Systems, methods, and devices for monitoring and expressing medical treatment compliance

Abstract

A compression garment controller and method for monitoring the compliance of a user wearing a compression garment wrapped around a limb of the user according to compression therapy. The method includes: directing a fluid flow from a pressurized fluid flow source to periodically inflate and deflate an inflatable bladder of the pressurized garment; receiving a pressure signal indicative of a fluid pressure in the inflatable bladder from the pressure sensor during at least one of inflation and deflation of the inflatable bladder during a plurality of successive pressurization cycles, the inflatable bladder communicatively coupled to the pressure sensor; processing the received pressure signal to determine compliance or non-compliance of the compression therapy; causing at least one light emitting diode (LED) to light in a first color upon indication of compliance with the compression therapy; and cause the at least one LED to light in a second color when indicating that the compression therapy is not compliant.

Description

[0001] Priority Claim

[0002] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 384,359, filed on November 18, 2022, entitled "Systems, Methods, and Devices for Monitoring and Expressing Compliance with Medical Treatments", the disclosure of which is incorporated herein by reference. Technical Field

[0003] Aspects of the present disclosure relate to systems, methods, and devices for controlling, monitoring, and expressing compliance with a treatment and more particularly for controlling, monitoring, and expressing compliance with a compression treatment. Background Art

[0004] Intermittent pneumatic compression (IPC) systems include devices for applying a pressurized fluid (such as air) to a patient's or wearer's limb. In some cases, pressurized air is applied to the lower limbs of a patient at risk of developing deep vein thrombosis (DVT). IPC systems typically include a pumping unit that manages fluid pressurization, a set of tubes that extend fluid delivery beyond the pumping unit, and a compression garment that wraps around the patient's limb and contains the pressurized fluid. The IPC system intermittently pressurizes the garment to apply a therapeutic compression to the patient's limb, causing blood to move from that area of the limb. However, the effectiveness of such IPC systems for DVT prevention depends on the patient's compliance with the compression treatment or the prescribed treatment regimen that includes the IPC system. Summary of the Invention

[0005] In some aspects, the techniques described herein relate to a compression garment controller for monitoring a user's compliance with wearing a compression garment according to a compression therapy, the controller comprising: a display screen configured to display a graphical user interface; at least one light emitting diode (LED) configured to selectively illuminate different colors; at least one computer-readable storage medium configured to store one or more monitored parameters; one or more processors coupled to the at least one computer-readable storage medium; and computer-executable instructions embodied on the at least one computer-readable storage medium, the instructions including instructions that cause the one or more processors to perform the following operations: direct a fluid flow from a pressurized fluid flow source to periodically / repeatedly inflate and deflate at least one inflatable bladder of the compression garment, the inflatable bladder being configured to wrap around a limb of a wearer of the garment; during at least one of inflation and deflation of the at least one inflatable bladder in a plurality of successive pressurization cycles, receive a pressure signal indicative of a fluid pressure in the at least one inflatable bladder from a pressure sensor, the at least one inflatable bladder communicatively coupled to the pressure sensor; process the received pressure signal; in response to the received pressure signal indicating compliance with the compression therapy, cause at least one LED to illuminate a first color; and in response to the received pressure signal indicating an operation interruption or non-compliance with the compression therapy, cause at least one LED to illuminate a second color.

[0006] In some aspects, the techniques described herein relate to a controller attachment configured to couple a compression garment controller to a rod, the controller attachment comprising: a first receiving portion including a concave portion adapted to receive a portion of a handle of the compression garment controller; a second receiving portion coupled to the first receiving portion and including a passage adapted to receive one or more wires or tubes; an interconnecter coupled to the second receiving portion; and a rod attachment portion coupled to the interconnecter and having a U-shaped configuration adapted to captively receive the rod.

[0007] In some aspects, the techniques described herein relate to a method for a pressurized garment controller that monitors a user's compliance with wearing a pressurized garment wrapped around a limb of the user for pressurization therapy. The method includes: directing a fluid flow from a pressurized fluid flow source to periodically inflate and deflate an inflatable bladder of the pressurized garment; during at least one of inflation and deflation of the inflatable bladder in a plurality of successive pressurization cycles, receiving a pressure signal indicative of the fluid pressure in the inflatable bladder from a pressure sensor communicatively coupled to the inflatable bladder; processing the received pressure signal to determine compliance or non-compliance with the pressurization therapy; in response to the received pressure signal indicating compliance with the pressurization therapy, causing at least one light-emitting diode (LED) to illuminate in a first color; and in response to the received pressure signal indicating an operation interruption or non-compliance with the pressurization therapy, causing at least one LED to illuminate in a second color.

[0008] In some aspects, the techniques described herein relate to a pressurized garment system that includes: a pressurized garment and a controller. The controller includes: a display screen configured to display a graphical user interface (GUI); a plurality of light-emitting diodes (LEDs) arranged at a visible angle on the controller; a memory; a processor coupled to the memory and configured to: direct a fluid flow from a pressurized fluid flow source to periodically inflate and deflate an inflatable bladder of the pressurized garment configured to wrap around a limb of a wearer of the pressurized garment; during at least one of inflation and deflation of the inflatable bladder in a plurality of successive pressurization cycles, receive a pressure signal indicative of the fluid pressure in the inflatable bladder from a pressure sensor communicatively coupled to the inflatable bladder; process the received pressure signal to determine compliance or non-compliance with the pressurization therapy; in response to the received pressure signal indicating compliance with the pressurization therapy, cause the plurality of LEDs to illuminate in a first color; and in response to the received pressure signal indicating an operation interruption or non-compliance with the pressurization therapy, cause the plurality of LEDs to illuminate in a second color.

[0009] Other aspects, features, and advantages will become apparent from the specification, the drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1 is a perspective view of a pressurized system including a pressurized garment and a controller according to one aspect of the present invention.

[0011] Figure 2 is Figure 1 a schematic representation of the pressurized system of, the pressurized system including a schematic diagram of a pneumatic circuit according to one aspect of the present invention.

[0012] Figure 3 is Figure 1Schematic representation of another exemplary pressurization system, including a schematic diagram of a pneumatic circuit according to one aspect of the present invention.

[0013] Figure 4 Is a graphical representation of the pressure characteristic curve generated by the pressurization system according to one aspect of the present invention when the pressurized garment is in a wrapped configuration on a leg mold (simulating the limb of a wearer). Figure 1

[0014] Figure 5 Is a graphical representation of the pressure characteristic curve generated by the pressurization system according to one aspect of the present invention when the pressurized garment of the system is in an unwrapped configuration and away from the leg mold (simulating the limb of a wearer). Figure 1

[0015] Figure 6 Is Figure 1 A graphical representation of the manifold pressure signals of the pressurization system, which respectively correspond to the manifold pressure signals of the wrapped pressurized garment configuration in Figure 4 And the unwrapped pressurized garment configuration in Figure 5

[0016] Figure 7 Is a perspective view of the controller of the pressurization system according to one aspect of the present invention.

[0017] Figure 8 Is a side view of the controller attached to the bedplate according to one aspect of the present invention.

[0018] Figure 9A Is a rear view of the rod attachment portion of the attachment member before being attached to the rod according to one aspect of the present invention.

[0019] Figure 9B Is a rear view of the rod attachment portion of the attachment member attached to the rod according to one aspect of the present invention.

[0020] Figure 10A Is a front perspective view of the attachment member according to one aspect of the present invention.

[0021] Figure 10B Is a front view of the attachment member according to one aspect of the present invention.

[0022] Figure 10C Is a side view of the attachment member according to one aspect of the present invention.

[0023] Figure 10D Is a rear view of the attachment member according to one aspect of the present invention.

[0024] Figure 10E Is a top view of the attachment member according to one aspect of the present invention.

[0025] ​​​Figure 10F Perspective view of a controller attached to an attachment member according to one aspect of the present invention.

[0026] Figure 11 Front view of a display of a controller according to one aspect of the present invention.

[0027] Figure 12A and Figure 12B Exemplary flowchart of a method for activating a controller according to one aspect of the present invention.

[0028] Figure 13A and Figure 13B Exemplary flowchart of a method for expressing compliance with compression therapy according to one aspect of the present invention.

[0029] Figure 14A Graphical representation of a graphical user interface (GUI) showing an icon of a single three - bladder leg sleeve garment according to one aspect of the present invention.

[0030] Figure 14B Graphical representation of an icon of a foot sheath according to one aspect of the present invention.

[0031] Figure 14C Graphical representation of an icon of a three - bladder leg sleeve according to one aspect of the present invention.

[0032] Figure 14D Graphical representation of an icon of a single - bladder leg sleeve according to one aspect of the present invention.

[0033] Figure 14E Graphical representation of an icon of vascular refill detection according to one aspect of the present invention.

[0034] Figure 14F Graphical representation of an icon of a garment mismatch error according to one aspect of the present invention.

[0035] Figure 15 Graphical representation of a graphical user interface (GUI) showing a graphical meter of compliance with compression therapy according to one aspect of the present invention.

[0036] Figure 16 Graphical representation of a graphical user interface (GUI) showing multiple graphical meters of compliance with compression therapy according to one aspect of the present invention.

[0037] Figure 17 Exemplary flowchart of a method for selecting a current time zone according to one aspect of the present invention.

[0038] Figure 18 Graphical representation of a graphical user interface (GUI) showing a menu according to one aspect of the present invention.

[0039] Figure 19 is a graphical representation of a graphical user interface (GUI) showing a world map for selecting a current time zone according to one aspect of the present invention.

[0040] Figure 20 is a method of compliance monitoring using Figure 1 an exemplary flowchart of a pressurization system according to one aspect of the present invention.

[0041] Figure 21A and Figure 21B is a flowchart of an exemplary implementation of a method for detecting sleeve removal according to multiple aspects of the present invention.

[0042] Figure 22 is a flowchart of an exemplary implementation of a method for detecting sleeve re - application according to multiple aspects of the present invention.

[0043] Figure 23 is a graphical representation of a polynomial curve - fitting line of the pressure in a manifold in both a wrapped configuration and an unwrapped configuration during an inflation phase of an airbag of a pressurized garment according to one aspect of the present invention.

[0044] Figure 24 is, when a pressurized garment is in a wrapped configuration on a wearer's limb according to one aspect of the present invention, Figure 1 a graphical representation of a first pressure signature curve generated by a pressurization system.

[0045] Figure 25 is, when a pressurized garment is in an unwrapped configuration and away from a wearer's limb according to one aspect of the present invention, Figure 1 a graphical representation of a first pressure signature curve generated by a pressurization system.

[0046] Figure 26 is a method of compliance monitoring using Figure 1 a flowchart of a first method of a pressurization system according to one aspect of the present invention.

[0047] Figure 27 is a method of compliance monitoring using Figure 1 a flowchart of a second method of a pressurization system according to multiple aspects of the present invention.

[0048] Figures 28A - 28C is, when a pressurized garment is in a wrapped configuration on a wearer's limb according to one aspect of the present invention, Figure 1 a graphical representation of a first set of pressure signature curves generated by a pressurization system.

[0049] Figure 29 is, when a pressurized garment is in an unwrapped and away from a wearer's limb, Figure 1Graphical representation of the second pressure characteristic curve generated by the pressurization system.

[0050] Figure 30A and Figure 30B is a graphical representation of the third pressure characteristic curve generated by the pressurization system when a pressurized garment is wrapped around a limb of a wearer according to one aspect of the present invention. Figure 1 Graphical representation of the third pressure characteristic curve generated by the pressurization system.

[0051] Figure 31 is a flowchart of an exemplary method for analyzing waveform data received from a pressure sensor by detecting pulsations associated with the heart rate of a wearer to determine whether a pressurized garment is in a wrapped configuration or an unwrapped configuration around a limb of the wearer of the garment according to one aspect of the present invention.

[0052] Figure 31

[0053] Figure 32 is a flowchart of an exemplary method for analyzing waveform data received from a pressure sensor during a garment verification process to determine whether a pressurized garment is in a wrapped configuration or an unwrapped configuration according to one aspect of the present invention.

[0054] Figure 33 is a flowchart of an exemplary method for analyzing waveform data received from a pressure sensor after a cyclic pressure ends to determine whether a pressurized garment is in a wrapped configuration or an unwrapped configuration according to one aspect of the present invention.

[0055] Figure 34 is a flowchart of an exemplary method for analyzing waveform data received from a pressure sensor during a venous refill determination (VRD) process to determine whether a pressurized garment is in a wrapped configuration or an unwrapped configuration according to one aspect of the present invention.

[0056] Figure 35 is a flowchart of an exemplary method for analyzing waveform data received from a pressure sensor as an independent cycle to determine whether a pressurized garment is in a wrapped configuration or an unwrapped configuration according to one aspect of the present invention.

[0057] Figures 36A to 36C is a flowchart of a first exemplary method for analyzing waveform data received from a pressure sensor by detecting pulsations associated with the heart rate of a wearer to determine whether a pressurized garment is in a wrapped configuration or an unwrapped configuration around a limb of the wearer of the pressurized garment according to one aspect of the present invention.

[0058] Figure 37 is a graphical representation of a signal after passing through a low-pass filter when a pressurized garment is in a wrapped configuration on a limb of a wearer according to one aspect of the present invention.

[0059] Figure 38Graphical representation of peak detection when a compression garment is in a wrapped configuration on a limb of a wearer, in accordance with one aspect of the present invention.

[0060] Figures 39A to 39C Flowchart of a second exemplary method for analyzing waveform data received from a pressure sensor by detecting pulsations associated with a wearer's heart rate to determine whether a compression garment is in a wrapped configuration or an unwrapped configuration around a limb of the wearer of the compression garment, in accordance with one aspect of the present invention.

[0061] Figure 40 Block diagram of an example system diagram of different hardware components and other features used in accordance with one aspect of the present disclosure.

[0062] Throughout the figures, corresponding reference numerals indicate corresponding components. Detailed Description

[0063] As used herein, the terms "proximal" and "distal" denote the relative positions of components, parts, etc. of a compression garment when the compression garment is worn. For example, a "proximal" component is arranged closest to the wearer's torso, a "distal" component is arranged farthest from the wearer's torso, and an "intermediate" component is generally arranged anywhere between the proximal component and the distal component. Additionally, as used herein, the term "wrapped" or "wrapped configuration" refers to a compression garment being properly wrapped around a limb of a wearer. "Unwrapped" or "unwrapped configuration" refers to a compression garment not being wrapped around a limb of a wearer, the compression garment being in a laid configuration, the compression garment being wrapped but not around a limb of a wearer (e.g., wrapped on itself), or the compression garment being loosely wrapped around a limb of a wearer but providing an indeterminate reading by one or more pressure sensors. "Prescribed treatment regimen", "prescribed treatment", "compression treatment regimen", and "compression treatment" are used interchangeably and describe the use of a compression system. Some methods in this application include the step of exhausting an air bladder to a target value or target pressure. Alternatively, the air bladder can be exhausted and then inflated to a target value or target pressure.

[0064] Reference Figures 1 to 3 , compression system 1 includes compression garment 10 and controller 5. Compression garment 10 is for applying a compression treatment to a limb of a wearer. Controller 5 has one or more processors 7 and is on a computer-readable storage medium 33 (in Figure 2 and Figure 3Computer-executable instructions ("CEI") 33a implemented on a non-transitory computer-readable medium (shown as "memory" in FIG. ), the computer-executable instructions including instructions that cause one or more processors to control the operation of the pressurization system 1. Depending on the pressurized garment 10, the pressurization treatment can be sequential or non-sequential pressurization treatment. The pressurized garment can be a three-airbag pressurized sleeve, a single-airbag pressurized sleeve, a foot sheath, or any other type of pressurized garment that can be used in a pressurization treatment. Although this application describes the use of a three-airbag pressurized sleeve, those of ordinary skill in the art will understand that the pressurized garment 10 can be a single-airbag pressurized sleeve, a foot sheath, and / or any other type of pressurized garment that can be used for pressurization treatment without departing from the scope of the present invention. As shown, the pressurized garment 10 includes a distal inflatable airbag 13a, a middle inflatable airbag 13b, and a proximal inflatable airbag 13c. The pressurized garment 10 can be fastened around the wearer's limb and is adjustable in one aspect to fit limbs of different circumferences.

[0065] As described in further detail below, the controller 5 controls the operation of the pressurization system 1 to perform an inflation cycle, in which the inflatable airbags 13a, 13b, 13c are inflated during one or more pressurization cycles to apply pressure to the wearer's limb, thereby establishing a gradient pressure applied to the wearer's limb through the inflatable airbags 13a, 13b, 13c of the pressurized garment 10. Also as described in further detail below, for the purposes of this specification, each therapeutic pressurization cycle includes an inflation phase of all three airbags 13a, 13b, 13c, a decay phase of airbags 13a, 13b, and an exhaust phase of all three airbags 13a, 13b, 13c. The end-of-cycle pressure of each airbag 13a, 13b, 13c is the pressure in each airbag 13a, 13b, 13c before the start of the exhaust phase of the corresponding airbag 13a, 13b, 13c. As will be explained in more detail below, the controller 5 determines, at least in part, based on the measured pressure of one or more of the inflatable airbags 13a, 13b, 13c, whether the pressurized garment 10 is applied to (i.e., wrapped around and configured on) the wearer's limb, and in some aspects of the present disclosure provides an indication of this determination (e.g., by incrementing a timer, by pausing a timer, by providing an audible alarm, and / or by providing a visual indication on a graphical user interface (GUI) and / or a light-emitting diode (LED)). Determining whether the pressurized garment 10 is being worn (i.e., wrapped around and configured on the wearer's limb) provides a compliance monitoring function that enables the pressurization system 1 to track when the garment is being properly used to achieve a prescribed treatment, such as a pressurization treatment. Also as described in further detail below, the controller 5 can control the operation of the pressurization system 1 to perform an inflation cycle, in which the inflatable airbags 13a, 13b, 13c are inflated during one or more pressurization cycles to apply pressure to the wearer's limb, thereby establishing a gradient pressure applied to the wearer's limb, for example, through the inflatable airbags 13a, 13b, 13c of the pressurized garment 10.

[0066] The pressurized garment 10 is a thigh-length sleeve that is positioned / locatable around the wearer's leg, where the distal airbag 13a is around the wearer's ankle, the intermediate airbag 13b is around the wearer's calf, and the proximal airbag 13c is around the wearer's thigh. The inflatable airbags 13a, 13b, 13c expand and contract under the influence of a fluid (e.g., air or other fluid) delivered from a pressurized fluid source 21 (e.g., a pump or compressor) that is in electrical communication with the controller 5. The pressurized fluid source 21 delivers a pressurized fluid (e.g., air) to the inflatable airbags 13a, 13b, 13c through a conduit 23.

[0067] Reference Figure 2, each inflatable airbag 13a, 13b, 13c is in fluid communication with a corresponding valve 25a, 25b, 25c. A pressure sensor 27 is in communication (e.g., fluid communication) with the manifold 29 to measure a signal indicative of the pressure in the manifold 29. The fluid communication between the manifold 29 and the corresponding inflatable airbags 13a, 13b, 13c can be controlled by controlling the position of the corresponding valves 25a, 25b, 25c (e.g., by activation and / or deactivation of the corresponding valves 25a, 25b, 25c). The pressure sensor 27 is in electrical communication with the controller 5 such that the controller 5 receives from the pressure sensor 27 a signal indicative of the pressure in the manifold 29 and / or a signal indicative of the pressure in one or more of the inflatable airbags 13a, 13b, 13c that are in fluid communication with the manifold 29 due to the position of the corresponding valves 25a, 25b, 25c. If only one airbag 13a, 13b, or 13c is in fluid communication with the manifold 29, the signal received from the pressure sensor 27 represents the pressure in the corresponding airbag 13a, 13b, 13c that is in fluid communication with the manifold 29. For example, when valve 25a is open and valves 25b, 25c are closed, the pressure sensor 27 provides a signal indicative of the pressure in the inflatable airbag 13a. Similarly, when valve 25b is open and valves 25a, 25c are closed, the pressure sensor 27 provides a signal indicative of the pressure in the airbag 13b. Likewise, when valve 25c is open and valves 25a, 25b are closed, the pressure sensor 27 provides a signal indicative of the pressure in the inflatable airbag 13c. In one aspect of the present invention, an exhaust valve 25d is actuatable to control the fluid communication between the manifold 29 and an exhaust port 15 that leads to the surrounding atmosphere. All airbags 13a, 13b, 13c can be exhausted using the exhaust valve 25d. In another aspect of the present disclosure, the exhaust valve may not be implemented on the device.

[0068] Each valve 25a, 25b, 25c is a two-position two-way normally open solenoid valve. Each valve 25a, 25b, 25c includes two ports (X and Y) and is actuatable to fluidly connect an inlet port to an airbag port in a first open position. Each valve 25a, 25b, 25c is further actuatable to cut off the fluid communication between the inlet port and the airbag port. The inlet port of each valve 25a, 25b, 25c is in fluid communication with a pressurized fluid source 21 and the manifold 29. The airbag port of each valve 25a, 25b, 25c is in fluid communication with a corresponding inflatable airbag 13a, 13b, 13c.

[0069] Any one of the airbags 13a, 13b, 13c can be placed in fluid communication with the pressurized fluid source 21 and the manifold 29 through the corresponding valves 25a, 25b, 25c to deliver the pressurized fluid to the airbags 13a, 13b, 13c. After the airbags 13a, 13b, 13c are inflated, the corresponding valves 25a, 25b, 25c can hold the fluid in the corresponding airbags 13a, 13b, 13c. Thus, the airbags 13a, 13b, 13c of the pressurized garment 10 can be inflated individually by opening the corresponding valves 25a, 25b, 25c and closing the other valves 25a, 25b, 25c, such that only one airbag 13a, 13b, 13c associated with the opened valves 25a, 25b, 25c is in fluid communication with the pressurized fluid source 21 and the manifold 29.

[0070] The exhaust valve 25d is also a two-position two-way normally open solenoid valve. The exhaust valve 25d includes two ports (X and Y) and is actuable to place the inlet port in fluid communication with the exhaust port 15 in a first open position. The exhaust inlet port is in fluid communication with the exhaust port 15 in the first open position. The exhaust valve 25d is further actuable to cut off the fluid communication between the inlet port and the exhaust port 15. The inlet port of the exhaust valve 25d is in fluid communication with the pressurized fluid source 21 and the manifold 29. The exhaust port 15 of the exhaust valve 25d is in fluid communication with the surrounding atmosphere.

[0071] It should be understood that the valves 25a, 25b, 25c, 25d can be of other types and have other arrangements within the pressurization system 1 without departing from the scope of the present disclosure. For example, referring to Figure 3 , these valves can be valves 35a, 35b, 35c, which are two-position three-way solenoid valves and are actuable to control the pressure in the airbags 13a, 13b, 13c without using an exhaust valve.

[0072] Referring again to Figure 2, the computer-executable instructions embodied on the computer-readable storage medium 33 include instructions that cause one or more processors 7 to pressurize (e.g., inflate) the inflatable airbags 13a, 13b, 13c to provide a periodic therapeutic pressurizing pressure to a limb of the wearer. For example, the computer-executable instructions embodied on the computer-readable storage medium 33 include the following instructions: causing one or more processors 7 to control the pressurized fluid source 21 and / or valves 25a, 25b, 25c, 25d to pressurize the inflatable airbags 13a, 13b, 13c to a therapeutic pressurizing pressure for a predetermined period of time, thereby moving blood in the limb from the area under the inflatable airbags 13a, 13b, 13c. The duration for which the airbags 13a, 13b are maintained at the pressurizing pressure is referred to herein as the decay phase. After the decay phase is the exhaust phase, during which the computer-executable instructions include the following instructions: causing one or more processors 7 to control the pressurized fluid source 21 and / or valves 25a, 25b, 25c, 25d to reduce the pressure in the inflatable airbags 13a, 13b, 13c to a lower pressure (e.g., atmospheric pressure).

[0073] The pressurization system 1 can determine whether the pressurized garment 10 is applied (i.e., wrapped) to a limb of the wearer, and in certain aspects of the present disclosure, can provide an indication of this determination, which can help, for example, track the wearer's compliance with the prescribed use of the pressurized garment 10 (e.g., pressurization therapy). The computer-executable instructions embodied on the non-transitory computer-readable storage medium 33 include instructions that cause one or more processors 7 to analyze pressure signal data received from the pressure sensor 27 during a decompression period of a treatment cycle of the pressurization system 1. The computer-executable instructions embodied on the non-transitory computer-readable storage medium 33 include instructions that cause one or more processors 7 to determine whether the characteristics of the received pressure signal data satisfy one or more conditions indicative of the pressurized garment 10 being located on a limb of the wearer.

[0074] In an exemplary aspect, computer-executable instructions cause one or more processors 7 to receive pressure signal data from a pressure sensor 27. The computer-executable instructions can include instructions that cause one or more processors 7 to process a single waveform representative of the pressure within one or more of the air bladders 13a, 13b, 13c. It should be understood that one or more processors 7 can process multiple waveforms without departing from the scope of the present disclosure. By monitoring the pressure signal and corresponding pressure data during a decompression period, such as during a treatment cycle, one or more processors 7 can detect certain characteristics on the waveform that indicate whether the compression garment 10 is properly wrapped around the wearer's limb or unwrapped from the wearer's limb. In some aspects, during the decompression period, the pressure sensor 27 is maintained (or intentionally placed) in constant communication (e.g., fluid and / or mechanical communication) with one or more of the air bladders 13a, 13b, 13c. Exemplary static periods include non-treatment cycles (e.g., the pressure in the air bladders 13a, 13b, 13c is less than about 29 mmHg), subsets of an initial garment detection period, and / or venous refill measurement periods.

[0075] In Figure 3 an exemplary operation of one aspect, where a two-position three-way valve (e.g., a two-position three-way solenoid valve) is utilized, the computer-executable instructions embodied on a computer-readable storage medium 33 include instructions that cause one or more processors 7 to control one or more valves 35a, 35b, 35c of a particular one or more of the air bladders 13a, 13b, 13c such that a fluid path is established between the pressure sensor 27 and one or more of the air bladders 13a, 13b, 13c.

[0076] In Figure 2 an exemplary operation of one aspect, where a two-position two-way valve (e.g., a two-position two-way solenoid valve) is utilized, the computer-executable instructions embodied on a computer-readable storage medium 33 include instructions that cause one or more processors 7 to open or close the exhaust valve 25d such that the manifold 29 is no longer vented. One or more of these computer-executable instructions cause one or more processors 7 to determine whether random pressure pulses and peaks that are expected to occur due to wearer movement (e.g., moving the leg, bending the calf, coughing, sneezing, normal breathing, etc.) are present in the signal received from the pressure sensor 27. Since a certain volume of fluid (e.g., air) remains within one or more of the air bladders 13a, 13b, 13c and extends into the manifold 29 (and thus to the pressure sensor 27), even slight movement will cause the air bladders to move or deform and create pressure peaks in the pressure signal generated by the pressure sensor 27. In contrast, for a compression garment 10 that has been removed from the wearer's limb, the pressure signal generated by the pressure sensor 27 is static and does not have random noise or pressure pulses.

[0077] Now refer to Figure 4 , which shows a representative pressure profile of a pressurized garment 10 configured to wrap around a leg mold (which simulates the leg of a wearer). The leg mold has dimensions, shape, and stiffness similar to those of a human leg. Thus, the leg mold is a suitable analog for a human wearer's leg for analyzing the performance of the algorithms described in this disclosure. Unless otherwise specified, all data shown herein was obtained using the leg mold in an experimental setup.

[0078] This figure shows signals from an experimental setup in which pressure sensors are used to measure the pressure in individual air bladders 13a, 13b, 13c, and pressure sensor 27 is used to measure the pressure in manifold 29. As described in further detail below, using this experimental setup, the pressure measured in air bladders 13a, 13b, 13c is compared to the pressure measured by pressure sensor 27 in manifold 29. It should be understood that in normal use, controller 5 receives signals from pressure sensor 27 to control the operation of pressurization system 1. Figure 4 Shows the correspondence between the manifold pressure measured by pressure sensor 27 and the pressure measured by pressure sensors disposed in each of air bladders 13a, 13b, 13c.

[0079] A single pressurization cycle for at least one of air bladders 13a, 13b, 13c includes an inflation phase, a decay phase, and an exhaust phase for air bladders 13a, 13b, and an inflation phase and an exhaust phase for air bladder 13c. Pressure plot 402 shows the pressure signal for the entire single treatment pressurization cycle of distal air bladder 13a, pressure plot 404 shows the pressure for the entire single treatment pressurization cycle of intermediate air bladder 13b, pressure plot 406 shows the pressure for the entire single treatment pressurization cycle of proximal air bladder 13c, and pressure plot 408 shows the manifold pressure measured by pressure sensor 27 during each of the foregoing treatment pressurization cycles. Each of plots 402, 404, 406 includes an initial air bladder filling period that defines the inflation phase of the treatment pressurization cycle for the corresponding air bladder 13a, 13b, 13c. Once the corresponding target pressure is reached in air bladders 13a, 13b, inflation stops, and the pressure in the air bladders may be maintained at or near the target pressure, thus defining the decay phase of the treatment pressurization cycle for air bladders 13a, 13b. After the decay phase, in the case of air bladders 13a, 13b, or after the inflation phase, in the case of air bladder 13c, during the exhaust phase of the treatment pressurization cycle for each of air bladders 13a, 13b, 13c, the fluid in each of air bladders 13a, 13b, 13c is expelled from the corresponding air bladder.

[0080] At the start of the treatment pressurization cycle, valves 25b, 25c, 25d are energized to the closed position. To inflate the distal balloon 13a, pressurized fluid from the pressurized fluid source 21 is delivered to the distal balloon 13a via valve 25a and conduit 23. Once the target pressure of the distal balloon 13a is reached, or after a period of time measured by timer 31 (after which the target pressure is expected to be reached), valve 25a is energized to close, thereby retaining the pressurized fluid within the distal balloon 13a. Next, the intermediate balloon 13b is inflated by de-energizing valve 25b to the open position such that pressurized fluid from the pressurized fluid source 21 flows into the intermediate balloon 13b. Once the target pressure of the intermediate balloon 13b is reached, or after a period of time measured by timer 31 (after which the target pressure is expected to be reached), valve 25b is energized to close, thereby retaining the pressurized fluid within the intermediate balloon 13b. Next, the proximal 13c is inflated by de-energizing valve 25c to the open position such that pressurized fluid from the pressurized fluid source 21 flows into the proximal balloon 13c. Once the target pressure of the proximal balloon 13c is reached, or after a period of time measured by timer 31 (after which the target pressure is expected to be reached), valves 25a, 25b, 25d are also de-energized to their respective open positions. The open exhaust valve 25d allows the fluid within each of the balloons 13a, 13b, 13c to exhaust to the atmosphere.

[0081] Pressurization system 1 has been described as inflating each balloon 13a, 13b, 13c individually such that only one balloon is filled with pressurized fluid at a time. However, it should be understood that balloons 13a, 13b, 13c may alternatively or additionally be inflated simultaneously or in combination with one another. In certain embodiments, the opening and closing of valves 25a, 25b, 25c, 25d are timed such that only one balloon 13a, 13b, 13c is in fluid communication with pressure sensor 27 and manifold 29 at a time. This facilitates, for example, the use of pressure sensor 27 to measure signals representative of each pressure of each balloon 13a, 13b, 13c.

[0082] Computer-executable instructions embodied on a computer-readable storage medium 33 include instructions that cause one or more processors 7 to receive a measured pressure signal from a pressure sensor 27 throughout a treatment pressurization cycle. When the distal balloon 13a is inflated, one or more processors 7 receive from the pressure sensor 27 a signal indicative of the pressure in the manifold 29, which signal represents the pressure in the distal balloon 13a. In this way, the pressure throughout the entire inflation phase of the distal balloon 13a is measured, including the end-inflation pressure just before the valve 25a closes. When the intermediate balloon 13b is inflated, one or more processors 7 receive from the pressure sensor 27 a signal indicative of the pressure in the manifold 29, which signal represents the pressure in the intermediate balloon 13b. The pressure throughout the entire inflation phase of the intermediate balloon 13b is measured, including the end-inflation pressure just before the valve 25b closes. When the proximal balloon 13c is inflated, one or more processors 7 receive from the pressure sensor 27 a signal indicative of the pressure in the manifold 29, which signal represents the pressure in the proximal balloon 13c. The pressure throughout the entire inflation phase of the proximal balloon 13c is measured, including the end-inflation pressure.

[0083] The computer-executable instructions include instructions that cause one or more processors 7 to determine an end-of-cycle pressure in each of the balloons 13a, 13b, 13c. As used herein, the end-of-cycle pressure is the pressure in each respective balloon 13a, 13b, 13c before the exhaust phase. Thus, for balloons 13a, 13b, the end-of-cycle pressure for each of balloons 13a, 13b is the pressure in each of balloons 13a, 13b at the end of the respective decay phase of the treatment pressurization cycle for each of balloons 13a, 13b. For balloon 13c, the end-of-cycle pressure is the pressure in balloon 13c at the end of the inflation phase of balloon 13c.

[0084] To measure the end-of-cycle pressure, after the proximal balloon 13c is inflated to its target pressure, the valves 25a, 25b, 25c are sequentially switched open and closed to measure the end-of-cycle pressure in each of the balloons 13a, 13b, 13c ( Figure 4 ). Since the valve 25c is open from just after inflating the proximal balloon 13c, the end-of-cycle pressure of the proximal balloon 13c is measured first. As can be seen from Figure 6As will be understood from the pressure characteristic curves therein, for the proximal balloon 13c, the end-of-inflation pressure and the end-of-cycle pressure are the same because the proximal balloon does not experience a decay phase. Valve 25c can be closed and then switched back to open at the end of the pressurization cycle of the proximal balloon 13c. One or more processors 7 switch valve 25a to open and valve 25c to closed to measure the end-of-cycle pressure of the distal balloon 13a. One or more processors 7 switch valve 25b to open and valve 25a to closed to measure the end-of-cycle pressure of the intermediate balloon 13b. Although a specific switching sequence of valves 25a, 25b, 25c has been described, it should be understood that other switching sequences of valves 25a, 25b, 25c are also within the scope of the present disclosure. In one embodiment, each of valves 25a, 25b, 25c is switched to open for approximately 150 milliseconds (ms) to measure the end-of-cycle pressure in the respective balloons 13a, 13b, 13c. Valves 25a, 25b, 25c can be switched to open for a shorter or longer period of time. For example, valves 25a, 25b, 25c can be switched to open for at least approximately 75 ms. Other time periods are also contemplated. The pressure readings measured by pressure sensor 27 are stored in memory 33. During operation, the pressurization cycle is repeated successively a number of times to complete the pressurization treatment.

[0085] The computer-executable instructions can include instructions that cause one or more processors 7 to use the end-of-inflation pressure and the end-of-cycle pressure of at least one of the balloons 13a, 13b to determine a representative line fit. Using these two pressure points, a line representing the decay phase is generated. The values of the representative line are compared with the end-of-inflation pressures of balloons 13b, 13c to determine whether the pressure of the subsequently inflated balloons 13b, 13c potentially rises above the pressure of the previously inflated balloons 13a, 13b at any point during the pressurization cycle.

[0086] Reference Figure 5 , illustrates a representative pressurization cycle pressure characteristic curve of the unwrapped configuration of the pressurization system 1. The pressurization system 1 generates Figure 5 the pressure characteristic curve operates in the same manner as described above for the Figure 4 pressurization cycle pressure characteristic curve. The only difference is that Figure 5 the pressure signal in Figure 5 is obtained when the pressurization garment 10 is in the unwrapped configuration. Pressure graphs 502, 504, 506 show the actual pressures of the distal balloon 13a, the intermediate balloon 13b, and the proximal balloon 13c throughout a single pressurization cycle when the garment 10 is in the unwrapped configuration. Figure 5 The pressure signal from pressure sensor 27 is also shown in pressure graph 508 in

[0087] Reference Figure 6, the pressure signals of the representative pressurization cycle pressure profiles for the wrapped configuration and the unwrapped configuration detected by the pressure sensor 27 are plotted together. As will be explained in more detail below, there are features in the representative pressurization cycle pressure profiles that distinguish between the wrapped configuration and the unwrapped configuration. For example, see Figure 5 , there is a period of time (e.g., around 6436 ms) during which the pressure in the intermediate airbag 13b (504) exceeds the pressure in the distal airbag 13a (502). Additionally, the pressure of the airbags 13a, 13b, 13c before airbag inflation (i.e., the initial pressure offset when time = 0) is slightly higher in the unwrapped configuration. This offset is the result of more residual air remaining in the airbags 13a, 13b, 13c when the garment 10 is removed from the limb. The applicant believes this is because the unwrapped sleeve is less constrained and thus exerts a smaller expulsion force to expel the residual air (i.e., the sleeve can remain "bulged" and thus appears as if it is smaller in volume). Without wishing to be bound by theory, it is believed that this offset stems from the less constrained pressurized garment 10 in the unwrapped configuration, resulting in a smaller expulsion force being exerted to expel the residual air. Additionally, the end-of-inflation pressure of the airbags 13a, 13b in the unwrapped configuration is slightly higher than the end-of-inflation pressure of the airbags 13a, 13b in the wrapped configuration. For the proximal airbag 13c, the situation is the opposite, where the end-of-inflation pressure for the wrapped configuration is slightly higher than the end-of-inflation pressure for the unwrapped configuration. Another distinguishing feature is that the difference between the end-of-inflation pressures in the distal airbag 13a and the intermediate airbag 13b for the unwrapped configuration is less than the difference between the end-of-inflation pressures in the distal airbag 13a and the intermediate airbag 13b for the wrapped configuration.

[0088] The computer-executable instructions embodied on the computer-readable storage medium 33 include instructions that cause one or more processors 7 to model the pressure signals from the pressure sensor 27 for both the wrapped configuration and the unwrapped configuration. In an embodiment, a best-fit line is used to model the pressure signal from the inflation phase of the distal airbag 13a in the wrapped configuration. For example, the model is a best-fit line generated by simple linear regression.

[0089] Analyzing the pressure signal data using a best fit line can provide an indication of whether the air bladder 13a is in a compliant wrap configuration or a non-compliant unwrapped configuration when applying pressure therapy. The difference between the best fit line and the observed pressure signal can be mathematically quantified as a mean squared error (MSE) value. In this case, the MSE value is an indicator of the degree of curvature of the pressure trend observed over a given interval (e.g., inflation of the air bladders of the pressure garment 10). Thus, a larger MSE value indicates a greater curvature of the curve-fitted data, while a low MSE value indicates a smaller curvature of the curve-fitted data. In an embodiment, the graph of the wrap configuration is generally straighter (i.e., more closely conforms to the corresponding best fit line) than the graph of the unwrapped configuration. Mathematically, this means that the MSE value for the curve-fitted line of the graph of the wrap configuration is smaller. In an embodiment, an MSE value below a predetermined amount indicates that the air bladder is in the wrap configuration, while an MSE value greater than or equal to the predetermined amount indicates that the air bladder is in the unwrapped configuration. It is contemplated that other factors can provide an indication of the configuration of the air bladder.

[0090] Reference Figure 7 and Figure 8 , the controller 5 can include a device handle 702 and a pivot handle 704. To secure the controller 5 to the bed, such as a footrest 802, the device handle 702 and the pivot handle 704 are squeezed together, which causes the pivot handle 702 to pivot away from the dorsal side 706 of the controller 5 and increases the gap 710 between the extension 708 of the pivot handle 704 and the dorsal side 706 of the controller 5, as Figure 7 shown. The controller 5 can then be placed on the footrest 802, where the extension of the pivot handle 704 is on one side of the footrest and the dorsal side 706 of the controller 5 is on the other side of the footrest 802. By releasing the device handle 702 and the pivot handle 704, the controller 5 rests on top of the footrest 802, where the extension of the pivot handle 704 presses against the footrest 802, thereby securing the controller 5 to the footrest 802. In one or more alternative aspects, the controller 5 can be placed on a flat surface (e.g., a table, desk, shelf, etc.).

[0091] Reference Figure 9A and Figure 9B , the controller 5 can be secured to a pole 910 (e.g., an intravenous (IV) pole) via an attachment member 1000 ( Figures 10A to 10F shown in). As Figure 9AAs shown, the rod attachment portion 906 of the attachment member 1000 (explained in more detail below) includes an opening 908 that is adapted to captively receive and engage a rod 910 (e.g., an IV rod). The rod attachment portion 906 can be generally U-shaped. A threaded hole is formed on one side of the rod attachment portion 906 to receive a first end of a screw 904, where a second end of the screw is attached to a knob 902, with the first end and the second end being opposite each other. The first end of the screw 904 is inserted into the threaded hole, and the knob 902 is rotated until the first end of the screw 904 presses against the rod 910, thereby fixing and / or clamping the attachment member to the rod 910. Although Figure 9B FIG. illustrates attaching the attachment member 1000 to the rod 910 using a threaded knob 902, attachment can be accomplished using other fasteners such as screws, clamps, ratchets, etc. In one aspect of the present disclosure, the attachment member 1000 can also include a rubber gasket or the like to help maintain the fixation. By rotating the threaded knob 902 in a clockwise direction, the first end of the screw 904 moves toward the rod 910 (e.g., an IV rod) and engages the rod 910. By rotating the threaded knob 902 in a counterclockwise direction, the first end of the screw 904 moves away from the rod 910 (e.g., an IV rod) and disengages from the rod 910.

[0092] Referring Figures 10A to 10F , different views of the attachment member 1000 are illustrated. For example, Figure 10A shows a front perspective view of the attachment member 1000, Figure 10B shows a front view of the attachment member 1000, Figure 10C shows a side view of the attachment member 1000, Figure 10D shows a rear view of the attachment member 1000, Figure 10E shows a top view of the attachment member 1000, and Figure 10F shows a controller 5 engaged with the attachment member 1000. As shown, the attachment member 1000 includes a first receiving portion 1002, a second receiving portion 1006, an interconnecter 1010, and a rod attachment portion 906. The first receiving portion 1002 includes a recessed portion 1004 adapted to receive a portion of a pivot handle 704 of a controller. More specifically, the first receiving portion 1004 is sized and adapted to receive a portion of an extension 708 of the pivot handle 704 of the controller 5, as Figure 10F shown. The second receiving portion 1006 is coupled to the first receiving portion 1002. In one or more aspects, the first receiving portion 1002 and the receiving portion 1006 are integral. The second receiving portion 1006 includes a channel 1008 that is adapted to receive one or more wires or tubes. The interconnecter 1010 can have a U-shaped configuration, where a first side of the vertical portion of the U is inclined and is coupled to the back side of the second receiving portion 1006, asFigure 10E As shown. The second side of the vertical portion of U is upright and coupled to the rod attachment portion 906.

[0093] The controller 5 can operate and control up to two compression garments attached to the controller 5 and the wearer (e.g., patient and / or user). For example, a first compression garment can be placed on a first limb of the wearer and a second compression garment can be placed on another limb of the wearer. In another example, a first compression sleeve garment can be placed on a limb of the wearer and a foot sheath can be placed on the foot of the same limb of the wearer. The controller 5 can include two sets of tubes. Each set of tubes can be coupled to the pump 21 of the controller 5 at a first end, and a connector can be coupled to the second end. One or both sets of tubes can be coupled to the connector of the compression garment. The first set of tubes of the controller 5 can be labeled "A", and the second set of tubes of the controller 5 can be labeled "B".

[0094] Reference Figure 11 , a top view 1100 of the display 1102 of the controller 5 is illustrated. As shown, the display 1102 of the controller 5 can include a power-on indicator 1104, a power-on / standby button 1106, one or more navigation buttons 1108, an AC power / battery charge indicator 1110, one or more LEDs 1112, and a display screen 1114. When the controller 5 is powered on, the power-on indicator 1104 (e.g., a light or an LED) lights up. Power can be via the power of a plug (e.g., an alternating current (AC) power source) or one or more batteries (e.g., a direct current (DC) power source). The controller 5 can include a power-on / standby button 1106. In one aspect of the present disclosure, when the power-on / standby button 1106 is pressed, the controller 5 can be powered on. When the power-on / standby button 1106 is pressed a second time, the controller 5 can be powered off. Any combination of presses of the power-on / standby button 1106 can be configured to operate the controller 5. One or more navigation buttons 1108 can be buttons and are further explained in detail below. In one or more aspects, one or more navigation buttons 1108 can be displayed on a graphical user interface (GUI) displayed on the display screen 1114 (e.g., a touch screen display). The AC power / battery charge indicator 1110 can light up when AC power is supplied to the controller 5 and can charge one or more batteries when AC power is supplied to the controller 5. One or more LEDs 1112 can light up different colors, e.g., green, yellow, red, and / or combinations thereof. Any combination of colors can be implemented. For example, green can indicate the compliance of the patient wearing the compression garment, and yellow can indicate the non-compliance of the patient wearing the compression garment. Additional colors can also be used. For example, red can indicate an error of the controller 5, and another color can indicate that no compression garment is attached to the controller 5.

[0095] In one or more aspects, one or more LEDs 1112 are positioned on the inclined portion 1116 of the controller housing 1118, as Figure 11 shown. The inclined portion 1116 can be inclined (e.g., at an angle of about 15 degrees (15°) with respect to the horizontal line or any variation thereof) to ensure visibility by the user. The one or more LEDs 1112 are positioned in such a way that they can be seen from the side. Thus, a passing nurse or doctor can see the one or more LEDs 1112 and can know the status of the controller 5 by the color displayed by the one or more LEDs 1112. In another aspect of the present disclosure, the LEDs can be seen from a distance farther than the distance to view the display screen. For example, a nurse or doctor can immediately determine the status of the device regarding the patient when walking past the patient's room. This efficiency provided by the LEDs saves valuable time for the provider. For example, in the absence of visible LEDs, a nurse or doctor may waste time entering the patient's room and checking the status of the devices in the patient's room, where the patients may not need assistance. Additionally, in an already understaffed hospital environment, every second spent entering the ward for unnecessary reasons could have been used for more efficient and necessary scenarios, such as handling emergencies.

[0096] Furthermore, when the controller 5 is attached to a foot pedal, attached to an IV pole, or placed on a surface (e.g., a flat surface), a nurse or doctor can see the one or more LEDs 1112 from various advantageous positions at a relatively far distance. Conventional controllers do not provide this feature.

[0097] Referring Figures 12A to 12B , computer-executable instructions embodied on a computer-readable storage medium 33 cause one or more processors 7 of the controller 5 to execute a method 1200 for initializing the controller 5 at startup. The method 1200 begins at block 1202, initiating the startup of the controller. For example, in response to the power button 1106 being pressed, the startup of the controller 5 is initiated. During startup, the one or more LEDs 1112 can display or flash a first color, such as green.

[0098] At block 1204, the method 1200 includes operating the pump and valve, where fluid is delivered to at least one attached pressurized garment. For example, one or more processors 7 send a signal to the pump 21 (e.g., a pressurized fluid flow source), causing the pump 21 to pump fluid or direct the flow of fluid (e.g., air) into at least one attached pressurized garment. This feature is discussed in more detail herein.

[0099] At block 1206, the method includes determining whether at least one attached compression garment is properly coupled / attached to the controller. During startup, the pump 21 and valves are operated and air is delivered out of the controller ports to detect the number and type of garments coupled to the controller 5. For example, at least one processor 7 automatically determines whether a leg sleeve garment is being used and whether the leg sleeve garment is the default. Examples of garment types can be foot sheaths, three - bladder leg sleeves, and single - bladder leg sleeves. If one or both garments are properly coupled to the controller 5, the method proceeds to block 1208. If one or both garments are not properly coupled to the controller 5, the method proceeds to block 1210.

[0100] At block 1208, at least one icon of at least one properly coupled compression garment is displayed. For example, if at least one processor 7 senses that the garment is properly attached, the corresponding icon of the detected compression garment is displayed on the screen 814. For example, if only one controller port is coupled to a garment, the open port is ignored and both the leg and foot will be grayed out. For example, Figure 14A An example of the GUI is shown that displays a single three - bladder leg sleeve garment icon attached to port A and no garment attached to port B on the display screen 1114, where the second garment icon representing the leg (“(B)”) is shown in gray. In different embodiments, the gray - displayed icon indicates that the component it represents is not activated or has failed. Figures 14B - 14E An example of a foot sheath icon, a three - bladder leg sleeve icon, a single - bladder leg sleeve icon, and a vascular refill detection icon are shown. Depending on the attached garments, at least one processor 7 displays one or more of these icons on the display screen 1114 via the GUI. If one or two garments are properly coupled to the controller 5, a compression treatment is provided, as discussed in more detail below.

[0101] At block 1210, a garment mismatch error icon is displayed on the GUI. For example, if one or two garments are not properly coupled to the controller 5, at least one processor 7 displays a garment mismatch error icon on the GUI on the display screen 1114. Figure 14F An example of the garment mismatch error icon is shown.

[0102] At block 1212, a required action is taken. For example, if no garments are properly detected or if no garments are coupled to the controller 5, at least one processor 7 will display an error message on the GUI of the display screen 1114 as described above, and the user (e.g., a nurse or doctor) can take appropriate action to resolve the error. The method can return to block 1206 to determine whether the action taken has resolved the error.

[0103] At block 1214, intermittent pressure is applied to at least one suitably coupled compression garment. For example, at least one processor 7 automatically begins to apply intermittent pressure to at least one suitably coupled compression garment. If two garments are coupled to the controller 5, intermittent pressure is applied to the garments by alternating between the two garments. In successive cycles, at least one processor 7 automatically adjusts the operating parameters to maintain a set pressure. For example, for sequential airbag leg sleeves, the set pressure is 45 mmHg, for foot sheaths, the set pressure is 130 mmHg, and for uniform airbag sleeves, the set pressure is 40 mmHg. As explained in more detail below, the vascular refill detection method provides customized treatment for each patient's physiology. This block is explained in more detail below.

[0104] At block 1216, a compliance gauge graphic is displayed. For example, at least one processor 7 displays a compliance gauge graphic on the GUI of the display screen 814. Figure 15 A compliance gauge graphic 1500 for compression therapy is shown. The compliance gauge graphic 1500 may include a circular bar 1502 representing a 24-hour clock. The circular bar 1502 may display the time elapsed when compression therapy is received, represented in one color (e.g., blue), and the time elapsed when compression therapy is not given, represented in a second color (e.g., orange). For example, compression therapy may not be given because the compression therapy is paused due to a patient program or a lounge break. The compliance gauge graphic 1500 may include numbers 1504 representing the time elapsed for compression therapy. The time elapsed begins when the compliance gauge is reset for that day or when compression therapy starts. The compliance gauge graphic 1500 may include a date 1506, such as October 23, 2021. As shown, for example, on October 23, 2021, the patient starts compression therapy at 2:00 PM and receives 7 hours of compression therapy during a 10-hour period, where the patient does not receive therapy (e.g., is non-compliant) for 1 hour. The compliance gauge graphic 1500 may also show the type of garment attached to the patient. For example, as shown, the patient has two leg sleeve garments applied as represented by the icon 1508. The graphic 1500 may also include a detection icon 1510 indicating that the garment is currently attached to the patient.

[0105] At block 1218, data associated with the compression therapy is recorded. For example, at least one processor 7 may store data associated with the compression therapy in a memory (e.g., computer-readable storage medium 33).

[0106] At block 1220, multiple compliance gauge graphics are displayed in response to a received history instruction. For example, at least one processor 7 may display multiple compliance gauges in response to receiving a history instruction. Figure 16Shows multiple compliance gauges being displayed. In one or more aspects, up to six compliance gauges may be displayed. As shown, the compliance gauges may be shown on a daily basis. As shown, the patient started pressure therapy at approximately noon on October 26, 2021 and received approximately 9.5 hours of pressure therapy. On October 27, 2021, the patient received approximately 21 hours of pressure therapy. On October 28, 2021, the patient received approximately 21.5 hours of pressure therapy. On October 29, 2021, the patient received approximately 21 hours of pressure therapy. On October 30, 2021, the patient received approximately 21.5 hours of pressure therapy. On October 31, 2021, the patient received approximately 19 hours of pressure therapy. The display may include the current date, e.g., October 31, 2021.

[0107] Reference Figure 13A and Figure 13B , computer-executable instructions embodied on a computer-readable storage medium 33 cause one or more processors 7 of a controller 5 to execute a method 1300 for a pressure therapy program. Method 1300 begins at block 1302, directing a fluid flow from a pressurized fluid flow source to repeatedly (or cyclically) inflate and deflate an inflatable bladder of a pressure garment. For example, a pump 21 directs a fluid (e.g., air) flow to repeatedly inflate and deflate at least one inflatable bladder of the pressure garment (e.g., appropriately connected to the pressure garment 10).

[0108] At block 1304, during at least one of inflation and deflation of at least one inflatable bladder in a plurality of successive pressurization cycles, a pressure signal indicative of the fluid pressure in the at least one inflatable bladder is received from a pressure sensor, the at least one inflatable bladder being communicatively coupled to the pressure sensor. For example, at least one processor 7 receives a pressure signal indicative of the fluid pressure in the at least one inflatable bladder from the pressure sensor during at least one of inflation and deflation of the at least one inflatable bladder in a plurality of successive pressurization cycles, the at least one inflatable bladder being communicatively coupled to the pressure sensor. For example, as described with respect to Figures 39A - 39C , at least one inflatable bladder may be vented to a target value, held under pressure, and a signal acquired. Thus, for example, during deflation, a signal may be received to determine if the target value has been reached. Similarly, if at least one inflatable bladder is vented and then inflated to a target value, a signal may be received during inflation. When at least one bladder is held at the target value / pressure, e.g., during inflation, a signal may be received - at least one bladder is being inflated.

[0109] At block 1306, the received pressure signal is processed and it is determined whether the received pressure signal indicates compliance or non - compliance with the pressurization therapy. For example, at least one processor 7 determines whether the received pressure signal indicates compliance or non - compliance with the pressurization therapy. Additionally or alternatively, if at least one processor 7 cannot determine compliance or non - compliance based on the received pressure signal, at least one processor 7 may indicate an indeterminate error. For example, Figures 39A - 39C Further details for determining compliance, non - compliance, and indeterminate / error are provided. Depending on the determination, method 1300 may proceed to block 1308, 1310, or 1312, and thus blocks 1308, 1310, or 1312 are optional.

[0110] At block 1308, in response to determining compliance with the pressurization therapy, at least one LED is caused to light up in a first color. For example, at least one processor 7 causes at least one LED 1112 to light up in a first color, such as green, in response to determining compliance with the pressurization therapy. During compliance with the pressurization therapy, the lighting of the first color can be continuous or flashing. Any change in color can be implemented.

[0111] At block 1310, in response to determining non - compliance with the pressurization therapy, at least one LED is caused to light up in a second color. For example, at least one processor 7 causes at least one LED 1112 to light up in a second color, such as yellow, in response to determining non - compliance with the pressurization therapy. During non - compliance with the pressurization therapy, the lighting of the second color can be continuous or flashing. Any change in color can be implemented.

[0112] At block 1312, in response to determining an error or indeterminacy, at least one LED is caused to light up in a third color. For example, at least one processor 7 causes at least one LED 1112 to light up in a third color, such as red, in response to determining compliance or non - compliance with the pressurization therapy. The lighting of the third color can be continuous or flashing. Any change in color can be implemented.

[0113] At optional block 1314, a gauge of compliance (and / or non - compliance) with the pressurization therapy or the pressurization therapy regimen is displayed on the graphical user interface (GUI) of the controller. For example, at least one processor 7 displays a compliance gauge as Figure 15 shown and as further described with respect to Figure 12A and Figure 12B the compliance gauge.

[0114] At optional block 1316, multiple gauges of compliance (and / or non - compliance) with the pressurization therapy or the pressurization therapy regimen are displayed on the graphical user interface (GUI) of the controller on a daily basis. For example, at least one processor 7 displays a gauge as Figure 16 shown and as further described with respect to Figure 12A and Figure 12BThe compliance meter is further described.

[0115] Reference Figure 17 , computer-executable instructions embodied on a computer-readable storage medium 33 cause one or more processors 7 of a controller 5 to execute a method 1700 for setting the time of the controller 5. The method 1700 begins at block 1702, receiving a selection of a system time icon from a displayed menu. For example, at least one processor 7 receives a selection of the system time icon 1802 from a menu displayed by the GUI on the display screen 1114. For example, as Figure 18 shown, the display screen 1114 includes a plurality of icons, the plurality of icons including a system time icon 1802, a shift icon 1804, and a patient icon 1806. The system time icon 1802 is used to set the system time. As described with respect to Figure 15 1502 of, the shift icon 1804 is used to set a shift and / or a display period, such as 8 hours, 12 hours, or 24 hours. The patient icon 1806 is used to indicate whether patient detection monitoring is on or off. A selection box 1808 can be moved between menu options by using navigation buttons, and a menu option can be selected by using a selection button. For navigation, a return command is associated with a first button 1108A, a left movement command is associated with a second button 1108B, a right movement command is associated with a third button 1108C, and a selection command is associated with a fourth button 1108D. As shown, the system time icon 1802 is selected.

[0116] At block 1704, a world map and the current time are displayed. For example, at least one processor 7 causes a world map 1902 to be displayed and the current time of a highlighted time zone to be displayed in response to the system time icon being selected. For example, as Figure 19 shown, the GUI displays the time 1906 as 3:00 in a given time zone 1904 on the display screen 1114, where the given time zone is highlighted. The world map is segmented according to each time zone.

[0117] At block 1706, the current time is displayed in response to a navigation command. For example, at least one processor 7 causes the current time to be displayed in response to a navigation command. For example, Figure 19 shows the highlighted time zone 1904 and the current time 1906. By using the left movement command associated with the second button 1108B, the selected time zone moves to the left, and by using the right movement command associated with the third button 808C, the selected time zone moves to the right. The displayed time zone and the current time change in response to the use of buttons 1108B, 1108C.

[0118] At block 1708, a selection of the currently highlighted time zone is received. For example, at least one processor 7 receives a selection of a time zone in response to a selection button associated with the fourth button 1108D being selected.

[0119] At block 1710, the selected current time zone is saved. For example, at least one processor 7 saves the selected current time zone in a memory (e.g., computer-readable storage medium 33).

[0120] Reference Figures 20 to 22 , computer-executable instructions embodied on a computer-readable storage medium 33 cause one or more processors 7 to perform method 2040: determining whether the compression garment 10 is in a wrapped configuration or an unwrapped configuration when compression therapy is being applied. Figure 20 The steps illustrated in show a method for determining whether the compression garment 10 is in a wrapped configuration or an unwrapped configuration at a generally high level, and FIGS. 21 and Figure 22 describe the method in more detail. When describing the compliance method performed by one or more processors 7, all three figures will be referenced.

[0121] Reference Figure 20 and FIG. 21, at the start of compliance determination method 2040, the compression system 1 operates to inflate and deflate the air bladders 13a, 13b, 13c in sequence to apply compression therapy to the wearer's limb. The therapy is preferably carried out according to a predetermined compression protocol or compression treatment which, among other things, includes a prescribed period of time during which the patient should receive the treatment. In one aspect of the invention, the compression system 1 can operate indefinitely until stopped. The patient's compliance with the prescribed treatment time or compression treatment time is monitored. The compression system 1 operates for several or more cycles as needed to allow the system to stabilize to a steady state and to collect steady state data before the start of compliance determination. However, a compliance timer or counter can start before the start of compliance determination (e.g., as implemented herein such as in Figure 15 and Figure 16 disclosed). Thus, at the start of compliance determination method 2040, the compression garment 10 is in a wrapped configuration and is operating under normal (steady state) operating conditions. At step 2050, the system 1 operates under default conditions where one or more processors 7 direct the pressure sensor 27 to measure the pressure in the manifold 29 throughout the compression cycle. Over time, the pressure data is discarded and, when new and more recent pressure data becomes available, it replaces the pressure data. At 2060, one or more processors 7 check whether a trigger has occurred indicating that the compression garment 10 may have been unwrapped.

[0122] Typically, a trigger can occur when a measurement result is different from an expected result, which is based on the most recent adjustment history and the steady state control error(s). The trigger can include, for example but not limited to, one or more of the following: a change in the end-of-cycle pressure of at least one of the airbags 13a, 13b, 13c compared to a previous pressurization cycle; a change in the end-of-inflation pressure of at least one of the airbags 13a, 13b, 13c compared to a previous pressurization cycle; an adjustment of the pump 21 caused by the pressure (e.g., an error in the target measurement); a change in the curvature coefficient of at least one of the airbags 13a, 13b, 13c compared to a previous inflation phase; a change in the slope of the inflation phase of at least one of the airbags 13a, 13b, 13c compared to a previous pressurization cycle; a change in the measured pressure of one or more airbags at the end of an operating cycle; a change in the slope of the measured pressure during an exhaust phase; a change in the initial offset of the measured pressure from zero compared to a previous pressurization cycle; the pressure of one of the inflatable airbags 13b, 13c having a lower target pressure exceeding the pressure in the other of the inflatable airbags 13a, 13b having a higher target pressure; a smaller difference in peak pressure between airbag 13a and airbag 13b; a change in the magnitude of the adjustment made to the operation of the pump 21; a statistically significant change in the pressure waveform and any unexpected disturbance or unexpected adjustment of the measured pressure made by the pressurization system 1.

[0123] Reference Figure 21A and Figure 21B , the pressurization system 1 continues normal operation until a trigger is detected to occur (step 2162). If a trigger is detected to occur, it is determined at 2164 whether the occurrence exceeds a predetermined condition, e.g., the expected error of steady state operation. Additionally or alternatively, a pressure change / disturbance of the generated control system response being greater than three times the expected change / disturbance can be used as a predetermined condition. The "expected change / disturbance" can be pre-set or can be a criterion established by the controller 5 by operating the controller in the steady state for a period of time. Additionally or alternatively, an adjustment to the pump 21 being greater than a predetermined threshold compared to the most recent adjustment can be used as a predetermined condition. For example, a trigger can occur when the new adjustment of the pump 21 is greater than 100% of the previous adjustment. If it is determined that the trigger occurrence does not exceed the predetermined threshold or does not meet the criterion, the pressurization system 1 continues normal operation at 2162.

[0124] Reference Figures 20 - 22, if it is determined that a triggering event has occurred effectively to confirm that a condition change from wrapped to unwrapped has occurred for the compression garment 10, data collection begins at 2070. At 2072, one or more processors 7 activate a "sleeve removal" compression cycle counter to count the number of "sleeve removal" compression cycles for which data is collected to confirm the triggering event, as an indication that the garment 10 has become unwrapped. At 2074, the number of "sleeve removal" compression cycles is counted until a sufficient amount of data (i.e., pressure signals) is obtained. The number of "sleeve removal" compression cycles required to obtain a sufficient amount of data to determine whether the garment 10 is in an unwrapped configuration can be different in different situations. In one aspect, the number of "sleeve removal" compression cycles is between approximately ten and approximately twenty compression cycles. Generally, it is determined that a sufficient amount of data has been obtained when the pressure signal reaches a steady state again after the initial triggering event. The memory 33 stores the data related to the "sleeve removal" cycle separately from the reference data obtained during the normal operation of the system 1. Once sufficient data is obtained at 2076, one or more processors 7 extract the data obtained during the normal operation of the system 1 at step 2078. At 2080, one or more processors 7 analyze the "sleeve removal" data after the pressure signal reaches a steady state to determine the airbag pressure value for comparison with the data obtained when the compression system 1 operates under normal conditions.

[0125] At step 2090, one or more processors 7 determine whether the garment 10 is in a wrapped state or an unwrapped state by comparing the "sleeve removal" data with normal operating condition reference data. If at 1892 one or more processors 7 determine that the garment 10 has not been removed and remains in the wrapped configuration, the pressurization system 1 continues normal operation. If at 2094 it is determined that the garment 10 has been removed and the garment is placed in the unwrapped configuration, one or more processors 7 change the recording of the monitored parameters. At step 2090, comparing the "sleeve removal" data with the normal operating condition data may include, but is not limited to, one or more of the following: comparing the end-of-cycle pressure from the "sleeve removal" data with the end-of-cycle pressure of the normal operating condition data from at least one of the airbags 13a, 13b, 13c; comparing the end-of-inflation pressure from the "sleeve removal" data with the end-of-inflation pressure of the normal operating condition data from at least one of the airbags 13a, 13b, 13c; comparing the curvature coefficient of the curve fit on the "sleeve removal" data with the curvature coefficient of the curve fit on the normal operating condition data; comparing the inflation phase slope from the "sleeve removal" data with the inflation phase slope of the normal operating condition data from at least one of the airbags 13a, 13b, 13c; comparing the initial offset of the measured pressure from zero on the "sleeve removal" data with the initial offset of the measured pressure from zero on the normal operating condition data; comparing the exhaust phase slope from the "sleeve removal" data with the exhaust phase slope of the normal operating condition data of at least one of the airbags 13a, 13b, 13c; comparing the measured pressures to determine whether an inflatable airbag with a lower target pressure has a higher measured pressure than an inflatable airbag with a higher target pressure; comparing the peak pressure difference between the inflatable airbags 13a, 13b from the "sleeve removal" data with the peak pressure difference between the airbags 13a, 13b in the normal operating condition data to reduce the difference; comparing the adjustment amplitude of the operation of the pump 21 in the "sleeve removal" data with the adjustment amplitude made in the normal operation data; looking for a statistically significant difference in the pressure waveforms between the "sleeve removal" data and the normal operation data. For example, a pressure peak during the exhaust phase of one of the airbags 13a, 13b, 13c is an indication that the garment 10 is in the wrapped configuration. The comparison step 2090 is a confirmation analysis for confirming the occurrence of a trigger as an indication that the garment is in the unwrapped configuration.

[0126] If the data comparison 2090 indicates a statistically significant change in pressure for any one of the data comparisons and for any one of the air bladders 13a, 13b, 13c, then one or more processors 7 indicate that the garment 10 is in the unwrapped configuration and is no longer being used in a compliant manner. Additionally or alternatively, one or more processors 7 require confirmation for at least two of the air bladders 13a, 13b, 13c: that for any one of the data comparisons, the pressure has changed significantly statistically. Additionally or alternatively, one or more processors 7 require confirmation for all of the air bladders 13a, 13b, 13c: that for any one of the data comparisons, the pressure has changed significantly statistically. Additionally or alternatively, one or more processors 7 require confirmation that for at least two of the data comparisons, the pressure has changed significantly statistically.

[0127] At step 2094, in response to confirmation of the pressure change, one or more processors 7 change the recording of the monitored parameter by at least one of the following: blocking the compliance meter such that no further pressurization cycles are indicated as compliant with the pressurization treatment protocol or pressurization therapy (e.g., the compliance timer stops incrementing); providing an alert indication of non-compliance to the wearer or clinician; blocking the operation of the pressurization system 1; and storing the comparison result in the memory 33 (e.g., a flag).

[0128] Optionally, refer to Figure 22, after one or more processors 7 determine that the garment 10 is in an uncompliant unwrapped configuration, method 2040 for determining whether the pressurized garment 10 is in a wrapped configuration or an unwrapped configuration continues by collecting additional "sleeve removal" data at step 2202. At 2204, one or more processors 7 analyze and compare the additional "sleeve removal" data with the normal operating condition data. If the data comparison at 2204 indicates that the additional "sleeve removal" data matches or nearly matches the normal operating condition data for any one of the airbags 13a, 13b, 13c, then at 2206 one or more processors 7 determine that the garment 10 has returned to the wrapped configuration and is again being used in a compliant manner. In response, one or more processors 7 change the recording of the monitored parameters by at least one of the following: resuming operation of the pressurization system 1, resuming the compliance meter such that subsequent pressurization cycles are indicated as compliant, providing a message warning the wearer or clinician of compliance, and storing the result of the comparison in the memory 33. If the data comparison at 2204 indicates a statistically significant change in pressure for any one of the data comparisons in the data comparison, then at 2202, one or more processors 7 continue to collect additional "sleeve removal" data until one or more processors 7 determine that the pressure signal (such as the measurement described above) matches or nearly matches the normal operating condition pressure signal.

[0129] In various aspects, the linear regression of the inflation phase of airbags 13a, 13b, 13c can be further analyzed for comparing the wrapped state and the unwrapped state. For example, the standard deviation, p-value, maximum and minimum values, and average value between the wrapped state and the unwrapped state can be calculated and compared to further distinguish between the two states. Advanced statistical methods related to regression analysis (such as the curve fitting analysis described herein), such as residual analysis for distinguishing between the sleeve worn state and the removed state, are also within the scope of the present disclosure.

[0130] Although the curve fitting for the inflation phase of airbags 13a, 13b, 13c has been described as a best fit line, these models can be polynomial curve fittings. Refer to Figure 23 , the pressure signal from the inflation phase of airbag 13a is modeled with a fifth-order polynomial curve fitting in the wrapped configuration (2302) and the unwrapped configuration (2304). The fifth-order polynomial curve fitting accurately represents the more dynamic curvature of the inflation phase without overly responding to changes in the pressure signal. Other order polynomial curve fittings are also conceivable. As an example, a lower order can be used, for example, when the curvature is less dynamic and a higher order is not required.

[0131] During the inflation phase of airbags 13a, 13b, 13c in the wrapped configuration, the polynomial curve fitting is generally straighter (i.e., more linear) than the polynomial curve fitting during the inflation phase of airbags 13a, 13b, 13c in the unwrapped configuration. Additionally, for the distal airbag 13a and the intermediate airbag 13b, the pressure during the entire inflation phase of the unwrapped configuration is higher than the pressure during the entire inflation phase of the wrapped configuration. For the proximal airbag 13c, the situation is exactly the opposite, where the pressure during the majority of the inflation phase of the wrapped configuration is higher than the pressure during the majority of the inflation phase of the unwrapped configuration. Additionally, the initial pressure or offset of airbags 13a, 13b in the unwrapped configuration is higher than the initial pressure of airbags 13a, 13b in the wrapped configuration. By identifying the occurrence of these different characteristics, the pressurization system 1 can determine when the garment 10 is in the compliant wrapped configuration and when the garment 10 is in the non-compliant unwrapped configuration.

[0132] In addition, the polynomial curve fitting of the inflation phase of airbags 13a, 13b, 13c can be further analyzed for comparison between the wrapped state and the unwrapped state. For example, the standard deviation, P-value, maximum and minimum values, and average value between the wrapped state and the unwrapped state can be calculated and compared to further distinguish between the two states. Advanced statistical methods related to regression analysis, such as the curve fitting analysis described herein, such as residual analysis for distinguishing between the sleeve worn state and the removed state, are also within the scope of the present disclosure.

[0133] Reference Figure 24 , illustrates a representative pressurization cycle pressure characteristic curve of the wrapped configuration of the pressurized garment 10. This graph shows the signal from the pressure sensor 27. A single pressurization cycle of all three airbags 13a, 13b, 13c in the wrapped configuration of the pressurized garment 10 includes a pressurization period 2402 and a depressurization period 2404. Reference Figure 25 , illustrates a representative pressurization cycle pressure characteristic curve of the unwrapped configuration of the pressurized garment 10. The pressurization period 2502 and the depressurization period 2504 illustrate a single pressurization cycle of all three airbags 13a, 13b, 13c for the unwrapped configuration of the pressurized garment 10. The computer-executable instructions embodied on the computer-readable storage medium 33 include instructions that cause one or more processors 7 to monitor signals from the pressure sensor 27 indicating the airbag pressure during the depressurization periods 2404, 2504. The computer-executable instructions cause one or more processors 7 to detect the difference between the pressure signal during the depressurization period 2404 and the pressure signal during the depressurization period 2504. For example, the pressure signal during the depressurization period 2404 includes a pressure pulse, in Figure 24Generally, at 2406, when the compression garment 10 is in the wrapped configuration, the controller 5 interprets this as indicating movement of the wearer. The pressure signal during the decompression period 2504 is relatively static (i.e., there are no pulses), and the controller 5 interprets this as indicating that the compression garment 10 is in the unwrapped configuration. By analyzing the pressure signals during the decompression periods 2404, 2504, computer-executable instructions cause one or more processors 7 to determine whether the compression garment 10 is in the wrapped configuration or the unwrapped configuration based on the presence (i.e., occurrence) or absence (i.e., non-occurrence) of one or more pressure pulses 2406 during the decompression periods 2404, 2504.

[0134] Referring again to Figure 24 , in another aspect of the pressurization system 1, the bladder pressures of the bladders 13a, 13b, 13c are locked, and computer-executable instructions cause one or more processors 7 to detect an increase (e.g., an increase) in the pressure signal during the decompression period 2404 when the compression garment 10 is in the wrapped configuration generally around the limb of the wearer. The pressure signal during the decompression period 2504 ( Figure 25 ) is relatively static (i.e., there is no increase in pressure), and the controller 5 interprets this as indicating that the compression garment 10 is in the unwrapped configuration. Computer-executable instructions cause one or more processors 7 to determine whether the compression garment 10 is in the wrapped configuration or the unwrapped configuration based on the presence (i.e., occurrence) or absence (i.e., non-occurrence) of an increase in pressure during the decompression periods 2404, 2504.

[0135] Refer to Figure 26, computer-executable instructions embodied on a computer-readable storage medium 33 cause one or more processors 7 to perform the following method 2600: Determine whether the compression garment is in a wrapped configuration or an unwrapped configuration by detecting one or more pressure pulses in a pressure signal received from a pressure sensor 27. At step 2602, the compression system 1 operates to inflate and deflate the air bladders 13a, 13b, 13c to apply compression therapy to the wearer's limb and exhaust the air bladders 13a, 13b, 13c to a target value, such as 1 mmHg - 2 mmHg. At step 2604, the computer-executable instructions cause one or more processors 7 to determine whether the pressure in the air bladders 13a, 13b, 13c has reached the target value. If the target value has not been reached, the computer-executable instructions cause one or more processors 7 to continue exhausting the air bladders 13a, 13b, 13c and the process returns to step 2604. If the target value has been reached, then at step 2606, the computer-executable instructions cause one or more processors 7 to stop exhausting the air bladders 13a, 13b, 13c and monitor the pulses of the pressure signal from the pressure sensor 27 during a decompression period. It should be understood that a filtered signal may be assumed such that any observed pulses will be above the baseline signal noise without departing from the scope of the present disclosure. The signal may be filtered, for example, by a filter circuit in the controller 5 and / or by digital filtering techniques implemented by one or more processors 7 via computer-executable instructions. It should be understood that the computer-executable instructions may cause one or more processors 7 to perform waveform peak detection to determine the amplitude of abnormal peaks and peaks within the expected noise without departing from the scope of the present disclosure. It should also be understood that the computer-executable instructions may cause one or more processors 7 to utilize signal threshold limit detection without departing from the scope of the present disclosure. For example, if a pulse higher than the noise by more than 1 mmHg is detected, then the pulse is considered a pressure pulse. The computer-executable instructions cause one or more processors 7 to implement a counter that maintains a count of the number of consecutive periods in which no pulses are observed.

[0136] At step 2608, the computer-executable instructions cause one or more processors 7 to determine whether the processor 7 detected a pulse at step 2606. If a pulse was detected during step 2606, the computer-executable instructions cause one or more processors 7 to reset counter 2610 to zero because the pulse indicates that the pressurized garment 10 is in a wrapped configuration generally around the limb of the wearer. If no pulse was detected during step 2606, the absence of such a pulse (i.e., non-existence) indicates that the pressurized garment 10 is in an unwrapped configuration away from the limb of the wearer. In such a case, at step 2612, the computer-executable instructions cause one or more processors 7 to determine whether the count of the counter has met or exceeded a counter threshold. For example, the threshold could be ten consecutive cycles, but those skilled in the art will understand that the threshold can be any integer value. Meeting or exceeding the threshold indicates that the pressurized garment 10 is in an unwrapped configuration away from the limb of the wearer because if the pressurized garment 10 were in a wrapped configuration, a pressure anomaly (e.g., a pressure pulse) would have been detected by one or more processors 7.

[0137] If at step 2612 one or more processors 7 determine that the count of the counter has met or exceeded the counter threshold, then at step 2614 the computer-executable instructions cause one or more processors to take the required action. For example, one or more processors 7 can block an operation, stop a compliance timer, warn a user (e.g., the wearer or a caregiver), etc. If at step 2612 one or more processors 7 determine that the count of the counter has not reached the counter threshold, then at step 2616 the computer-executable instructions cause one or more processors 7 to increment the count of the counter and fully exhaust airbags 20a, 20b, 20c, and the process returns to step 2602.

[0138] In an alternative aspect, Figure 26The method 2600 is implemented during venous refill measurement. In such aspects, the airbag 13b is at a pressurized value (e.g., 45 mmHg), the airbag 13b is vented to a target pressure (e.g., 5 mmHg - 7 mmHg) and thus contacts the wearer's limb more firmly compared to deflating the airbag 13b. Alternatively, the airbag 13b can be deflated and then inflated to the target airbag pressure. Accordingly, pressure pulses caused by patient movement are even more apparent in the pressure signal of the pressure sensor 27. For example, at step 2604 the airbag 13b is vented to the target pressure (e.g., 6 mmHg), and at steps 2606 and 2608 the standard deviation and fast Fourier transform (FFT) of the airbag pressure response are monitored / analyzed, as explained with respect to FIG. 39. If the standard deviation exceeds a threshold (e.g., 25) and the FFT maximum exceeds a threshold (e.g., 5), then the method 2600 determines that there are sufficient pressure pulses to indicate that the compression garment 10 is being worn by the wearer (e.g., the patient).

[0139] Reference Figure 27, computer-executable instructions embodied on a computer-readable storage medium 33 cause one or more processors 7 to perform the following method 2700: Determine whether the compression garment is in a wrapped configuration or an unwrapped configuration by detecting an increase (e.g., an increase) in the pressure signal received from the pressure sensor 27. At step 2702, the compression system 1 operates to inflate and deflate the air bladders 13a, 13b, 13c to apply compression therapy to the limb of the wearer and exhaust the air bladders 13a, 13b, 13c to a target value, such as 1 mmHg - 2 mmHg. At step 2704, the computer-executable instructions cause one or more processors 7 to determine whether the pressure in the air bladders 13a, 13b, 13c has reached the target value. If the target value has not been reached, the computer-executable instructions cause one or more processors 7 to continue exhausting the air bladders 13a, 13b, 13c, and the process returns to step 2704. If the target value has been reached, then at step 2706 the computer-executable instructions cause one or more processors 7 to stop exhausting the air bladders 13a, 13b, 13c and monitor an increase in the pressure signal from the pressure sensor 27 during a decompression period. In one aspect, a filtered signal may be assumed such that any observed increase will be above the baseline signal noise. The signal may be filtered, for example, by a filter circuit in the controller 5 and / or by digital filtering techniques implemented by one or more processors 7 via computer-executable instructions. One or more processors 7 monitor that the pressure increase of the pressure signal is greater than a threshold (e.g., 1 mmHg - 2 mmHg), which indicates that the compression garment 10 is in a wrapped configuration generally around the limb of the wearer. No increase or an increase less than the threshold in the pressure signal indicates that the compression garment 10 is in an unwrapped configuration away from the limb of the wearer. The computer-executable instructions cause one or more processors 7 to implement a counter that maintains a count for each cycle in which the threshold pressure increase is not achieved.

[0140] At step 2708, the computer-executable instructions cause one or more processors 7 to determine whether, at step 2706, the processor 7 detected a pressure increase greater than a threshold. If a pressure increase greater than the threshold is detected during step 2706, the computer-executable instructions cause one or more processors 7 to reset counter 2710 to zero because the pressure increase indicates that the compression garment 10 is in a wrapped configuration around the wearer's limb. If no increase above the threshold is detected during step 2706, the non-occurrence of such a pressure increase indicates that the compression garment 10 is in an unwrapped configuration away from the wearer's limb. In such a case, at step 2712, the computer-executable instructions cause one or more processors 7 to determine whether the count of the counter has met or exceeded the counter threshold. For example, the threshold could be ten consecutive cycles, but those skilled in the art will understand that the threshold could be any integer value. Meeting or exceeding the threshold indicates that the compression garment 10 is in an unwrapped configuration away from the wearer's limb because if the compression garment 10 were in a wrapped configuration, a pressure anomaly (e.g., a pressure increase) would have been detected by one or more processors 7.

[0141] If, at step 2712, one or more processors 7 determine that the count of the counter has met or exceeded the counter threshold, then at step 2714 the computer-executable instructions cause one or more processors to take the desired action. For example, one or more processors 7 may block an operation, stop a compliance timer, alert a user (e.g., the wearer or a caregiver), etc. If, at step 2712, one or more processors 7 determine that the count of the counter has not reached the counter threshold, then at step 2716 the computer-executable instructions cause one or more processors 7 to increment the count of the counter and fully exhaust airbags 13a, 13b, 13c, and the process returns to step 2702.

[0142] In an alternative aspect, the actual shape of the pressure profile of the signal generated by pressure sensor 27 itself is an indicator of potential. For example, the shape of the profile can be calculated such that when the resulting function (i.e., the shape) matches a predetermined function (i.e., the shape), the computer-executable instructions cause one or more processors 7 to determine that the compression garment 10 is in a wrapped configuration. Conversely, the failure of the resulting function to match the predetermined function will cause the computer-executable instructions to cause one or more processors 7 to determine that the compression garment 10 is in an unwrapped configuration. This aspect can be used in conjunction with the counter described in connection with methods 2600, 2700 above.

[0143] Reference Figure 28A, shows the pressure signal from the pressure sensor 27 for one of the air bladders 13a, 13b, 13c in a wrapped configuration of the pressurized garment 10 on a wearer's limb during a representative air bladder inflation period 2802 and a pressure hold period 2804. In Figure 28A example, the duration of the pressure hold period 2804 is about 27 seconds and represents the air bladders 13a, 13b, 13c being inflated to about 45 mmHg, which is a typical inflation threshold for the treatment cycle of the air bladders 13a, 13b, 13c. According to another aspect of the present disclosure, the duration of the pressure hold period 2804 can be about 20 seconds and represents one of the air bladders 13a, 13b, or 13c being inflated to about 200 mmHg. Thus, for an air bladder inflated to about 200 mmHg, the oscillation amplitude in the pressure signal will be higher than the oscillation amplitude associated with an air bladder inflated to about 45 mmHg as shown herein.

[0144] Reference Figure 28B , waveform 2804’ shows the result of applying a bandpass filtering technique to a subset of the signals of interest for the pressure hold period 2804 such that a frequency range (e.g., 0.5 Hz to 25 Hz, 0.5 Hz to 5 Hz, etc.) has been extracted. Compared with Figure 28A , a representative subset portion of the pressure hold period 2804 is shown in a smaller scale such that a pulse can be seen in the pressure signal during the pressure hold period 2804’. Figure 28B The pulse in the pressure pulse in is associated with the pressure effect generated by the wearer's pulse on the air bladders 13a, 13b, or 13c. The waveform pulsation associated with the wearer's pulse of the pressurized garment 10 remains evident in waveform 2804’. Computer-executable instructions embodied on a non-transitory computer-readable storage medium 33 include instructions that cause one or more processors 7 to receive a signal from the pressure sensor 27, the received signal indicating the fluid pressure in one or more of the air bladders 13a, 13b, 13c during the air bladder inflation period 2802 and the pressure hold period 2804.

[0145] In some aspects, the computer-executable instructions further include the following instructions: causing one or more processors 7 to further refine the signal from the pressure sensor 27 to extract only the frequencies associated with the typical human cardiac cycle range during the pressure hold period 2804. For example, the computer-executable instructions can include computer-executable instructions that cause one or more processors 7 to extract (e.g., by a bandpass filtering technique) the frequencies in the range of 0.5 Hz to 25 Hz.

[0146] Figure 28BIt is shown that as the oscillation amplitude decreases, the influence of noise on the signal becomes more significant (i.e., the signal-to-noise ratio is smaller). Additional preprocessing and / or postprocessing of the data can be used to obtain a less distorted result. In some aspects, the computer-executable instructions further include the following instructions: causing one or more processors 7 to filter the signal during the pressure hold period 2804 to remove frequencies not associated with the pulse of the human wearer and causing one or more processors 7 to implement one or more peak detection algorithms and / or compliance monitoring algorithms. In certain aspects, one or more computer-executable instructions further include the following instructions: causing one or more processors 7 to perform additional preprocessing and / or postprocessing to reduce the influence of noise on the signal received from the pressure sensor 27. It should be understood that the signal received from the pressure sensor 27 and processed by one or more processors 7 includes pulsations associated with the wearer's heart rate, rather than the actual heart rate of the wearer. For example, the blood flow at the wearer's heart rate generates a pressure on at least one of the inflatable airbags 13a, 13b, 13c, and the pressure sensor 27 detects this pressure and generates a pressure signal representing this pressure.

[0147] Reference Figure 28C , waveform 2804' overlaps with waveform 2804", and waveform 2804" is the result after one or more processors 7 apply a smoothing algorithm filtering technique to waveform 2804'. In Figure 28C this exemplary aspect, the smoothing follows a rectangular window with a moving range of five (e.g., 5×). Even at pressures as low as those associated with typical venous refill detection (VRD) techniques (e.g., about 5 mmHg to about 20 mmHg), the waveform still provides signs of pulsation, indicating sufficient contact between the wearer and the compression garment 10.

[0148] Figure 29 shows the pressure signal received from the pressure sensor 27 during the representative airbag pressure hold period 2902 of one of the airbags 13a, 13b, 13c in the unwrapped configuration of the compression garment 10. The total amplitude of the pressure signature 2902 is less than the amplitude of a similar pressure hold period 2804 ( Figure 28A shown in). The absence of a clear, repeating pulse in the pressure signature 2902 is an indication that the compression garment 10 is in the unwrapped configuration or not properly worn by the wearer.

[0149] Figure 30AShows the pressure signal received from the pressure signal 27 and a representative balloon pressure characteristic curve of one of the balloons 13a, 13b, 13c. The pressure characteristic curve includes a treatment cycle period 3002, a balloon exhaust period 3004, a balloon test inflation period 3006, and a balloon pressure hold period 3008. At the end of the treatment cycle period 3002, the tested balloon (e.g., one of the balloons 13a, 13b, 13c) is exhausted during the balloon exhaust period 3004. After the balloon exhaust period 3004, a brief inflation is applied to the tested balloon during the balloon inflation period 3006 until the tested balloon reaches a pressure of about 30 mmHg. One or more processors 7 execute computer-executable instructions such that pulse detection (described further below) is performed by the one or more processors 7 during the balloon pressure hold period 3008, and the balloon pressure hold period 3008 is about 10 seconds in this exemplary aspect. The balloon pressure hold period 3008 may last for a longer or shorter duration, as long as the duration is long enough to ensure that multiple pulses occur within that duration.

[0150] Figure 30B Illustrates a waveform 3008’, which indicates the result of applying a filtering technique to the signal of interest during the pressure hold period 3008. In some aspects, the computer-executable instructions include the following instructions: causing one or more processors 7 to detect a main peak and check the waveform that falls within an expected range (e.g., 60 beats per minute (bpm) - 100 beats per minute (bpm) for a human wearer). In some aspects, for a human wearer, the expected range is 60 beats per minute (bpm) - 100 beats per minute (bpm). However, it should be understood that a wider range (e.g., 30 bpm - 120 bpm) can be used to account for wearers who may have poor health and / or to account for measurements taken at locations on the body that are far from the heart (e.g., calf). In this exemplary aspect, one or more processors 7 detect the pulsations associated with the wearer's heart rate, rather than the actual heart rate of the wearer.

[0151] Figure 31 Is a schematic representation of an exemplary method 3100 that analyzes waveform data received from a pressure sensor 27 by detecting pulsations associated with the heart rate of a wearer of a garment to determine whether a pressurized garment 10 is in a wrapped configuration or an unwrapped configuration around a limb of the wearer of the garment. The exemplary method can be performed by one or more processors 7 by executing computer-executable instructions embodied on a non-transitory computer-readable storage medium 33.

[0152] One or more processors 7 execute computer-executable instructions to sample 3102 an initial pressure. In some aspects, the initial pressure is sampled at a rate of 100 Hz or higher, and typical signal conditioning is used to remove baseline noise. Additionally or alternatively, the sampling 3102 can be extended to include attenuation at frequencies just below a low cutoff (e.g., 0.25 Hz).

[0153] Post-processing waveform analysis 3104 further includes a bandpass filter 3106, additional filtering 3108, and peak detection 3110. During the bandpass filter 3106, the signal of interest is filtered using bandpass filtering techniques within a typical frequency range associated with the typical heart rate range of a human wearer (e.g., 0.5 Hz - 4 Hz for a human wearer).

[0154] During the additional filtering 3108, the peaks of the bandpass-filtered signal are further refined. The additional filtering can include a low-pass filter with a cutoff value of 5 Hz to produce a filtered value. Additionally or alternatively, the additional filtering can include a smoothing algorithm that uses five of the most recent samples in a moving range to produce a filtered value. It should be understood that more than one filtering technique can be applied to the bandpass-filtered signal during the additional filtering step 3108.

[0155] During the peak detection 3110, peak detection is performed to check that the peaks of the filtered signal correspond to the heart rate range of a typical human wearer. The peak detection 3110 can be based on a predetermined threshold (e.g., only looking at peaks with an amplitude greater than 0.05 mmHg). Additionally or alternatively, the peak detection 3110 can be based on checking for a repeating signal with a frequency within the heart rate range of a typical human wearer, regardless of amplitude (e.g., extended to 30 bpm - 240 bpm for a margin). For example, a frequency analysis calculation can be performed to check for a repeating signal with a frequency within the heart rate range of a typical human wearer. Additionally or alternatively, the peak detection 3110 can be based on the highest amplitude peaks and checking that the frequencies of those peaks fall within the expected heart rate range of a typical human wearer. It should be understood that more than one peak detection technique can be used during the peak detection 3110. In some aspects, the peak detection 3110 includes a combination of peak detection based on a predetermined threshold and based on the highest amplitude peaks and checking that the frequencies of those peaks fall within the expected heart rate range of a typical human wearer, because the signal-to-noise ratio is high enough such that the pulse is visibly apparent.

[0156] During peak detection 3110, computer-executable instructions cause one or more processors 7 to determine 3112 whether a characteristic of the wearer's pulse is detected. If it is determined 3112 that there is a characteristic of a pulse, a positive determination result may be indicated 3116. For example, indicating 3116 may include sending a visual representation to a display device associated with the pressurization system 1. Additionally or alternatively, indicating 3116 may include incrementing and / or pausing a timer. When indicating 3116, the process ends at step 3118 and returns to step 3102. If a pulse is not detected at step 3112, at step 3114, the computer-executable instructions cause one or more processors 7 to return a null value. After step 3114, the process ends at step 3118 and returns to sampling 3102.

[0157] Reference Figure 32 , is a schematic representation of an exemplary method 3200 for analyzing waveform data received from a pressure sensor (e.g., pressure sensor 27) during a garment verification process to determine whether a pressurized garment (e.g., pressurized garment 10) is in a wrapped configuration or an unwrapped configuration. For ease of illustration and for clarity, method 3200 is described for a single airbag (e.g., one of airbags 13a, 13b, or 13c). However, it should be understood that method 3200 may be repeated to check additional airbags corresponding to different valves.

[0158] Method 3200 begins at step 3202 and opens 3204 the desired airbag valve (e.g., airbag valves 25a, 25b, 25c). The pressurized fluid source (e.g., pressurized fluid source 21) is activated 3206 until the pressure in the corresponding airbag exceeds approximately 120 mmHg.

[0159] A pressure signal is received 3208 from the pressure sensor 27 for a period of time. A determination 3210 is made as to whether all data is available. If all data is not available, the pressure signal continues to be acquired 3212 and the pressure signal is received 3208. If a determination 3210 is made at step 3210 that all data is available, the corresponding valve is closed 3214 and a pulse detection algorithm is executed.

[0160] In some aspects, the pulse detection algorithm includes one or more steps of the post-processing waveform analysis 3104 described above.

[0161] Make a determination 3216 as to whether a pulse is detected after the 3214 valve is closed and the fluid is isolated in the airbag. The absence of a detected pulse at step 3218 indicates that the compression garment 10 is in an unwrapped configuration away from the wearer's limb, and the method proceeds to step 3232, where the compliance time is not incremented before ending the method at step 3236. Detection of a pulse at step 3216 indicates that the compression garment 10 is in a wrapped configuration around the wearer's limb at step 3220, and the method continues to step 3230.

[0162] At step 3222, the computer-executable instructions cause one or more processors 7 to read the pressure after the pump has been turned on in step 3206 for one second. At step 3224, the computer-executable instructions cause one or more processors 7 to determine whether the pressure is greater than 2.0 mmHg. A pressure exceeding 2.0 mmHg at step 3224 indicates the presence of the compression garment 10 (e.g., in fluid communication with valves 25a, 25b, 25c) at step 3226, and the method proceeds to step 3230. A pressure not exceeding 2.0 mmHg at step 3224 indicates the absence of the compression garment 10 (e.g., not in fluid communication with valves 25a, 25b, 25c) at step 3228, and the method proceeds to step 3232, where the compliance time is not incremented before ending the method at step 3236.

[0163] At step 3230, the computer-executable instructions cause one or more processors 7 to determine whether the compression garment 10 is present and in a wrapped configuration around the wearer's limb. If it is determined that the compression garment 10 is not present or not in a wrapped configuration around the wearer's limb, the method proceeds to step 3232, where the compliance time is not incremented before ending the method at step 3236. If the compression garment 10 is determined by one or more processors 7 to be present and in a wrapped configuration, the method proceeds to step 3234, where the compliance time is incremented before ending the method at step 3236.

[0164] Reference Figure 33, computer-executable instructions embodied on a computer-readable storage medium 33 cause one or more processors 7 to execute method 3300, which analyzes waveform data received from pressure sensor 27 to determine whether the pressurized garment is in a wrapped configuration or an unwrapped configuration after the end-of-cycle pressure. Method 3300 begins at step 3302 and proceeds to step 3304, where the computer-executable instructions cause one or more processors 7 to complete a prophylactic pressurization cycle. At step 3306, the computer-executable instructions cause one or more processors 7 to deflate the air bladders corresponding to the wearer's ankles and thighs (e.g., air bladders 13a, 13c). At step 3308, the computer-executable instructions cause one or more processors 7 to hold the pressure in the air bladder corresponding to the wearer's calf (e.g., air bladder 13b) for a predetermined period of time (e.g., 10 seconds) and acquire a pressure signal via pressure sensor 27.

[0165] At step 3310, the computer-executable instructions cause one or more processors 7 to determine whether all data is available. If all data is not available at step 3310, the method proceeds to step 3312 to continue acquiring the pressure signal from pressure sensor 27 before returning to step 3308. If all data is available at step 3310, the method proceeds to step 3314, where the computer-executable instructions cause one or more processors 7 to execute a pulse detection algorithm. In some aspects, the pulse detection algorithm includes one or more steps of the post-processing waveform analysis 3104 described above. At step 3316, the computer-executable instructions cause one or more processors 7 to determine whether a pulse was detected at step 3314. No detected pulse indicates that the pressurized garment 10 is in an unwrapped configuration away from the wearer's limb at step 3322. The method then proceeds to step 3324, where the computer-executable instructions cause one or more processors 7 not to increment the compliance time and cause one or more processors 7 to take one or more actions (e.g., warn the user) before ending the method at step 3326. At step 3316, detection of a pulse indicates that the pressurized garment 10 is in a wrapped configuration around the wearer's limb at step 3318. The method then proceeds to step 3320, where the computer-executable instructions cause one or more processors 7 to increment the compliance time before ending the method at step 3326.

[0166] Reference Figure 34, computer-executable instructions embodied on a computer-readable storage medium 33 cause one or more processors 7 to execute method 3400, which analyzes waveform data received from pressure sensor 27 to determine whether the compression garment is in a wrapped configuration or an unwrapped configuration during venous refill determination (VRD). Method 3400 begins at step 3402 and proceeds to step 3404, where the computer-executable instructions cause one or more processors 7 to complete a compression cycle or a prophylactic compression cycle. At step 3406, the computer-executable instructions cause one or more processors 7 to deflate the air bladders (e.g., air bladders 13a, 13c) corresponding to the wearer's ankles and thighs. At step 3408, the computer-executable instructions cause one or more processors 7 to deflate the pressure in the air bladder (e.g., air bladder 13b) corresponding to the wearer's calf to the VRD target. Alternatively, the computer-executable instructions cause one or more processors 7 to deflate the air bladders (e.g., air bladders 13a, 13c) corresponding to the wearer's ankles and thighs and then inflate the ankle air bladder and the thigh air bladder to the VRD target. At step 3410, the computer-executable instructions cause one or more processors 7 to perform VRD according to a schedule. Once the VRD measurement is initiated, the computer-executable instructions cause one or more processors 7 to begin acquiring pressure data from pressure sensor 27 for auxiliary processing of parallel pulse detection. At step 3414, the computer-executable instructions cause one or more processors 7 to acquire a pressure signal from pressure sensor 27 while VRD is in progress.

[0167] At step 3416, the computer-executable instructions cause one or more processors 7 to determine whether all data is available. If all data is not available at step 3416, the method proceeds to step 3418 to continue obtaining pressure signals from the pressure sensor 27 before returning to step 3414. If all data is available at step 3416, the method proceeds to step 3420, where the computer-executable instructions cause one or more processors 7 to execute a pulse detection algorithm. In some aspects, the pulse detection algorithm includes one or more steps of the post-processing waveform analysis described above. At step 3422, the computer-executable instructions cause one or more processors 7 to determine whether a pulse is detected at step 3420. Failure to detect a pulse indicates that the compression garment 10 is in an unwrapped configuration away from the wearer's limb at step 3428. The method then proceeds to step 3430, where the computer-executable instructions cause one or more processors 7 not to increment the compliance time and cause one or more processors 7 to take one or more actions (e.g., warning the user) before ending the method at step 3432. Detection of a pulse at step 3422 indicates that the compression garment 10 is in a wrapped configuration around the wearer's limb at step 3424. The method then proceeds to step 3426, where the computer-executable instructions cause one or more processors 7 to increment the compliance time before ending the method at step 3432.

[0168] Reference Figure 35 , the computer-executable instructions embodied on the computer-readable storage medium 33 cause one or more processors 7 to execute method 3500, which analyzes the waveform data received from the pressure sensor 27 as an independent cycle analysis to determine whether the compression garment is in a wrapped configuration or an unwrapped configuration. Method 3500 begins at step 3502 and proceeds to step 3504, where the computer-executable instructions cause one or more processors 7 to complete a prophylactic compression cycle. At step 3506, the computer-executable instructions cause one or more processors 7 to exhaust the airbags 13a, 13b, 13c. At step 3508, the computer-executable instructions cause one or more processors 7 to open a desired valve (e.g., valve 25b) and inflate a desired airbag (e.g., airbag 13b) to a desired pressure (e.g., 10 mmHg - 120 mmHg). At step 3510, the computer-executable instructions cause one or more processors 7 to obtain a pressure signal via the pressure sensor 27 for a predetermined period of time (e.g., 10 seconds).

[0169] At step 3512, the computer-executable instructions cause one or more processors 7 to determine whether all data is available. If all data is not available at step 3512, the method proceeds to step 3514 to continue obtaining pressure signals from the pressure sensor 27 before returning to step 3510. If all data is available at step 3512, the method proceeds to step 3516, where the computer-executable instructions cause one or more processors 7 to close a corresponding valve (e.g., 25b) and execute a pulse detection algorithm. In some aspects, the pulse detection algorithm includes one or more steps of the post-processing waveform analysis 804 described above. At step 3518, the computer-executable instructions cause one or more processors 7 to determine whether a pulse was detected at step 3516. Failure to detect a pulse indicates that the compression garment 10 is in an unwrapped configuration away from the wearer's limb at step 3524. The method then proceeds to step 3526, where the computer-executable instructions cause one or more processors 7 not to increment the compliance time and cause one or more processors 7 to take one or more actions (e.g., warning the user) before ending the method at step 3528. At step 3518, detection of a pulse indicates that the compression garment 10 is in a wrapped configuration around the wearer's limb at step 3520. The method then proceeds to step 3522, where the computer-executable instructions cause one or more processors 7 to increment the compliance time before ending the method at step 3528.

[0170] Figures 36A - 36C is a schematic representation of an exemplary method 3600 that analyzes waveform data received from a pressure sensor 27 by detecting pulsations associated with the heart rate of a wearer of a garment to determine whether a compression garment 10 is in a wrapped or unwrapped configuration around a limb of the wearer of the garment. The exemplary method can be performed by one or more processors 7 by executing computer-executable instructions embodied on a non-transitory computer-readable storage medium 33.

[0171] Method 3600 begins and proceeds to step 3602, where the computer-executable instructions cause one or more processors 7 to complete a pressurization cycle or a prophylactic pressurization cycle. At step 3604, the computer-executable instructions cause one or more processors 7 to exhaust the airbags (e.g., airbags 13a, 13c) corresponding to, for example, the wearer's ankle and thigh and the airbag (e.g., airbag 13b) corresponding to, for example, the wearer's calf until a target pressure is reached. In one aspect, the target pressure includes an initial lower target pressure of about 5 mmHg to about 7 mmHg. Alternatively, when the initial lower target pressure does not produce the desired result, the target pressure includes about 26 mmHg to about 32 mmHg. The initial lower target pressure provides the following exemplary benefits: a smaller pressure (more comfortable for the patient relative to a higher pressure) is applied to the wearer's limb before reattempting the higher target pressure, which is less comfortable for the patient.

[0172] At step 3606, when the target pressure is reached, the computer-executable instructions cause one or more processors 7 to maintain the pressure in the airbag (e.g., airbag 13b) corresponding to the wearer's calf for at least about 15 seconds while acquiring signals at a rate of about 100 Hz. In one aspect, the period includes a pressure holding period 2804, as further described herein. Holding periods longer than about 15 seconds may also be used without departing from the scope of the present invention. At step 3608, the computer-executable instructions cause one or more processors 7 to exhaust the pressure in the airbag (e.g., airbag 13b) corresponding to the wearer's calf.

[0173] After measuring the exhaust of the airbag (e.g., airbag 13b), the computer-executable instructions cause one or more processors 7 to perform further signal conditioning to prepare data for the patient detection algorithm. As Figure 36A shown, the computer-executable instructions cause one or more processors 7 to apply a band-pass filter 3610 to the waveform data. In one aspect, the most recently acquired 1024 samples (corresponding to a time window of about 10 seconds) are passed through a band-pass filter 3610 having a passband of about 0.5 Hz - 5 Hz to separate the signal reflecting the wearer's cardiac cycle. In one aspect, the first three samples of the 1024 acquired samples are ignored as a stable time period. Those of ordinary skill in the art will understand that other numbers of most recently acquired samples may be used without departing from the scope of the present invention. For example, any number of most recently acquired samples that is a power of 2 aids in frequency calculation.

[0174] The computer-executable instructions cause one or more processors 7 to pass the output of the band-pass filter 3610 through a low-pass filter 3612 having a low-pass cut-off frequency of approximately 5 Hz. In one aspect, the low-pass filter 3612 further removes noise in the waveform data and reveals pulsations associated with the periodic system of the wearer's lower limbs. Referring to FIG. 36, an exemplary signal from the output of the low-pass filter 3612 is shown. In this aspect, the signal includes approximately 1024 samples that have distinct pulsations associated with the periodic system of the wearer's lower limbs.

[0175] Since the filtered waveform data is available, the computer-executable instructions cause one or more processors 7 to perform several subsequent calculations on the filtered waveform data to determine whether the compression garment 10 is in a wrapped configuration or an unwrapped configuration around the limb of the wearer of the garment. In one aspect, the subsequent calculations are referred to as post-processing of the filtered waveform.

[0176] Referring again to Figure 36A , the computer-executable instructions cause one or more processors 7 to perform post-processing of the filtered waveform at 3614, 3616, 3618. As shown, one or more processors 7 calculate the standard deviation of the filtered waveform data and / or portions thereof. It is empirically known that a compression garment in an unwrapped configuration (i.e., idle) has a stable, smooth pressure signal that includes only normal white noise. In contrast, a pressure signal representing the pressure in a compression garment in a wrapped configuration around the limb of the wearer of the garment includes pulsations and / or other measurable signal features. Thus, a compression garment in a wrapped configuration around the limb of the wearer can be distinguished from a compression garment in an unwrapped configuration, in whole or in part, based on this calculation.

[0177] In one aspect, the computer-executable instructions cause one or more processors 7 to divide the low-pass filtered signal (e.g., 1024 samples) into five sample groups and calculate the standard deviation 3614 (σ) of each group. Those of ordinary skill in the art will understand that the low-pass filtered signal can be divided into different numbers of sample groups, such as when using different numbers of samples. An exemplary purpose of dividing the low-pass filtered signal into sample groups is to isolate time portions. For example, large abnormal pressure peaks in a representative pressure signal (e.g., due to the wearer sneezing, coughing, etc.) occur during normal treatment due to movement of the wearer's limb and / or other factors. Time slicing the signal (e.g., dividing the signal into sample groups) allows one or more processors 7 to determine whether the entire waveform is "stable" or whether there are anomalies within a particular range of samples. In one aspect, the computer-executable instructions cause one or more processors 7 to calculate the total standard deviation 3614 (σ) of the entire low-pass filtered signal (e.g., 1024 samples).

[0178] After calculating the standard deviation, the computer-executable instructions cause one or more processors 7 to perform peak detection 3616. In one aspect, the one or more processors 7 process the filtered waveform (e.g., 1024 samples) using a windowing technique that includes 32 samples per window. The one or more processors 7 index the peaks one by one for each 32-sample window to produce a downsampled waveform that includes only the signal peaks (e.g., the signal of interest). For example, the one or more processors 7 may initially index each peak from 1 to 32 and then increment the index by one (e.g., from 2 to 33), generating additional waveform signal data. The one or more processors 7 ignore negative peaks. In one aspect, the 32-sample window leaves a local maximum for each window. Additionally and / or alternatively, the 32-sample window reduces the number of samples by a quarter, removes negative peaks, and indicates that the downsampled signal represents approximately 10 seconds of real-time duration. Refer to Figure 38 , an exemplary signal showing the output from peak detection 3616 is shown, including only the true peaks that ultimately reveal the pulsation of interest. In this aspect, the signal includes approximately 250 to 300 samples, which still correspond to approximately 10 seconds of real-time duration. In one aspect, the number of samples will vary depending on the number of peaks identified by the one or more processors 7. In Figure 25 One aspect shown, the sampling frequency is calculated as the result of dividing the number of samples by the amount of time (e.g., sampling f = N samples / 10.24 seconds).

[0179] Further refer to Figure 36A , in the case where the downsampled peak detection waveform is available, the one or more processors 7 utilize the fundamental frequency to assist in confirming whether the compression garment 10 is in a wrapped configuration around the limb of the wearer of the garment by performing a time-frequency transform 3618. In one aspect, the computer-executable instructions cause the one or more processors 7 to calculate the Fourier transform of the signal (e.g., a fast Fourier transform) and output the highest magnitude between 0.5 Hz (e.g., approximately 30 bpm) and 4 Hz (e.g., approximately 200 bpm). Those of ordinary skill in the art will understand that, without departing from the scope of the present invention, transforms other than the fast Fourier transform may be used to find the wearer's cardiac cycle.

[0180] After post-processing is completed, the computer-executable instructions cause the one or more processors 7 to determine whether the compression garment 10 is in an unwrapped configuration or a wrapped configuration around the limb of the wearer of the garment. Refer to Figure 36B, computer-executable instructions cause one or more processors 7 to determine at step 3620 whether the total standard deviation 3614 (σ) of the entire low-pass filtered signal (e.g., 1024 samples) is less than or equal to an unwrapping threshold (e.g., 0.18). When one or more processors 7 determine that the total standard deviation is not less than or equal to the unwrapping threshold, method 3600 proceeds to step 3636, as further described herein. When one or more processors 7 determine that the total standard deviation is less than or equal to the unwrapping threshold, method 3600 proceeds to step 3622.

[0181] At step 3622, computer-executable instructions cause one or more processors 7 to determine whether each of a predetermined number of segments (e.g., groups of samples) into which the low-pass filtered signal has been divided is less than or equal to an unwrapping threshold (e.g., 0.18). In an alternative aspect, one or more processors 7 divide the low-pass filtered signal into five groups of samples and determine at 3622 whether the standard deviation of each of the five groups of samples is less than or equal to the unwrapping threshold. Alternatively, one or more processors 7 divide the low-pass filtered signal into five groups of samples and determine at 3622 whether the standard deviation of at least three of the five groups of samples is less than or equal to the unwrapping threshold. When one or more processors 7 determine that each of the predetermined number of segments is not less than or equal to the unwrapping threshold, method 3600 returns to step 3602 to retry the cycle. When one or more processors 7 determine that each of the predetermined number of segments is less than or equal to the unwrapping threshold, the process proceeds to step 3624.

[0182] At step 3624, computer-executable instructions cause one or more processors 7 to determine whether the maximum (e.g., highest amplitude) magnitude of the time-frequency transform (e.g., fast Fourier transform) signal in the range of 0.5 Hz - 4.0 Hz is less than or equal to a threshold X (e.g., 5 Hz). When one or more processors 7 determine that the maximum magnitude in the range of 0.5 Hz - 4.0 Hz is not less than or equal to threshold X, method 3600 ends. When processor 7 determines at 3624 that the maximum magnitude in the range of 0.5 Hz - 4.0 Hz is less than or equal to threshold X, one or more processors 7 determine at step 3626 that the pressurized garment 10 is in an unwrapped configuration. In one aspect, when the Boolean result of step 3620 is logically true AND (and) the result of step 3622 is logically true AND (and) the result of step 3624 is logically true, computer-executable instructions cause one or more processors 7 to announce that the pressurized garment 10 is in an unwrapped configuration (e.g., the wearer is not wearing the pressurized garment).

[0183] At step 3628, the computer-executable instructions cause one or more processors 7 to determine whether the unwrapping configuration detection at step 3626 is the second consecutive such determination. When one or more processors 7 determine that the unwrapping configuration detection 3626 is not the second consecutive detection, method 3600 continues back to step 3602 to perform a second measurement on the corresponding limb of the wearer in the next cycle. When one or more processors 7 determine that the unwrapping configuration 3626 is the second consecutive detection, method 3600 continues to at least one of three steps. At step 3630, the computer-executable instructions cause one or more processors 7 to activate an audible alarm, such as via a speaker and / or other electro-mechanical devices that produce sound connected to the controller 5 of the pressurization system 1. In one aspect, the alarm is a multi-tone audible alarm. At step 3632, the computer-executable instructions cause one or more processors 7 to display an error message on a display device associated with the pressurization system 1. At step 3634, the computer-executable instructions cause one or more processors 7 not to increment the compliance time before ending method 3600. In one aspect, the treatment using the pressurized garment 10 does not stop by blocking the 3634 compliance time, and the compliance time remains in its current state until a response (e.g., from a human user) is received via the display device and / or input device.

[0184] Reference Figure 36C , the computer-executable instructions cause one or more processors 7 to determine at step 3636 whether the total standard deviation 3614 (σ) of the entire low-pass filtered signal (e.g., 1024 samples) is greater than or equal to a wrapping threshold (e.g., 0.35). When one or more processors 7 determine that the total standard deviation is not greater than or equal to the wrapping threshold, method 3600 continues back to step 3602. When one or more processors 7 determine that the total standard deviation is greater than or equal to the wrapping threshold, method 3600 continues to step 3638 and / or step 3640.

[0185] In one aspect, method 3600 continues to step 3638, in which the computer-executable instructions cause one or more processors 7 to determine whether the total standard deviation 3614 (σ) of the entire low-pass filtered signal (e.g., 1024 samples) is less than or equal to a maximum limit threshold (e.g., 10.0). When one or more processors 7 determine that the total standard deviation of the entire low-pass filtered signal is not less than or equal to the maximum limit threshold, method 3600 ends. When one or more processors 7 determine that the total standard deviation of the entire low-pass filtered signal is less than or equal to the maximum limit threshold, method 3600 continues to step 3640.

[0186] At step 3640, the computer-executable instructions cause one or more processors 7 to determine whether each of a predetermined number of segments (e.g., groups of samples) into which the low-pass filtered signal has been divided is greater than or equal to a wrapping threshold (e.g., 0.35). In one aspect, one or more processors 7 divide the low-pass filtered signal into five groups of samples and determine 3640 whether the standard deviation of each of the five groups of samples is greater than or equal to the wrapping threshold. Alternatively, one or more processors 7 divide the low-pass filtered signal into five groups of samples and determine 3640 whether the standard deviation of at least three of the five groups of samples is greater than or equal to the wrapping threshold. When one or more processors 7 determine that each of the predetermined number of segments is not greater than or equal to the wrapping threshold, method 3600 continues to return to step 3602 to retry the cycle. When one or more processors 7 determine that each of the predetermined number of segments is greater than or equal to the wrapping threshold, the process continues to step 3642 and / or step 3644.

[0187] At step 3642, the computer-executable instructions cause one or more processors 7 to determine whether each of the predetermined number of segments (e.g., groups of samples) into which the low-pass filtered signal has been divided is less than or equal to a maximum limit threshold (e.g., 10.0). When one or more processors 7 determine that each of the predetermined number of segments (e.g., all five or at least three of five) is not less than or equal to the maximum limit threshold, method 3600 ends. When one or more processors 7 determine that each of the predetermined number of segments is less than or equal to the maximum limit threshold, method 3600 continues to step 3644.

[0188] At step 3644, the computer-executable instructions cause one or more processors 7 to determine whether the maximum (e.g., highest amplitude) magnitude of the time-frequency transformed (e.g., fast Fourier transform) signal in the range of 0.5 Hz - 4.0 Hz is both greater than a threshold Y (e.g., 20) and less than or equal to a threshold Z (e.g., 50.0). When one or more processors 7 determine that the maximum magnitude in the range of 0.5 Hz - 4.0 Hz is not greater than threshold Y and not less than or equal to threshold Z, method 3600 ends. When one or more processors 7 determine that the maximum magnitude in the range of 0.5 Hz - 4.0 Hz is greater than threshold Y and less than or equal to threshold Z, one or more processors 7 determine that the compression garment 10 is in the wrapped configuration 3646 around the limb of the wearer of the garment. In one aspect, when the boolean result of step 3636 is logically true AND the result of step 3638 is logically true AND the result of step 3640 is logically true AND the result of step 3642 is logically true AND the result of step 3644 is logically true, the computer-executable instructions cause one or more processors 7 to announce that the compression garment 10 is in the wrapped configuration (e.g., the wearer is wearing the compression garment). Alternatively, when the boolean result of step 3636 is logically true AND the result of step 3640 is logically true AND the result of step 3644 is logically true, the computer-executable instructions cause one or more processors 7 to announce that the compression garment 10 is in the wrapped configuration.

[0189] After determining that the compression garment 10 is in the wrapped configuration 3646, method 3600 proceeds to step 3648, in which the computer-executable instructions cause one or more processors 7 to increment the compliance time before ending method 3600.

[0190] Figures 39A - 39C is a schematic representation of a second exemplary method 3900 according to an aspect of the present invention, which analyzes waveform data received from the pressure sensor 27 by detecting pulsations associated with the heart rate of the wearer of the compression garment 10 to determine whether the compression garment 10 is in a wrapped configuration or an unwrapped configuration around the limb of the wearer. This exemplary method can be implemented by one or more processors 7 by executing computer-executable instructions embodied on a non-transitory computer-readable storage medium 33. Method 3900 occurs during VRD (starting from step 3904) and is Figure 34 a more detailed flowchart of.

[0191] Method 3900 begins and proceeds to step 3902, where computer-executable instructions cause one or more processors 7 to complete a pressurization cycle or a prophylactic pressurization cycle. At step 3904, the computer-executable instructions cause one or more processors 7 to deflate the air bladders (e.g., air bladders 13a, 13c) corresponding to, for example, the wearer's ankle and thigh and to deflate the air bladder (e.g., air bladder 13b) corresponding to, for example, the wearer's calf until a target pressure is reached. Alternatively, the computer-executable instructions cause one or more processors 7 to deflate the air bladders (e.g., air bladders 13a, 13c) corresponding to, for example, the wearer's ankle and thigh and to deflate the air bladder (e.g., air bladder 13b) corresponding to, for example, the wearer's calf and then to inflate the air bladder (e.g., air bladder 13b) corresponding to, for example, the wearer's calf until the target pressure is reached. In one aspect, the target pressure includes an initial lower target pressure of about 5 mmHg to about 7 mmHg. Alternatively, when the initial lower target pressure does not produce the desired result, the target pressure includes about 26 mmHg to about 32 mmHg. The initial lower target pressure provides the following exemplary benefit: a lower pressure (which is more comfortable for the patient relative to a higher pressure) is applied to the wearer's limb before reattempting the higher target pressure (which is less comfortable for the patient).

[0192] At step 3906, upon reaching the target pressure, the computer-executable instructions cause one or more processors 7 to maintain / hold the pressure in the air bladder (e.g., air bladder 13b) corresponding to the wearer's calf for at least about 15 seconds while acquiring signals at a rate of about 100 Hz. In one aspect, the period includes a pressure hold period 2804 as further described herein. Without departing from the scope of the present invention, a hold period longer than about 15 seconds may also be used. For example, at least one inflatable air bladder may be deflated to the target value, held at that pressure, and signals acquired. Thus, for example, during deflation, signals may be received to determine if the target value is reached. Similarly, if at least one inflatable air bladder is deflated and then inflated to the target value, signals may be received during inflation. When at least one air bladder is held at the target value / pressure, e.g., during inflation, signals may be received that at least one air bladder is inflated.

[0193] During signal acquisition, waveform data is acquired from the measurement air bladder (e.g., air bladder 13b) in real time, and the computer-executable instructions cause one or more processors 7 to perform further signal conditioning to prepare data for the patient detection algorithm. As Figure 39AAs shown, at step 3908, the computer-executable instructions cause one or more processors 7 to perform band-pass filtering on the waveform data. In one aspect, the most recently acquired 1024 samples (corresponding to a time window of approximately 10 seconds) are passed through a band-pass filter 3908 having a passband of approximately 0.5 Hz - 5 Hz to isolate the signal reflecting the wearer's cardiac cycle. In one aspect, the first three samples of the 1024 acquired samples are ignored as a stabilization period. Those of ordinary skill in the art will understand that other numbers of recently acquired samples may be used without departing from the scope of the present invention. For example, any number of recently acquired samples that is a power of 2 aids in frequency calculation.

[0194] At step 3910, the computer-executable instructions cause one or more processors 7 to pass the output of the band-pass filter through a low-pass filter having a low-pass cut-off frequency of approximately 5 Hz. In one aspect, the low-pass filter 3910 further removes noise in the waveform data and reveals the pulsations associated with the periodic system of the wearer's lower extremities. Refer to Figure 37 , which shows an exemplary signal from the output of the low-pass filter. In this aspect, the signal includes approximately 1024 samples that have a clear pulsation associated with the periodic system of the wearer's lower extremities.

[0195] Since the filtered waveform data is available, the computer-executable instructions cause one or more processors 7 to perform several subsequent calculations on the filtered waveform data to determine whether the compression garment 10 is in a wrapped configuration or an unwrapped configuration around the limb of the wearer of the garment. In one aspect, the subsequent calculations are referred to as post-processing of the filtered waveform. In one aspect, method 3900 maintains the last 1024 samples as a patient detection (PD) filtered data set for further calculations as described below.

[0196] Referring again to Figure 39A, at step 3912, the computer-executable instructions cause one or more processors 7 to exhaust the pressure in the airbag (e.g., airbag 13b) corresponding to the wearer's calf to the ambient value, e.g., release the pressure in the airbag. Next, at steps 3914, 3916, 3918, the computer-executable instructions cause one or more processors to perform post-processing of the filtered waveform. As shown, one or more processors 7 calculate the standard deviation of the filtered waveform data and / or portions thereof. It is empirically known that a pressurized garment in an unwrapped configuration (i.e., idle) has a stable, flat pressure signal that includes only normal white noise. In contrast, the pressure signal representing the pressure in a pressurized garment in a wrapped configuration around the wearer's limb of the garment includes pulsations and / or other measurable signal features. Thus, a pressurized garment in a wrapped configuration around the wearer's limb can be distinguished from a pressurized garment in an unwrapped configuration, either wholly or in part, based on this calculation.

[0197] At step 3914, the computer-executable instructions cause one or more processors 7 to calculate the standard deviation (σ). For example, the computer-executable instructions cause one or more processors 7 to divide the low-pass filtered signal (e.g., 1024 samples / PD filtered data set) into five sample groups and calculate the standard deviation 3914 (σ) of each group. For example, four groups include samples of 200 PD filtered data sets and one group includes samples of 224 PD filtered data sets. These groups can be referred to as s1-s5. Thus, five standard deviations are calculated (e.g., the standard deviation of each group s1-s5). Those of ordinary skill in the art will understand that the low-pass filtered signal can be divided into a different number of sample groups, such as when using a different number of groups. An exemplary purpose of dividing the low-pass filtered signal into sample groups is to isolate time portions. For example, large abnormal pressure peaks in a representative pressure signal (e.g., due to the wearer sneezing, coughing, etc.) occur during normal treatment due to movement of the wearer's limb and / or other factors. Time slicing the signal (e.g., dividing the signal into sample groups) allows one or more processors 7 to determine whether the entire waveform is "stable" or whether there are anomalies within a particular range of samples. For example, the computer-executable instructions cause one or more processors 7 to calculate the total standard deviation 3914 (σ) of the entire low-pass filtered signal (e.g., 1024 samples / PD filtered data set), which can be referred to as "s".

[0198] At step 3916, the computer-executable instructions cause one or more processors 7 to perform peak detection. For example, one or more processors 7 process the filtered waveform (e.g., 1024 samples) using a windowing technique that includes 32 samples per window. One or more processors 7 index the peaks for each 32-sample window one by one to produce a downsampled waveform that includes only the signal peaks (e.g., the signal of interest). For example, one or more processors 7 may initially index each peak from 1 to 32 and then increment the index by one (e.g., from 2 to 33), generating additional waveform signal data. One or more processors 7 ignore negative peaks. In one aspect, the 32-sample window leaves a local maximum for each window. Additionally and / or alternatively, the 32-sample window reduces the number of samples by a quarter, removes negative peaks, and indicates that the downsampled signal represents approximately 10 seconds of real-time duration. Refer to Figure 38 , which shows an exemplary signal from the output of peak detection 3916, including only the true peaks that ultimately reveal the pulsation of interest. In this aspect, the signal includes approximately 250 to 300 samples, which still correspond to approximately 10 seconds of real-time duration. In one aspect, the number of samples will vary depending on the number of peaks identified by one or more processors 7. In Figure 25 , in one aspect illustrated, the sampling frequency is calculated as the result of dividing the number of samples by the amount of time (e.g., sampling f = N samples / 10.24 seconds).

[0199] Further refer to Figure 39A , in the case where the downsampled peak detection waveform is available, one or more processors 7 utilize the fundamental frequency to help confirm whether the pressure garment 10 is in a wrapped configuration around the limb of the wearer of the garment by performing a time-frequency transform 3918. At step 3918, the computer-executable instructions cause one or more processors 7 to calculate the Fourier transform (e.g., fast Fourier transform or FFT) of the signal / PF filtered data set and output the highest magnitude between 0.5 Hz (e.g., approximately 30 bpm) and 4 Hz (e.g., approximately 200 bpm). Those of ordinary skill in the art will understand that, without departing from the scope of the present invention, transforms other than the fast Fourier transform may be used to discover the wearer's cardiac cycle.

[0200] After post-processing is completed, the computer-executable instructions cause one or more processors 7 to determine whether the pressure garment 10 is in an unwrapped configuration or a wrapped configuration around the limb of the wearer of the garment. Refer to Figure 39B, computer-executable instructions cause one or more processors 7 to determine at step 3920 whether the total standard deviation 3914 (σ) of the entire low-pass filtered signal (e.g., 1024 samples / PD filtered data set) (also referred to as group s) and the overall standard deviation are less than or equal to an unwrapping threshold (e.g., 0.18). When one or more processors 7 determine that the total standard deviation is not less than or equal to the unwrapping threshold, method 3900 proceeds to step 3934, as further described herein. When one or more processors 7 determine that the total standard deviation is less than or equal to the unwrapping threshold, method 3900 proceeds to step 3922.

[0201] At step 3922, computer-executable instructions cause one or more processors 7 to determine whether the standard deviation (S.D.) of a predetermined number of segments (e.g., sample groups s1-s5) into which the low-pass filtered signal has been divided is each less than or equal to the unwrapping threshold (e.g., 0.18). In an alternative aspect, one or more processors 7 divide the low-pass filtered signal into five sample groups and determine at 3922 whether the standard deviation of each of the five sample groups is less than or equal to the unwrapping threshold. Alternatively, one or more processors 7 divide the low-pass filtered signal into five sample groups and determine at 3922 whether the standard deviation of at least three of the five sample groups is less than or equal to the unwrapping threshold. When one or more processors 7 determine that each of the predetermined number of segments is not less than or equal to the unwrapping threshold, method 3900 proceeds to step 3944 to determine whether to re-attempt the cycle. When one or more processors 7 determine that each of the predetermined number of segments is less than or equal to the unwrapping threshold, the process proceeds to step 3924.

[0202] At step 3924, using the low-pass filtered signal (e.g., 1024 samples / PD filtered data set), the computer-executable instructions cause one or more processors 7 to determine whether the maximum (e.g., highest amplitude) magnitude of the time-frequency transformed (e.g., Fast Fourier Transform) signal in the range of 0.5 Hz - 4.0 Hz is less than or equal to a threshold X (e.g., 5). When one or more processors 7 determine that the maximum magnitude in the range of 0.5 Hz - 4.0 Hz is not less than or equal to the threshold X, method 3900 proceeds to step 3944 to determine whether to re-attempt the cycle. When processor 7 determines at 3924 that the maximum magnitude in the range of 0.5 Hz - 4.0 Hz is less than or equal to the threshold X, one or more processors 7 determine at step 3926 that the compression garment 10 is in the unwrapped configuration. In one aspect, when the boolean result of step 3920 is logically true AND the result of step 3922 is logically true AND the result of step 3924 is logically true, the computer-executable instructions cause one or more processors 7 to declare that the compression garment 10 is in the unwrapped configuration (e.g., the wearer is not wearing the compression garment).

[0203] At step 3926, the computer-executable instructions cause one or more processors 7 to determine that the compression garment is unwrapped, e.g., not wrapped around the wearer's limb.

[0204] At step 3928, the computer-executable instructions cause one or more processors 7 to activate an audible alarm, such as via a speaker and / or other electromechanical device connected to the controller 5 of the compression system 1 that produces sound. In one aspect, the alarm is a multi-tone audible alarm. At step 3930, the computer-executable instructions cause one or more processors 7 to display an error message on a display device associated with the compression system 1. At step 3932, the computer-executable instructions cause one or more processors 7 not to increment the compliance time before ending method 3900. In one aspect, the treatment using the compression garment 10 does not stop by preventing the 3932 compliance time, and the compliance time remains in its current state until a response (e.g., from a human user) is received via the display device and / or input device.

[0205] Reference Figure 39C , at step 3934, the computer-executable instructions cause one or more processors 7 to determine whether the total / overall standard deviation 3914 (σ) of the entire low-pass filtered signal (e.g., 1024 samples / PD filtered data set) is greater than or equal to a wrapping threshold (e.g., 0.25). When one or more processors 7 determine that the total standard deviation is not greater than or equal to the wrapping threshold, method 3900 proceeds to step 3944 to determine whether to re-attempt the cycle. When one or more processors 7 determine that the total standard deviation is greater than or equal to the wrapping threshold, method 3900 proceeds to step 3936.

[0206] At step 3936, the computer-executable instructions cause one or more processors 7 to determine whether the standard deviation (S.D.) of each of a predetermined number of segments (e.g., sample groups s1-s5) into which the low-pass filtered signal has been divided is greater than or equal to a wrap threshold (e.g., 0.25). In one aspect, one or more processors 7 determine whether the standard deviation of each of the five sample groups is greater than or equal to the wrap threshold. Alternatively, one or more processors 7 divide the low-pass filtered signal into five sample groups and determine whether the standard deviation of at least three of the five sample groups is greater than or equal to the wrap threshold. When one or more processors 7 determine that each of the predetermined number of segments is not greater than or equal to the wrap threshold, method 3900 proceeds to step 3944 to determine whether to re-attempt the cycle. When one or more processors 7 determine that each of the predetermined number of segments is greater than or equal to the wrap threshold, method 3900 proceeds to step 3938.

[0207] At step 3938, the computer-executable instructions cause one or more processors 7 to determine whether the maximum (e.g., highest amplitude) magnitude of the time-frequency transform (e.g., fast Fourier transform (FFT)) signal in the range of 0.5 Hz - 4.0 Hz is greater than a threshold Y (e.g., 5). When one or more processors 7 determine that the maximum magnitude in the range of 0.5 Hz - 4.0 Hz is not greater than threshold Y, method 3900 proceeds to step 3944 to determine whether to re-attempt the cycle. When one or more processors 7 determine that the maximum magnitude in the range of 0.5 Hz - 4.0 Hz is greater than threshold Y, one or more processors 7 determine that the pressure garment 10 is in the wrap configuration 3940 around the limb of the wearer of the garment. When the boolean result of step 3934 is logically true AND the result of step 3936 is logically true AND the result of step 3938 is logically true, the computer-executable instructions cause one or more processors 7 to declare that the pressure garment 10 is in the wrap configuration.

[0208] After determining that the pressure garment 10 is in the wrap configuration 3940, method 3900 proceeds to step 3942, in which the computer-executable instructions cause one or more processors 7 to increment the compliance time before ending method 3900.

[0209] At step 3944, one or more processors 7 determine any of the following three criteria: 1) overall S.D.; 2) segmented S.D.; or, FFT max is first undetermined. If one or more processors 7 determine that any of the three criteria is first undetermined, method 3900 proceeds to step 3902. If one or more processors 7 determine any of the three criteria: 1) overall S.D.; 2) segmented S.D.; or, FFT max is second undetermined, then one or more processors 7 determine that the compression garment is unwrapped, e.g., not wrapped around the wearer's limb, and method 3900 proceeds to step 3926. Undetermined means that it cannot be determined whether the compression garment 10 is in a wrapped configuration or an unwrapped configuration.

[0210] Although certain aspects have been described, other aspects are additionally or alternatively possible.

[0211] Although the compression system has been described as being used with thigh-length compression sleeves, it should be understood that these compression systems can additionally or alternatively be used with other types of compression garments. For example, these compression systems can be used with knee-length compression sleeves and / or with sleeves having different numbers of air bladders configured to be arranged on different regions of the wearer's body.

[0212] Aspects of the present disclosure can be implemented using hardware, software, or a combination thereof, and can be implemented in one or more computer systems or other processing systems. In one aspect, the present disclosure relates to one or more computer systems capable of performing the functions described herein. Figure 40 An example of such a computer system 4000 is shown in

[0213] Figure 40 An example system diagram presenting different hardware components and other features for use in accordance with one aspect of the present disclosure is presented. Aspects of the present disclosure can be implemented using hardware, software, or a combination thereof, and can be implemented in one or more computer systems or other processing systems. In one example variant, aspects described herein can relate to one or more computer systems capable of implementing the functionality described herein. Figure 40 An example of such a computer system 4000 is shown in

[0214] Computer system 4000 includes one or more processors, such as processor 4004. Processor 4004 is connected to a communication infrastructure 4006 (e.g., a communication bus, crossbar, or network). In one example, the above Figures 1 - 2The processor 7 in may include a processor 4004. Different software aspects are described with respect to this example computer system. After reading this specification, it will become clear to those skilled in the relevant art how to implement one aspect described herein using other computer systems and / or architectures.

[0215] The computer system 4000 may include a display interface 4002 that forwards graphics, text, and other data from the communication infrastructure 4006 (or from a frame buffer not shown) for display on the display unit 4030. The computer system 4000 also includes a main memory 4008, preferably a random access memory (RAM), and may also include an auxiliary memory 4010. The auxiliary memory 4010 may include, for example, a hard disk drive 4012 and / or a removable storage drive 4014 (representing a floppy disk drive, a tape drive, an optical disk drive, etc.). The removable storage drive 4014 reads from and / or writes to a removable storage unit 4018 in a well-known manner. The removable storage unit 4018 represents a floppy disk, a tape, an optical disk, etc., which is read by and written to the removable storage drive 4014. As will be appreciated, the removable storage unit 4018 includes a computer-usable storage medium having computer software and / or data stored therein.

[0216] In an alternative aspect, the auxiliary memory 4010 may include other similar devices for allowing a computer program or other instructions to be loaded into the computer system 4000. Such devices may include, for example, a removable storage unit 4022 and an interface 4020. Such examples may include a program cartridge and cartridge interface (such as that found in video game devices), a removable memory chip (such as an erasable programmable read-only memory (EPROM) or programmable read-only memory (PROM)) and associated socket, and other removable storage units 4022 and interfaces 4020 that allow software and data to be transferred from the removable storage unit 4022 to the computer system 4000.

[0217] The computer system 4000 may also include a communication interface 4024. The communication interface 4024 allows software and data to be transferred between the computer system 4000 and external devices. Examples of the communication interface 4024 may include a modem, a network interface (such as an Ethernet card), a communication port, a Personal Computer Memory Card International Association (PCMCIA) slot and card, etc. The software and data transferred via the communication interface 4024 are in the form of signals 4028, and these signals 4028 may be electronic signals, electromagnetic signals, optical signals or other signals that can be received by the communication interface 4024. These signals 4028 are provided to the communication interface 4024 via a communication path (e.g., a channel) 4026. The communication path 4026 carries the signals 4028 and may be implemented using wires or cables, optical fibers, telephone lines, cellular links, radio frequency (RF) links, and / or other communication channels. In this document, the terms "computer program medium" and "computer usable medium" are used to generally refer to media such as a removable storage drive 4080, a hard disk installed in the hard disk drive 4070, and the signals 4028, etc. These computer program products provide software to the computer system 400. Many aspects described herein may relate to such computer program products.

[0218] A computer program (also referred to as computer control logic) is stored in the main memory 4008 and / or the secondary memory 4010. The computer program may also be received via the communication interface 4024. When such a computer program is executed, it enables the computer system 4000 to perform various features in accordance with the many aspects described herein. Specifically, when the computer program is executed, it enables the processor 4004 to perform these features. Thus, such a computer program represents the controller of the computer system 4000.

[0219] In a software-implemented variant described herein, the software may be stored in a computer program product and loaded into the computer system 4000 using a removable storage drive 4014, a hard disk drive 4012, or a communication interface 4020. The control logic (software), when executed by the processor 4004, causes the processor 4004 to perform the functions in accordance with the many aspects described herein. In another variant, the many aspects are mainly implemented in hardware using, for example, hardware components such as an application specific integrated circuit (ASIC). Implementing a hardware state machine to perform the functions described herein will be apparent to those skilled in the relevant art.

[0220] In yet another additional example variant, the many aspects described herein are implemented using a combination of both hardware and software.

[0221] The various aspects discussed herein can also be described and implemented in the context of a computer-readable storage medium storing computer-executable instructions. The computer-readable storage medium includes computer storage media and communication media. For example, flash drives, digital versatile discs (DVDs), compact discs (CDs), floppy disks, and magnetic tape cartridges. The computer-readable storage medium can include volatile and non-volatile, removable and non-removable media implemented in any method or technology for storing information such as computer-readable instructions, data structures, modules, or other data.

[0222] It should be understood that the different implementations of the above-disclosed and other features and functions or their alternatives or variations can be desirably combined into many other different systems or applications. In addition, those skilled in the art may subsequently make various alternatives, modifications, variations, or improvements that are currently unforeseen or unanticipated, and they are also intended to be covered by the appended claims.

[0223] Multiple aspects have been described. However, it should be understood that various modifications can be made without departing from the spirit and scope of the present disclosure. For example, although a controller with a single pressure sensor has been described, additional pressure sensors (e.g., one pressure sensor per inflatable airbag) can also be used without departing from the scope of the present disclosure. Accordingly, other aspects are within the scope of the following claims.

Claims

1. A compression garment controller for monitoring a user's compliance with wearing a compression garment according to a compression therapy, the controller comprising: a display screen configured to display a graphical user interface; at least one light emitting diode (LED) configured to selectively illuminate different colors; at least one computer-readable storage medium configured to store one or more monitored parameters; one or more processors coupled to the at least one computer-readable storage medium; and computer-executable instructions embodied on the at least one computer-readable storage medium, the computer-executable instructions including instructions for causing the one or more processors to perform the following operations: directing a fluid flow from a pressurized fluid flow source to periodically inflate and deflate at least one inflatable bladder of the compression garment, the at least one inflatable bladder being configured to wrap around a limb of the wearer of the garment; receiving, during at least one of inflation and deflation of the at least one inflatable bladder, in a plurality of successive pressurization cycles, a pressure signal indicative of the fluid pressure in the at least one inflatable bladder from a pressure sensor communicatively coupled to the at least one inflatable bladder; processing the received pressure signal; in response to the received pressure signal indicating compliance with the compression therapy, causing the at least one LED to illuminate a first color; and in response to the received pressure signal indicating an operation interruption or non-compliance with the compression therapy, causing the at least one LED to illuminate a second color.

2. The pressure garment controller according to claim 1, wherein, The at least one processor is further configured to, in response to the received pressure signal indicating an error in the compression therapy, cause the at least one LED to illuminate a third color.

3. The pressurized garment controller according to claim 1, wherein, The compression garment controller further includes a housing having inclined surfaces on each vertical side of the display screen, wherein the LEDs are located on each inclined surface such that at least one LED is visible from the side of the compression garment controller.

4. The pressure garment controller according to claim 1, wherein, The at least one processor is further configured to display a graphical user interface (GUI) on the display screen, wherein the GUI includes a compliance meter indicative of compliance with the compression therapy.

5. The pressurized garment controller according to claim 4, wherein, The compliance meter is displayed as a twenty-four (24)-hour circular bar, wherein the first color indicates compliance and the second color indicates non-compliance.

6. The pressurized garment controller according to claim 5, wherein, The first color is blue.

7. The pressurized garment controller according to claim 5, wherein, The second color is orange.

8. The pressure garment controller according to claim 5, wherein, The displayed compliance meter indicates the amount of time used for the compression therapy during a twenty-four-hour period.

9. The pressure garment controller according to claim 8, wherein, The displayed compliance meter includes the current time and date within the circular bar.

10. The pressurized garment controller according to claim 1, wherein, The at least one processor is further configured to display a graphical user interface (GUI) on the display screen, wherein the GUI includes a plurality of compliance meters indicative of compliance with the compression therapy on a daily basis.

11. The pressure garment controller according to claim 10, wherein, The GUI displays up to six compliance gauges on the display screen.

12. The pressure garment controller according to claim 1, wherein, The at least one processor is further configured to: Receive a selection of a system time icon from a displayed menu; Display a world map and the current time; Display the current time in response to a navigation command; Receive a selection of a highlighted current time zone; And Save the selected current time zone.

13. A controller attachment configured to couple a pressure garment controller to a pole, the controller attachment comprising: A first receiving portion including a recess portion adapted to receive a portion of a handle of the pressure garment controller; A second receiving portion coupled to the first receiving portion and including a channel adapted to receive one or more wires or tubes; An interconnect coupled to the second receiving portion; And A pole attachment portion coupled to the interconnect and having a U-shaped configuration adapted to captively receive a pole.

14. The controller attachment according to claim 13, wherein, The pole attachment portion includes a threaded hole adapted to receive a screw with a knob coupled to an opposite end of the screw, whereby turning the knob advances the screw to secure the pole to the pole attachment portion.

15. The controller attachment according to claim 14, wherein, The pole is an intravenous (IV) pole.

16. A pressure garment system for monitoring a user's compliance with wearing a pressure garment wrapped around a limb of the user according to a pressure treatment, the system comprising: A pressure garment; And A controller, wherein the controller includes: A display screen configured to display a graphical user interface (GUI); A plurality of light-emitting diodes (LEDs) arranged at a visible angle on the controller; A memory; and A processor coupled to the memory and configured to: Direct a fluid flow from a pressurized fluid source to periodically inflate and deflate an inflatable bladder of the pressure garment configured to wrap around a limb of a wearer of the pressure garment; During at least one of inflation and deflation of the inflatable bladder in a plurality of successive pressure cycles, receive a pressure signal indicative of a fluid pressure in the inflatable bladder from a pressure sensor communicatively coupled to the inflatable bladder; Process the received pressure signal to determine compliance or non-compliance with the pressure treatment; In response to the received pressure signal indicative of compliance with the pressure treatment, cause the plurality of LEDs to illuminate in a first color; and In response to the received pressure signal indicative of an operation interruption or non-compliance with the pressure treatment, cause the plurality of LEDs to illuminate in a second color.

17. The pressurized garment system according to claim 16, wherein, The pressure garment is at least one of a leg sleeve, an ankle sleeve, a thigh sleeve, or a calf sleeve.

18. The pressurized garment system according to claim 17, wherein, The pressure garment includes a plurality of garments.

19. The pressurized garment system according to claim 18, wherein, The plurality of garments includes a combination of different sleeves.

20. The pressure garment system according to claim 18, wherein, The plurality of garments includes two identical sleeves.

21. The pressure garment system according to claim 16, further comprising a rod attachment portion configured to secure the controller to a rod.

22. A method for a pressure garment controller for monitoring a user's compliance with wearing a pressure garment wrapped around a limb of the user according to a pressure treatment, the method comprising: Directing a fluid flow from a pressurized fluid flow source to periodically inflate and deflate an inflatable bladder of the pressure garment; Receiving, during at least one of inflation and deflation of the inflatable bladder, in a plurality of successive pressure cycles, a pressure signal indicative of a fluid pressure in the inflatable bladder, the inflatable bladder being communicatively coupled to the pressure sensor; Processing the received pressure signal to determine compliance or non-compliance with the pressure treatment; In response to the received pressure signal indicative of compliance with the pressure treatment, causing at least one light emitting diode (LED) to illuminate in a first color; and In response to the received pressure signal indicative of an interruption of operation or non-compliance with the pressure treatment, causing the at least one LED to illuminate in a second color.

23. The method according to claim 22, further comprising displaying a compliance gauge on a graphical user interface (GUI) of the controller, the compliance gauge indicating compliance with the pressure treatment.

24. The method according to claim 23, wherein The compliance gauge is displayed as a twenty-four (24)-hour circular bar, wherein a first color indicates compliance and a second color indicates non-compliance.

25. The method according to claim 23, wherein, The displayed compliance gauge indicates the amount of time used for the pressure treatment during a twenty-four-hour period.

26. The method according to claim 24, wherein, The displayed compliance gauge includes the current time and date within the circular bar.

27. The method according to claim 22, further comprising, in response to the received pressure signal indicative of an error in the pressure treatment, causing the LED to illuminate in a third color.

28. The method according to claim 22, further comprising displaying a plurality of compliance gauges on a graphical user interface (GUI) of the controller indicative of compliance with the pressure treatment on a daily basis.

29. The method according to claim 28, wherein, The GUI displays up to six compliance gauges.

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