includes a cuff fastening arrangement (not shown) to releasably secure BFRT cuff 310 to a user. The type of fastening arrangement is non-limiting (e.g., snap connection arrangement, hook and loop fastener, snap fastener, button fastener, etc.).
Operation of BFRT System
[0138] The operation of BFRT system 300 can be the same of similar to the operation as described above with regard to BFRT system 20.
[0139] Another non-limiting operation sequence of BFRT system 300 is set forth below. It will be understood that one or more steps described above with regard to BFRT system 20 can be used with the one or more step of BFRT system 300 described below.
[0140] In the first step, a user (not shown) selects an appropriate size of BFRT cuff 310 based on the user's upper arm girth if exercising the upper limbs, or upper thigh girth if exercising the lower limbs.
[0141] In the next step, the user applies BFRT cuff 310 about his/her arm or leg and secures BFRT cuff 310 in the desired position on his/her arm or leg. Motor/pump unit 320 should be connected to BFRT cuff 310 prior to attempting to inflate the air inflatable system of BFRT cuff 310. In some non-limiting embodiments, motor/pump unit 320 is integrated in BFRT cuff 310, thus does not need to be connected to BFRT cuff 310.
[0142] The next step is to inflate the air inflatable system in BFRT cuff 310. This can be accomplished by manually activating motor/pump unit 320, or by wirelessly activating motor/pump unit 320. Such wireless activation can be accomplished by using a mobile app or program on a smart device (e.g., smart phone, tablet, computer, laptop computer, server, data hub, cloud, etc.) and the like. As can be appreciated, a smart device and the like can also or alternatively be wired connected to motor/pump unit 320 or BFRT cuff 310 (when motor/pump unit 320 is integrated in BFRT cuff 310).
[0143] The pump in motor/pump unit 320 injects air into the air inflatable system in BFRT cuff 310 until a desired pressure is reached. The pressure in the air inflatable system can be optionally viewed on display 324 on housing 322 of motor/pump unit 320 and/or on another device (e.g., smart phone, computer, tablet, etc.). BFRT cuff 310 can optionally include a pressure limiting valve (not shown) to prevent over pressurization of the air inflatable system. Once the desired pressure is achieved in the air inflatable system, the operation of the pump is terminated. Thereafter, the user can proceed to exercise.
[0144] During exercise, the BFRT system can include an Auto Regulation Feature whereby if the pressure sensor determines that the pressure in the air inflatable system has exceed a predetermined pressure, air pressure can be released from the air inflatable system until the predetermined pressure in the air inflatable system is obtained. If the pressure sensor determines that the pressure in the air inflatable system is below a predetermined pressure, air pressure can be increased in the air inflatable system by activating motor/pump unit 320 until the predetermined pressure in the air inflatable system is obtained. The increase/decrease in pressure in the air inflatable system can occur during the use of BFRT cuff 310 without requiring the user to interrupt his/her exercise. Such a feature is a significant improvement over prior art BFRT arrangements wherein a user needed to stop exercising to manually increase or decrease the air pressure in the BFRT arrangement.
[0145] As illustrated in
[0146] When the user is through with the desired exercises, the user may manually release the pressure in the air inflatable system, use an app or program on a computer or other type of smart device to deflate the air inflatable system, and/or the air inflatable system can be automatically deflated. Thereafter, the user can remove BFRT cuff 310 from his/her arm or leg.
[0147] As can be appreciated, many of the steps of operation of BFRT cuff 310 can be the same or similar to the steps of operation of BFRT cuff 100 as described above.
[0148] BFRT cuff 310 of the present disclosure includes several unique features as discussed in more detail below.
[0149] BFRT cuff 310 can have a urethane-coated air bladder. The urethane coating on the bladder adds to patient comfort by reducing pinching of the skin by the bladder when inflated.
[0150] BFRT cuff 310 includes a motor/pump unit 320 to inflate/deflate the one or more air chambers in BFRT cuff 310, and which motor/pump unit 320 is detachable connectable to BFRT cuff 310 and can remain connected to BFRT cuff or be removed from the BFRT cuff prior to, during, and/or after use of BFRT cuff 310. When motor/pump unit 320 remains on BFRT cuff 310 while the user exercises, motor/pump unit 320 can be configured to automatically activate to reduce or increase air pressure in the air inflatable system so as to maintain a desired air pressure in the air inflatable system during the exercise routine. Alternatively, the user can manually activate motor/pump unit 320 to increase/decrease the pressure in the air inflatable system. Motor/pump unit 320 can be removed from BFRT cuff motor/pump unit 320 to reduce the weight of BFRT system 300 on the user during exercise or to prevent inadvertent damage to motor/pump unit 320 during rigorous exercise. Motor/pump unit 320 can be connected to and detached from BFRT cuff 310 at any time prior to, during, or after an exercise routine. BFRT cuff 310 includes a valve arrangement that prevents undesired deflation of the air inflatable system during the connection and detachment of motor/pump unit 320 to/from BFRT cuff 310.
[0151] Motor/pump unit 320 can be powered by a battery contained in the housing of motor/pump unit 320. Such a feature eliminates the need for power cords to operate motor/pump unit 320, thus providing more flexibility and ease of use of BFRT cuff 310. The battery can be rechargeable and housing 322 of motor/pump unit 320 can optionally include a power port so that a power cord, USB cord, etc. can be connected to housing 322 to recharge the battery. As can be appreciated, motor/pump unit 320 can be designed to allow for wireless charging of the battery.
[0152] Motor/pump unit 320 used with BFRT cuff 310 can include one or more displays 324. These one or more displays 324 can be used to inform a user of a) whether the pump is on/off, b) battery status, c) pressure level for pressure in the one or more air chambers of BFRT cuff 310, d) time/date, e) whether pressure in the one of more air chambers of BFRT cuff 310 is at or below limb occlusion pressure, f) error notification/status, g) security status locked, unlocked, etc.), h) ambient temperature, i) timer/clock information, j) alarm status/notification, k) time of use, l) pressure mode, operation mode, and/or selected training session, m) whether full occlusion has been obtained, n) whether maximum workout time period has occurred, and/or o) wireless connection status to computer, tablet, smart phone, and/or other type of smart device.
[0153] Motor/pump unit 320 on BFRT cuff 310 can be configured to be manually controlled by the user activating/pressing/moving buttons, switches, locations on the display, etc., and/or motor/pump unit 320 can be configured to be controlled wirelessly and/or wired by a computer, tablet, smart phone, and/or other type of smart device. The wired and/or wireless control of motor/pump unit 320 can be accomplished via a program or app running on a computer, tablet, smart phone, and/or other type of smart device, Wired and/or wireless control of motor/pump unit 320 can also be accomplished by voice commands. As can be appreciated, motor/pump unit 320 can include electronics, software, etc. to enable voice control of motor/pump unit 320 without the need of a computer or other type of smart device. When programs or apps are used to wire and/or wirelessly control motor/pump unit 320, these programs or apps can be used to both monitor the operation of motor/pump unit 320 as well as control the operation of motor/pump unit 320 and/or monitor the status of BFRT cuff 310.
[0154] BFRT cuff 310 can optionally include a pressure sensor and one or more processors to a) facilitate in controlling/maintaining/regulating; the pressure in the one or more air chambers of BFRT cuff 310, b) provide pressure information to motor/pump unit 320 to be displayed on motor/pump unit 320 and/or wired and/or wirelessly sent to a remote device, c) provide pressure information to be displayed on one or more displays on BFRT cuff 310 and/or wired and/or wirelessly sent to a remote device, d) provide pressure information wirelessly to a computer, tablet, smart phone, and/or other type of smart device and have such information displayed using a computer program or mobile app. The one or more pressure sensors can be part of the motor/pump unit 320 and/or be located at a different location on BFRT cuff 310.
[0155] Motor/pump unit 320 on BFRT cuff 310 can be configured to allow a user to manually input a predetermined limb occlusion pressure; motor/pump unit 320 uses such information to control/maintain/regulate the pressure in the one or more air chambers of BFRT cuff 310. BFRT cuff 310 can also or alternatively be configured to wired and/or wirelessly receive information regarding the automatic calculation of a predetermined limb occlusion pressure via a computer program or mobile app running on a computer, tablet, smart phone, and/or other type of smart device and to then use such information to control/maintain/regulate the pressure in the one or more air chambers of BFRT cuff 310.
[0156] BFRT cuff 310 can include one or more sensors and/or control systems to automatically shut off the pump and/or release pressure in the one or more air chambers of BFRT cuff 310 after sensing that an occlusion pressure in the one or more air chambers has been maintained for some preset period of time 0.001-30 seconds, 0.001 seconds to 1 minute, 0.001 seconds to 4 minutes, 0.001 seconds to 5 minutes, etc.). In one non-limiting arrangement, BFRT cuff 310 and/or motor/pump unit 320 can include one or more sensors and/or control systems to automatically shut off the pump and/or release pressure in the one or more air chambers of BFRT cuff 310 after sensing that an occlusion pressure in the one or more air chambers has been maintained for 0.001 seconds to 45 seconds (and all values and ranges therebetween). Such a feature facilitates in the proper use of BFRT cuff 310 and prevents extended periods of time of occlusion pressure being applied to user so as to not damage or impair rehabilitation of the tissue of the user during the use of BFRT cuff 310.
[0157] BFRT cuff 310 and/or motor/pump unit 320 can include a sensor and/or control system to automatically shut off the motor/pump unit and/or to release pressure in the one or more air chambers of BFRT cuff 310 after some preset period of time (e.g., 20 minutes, etc.). Such a feature preserves the life of BFRT cuff 310 and functions as another safety feature of BFRT cuff 310. In one non-limiting arrangement, BFRT cuff 310 and/or motor/pump unit 320 include one or more sensors and/or control systems to automatically shut off pump and/or motor/pump unit 320, and/or to release pressure in the one or more air chambers of BFRT cuff 310 after 2-20 minutes (and all values and ranges therebetween).
[0158] BFRT cuff 310 and/or motor/pump unit 320 can include one or more sensors to detect use and non-use of BFRT cuff 310 (e.g., motion sensor, etc.) and to automatically shut off the pump and/or releases pressure in the one or more air chambers of BFRT cuff 310 after some preset period of time of non-use of BFRT cuff 310 (e.g., 1-20 minutes, etc.). Such a feature preserves the life of BFRT cuff 310. In one non-limiting arrangement, BFRT cuff 310 and/or motor/pump unit 320 include one or more sensors to detect use and non-use of BFRT cuff 310 and to automatically shut off the pump and/or releases pressure in the one or more air chambers of BFRT cuff 310 after 1-10 minutes (and all values and ranges therebetween) of non-use of BFRT cuff 310.
[0159] BFRT cuff 310 can optionally include a UPS sensor or other type of location sensor. This type of sensor is used to track the location of BFRT cuff 310 and/or to monitor movement of BFRT cuff 310 during an exercise routine to determine if proper use of BFRT cuff 310 is being utilized by the user during a certain exercise routine.
[0160] BFRT cuff 310 can optionally include one or more lateral sensors, movement sensors and/or a gyroscope arrangement to monitor movement of BFRT cuff 310 during an exercise routine to determine if proper use of BFRT cuff 310 is being utilized by the user during a certain exercise routine.
[0161] BFRT cuff 310 can include one or more pressure modes (e.g., ischemic preconditioning mode (“IPC”), manual mode, auto mode, etc.). These modes can be manually selected, wirelessly selected, wire selected, and/or selected by voice command. The IPC mode is a mode in which BFRT cuff 310 is inflated to full occlusion of the artery for some time period (e.g., 10 seconds-5 minutes [and all values and ranges therebetween], etc.) and at some rest period interval (e.g., 10 seconds-4 minutes [and all values and ranges therebetween], etc.) between the periods of occlusion. In auto mode, motor/pump unit 320 automatically sets the optimal pressure based on what LOP % set by the user or by information wirelessly received from a device that has automatically calculated the pressure optimal pressure based on what LOP % that is set by the user. In the manual mode, the user manually sets the pressures on BFRT cuff 310 or on a device that then wired and/or wirelessly sends the pressure information to BFRT cuff 310.
[0162] BFRT cuff 310 can be monitored and/or controlled by a computer program and/or mobile app running on a computer, tablet, smart phone, and/or other type of smart device. The computer program and/or mobile app can 1) select a mode of operation for BFRT cuff 310, 2) activate/deactivate BFRT cuff 310, 3) transmit/receive information to/from BFRT cuff 310, 4) select/control/maintain/reduce the pressure in the one or more air chambers of BFRT cuff 310 while the user uses BFRT cuff 310, 5) monitor the operation of BFRT cuff 310, 6) maintain a log regarding the use of BFRT cuff 310, 7) provide an exercise plan for a user that is using BFRT cuff 310, 8) record/monitor the progress/compliance of a user's exercise plan, 9) select/recommend a BFRT training session for a user, 10) keep track of a user's BFRT training sessions, 10) provide suggested training tips for RPM' to the user, 11) provide BFRT information to a user, 12) transmit/receive data to/from a user's BFRT trainer or instructor, 13) maintained a pressure or pressure range or % LOP or rang of % LOP in the BFRT cuff during use, and/or 14) partially or fully deflate the BFRT cuff for a certain period of time after an exercise is completed, between exercise routines, or after non-use of the BFRT cuff is detected.
[0163] BFRT cuff 310 can include security protocols to prevent misuse and/or unauthorized use of BFRT cuff 310. A computer program or mobile app that can run on a computer, tablet, smart phone, and/or other type of smart device can include password protection and/or other security controls to prevent unauthorized use of BFRT cuff 310 and/or access to personal information regarding the use of BFRT cuff 310. The motor/pump unit 320 can also include password protection to prevent unauthorized operation of BFRT cuff 310.
[0164] To aid the Patent Office and any readers of this application and any resulting patent in interpreting the claims appended hereto, Applicant does not intend any of the appended claims or claim elements to invoke 35 U.S.C. 112(f) unless the words “means for” or “step for” are explicitly used in the particular claim.
[0165] It will thus be seen that the objects set forth above, among those made apparent from the preceding description, are efficiently attained, and since certain changes may be made in the constructions set forth without departing from the spirit and scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense. The invention has been described with reference to preferred and alternate embodiments. Modifications and alterations will become apparent to those skilled in the art upon reading and understanding the detailed discussion of the invention provided herein. This invention is intended to include all such modifications and alterations insofar as they come within the scope of the present invention. It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described and all statements of the scope of the invention, which, as a matter of language, might be said to fall there between. The invention has been described with reference to the preferred embodiments. These and other modifications of the preferred embodiments as well as other embodiments of the invention will be obvious from the disclosure herein, whereby the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation. It is intended to include all such modifications and alterations insofar as they come within the scope of the appended claims.