Systems, methods and devices for monitoring and expressing compliance with medical treatments

Abstract

A compression garment controller and method for monitoring compliance of a user wearing a compression garment wrapped around the user's limb in accordance with a compression therapy includes directing a fluid flow from a pressurized fluid flow source to cyclically inflate and deflate an inflatable bladder of the compression garment, receiving a pressure signal indicative of fluid pressure within the inflatable bladder from a pressure sensor communicatively coupled to the inflatable bladder during at least one of the inflation and deflation of the inflatable bladder in a plurality of successive compression cycles, processing the received pressure signal to determine compliance or non-compliance with the compression therapy, and illuminating at least one light emitting diode (LED) in a first color indicative of compliance with the compression therapy and illuminating at least one LED in a second color indicative of non-compliance with the compression therapy.

Description

[Technical Field]

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 384,359, filed November 18, 2022, entitled "SYSTEM, METHOD AND DEVICE FOR MONITORING AND EXPRESSING COMPLIANCE OF A MEDICAL TREATMENT," the disclosure of which is incorporated herein by reference.

[0002] The present disclosure relates to systems, methods, and devices for controlling, monitoring, and representing compliance with medical treatments, and more particularly, to systems, methods, and devices for controlling, monitoring, and representing compliance with compression therapy. [Background technology]

[0003] Intermittent pneumatic compression (IPC) systems include devices used to apply pressurized fluid, such as air, to a patient's or wearer's limbs. In some cases, pressurized air is applied to the lower limbs of patients at risk for developing deep vein thrombosis (DVT). IPC systems typically include a pumping unit for managing the pressurization of the fluid, a tubing set for extending fluid delivery beyond the pumping unit, and a compression garment that is wrapped around the patient's limb and contains the pressurized fluid. The IPC system intermittently compresses the garment to apply therapeutic compression to the patient's limb and move blood from that area of ​​the limb. However, the effectiveness of such IPC systems for DVT prevention depends on the patient's compliance with a prescribed treatment protocol that includes compression therapy or the IPC system. Summary of the Invention

[0004] In some aspects, the techniques described herein may include a compression garment controller for monitoring user compliance with wearing a compression garment in accordance with a compression therapy, the compression garment controller including 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 in the at least one computer readable storage medium that cause the one or more processors to control at least one inflation of the compression garment configured to be wrapped around a limb of a compression garment wearer. and computer-executable instructions to: direct a flow of fluid from a pressurized fluid flow source to periodically / repeatedly inflate and deflate an inflatable bladder; receive, during at least one of the inflation and deflation of the at least one inflatable bladder over a plurality of successive compression cycles, a pressure signal indicative of the fluid pressure within the at least one inflatable bladder from a pressure sensor communicatively coupled to the at least one inflatable bladder; process the received pressure signal; and illuminate at least one LED a first color in response to the received pressure signal indicating compliance with compression therapy, and illuminate at least one LED a second color in response to the received pressure signal indicating a cessation of operation or non-compliance with compression therapy.

[0005] In some aspects, the techniques described herein relate to a controller attachment configured to couple a compression garment controller to a pole, the controller attachment including: a first receiving portion including a recessed 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 channel adapted to receive one or more wires or tubes; an interconnector coupled to the second receiving portion; and a pole attachment portion coupled to the interconnector and having a U-shape adapted to capturably receive the pole.

[0006] In some aspects, techniques described herein relate to a method for a compression garment controller to monitor compliance of a user wearing a compression garment wrapped around the user's limb in accordance with a compression therapy, the method including: directing a flow of fluid from a pressurized fluid flow source to cyclically inflate and deflate an inflatable bladder of the compression garment; receiving, during at least one of the inflation and deflation of the inflatable bladder in a plurality of successive compression cycles, a pressure signal indicative of fluid pressure within 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 compression therapy; illuminating at least one light emitting diode (LED) a first color in response to the received pressure signal indicative of compliance with the compression therapy; and illuminating at least one LED a second color in response to the received pressure signal indicative of cessation of operation or non-compliance with the compression therapy.

[0007] In some aspects, the techniques described herein relate to a compression garment system including a compression garment and a controller, the controller including a display screen configured to display a graphical user interface (GUI), a plurality of light emitting diodes (LEDs) positioned at a viewable angle to the controller, a memory, and a processor coupled to the memory, the processor configured to: direct a flow of fluid from a pressurized fluid flow source to cyclically inflate and deflate an inflatable bladder of the compression garment configured to be wrapped around a limb of a wearer of the compression garment; receive, during at least one of the inflation and deflation of the inflatable bladder in a plurality of successive compression cycles, a pressure signal indicative of the fluid pressure within 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 compression therapy; illuminate a plurality of LEDs a first color in response to the received pressure signal indicating compliance with the compression therapy; and illuminate a plurality of LEDs a second color in response to the received pressure signal indicating an interruption in operation or non-compliance with the compression therapy.

[0008] Other aspects, features, and advantages will be apparent from the description and drawings, and from the claims. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a perspective view of a compression system including a compression garment and a controller, according to one aspect of the present invention.

[0010] [Figure 2] FIG. 2 is a simplified schematic diagram of the compression system of FIG. 1, including a schematic of a pneumatic circuit, according to one embodiment of the present invention.

[0011] [Figure 3] FIG. 2 is a schematic diagram of another exemplary compression system of FIG. 1, including a schematic of a pneumatic circuit, according to an embodiment of the present invention.

[0012] [Figure 4] 2 is a graphical illustration of a pressure profile produced by the compression system of FIG. 1 when the compression garment is in a wrap configuration against a leg morphology simulating a wearer's limb, in accordance with one embodiment of the present invention.

[0013] [Figure 5] FIG. 2 is a graphical illustration of a pressure profile generated by the compression system of FIG. 1 when the compression garment of the system is in a non-wrapped configuration and away from a leg configuration simulating a wearer's limb, according to one embodiment of the present invention.

[0014] [Figure 6] 6 is a graphical representation of the manifold pressure signal of the compression system of FIG. 1 corresponding to the manifold pressure signals for the wrapped and non-wrapped compression garment configurations of FIGS. 4 and 5, respectively.

[0015] [Figure 7] FIG. 1 is a perspective view of a controller of a compression system according to one aspect of the present invention.

[0016] [Figure 8] FIG. 1 is a side view of a controller mounted on a bed board according to one aspect of the present invention.

[0017] [Figure 9A] FIG. 10 is a rear view of a pole mounting portion of a mounting member prior to attachment to a pole, according to one aspect of the present invention.

[0018] [Figure 9B] FIG. 10 is a rear view of a pole mounting portion of a mounting member attached to a pole, according to one aspect of the present invention.

[0019] [Figure 10A] FIG. 2 is a front perspective view of a mounting member according to one aspect of the present invention.

[0020] [Figure 10B]FIG. 2 is a front view of a mounting member according to one aspect of the present invention.

[0021] [Figure 10C] FIG. 2 is a side view of a mounting member according to one aspect of the present invention.

[0022] [Figure 10D] FIG. 10 is a rear view of a mounting member according to one aspect of the present invention.

[0023] [Figure 10E] FIG. 2 is a top view of a mounting member according to one aspect of the present invention.

[0024] [Figure 10F] FIG. 1 is a perspective view of a controller mounted on a mounting member according to one aspect of the present invention.

[0025] [Figure 11] FIG. 10 is a front view of a display of a controller according to one aspect of the present invention.

[0026] [Figure 12A] 1 is an exemplary flow diagram of a method for starting a controller, according to an aspect of the present invention. [Figure 12B] 1 is an exemplary flow diagram of a method for starting a controller, according to an aspect of the present invention.

[0027] [Figure 13A] 1 is an exemplary flow diagram of a method for expressing compliance with compression therapy, according to an aspect of the present invention; [Figure 13B] 1 is an exemplary flow diagram of a method for expressing compliance with compression therapy, according to an aspect of the present invention;

[0028] [Figure 14A] FIG. 1 is a graphical illustration of a graphical user interface (GUI) displaying a single three capsule leg sleeve garment icon according to one embodiment of the present invention.

[0029] [Figure 14B] FIG. 10 is a graphical illustration of a foot cuff icon according to one aspect of the present invention.

[0030] [Figure 14C] FIG. 10 is a graphical representation of three capsular sleeve icons, according to one embodiment of the present invention.

[0031] [Figure 14D] FIG. 10 is a graphical representation of a single capsular sleeve icon, according to one aspect of the present invention.

[0032] [Figure 14E] FIG. 10 is a graphical illustration of a vascular refill detection icon, according to one aspect of the present invention.

[0033] [Figure 14F] FIG. 10 is a graphical illustration of a clothing mismatch error icon, in accordance with one aspect of the present invention.

[0034] [Figure 15] FIG. 1 is a graphical illustration of a graphical user interface (GUI) displaying an adherence meter graphic for compression therapy, according to one embodiment of the present invention.

[0035] [Figure 16] FIG. 1 is a graphical illustration of a graphical user interface (GUI) displaying multiple adherence meter graphics for compression therapy, according to one embodiment of the present invention.

[0036] [Figure 17] FIG. 10 is an exemplary flow diagram for selecting a current time zone, according to an aspect of the present invention.

[0037] [Figure 18] FIG. 2 is a graphical illustration of a graphical user interface (GUI) displaying a menu, according to one aspect of the present invention.

[0038] [Figure 19] FIG. 2 is a graphical illustration of a graphical user interface (GUI) displaying a world map for selecting a current time zone, according to one aspect of the present invention.

[0039] [Figure 20] 2 is an exemplary flow diagram of a method for compliance monitoring using the compression system of FIG. 1 according to one embodiment of the present invention.

[0040] [Figure 21A] 1 is a flow diagram of an exemplary implementation of a sleeve removal detection method, according to an aspect of the present invention. [Figure 21B] 1 is a flow diagram of an exemplary implementation of a sleeve removal detection method, according to an aspect of the present invention.

[0041] [Figure 22] 1 is a flow diagram of an exemplary implementation of a sleeve reapplication detection method, according to an aspect of the present invention.

[0042] [Figure 23] 10A-10C are graphical representations of polynomial curve fit lines of pressure within the manifold during the inflation phase of the compression garment bladder in both wrapped and unwrapped configurations, according to one aspect of the present invention.

[0043] [Figure 24] 2 is a graphical illustration of a first pressure profile produced by the compression system of FIG. 1 when the compression garment is in a wrapped configuration about a wearer's limb, in accordance with one embodiment of the present invention.

[0044] [Figure 25] 2 is a graphical illustration of a first pressure profile produced by the compression system of FIG. 1 when the compression garment is in a non-wrapped configuration and away from the wearer's limb, in accordance with one embodiment of the present invention.

[0045] [Figure 26]2 is a flow diagram of a first method of compliance monitoring using the compression system of FIG. 1 according to one embodiment of the present invention.

[0046] [Figure 27] 2 is a flow diagram of a second method of compliance monitoring using the compression system of FIG. 1 according to an embodiment of the present invention.

[0047] [Figure 28A] 2 is a graphical illustration of a first set of pressure profiles produced by the compression system of FIG. 1 when the compression garment is in a wrapped configuration about a wearer's limb, in accordance with an embodiment of the present invention. [Figure 28B] 2 is a graphical illustration of a first set of pressure profiles produced by the compression system of FIG. 1 when the compression garment is in a wrapped configuration about a wearer's limb, in accordance with an embodiment of the present invention. [Figure 28C] 2 is a graphical illustration of a first set of pressure profiles produced by the compression system of FIG. 1 when the compression garment is in a wrapped configuration about a wearer's limb, in accordance with an embodiment of the present invention.

[0048] [Figure 29] 10 is a graphical representation of a second pressure profile generated by the compression system of FIG. 1 when the compression garment is in a non-wrapped configuration and away from the wearer's limb, in accordance with one embodiment of the present invention. FIG.

[0049] [Figure 30A] 10 is a graphical representation of a third pressure profile produced by the compression system of FIG. 1 when the compression garment is in a wrapped configuration about a wearer's limb, in accordance with one embodiment of the present invention. FIG. [Figure 30B] 10 is a graphical representation of a third pressure profile produced by the compression system of FIG. 1 when the compression garment is in a wrapped configuration about a wearer's limb, in accordance with one embodiment of the present invention. FIG.

[0050] [Figure 31]1 is a flowchart of an exemplary method for determining whether a compression garment is in a wrapped or non-wrapped configuration around a limb of a wearer of the garment by analyzing waveform data received from a pressure sensor to detect pulsations associated with the wearer's heartbeat, in accordance with aspects of the present invention.

[0051] [Figure 32] 1 is a flowchart of an exemplary method for analyzing waveform data received from a pressure sensor to determine whether a compression garment is in a wrapped or non-wrapped configuration during a garmenting process, according to one aspect of the present invention.

[0052] [Figure 33] 1 is a flowchart of an exemplary method for analyzing waveform data received from a pressure sensor to determine whether a compression garment is in a wrapped or non-wrapped configuration after completion of a cycle pressure, according to one aspect of the present invention.

[0053] [Figure 34] 1 is a flowchart of an exemplary method for analyzing waveform data received from a pressure sensor to determine whether a compression garment is in a wrapped or non-wrapped configuration during Venous Refill Determination (VRD), in accordance with an aspect of the present invention.

[0054] [Figure 35] 10 is a flowchart of an exemplary method for analyzing waveform data received from a pressure sensor to determine whether a compression garment is in a wrapped or non-wrapped configuration as an independent cycle, in accordance with aspects of the present invention.

[0055] [Figure 36A] FIG. 1 is a flow diagram of a first exemplary method for determining whether a compression garment is in a wrapped or non-wrapped configuration about a limb of a wearer of the compression garment by analyzing waveform data received from a pressure sensor to detect pulsations associated with the wearer's heartbeat, in accordance with an aspect of the present invention. [Figure 36B]FIG. 1 is a flow diagram of a first exemplary method for determining whether a compression garment is in a wrapped or non-wrapped configuration about a limb of a wearer of the compression garment by analyzing waveform data received from a pressure sensor to detect pulsations associated with the wearer's heartbeat, in accordance with an aspect of the present invention. [Figure 36C] FIG. 1 is a flow diagram of a first exemplary method for determining whether a compression garment is in a wrapped or non-wrapped configuration about a limb of a wearer of the compression garment by analyzing waveform data received from a pressure sensor to detect pulsations associated with the wearer's heartbeat, in accordance with an aspect of the present invention.

[0056] [Figure 37] FIG. 10 is a graphical illustration of a signal after passing through a low pass filter when the compression garment is in a wrapped configuration about a wearer's limb, in accordance with one aspect of the present invention.

[0057] [Figure 38] FIG. 10 is a graphical illustration of peak detection when the compression garment is in a wrapped configuration about the wearer's limb, in accordance with one aspect of the present invention.

[0058] [Figure 39A] FIG. 10 is a flow diagram of a second exemplary method for determining whether a compression garment is in a wrapped or non-wrapped configuration about a limb of a wearer of the compression garment by analyzing waveform data received from a pressure sensor to detect pulsations associated with the wearer's heartbeat, in accordance with an embodiment of the present invention. [Figure 39B] FIG. 10 is a flow diagram of a second exemplary method for determining whether a compression garment is in a wrapped or non-wrapped configuration about a limb of a wearer of the compression garment by analyzing waveform data received from a pressure sensor to detect pulsations associated with the wearer's heartbeat, in accordance with an embodiment of the present invention. [Figure 39C] FIG. 10 is a flow diagram of a second exemplary method for determining whether a compression garment is in a wrapped or non-wrapped configuration about a limb of a wearer of the compression garment by analyzing waveform data received from a pressure sensor to detect pulsations associated with the wearer's heartbeat, in accordance with an embodiment of the present invention.

[0059] [Figure 40] FIG. 1 is a block diagram of an exemplary system diagram of various hardware components and other features for use in accordance with aspects of the present disclosure.

[0060] Corresponding reference characters indicate corresponding parts throughout the drawings. DETAILED DESCRIPTION OF THE INVENTION

[0061] As used herein, the terms "proximal" and "distal" refer to the relative locations of components, parts, etc. of a compression garment when the compression garment is worn. For example, a "proximal" component is disposed closest to the wearer's torso, a "distal" component is disposed furthest from the wearer's torso, and an "intermediate" component is generally disposed anywhere between the proximal and distal components. Furthermore, as used herein, the term "wrapped" or "wrapped configuration" refers to a compression garment that is properly wrapped around a wearer's limb. "Non-wrapped" or "non-wrapped configuration" refers to a compression garment that is not wrapped around a wearer's limb, a compression garment that is in an unwrapped configuration, a compression garment that is wrapped but not wrapped (e.g., wrapped) around the wearer's limb, or a compression garment that is loosely wrapped around the wearer's limb and provides an indeterminate reading by one or more pressure sensors. "Prescription treatment protocol," "prescription therapeutic," "compression treatment regimen," and "compression therapy" are used interchangeably to describe the use of a compression system. Some of the methods in this application include the step of venting the bladder to a target value or pressure. Alternatively, the bladder can be vented and then inflated to a target value or pressure.

[0062] 1-3, compression system 1 includes a compression garment 10 for applying compression therapy to a wearer's limb, one or more processors 7, and a controller 5 having computer-executable instructions ("CEI") 33a embodied in a computer-readable storage medium 33 (shown as "Memory" in FIGS. 2 and 3), the computer-executable instructions including instructions for causing the one or more processors to control the operation of compression system 1. Compression therapy can be sequential or non-sequential, depending on compression garment 10. The compression garment can be a three-bladder compression sleeve, a single-bladder compression sleeve, a foot cuff, or any other type of compression garment that can be used with compression therapy. While the present application describes the use of a three-bladder compression sleeve, those skilled in the art will understand that compression garment 10 can be a single-bladder compression sleeve, a foot cuff, and / or any other type of compression garment that can be used with compression therapy without departing from the scope of the present invention. As shown, compression garment 10 includes distal inflatable bladder 13a, intermediate inflatable bladder 13b, and proximal inflatable bladder 13c. Compression garment 10 can be secured around a wearer's limb and, in one aspect, is adjustable to fit limbs of different circumferences.

[0063] As described in more detail below, the controller 5 controls the operation of the compression system 1 to perform inflation cycles in which the inflatable bladders 13a, 13b, 13c inflate to apply pressure to the wearer's limb and establish a gradient pressure applied to the wearer's limb by the inflatable bladders 13a, 13b, 13c of the compression garment 10 during one or more compression cycles. Also, as described in more detail below, for purposes of this description, each therapeutic compression cycle includes an inflation phase for all three bladders 13a, 13b, 13c, a decay phase for bladders 13a, 13b, and a venting phase for all three bladders 13a, 13b, 13c. The pressure in each bladders 13a, 13b, 13c at the end of the cycle is the pressure in each bladders 13a, 13b, 13c prior to the start of the venting phase for its respective bladders 13a, 13b, 13c. As described in more detail below, the controller 5 determines whether the compression garment 10 is applied to the wearer's limb (i.e., in a wrap configuration around the limb) based at least in part on the measured pressure in one or more of the inflatable bladders 13a, 13b, 13b, and in some embodiments of the present disclosure provides an indication of the determination (e.g., by incrementing a timer, by pausing a timer, by providing an audible alert, and / or by providing a visual indication in a graphical user interface (GUI) and / or light-emitting diode (LED)). Determining whether the compression garment 10 is being worn (i.e., in a wrap configuration around the wearer's limb) provides a compliance monitoring function that enables the compression system 1 to track when the garment is being properly used to achieve a prescribed treatment, e.g., compression therapy. Additionally, as described in more detail below, the controller 5 controls the operation of the compression system 1 to perform inflation cycles in which the inflatable bladders 13a, 13b, 13c are inflated to apply pressure to the wearer's limb, e.g., to establish a gradient pressure applied to the wearer's limb by the inflatable bladders 13a, 13b, 13c of the compression garment 10 during one or more compression cycles.

[0064] Compression garment 10 is a thigh-length sleeve that is / can be positioned around the wearer's leg, with distal bladder 13a around the wearer's ankle, intermediate bladder 13b around the wearer's calf, and proximal bladder 13c around the wearer's thigh. Inflatable bladders 13a, 13b, 13c expand and contract under the influence of fluid (e.g., air or other fluid) delivered from a pressurized fluid source 21 (e.g., a pump or compressor) in electrical communication with control device 5. Pressurized fluid source 21 delivers pressurized fluid (e.g., air) to inflatable bladders 13a, 13b, 13c through tubing 23.

[0065] 2, each inflatable bladder 13a, 13b, 13c is in fluid communication with a respective valve 25a, 25b, 25c. A pressure sensor 27 is in communication (e.g., fluid communication) with a manifold 29 and measures a signal indicative of the pressure within the manifold 29. Fluid communication between the manifold 29 and each inflatable bladder 13a, 13b, 13c can be controlled through control of the position of each valve 25a, 25b, 25c (e.g., through activation and / or deactivation of each valve 25a, 25b, 25c). The pressure sensor 27 is in electrical communication with the controller 5 such that the controller 5 receives a signal from the pressure sensor 27 indicative of the pressure in the manifold 29 and / or one or more inflatable bladders 13a, 13b, 13c that are in fluid communication with the manifold 29 as a result of the position of each valve 25a, 25b, 25c. When only one bladder 13a, 13b, or 13c is in fluid communication with manifold 29, the signal received from pressure sensor 27 is indicative of the pressure in the respective bladder 13a, 13b, 13c in fluid communication with manifold 29. For example, pressure sensor 27 provides a signal indicative of the pressure in inflatable bladder 13a when valve 25a is open and valves 25b and 25c are closed. Similarly, pressure sensor 27 provides a signal indicative of the pressure in inflatable bladder 13b when valve 25b is open and valves 25a and 25c are closed. Similarly, pressure sensor 27 provides a signal indicative of the pressure in inflatable bladder 13c when valve 25c is open and valves 25a and 25b are closed. In one aspect of the present disclosure, vent valve 25d is operable to control fluid communication between manifold 29 and vent port 15, which vents to the ambient atmosphere. All bladders 13a, 13b, 13c may be vented using vent valve 25d. In another embodiment of the present disclosure, a vent valve may not be implemented in the device.

[0066] Each valve 25a, 25b, 25c is a two-way / two-position normally open solenoid valve. Each valve 25a, 25b, 25c includes two ports (X and Y) and is operable, in a first, open position, to fluidly connect the inlet port to the bladder port. Each valve 25a, 25b, 25c is further operable to block fluid communication between the inlet port and the bladder port. The inlet port of each valve 25a, 25b, 25c is in fluid communication with the pressurized fluid source 21 and the manifold 29. The bladder port of each valve 25a, 25b, 25c is in fluid communication with a respective inflatable bladder 13a, 13b, 13c.

[0067] Any one of the bladders 13a, 13b, 13c may be placed in fluid communication with the pressurized fluid source 21 and the manifold 29 via a respective valve 25a, 25b, 25c to deliver pressurized fluid to the bladders 13a, 13b, 13c. After the bladders 13a, 13b, 13c are inflated, the respective valves 25a, 25b, 25c may retain fluid within the respective bladders 13a, 13b, 13c. Thus, the bladders 13a, 13b, 13c of the compression garment 10 may be individually inflated by opening the respective valve 25a, 25b, 25c and closing the other valves 25a, 25b, 25c, such that only the one bladders 13a, 13b, 13c associated with the open valve 25a, 25b, 25c is in fluid communication with the pressurized fluid source 21 and the manifold 29.

[0068] Vent valve 25d is also a two-way / two-position normally open solenoid valve. Vent valve 25d includes two ports (X and Y) and is operable to place the inlet port in fluid communication with vent port 15 in a first position. The vent inlet port is in fluid communication with vent port 15 in the first position. Vent valve 25d is further operable to block fluid communication between the inlet port and vent port 15. The inlet port of vent valve 25d is in fluid communication with pressurized fluid source 21 and manifold 29. Vent port 15 of vent valve 25d is in fluid communication with the ambient atmosphere.

[0069] It should be understood that valves 25a, 25b, 25c, 25d may be of other types and have other arrangements within compression system 1 without departing from the scope of this disclosure. For example, with reference to Figure 3, the valves may be valves 35a, 35b, 35c that are three-way / two-position solenoid valves and are operable to control pressure within bladders 13a, 13b, 13c without vent valves.

[0070] 2, the computer-executable instructions embodied in the computer-readable storage medium 33 include instructions for causing the one or more processors 7 to pressurize (e.g., inflate) the inflatable bladders 13a, 13b, 13c to provide a cyclical therapeutic compression pressure to the wearer's limb. For example, the computer-executable instructions embodied in the computer-readable storage medium 33 include instructions for causing the one or more processors 7 to control the pressurized fluid source 21 and / or the valves 25a, 25b, 25c, 25d to pressurize the inflatable bladders 13a, 13b, 13c to a therapeutic compression pressure for a predetermined period of time to displace blood in the limb from the area underlying the inflatable bladders 13a, 13b, 13c. The length of time that the bladders 13a, 13b are held at the compression pressure is referred to herein as the decay phase. The dampening phase is followed by a ventilation phase, in which the computer-executable instructions include instructions for causing the one or more processors 7 to control the pressurized fluid source 21 and / or the valves 25a, 25b, 25c, 25d to reduce the pressure within the inflatable bladders 13a, 13b, 13c to a lower pressure (e.g., atmospheric pressure).

[0071] The compression system 1 can determine whether the compression garment 10 is applied (i.e., wrapped) to a wearer's limb, and in certain embodiments of the present invention can provide an indication of that determination, which can, for example, facilitate tracking wearer compliance with prescribed therapeutic, e.g., compression therapy, use of the compression garment 10. The computer-executable instructions embodied in the non-transitory computer-readable storage medium 33 include instructions that cause the one or more processors 7 to analyze pressure signal data received from the pressure sensors 27 during a decompression period of a therapeutic cycle of the compression system 1. The computer-executable instructions embodied in the non-transitory computer-readable storage medium 33 include instructions that cause the one or more processors 7 to determine whether characteristics of the received pressure signal data satisfy one or more conditions that indicate the compression garment 10 is positioned on the wearer's limb.

[0072] In exemplary embodiments, the computer-executable instructions cause the one or more processors 7 to receive pressure signal data from the pressure sensor 27. The computer-executable instructions may include instructions causing the one or more processors 7 to process a single waveform representative of the pressure within one or more of the bladders 13a, 13b, and 13c. It should be understood that the one or more processors 7 may process multiple waveforms without departing from the scope of the present disclosure. For example, by monitoring the pressure signal and corresponding pressure data during a decompression period of a treatment cycle, the one or more processors 7 may detect particular characteristics in the waveform that indicate whether the compression garment 10 is properly wrapped around the wearer's limb or is not wrapped around the wearer's limb. In certain embodiments, the pressure sensor 27 remains (or is purposely positioned) in constant communication (e.g., fluid and / or mechanical communication) with one or more of the bladders 13a, 13b, and 13c during the decompression period. Exemplary rest periods include non-therapeutic cycles (eg, pressure within the sacs 13a, 13b, 13c less than about 29 mmHg), a subset of the early garment detection period, and / or a venous refill measurement period.

[0073] In an exemplary operation of the embodiment of FIG. 3 in which a three-way / two-position valve (e.g., a three-way / two-position solenoid valve) is utilized, the computer-executable instructions embodied in the computer-readable storage medium 33 include instructions that cause the one or more processors 7 to control one or more valves 35a, 35b, 35c for one or more of the particular bladders 13a, 13b, 13c such that a fluid path is established between the pressure sensor 27 and one or more of the bladders 13a, 13b, 13c.

[0074] 2 embodiment in which a two-way / two-position valve (e.g., a two-way / two-position solenoid valve) is utilized, the computer-executable instructions embodied in the computer-readable storage medium 33 include instructions that cause the one or more processors 7 to open or close the vent valve 25d so that the manifold 29 can no longer vent. One or more of the computer-executable instructions cause the one or more processors 7 to determine whether the signal received from the pressure sensor 27 contains random pressure impulses and spikes that are expected to occur when the wearer moves (e.g., moves a leg, flexes a calf, coughs, sneezes, breathes, etc.). Due to the amount of fluid (e.g., air) held within one or more of the bladders 13a, 13b, 13c and extending to the manifold 29 and thus the pressure sensor 27, even slight movements can cause the bladders to move or change shape, creating pressure spikes in the pressure signal generated by the pressure sensor 27. Conversely, with the compression garment 10 removed from the wearer's limb, the pressure signal generated by the pressure sensor 27 is static and free of random noise or pressure impulses.

[0075] Referring now to FIG. 4, a representative compression cycle pressure profile is shown for a compression garment 10 in a wrap configuration around a leg form simulating a wearer's leg. The leg form has a size, shape, and stiffness similar to a human leg. Therefore, for purposes of analyzing the performance of the algorithms described in this disclosure, the leg form is a suitable analog to a human wearer's leg. Unless otherwise stated, all data presented herein was acquired in an experimental set using the leg form.

[0076] The graph shows signals from an experimental setup in which pressure sensors are used to measure pressure in individual bladders 13a, 13b, 13c and pressure sensor 27 is used to measure pressure in manifold 29. As described in more detail below, using this experimental setup, the measured pressures in bladders 13a, 13b, 13c are 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 compression system 1. Figure 4 shows the correspondence between manifold pressure measured by pressure sensor 27 and the pressure measured by the pressure sensors disposed in each of bladders 13a, 13b, 13c.

[0077] A single compression cycle for at least one of the sacs 13a, 13b, 13c includes an inflation phase, a damping phase, and a vent phase for the sacs 13a, 13b, and an inflation phase and a vent phase for the sac 13c. Pressure plot 402 shows the pressure signal throughout a single therapeutic compression cycle for the distal sac 13a, pressure plot 404 shows the pressure throughout a single therapeutic compression cycle for the middle sac 13b, pressure plot 406 shows the pressure throughout a single therapeutic compression cycle for the proximal sac 13c, and pressure plot 408 shows the manifold pressure measured by pressure sensor 27 during each of these therapeutic compression cycles. Each plot 402, 404, 406 includes an initial sac filling period that defines the inflation phase of the therapeutic compression cycle for the respective sac 13a, 13b, 13c. Once the respective target pressures are achieved in sacs 13 a, 13 b, inflation may be stopped and the pressure in the sacs may be maintained at or near the target pressure defining the decay phase of the therapeutic compression cycle for sacs 13 a, 13 b. After the decay phase in the case of sacs 13 a, 13 b, or immediately after the inflation phase in the case of sac 13 c, fluid within each sac 13 a, 13 b, 13 c is evacuated from the respective sac during a vent phase of the therapeutic compression cycle for each sac 13 a, 13 b, 13 c.

[0078] At the beginning of a therapeutic compression cycle, valves 25b, 25c, and 25d are energized to their closed positions. To inflate distal sac 13a, pressurized fluid from pressurized fluid source 21 is delivered to distal sac 13a via valve 25a and tubing 23. Once the target pressure for distal sac 13a is achieved, or after a time measured by timer 31 that predicts the target pressure will be achieved, valve 25a is energized to close, retaining pressurized fluid within distal sac 13a. Next, intermediate sac 13b is inflated by de-energizing valve 25b to its open position, allowing pressurized fluid from pressurized fluid source 21 to flow into intermediate sac 13b. Once the target pressure for intermediate sac 13b is achieved, or after a time measured by timer 31 that predicts the target pressure will be achieved, valve 25b is energized to close, retaining pressurized fluid within intermediate sac 13b. Proximal bladder 13c is then inflated by de-energizing valve 25c to its open position, allowing pressurized fluid from pressurized fluid source 21 to flow into proximal bladder 13c. Once the target pressure for proximal bladder 13c is achieved, or after a time measured by timer 31 by which the target pressure is expected to be achieved, valves 25a, 25b, and 25d are de-energized to their respective open positions. Open vent valve 25d allows fluid within each of bladders 13a, 13b, 13c to vent to atmosphere.

[0079] Compression system 1 is described as inflating each bladder 13a, 13b, 13c individually so that only one bladder is filled with pressurized fluid at a time. However, it should be understood that sacs 13a, 13b, 13c may be inflated additionally or alternatively, simultaneously, or in any combination with one another. In certain embodiments, the opening and closing of valves 25a, 25b, 25c, and 25d are timed so that only one bladder 13a, 13b, 13c at a time is in fluid communication with pressure sensor 27 and manifold 29. This facilitates measuring a signal indicative of the pressure in each of sacs 13a, 13b, 13c using pressure sensor 27, for example.

[0080] The computer-executable instructions embodied in the computer-readable storage medium 33 include instructions that cause the one or more processors 7 to receive measured pressure signals from the pressure sensor 27 throughout a therapeutic compression cycle. When the distal sac 13a is inflated, the one or more processors 7 receive a signal from the pressure sensor 27 indicative of the pressure in the manifold 29, which represents the pressure in the distal sac 13a. In this manner, the pressure throughout the inflation phase of the distal sac 13a is measured, including the end of the inflation pressure just before the valve 25a closes. When the middle sac 13a is inflated, the one or more processors 7 receive a signal from the pressure sensor 27 indicative of the pressure in the manifold 29, which represents the pressure in the middle sac 13b. The pressure throughout the inflation phase of the middle sac 13b is measured, including the end of the inflation pressure just before the valve 25b closes. When the proximal sac 13c is inflated, the one or more processors 7 receive a signal from the pressure sensor 27 indicative of the pressure in the manifold 29, which represents the pressure in the proximal sac 13c. The pressure throughout the inflation stage of the proximal bladder 13c is measured, including the end of inflation pressure.

[0081] The computer-executable instructions include instructions that cause the one or more processors 7 to determine the end-of-cycle pressure in each bladder 13 a, 13 b, 13 c. As used herein, the end-of-cycle pressure is the pressure in each bladder 13 a, 13 b, 13 c before the venting phase. Thus, for bladders 13 a, 13 b, the end-of-cycle pressure for each bladder 13 a, 13 b is the pressure in each bladder 13 a, 13 b at the end of the decay phase of the therapeutic compression cycle for each bladder 13 a, 13 b. For bladder 13 c, the end-of-cycle pressure is the pressure in bladder 13 c at the end of the inflation phase for bladder 13 c.

[0082] To measure the end-of-cycle pressure, after the proximal sac 13c is inflated to its target pressure, valves 25a, 25b, and 25c are sequentially switched open and closed to measure the end-of-cycle pressure in each sac 13a, 13b, and 13c ( FIG. 4 ). Because valve 25c is open immediately after inflating the proximal sac 13c, the end-of-cycle pressure for the proximal sac 13c is measured first. As can be seen from the pressure profile in FIG. 6 , the end-of-inflation pressure and the end-of-cycle pressure for the proximal sac 13c are the same because the proximal sac does not undergo a decay phase. Valve 25c is switched off and then switched on again at the end of the compression cycle for the proximal sac 13c. The one or more processors 7 switch valve 25a open and valve 25c closed to measure the end-of-cycle pressure for the distal sac 13a. The one or more processors 7 switch valve 25b open and valve 25a closed to measure the end-of-cycle pressure in the middle sac 13b. While a specific switching sequence for valves 25a, 25b, and 25c is described, it should be understood that other switching sequences for valves 25a, 25b, and 25c are within the scope of this disclosure. In one embodiment, each valve 25a, 25b, and 25c is switched open for approximately 150 milliseconds (ms) to measure the end-of-cycle pressure in its respective sac 13a, 13b, and 13c. Valves 25a, 25b, and 25c can be switched open for shorter or longer periods. For example, valves 25a, 25b, and 25c can be switched open for at least approximately 75 ms. Still other periods are contemplated. Pressure readings measured by pressure sensor 27 are stored in memory 33. During operation, the compression cycle is repeated multiple times in succession to complete the compression treatment.

[0083] The computer-executable instructions may include instructions that cause the one or more processors 7 to determine a representative line fit using the end-of-inflation pressure and the end-of-cycle pressure for at least one of the bladders 13a, 13b. A line representing the decay phase is generated using the two pressure points. The value of this representative line is compared to the end-of-inflation pressure for the bladders 13b, 13c to determine whether the pressure in the subsequently inflated bladders 13b, 13c is potentially higher than the pressure in the previously inflated bladders 13a, 13b at any point during the compression cycle.

[0084] Referring to Figure 5, a representative compression cycle pressure profile for the non-wrapped configuration of compression system 1 is illustrated. The operation of compression system 1 to generate the pressure profile of Figure 5 is identical to that described above for the compression cycle pressure profile of Figure 4. The only difference is that the pressure signal in Figure 5 was taken when compression garment 10 was in the non-wrapped configuration. Pressure plots 502, 504, and 506 show the actual pressure in distal sac 13a, middle sac 13b, and proximal sac 13c throughout a single compression cycle when garment 10 is in the non-wrapped configuration. The pressure signal from pressure sensor 27, representing the pressure within manifold 29 during a therapeutic compression cycle, is also shown in Figure 5 as pressure plot 508.

[0085] Referring to FIG. 6, pressure signals detected by the pressure sensor 27 for a typical compression cycle pressure profile are plotted together for the wrapped and unwrapped configurations. As will be explained in more detail below, the typical compression cycle pressure profile has characteristics that distinguish the wrapped and unwrapped configurations. For example, referring to FIG. 5, there is a period (e.g., around 6436 ms) where the pressure in the middle bladder 13b (504) exceeds the pressure in the distal bladder 13a (502). Additionally, the pressure in the bladders 13a, 13b, and 13c before the bladders inflate (i.e., the initial pressure offset at time = 0) is slightly higher in the unwrapped configuration. This offset is a result of more residual air being present in the bladders 13a, 13b, and 13c when the garment 10 is removed from the limb. Applicant believes this is because the non-wrapped sleeve is less constrained, thereby requiring less evacuation force to evacuate any remaining air (i.e., the sleeve is able to remain "inflated," thus appearing to have a smaller volume). While not wishing to be bound by theory, it is believed that this offset results from the non-wrapped compression garment 10 being less constrained, resulting in less evacuation force being applied to evacuate any remaining air. Additionally, the end-of-inflation pressures for the sacs 13a and 13b in the non-wrapped configuration are slightly higher than the end-of-inflation pressures for the sacs 13a and 13b in the wrapped configuration. The opposite is true for the proximal sac 13c, where the end-of-inflation pressure for the wrapped configuration is slightly higher than the end-of-inflation pressure for the non-wrapped configuration. Another differentiating feature is that the difference between the end-of-inflation pressure in the distal sac 13a and the middle sac 13b is smaller in the non-wrapped configuration than in the wrapped configuration.

[0086] The computer-executable instructions embodied in the computer-readable storage medium 33 include instructions that cause the one or more processors 7 to model the pressure signal from the pressure sensor 27 in both the wrapped and unwrapped configurations. In one embodiment, the pressure signal from the inflation phase of the distal sac 13a in the wrapped configuration is modeled by a best-fit line. For example, the model is a best-fit line generated by simple linear regression.

[0087] Analysis of the pressure signal data using the best-fit line can provide an indication of whether the sac 13a is in a compliant wrapped configuration or a non-compliant unwrapped configuration when compression therapy is applied. 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 observed pressure trend over a predetermined interval, such as inflation of the sac of the compression garment 10. Thus, a larger MSE value indicates a greater curvature in the curve fit data, and a smaller MSE value indicates a lesser curvature in the curve fit data. In one embodiment, the plot for the wrapped configuration is generally more linear (i.e., fits the corresponding best-fit line more closely) than the plot for the unwrapped configuration. Mathematically, this means that the curve fit line of the plot for the wrapped configuration will have a smaller MSE value. In one embodiment, an MSE value below a predetermined number indicates the sac is in a wrapped configuration, and an MSE value above a predetermined number indicates the sac is in a unwrapped configuration. It is contemplated that other factors may provide an indication of the sac configuration.

[0088] 7 and 8 , the controller 5 may include a device handle 702 and a pivot handle 704. To secure the controller 5 to a bed, such as a footboard 802, the device handle 702 and the pivot handle 704 are squeezed together, which pivots the pivot handle 704 away from the rear surface 706 of the controller 5, increasing a gap 710 between the extension 708 of the pivot handle 704 and the rear surface 706 of the controller 5, as shown in FIG. 7 . The controller 5 is then placed on the footboard 802 with the extension of the pivot handle 704 on one side of the footboard 802 and the rear surface 706 of the controller 5 on the other side of the footboard 802. By releasing the device handle 702 and the pivot handle 704, the controller 5 is placed on the footboard 802 and the extension of the pivot handle 704 presses against the footboard 802, securing the controller 5 to the footboard 802. In one or more alternative embodiments, the controller 5 may be placed on a flat surface, such as a table, desk, shelf, or the like.

[0089] 9A and 9B, the controller 5 can be secured to a pole 910, e.g., an intravenous (IV) pole, via a mounting member 1000 (shown in FIGS. 10A-10F). As shown in FIG. 9A, a pole mounting portion 906 of the mounting member 1000 (described in more detail below) includes an opening 908 adapted to captively receive and engage the pole 910, e.g., an IV pole. The pole mounting portion 906 can be substantially U-shaped. One side of the pole mounting portion 906 has a threaded hole formed therein for receiving a first end of a screw 904, and a second end of the screw is attached to a knob 902, the first and second ends 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 is pressed against the pole 910, thereby securing and / or clamping the mounting member to the pole 910. 9B shows the mounting member 1000 attached to the pole 910 using the threaded knob 902, although attachment may be achieved using other fasteners, such as screws, clamps, ratchets, etc. In one embodiment of the present disclosure, the mounting member 1000 may include a rubber gasket or the like to aid in securing the member. By rotating the threaded knob 902 in a clockwise direction, the first end of the screw 904 moves toward and engages the pole 910, e.g., an IV pole. By rotating the threaded knob 902 in a counterclockwise direction, the first end of the screw 904 moves away from and disengages the pole 910, e.g., an IV pole.

[0090] 10A-10F, different views of the mounting member 1000 are illustrated. For example, FIG. 10A is a front perspective view of the mounting member 1000, FIG. 10B is a front view of the mounting member 1000, FIG. 10C is a side view of the mounting member 1000, FIG. 10D is a rear view of the mounting member 1000, FIG. 10E is a top view of the mounting member 1000, and FIG. 10F shows the controller 5 engaging with the mounting member 1000. As shown in the figures, the mounting member 1000 includes a first receiving portion 1002, a second receiving portion 1006, an interconnector 1010, and a pole mounting portion 906. The first receiving portion 1002 includes a recessed portion 1004 adapted to receive a portion of the pivot handle 704 of the controller. More specifically, the first receiving portion 1004 is sized and adapted to receive a portion of the extension 708 of the pivoting handle 704 of the controller 5, as shown in FIG. 10F . The second receiving member 1006 is coupled to the first receiving portion 1002. In one or more embodiments, the first receiving portion 1002 and the receiving portion 1006 are integral. The second receiving portion 1006 includes a channel 1008 adapted to receive one or more wires or tubes. The interconnector 1010 can have a U-shape, with a first side of the vertical portion of the U being sloped and coupled to the back surface of the second receiving portion 1006, as shown in FIG. 10E . A second side of the vertical portion of the U is vertical and coupled to the pole mounting portion 906.

[0091] The controller 5 can operate and control up to two compression garments attached to the controller 5 and attached to a wearer, e.g., a 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 the other limb of the wearer. In another example, a first compression sleeve garment can be placed on a limb of the wearer and a foot cuff can be placed on the foot of the same limb of the wearer. The controller 5 can include two sets of tubing. Each set of tubing can be coupled to a pump 21 of the controller 5 at a first end and a connector can be coupled to a second end. One or both sets of tubing can be coupled to a connector on the compression garment. The first set of tubing on the controller 5 is marked "A" and the second set of tubing on the controller 5 is marked "B."

[0092] Referring to FIG. 11 , a top view 1100 of a display 1102 of a controller 5 is illustrated. As shown, the display 1102 of the controller 5 may include a power on indicator 1104, a power on / standby button 1106, one or more navigation buttons 1108, an AC power / battery charging indicator 1110, one or more LEDs 1112, and a display screen 1114. The power on indicator 1104 is, for example, a light or LED, and is illuminated when the controller 5 is powered on. Power may be provided via 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 may include a power on / standby button 1106. In one aspect of the present invention, when the power on / standby button 1106 is pressed, the controller 5 may power on. When the power on / standby button 1106 is pressed a second time, the controller 5 may power off. Any combination of pressing the power on / standby button 1106 may be configured to activate the controller 5. The one or more navigation buttons 1108 can be buttons, as described in more detail below. In one or more embodiments, the one or more navigation buttons 1108 can be displayed on a graphical user interface (GUI) displayed on a display screen 1114, such as a touchscreen display. The AC power / battery charging indicator 1110 can illuminate when AC power is provided to the controller 5 and can charge one or more batteries when AC power is provided to the controller 5. The one or more LEDs 1112 can illuminate in different colors, such as green, yellow, red, and / or combinations thereof. Any combination of colors may be implemented. For example, green can indicate compliance of a patient wearing a compression garment, and yellow can indicate non-compliance of a patient wearing a compression garment. Additional colors can also be used. For example, red can indicate an error in the controller 5, and additional colors can indicate that a compression garment is not attached to the controller 5.

[0093] In one or more embodiments, the one or more LEDs 1112 are positioned on an angled portion 1116 of the controller housing 1118, as shown in FIG. 11 . The angled portion 1116 can be, for example, angled approximately fifteen degrees (15°) from horizontal, or any variation thereof to ensure user visibility. Positioning the one or more LEDs 1112 in this manner allows the one or more LEDs 1112 to be visible from the side. Thus, a nurse or doctor walking by can see the one or more LEDs 1112 and can determine the status of the controller 5 by the color displayed by the one or more LEDs 1112. In another embodiment of the present disclosure, the LEDs are visible from a distance greater than that of a display screen. For example, a nurse or doctor can walk by a patient's room and instantly determine the status of the device relative to the patient. This efficiency provided by the LEDs saves valuable time for the provider. For example, without the visibility of the LEDs, a nurse or doctor may waste time entering a patient's room to check the status of the device, even if the patient may not necessarily require assistance. Additionally, in an already understaffed hospital environment, these seconds and minutes used to walk into a room for unnecessary reasons could be used to help or assist in more efficient and desirable situations, such as emergency situations.

[0094] Additionally, when the controller 5 is mounted on a footboard, an IV pole, or placed on a surface, such as a flat surface, a nurse or doctor can view one or more LEDs 1112 from a variety of superior positions from a greater distance. Conventional controllers do not offer such a feature.

[0095] 12A-12B, computer-executable instructions embodied on computer-readable storage medium 33 cause one or more processors 7 of controller 5 to perform a method 1200 for initializing controller 5 at power-on. Method 1200 begins at block 1202 by initiating controller power-on. For example, initiating controller power-on may be in response to pressing power button 1106. During power-on, one or more LEDs 1112 may display or flash a first color, for example, green.

[0096] At block 1204, method 1200 includes operating pumps and valves with fluid delivered to at least one attached compression garment. For example, one or more processors 7 send signals to a pump 21, e.g., a pressurized fluid flow source, causing the pump 21 to pump fluid or direct a flow of fluid, e.g., air, to the at least one attached compression garment. This feature is discussed in more detail herein.

[0097] At block 1206, the method includes determining whether at least one attached compression garment is properly coupled / attached to the controller 5. During startup, the pump 21 and valves operate and air is pumped out of the controller port to detect the number and type of garments coupled to the controller 5. For example, the at least one processor 7 automatically determines whether leg sleeve garments are being used, with leg sleeve garments being the default. Examples of garment types may be foot cuffs, three-capsule leg sleeves, and single-capsule leg sleeves. If one or two garments are properly coupled to the controller 5, the method proceeds to block 1208. If one or two garments are not properly coupled to the controller 5, the method proceeds to block 1210.

[0098] In block 1208, an icon for at least one properly coupled compression garment is displayed at least once. For example, if the at least one processor 7 senses a properly attached garment, the corresponding icon for the detected compression garment is displayed on 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 are grayed out. For example, FIG. 14A shows an example GUI displaying on display screen 1114 a single three-capsule-leg-sleeve garment icon attached to port A and no garment attached to port B, with a second garment icon representing the leg ("(B)") shown in gray. In various embodiments, an icon shown in gray indicates that its representative component is inactive or malfunctioning. FIGS. 14B-14E show a foot cuff icon, a three-capsule-leg-sleeve icon, a single capsule-leg-sleeve icon, and a vascular refill detection icon, respectively. Depending on the attached garment, the at least one processor 7 displays one or more of these icons on display screen 1114 via the GUI. When one or two garments are properly coupled to the controller 5, compression therapy is provided, as discussed in more detail below.

[0099] In block 1210, a clothing mismatch error icon is displayed in the GUI. For example, if one or two clothing pieces are improperly coupled to the controller 5, the at least one processor 7 displays a clothing mismatch error icon in the GUI on the display screen 1114. Figure 14F shows an example of a clothing mismatch error icon.

[0100] At block 1212, necessary action is taken. For example, if the garment is not properly detected or if the garment is not coupled to the controller 5, the at least one processor 7 displays an error message in the GUI of the display screen 1114, as discussed above, so that a user, e.g., a nurse or doctor, can take appropriate action to address the error. The method may return to block 1206 to determine whether the action taken addressed the error.

[0101] In block 1214, intermittent compression is applied to at least one properly coupled compression garment. For example, at least one processor 7 automatically begins applying intermittent compression to at least one properly coupled compression garment. If two garments are coupled to controller 5, intermittent compression is applied to the garments by alternating between the two garments. In successive cycles, at least one processor 7 automatically adjusts operating parameters to maintain a set pressure. For example, the set pressure is 45 mmHg for the continuous capsular sleeve, the set pressure is 130 mmHg for the foot cuff, and the set pressure is 40 mmHg for the uniform capsular sleeve. The vascular refill detection method provides a customized therapy for each patient's physiology, as described in more detail below. This block is described in more detail below.

[0102] In block 1216, an adherence meter graphic is displayed. For example, the at least one processor 7 displays the adherence meter graphic in a GUI on the display screen 814. FIG. 15 shows an adherence meter graphic 1500 for compression therapy. The adherence meter graphic 1500 may include a circular bar 1502 representing a 24-hour clock. The circular bar 1502 may indicate elapsed time when compression therapy was received in one color, e.g., blue, and time when compression therapy was not administered in a second color, e.g., orange. For example, compression therapy may not be administered because compression therapy was paused for patient treatment or a bathroom break. The adherence meter graphic 1500 may include a number 1504 representing the elapsed time for compression therapy. The elapsed time begins when the adherence meter is reset for the day or when compression therapy begins. The adherence meter graphic 1500 may include a date 1506, e.g., October 23, 2021. For example, on October 23, 2021, the patient may have started compression therapy at 2:00 PM, received seven hours of compression therapy over a ten-hour period, and had one hour in which the patient did not receive therapy, e.g., was non-compliant. The adherence meter graphic 1500 may also indicate the type of garment applied to the patient. For example, as shown, the patient has two leg sleeve garments applied, as represented by icon 1508. The graphic 1500 may also include a detection icon 1510 indicating which garment is currently applied to the patient.

[0103] At block 1218, data related to the compression treatment is recorded. For example, the at least one processor 7 may record data related to the compression treatment in a memory, for example, the computer-readable storage medium 33.

[0104] At block 1220, multiple adherence meter graphics are displayed in response to the received history command. For example, at least one processor 7 may display multiple adherence meters in response to receiving a history command. FIG. 16 illustrates multiple adherence meters being displayed. In one or more embodiments, up to six adherence meters may be displayed. As shown, the adherence meters may be displayed on a daily basis. As shown, the patient began compression therapy on October 26, 2021, at approximately noon and received approximately 9.5 hours of compression therapy. On October 27, 2021, the patient received approximately 21 hours of compression therapy. On October 28, 2021, the patient received approximately 21.5 hours of compression therapy. On October 29, 2021, the patient received approximately 21 hours of compression therapy. On October 30, 2021, the patient received approximately 21.5 hours of compression therapy. On October 31, 2021, the patient received approximately 19 hours of compression therapy. The display may include the current date, for example, October 31, 2021.

[0105] 13A and 13B, computer-executable instructions embodied on computer-readable storage medium 33 cause one or more processors 7 of controller 5 to perform a method 1300 for a compression therapy procedure. Method 1300 begins at block 1302 by directing a flow of fluid from a pressurized fluid flow source to repeatedly (or cyclically) inflate and deflate one inflatable bladder of a compression garment. For example, pump 21 directs a flow of fluid, e.g., air, to repeatedly inflate and deflate at least one inflatable bladder of a compression garment, e.g., appropriately connected compression garment 10.

[0106] In block 1304, a pressure signal indicative of the fluid pressure in the at least one inflatable bladder is received from a pressure sensor communicatively coupled to the at least one inflatable bladder during at least one of inflation and deflation of the at least one inflatable bladder in a plurality of successive compression cycles. For example, the at least one processor 7 receives 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 during at least one of inflation and deflation of the at least one inflatable bladder in a plurality of successive compression cycles. For example, as described with respect to FIGS. 39A-39C , the at least one inflatable bladder can be vented to a target value, held at that pressure, and a signal acquired. Thus, a signal can be received to determine whether the target value has been reached, for example, during deflation. Similarly, if the at least one inflatable bladder is vented and then inflated to a target value, a signal can be received during inflation. A signal can be received while the at least one bladder is held at the target value / pressure, for example, during inflation when the at least one bladder is inflated.

[0107] At block 1306, the received pressure signal is processed to determine whether the received pressure signal indicates compliance or non-compliance with compression therapy. For example, the at least one processor 7 determines whether the received pressure signal indicates compliance or non-compliance with compression therapy. Additionally or alternatively, the at least one processor 7 may be unable to determine compliance or non-compliance based on the received pressure signal, and the at least one processor 7 may indicate an indeterminate error. For example, FIGS. 39A-39C provide further details for determining compliance, non-compliance, and indeterminate / error. Depending on the determination, method 1300 may proceed to block 1308, 1310, or 1312; thus, blocks 1308, 1310, or 1312 are optional.

[0108] At block 1308, in response to determining compliance with compression therapy, at least one LED is illuminated in a first color. For example, at least processor 7 illuminates at least one LED 1112 in a first color, e.g., green, in response to determining compliance with compression therapy. Illumination of the first color may be continuous or flashing during compliance with compression therapy. Any variation of colors may be implemented.

[0109] At block 1310, in response to determining non-adherence to compression therapy, at least one LED is illuminated in a second color. For example, at least processor 7 illuminates at least one LED 1112 in a second color, e.g., yellow, in response to determining non-adherence to compression therapy. Illumination of the second color may be continuous or flashing during non-adherence to compression therapy. Any variation of colors may be implemented.

[0110] In block 1312, in response to determining an error or indeterminacy, at least one LED is illuminated in a third color. For example, in response to not determining compliance or non-compliance with compression therapy, at least one processor 7 illuminates at least one LED 1112 in a third color, e.g., red. The illumination of the third color may be continuous or flashing. Any variation of colors may be implemented.

[0111] In optional block 1314, a graphical user interface (GUI) of the controller displays an adherence meter (and / or non-adherence) to the compression therapy or compression therapy regimen. For example, at least one processor 7 displays an adherence meter as shown in FIG. 15 and further described with respect to FIGS. 12A and 12B.

[0112] In optional block 1316, a graphical user interface (GUI) of the controller displays a plurality of adherence meters (and / or non-adherence) to the compression therapy or compression therapy regimen on a daily basis. For example, at least one processor 7 displays adherence meters as shown in FIG. 16 and further described with respect to FIGS. 12A and 12B.

[0113] 17 , computer-executable instructions embodied in computer-readable storage medium 33 cause one or more processors 7 of controller 5 to perform a method 1700 for setting a time for controller 5. Method 1700 begins at block 1702 by receiving a selection of a system time icon from a displayed menu. For example, at least one processor 7 receives a selection of a system time icon 1802 from a menu displayed by a GUI on display screen 1114. For example, as shown in FIG. 18 , display screen 1114 includes multiple icons, including a system time icon 1802, a shift icon 1804, and a patient icon 1806. System time icon 1802 is for setting the system time. Shift icon 1804 is for setting a shift and / or display period, e.g., 8, 12, or 24 hours, as described in connection with 1502 of FIG. 15 . Patient icon 1806 indicates whether patient detection monitoring is on or off. A selection box 1808 can be used to move between menu options, and a select button can be used to select a menu option. To navigate, a back command is associated with the first button 1108A, a move left command is associated with the second button 1108B, a move right command is associated with the third button 1108C, and a select command is associated with the fourth button 1108D. As shown, the system time icon 1802 is selected.

[0114] In block 1704, a world map is displayed along with the current time. For example, in response to the selection of the system time icon, at least one processor 7 may cause a world map 1902 to be displayed, showing the current time for the highlighted current time zone. For example, as shown in FIG. 19, the GUI may display on the display screen 1114 that the time 1906 is 3:00, with a given time zone 1904 highlighted. The world map is segmented according to each time zone.

[0115] In block 1706, the current item is displayed in response to a navigation command. For example, at least one processor 7 may display the current time in response to a navigation command. For example, FIG. 19 shows a highlighted time zone 1904 and a current time 1906. Using the left movement command associated with the second button 1108B, the selected time zone moves left, and using the right movement command associated with the third button 1108C, the selected time zone moves right. The displayed time zone and current time change in response to use of buttons 1108B, 1108C.

[0116] A selection of the highlighted current time zone is received at block 1708. For example, at least one processor 7 receives the time zone selection in response to a selection button associated with fourth button 1108D being selected.

[0117] The selected current time zone is saved at 1710. For example, the at least one processor 7 saves the selected current time zone in a memory, for example, the computer-readable storage medium 33.

[0118] 20-22, computer-executable instructions embodied on the computer-readable storage medium 33 cause the one or more processors 7 to perform a method 2040 for determining whether the compression garment 10 is in a wrapped or non-wrapped configuration when compression therapy is being applied. The steps set forth in FIG. 20 describe, at a generally high level, the method for determining whether the compression garment 10 is in a wrapped or non-wrapped configuration, while FIGS. 21 and 22 describe the method in more detail. Reference will be made to all three figures when describing the compliance method performed by the one or more processors 7.

[0119] 20 and 21 , at the start of compliance determination method 2040, compression system 1 operates to sequentially inflate and deflate bladders 13 a, 13 b, and 13 c to apply compression treatment to the wearer's limb. Treatment is preferably performed according to a predetermined compression regimen or compression therapy, which includes, among other things, a prescribed duration for which the patient should receive treatment. In one aspect of the present disclosure, compression system 1 may operate indefinitely until stopped. Patient compliance with the prescribed treatment time or compression therapy time is monitored. Compression system 1 is operated for several or more cycles, as necessary, to allow the system to stabilize to a steady state and collect steady-state data before compliance determination begins. However, a compliance timer or counter may be started prior to the start of compliance determination (e.g., implemented as disclosed herein, e.g., in FIGS. 15 and 16 ). Thus, at the start of compliance determination method 2040, compression garment 10 is in the wrapped configuration and operating under normal (steady-state) operating conditions. The system 1 operates under default conditions in which the one or more processors 7 instruct the pressure sensors 27 to measure the pressure in the manifold 29 throughout the compression cycle at step 2050. The pressure data is discarded over time and replaced with new, up-to-date pressure data as it becomes available. The one or more processors 7 check at 2060 for the occurrence of a trigger that indicates the compression garment 10 may not be wrapped.

[0120] In general, a trigger may occur when a measured result differs from an expected result, which is based on recent adjustment history and steady-state control error. Triggers may include, for example, but are not limited to, one or more of the following: end-of-cycle pressure change for at least one of the sacs 13a, 13b, 13c from a previous compression cycle; end-of-inflation pressure change for at least one of the sacs 13a, 13b, 13c from a previous compression cycle; adjustment of pump 21 caused by that pressure (e.g., error in target measurement); change in curvature coefficient from a previous inflation stage for at least one of the sacs 13a, 13b, 13c; change in inflation stage slope from a previous compression cycle for at least one of the sacs 13a, 13b, 13c; measured pressure of one or more sacs at the end of an operating cycle. changes in pressure, changes in the gradient of the measured pressure during the ventilation phase, changes in the initial offset of the measured pressure from zero from the previous compression cycle, the pressure of one of the inflatable sacs 13b, 13c having a lower target pressure exceeding the pressure of the other inflatable sac 13a, 13b having a higher target pressure, a smaller difference in peak pressure between the sacs 13a, 13b, changes in the magnitude of adjustments made to the operation of the pump 21, statistically significant changes in the pressure waveform, and any unplanned disturbances in the measured pressure or any unplanned adjustments made by the compression system 1.

[0121] 21A and 21B, the compression system 1 continues normal operation until a trigger occurrence is detected (step 2162). If a trigger occurrence is detected, a determination is made at 2164 as to whether the occurrence exceeds a predetermined condition, such as an expected error relative to steady-state operation. Additionally or alternatively, a pressure change / disturbance producing a control system response greater than three times the expected change / disturbance can serve as the predetermined condition. The "expected change / disturbance" can be a preset criterion established by the controller 5 through steady-state operation for a period of time. Alternatively or additionally, an adjustment to the pump 21 greater than a predetermined threshold compared to the most recent adjustment can serve as the predetermined condition. For example, a trigger can occur when a new adjustment to 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 meet the criterion, the compression system 1 continues normal operation (2162).

[0122] 20-22 , if a trigger occurrence is determined to be valid for use in identifying a change in the condition of the compression garment 10 from wrapped to unwrapped, data collection begins at 2070. The one or more processors 7 activate a “sleeve removal” compression cycle counter at 2072 to count the number of “sleeve removal” compression cycles for which data is collected to identify the trigger occurrence as an indication that the garment 10 is unwrapped. The number of “sleeve removal” compression cycles is counted at 2074 until a sufficient amount of data (i.e., pressure signal) is acquired. The number of “sleeve removal” compression cycles required to acquire a sufficient amount of data to determine whether the garment 10 is in the unwrapped configuration may vary under different circumstances. In one embodiment, the number of “sleeve removal” compression cycles is about 10 to about 20 compression cycles. Generally, a sufficient amount of data is determined to have been acquired when the pressure signal reaches a steady state again after the initial trigger occurrence. Memory 33 stores data associated with the “sleeve removal” cycles separately from reference data acquired during normal operation of system 1. Once sufficient data has been acquired at 2076, the one or more processors 7 retrieve at step 2078 the data acquired during normal operation of the system 1. The one or more processors 7 analyze the "sleeve removal" data at 2080 after the pressure signal reaches a steady state to determine a bladder pressure value for comparison with data acquired while the compression system 1 is operating under normal conditions.

[0123] The one or more processors 7 determine whether the garment 10 is in a wrapped or non-wrapped condition by comparing the "sleeve removed" data to reference data for normal operating conditions in step 2090. The compression system 1 continues normal operation if the one or more processors 7 determine in 1892 that the garment 10 has not been removed and is still in a wrapped configuration. The one or more processors 7 alter the recording of the monitored parameters to place the garment in a non-wrapped configuration if it is determined that the garment 10 has been removed in 2094. Comparing the "sleeve removed" data to normal operating condition data in step 2090 can include, but is not limited to, one or more of the following:comparing the end-of-cycle pressure from the "sleeve removed" data with the end-of-cycle pressure from normal operating condition data for at least one of the bladders 13a, 13b, 13c; comparing the end-of-inflation pressure from the "sleeve removed" data with the end-of-inflation pressure from normal operating condition data for at least one of the bladders 13a, 13b, 13c; comparing the curvature coefficient from a curve fit of the "sleeve removed" data with the curvature coefficient from a curve fit to the normal operating condition data; comparing the inflation step slope from the "sleeve removed" data with the inflation step slope from normal operating condition data for at least one of the bladders 13a, 13b, 13c; comparing an initial offset of the measured pressure from zero for the "sleeve removed" data with an initial offset of the measured pressure from zero from the normal operating condition data. comparing the offset; comparing the ventilation phase slope from the "Sleeve Removed" data with the ventilation phase slope from normal operating condition data for at least one of the bladders 13a, 13b, 13c; comparing the measured pressures to determine if an inflatable bladder having a lower target pressure has a higher measured pressure than an inflatable bladder having a higher target pressure; comparing the difference in peak pressures of the inflatable bladders 13a, 13b from the "Sleeve Removed" data with the difference in peak pressures of the bladders 13a, 13b in the normal operating condition data to look for a decrease in the difference; comparing the magnitude of adjustments to operation of the pump 21 in the "Sleeve Removed" data with the magnitude of adjustments made in the normal operating data; and looking for statistically significant differences in the pressure waveforms between the "Sleeve Removed" data and the normal operating data. For example, a pressure spike during the ventilation phase of one of the bladders 13a, 13b is an indication that the garment 10 is in the wrapped configuration. Comparison step 2090 is a confirmatory analysis to confirm the trigger occurrence as an indication that the garment is in the non-wrapped configuration.

[0124] If the data comparisons 2090 indicate that a statistically significant change in pressure has occurred for any one of the data comparisons and for any one of the sacs 13a, 13b, 13c, the one or more processors 7 indicate that the garment 10 is in a non-wrapped configuration and is no longer being used in a compliant manner. Additionally or alternatively, the one or more processors 7 require confirmation from at least two of the sacs 13a, 13b, 13c that a statistically significant change in pressure has occurred for any one of the data comparisons. Additionally or alternatively, the one or more processors 7 require confirmation from all of the sacs 13a, 13b, 13c that a statistically significant change in pressure has occurred for any one of the data comparisons. Additionally or alternatively, the one or more processors 7 require confirmation that a statistically significant change in pressure has occurred for at least two of the data comparisons.

[0125] In response to determining the pressure change, the one or more processors 7, in step 2094, alter the record of the monitored parameter by at least one of stopping the compliance meter (e.g., the compliance timer stops incrementing) so that no further compression cycles are indicated as being compliant with the compression therapy regimen or therapy, providing an alarm indication to alert the wearer or clinician of non-compliance, ceasing operation of the compression system 1, and storing the result of the comparison in memory 33 (e.g., a flag).

[0126] Optionally, and referring to FIG. 22 , the method 2040 for determining whether a compression garment 10 is in a wrapped or non-wrapped configuration continues, after a determination is made by the one or more processors 7 that the garment 10 is in a non-compliant non-wrapped configuration, by collecting additional “sleeve removal” data at step 2202. The one or more processors 7 analyze and compare the additional “sleeve removal” data to normal operating condition data at 2204. The one or more processors 7 determine, at 2206, that the garment 10 has returned to the wrapped configuration and is again being used in a compliant manner if the data comparison at 2204 indicates that the additional “sleeve removal” data matches or nearly matches the normal operating condition data of any one of the bladders 13 a, 13 b, 13 c. In response, the one or more processors 7 alter the recording of the monitored parameter by at least one of resuming operation of the compression system 1, resuming the compliance meter so that subsequent compression cycles are indicated as compliant, providing a compliance alert message to the wearer or clinician, and storing the results of the comparison in memory 33. If the one or more processors 7 at 2204 indicate that a statistically significant change in pressure remains for any one of the data comparisons, then the one or more processors 7 continue to collect additional "sleeve removed" data at 2202 until the one or more processors 7 determine that the pressure signal, such as the measurements described above, matches or nearly matches the pressure signal for normal operating conditions.

[0127] In various embodiments, the linear regression for the expansion stages of sacs 13a, 13b, 13c can be further analyzed to compare wrapped and unwrapped conditions. For example, standard deviations, P values, maximum and minimum values, and average values ​​can be calculated and compared between wrapped and unwrapped conditions to further distinguish between the two conditions. Advanced statistics associated with regression analysis, such as analysis of residuals to distinguish between sleeve-on and sleeve-off conditions (e.g., curve fitting analysis as described herein), are also within the scope of this disclosure.

[0128] While the curve fits for the inflation stages of sacs 13a, 13b, and 13c are described as best-fit lines, the model can also be a polynomial curve fit. Referring to FIG. 23, the pressure signal from the inflation stage of sac 13a was modeled using a fifth-order polynomial curve fit in a wrapped configuration (2302) and an unwrapped configuration (2304). The fifth-order polynomial curve fit accurately represents the more dynamic curvature of the inflation stage without being overly responsive to changes in the pressure signal. Polynomial curve fits of other orders are also contemplated. As an example, a lower order may be used when the curvature is less dynamic and a higher order is not required.

[0129] The polynomial curves fitted during the inflation phase of the sacs 13a, 13b, 13c in the wrapped configuration are generally more linear (i.e., more linear) than the polynomial curve fits for the inflation phase of the sacs 13a, 13b, 13c in the wrapped configuration. Additionally, for the distal sac 13a and the middle sac 13b, the pressure throughout the inflation phase in the non-wrapped configuration is higher than the pressure throughout the inflation phase in the wrapped configuration. The opposite is true for the proximal sac 13c, where the pressure throughout most of the inflation phase in the wrapped configuration is higher than the pressure throughout most of the inflation phase in the non-wrapped configuration. Additionally, the starting pressure, or offset, for the sacs 13a and 13b in the non-wrapped configuration is higher than the starting pressure for the sacs 13a and 13b in the wrapped configuration. By recognizing the occurrence of these different characteristics, the compression system 1 can determine when the garment 10 is in a compliant wrapped configuration and when the garment 10 is in a non-compliant non-wrapped configuration.

[0130] Additionally, the polynomial curve fits for the expansion stages of the sacs 13a, 13b, 13c can be further analyzed to compare the wrapped and unwrapped conditions. For example, the standard deviation, P-value, maximum and minimum values, and average values ​​can be calculated and compared between the wrapped and unwrapped conditions to further distinguish between the two conditions. Advanced statistics associated with regression analysis, such as analysis of residuals to distinguish between sleeve-on and sleeve-off conditions (e.g., curve fitting analysis as described herein), are also within the scope of this disclosure.

[0131] Referring to Figure 24, a typical compression cycle pressure profile for the wrapped configuration of the compression garment 10 is illustrated. The graph illustrates the signal from the pressure sensor 27. A single compression cycle for all three bladders 13a, 13b, 13c in the wrapped configuration of the compression garment 10 includes a compression period 2402 and a decompression period 2404. Referring to Figure 25, a typical compression cycle pressure profile for the non-wrapped configuration of the compression garment 10 is illustrated. A compression period 2502 and a decompression period 2504 illustrate a single compression cycle for all three bladders 13a, 13b, 13c in the non-wrapped configuration of the compression garment 10. Computer-executable instructions embodied on the computer-readable storage medium 33 include instructions for causing the one or more processors 7 to monitor signals from the pressure sensor 27 indicative of bladder pressure during the decompression periods 2404, 2504. The computer-executable instructions cause the one or more processors 7 to detect a difference between the pressure signal during the decompression period 2404 and the pressure signal during the decompression period 2504. For example, the pressure signal during the decompression period 2404 includes pressure impulses, shown generally at 2406 in FIG. 24 , which the controller 5 interprets as indicating wearer movement when the compression garment 10 is in the wrapped configuration. The pressure signal during the decompression period 2504 is relatively static (i.e., no impulses are present), which the controller 5 interprets as indicating that the compression garment 10 is in the non-wrapped configuration. By analyzing the pressure signal during the decompression periods 2404, 2504, the computer-executable instructions cause the one or more processors 7 to determine whether the compression garment 10 is in the wrapped or non-wrapped configuration based on the presence (i.e., occurrence) or absence (i.e., non-occurrence) of one or more pressure impulses 2406 during the decompression periods 2404, 2504.

[0132] 24 , in another embodiment of compression system 1, the bladder pressures in bladders 13a, 13b, 13c are locked and the computer-executable instructions cause the one or more processors 7 to detect an increase (e.g., an increase) in the pressure signal during decompression period 2404 when the compression garment 10 is substantially in a wrapped configuration about the wearer's limb. The pressure signal during decompression period 2504 ( FIG. 25 ) is relatively static (i.e., there is no pressure increase), which the controller 5 interprets as an indication that the compression garment 10 is in a non-wrapped configuration. The computer-executable instructions cause the one or more processors 7 to determine whether the compression garment 10 is in a wrapped or non-wrapped configuration based on the presence (i.e., occurrence) or absence (i.e., absence) of a pressure increase during decompression periods 2404, 2504.

[0133] 26, computer-executable instructions embodied on computer-readable storage medium 33 cause one or more processors 7 to perform a method 2600 for determining whether a compression garment is in a wrapped or unwrapped configuration by detecting one or more pressure impulses in a pressure signal received from pressure sensor 27. Compression system 1 applies compression treatment to a wearer's limb by inflating and deflating bladders 13a, 13b, 13c in step 2602 and ventilates bladders 13a, 13b, 13c to a target value, e.g., 1-2 mmHg. The computer-executable instructions also cause one or more processors 7 to determine in step 2604 whether the pressure in 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 ventilating bladders 13a, 13b, 13c, and the process returns to step 2604. If the target value is reached, the computer-executable instructions, in step 2606, cause the one or more processors 7 to stop inflating the bladders 13a, 13b, 13c and monitor the pressure signal from the pressure sensor 27 for impulses during the decompression period. It is understood that a filtered signal can be envisioned without departing from the scope of this disclosure, such that any impulses observed are above baseline signal noise. The signal can be filtered, for example, by filtering circuitry within the controller 5 and / or by digital filtering techniques implemented by the one or more processors 7 via the computer-executable instructions. The computer-executable instructions can also cause the one or more processors 7 to perform waveform peak detection to determine the amplitude of abnormal peaks versus peaks within the expected noise, without departing from the scope of this disclosure. It is also understood that the computer-executable instructions can also cause the one or more processors 7 to utilize signal threshold limit detection without departing from the scope of this disclosure. For example, if an impulse is detected that is 1 mmHg or more above the noise, the impulse is considered a pressure impulse. The computer executable instructions cause the one or more processors 7 to implement a counter with which a count is maintained of the number of consecutive cycles in which no impulse is observed.

[0134] At step 2608, the computer-executable instructions cause the one or more processors 7 to determine whether an impulse was detected by the processors 7 at step 2606. If an impulse is detected during step 2606, the computer-executable instructions cause the one or more processors 7 to reset 2610 a counter to zero, since the impulse indicates that the compression garment 10 is in a substantially wrapped configuration around the wearer's limb. If an impulse is not detected during step 2606, the absence (i.e., non-occurrence) of such an impulse indicates that the compression garment 10 is in a non-wrapped configuration away from the wearer's limb. In such a case, the computer-executable instructions cause the one or more processors 7 to determine at step 2612 whether the count of the counter meets or exceeds a counter threshold. For example, the threshold may be 10 consecutive cycles, although one skilled in the art will understand that the threshold may be any integer value. Meeting or exceeding the threshold indicates that the compression garment 10 is in a non-wrapped configuration away from the wearer's limb, since a pressure abnormality (e.g., a pressure impulse) may be detected by one or more processors 7 when the compression garment 10 is in a wrapped configuration.

[0135] If, in step 2612, the one or more processors 7 determine that the counter count has met or exceeded the counter threshold, the computer-executable instructions cause the one or more processors 7 to take the necessary action in step 2614. For example, the one or more processors 7 may cease operation, stop a compliance timer, alert a user (e.g., wearer or caregiver), etc. If, in step 2612, the one or more processors 7 determine that the counter count has not reached the counter threshold, the computer-executable instructions cause the one or more processors 7 to increment the counter count and fully vent sacs 20a, 20b, 20c in step 2616, and the process returns to step 2602.

[0136] In an alternative embodiment, method 2600 of FIG. 26 is implemented during venous refill measurement. In such an embodiment, sac 13b is at a compression value of, for example, 45 mmHg, and sac 13b is vented to a target pressure (e.g., 5-7 mmHg), thus providing a firmer contact with the wearer's limb compared to deflating sac 13b. Alternatively, sac 13b can be deflated and then inflated to the target sac pressure. Thus, pressure impulses due to patient movement are more evident in the pressure signal of pressure sensor 27. For example, in step 2604, sac 13b is vented to a target pressure (e.g., 6 mmHg), and in steps 2606 and 2608, the sac pressure response is monitored / analyzed for standard deviation and fast Fourier transform (FFT), as described with respect to FIG. 39. If the standard deviation exceeds a threshold value (e.g., 0.25) and the maximum FFT value exceeds a threshold value (e.g., 5), method 2600 determines that there are sufficient pressure impulses to indicate that the compression garment 10 is being worn by a wearer (e.g., a patient).

[0137] 27, computer-executable instructions embodied on computer-readable storage medium 33 cause one or more processors 7 to perform a method 2700 for determining whether a compression garment is in a wrapped or unwrapped configuration by detecting an elevation (e.g., increase) in a pressure signal received from pressure sensor 27. Compression system 1 applies compression treatment to a wearer's limb by inflating and deflating bladders 13a, 13b, 13c in step 2702 and ventilates bladders 13a, 13b, 13c to a target value, e.g., 1-2 mmHg. The computer-executable instructions also cause one or more processors 7 to determine in step 2704 whether the pressure in bladders 13a, 13b, 13c reaches the target value. If the target value has not been reached, the computer-executable instructions cause one or more processors 7 to continue ventilating bladders 13a, 13b, 13c, and the process returns to step 2704. If the target value is reached, the computer-executable instructions cause the one or more processors 7 to stop venting the bladders 13a, 13b, 13c and monitor the pressure signal from the pressure sensor 27 for an increase during the decompression period, at step 2706. In one aspect, a filtered signal is assumed such that any observed increase is above baseline signal noise. The signal may be filtered, for example, by filtering circuitry within the controller 5 and / or by digital filtering techniques implemented by the one or more processors 7 via the computer-executable instructions. The one or more processors 7 monitor the pressure signal for a pressure increase greater than a threshold (e.g., 1-2 mmHg) that indicates the compression garment 10 is substantially in a wrapped configuration around the wearer's limb. The absence of an increase in the pressure signal, or an increase below the threshold, indicates the compression garment 10 is in a non-wrapped configuration away from the wearer's limb. The computer-executable instructions also cause the one or more processors 7 to implement a counter, with which a count is maintained for each cycle that does not achieve the threshold pressure increase.

[0138] At step 2708, the computer-executable instructions cause the one or more processors 7 to determine whether a pressure rise greater than a threshold value was detected by the processor 7 at step 2706. If a pressure rise greater than the threshold value is detected during step 2706, the computer-executable instructions cause the one or more processors 7 to reset 2710 a counter to zero, since the pressure rise indicates that the compression garment 10 is in a substantially wrapped configuration around the wearer's limb. If no rise greater than the threshold value is detected during step 2706, the absence of such a pressure rise indicates that the compression garment 10 is in a non-wrapped configuration away from the wearer's limb. In such a case, the computer-executable instructions cause the one or more processors 7 to determine at step 2712 whether the count of the counter meets or exceeds a counter threshold value. For example, the threshold value may be 10 consecutive cycles, although one skilled in the art will understand that the threshold value may be any integer value. Meeting or exceeding the threshold indicates that the compression garment 10 is in a non-wrapped configuration away from the wearer's limb, since a pressure abnormality (e.g., a pressure increase) may be detected by one or more processors 7 when the compression garment 10 is in a wrapped configuration.

[0139] If, in step 2712, the one or more processors 7 determine that the counter count has met or exceeded the counter threshold, the computer-executable instructions cause the one or more processors 7 to take the necessary action in step 2714. For example, the one or more processors 7 may cease operation, stop a compliance timer, alert a user (e.g., wearer or caregiver), etc. If, in step 2712, the one or more processors 7 determine that the counter count has not reached the counter threshold, the computer-executable instructions cause the one or more processors 7 to increment the counter count and fully vent the bladders 13a, 13b, 13c in step 2716, and the process returns to step 2702.

[0140] In alternative embodiments, the actual shape of the pressure profile of the signal generated by pressure sensor 27 is itself a potential indicator. For example, the shape of the profile may be calculated such that when the resulting function (i.e., shape) matches a predetermined function (i.e., shape), the computer-executable instructions will cause the one or more processors 7 to determine that the compression garment 10 is in a wrapped configuration. Conversely, when the resulting function does not match the predetermined function, the computer-executable instructions will cause the one or more processors 7 to determine that the compression garment 10 is in a non-wrapped configuration. Such embodiments may be used with the counters described in conjunction with methods 2600, 2700 above.

[0141] 28A , a pressure signal from pressure sensor 27 is shown for one of sacs 13a, 13b, 13c in a wrapped configuration of compression garment 10 against a wearer's limb during a representative sac inflation period 2802 and pressure hold period 2804. In the example of FIG. 28A , pressure hold period 2804 is approximately 27 seconds in duration and represents sacs 13a, 13b, 13c inflated to approximately 45 mmHg, which is a typical inflation threshold for a therapeutic cycle of sacs 13a, 13b, 13c. According to another aspect of the present disclosure, pressure hold period 2804 may be approximately 20 seconds in duration and represents one of sacs 13a, 13b, or 13c inflated to approximately 200 mmHg. Thus, the oscillation amplitude of the pressure signal for a sac inflated to approximately 200 mmHg will be higher than the oscillation amplitude illustrated herein in connection with a sac inflated to approximately 45 mmHg.

[0142] Referring to FIG. 28B, waveform 2804′ illustrates the result of a bandpass filtering technique applied to a subset signal of interest during pressure hold period 2804 such that a frequency range (e.g., 0.5 Hz to 25 Hz, 0.5 Hz to 5 Hz, etc.) is extracted. A representative subset portion of pressure hold period 2804 is shown at a smaller scale compared to FIG. 28A so that pulses are visible in the pressure signal during pressure hold period 2804′. The pulses in the pressure pulses in FIG. 28B are associated with the pressure effect caused on sacs 13a, 13b, and 13c by the wearer's pulses. The waveform pulsation associated with the wearer's pulses of compression garment 10 remains evident in waveform 2804′. Computer-executable instructions embodied in non-transitory computer-readable storage medium 33 include instructions for causing one or more processors 7 to receive signals from pressure sensors 27, the received signals indicative of fluid pressure in one or more of sacs 13a, 13b, and 13c during sac inflation period 2802 and pressure hold period 2804.

[0143] In certain embodiments, the computer-executable instructions further include instructions that cause the one or more processors 7 to further refine the signal from the pressure sensor 27 to extract only frequencies associated with a range of a typical human cardiac cycle during the pressure hold period 2804. For example, the computer-executable instructions may include computer-executable instructions that cause the one or more processors 7 to extract frequencies in the range of 0.5 Hz to 25 Hz (e.g., through bandpass filtering techniques).

[0144] FIG. 28B illustrates that as the vibration amplitude decreases, the effect of noise on the signal becomes more significant (i.e., the signal-to-noise ratio decreases). Additional pre- and / or post-processing of the data can be useful to obtain less distorted results. In some embodiments, the computer-executable instructions further include instructions for causing the one or more processors 7 to filter the signal during the pressure hold period 2804 to remove frequencies not associated with the pulse of a human wearer, and for causing the one or more processors 7 to implement one or more peak detection and / or adherence monitoring algorithms. In particular embodiments, the one or more computer-executable instructions further include instructions for causing the one or more processors 7 to perform additional pre- and / or post-processing to reduce the effect 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 the one or more processors 7 includes pulsations associated with the wearer's heartbeat, rather than the wearer's actual heart rate. For example, blood flow as the wearer's heart beats creates pressure against at least one of the inflatable bladders 13a, 13b, 13c, which the pressure sensor 27 detects and generates a pressure signal representative thereof.

[0145] Referring to FIG. 28C, waveform 2804′ is overlaid on waveform 2804″, which is the result of a smoothing algorithm filtering technique applied to waveform 2804′ by one or more processors 7. In this exemplary embodiment of FIG. 28C, the smoothing follows a rectangular window of five times (e.g., 5×) the range of motion. Even at pressures as low as those associated with typical venous refill detection (VRD) techniques (e.g., about 5 to about 20 mmHg), the waveform provides evidence of pulsation indicating sufficient contact between the wearer and the compression garment 10.

[0146] Figure 29 shows the pressure signal received from pressure sensor 27 during a representative bladder pressure hold period 2902 for one of the bladders 13a, 13b, 13c for a non-wrapped configuration of the compression garment 10. The overall amplitude of pressure profile 2902 is less than the amplitude of a similar pressure hold period 2804 (shown in Figure 28A). The absence of clear repetitive pulses in pressure profile 2902 is an indication that the compression garment 10 is in a non-wrapped configuration or is not being worn properly by the wearer.

[0147] 30A shows a pressure signal received from pressure sensor 27 and a representative bladder pressure profile for one of bladders 13a, 13b, 13c. The pressure profile includes a therapy cycle period 3002, a bladder vent period 3004, a bladder test inflation period 3006, and a bladder pressure hold period 3008. At the end of therapy cycle period 3002, the tested bladder (e.g., one of bladders 13a, 13b, 13c) is vented during bladder vent period 3004. After bladder vent period 3004, during bladder inflation period 3006, a brief inflation is applied to the tested bladder until it achieves a pressure of approximately 30 mmHg. The one or more processors 7 execute computer-executable instructions such that pulse detection is performed by the one or more processors 7 during bladder pressure hold period 3008, which in this exemplary embodiment is approximately 10 seconds. The bladder pressure hold period 3008 can be of longer or shorter duration, provided that the duration is long enough to ensure that multiple pulses occur within the duration.

[0148] FIG. 30B illustrates a waveform 3008′ showing the results of a filtering technique applied to the signal of interest during pressure hold period 3008. In some embodiments, the computer-executable instructions include instructions that cause the one or more processors 7 to detect dominant peaks and check that the waveform is within an expected range (e.g., 60-100 beats per minute (bpm) for a human wearer). In some embodiments, the expected range is 60-100 beats per minute (bpm) for a human wearer. However, it should be understood that a wider range (e.g., 30-120 bpm) can be used to account for wearers who may be less healthy and / or to account for measurements that may occur at locations on the body farther from the heart (e.g., the lower extremities). In this exemplary embodiment, the one or more processors 7 detect pulsations associated with the wearer's heartbeat, rather than the wearer's actual heartbeat.

[0149] 31 is a schematic diagram of an exemplary method 3100 for determining whether a compression garment 10 is in a wrapped or unwrapped configuration about a limb of a wearer of the garment by analyzing waveform data received from pressure sensor 27 to detect pulsations associated with the wearer's heartbeat. This exemplary method may be performed by one or more processors 7 through execution of computer-executable instructions embodied in a non-transitory computer-readable storage medium 33.

[0150] One or more processors 7 execute computer-executable instructions to sample 3102 the initial pressure. In some embodiments, the initial pressure sampling occurs at a rate of 100 Hz or greater, and typical signal conditioning is used to remove baseline noise. Additionally or alternatively, sampling 3102 may be extended to include attenuation of frequencies just below a low cutoff (e.g., 0.25 Hz).

[0151] Post-processing waveform analysis 3104 further includes bandpass filtering 3106, additional filtering 3108, and peak detection 3110. During bandpass filtering 3106, the signal of interest is filtered using bandpass filtering techniques in a typical frequency range associated with a typical heart rate range of a human wearer (e.g., 0.5-4 Hz for a human wearer).

[0152] During additional filtering 3108, the peaks of the bandpass filtered signal are further refined. The additional filtering may include a lowpass filter with a 5 Hz cutoff to generate the filtered value. Additionally or alternatively, the additional filtering may include a smoothing algorithm that uses the five most recent samples of the moving range to generate the filtered value. It should be understood that more than one filtering technique may be applied to the bandpass filtered signal during the additional filtering step 3108.

[0153] During peak detection 3110, peak detection is performed to check that peaks in the filtered signal correspond to the heart rate range of a typical human wearer. Peak detection 3110 can be based on a predetermined threshold (e.g., looking only at peaks with a magnitude greater than 0.05 mmHg). Additionally or alternatively, peak detection 3110 can be based on examining repetitive signals with frequencies within the heart rate range of a typical human wearer, regardless of magnitude (e.g., extended to 30-240 bpm with a margin). For example, a frequency analysis calculation may be performed to check that repetitive signals with frequencies within the heart rate range of a typical human wearer are detected. Additionally or alternatively, peak detection 3110 can be based on the highest magnitude peaks and checking that the frequencies of those peaks are within the expected heart rate range of a typical human wearer. It should be understood that more than one peak detection technique may be used during peak detection 3110. In some embodiments, peak detection 3110 includes a combination of peak detection based on a predetermined threshold, peak detection based on the highest magnitude peaks, and checking that the signal to noise ratio is high enough that pulses are clearly visible, and therefore that the frequency of these peaks is within the expected heart rate range of a typical human wearer.

[0154] The computer-executable instructions cause the one or more processors 7 to determine 3112 whether a pulse characteristic of the wearer is detected during peak detection 3110. If a pulse characteristic is determined to be present 3112, a positive determination result may be indicated 3116. For example, the instructions 3116 may include sending a visual representation to a display device associated with the compression system 1. Additionally or alternatively, the instructions 3116 may include incrementing and / or pausing a timer. If the instructions 3116 are present, the process ends at step 3118 and returns to step 3102. If no impulse is detected at step 3112, the computer-executable instructions cause the one or more processors 7 to return a null value at step 3114. After step 3114, the process ends at step 3118 and returns to sampling 3102.

[0155] 32, there is shown a schematic diagram of an exemplary method 3200 for analyzing waveform data received from a pressure sensor (e.g., pressure sensor 27) to determine whether a compression garment (e.g., compression garment 10) is in a wrapped or unwrapped configuration during a garment verification process. For ease of explanation and clarity, method 3200 is described for a single pouch (e.g., one of pouches 13a, 13b, or 13c). However, it should be understood that method 3200 can be repeated to check additional pouches corresponding to different valves.

[0156] The method 3200 begins at step 3202, where the desired pouch valve (e.g., pouch valve 25a, 25b, 25c) is opened 3204. A pressurized fluid source (e.g., pressurized fluid source 21) is turned on 3206 until the pressure within the corresponding pouch exceeds approximately 120 mmHg.

[0157] A pressure signal is received 3208 from the pressure sensor 27 over a period of time. A determination 3210 is made as to whether all data is available. If all data is not available, pressure signal acquisition continues 3212 and a pressure signal is received 3208. If a determination 3210 is made that all data is available, the corresponding valve is closed 3214 and a pulse detection algorithm is executed.

[0158] In some embodiments, the pulse detection algorithm includes one or more steps of post-processing waveform analysis 3104 described above.

[0159] After the valve is closed 3214 and the fluid is isolated within the bladder, a determination 3216 is made as to whether a pulse is detected. No pulse detected indicates that the compression garment 10 is in a non-wrapped configuration away from the wearer's limb in step 3218, and the compliance time is not incremented before terminating the method in step 3232. Detection of a pulse in step 3216 indicates that the compression garment 10 is in a wrapped configuration around the wearer's limb in step 3220, and the method continues to step 3230.

[0160] In step 3222, the computer-executable instructions cause the one or more processors 7 to read the pressure one second after the pump is turned on in step 3206. In step 3224, the computer-executable instructions cause the one or more processors 7 to determine whether the pressure is greater than 2.0 mmHg. A pressure greater than 2.0 mmHg in step 3224 indicates that a compression garment 10 is present (e.g., in fluid communication with valves 25A, 25b, 25c) in step 3226, and the method proceeds to step 3230. A pressure not greater than 2.0 mmHg in step 3224 indicates that a compression garment 10 is not present (e.g., not in fluid communication with valves 25A, 25b, 25c) in step 3228, and the method proceeds to step 3232, where the compliance time is not incremented before the method terminates in step 3236.

[0161] In step 3230, the computer-executable instructions cause the one or more processors 7 to determine whether a compression garment 10 is present and in a wrapped configuration around the wearer's limb. If it is determined that a compression garment 10 is not present or not in a wrapped configuration around the wearer's limb, the method proceeds to step 3232 and the compliance time is not incremented before terminating the method in step 3236. If a compression garment 10 is determined by the one or more processors 7 to be present and in a wrapped configuration, the method proceeds to step 3234 and the compliance time is incremented before terminating the method in step 3236.

[0162] 33 , computer-executable instructions embodied in computer-readable storage medium 33 cause one or more processors 7 to perform a method 3300 for analyzing waveform data received from pressure sensor 27 to determine whether the compression garment is in a wrapped or non-wrapped configuration after completion of a 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 compression cycle. In step 3306, the computer-executable instructions cause one or more processors 7 to vent bladders corresponding to the wearer's ankle and thigh (e.g., bladders 13a and 13c). In step 3308, the computer-executable instructions cause one or more processors 7 to hold pressure in a bladders corresponding to the wearer's calf (e.g., bladders 13b) for a predetermined period of time (e.g., 10 seconds) and acquire a pressure signal via pressure sensor 27.

[0163] At step 3310, the computer-executable instructions cause the one or more processors 7 to determine whether all of the data is available. If at step 3310, not all of the data is available, the method proceeds to step 3312, where the method continues acquiring pressure signals from the pressure sensors 27 before returning to step 3308. If at step 3310, all of the data is available, the method proceeds to step 3314, where the computer-executable instructions cause the one or more processors 7 to execute a pulse detection algorithm. In some embodiments, the pulse detection algorithm includes one or more steps of post-processing waveform analysis 3104 described above. At step 3316, the computer-executable instructions cause the one or more processors 7 to determine whether a pulse was detected at step 3314. The absence of a pulse indicates that the compression garment 10 is in a non-wrapped configuration away from the wearer's limb at step 3322. The method then proceeds to step 3324, where the computer-executable instructions cause the one or more processors 7 not to increment the compliance time and to take one or more actions (e.g., alert the user) before terminating the method in step 3326. Detection of a pulse in step 3316 indicates that the compression garment 10 is in a wraparound configuration around the wearer's limb in step 3318. The method then proceeds to step 3320, where the computer-executable instructions cause the one or more processors 7 to increment the compliance time before terminating the method in step 3326.

[0164] 34 , computer-executable instructions embodied in computer-readable storage medium 33 cause one or more processors 7 to perform a method 3400 for analyzing waveform data received from pressure sensor 27 to determine whether a compression garment is in a wrapped or non-wrapped 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. In step 3406, the computer-executable instructions cause one or more processors 7 to vent bladders corresponding to the wearer's ankle and thigh (e.g., bladders 13a and 13c). In step 3408, the computer-executable instructions cause one or more processors 7 to vent pressure in a bladders corresponding to the wearer's calf (e.g., bladders 13b) to a VRD target. Alternatively, the computer-executable instructions cause the one or more processors 7 to vent bladders (e.g., bladders 13a and 13c) corresponding to the wearer's ankles and thighs, and then inflate the ankle and thigh bladders to the VRD targets. In step 3410, the computer-executable instructions cause the one or more processors 7 to execute the VRD as scheduled. Once a VRD measurement is initiated, the computer-executable instructions cause the one or more processors 7 to initiate a secondary process to acquire pressure data from pressure sensor 27 for parallel pulse detection. In step 3414, the computer-executable instructions cause the one or more processors 7 to acquire pressure signals from pressure sensor 27 while the VRD is running.

[0165] At step 3416, the computer-executable instructions cause the one or more processors 7 to determine whether all of the data is available. If at step 3416, all of the data is not available, the method proceeds to step 3418, where the method continues acquiring pressure signals from the pressure sensors 27 before returning to step 3414. If at step 3416, all of the data is available, the method proceeds to step 3420, where the computer-executable instructions cause the one or more processors 7 to execute a pulse detection algorithm. In some embodiments, the pulse detection algorithm includes one or more steps of post-processing waveform analysis, as described above. At step 3422, the computer-executable instructions cause the one or more processors 7 to determine whether a pulse was detected at step 3420. The absence of a pulse indicates that the compression garment 10 is in a non-wrapped configuration away from the wearer's limb at step 3428. The method then proceeds to step 3430, where the computer-executable instructions cause the one or more processors 7 not to increment the compliance time and to take one or more actions (e.g., alert the user) before terminating the method in step 3432. Detection of a pulse in step 3422 indicates that the compression garment 10 is in a wraparound configuration around the wearer's limb in step 3424. The method then proceeds to step 3426, where the computer-executable instructions cause the one or more processors 7 to increment the compliance time before terminating the method in step 3432.

[0166] 35, computer-executable instructions embodied in computer-readable storage medium 33 cause one or more processors 7 to perform a method 3500 for analyzing waveform data received from pressure sensor 27 to determine whether the compression garment is in a wrapped or unwrapped configuration as an independent cycle. 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. In step 3506, the computer-executable instructions cause one or more processors 7 to vent bladders 13a, 13b, 13c. In 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 bladders (e.g., bladders 13b) to a desired pressure (e.g., 10-120 mmHg). In step 3510, the computer-executable instructions cause the one or more processors 7 to acquire pressure signals via the pressure sensors 27 for a predetermined period of time (eg, 10 seconds).

[0167] At step 3512, the computer-executable instructions cause the one or more processors 7 to determine whether all of the data is available. If at step 3512, all of the data is not available, the method proceeds to step 3514, where the method continues acquiring pressure signals from the pressure sensors 27 before returning to step 3510. If at step 3512, all of the data is available, the method proceeds to step 3516, where the computer-executable instructions cause the one or more processors 7 to close the corresponding valve (e.g., 25b) and execute a pulse detection algorithm. In some embodiments, the pulse detection algorithm includes one or more steps of post-processing waveform analysis 804 described above. At step 3518, the computer-executable instructions cause the one or more processors 7 to determine whether a pulse was detected at step 3516. The absence of a pulse indicates that the compression garment 10 is in a non-wrapped configuration away from the wearer's limb at step 3524. The method then proceeds to step 3526, where the computer-executable instructions cause the one or more processors 7 not to increment the compliance time and to take one or more actions (e.g., alert the user) before terminating the method in step 3528. Detection of a pulse in step 3518 indicates that the compression garment 10 is in a wraparound configuration around the wearer's limb in step 3520. The method then proceeds to step 3522, where the computer-executable instructions cause the one or more processors 7 to increment the compliance time before terminating the method in step 3528.

[0168] 36A-36C are flowcharts of an exemplary method 3600 for determining whether the compression garment 10 is in a wrapped or non-wrapped configuration about a limb of a wearer of the garment by analyzing waveform data received from pressure sensor 27 to detect pulsations associated with the wearer's heartbeat. The exemplary method may be performed by one or more processors 7 through execution of computer-executable instructions embodied in a non-transitory computer-readable storage medium 33.

[0169] Method 3600 begins at step 3602, where computer-executable instructions cause one or more processors 7 to complete a compression cycle or a prophylactic compression cycle. In step 3604, the computer-executable instructions cause one or more processors 7 to vent bladders (e.g., bladders 13a and 13c) corresponding to, for example, the wearer's ankle and thigh, and ventilate bladders (e.g., bladders 13b) corresponding to, for example, the wearer's calf, until a target pressure is achieved. In one embodiment, the target pressure comprises an initial lower target pressure of about 5 to about 7 mmHg. Alternatively, when the initial lower target pressure does not produce expected results, the target pressure comprises about 26 to about 32 mmHg. The initial lower target pressure provides an exemplary advantage of exerting less pressure on the wearer's limb, which may be more comfortable to the patient compared to a higher pressure, before retrying at a higher target pressure that may be less comfortable to the patient.

[0170] In step 3606, once the target pressure is reached, the computer-executable instructions cause the one or more processors 7 to hold the pressure in the bladder (e.g., bladder 13b) corresponding to the wearer's calf while signals are acquired at a rate of about 100 Hz for a period of at least about 15 seconds. In one embodiment, this period comprises a pressure hold period 2804, as described further herein. Hold periods longer than about 15 seconds may also be utilized without departing from the scope of the present invention. In step 3608, the computer-executable instructions cause the one or more processors 7 to vent the pressure in the bladder (e.g., bladder 13b) corresponding to the wearer's calf.

[0171] Following ventilation of the measurement bladder (e.g., bladder 13b), the computer-executable instructions may cause the one or more processors 7 to perform further signal conditioning to prepare the data for the patient detection algorithm. As shown in FIG. 36A, the computer-executable instructions may also cause the one or more processors 7 to bandpass filter 3610 the waveform data. In one embodiment, the most recent 1024 acquired samples, corresponding to a time window of approximately 10 seconds, are passed through bandpass filter 3610 having a passband of approximately 0.5 Hz to 5 Hz to isolate signals reflecting the wearer's cardiac cycle. In one embodiment, the first three samples of the 1024 acquired samples are ignored as a settling time period. Those skilled in the art will appreciate that other amounts of recently acquired samples may be utilized without departing from the scope of the present invention. For example, any number of recently acquired samples that is a power of two may aid in frequency calculations.

[0172] The computer-executable instructions cause the one or more processors 7 to pass the output of the bandpass filter 3610 through a low-pass filter 3612 having a low-pass cutoff frequency of approximately 5 Hz. In one embodiment, the low-pass filter 3612 further removes noise in the waveform data and reveals pulsations associated with the circulatory system of the wearer's lower extremities. Referring to FIG. 36, an exemplary signal from the output of the low-pass filter 3612 is shown. In this embodiment, the signal includes approximately 1024 samples having sharp pulsations associated with the circulatory system of the wearer's lower extremities.

[0173] With the filtered waveform data available, the computer-executable instructions cause the 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 or non-wrapped configuration about the limb of the garment wearer. In one aspect, the subsequent calculations are referred to as post-processing of the filtered waveform.

[0174] Referring again to FIG. 36A , the computer-executable instructions cause the one or more processors 7 to perform post-processing of the filtered waveform at 3614, 3616, and 3618. As shown, the one or more processors 7 calculate the standard deviation of the filtered waveform data and / or portions thereof. Empirically, a compression garment in a non-wrapped configuration (i.e., idle state) is known to have a stable, flat pressure signal containing only normal white noise. In contrast, a pressure signal representative of the pressure within a compression garment in a wrapped configuration around the limb of the garment wearer will contain pulsations and / or other measurable signal characteristics. Therefore, based on this calculation, it is possible to distinguish, in whole or in part, between a compression garment in a wrapped configuration around the limb of the wearer and a compression garment in a non-wrapped configuration.

[0175] In one embodiment, the computer-executable instructions cause the one or more processors 7 to divide the low-pass filtered signal (e.g., 1024 samples) into five sample groups and calculate a standard deviation 3614 (σ) for each group. It will be understood by those skilled in the art that the low-pass filtered signal may be divided into a different number of sample groups, e.g., when a different number of samples is used. An exemplary purpose for dividing the low-pass filtered signal into sample groups is to isolate portions of time. For example, large, abnormal pressure spikes in a representative pressure signal (e.g., due to the wearer sneezing, coughing, etc.) are known to occur during normal treatment due to movement of the wearer's limbs and / or other factors. By time-slicing the signal (e.g., dividing the signal into sample groups), the one or more processors 7 can determine whether the entire waveform is "steady" or whether there are abnormalities within certain ranges of samples. In one embodiment, the computer-executable instructions cause the one or more processors 7 to calculate an overall standard deviation 3614 (σ) for the entire low-pass filtered signal (e.g., 1024 samples).

[0176] After calculating the standard deviation, the computer-executable instructions cause the one or more processors 7 to perform peak detection 3616. In one embodiment, the one or more processors 7 process the filtered waveform (e.g., 1024 samples) using a windowing technique including 32 samples per window. The one or more processors 7 sequentially index the peaks from each 32-sample window to generate 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 increment the index by 1 (e.g., from 2 to 33) as additional waveform signal data is generated. The one or more processors 7 ignore negative peaks. In one embodiment, a 32-sample window leaves local maxima for each window. Additionally and / or alternatively, a 32-sample window reduces the number of samples by a factor of four, eliminating negative peaks and providing recognition that the downsampled signal represents approximately 10 seconds of real time. Referring to FIG. 38, an exemplary signal from the output of peak detection 3616 is shown, which includes only true peaks that ultimately reveal the target pulsation. In this embodiment, the signal includes approximately 250-300 samples, which still corresponds to approximately 10 seconds of real time. In one embodiment, the number of samples varies depending on the number of peaks identified by the one or more processors 7. In the embodiment illustrated in FIG. 25, 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).

[0177] 36A , with the downsampled peak-detected waveform available, the one or more processors 7 utilize the fundamental frequency to perform a time-to-frequency transform 3618 to assist in determining whether the compression garment 10 is in a wrapped configuration around the limb of the garment wearer. In one embodiment, the computer-executable instructions cause the one or more processors 7 to calculate a Fourier transform (e.g., a fast Fourier transform) of the signal and output the highest magnitude between 0.5 Hz (e.g., about 30 bpm) and 4 Hz (e.g., about 200 bpm). Those skilled in the art will appreciate that transforms other than a fast Fourier transform may be used to find the wearer's cardiac cycle without departing from the scope of the present invention.

[0178] After completing post-processing, the computer-executable instructions cause the one or more processors 7 to determine whether the compression garment 10 is in a non-wrapped configuration or a wrapped configuration around the limb of the garment wearer. Referring to FIG. 36B , the computer-executable instructions cause the one or more processors 7 to determine, in step 3620, whether the total standard deviation 3614 (σ) for the entire low-pass filtered signal (e.g., 1024 samples) is less than or equal to a non-wrap threshold (e.g., 0.18). When the one or more processors 7 determine that the total standard deviation is not less than or equal to the non-wrap threshold, method 3600 continues to step 3636, as described further herein. When the one or more processors 7 determine that the total standard deviation is less than or equal to the non-wrap threshold, method 3600 continues to step 3622.

[0179] In step 3622, the computer-executable instructions cause the one or more processors 7 to determine whether a predetermined number of segments (e.g., sample groups) into which the low-pass filtered signal has been divided are each less than or equal to the unwrap threshold (e.g., 0.18). In another aspect, the one or more processors 7 divide the low-pass filtered signal into five sample groups and determine in 3622 whether the standard deviation of each of the five sample groups is less than or equal to the unwrap threshold. Alternatively, the one or more processors 7 divide the low-pass filtered signal into five sample groups and determine in 3622 whether the standard deviation of at least three of the five sample groups is less than or equal to the unwrap threshold. When the one or more processors 7 determine that each of the predetermined number of segments is not less than or equal to the unwrap threshold, method 3600 returns to step 3602 and tries the cycle again. When the one or more processors 7 determine that each of the predetermined number of segments is less than or equal to the unwrap threshold, the process continues to step 3624.

[0180] At step 3624, the computer-executable instructions cause the one or more processors 7 to determine whether the maximum magnitude (e.g., highest amplitude) in the 0.5-4.0 Hz range for the time-frequency transformed (e.g., Fast Fourier Transformed) signal is less than or equal to a threshold X (e.g., 5 Hz). When the one or more processors 7 determine that the maximum magnitude in the 0.5-4.0 Hz range is not less than or equal to the threshold X, method 3600 ends. When the processors 7 determine at 3624 that the maximum magnitude in the 0.5-4.0 Hz range is less than or equal to the threshold X, the one or more processors 7 determine at step 3626 that the compression garment 10 is in the non-wrapped configuration. In one aspect, the computer-executable instructions cause the one or more processors 7 to declare that the compression garment 10 is in a non-wrapped configuration (e.g., the wearer is not wearing the compression garment) when the Boolean result of step 3620 is logically true, and the result of step 3622 is logically true, and the result of step 3624 is logically true.

[0181] In step 3628, the computer-executable instructions cause the one or more processors 7 to determine whether the non-wrapped configuration detection in step 3626 is a second consecutive such determination. When the one or more processors 7 determine that the non-wrapped configuration detection 3626 is not a second consecutive detection, method 3600 returns to step 3602 to perform a second measurement on the wearer's corresponding limb in the next cycle. When the one or more processors 7 determine that the non-wrapped configuration 3626 is a second consecutive detection, method 3600 continues to at least one of three steps. In step 3630, the computer-executable instructions cause the one or more processors 7 to activate an audible alert, such as via a sound-generating speaker and / or other electromechanical device connected to the controller 5 of the compression system 1. In one aspect, the alert is a multi-tone audible alert. In step 3632, the computer-executable instructions cause the one or more processors 7 to display an error message on a display device associated with the compression system 1. In step 3634, the computer-executable instructions cause the one or more processors 7 to stop incrementing the compliance time before terminating the method 3600. In one aspect, therapy using the compression garment 10 is not stopped by stopping the compliance time 3634, and the compliance time remains in its current state until a response is received via a display device and / or an input device (e.g., from a human user).

[0182] 36C , the computer-executable instructions cause the one or more processors 7 to determine whether the total standard deviation 3614 (σ) for the entire low-pass filtered signal (e.g., 1024 samples) is greater than or equal to a wrap-around threshold (e.g., 0.35) in step 3636. If the one or more processors 7 determine that the total standard deviation is not greater than or equal to the wrap-around threshold, method 3600 returns to step 3602. When the one or more processors 7 determine that the total standard deviation is greater than or equal to the wrap-around threshold, method 3600 continues to step 3638 and / or step 3640.

[0183] In one aspect, method 3600 continues at step 3638, where the computer-executable instructions cause the one or more processors to determine whether the total standard deviation 3614 (σ) for the entire low-pass filtered signal (e.g., 1024 samples) is less than or equal to a non-wraparound threshold (e.g., 10.0). When the one or more processors 7 determine that the total standard deviation for the entire low-pass filtered signal is not less than or equal to the maximum limit threshold, the method 3600 ends. When the one or more processors 7 determine that the total standard deviation for the entire low-pass filtered signal is less than or equal to the maximum limit threshold, the method 3600 proceeds to step 3640.

[0184] In step 3622, the computer-executable instructions cause the one or more processors 7 to determine whether a predetermined number of segments (e.g., sample groups) into which the low-pass filtered signal has been divided are each greater than or equal to the wrap threshold (e.g., 0.35). In one aspect, the one or more processors 7 divide the low-pass filtered signal into five sample groups and determine 3640 whether the standard deviation of each of the five sample groups is greater than or equal to the wrap threshold. Alternatively, the one or more processors 7 divide the low-pass filtered signal into five sample groups and determine 3640 whether the standard deviation of at least three of the five sample groups is greater than or equal to the wrap threshold. When the one or more processors 7 determine that each of the predetermined number of segments is not greater than or equal to the wrap threshold, the method 3600 returns to step 3602 and retries the cycle. When the one or more processors 7 determine that each of the predetermined number of segments is greater than or equal to the wrap threshold, the process continues to step 3642 and / or step 3644.

[0185] In step 3642, the computer-executable instructions cause the one or more processors 7 to determine whether each of a predetermined number of segments (e.g., sample groups) into which the low-pass filtered signal has been divided is each less than or equal to a maximum limit threshold (e.g., 10.0). When the one or more processors 7 determine that the predetermined number of segments (e.g., all five, or at least three of the five) are not each less than or equal to the maximum limit threshold, method 3600 ends. When the one or more processors 7 determine that the predetermined number of segments are each less than or equal to the maximum limit threshold, method 3600 proceeds to step 3644.

[0186] In step 3644, the computer-executable instructions cause the one or more processors 7 to determine whether the maximum magnitude (e.g., highest amplitude) in the 0.5 to 4.0 Hz range for the time-frequency transformed (e.g., fast Fourier transformed) signal is both greater than threshold Y (e.g., 20) and less than or equal to threshold Z (e.g., 50.0). When the one or more processors 7 determine that the maximum magnitude in the 0.5 to 4.0 Hz range is not both greater than threshold Y and less than or equal to threshold Z, method 3600 ends. When the one or more processors 7 determine that the maximum magnitude in the 0.5 to 4.0 Hz range is both greater than threshold Y and less than or equal to threshold Z, the one or more processors 7 determine that the compression garment 10 is in a wrapped configuration 3646 around a limb of the garment wearer. In one aspect, the computer-executable instructions cause the one or more processors 7 to declare that the compression garment 10 is in the wrap configuration (e.g., the wearer is wearing the compression garment) 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. Alternatively, the computer-executable instructions cause the one or more processors 7 to declare that the compression garment 10 is in the wrap configuration 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.

[0187] After determining that the compression garment 10 is in the wrapped configuration 3646, the method 3600 continues to step 3648 where the computer-executable instructions cause the one or more processors 7 to increment the compliance time before terminating the method 3600.

[0188] 39A-39C are schematic diagrams of a second exemplary method 3900 for determining whether a compression garment 10 is in a wrapped or unwrapped configuration around a limb of a wearer of the compression garment 10 by analyzing waveform data received from pressure sensor 27 to detect pulsations associated with the wearer's heartbeat, according to an embodiment of the present invention. This exemplary method may be performed by one or more processors 7 through execution of computer-executable instructions embodied in a non-transitory computer-readable storage medium 33. Method 3900 occurs during VRD (starting at step 3904) and is a more detailed flowchart of FIG.

[0189] Method 3900 begins at step 3902 and proceeds to step 3602, where computer-executable instructions cause one or more processors 7 to complete a compression cycle or a prophylactic compression cycle. In step 3904, the computer-executable instructions cause one or more processors 7 to vent bladders corresponding to, for example, the wearer's ankle and thigh (e.g., bladders 13a and 13c), and to vent bladders corresponding to, for example, the wearer's calf (e.g., bladders 13b) until a target pressure is achieved. Alternatively, the computer-executable instructions cause one or more processors 7 to vent bladders corresponding to, for example, the wearer's ankle and thigh (e.g., bladders 13a and 13c), and to vent bladders corresponding to, for example, the wearer's calf (e.g., bladders 13b), and then to inflate bladders corresponding to, for example, the wearer's calf (e.g., bladders 13b) until a target pressure is achieved. In one embodiment, the target pressure includes an initial lower target pressure of about 5 to about 7 mmHg. Alternatively, the target pressure may comprise about 26 to about 32 mmHg when an initial lower target pressure does not produce the expected results. The initial lower target pressure provides the exemplary advantage of exerting less pressure on the wearer's limb, which may be more comfortable for the patient compared to a higher pressure, before trying again at a higher target pressure that may be less comfortable for the patient.

[0190] In step 3906, once the target pressure is reached, the computer-executable instructions cause the one or more processors 7 to hold the pressure in the bladder corresponding to the wearer's calf (e.g., bladder 13b) while a signal is acquired at a rate of about 100 Hz for a period of at least about 15 seconds. In one embodiment, this period includes the pressure hold period 2804, as described further herein. Hold periods longer than about 15 seconds may also be utilized without departing from the scope of the present invention. For example, at least one inflatable bladder can be inflated to a target value, held at that pressure, and a signal acquired. Thus, a signal can be received to determine whether the target value has been reached, for example, during deflation. Similarly, if at least one inflatable bladder is vented and then inflated to a target value, a signal can be received during inflation. A signal can be received while the at least one bladder is held at the target value / pressure, for example, during inflation when the at least one bladder is inflated.

[0191] During signal acquisition, waveform data is acquired, for example, in real time, from a measurement pouch (e.g., pouch 13b), and the computer-executable instructions cause the one or more processors 7 to perform further signal conditioning to prepare the data for the patient detection algorithm. As shown in FIG. 39A, in step 3908, the computer-executable instructions may cause the one or more processors 7 to bandpass filter 3610 the waveform data. In one embodiment, the most recent 1024 acquired samples, corresponding to a time window of approximately 10 seconds, are passed through a bandpass filter 3908 having a passband of approximately 0.5 Hz to 5 Hz to isolate signals reflecting the wearer's cardiac cycle. In one embodiment, the first three samples of the 1024 acquired samples are ignored as a settling time period. Those skilled in the art will appreciate that other amounts of recently acquired samples may be utilized without departing from the scope of the present invention. For example, any number of recently acquired samples being a power of two can aid in frequency calculations.

[0192] In step 3910, the computer-executable instructions cause the one or more processors 7 to pass the output of the bandpass filter through a low-pass filter having a low-pass cutoff frequency of approximately 5 Hz. In one embodiment, the low-pass filter 3910 further removes noise in the waveform data and reveals pulsations associated with the circulatory system of the wearer's lower extremities. Referring to FIG. 37, an exemplary signal from the output of the low-pass filter is shown. In this embodiment, the signal includes approximately 1024 samples with sharp pulsations associated with the circulatory system of the wearer's lower extremities.

[0193] With the filtered waveform data available, the computer-executable instructions cause the 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 or non-wrapped configuration around the limb of the garment wearer. In one aspect, the subsequent calculations are referred to as post-processing of the filtered waveform. In one aspect, the method 3900 retains the last 1024 samples as a patient detection (PD) filtered data set for further calculations as described below.

[0194] Referring again to FIG. 39A , in step 3912, the computer-executable instructions cause the one or more processors 7 to vent the pressure in a bladder (e.g., bladder 13b) corresponding to the wearer's calf to ambient, e.g., release the pressure in the bladder. Next, in steps 3914, 3916, and 3918, the computer-executable instructions cause the one or more processors 7 to perform post-processing of the filtered waveform. As shown, the one or more processors 7 calculate the standard deviation of the filtered waveform data and / or portions thereof. Empirically, a compression garment in a non-wrapped configuration (i.e., idle state) has been found to have a stable, flat pressure signal containing only normal white noise. In contrast, a pressure signal representative of the pressure in a compression garment in a wrapped configuration around the wearer's limb will contain pulsations and / or other measurable signal characteristics. Therefore, based on this calculation, it is possible to distinguish, in whole or in part, between a compression garment in a wrapped configuration around the wearer's limb and a compression garment in a non-wrapped configuration.

[0195] In step 3914, the computer-executable instructions cause the one or more processors 7 to calculate a standard deviation (σ). For example, the computer-executable instructions cause the 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 a standard deviation 3914 (σ) for each group. For example, four groups include 200 samples of the PD filtered data set and one group includes 224 samples of the PD filtered data set. These groups are referred to as s1-s5. This results in five standard deviations (e.g., a standard deviation for each group s1-s5). It will be understood by those skilled in the art that the low-pass filtered signal may be divided into different numbers of sample groups, for example, when a different number of samples is used. An exemplary purpose of dividing the low-pass filtered signal into sample groups is to isolate portions of time. For example, large, abnormal pressure spikes in a representative pressure signal (e.g., due to the wearer sneezing, coughing, etc.) are known to occur during normal treatment due to movement of the wearer's limbs and / or other factors. By time slicing the signal (e.g., dividing the signal into sample groups), the one or more processors 7 can determine whether the entire waveform is "steady" or whether there are abnormalities within certain ranges of samples. For example, the computer-executable instructions may cause the one or more processors 7 to calculate the total standard deviation 3914 (σ) for the entire low-pass filtered signal (e.g., 1024 samples / PD filtered data set), which may be referred to as "s."

[0196] In step 3916, the computer-executable instructions cause the one or more processors 7 to perform peak detection. For example, the one or more processors 7 process the filtered waveform (e.g., 1024 samples) using a windowing technique including 32 samples per window. The one or more processors 7 sequentially index the peaks from each 32-sample window to generate 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 increment the index by 1 (e.g., from 2 to 33) as additional waveform signal data is generated. The one or more processors 7 ignore negative peaks. In one embodiment, a 32-sample window leaves local maxima for each window. Additionally and / or alternatively, a 32-sample window reduces the number of samples by a factor of four, eliminating negative peaks and providing recognition that the downsampled signal represents approximately 10 seconds of real time. Referring to FIG. 38, an exemplary signal from the output of peak detection 3916 is shown, which includes only true peaks that ultimately reveal the target pulsation. In this embodiment, the signal includes approximately 250-300 samples, which still corresponds to approximately 10 seconds of real time. In one embodiment, the number of samples varies depending on the number of peaks identified by the one or more processors 7. In the embodiment illustrated in FIG. 25, 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).

[0197] 39A , with the downsampled peak detected waveform available, the one or more processors 7 utilize the fundamental frequency to perform a time-to-frequency transform 3918 to assist in determining whether the compression garment 10 is in a wrapped configuration around the limb of the garment wearer. In step 3918, the computer-executable instructions cause the one or more processors 7 to calculate a Fourier transform (e.g., a 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 skilled in the art will appreciate that transforms other than a Fast Fourier Transform may be used to find the wearer's cardiac cycle without departing from the scope of the present invention.

[0198] After completing post-processing, the computer-executable instructions cause the one or more processors 7 to determine whether the compression garment 10 is in a non-wrapped configuration or a wrapped configuration around the limb of the garment wearer. Referring to FIG. 39B , the computer-executable instructions cause the one or more processors 7 to determine, in step 3920, whether the total standard deviation 3914 (σ) for 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 a non-wrap threshold (e.g., 0.18). When the one or more processors 7 determine that the total standard deviation is not less than or equal to the non-wrap threshold, method 3900 continues to step 3934, as described further herein. When the one or more processors 7 determine that the total standard deviation is less than or equal to the non-wrap threshold, method 3900 continues to step 3922.

[0199] In step 3922, the computer-executable instructions cause the one or more processors 7 to determine whether the standard deviation (SD) 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 an unwrap threshold (e.g., 0.18). In another aspect, the one or more processors 7 divide the low-pass filtered signal into five sample groups and determine in 3922 whether the standard deviation of each of the five sample groups is less than or equal to the unwrap threshold. Alternatively, the one or more processors 7 divide the low-pass filtered signal into five sample groups and determine in 3922 whether the standard deviation of at least three of the five sample groups is less than or equal to the unwrap threshold. When the one or more processors 7 determine that each of the predetermined number of segments is not less than or equal to the unwrap threshold, method 3900 continues to step 3944 to determine whether to retry the cycle. When the one or more processors 7 determine that each of the predetermined number of segments is less than or equal to the unwrap threshold, the process continues to step 3924.

[0200] At step 3924, using the low pass filtered signal (e.g., 1024 samples / PD filtered data set), the computer executable instructions cause the one or more processors 7 to determine whether the maximum magnitude (e.g., highest amplitude) in the 0.5-4.0 Hz range for the time-frequency transformed (e.g., Fast Fourier Transformed) signal is less than or equal to a threshold value X (e.g., 5). When the one or more processors 7 determine that the maximum magnitude in the 0.5-4.0 Hz range is not less than or equal to threshold value X, method 3900 proceeds to step 3944 to determine whether to retry the cycle. When the processor 7 determines at 3924 that the maximum magnitude in the 0.5-4.0 Hz range is less than or equal to threshold value X, the one or more processors 7 determine at step 3926 that the compression garment 10 is in the non-wrapped configuration. In one aspect, the computer-executable instructions cause the one or more processors 7 to declare that the compression garment 10 is in a non-wrapped configuration (e.g., the wearer is not wearing the compression garment) 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.

[0201] In step 3926, the computer executable instructions cause the one or more processors 7 to determine that the compression garment is non-wraparound, eg, not wrapped around a limb of the wearer.

[0202] At step 3928, the computer-executable instructions cause the one or more processors 7 to activate an audible alert, such as via a sound-generating speaker and / or other electromechanical device connected to the controller 5 of the compression system 1. In one aspect, the alert is a multi-tone audible alert. At step 3930, the computer-executable instructions cause the 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 the one or more processors 7 to stop incrementing the compliance time before terminating the method 3900. In one aspect, therapy using the compression garment 10 is not stopped by stopping the compliance time 3932, and the compliance time remains in its current state until a response is received via a display device and / or an input device (e.g., from a human user).

[0203] 39C , in step 3934, the computer-executable instructions cause the one or more processors 7 to determine whether the total / overall standard deviation 3914 (σ) for the entire low-pass filtered signal (e.g., 1024 samples / PD filtered data set) is greater than or equal to a wrap-around threshold (e.g., 0.25). When the one or more processors 7 determine that the total standard deviation is greater than or equal to the wrap-around threshold, method 3900 continues to step 3944 to determine whether to retry the cycle. When the one or more processors 7 determine that the total standard deviation is greater than or equal to the wrap-around threshold, method 3900 continues to step 3936.

[0204] In step 3936, the computer-executable instructions cause the one or more processors 7 to determine whether the standard deviation (SD) of a predetermined number of segments (e.g., sample groups s1-s5) into which the low-pass filtered signal is divided is each greater than or equal to a wrap threshold (e.g., 0.25). In one aspect, the one or more processors 7 determine 3936 whether the standard deviation of each of five sample groups is greater than or equal to the wrap threshold. Alternatively, the 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 the 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 retry the cycle. When the 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 continues to step 3938.

[0205] At step 3938, the computer-executable instructions cause the one or more processors 7 to determine whether the maximum (e.g., highest amplitude) magnitude in the 0.5-4.0 Hz range for the time-frequency transformed (e.g., fast Fourier transformed (FFT)) signal is greater than a threshold Y (e.g., 5). When the one or more processors 7 determine that the maximum magnitude in the 0.5-4.0 Hz range is not greater than threshold Y, method 3900 continues to step 3944, where it determines whether to retry the cycle. When the one or more processors 7 determine that the maximum magnitude in the 0.5-4.0 Hz range is greater than threshold Y, the one or more processors 7 determine that the compression garment 10 is in a wrapped configuration 3940 around the limb of the garment wearer. The computer-executable instructions cause the one or more processors 7 to declare the compression garment 10 to be in a wrapped configuration when the Boolean result of step 3934 is logically true, the result of step 3936 is logically true, and the result of step 3938 is logically true.

[0206] After determining that the compression garment 10 is in the wrapped configuration 3940, the method 3900 continues to step 3942 where the computer-executable instructions cause the one or more processors 7 to increment the compliance time before terminating the method 3900.

[0207] In step 3944, the one or more processors 7 determine whether any one of the three criteria, 1) overall SD, 2) segment SD, or FFT max, is initially indeterminate. If the one or more processors 7 determine that any one of the three criteria, 1) overall SD, 2) segment SD, or FFT max, is initially indeterminate, method 3900 proceeds to step 3902. If the one or more processors 7 determine that any one of the three criteria, 1) overall SD, 2) segment SD, or FFT max, is indeterminate a second time, the one or more processors 7 determine that the compression garment is non-wrapped, e.g., not wrapped around the wearer's limb, and method 3900 proceeds to step 3926. Indeterminate refers to an inability to determine whether the compression garment 10 is in a wrapped or non-wrapped configuration.

[0208] Although particular embodiments have been described, other embodiments are additionally or alternatively possible.

[0209] Although the compression system has been described as being used with thigh-length compression sleeves, it should be understood that the compression system may additionally or alternatively be used with other types of compression garments, for example, the compression system may be used with knee-length compression sleeves and / or sleeves having different numbers of bladders configured to be disposed over different regions of the wearer's body.

[0210] Aspects of the present disclosure may be implemented using hardware, software, or a combination thereof, and may be implemented in one or more computer systems or other processing systems. In one aspect, the present disclosure is directed to one or more computer systems capable of performing the functionality described herein. An example of such a computer system 4000 is shown in FIG. 40.

[0211] FIG. 40 presents an exemplary system diagram of various hardware components and other features for use in accordance with aspects of the present disclosure. Aspects of the present disclosure may be implemented using hardware, software, or a combination thereof, and may be implemented in one or more computer systems or other processing systems. In one exemplary variation, aspects described herein are directed to one or more computer systems capable of performing the functionality described herein. An example of such a computer system 4000 is shown in FIG. 40.

[0212] Computer system 4000 includes one or more processors, such as processor 4004. Processor 4004 is connected to a communications infrastructure 4006 (e.g., a communications bus, crossover bar, or network). In one example, processor 7 of FIGS. 1-2 above may include processor 4004. Various software aspects are described with respect to this exemplary computer system. After reading this description, it will become apparent to one skilled in the relevant art how to implement aspects described herein using other computer systems and / or architectures.

[0213] The computer system 4000 may include a display interface 4002 that transfers graphics, text, and other data from a communications infrastructure 4006 (or a frame buffer, not shown) for display on a display unit 4030. The computer system 4000 also includes a main memory 4008, preferably random access memory, and may also include a secondary memory 4010. The secondary memory 4010 may include a hard disk drive 4012 and / or a removable storage drive 4014, representing, for example, a floppy disk drive, magnetic tape drive, optical disk drive, etc. The removable storage drive 4014 reads from and / or writes to a removable storage unit 4018, in well-known fashion. The removable storage unit 4018 may represent a floppy disk, magnetic tape, optical disk, etc., which is read from and written to by the removable storage drive 4014. As will be appreciated, the removable storage unit 4018 includes a computer-usable storage medium having stored thereon computer software and / or data.

[0214] In alternative embodiments, secondary memory 4010 may include other similar devices for allowing computer programs or other instructions to be loaded into computer system 4000. Such devices may include, for example, removable storage units 4022 and interfaces 4020. Examples of such devices may include program cartridges and cartridge interfaces (such as those found in video game devices), removable memory chips (such as erasable programmable read-only memories (EPROMs) or programmable read-only memories (PROMs)) and associated sockets, and other removable storage units 4022 and interfaces 4020 that allow software and data to be transferred from removable storage units 4022 to computer system 4000.

[0215] The computer system 4000 may also include a communications interface 4024. The communications interface 4024 allows software and data to be transferred between the computer system 4000 and external devices. Examples of the communications interface 4024 may include a modem, a network interface (such as an Ethernet card), a communications port, a PCMCIA (Personal Computer Memory Card International Association) slot and card, etc. The software and data transferred via the communications interface 4024 are in the form of signals 4028, which may be electronic, electromagnetic, optical, or other signals capable of being received by the communications interface 4024. These signals 4028 are provided to the communications interface 4024 via a communications path (e.g., channel) 4026. This communications path 4026 carries the signals 4028 and may be implemented using wire or cable, fiber optics, a telephone line, a cellular link, a radio frequency (RF) link, and / or other communications channels. In this document, the terms "computer program medium" and "computer usable medium" are used generally to refer to media such as removable storage drive 4080, a hard disk installed in hard disk drive 4070, or signal 4028. These computer program products provide software to computer system 400. Aspects described herein may be directed to such computer program products.

[0216] Computer programs (also called computer control logic) are stored in main memory 4008 and / or secondary memory 4010. Computer programs may be received via communications interface 4024. Such computer programs, when executed, enable computer system 4000 to perform various features in accordance with aspects described herein. In particular, computer programs, when executed, enable processor 4004 to perform such features. Such computer programs thus represent controllers of computer system 4000.

[0217] In variations in which the aspects described herein are implemented using software, the software may be stored in a computer program product and loaded into the computer system 4000 using the removable storage drive 4014, the hard disk drive 4012, or the communications interface 4020. The control logic (software), when executed by the processor 4004, causes the processor 4004 to perform the functions as described herein in accordance with the aspects described herein. In another variation, the aspects are implemented primarily in hardware using, for example, hardware components such as application specific integrated circuits (ASICs). Implementation of hardware state machines to perform the functions described herein will be apparent to those skilled in the art.

[0218] In yet another variation, aspects described herein are implemented using a combination of both hardware and software.

[0219] Aspects discussed herein may also be described and implemented in the context of computer-readable storage media that store computer-executable instructions. Computer-readable storage media include computer storage media and communication media, such as flash memory drives, digital versatile disks (DVDs), compact disks (CDs), floppy disks, tape cassettes, etc. Computer-readable storage media may include volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information, such as computer-readable instructions, data structures, modules, or other data.

[0220] It will be appreciated that various implementations of the above-disclosed features and functions, or alternatives or variations thereof, may be desirably combined into many other different systems or applications, and various presently unforeseen or unanticipated substitutions, modifications, variations, or improvements may thereafter be made by those skilled in the art, which are also intended to be encompassed by the following claims.

[0221] Many aspects have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the disclosure. For example, while a controller having a single pressure sensor has been described, additional pressure sensors (e.g., one for each inflatable bladder) may be used without departing from the scope of the disclosure. Accordingly, other aspects are within the scope of the following claims.

Claims

1. 1. A compression garment controller for monitoring a user's compliance with wearing a compression garment in accordance with a compression therapy regimen, 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; at least one processor coupled to the at least one computer-readable storage medium; and computer-executable instructions embodied in the at least one computer-readable storage medium, the computer-executable instructions causing the at least one processor to: directing a flow of fluid from a pressurized fluid flow source to cyclically inflate and deflate at least one inflatable bladder of the compression garment configured to be wrapped around a limb of a wearer of the compression garment; receiving a pressure signal indicative of a fluid pressure within the at least one inflatable bladder from a pressure sensor communicatively coupled to the at least one inflatable bladder during at least one of inflation and deflation of the at least one inflatable bladder over a plurality of successive compression cycles; processing the received pressure signal; illuminating the at least one LED in a first color in response to the received pressure signal indicating compliance with the compression therapy; and responsive to the received pressure signal indicating a cessation of activity or non-compliance with compression therapy, causing the at least one LED to illuminate a second color.

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

3. 2. The compression garment controller of claim 1, further comprising a housing having a sloped surface on each of the vertical sides of the display screen, with an LED located on each sloped surface, whereby at least one LED is visible from a side of the compression garment controller.

4. 10. The compression garment controller of claim 1, wherein the at least one processor is further configured to display a graphical user interface (GUI) on the display screen, the GUI including an adherence meter indicating adherence to the compression therapy.

5. 5. The compression garment controller of claim 4, wherein the adherence meter is displayed as a 24-hour circular bar having a first color indicating adherence and a second color indicating non-adherence.

6. The compression garment controller of claim 5 , wherein the first color is blue.

7. 6. The compression garment controller of claim 5, wherein the second color is orange.

8. 6. The compression garment controller of claim 5, wherein the displayed adherence meter indicates the amount of time for the compression therapy in a 24 hour period.

9. 9. The compression garment controller of claim 8, wherein the displayed compliance meter includes a current date and time within the circular bar.

10. 10. The compression garment controller of claim 1, wherein the at least one processor is further configured to display a graphical user interface (GUI) on the display screen, the GUI including a plurality of adherence meters indicating adherence to the compression therapy on a day-to-day basis.

11. The compression garment controller of claim 10 , wherein the GUI displays up to six compliance meters on the display screen.

12. The at least one processor receiving a selection of a system time icon from the displayed menu; Displaying a world map with the current time, Displaying the current time in response to a navigation command; receiving a highlighted current time zone selection; 2. The compression garment controller of claim 1, further configured to: save the selected current time zone.

13. a controller attachment configured to couple a compression garment controller to a pole, a first receiving portion including a recessed 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 channel adapted to receive one or more wires or tubes; an interconnector coupled to the second receiving portion; a pole mounting portion coupled to the interconnect and having a U-shape adapted to capturably receive a pole.

14. 14. The controller attachment of claim 13, wherein the pole mounting 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 mounting portion.

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

16. 1. A compression garment system for monitoring compliance of a user wearing a compression garment wrapped around a limb of the user in accordance with compression therapy, comprising: Compression garments and a controller, the controller comprising: a display screen configured to display a graphical user interface (GUI); a plurality of light emitting diodes (LEDs) positioned at a viewing angle to the controller; Memory and a processor coupled to the memory, the processor comprising: directing a flow of fluid from a pressurized fluid flow source to cyclically inflate and deflate an inflatable bladder of the compression garment configured to be wrapped around a limb of a wearer of the compression garment; receiving a pressure signal indicative of a fluid pressure within the inflatable bladder from a pressure sensor communicatively coupled to the inflatable bladder during at least one of inflation and deflation of the inflatable bladder in a plurality of successive compression cycles; processing the received pressure signals to determine compliance or non-compliance with the compression therapy; illuminating the plurality of LEDs in a first color in response to the received pressure signal indicating compliance with compression therapy; and responsive to the received pressure signal indicating a cessation of movement or non-compliance with the compression therapy, causing the plurality of LEDs to illuminate a second color.

17. 17. The compression garment system of claim 16, wherein the compression garment is at least one of a leg sleeve, an ankle sleeve, a thigh sleeve, or a calf sleeve.

18. 20. The compression garment system of claim 17, wherein the compression garment comprises multiple garments.

19. 20. The compression garment system of claim 18, wherein the plurality of garments includes different sleeve combinations.

20. 20. The compression garment system of claim 18, wherein the plurality of garments includes two identical sleeves.

21. 17. The compression garment system of claim 16, further comprising a pole attachment portion configured to secure the controller to a pole.

22. 1. A method for a compression garment controller to monitor compliance of a user wearing a compression garment wrapped around a limb of the user in accordance with compression therapy, comprising: directing a flow of fluid from a pressurized fluid flow source to cyclically inflate and deflate an inflatable bladder of the compression garment; receiving a pressure signal indicative of a fluid pressure within the inflatable bladder from a pressure sensor communicatively coupled to the inflatable bladder during at least one of inflation and deflation of the inflatable bladder over a plurality of successive compression cycles; processing the received pressure signals to determine compliance or non-compliance with the compression therapy; illuminating the at least one light emitting diode (LED) in a first color in response to the received pressure signal indicating compliance with the compression therapy; and responsive to the received pressure signal indicating a cessation of motion or non-compliance with the compression therapy, illuminating the at least one LED in a second color.

23. 23. The method of claim 22, further comprising displaying, on a graphical user interface of the compression garment controller, an adherence meter indicating adherence to the compression therapy.

24. 24. The method of claim 23, wherein the adherence meter is displayed as a 24-hour circular bar having a first color indicating adherence and a second color indicating non-adherence.

25. 24. The method of claim 23, wherein the displayed adherence meter indicates the amount of time for compression therapy in a 24 hour period.

26. 25. The method of claim 24, wherein the displayed adherence meter includes the current date and time within a circular bar.

27. 23. The method of claim 22, further comprising, in response to the received compression signal indicating an error in the compression therapy, causing the LED to illuminate a third color.

28. 23. The method of claim 22, further comprising displaying, on a graphical user interface (GUI) of the controller, a plurality of adherence meters indicating adherence to the compression therapy on a daily basis.

29. 30. The method of claim 28, wherein the GUI displays up to six compliance meters.

Images