Compression Garment Compliance

Abstract

Whether a compression garment is worn by a wearer of the garment is determined by analyzing a pressure signal waveform indicative of fluid pressure in an inflatable and deflatable bladder of the compression garment. Changes detected in the pressure signal waveform during the analysis indicate changes in the condition of the compression garment. In one aspect, the change in condition is verified using a confirmatory analysis. In another aspect, the change is one of a pressure rise and a pressure pulse. In yet another aspect, the change is an oscillation amplitude as a function of time representing a pulse of the wearer.

Description

[0001] This application is a divisional application of the application with the application date of October 10, 2016, application number 201680072486.7 and invention name “Compression Garment Conformity”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 239,566, entitled “Compression Garment Compliance,” filed on October 9, 2015, U.S. Provisional Patent Application Serial No. 62 / 239,527, entitled “Determining a Configuration of a Compression Garment,” filed on October 9, 2015, U.S. Provisional Patent Application Serial No. 62 / 239,493, entitled “Determining a Configuration of a Compression Garment,” filed on October 9, 2015, and U.S. Provisional Patent Application Serial No. 62 / 329,233, entitled “Determining a Configuration of a Compression Garment,” filed on April 29, 2016. The entire contents of the above-identified applications are expressly incorporated herein by reference, including the contents and teachings of any references contained herein. Background Art

[0004] An intermittent pneumatic compression (IPC) system includes a device for applying a pressurized fluid, such as air, to a patient's or wearer's limb. In some instances, pressurized air is applied to a patient's lower limb at risk of developing a deep vein thrombosis (DVT). An IPC system typically includes a pumping unit that manages the pressurization of the fluid, a tubing set that extends the delivery of the fluid beyond the pumping unit, and a compression garment that wraps around the patient's limb and contains the pressurized fluid. The IPC system intermittently pressurizes the garment so as to apply pneumatic compression to the patient's limb, moving blood from that area of ​​the limb. However, the effectiveness of such an IPC system for DVT prevention depends on the patient's compliance with a prescribed treatment regimen that includes the IPC system. Summary of the invention

[0005] In one aspect, the present disclosure is directed to systems and methods for monitoring a wearer's compliance with a course of compression therapy for use of a compression system. In another aspect, the present disclosure is directed to systems and methods for determining whether a compression garment is applied to a wearer's limb.

[0006] In one aspect, a compression device controller includes a memory device, one or more processors coupled to the memory device, and computer executable instructions embodied on a computer readable storage medium. The memory device is configured to store monitored parameters. The computer executable instructions include instructions for causing the one or more processors to direct a fluid flow from a pressurized fluid flow source to inflate and deflate an inflatable bladder of a compression garment. The compression garment is configured to wrap around a limb of a wearer of the garment. Also included are instructions for causing the one or more processors to receive a pressure signal from a pressure sensor communicatively coupled to the bladder, the pressure signal indicating a fluid pressure in the inflatable bladder. When caused by the instructions, the one or more processors process the received pressure signal during at least one of inflation and deflation of the inflatable bladder. The pressure signal is used to detect a change in the signal, the change in the signal indicating a change in the condition of the compression garment. The instructions also cause the one or more processors to change the state of at least one of the monitored parameters in the memory device in response to detecting a change in the received pressure signal. The changed state of the monitored parameter represents a change in the condition of the compression garment.

[0007] In another aspect, a computer-implemented method includes computer-executable instructions executed on one or more processors to control a pressurized fluid flow source through an operating cycle in which at least one inflatable bladder of a compression garment configured to be wrapped around a patient's limb is inflated and deflated. The one or more processors receive a pressure signal indicating a fluid pressure in the bladder from a pressure sensor communicatively coupled to the bladder. The computer-executable instructions executed on the one or more processors detect a change in the received pressure signal during inflation and deflation of the bladder, the change indicating a change in a condition of the compression garment. The computer-executable instructions executed on the one or more processors also change a state of at least one monitored parameter stored in a memory device in response to detecting the change in the received pressure signal. The memory device is coupled to the one or more processors, and the changed state of the monitored parameter represents a change in the condition of the compression garment.

[0008] In yet another aspect, a system includes a compression garment and a controller. The compression garment includes at least one inflatable and deflated bladder and can be secured around a limb of a wearer. The controller includes a memory device, one or more processors coupled to the memory device, and computer executable instructions embodied on a computer readable storage medium. The memory device is configured to store monitored parameters. The computer executable instructions include instructions for causing the one or more processors to direct a fluid flow from a pressurized fluid flow source to inflate and deflate the bladder of the compression garment. Also included are instructions for causing the one or more processors to receive a pressure signal indicating a fluid pressure in the bladder from a pressure sensor communicatively coupled to the bladder. When caused by the instructions, the one or more processors process the received pressure signal during at least one of inflation and deflation of the inflatable bladder. The pressure signal is used to detect a change in a signal indicating a change in a condition of the compression garment. The instructions also cause the one or more processors to change a state of at least one of the monitored parameters in the memory device in response to detecting a change in the received pressure signal. The changed state of the monitored parameter represents a change in the condition of the compression garment.

[0009] Embodiments may include one or more of the following advantages.

[0010] In some embodiments, compliance monitoring of the compression system is performed using a signal indicative of the pressure in the inflatable bladder of the compression garment, providing a real-time indication of the wearer's compliance with the use of the compression garment. This can, for example, provide a robust indication of compliance while reducing the burden on the caregiver to track compliance.

[0011] Other aspects, features, and advantages will be apparent from the description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 is a perspective view of a compression system including a compression garment and a controller.

[0013] Figure 2 yes Figure 1 Schematic representation of the compression system, including a schematic diagram of the pneumatic circuit.

[0014] Figure 3 yes Figure 1 A schematic representation of another exemplary compression system, including a schematic diagram of a pneumatic circuit.

[0015] Figure 4 The compression garment stimulates the wearer's limbs when it is in a wrapped configuration on the leg form. Figure 1 A graphical representation of the pressure contours produced by a compression system.

[0016] Figure 5 is when the compression garment of the system is in a non-wrapped configuration and is away from the leg form to stimulate the wearer's limb. Figure 1 A graphical representation of the pressure contours produced by a compression system.

[0017] Figure 6 yes Figure 1 A graphical representation of the manifold pressure signal of the compression system corresponding to the manifold pressure signal for Figure 4 and 5 Manifold pressure signals for wrapped and unwrapped compression garment configurations.

[0018] Figure 7 is used Figure 1 Flow chart of a method for compliance monitoring of a compression system.

[0019] Figure 8 and 9 yes Figure 7 Flowchart of an exemplary implementation of a compliance monitoring method.

[0020] Fig.10 is a graphical representation of a polynomial curve fit line for the pressure in the manifold during the inflation phase of the bladder of the compression garment in both wrapped and unwrapped configurations.

[0021] Fig.11 When the compression garment is in a wrapped configuration around the wearer's limbs, Figure 1 A graphical representation of the pressure contours produced by a compression system.

[0022] Fig.12 The compression garment is in a non-wrapped configuration and away from the wearer's limbs. Figure 1 A graphical representation of the pressure contours produced by a compression system.

[0023] Fig.13 and 14 is used Figure 1 Flow chart of a method for compliance monitoring of a compression system.

[0024] Figures 15A-15C When the compression garment is in a wrapped configuration around the wearer's limbs, Figure 1 A graphical representation of another pressure contour produced by a compression system.

[0025] Fig.16 The compression garment is in a non-wrapped configuration and away from the wearer's limbs. Figure 1 A graphical representation of another pressure contour produced by a compression system.

[0026] Fig.17A and 17BWhen the compression garment is in a wrapped configuration around the wearer's limbs, Figure 1 A graphical representation of another pressure contour produced by a compression system.

[0027] Figure 18-23C is used Figure 1 Flow chart of a method for compliance monitoring of a compression system.

[0028] Fig.24 and 25 When the compression garment is in a wrapped configuration around the wearer's limbs, Figure 1 A graphical representation of another pressure contour produced by a compression system.

[0029] Corresponding reference numerals indicate corresponding parts throughout the drawings. DETAILED DESCRIPTION

[0030] As used herein, the terms "proximal" and "distal" refer to the relative positions of components, portions, etc. of a compression garment when the 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. Additionally, as used herein, the terms "wrapped" and "unwrapped" define garment conditions in which the garment is properly applied to a wearer's limb (wrapped) and in which the garment is removed from the wearer's limb (unwrapped).

[0031] Reference Figure 1-3 , the compression system 1 includes a compression garment 10 for applying sequential compression therapy to a limb of a wearer and a controller 5 having one or more processors 7 and computer executable instructions embodied on a computer readable storage medium 33, the computer executable instructions including instructions for causing the one or more processors to control the operation of the compression system 1. The compression garment 10 includes a distal inflatable bladder 13a, a middle inflatable bladder 13b, and a proximal inflatable bladder 13c. The compression garment 10 can be secured around the limb of the wearer and, in one embodiment, can be adjusted to accommodate limbs of different circumferences.

[0032] As described in further detail below, the controller 5 controls the operation of the compression system 1 so as to perform an inflation cycle in which the inflatable bladders 13a, 13b, 13c are inflated to apply pressure to the wearer's limb, thereby establishing a gradual 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. As also described in further detail below, for the 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 and 13b, and a ventilation phase for all three bladders 13a, 13b, 13c. The end-of-cycle pressure of each bladder 13a, 13b, 13c is the pressure in each bladder 13a, 13b, 13c before the initiation of the ventilation phase of the corresponding bladder 13a, 13b, 13c. As will be explained in greater detail below, the controller 5 determines, at least in part, based on the measured pressure of one or more of the inflatable bladders 13a, 13b, 13c, whether the compression garment 10 is applied to the wearer's limb (i.e., in a wrap configuration around the wearer's limb), and in some embodiments, provides an indication of the determination (e.g., by incrementing a timer, by pausing a timer, by providing an audible alarm, and / or by providing a visual indication on a graphical user interface). 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 the prescribed therapy. As also described in further detail below, the controller 5 can control the operation of the compression system 1 so as to perform an inflation cycle in which the inflatable bladders 13a, 13b, 13c are inflated so as to apply pressure to the wearer's limbs, thereby establishing a gradual pressure applied to the wearer's limbs, for example by compressing the inflatable bladders 13a, 13b, 13c of the garment 10, during one or more compression cycles.

[0033] The compression garment 10 is a thigh-length sleeve positionable around the leg of the wearer, with the distal bladder 13a around the ankle of the wearer, the middle bladder 13b around the calf of the wearer, and the proximal bladder 13c around the thigh of the wearer. It will be appreciated by those of ordinary skill in the art that the compression garment 10 may be a knee-length sleeve, a foot garment, etc., without departing from the scope of the present invention. The inflatable bladders 13a, 13b, 13c expand and contract under the influence of a fluid (e.g., air or other fluid) delivered from a pressurized fluid source 21 (e.g., a pump or compressor) in electrical communication with the controller 5. The pressurized fluid source 21 delivers the pressurized fluid (e.g., air) to the inflatable bladders 13a, 13b, 13c through a conduit 23.

[0034] Reference Figure 2 , each inflatable bladder 13a, 13b, 13c is in fluid communication with a corresponding valve 25a, 25b, 25c. A pressure sensor 27 is in communication (e.g., fluid communication) with the manifold 29 to measure a signal indicative of the pressure in the manifold 29. The fluid communication between the manifold 29 and the corresponding inflatable bladder 13a, 13b, 13c can be controlled by control of the position of the corresponding valve 25a, 25b, 25c (e.g., by activation and / or deactivation of the corresponding valve 25a, 25b, 25c). The pressure sensor 27 is in electrical communication with the controller 5 so that the controller 5 receives from the pressure sensor 27 a signal indicative of the pressure of one or more of the inflatable bladders 13a, 13b, 13c in fluid communication with the manifold 29 and / or the manifold 29 as a result of the position of the corresponding valve 25a, 25b, 25c. If only one bladder 13a, 13b or 13c is in fluid communication with the manifold 29, the signal received from the pressure sensor 27 indicates the pressure of the corresponding bladder 13a, 13b, 13c in fluid communication with the manifold 29. For example, when the valve 25a is open and the valves 25b, 25c are closed, the pressure sensor 27 provides a signal indicating the pressure in the inflatable bladder 13a. Similarly, when the valve 25b is open and the valves 25a and 25c are closed, the pressure sensor 27 provides a signal indicating the pressure in the bladder 13b. Likewise, when the valve 25c is open and the valves 25a and 25b are closed, the pressure sensor 27 provides a signal indicating the pressure in the inflatable bladder 13c. The vent valve 25d is actuatable to control the fluid communication between the manifold 29 and the vent port 15, which is vented to the ambient atmosphere. All bladders 13a, 13b, 13c can be ventilated using the vent valve 25d.

[0035] Each valve 25a, 25b, 25c is a two-way / two-position, normally open solenoid valve. Each valve 25a, 25b, 25c includes two ports and is actuable to place the inlet port in fluid communication with the bladder port in a first open position. Each valve 25a, 25b, 25c is further actuable to shut off 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 the corresponding inflatable bladder 13a, 13b, 13c.

[0036] Any of the bladders 13a, 13b, 13c can be placed in fluid communication with the pressurized fluid source 21 and the manifold 29 through the corresponding valve 25a, 25b, 25c so as to deliver the pressurized fluid to the bladder 13a, 13b, 13c. After the bladder 13a, 13b, 13c is inflated, the corresponding valve 25a, 25b, 25c can be closed so as to keep the fluid in the corresponding bladder 13a, 13b, 13c. Thus, by opening the corresponding valve 25a, 25b, 25c and closing the other valves 25a, 25b, 25c, the bladders 13a, 13b, 13c of the compression garment 10 can be inflated individually, so that only one bladder 13a, 13b, 13c associated with the opened valve 25a, 25b, 25c is in fluid communication with the pressurized fluid source 21 and the manifold 29.

[0037] The vent valve 25d is also a two-way / two-position, normally open solenoid valve. The vent valve 25d includes two ports and is actuatable to place the inlet port in fluid communication with the vent port 15 in a first position. The vent inlet port is in fluid communication with the vent port 15 in the first position. The vent valve 25d is further actuatable to shut off the fluid communication between the inlet port and the vent port 15. The inlet port of the vent valve 25d is in fluid communication with the pressurized fluid source 21 and the manifold 29. The vent port 15 of the vent valve 25d is in fluid communication with the ambient atmosphere.

[0038] It should be appreciated that the valves 25a, 25b, 25c, 25d may be of other types and have other arrangements within the compression system 1 without departing from the scope of the present disclosure. Figure 3 , the valves may be valves 35a, 35b, 35c which are three-way / two-position solenoid valves and which are actuatable to control the pressure in the bladders 13a, 13b, 13c without a vent valve.

[0039] Refer again Figure 2, the computer executable instructions embodied on the computer readable storage medium 33 include instructions that cause the one or more processors 7 to pressurize (e.g., inflate) the inflatable bladders 13a, 13b, 13c to provide a cyclic therapeutic compression pressure to the wearer's limb. For example, the computer executable instructions embodied on the computer readable storage medium 33 include instructions that cause the one or more processors 7 to control the pressurized fluid source 21 and / or valves 25a, 25b, 25c, 25d to pressurize the inflatable bladders 13a, 13b, 13c to the therapeutic compression pressure for a predetermined amount of time, thereby moving blood in the limb from the area underlying the inflatable bladders 13a, 13b, 13c. The length of time that the bladders 13a, 13b remain under the compression pressure is referred to herein as the decay phase. The decay phase is followed by a ventilation phase in which the computer executable instructions include instructions causing the one or more processors 7 to control the pressurized fluid source 21 and / or valves 25a, 25b, 25c, 25d to reduce the pressure in the inflatable bladders 13a, 13b, 13c to a lower pressure (e.g., atmospheric pressure).

[0040] The compression system 1 can determine whether the compression garment 10 is applied (i.e., wrapped) to the wearer's limb, and in certain embodiments, can provide an indication of such a determination, which can, for example, facilitate tracking the wearer's compliance with prescribed therapeutic use of the compression garment 10. The computer executable instructions embodied on 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 sensor 27 during a decompression period of a treatment cycle of the compression system 1. The computer executable instructions embodied on 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 indicative of the compression garment 10 being positioned on the wearer's limb.

[0041] In an exemplary embodiment, 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 that cause the one or more processors 7 to process a single waveform representing the pressure within one or more of the bladders 13a, 13b, 13c. It should be appreciated that the one or more processors 7 can process multiple wavelengths without departing from the scope of the present disclosure. By monitoring the pressure signal and the corresponding pressure data during the decompression period of, for example, a treatment cycle, the one or more processors 7 can detect certain characteristics on the waveform that indicate whether the compression garment 10 is properly wrapped around the wearer's limb or unwrapped from the wearer's limb. In some embodiments, during the decompression period, the pressure sensor 27 remains (or is inadvertently placed) in constant communication (e.g., fluid communication and / or mechanical communication) with one or more of the bladders 13a, 13b, 13c. Exemplary quiescent periods include non-therapeutic cycles (eg, pressure in bladders 13a, 13b, 13c is less than about 25 mmHg), a subset of an initial garment detection period, and / or a venous refill measurement period.

[0042] In which three-way / two-position valves are used Figure 3 In an exemplary operation of an embodiment, the computer executable instructions embodied on 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 specific bladders 13a, 13b, 13c so that a fluid path is established between one or more of the bladders 13a, 13b, 13c and the pressure sensor 27.

[0043] In which two-way / two-position valves are used Figure 2 In an exemplary operation of an embodiment of the present invention, the computer executable instructions embodied on 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 be ventilated. One or more of the computer executable instructions cause the one or more processors to determine whether the signal received from the pressure sensor 27 for random pressure pulses and spikes is expected to occur when the wearer moves (e.g., moves a leg, flexes a calf, coughs, sneezes, generally breathes, etc.). Due to the volume of fluid (e.g., air) retained within one or more of the bladders 13a, 13b, 13c and extending to the manifold 29 and, thus, to the pressure sensor 27, even slight movement causes the bladder to move or change shape and produce a pressure spike in the pressure signal generated by the pressure sensor 27. In contrast, for a compression garment 10 that has been removed from a wearer's limb, the pressure signal generated by the pressure sensor 27 is static and free of random noise or pressure pulses.

[0044] Now refer to Figure 4 , representative compression cycle pressure profiles are shown for a compression garment 10 in a wrap configuration around a leg model (which stimulates the wearer's leg). The leg model has a size, shape, and stiffness similar to those of a human leg. Accordingly, for the purposes of analyzing the performance of the algorithms described in this disclosure, the leg model is a suitable analog for a human wearer's leg. Unless otherwise specified, all data shown herein was collected using the leg model in an experimental scenario.

[0045] The graph shows signals from an experimental scenario in which pressure sensors are used to measure the pressure in each bladder 13a, 13b, 13c, and pressure sensor 27 is used to measure the pressure in manifold 29. As described in further detail below, using this experimental scenario, the pressure measured in each bladder 13a, 13b, 13c is compared to the pressure measured in manifold 29 by pressure sensor 27. It should be appreciated that in normal use, controller 5 receives signals from pressure sensor 27 in order to control the operation of compression system 1. Figure 4 The correspondence between the pressure measured by the pressure sensor provided in each bladder 13a, 13b, 13c and the manifold pressure measured by the pressure sensor 27 is shown.

[0046] A single compression cycle for at least one of bladders 13a, 13b, 13c includes an inflation phase, a decay phase, and a ventilation phase for bladders 13a, 13b, and an inflation phase and a ventilation phase for bladder 13c. Pressure graph 402 shows a pressure signal throughout a single therapeutic compression cycle for distal bladder 13a, pressure graph 404 shows pressure throughout a single therapeutic compression cycle for intermediate bladder 13b, pressure graph 406 shows pressure throughout a single therapeutic compression cycle for proximal bladder 13c, and pressure graph 408 shows manifold pressure measured by pressure sensor 27 during each of the aforementioned therapeutic compression cycles. Each graph 402, 404, 406 includes an initial bladder fill period that defines the inflation phase of the therapeutic compression cycle for the respective bladder 13a, 13b, 13c. Once the respective target pressures are achieved in bladders 13a, 13b, inflation is stopped and the pressure in the bladders may be maintained at or near the target pressures, which defines a decay phase of the therapeutic compression cycle for bladders 13a, 13b. Following the decay phase in the case of bladders 13a, 13b, or immediately following the inflation phase in the case of bladder 13c, the fluid in each bladder 13a, 13b, 13c is evacuated from the respective bladders during a vent phase of the therapeutic compression cycle for each bladder 13a, 13b, 13c.

[0047] At the beginning of the therapeutic compression cycle, valves 25b, 25c, and 25d are actuated to the closed position. To inflate the distal bladder 13a, pressurized fluid is delivered to the distal bladder 13a from the pressurized fluid source 21 via valve 25a and conduit 23. Once the target pressure for the distal bladder 13a is achieved, or after a period of time measured by timer 31 (after which the target pressure is expected to be achieved), valve 25a is actuated to close, retaining the pressurized fluid in the distal bladder 13a. Next, the intermediate bladder 13b is inflated by de-actuating valve 25b to the open position, allowing pressurized fluid to flow from the pressurized fluid source 21 into the intermediate bladder 13b. Once the target pressure for the intermediate bladder 13b is achieved, or after a period of time measured by timer 31 (after which the target pressure is expected to be achieved), valve 25b is actuated to close, retaining the pressurized fluid in the intermediate bladder 13b. Next, the proximal bladder 13c is inflated by de-energizing valve 25c to an open position, allowing pressurized fluid to flow into the proximal bladder 13c from the pressurized fluid source 21. Once the target pressure for the proximal bladder 13c is achieved, or after a period of time measured by the timer 31 after which the target pressure is expected to be achieved, valves 25a, 25b and 25d are also de-energized to respective open positions. The open vent valve 25d allows the fluid in each bladder 13a, 13b, 13c to vent to atmosphere.

[0048] The compression system 1 has been 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 appreciated that the bladders 13a, 13b, 13c may additionally or alternatively be inflated simultaneously or in any combination with one another. In certain embodiments, the opening and closing of the valves 25a, 25b, 25c, and 25d are timed so that only one bladder 13a, 13b, 13c is in fluid communication with the pressure sensor 27 and the manifold 29 at a time. This facilitates, for example, using the pressure sensor 27 to measure a signal indicative of each pressure of each bladder 13a, 13b, 13c.

[0049] The computer executable instructions embodied on 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 the treatment compression cycle. When the distal bladder 13a is inflated, the one or more processors 7 receive a signal from the pressure sensor 27 indicating the pressure in the manifold 29, the signal representing the pressure in the distal bladder 13a. In this manner, the pressure is measured throughout the inflation phase of the distal bladder 13a, including the end of the inflation pressure just before the valve 25a is closed. When the intermediate bladder 13b is inflated, the one or more processors receive a signal from the pressure sensor 27 indicating the pressure in the manifold 29, the signal representing the pressure in the intermediate bladder 13b. The pressure is measured throughout the inflation phase of the intermediate bladder 13b, including the end of the inflation phase just before the valve 25b is closed. As the proximal bladder 13c inflates, the one or more processors 7 receive a signal from the pressure sensor 27 indicative of the pressure in the manifold 29, the signal representing the pressure in the proximal bladder 13c. The pressure is measured throughout the inflation phase of the proximal bladder 13c, including the end of inflation pressure.

[0050] The computer executable instructions include causing the one or more processors 7 to determine an end-of-cycle pressure in each bladder 13a, 13b, 13c. As used herein, the end-of-cycle pressure is the pressure in each respective bladder 13a, 13b, 13c prior to the ventilation phase. Thus, for bladders 13a, 13b, the end-of-cycle pressure for each bladder 13a, 13b is the pressure in each bladder 13a, 13b at the end of the respective decay phase of the therapeutic compression cycle of each bladder 13a, 13b. For bladder 13c, the end-of-cycle pressure is the pressure in bladder 13c at the end of the inflation phase of bladder 13c.

[0051] To measure the end-of-cycle pressure, after the proximal bladder 13c is inflated to its target pressure, the valves 25a, 25b, 25c are sequentially switched open and closed to measure the end-of-cycle pressure ( Figure 4 ). Because valve 25c is open due to the recent inflation of proximal bladder 13c, the end-of-cycle pressure for proximal bladder 13c is measured first. Figure 6, it is understood that the inflation end pressure and cycle end pressure for the proximal bladder 13c are the same as the pressure profile in the figure because the proximal bladder does not experience a decay phase. At the end of the compression cycle of the proximal bladder 13c, the valve 25c can be switched off and then switched back on. The one or more processors 7 switch open valve 25a and close valve 25c to measure the cycle end pressure for the distal bladder 13a. The one or more processors 7 switch open valve 25b and close valve 25a to measure the cycle end pressure for the intermediate bladder 13b. Although a specific switching sequence of valves 25a, 25b, 25c is described, it should be appreciated that other switching sequences of valves 25a, 25b, 25c are within the scope of the present disclosure. In one embodiment, each valve 25a, 25b, 25c is switched open within approximately 15 milliseconds (ms) to measure the cycle end pressure in the corresponding bladder 13a, 13b, 13c. The valves 25a, 25b, 25c may be switched open in a shorter or longer period of time. For example, the valves 25a, 25b, 25c may be switched open in at least about 75 ms. Other time periods are also contemplated. The pressure readings measured by the pressure sensor 27 are stored in the memory 33. During operation, the compression cycle is repeated multiple times in succession to complete the compression process.

[0052] The computer executable instructions may include instructions causing the one or more processors 7 to determine a corresponding line fit using the inflation end pressure and the cycle end pressure for at least one of the bladders 13a, 13b. Using the two pressure points, a line is generated that represents the decay phase. The values ​​of this representative line are compared to the inflation end pressure for the bladders 13b, 13c to determine whether the pressure of the subsequently inflated bladder 13b, 13c has potentially risen above the pressure of the previously inflated bladder 13a, 13b at any point during the compression cycle.

[0053] Reference Figure 5 , illustrates a representative compression cycle pressure profile for a non-wound configuration of the compression system 1. The compression system 1 produces Figure 5 The pressure profile operation is the same as above for Figure 4 The operation described by the compression cycle pressure profile is the same. The only difference is that Figure 5 The pressure signals in are taken when the compression garment 10 is in an unwrap configuration. Pressure graphs 502, 504, 506 show the actual pressures of the distal bladder 13a, the middle bladder 13b, and the proximal bladder 13c throughout a single compression cycle when the garment 10 is in an unwrap configuration. Figure 5 Also shown in FIG. 50 is a pressure signal from pressure sensor 27 as pressure graph 508 , which represents the pressure in manifold 29 during a therapy compression cycle.

[0054] Reference Figure 6 , together plotting the pressure signals detected by the pressure sensor 27 for representative compression cycle pressure profiles for both the wound and unwound configurations. As will be explained in more detail below, there are characteristics in the representative compression cycle pressure profiles that distinguish between the wound and unwound configurations. For example, referring to Figure 5 , there is a period of time (e.g., around 6436 ms) when the pressure of the intermediate bladder 13b (504) exceeds the pressure of the distal bladder 13a (502). Additionally, the pressure in the bladders 13a, 13b, 13c before the bladders are inflated (i.e., the initial pressure bias at time = 0) is slightly higher in the non-wrapped configuration. The bias is a result of more trapped air being in the bladders 13a, 13b, 13c when the garment 10 is removed from the limb. Applicants believe that this is because the non-wrapped sleeve is less constrained, thereby applying less evacuation force to expel the trapped air (i.e., the sleeve is able to remain "bulked" and thus appear as if it has less volume). Without wishing to be bound by theory, it is believed that this bias stems from the non-wrapped compression garment 10 being less constrained, resulting in less evacuation force being applied to expel the trapped air. Additionally, the inflation end pressure for bladders 13a and 13b in the non-wrap configuration is slightly higher than the inflation end pressure for bladders 13a and 13b in the wrapped configuration. The reverse condition holds true for the proximal bladder 13c, where the inflation end pressure for the wrapped configuration is slightly higher than the inflation end pressure for the non-wrap configuration. Another distinguishing feature is that there is less difference between the inflation end pressures in the distal and intermediate bladders 13a, 13b for the non-wrap configuration than for the wrapped configuration.

[0055] The computer executable instructions embodied on 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 configuration and the non-wrapped configuration. In an embodiment, the pressure signal from the inflation phase of the distal bladder 13a in the wrapped configuration is modeled by a best fit line. For example, the model is a best fit line generated by a simple linear regression.

[0056] Analysis of the pressure signal data using the best fit line can provide an indication of whether bladder 13a is in a conforming wrapped configuration or a non-conforming unwrapped configuration when compression therapy is being applied. The difference between the best fit line and the observed pressure signal can be mathematically quantified as a mean square error (MSE) value. In this example, the MSE value is an indicator of the degree of curvature of the pressure trend observed over a given interval (such as the inflation of the bladders of compression garment 10). Thus, a larger MSE value indicates that the curve fit data has a larger curvature, and a lower MSE value indicates that the curve fit data has a smaller curvature. In an embodiment, the curve fit data for the wrapped configuration is quantified as a mean square error (MSE) value. Figure 1The MSE values ​​for the curve fit line for the graph for the wrapped configuration are generally straighter than for the graph for the unwrapped configuration (i.e., more closely follow the corresponding best fit line). Mathematically, this translates into a smaller MSE value for the curve fit line for the graph for the wrapped configuration. In an embodiment, an MSE value below a predetermined number indicates that the bladder is in the wrapped configuration, while an MSE value greater than or equal to the predetermined number indicates that the bladder is in the unwrapped configuration. It is contemplated that other factors may provide an indication of the configuration of the bladder.

[0057] Reference Figure 7-9 , computer executable instructions embodied on the computer readable storage medium 33 cause the one or more processors 7 to perform a method 740 of determining whether the compression garment 10 is in a wrapped configuration or an unwrapped configuration when applying compression therapy. Figure 7 The steps set forth in the foregoing generally describe at a high level a method of determining whether the compression garment 10 is in a wrapped configuration or a non-wrapped configuration, and Figure 8 and 9 The method is described in more detail. In describing the compliance method performed by the one or more processors 7 reference will be made to all three figures.

[0058] Reference Figure 7 and 8 At the beginning of the compliance determination method 740, the compression system 1 is operated to inflate and deflate the bladders 13a, 13b, 13c sequentially so as to apply compression treatment to the wearer's limbs. The treatment is preferably made according to a predetermined compression treatment course, which includes, among other things, a prescription period in which the patient should receive the treatment. The compliance of the patient with the prescription treatment period is monitored. The compression system 1 is operated in several or more cycles as needed to allow the system to be placed in a stable state and to collect stable state data before the compliance determination begins. However, a compliance timer or counter can be started before the beginning of the compliance determination. Thus, at the beginning of the compliance determination method 740, the compression garment 10 is in a winding configuration and operates under normal (stable state) operating conditions. The system operates at step 750 under default conditions, wherein the one or more processors 7 instruct the pressure sensor 27 to measure the pressure in the manifold 29 throughout the compression cycle. Pressure data is discarded over time and replaced by new, more recent pressure data when it becomes available. The one or more processors 7 check at 760 for the occurrence of a trigger suggesting that the compression garment 10 may have been unwound.

[0059] In general, a trigger may occur when a measured result differs from an expected result, where the expected result is based on recent adjustment history and (multiple) steady state control errors. The trigger may include, for example, but is not limited to, one or more of the following: a change in cycle end pressure from a previous compression cycle(s) for at least one of the bladders 13a, 13b, 13c; a change in inflation end pressure from a previous compression cycle(s) for at least one of the bladders 13a, 13b, 13c; an adjustment of the pump 21 caused by said pressure (e.g., an error in the target measurement result); a change in curvature coefficient from a previous inflation phase(s) for at least one of the bladders 13a, 13b, 13c; a change in inflation phase slope from a previous compression cycle(s) for at least one of the bladders 13a, 13b, 13c; a change in the slope of the inflation phase(s) for the previous compression cycle(s) for at least one of the bladders 13a, 13b, 13c; a change in the pressure at the end of the operating cycle; a change in the measured pressure of one or more of the bladders at the bundle, a change in the slope of the measured pressure during the ventilation phase, a change in the initial bias of the measured pressure from zero from (multiple) previous compression cycles; the pressure in one of the inflatable bladders 13b, 13c having a lower target pressure exceeds the pressure in the other of the inflatable bladders 13a, 13b having a higher target pressure, a small difference in peak pressure between bladders 13a and 13b, a change in the amplitude of adjustments made to the operation of pump 21, a statistically significant change in the pressure waveform, and any unintentional disturbance in the measured pressure or unintentional adjustments made by compression system 1.

[0060] Reference Figure 8 , the compression system 1 continues normal operation (step 762) until a triggering occurrence is detected. If a triggering occurrence is detected, it is determined at 764 whether the occurrence exceeds a predetermined condition, such as, for example, an expected error for steady-state operation. Additionally or alternatively, a pressure change / disturbance that produces a control system response that is three times greater than the control system response of an expected change / disturbance can serve as a predetermined condition. The "expected change / disturbance" can be a preset, or can be a criterion established by the controller 5 through the operation of the controller in a steady state for a period of time. Additionally or alternatively, an adjustment to the pump 21 can serve as a predetermined condition, the adjustment being greater than a predetermined threshold compared to the most recent adjustment. For example, a trigger can occur when a new adjustment of the pump 21 is greater than 100% of the previous adjustment. If it is determined that the triggering occurrence does not exceed a predetermined threshold or meet the criterion, the compression system 1 continues 762 to operate normally.

[0061] Reference Figure 7 and 8, if it is determined that the triggering occurrence is valid for use in confirming that a change in the condition of the compression garment 10 from entanglement to non-entanglement has occurred, data collection begins at 770. The one or more processors 7 activate the compression cycle of "sleeve removal" at 772 for counting the number of compression cycles of "sleeve removal", and collect data within the compression cycle to confirm that the triggering occurrence is an indication that the garment 10 has become non-entangled. The number of compression cycles of "sleeve removal" is counted at 774 until a sufficient amount of data (i.e., pressure signal) is obtained. The number of compression cycles of "sleeve removal" required to obtain a sufficient amount of data to determine whether the garment 10 is in a non-entangled configuration may be different in different situations. In one embodiment, the number of compression cycles of "sleeve removal" is between about 10 and about 20 compression cycles. Generally, it is determined that a sufficient amount of data is obtained when the pressure signal reaches a stable state again after the initial triggering occurs. The memory 33 stores data associated with the cycle of "sleeve removal" separately from reference data obtained during normal operation of the system 1. Once sufficient data is obtained at 776, the one or more processors 7 retrieve data obtained during normal operation of the system 1 at step 778. After the pressure signal reaches a steady state, the one or more processors 7 analyze the "cuff removed" data at 780 to determine a bladder pressure value for comparison with data obtained when the compression system 1 is operating in normal conditions.

[0062] The one or more processors 7 determine whether the garment 10 is in a tangled or untangled condition by comparing the "sleeve removed" data with the normal operating condition reference data at step 790. If the one or more processors 7 determine at 792 that the garment 10 has not been removed and is still in a tangled configuration, the compression system 1 continues to operate normally. If it is determined at 794 that the garment 10 has been removed, placing the garment in an untangled configuration, the one or more processors 7 modify the record of the monitored parameters. Comparing the "cuff removed" data with the normal operating condition data at step 790 may include, but is not limited to, one or more of the following: comparing the end-of-cycle pressure from the "cuff removed" data with the end-of-cycle pressure from the normal operating condition data for at least one of the bladders 13a, 13b, 13c; comparing the end-of-inflation pressure from the "cuff removed" data with the end-of-inflation pressure from the normal operating condition data for at least one of the bladders 13a, 13b, 13c; comparing the curvature coefficient of the curve fit on the "cuff removed" data with the curvature coefficient of the curve fit on the normal operating condition data; comparing the inflation phase slope from the "cuff removed" data with the inflation phase slope from the normal operating condition data for at least one of the bladders 13a, 13b, 13c; comparing the initial offset of the measured pressure from zero on the "cuff removed" data with the initial offset of the measured pressure from zero on the "cuff removed" data; an initial biasing of the measured pressure from zero from the normal operating condition data; comparing the ventilation phase slope of the “sleeve removed” data with the ventilation phase slope from the normal operating condition data for at least one of the bladders 13a, 13b, 13c; comparing the measured pressures to determine whether an inflatable bladder with a lower target pressure has a higher measured pressure than an inflatable bladder with a higher target pressure; comparing the difference in the peak pressures of the inflatable bladders 13a, 13b from the “sleeve removed” data with the difference in the peak pressures of the bladders 13a, 13b in the normal operating condition data to obtain a reduction in the difference; comparing the magnitude of adjustments to the operation of the pump 21 in the “sleeve removed” data with the magnitude of adjustments made in the normal operating data; 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, 13c is an indication that the garment 10 is in a tangled configuration. Comparison step 790 is a confirmatory analysis to confirm that the triggering occurred as an indication that the garment is in a non-tangled configuration.

[0063] If the data 790 indicates a statistically significant change in pressure for any of the data comparisons and for any of the bladders 13a, 13b, 13c, the one or more processors 7 indicate that the garment 10 is in a non-entangled configuration and is no longer used in a conforming manner. Additionally or alternatively, the one or more processors 7 require confirmation from at least two of the bladders 13a, 13b, 13c of a statistically significant change in pressure for at least one of the data comparisons. Additionally or alternatively, the one or more processors 7 require confirmation from all of the bladders 13a, 13b, 13c of a statistically significant change in pressure for any of the data comparisons. Additionally or alternatively, the one or more processors 7 require confirmation of a statistically significant change in pressure for at least two of the data comparisons.

[0064] In response to confirmation of the pressure change, the one or more processors 7 at step 794 alter the record of the monitored parameter by at least one of: stopping the compliance meter so that no further compression cycles are indicated as being in compliance with the compression therapy session (e.g., the compliance counter stops incrementing), providing an alarm indication to alert the wearer or clinician of the non-compliance, stopping operation of the compression system 1, and storing the result of the comparison in the memory 33 (e.g., a flag).

[0065] Optionally, refer to Fig. 9After determining by the one or more processors 7 that the garment 10 is in a non-compliant non-wrapped configuration, the method 740 of determining whether the compression garment 10 is in a wrapped configuration or a non-wrapped configuration continues by collecting additional "cuff removal" data at step 902. The one or more processors 7 analyze and compare the additional "cuff removal" data with the normal operating condition data at 904. If the data comparison at 904 indicates that the additional "cuff removal" data matches or nearly matches the normal operating condition data for any of the bladders 13a, 13b, 13c, the one or more processors 7 determine at 906 that the garment 10 has been returned to the wrapped configuration and is again being used in a compliant manner. In response, the one or more processors 7 modify the record of the monitored parameters by at least one of: resuming operation of the compression system 1, resuming compliance instrumentation so that subsequent compression cycles are indicated as compliant, providing a message to alert the wearer or clinician of compliance, and storing the results of the comparison in the memory 33. The one or more processors 7 continue to collect additional "cuff removed" data at 902 until, if the data comparison at 904 indicates a statistically significant change in pressure for any of the data comparisons, the one or more processors 7 determine that the pressure signal (such as, the measurements described above) matches or nearly matches the normal operating condition pressure signal.

[0066] If you can Figure 4 and 5 It can be seen that the pressure measurement produced by pressure sensor 27 is slightly higher than the actual pressure within bladders 13a, 13b, 13c. For the purpose of determining compliance using the pressure sensor signal, the difference in pressure is negligible. Alternatively, the pressure measured by pressure sensor 27 is normalized to the actual pressure in the bladders in fluid communication with manifold 29 by briefly deactivating fluid source 21.

[0067] Additionally or alternatively, the linear regression for the inflation phase of the bladders 13a, 13b, 13c may be further analyzed for comparison between the entangled and unentangled conditions. For example, standard deviations, P values, maximum and minimum values, and average values ​​may be calculated and compared between the entangled and unentangled conditions to further distinguish between the two conditions. Advanced statistics associated with regression analysis (e.g., the curve fitting analysis described herein) for distinguishing between sleeve donning and sleeve donning conditions (such as analysis of residual volume) are also within the scope of the present disclosure.

[0068] Although the curve fit for the inflation phase of the bladders 13a, 13b, 13c has been described as a best fit line, the model may be a polynomial curve fit. Fig.10, the pressure signal from the inflation phase of the bladder 13a is modeled in the wrapped configuration (1002) and the unwrapped configuration (1004) using a fifth order polynomial curve fit. The fifth order polynomial curve fit accurately represents the more dynamic curvature of the inflation phase without overly responding to changes in the pressure signal. Other order polynomial curve fits are also contemplated. As an example, a lower order can be used, such as when the curvature is less dynamic and a higher order is not required.

[0069] The polynomial curve fit during the inflation phase of the bladders 13a, 13b, 13c in the wrapped configuration is generally straighter (i.e., more linear) than the polynomial curve fit for the inflation phase of the bladders 13a, 13b, 13c in the wrapped configuration. Additionally, for the distal and intermediate bladders 13a, 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 reverse condition is established for the proximal bladder 13c, wherein 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 bias for bladders 13a and 13b in the non-wrapped configuration is higher than the starting pressure for bladders 13a and 13b in the wrapped configuration. By identifying the occurrence of these different characteristics, the compression system 1 can determine when the garment 10 is in a conforming wrapped configuration and when the garment 10 is in a non-conforming non-wrapped configuration.

[0070] Additionally or alternatively, the polynomial curve fit for the inflation phase of the bladders 13a, 13b, 13c may be further analyzed for comparison between the entangled and unentangled conditions. For example, standard deviations, P values, maximum and minimum values, and average values ​​may be calculated and compared between the entangled and unentangled conditions to further distinguish between the two conditions. Advanced statistics associated with regression analysis (e.g., the curve fitting analysis described herein) for distinguishing between the sleeve donning and sleeve donning conditions (such as analysis of residual volume) are also within the scope of the present disclosure.

[0071] Reference Fig.11 , illustrates a representative compression cycle pressure profile for a wrapped configuration of compression garment 10. The graph illustrates the signal from pressure sensor 27. A single compression cycle for all three bladders 13a, 13b, 13c in a wrapped configuration of compression garment 10 includes a compression period 1102 and a decompression period 1104. Fig.12, illustrates a representative compression cycle pressure profile for a non-wrapped configuration of the compression garment 10. The compression period 1202 and the decompression period 1204 illustrate a single compression cycle for all three bladders 13a, 13b, 13c for the non-wrapped configuration of the compression garment 10. The computer executable instructions embodied on the computer readable storage medium 33 include instructions that cause the one or more processors 7 to monitor a signal from the pressure sensor 27 that indicates the bladder pressure during the decompression periods 1104, 1204. The computer executable instructions cause the one or more processors 7 to monitor the difference between the pressure signal for the decompression period 1104 and the pressure signal for the decompression period 1204. For example, the pressure signal during the decompression period 1104 includes a difference between the pressure signal for the decompression period 1104 and the pressure signal for the decompression period 1204. Fig.11 1106, which the controller 5 interprets as indicating that the wearer is moving when the compression garment 10 is in the wrapped configuration. The pressure signal during the decompression period 1204 is relatively static (i.e., no pulses are present), which the controller 5 interprets as indicating that the compression garment 10 is in the unwrapped configuration. By analyzing the pressure signals of the decompression periods 1104, 1204, the computer executable instructions cause the one or more processors 7 to determine whether the compression garment 10 is in the wrapped configuration or the unwrapped configuration based on the presence (i.e., occurrence) or absence (i.e., non-occurrence) of one or more pressure pulses 1106 during the decompression periods 1104, 1204.

[0072] Refer again Fig.11 In another embodiment of the compression system 1, the bladder pressure of the bladders 13a, 13b, 13c is locked, and when the compression garment 10 is in a wrap configuration substantially around a limb of the wearer, the computer executable instructions cause the one or more processors 7 to detect a rise (e.g., increase) in the pressure signal during the decompression period 1104. The pressure signal during the decompression period 1204 ( Fig.12 ) is relatively static (i.e., no pressure rise exists), the controller 5 interprets the pressure signal as indicating that the compression garment 10 is in the unwrapped configuration. The computer executable instructions cause the one or more processors 7 to determine whether the compression garment 10 is in the wrapped configuration or the unwrapped configuration based on the presence (i.e., occurrence) or absence (i.e., non-occurrence) of the pressure rise during the decompression period 1104, 1204.

[0073] Reference Fig.13, computer executable instructions embodied on the computer readable storage medium 33 cause the one or more processors 7 to perform the following method 1300: determine whether the compression garment is in a wrapped or unwrapped configuration by detecting one or more pressure pulses in the pressure signal received from the pressure sensor 27. The compression system 1 operates at step 1302 to inflate and deflate the bladders 13a, 13b, 13c to apply compression treatment to the wearer's limbs, and ventilate the bladders 13a, 13b, 13c downward to a target value, such as 1-2 mmHg. The computer executable instructions cause the one or more processors 7 to determine at step 1304 whether the pressure in the bladders 13a, 13b, 13c has reached the target value. If the target value has not been reached, the computer executable instructions cause the one or more processors 7 to continue to ventilate the bladders 13a, 13b, 13c, and the process returns to step 1304. If the target value has been 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 pulses during the decompression period at step 1306. It is appreciated that the filtered signal may be employed so that any pulse observed will be above the baseline signal noise without departing from the scope of the present disclosure. The signal may be filtered, for example, by a filtering circuit in the controller 5 and / or by a digital filtering technique implemented by the one or more processors 7 via computer executable instructions. It is appreciated that the computer executable instructions may cause the one or more processors 7 to perform waveform peak detection in order to determine the amplitude of the abnormal peak against the peak within the expected noise without departing from the scope of the present disclosure. It is also appreciated that the computer executable instructions may cause the one or more processors 7 to limit the detection using a signal threshold without departing from the scope of the present disclosure. For example, if a pulse greater than 1 mmHg above the noise is detected, then the pulse is considered a pressure pulse. The computer executable instructions cause the one or more processors 7 to implement a counter with which a count is kept for the number of consecutive cycles in which no pulses are observed.

[0074] At step 1308, the computer executable instructions cause the one or more processors 7 to determine whether a pulse is detected by the processor 7 at step 1306. If a pulse is detected during step 1306, the computer executable instructions cause the one or more processors 7 to reset 1310 the counter to zero, because the pulse indicates that the compression garment 10 is in a wrap configuration substantially around the wearer's limb. If a pulse is not detected during step 1306, then this non-occurrence (i.e., absence) of the pulse 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 1312 whether the count of the counter has reached or exceeded a counter threshold. For example, the threshold may be ten consecutive cycles, but those skilled in the art will appreciate that the threshold may be any integer value. Reaching or exceeding the threshold indicates that the compression garment 10 is in a non-wrapped configuration away from the wearer's limb, because if the compression garment 10 is in a wrap configuration, a pressure anomaly (e.g., a pressure pulse) will be detected by the one or more processors 7.

[0075] If the one or more processors 7 determine at step 1312 that the count of the counter has reached or exceeded the counter threshold, the computer executable instructions cause the one or more processors to take the required action at step 1314. For example, the one or more processors 7 may stop the operation, stop the compliance timer, alert the user (e.g., the wearer or caregiver), etc. If the one or more processors 7 determine at step 1312 that the count of the counter has not reached the counter threshold, the computer executable instructions cause the one or more processors 7 to increment the count of the counter and fully ventilate the bladder 13a, 13b, 13c at step 1316, and the process returns to step 1302.

[0076] In an alternative embodiment, Figure 6 The method 1300 is implemented during a venous refill measurement. In such an embodiment, the bladder 13b is vented to a higher pressure (e.g., 5-7 mmHg) and is therefore in more stable contact with the wearer's limb. In this embodiment, pressure pulses due to patient movement are even more evident in the pressure signal of the pressure sensor 27.

[0077] Reference Fig.14, computer executable instructions embodied on the computer readable storage medium 33 cause the one or more processors 7 to perform the following method 1400: determine whether the compression garment is in a wrapped or unwrapped configuration by detecting a rise (e.g., increase) in the pressure signal received from the pressure sensor 27. The compression system 1 operates at step 1402 to inflate and deflate the bladders 13a, 13b, 13c to apply compression treatment to the wearer's limb, and vent the bladders 13a, 13b, 13c downward to a target value, such as 1-2 mmHg. The computer executable instructions cause the one or more processors 7 to determine at step 1404 whether the pressure in the bladders 13a, 13b, 13c has reached the target value. If the target value has not been reached, the computer executable instructions cause the one or more processors 7 to continue venting the bladders 13a, 13b, 13c and the process returns to step 1404. If the target value has been reached, the computer executable instructions cause the one or more processors 7 to stop ventilating the bladders 13a, 13b, 13c during the decompression period at step 1406 and monitor the pressure signal from the pressure sensor 27 for a rise. In an embodiment, a filtered signal is used so that any rise observed will be above the baseline signal noise. The signal can be filtered, for example, by a filter circuit in the controller 5 and / or by a digital filtering technique implemented by the one or more processors 7 via computer executable instructions. The one or more processors 7 monitor the pressure signal to obtain a pressure rise greater than a threshold value (e.g., 1-2 mmHg), which indicates that the compression garment 10 is in a wrapping configuration substantially around the wearer's limbs. The lack of a rise in the pressure signal or a rise less than the threshold indicates that the compression garment 10 is in a non-wrapped configuration away from the wearer's limbs. The computer executable instructions cause the one or more processors 7 to implement a counter, which is used to keep a count for each cycle in which the threshold pressure rise is not achieved.

[0078] At step 1408, the computer executable instructions cause the one or more processors 7 to determine at step 1406 whether a pressure rise greater than a threshold is detected by the processor 7. If a pressure rise greater than a threshold is detected during step 1406, the computer executable instructions cause the one or more processors 7 to reset 1410 a counter to zero, because the pressure rise indicates that the compression garment 10 is in a wrap configuration substantially around the wearer's limb. If a rise above the threshold is not detected at step 1406, then this absence of 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 1412 whether the count of the counter has reached or exceeded a counter threshold. For example, the threshold may be ten consecutive cycles, but those skilled in the art will appreciate that the threshold may be any integer value. Reaching or exceeding the threshold indicates that the compression garment 10 is in a non-wrapped configuration away from the wearer's limb, because if the compression garment 10 is in a wrap configuration, a pressure anomaly (e.g., a pressure rise) will be detected by the one or more processors 7.

[0079] If the one or more processors 7 determine at step 1412 that the count of the counter has reached or exceeded the counter threshold, the computer executable instructions cause the one or more processors to take the required action at step 1414. For example, the one or more processors 7 may stop the operation, stop the compliance timer, alert the user (e.g., the wearer or caregiver), etc. If the one or more processors 7 determine at step 1412 that the count of the counter has not reached or exceeded the threshold, the computer executable instructions cause the one or more processors 7 to increment the count of the counter and fully ventilate the bladder 13a, 13b, 13c at step 1416, and the process returns to step 1402.

[0080] In an alternative embodiment, the actual shape of the pressure profile of the signal generated by the pressure sensor 27 is itself a potential indicator. For example, the shape of the profile can be calculated such that when the resulting function (i.e., shape) matches a predetermined function (i.e., shape), the computer executable instructions cause the one or more processors 7 to determine that the compression garment 10 is in a wrapped configuration. Conversely, a failure of the resulting function to match the predetermined function will result in the computer executable instructions causing the one or more processors 7 to determine that the compression garment 10 is in a non-wrapped configuration. Such an embodiment can be used with the counters described in conjunction with the methods 1300, 1400 described above.

[0081] Reference Fig.15A, a pressure signal from a pressure sensor 27 is shown for one of the bladders 13a, 13b, 13c in a wrapped configuration of the compression garment 10 on a wearer's limb during a representative bladder inflation period 1502 and a pressure hold period 1504. Fig.15A In the example of FIG. 1 , the pressure hold period 1504 is approximately 27 seconds in duration and represents the bladders 13a, 13b, 13c inflated to approximately 45 mmHg, which is a typical inflation threshold for a treatment cycle of the bladders 13a, 13b, 13c. According to another embodiment of the present disclosure, the pressure hold period 1504 may be approximately 20 seconds in duration and represent one of the bladders 13a, 13b, 13c inflated to approximately 200 mmHg. Accordingly, the amplitude of oscillations in the pressure signal for a bladder inflated to approximately 200 mmHg will be higher than the amplitude of oscillations associated with a bladder inflated to approximately 45 mmHg as illustrated herein.

[0082] Reference Fig. 15B , waveform 1504' shows the result of a bandpass filtering technique applied to a subset of signals of interest during the pressure hold period 1504 such that a frequency range (e.g., 0.5 Hz to 25 Hz, 0.5 Hz to 5 Hz, etc.) has been extracted. Fig.15A In contrast, a representative subset portion of pressure hold period 1504 is shown at a smaller scale so that pulses are visible in the pressure signal during pressure hold period 1504'. Fig. 15B The pulses in the pressure pulses in the compression garment 10 are associated with the pressure effects produced by the wearer's pulse on the bladder 13a, 13b, or 13c. The waveform pulsation associated with the pulse of the wearer of the compression garment 10 remains apparent in the waveform 1504'. The computer executable instructions embodied on the non-transitory computer readable storage medium 33 include instructions to cause the one or more processors 7 to receive a signal from the pressure sensor 27, the received signal indicating the fluid pressure in one or more of the bladders 13a, 13b, 13c during the bladder inflation period 1502 and the pressure maintenance period 1504.

[0083] In some embodiments, the computer executable instructions also include instructions causing the one or more processors 7 to further refine the signal from the pressure sensor 27 to extract only frequencies associated with a typical cardiac cycle range of a human during the pressure hold period 1504. For example, the computer executable instructions may include causing the one or more processors 7 to extract frequencies in the range of 0.5 Hz to 25 Hz (e.g., by bandpass filtering techniques).

[0084] Fig. 15BIt is shown that when the oscillation amplitude is reduced, the effect of noise on the signal is more significant (i.e., the signal-to-noise ratio is smaller). Additional pre-processing and / or post-processing of the data can help obtain less distorted results. In some embodiments, the computer executable instructions also include instructions that cause the one or more processors 7 to filter the signal of the pressure holding period 1504 to remove frequencies that are not associated with the pulse of the human wearer and cause the one or more processors 7 to implement one or more peak detection algorithms and / or compliance monitoring algorithms. In certain embodiments, the one or more computer executable instructions also include instructions that cause the one or more processors 7 to perform additional pre-processors and / or post-processing to reduce the effect of noise on the signal received from the pressure sensor 27. It should be appreciated 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 but not associated with the wearer's actual heart rate. For example, when the wearer's heart beats, blood flow creates pressure on at least one of the inflatable bladders 13a, 13b, 13c, and the pressure sensor 27 detects the pressure and generates a pressure signal representing it.

[0085] Reference Fig. 15C , waveform 1504' is superimposed on waveform 1504', which is the result of a smoothing algorithm filtering technique applied to waveform 1504' by the one or more processors 7. Fig. 15C In this exemplary embodiment of FIG. 1 , the smoothing closely follows the rectangular window with five times (e.g., 5x) 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 still provides evidence of pulsation indicating adequate contact between the wearer and the compression garment 10.

[0086] Fig.16 The pressure signal received from the pressure sensor 27 during a representative bladder pressure hold period 1602 pressure profile for one of the bladders 13a, 13b, 13c is shown for the unwrapped configuration of the compression garment 10. The overall amplitude of the pressure profile 1602 is less than that of the similar pressure hold period 1504 (during the Fig.15A The absence of clean, repetitive pulses in pressure profile 1602 is an indication that compression garment 10 is in an unwrapped configuration or is not being worn properly by the wearer.

[0087] Fig.17AA representative bladder pressure profile for one of bladders 13a, 13b, 13c and a pressure signal received from pressure signal 27 are shown. The pressure profile includes a therapy cycle period 1702, a bladder ventilation period 1704, a bladder test inflation period 1706, and a bladder pressure hold period 1708. At the end of therapy cycle 1702, the bladder under test (e.g., one of bladders 13a, 13b, 13c) is vented during bladder ventilation period 1704. Following bladder ventilation period 1704, a short inflation is applied to the bladder under test during bladder inflation period 1706 until the bladder under test achieves a pressure of approximately 30 mmHg. The one or more processors 7 execute computer executable instructions such that pulse detection as further described below is performed by the one or more processors 7 during the bladder pressure hold period 1708, which in this exemplary embodiment is approximately 10 seconds. The bladder pressure hold period 178 may be a longer or shorter duration, assuming the duration is long enough to ensure that multiple pulses occur within the duration.

[0088] Fig. 17B A waveform 1708' is illustrated which indicates the result of the filtering technique applied to the signal of interest during the pressure hold period 1708. In some embodiments, the computer executable instructions include instructions that cause the one or more processors 7 to detect a dominant peak and check that the waveform falls within an expected range (e.g., 60-100 beats per minute (bpm) for a human wearer). In some embodiments, the expected range for a human wearer is 60-100 beats per minute (bpm). However, it should be appreciated that a wider range (e.g., 30-120 bpm) may be used in order to account for wearers who may be ill and / or to account for locations on the body that may occur far from the heart (e.g., calves). In this exemplary embodiment, the one or more processors 7 detect pulsations that are associated with the wearer's heartbeat but not with the wearer's actual heart rate.

[0089] Fig.18 18 is a schematic representation of an exemplary method 1800 of analyzing waveform data received from a pressure sensor 27 to detect whether a compression garment 10 is in a wrapped or unwrapped configuration around a limb of a wearer of the garment by detecting pulsations associated with the wearer's heartbeat. The exemplary method may be implemented by the one or more processors 7 through execution of computer executable instructions embodied on a non-transitory computer readable storage medium 33.

[0090] The one or more processors 7 execute computer executable instructions to sample the initial pressure 1802. In some embodiments, the initial pressure sampling is done at a rate of 100 Hz or higher, and typical signal conditioning is used to remove baseline noise. Additionally or alternatively, the sampling 1802 can be extended to include attenuation of frequencies just below a low cutoff value (e.g., 0.25 Hz).

[0091] Post-processing waveform analysis 1804 further includes bandpass filtering 1806, additional filtering 1808, and peak detection 1810. During bandpass filtering 1806, the signal of interest is filtered using bandpass filtering techniques in a typical frequency range associated with a typical heart rate range for a human wearer (e.g., 0.5-4 Hz for a human wearer).

[0092] During additional filtering 1808, the peaks of the bandpass filtered signal are further refined. The additional filtering may include low pass filtering with a cutoff value of 5 Hz to produce filtered values. Additionally or alternatively, the additional filtering may include a smoothing algorithm using the five most recent samples of the moving range to produce filtered values. It should be appreciated that more than one filtering technique may be applied to the bandpass filtered signal during the additional filtering step 1808.

[0093] During peak detection 1810, peak detection is performed to check that the peak of the filtered signal corresponds to the heartbeat range of a typical human wearer. Peak detection 1810 can be based on a predetermined threshold (e.g., only looking at peaks with an amplitude greater than 0.05 mmHg). Additionally or alternatively, peak detection 1810 can be based on checking for repetitive signals with frequencies within the heartbeat range of a typical human wearer, regardless of amplitude (e.g., extending to 30-240 bpm to get a margin). For example, a frequency analysis calculation can be performed to check that repetitive signals with frequencies within the heartbeat range of a typical human wearer are detected. Additionally or alternatively, peak detection 1810 can be based on the highest amplitude peaks and checking that the frequencies of those peaks fall within the expected heartbeat range of a typical human wearer. It should be appreciated that more than one peak detection technique can be used during peak detection 1810. In some embodiments, peak detection 1810 includes a combination of peak detection based on a predetermined threshold and based on the highest amplitude peaks and checking that the frequency of those peaks falls within the expected heartbeat range of a typical human wearer because the signal-to-noise ratio is high enough to make the pulse clearly evident.

[0094] The computer executable instructions cause the one or more processors 7 to determine 1812 whether a characteristic of a wearer's pulse is detected during peak detection 1810. If it is determined 1812 that the characteristic of a pulse is present, the result of the affirmative determination may be indicated 1816. For example, the indication 1816 may include sending a visual representation to a display device associated with the compression system 1. Additionally or alternatively, the indication 1816 may include incrementing and / or pausing a timer. After indicating 1816, the process ends at step 1818 and returns to step 1802. If a pulse is not detected at step 1812, the computer executable instructions cause the one or more processors 7 to return a null value at step 1814. After step 1814, the process ends at step 1818 and returns to sampling 1802.

[0095] Reference Fig.19 , is a schematic representation of an exemplary method 1900 of 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 calibration process. For ease of explanation, and for clarity, method 1900 is described with respect to a single bladder (e.g., one of bladders 13a, 13b, or 13c). However, it should be appreciated that method 1900 can be repeated to examine additional bladders corresponding to different valves.

[0096] Method 1900 begins at step 1902, and the desired bladder valve (eg, bladder valve 25a, 25b, 25c) is opened 1904. A pressurized fluid source (eg, pressurized fluid source 21) is turned on 1906 until the pressure in the corresponding bladder exceeds approximately 120 mmHg.

[0097] A pressure signal is received 1908 from the pressure sensor 27 over a period of time. A determination is made 1910 as to whether all data is available. If not all data is available, pressure signals continue to be collected 1912 and pressure signals are received 1908. If a determination is made at step 1910 that all data is available, the corresponding valve is closed 1914 and a pulse detection algorithm is executed.

[0098] In some embodiments, the pulse detection algorithm includes one or more of the post-processing waveform analyses 1804 described above.

[0099] A determination is made 1916 as to whether a pulse is detected after the valve is closed 1914 and the fluid is isolated in the bladder. The lack of detection of a pulse indicates at step 1918 that the compression garment 10 is in a non-wrapped configuration away from the wearer's limb, and the method proceeds to step 1932 where the compliance time is not incremented before ending the method at step 1936. The detection of a pulse at step 1916 indicates at step 1920 that the compression garment 10 is in a wrapped configuration around the wearer's limb and the method continues to step 1930.

[0100] At step 1922, after one second has elapsed after the pump is turned on in step 1906, the computer executable instructions cause the one or more processors 7 to read the pressure. At step 1924, the computer executable instructions cause the one or more processors 7 to determine if the pressure is greater than 2.0 mmHg. A pressure exceeding 2.0 mmHg at step 1924 indicates at step 1926 that the compression garment 10 is present (e.g., in fluid communication with the valves 25a, 25b, 25c), and the method proceeds to step 1930. A pressure not exceeding 2.0 mmHg at step 1924 indicates at step 1928 that the compression garment 10 is not present (e.g., not in fluid communication with the valves 25a, 25b, 25c), and the method proceeds to step 1932 without incrementing the compliance time before terminating the method at step 1936.

[0101] At step 1930, the computer executable instructions cause the one or more processors 7 to determine whether the compression garment 10 is present and in a wrapped configuration around the wearer's limb. If it is determined that the compression garment 10 is not present or is not in a wrapped configuration around the wearer's limb, the method proceeds to step 1932, where the compliance time is not incremented before terminating the method at step 1936. If it is determined by the one or more processors 7 that the compression garment 10 is present and in a wrapped configuration, the method proceeds to step 1934, where the compliance time is incremented before terminating the method at step 1936.

[0102] Reference Fig. 20, computer executable instructions embodied on a computer readable storage medium 33 cause the one or more processors 7 to perform the following method 2000: analyzing waveform data received from the pressure sensor 27 to determine whether the compression garment is in a wrapped or unwrapped configuration after cycling the end pressure. Method 2000 begins at step 2002 and proceeds to step 2004, where the computer executable instructions cause the one or more processors 7 to complete a preventive compression cycle. At step 2006, the computer executable instructions cause the one or more processors 7 to ventilate the bladders (e.g., bladders 13a and 13c) corresponding to the wearer's ankles and thighs. At step 2008, the computer executable instructions cause the one or more processors 7 to maintain the pressure in the bladder (e.g., bladder 13b) corresponding to the wearer's calf for a predetermined period of time (e.g., 10 seconds) and collect pressure signals via the pressure sensor 27.

[0103] At step 2010, the computer executable instructions cause the one or more processors 7 to determine whether all data is available. If not all data is available at step 2010, the method proceeds to step 2012 to collect pressure signals from the pressure sensor 27 before continuing back to step 2008. If all data is available at step 2010, the method proceeds to step 2014, 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 the post-processing waveform analysis described above. At step 2016, the computer executable instructions cause the one or more processors 7 to determine whether a pulse is detected at step 2014. The lack of detection of a pulse indicates at step 2022 that the compression garment 10 is in a non-wrapped configuration away from the wearer's limb. The method then proceeds to step 2024, where the computer executable instructions cause the one or more processors 7 to not increment the compliance time and cause the one or more processors 7 to take one or more actions (e.g., remind the user) before ending the method at step 2026. The detection of the pulse at step 2016 indicates that the compression garment 10 is in a wrapped configuration around the wearer's limb at step 2018. The method then proceeds to step 2020 where the computer executable instructions cause the one or more processors 7 to increment the compliance time before ending the method at step 2026.

[0104] Reference Fig.21, computer executable instructions embodied on a computer readable storage medium 33 cause the one or more processors 7 to perform the following method 2100: analyzing waveform data received from the pressure sensor 27 to determine whether the compression garment is in a wrapped or unwrapped configuration during a venous refill determination (VRD). The method 2100 begins at step 2102 and proceeds to step 2104, where the computer executable instructions cause the one or more processors 7 to complete a preventative compression cycle. At step 2016, the computer executable instructions cause the one or more processors 7 to ventilate the bladders (e.g., bladders 13a and 13c) corresponding to the ankle and thigh of the wearer. At step 2018, 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 calf of the wearer to the VRD target. At step 2110, the computer executable instructions cause the one or more processors 7 to perform the VRD as arranged. Once VRD measurement is initiated, the computer executable instructions cause the one or more processors 7 to begin an auxiliary process to acquire pressure data from the pressure sensor 27 for concurrent pulse detection. At step 2114, the computer executable instructions cause the one or more processors 7 to acquire pressure signals from the pressure sensor 27 while VRD is in progress.

[0105] At step 2116, the computer executable instructions cause the one or more processors 7 to determine whether all data is available. If not all data is available at step 2116, the method proceeds to step 2118 to continue collecting pressure signals from the pressure sensor 27 before continuing back to step 2114. If all data is available at step 2116, the method proceeds to step 2120, 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 the post-processing waveform analysis 1804 described above. At step 2122, the computer executable instructions cause the one or more processors 7 to determine whether a pulse is detected at 2120. The lack of detection of a pulse indicates at step 2128 that the compression garment 10 is in a non-wrapped configuration away from the wearer's limb. The method then proceeds to step 2130, where the computer executable instructions cause the one or more processors 7 to not increment the compliance time, and cause the one or more processors 7 to take one or more actions (e.g., alert the user) before ending the method at step 2132. The detection of the pulse at step 2122 indicates at step 2124 that the compression garment 10 is in a wrapped configuration around the wearer's limb. The method then proceeds to step 2126 where the computer executable instructions cause the one or more processors 7 to increment the compliance time before ending the method at step 2132.

[0106] Reference Fig. 22 , computer executable instructions embodied on a computer readable storage medium 33 cause the one or more processors 7 to perform the following method 2200: analyzing waveform data received from the pressure sensor 27 to determine whether the compression garment is in a wrapped or unwrapped configuration as an independent environment. Method 2200 starts at step 2202 and proceeds to step 2204, where the computer executable instructions cause the one or more processors 7 to complete a preventive compression cycle. At step 2206, the computer executable instructions cause the one or more processors 7 to vent all bladders 13a, 13b, 13c. At step 2208, the computer executable instructions cause the one or more processors 7 to open a desired valve (e.g., valve 25b) and inflate a desired bladder (e.g., bladder 13b) to a desired pressure (e.g., 10-120 mmHg). At step 2210, the computer executable instructions cause the one or more processors 7 to collect pressure signals via the pressure sensor 27 within a predetermined time period (e.g., 10 seconds).

[0107] At step 2212, the computer executable instructions cause the one or more processors 7 to determine whether all data is available. If not all data is available at step 2212, the method proceeds to step 2214 to continue collecting pressure signals from the pressure sensor 27 before continuing back to step 2210. If all data is available at step 2212, the method proceeds to step 2216, 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 the post-processing waveform analysis 804 described above. At step 2218, the computer executable instructions cause the one or more processors 7 to determine whether a pulse is detected at step 2216. The lack of detection of a pulse indicates at step 2224 that the compression garment 10 is in a non-wrapped configuration away from the wearer's limb. The method then proceeds to step 2226, where the computer executable instructions cause the one or more processors 7 to not increment the compliance time, and cause the one or more processors 7 to take one or more actions (e.g., alert the user) before ending the method at step 2228. The detection of the pulse at step 2218 indicates at step 2220 that the compression garment 10 is in a wrapped configuration around the wearer's limb. The method then proceeds to step 2222, where the computer executable instructions cause the one or more processors 7 to increment the compliance time before ending the method at step 2228.

[0108] Fig.23A-C is a schematic representation of an exemplary method 2300 of analyzing waveform data received from the pressure sensor 27 to determine whether the compression garment 10 is in a wrapped or unwrapped configuration by detecting pulsations associated with the wearer's heartbeat. The exemplary method may be implemented by the one or more processors 7 through execution of computer executable instructions embodied on a non-transitory computer readable storage medium 33.

[0109] The method 2300 starts and proceeds to step 2302, where the computer executable instructions cause the one or more processors 7 to complete a preventive compression cycle. At step 2304, the computer executable instructions cause the one or more processors 7 to vent bladders (e.g., bladders 13a and 13c) corresponding to, for example, the wearer's ankles and thighs and vent bladders (e.g., bladders 13b) corresponding to, for example, the wearer's calves until a target pressure is achieved. In an embodiment, the target pressure includes an initial low target pressure of about 5 to about 7 mmHg. Alternatively, when the initial low target pressure does not produce the expected results, the target pressure includes about 26 to about 32 mmHg. The initial low target pressure provides the following exemplary benefits: less pressure is applied against the wearer's limb before trying again at a higher target pressure (which is less comfortable for the patient), which is more comfortable for the patient relative to a higher pressure.

[0110] When the target pressure is reached, the computer executable instructions cause the one or more processors 7 to maintain the pressure in the bladder (e.g., bladder 13b) corresponding to the wearer's calf while collecting signals at a rate of about 100 Hz for a period of at least about 15 seconds. In an embodiment, the period includes a pressure hold period 1504, as further described herein. A hold period longer than about 15 seconds may also be utilized without departing from the scope of the present disclosure. At step 2308, the computer executable instructions cause the one or more processors 7 to ventilate the pressure in the bladder (e.g., bladder 13b) corresponding to the wearer's calf.

[0111] Following measurement of bladder ventilation (eg, bladder 13b), the computer executable instructions cause the one or more processors 7 to perform further signal conditioning that prepares the data for use in a patient monitoring algorithm. Fig.23AAs shown in , the computer executable instructions cause the one or more processors 7 to bandpass filter the waveform data 2310. In an embodiment, the most recent 1024 samples collected (which correspond to a time window of approximately 10 seconds) are passed through a bandpass filter 2310 having a bandpass of approximately 0.5-25 Hz to isolate signals reflecting the wearer's cardiac cycle. In an embodiment, the first three samples of the 1024 collected samples are discarded as a settling time period. It will be understood by those of ordinary skill in the art that other numbers of the most recent samples collected may be utilized without departing from the scope of the present disclosure. For example, any number of the most recent samples collected as a power of 2 aids in frequency calculations.

[0112] The computer executable instructions cause the one or more processors 7 to pass the output of the bandpass filter 2310 through a low pass filter 2312 having a low pass cutoff frequency of approximately 5 Hz. In an embodiment, the low pass filter 2312 further removes noise from the waveform data and reveals pulsations associated with the circulatory system of the wearer's lower extremities. Fig.24 , shows an exemplary signal from the output of low pass filtering 2312. In this embodiment, the signal includes approximately 1024 samples with clear pulsations associated with the circulatory system of the wearer's lower extremity.

[0113] Where filtered waveform data is available, the computer executable instructions cause the one or more processors 7 to perform several frequency calculations on the filtered waveform data in order to determine whether the compression garment 10 is in a wrap or non-wrap configuration around a limb of the wearer of the garment. In an embodiment, the subsequent calculations are referred to as post-processing of the filtered waveform.

[0114] Refer again Fig.23A , the computer executable instructions cause the one or more processors 7 to perform post-processing of the filtered waveform at steps 2314, 2316 and 2318. As shown, the one or more processors 7 calculate the standard deviation of the filtered waveform data and / or portions thereof. It is known empirically that a compression garment in a non-wrap configuration (i.e., idle) has a stable flat pressure signal, including only normal white noise. In contrast, a pressure signal representing the pressure in a compression garment in a wrap configuration around a limb of a wearer of the garment includes pulsations and / or other measurable signal characteristics. Therefore, it is possible to distinguish a compression garment in a wrap configuration around a limb of a wearer from a compression garment in a non-wrap configuration partially or entirely based on this calculation.

[0115] In an 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 the standard deviation 2314 (σ) for each group. One of ordinary skill in the art will appreciate that the low pass filtered signal can be divided into different numbers of sample groups, such as when, for example, different numbers of samples are used. An exemplary purpose of dividing the low pass filtered signal into sample groups is to isolate temporal portions. For example, it is known that large abnormal pressure spikes in the representative pressure signal (e.g., due to the wearer sneezing, coughing, etc.) occur during normal handling due to movement of the wearer's limbs and / or other factors. The temporal segmentation of the signal (e.g., dividing the signal into sample groups) allows the one or more processors 7 to determine whether the entire waveform is "stable" or whether there are abnormalities within a specific range of samples. In an embodiment, the computer executable instructions cause the one or more processors 7 to calculate the overall standard deviation 2314 (σ) for the entire low pass filtered signal (e.g., 1024 samples).

[0116] After calculating the standard deviation, the computer executable instructions cause the one or more processors 7 to perform peak detection 2316. In an embodiment, the one or more processors 7 process the filtered waveform (e.g., 1023 samples) using a windowing technique (including 32 samples per window). The one or more processors 7 index the peaks from each 32-sample window one by one to produce a downsampled waveform that includes only signal peaks (e.g., signals of interest). For example, the one or more processors 7 may initially index each peak from 1 to 32, and then increase 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 an embodiment, the 23-sample window leaves a local maximum for each window. Additionally and / or alternatively, the 23-sample window reduces the number of samples by one-quarter, removes negative peaks, and provides a downsampled signal that represents approximately 10 seconds of real time. Reference Fig.25 , shows an exemplary signal from the output of the peak detection 2316, including only the true peaks that ultimately reveal the pulsation of interest. In this embodiment, the signal includes about 250 to 300 samples, which still corresponds to about 10 seconds of real time. In embodiments, the number of samples will vary depending on the number of peaks identified by the one or more processors 7. Fig.25 In the embodiment illustrated in FIG. 1 , the sampling frequency (eg, sampling frequency) is calculated as the number of samples divided by the amount of time. f = N samples / 10.24 seconds).

[0117] Further references Fig.23A, where the downsampled peak detected waveform is available, the one or more processors 7 utilize the fundamental frequency to assist in confirming whether the compression garment 10 is in a wrapped configuration around the limb of the wearer by performing a time-to-frequency conversion 2318. In an 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 amplitude between 0.5 Hz (e.g., approximately 30 bpm) and 4 Hz (e.g., approximately 200 bpm). One of ordinary skill in the art will appreciate that transforms other than fast Fourier transforms may be used to discover the wearer's cardiac cycle without departing from the scope of the present invention.

[0118] After the post-processing is completed, the computer executable instructions cause the one or more processors 7 to determine whether the compression garment 10 is in a wrapped configuration or a non-wrapped configuration around the limb of the wearer being assisted. Fig. 23B , the computer executable instructions cause the one or more processors 7 to determine at step 2320 that the population standard deviation 2314 (σ) for the entire low-pass filtered signal (e.g., 1024 samples) is less than or equal to a non-winding threshold (e.g., 0.25). When the one or more processors 7 determine that the population standard deviation is not less than or equal to the non-winding threshold, the method 2300 proceeds to step 2336, as further described herein. When the one or more processors 7 determine that the population standard deviation is less than or equal to the non-winding threshold, the method 2300 proceeds to step 2322.

[0119] At step 2322, the computer executable instructions cause the one or more processors 7 to determine whether each of the predetermined number of segments (e.g., sample groups) into which the low pass filtered signal has been divided is less than or equal to a non-winding threshold value (e.g., 0.25). In an alternative embodiment, the one or more processors 7 divide the low pass filtered signal into five sample groups, and determine at 2322 whether the standard deviation of each of the five sample groups is less than or equal to the non-winding threshold value. Alternatively, the one or more processors 7 divide the low pass filtered signal into five sample groups, and determine at 2322 that the standard deviation of at least three of the five sample groups is less than or equal to the non-winding threshold value. When the one or more processors 7 determine that each of the predetermined number of segments is not less than or equal to the non-winding threshold value, the method 2300 continues back to step 2302 to retry the loop. When the one or more processors 7 determine that each of the predetermined number of segments is less than or equal to the non-winding threshold value, the process continues to step 2324.

[0120] At step 2324, the computer executable instructions cause the one or more processors 7 to determine whether the maximum magnitude (e.g., maximum amplitude) in the 0.5-4.0 Hz range of the time-to-frequency transformed (e.g., Fast Fourier Transformed) signal is less than or equal to a threshold value X (e.g., 0.2). 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 value X, the method 2300 ends. When the processor 7 determines at 2324 that the maximum magnitude in the 0.5-4.0 Hz range is less than or equal to the threshold value X, the one or more processors 7 determine at 2326 that the compression garment 10 is in the unwrapped configuration. In an embodiment, when the Boolean result of step 2320 is a logical true value and the result of step 2322 is a logical true value and the result of step 2324 is a logical true value, the computer executable instructions cause the one or more processors 7 to declare that the compression garment 10 is in the unwrapped configuration (e.g., the wearer is not wearing the compression garment).

[0121] At step 2328, the computer executable instructions cause the one or more processors 7 to determine whether the non-entangled configuration detection at 2326 is the second consecutive such determination. When the one or more processors 7 determine that the non-entangled configuration detection 2326 is not the second consecutive detection, the method 2300 continues back to step 2302 to perform a second measurement on the next cycle for the corresponding limb of the wearer. When the one or more processors 7 determine that the non-entangled configuration 2326 is the second consecutive detection, the method 2300 continues to at least one of the three steps. At step 2330, the computer executable instructions cause the one or more processors 7 to activate an audible reminder, such as, via a speaker and / or other motor device connected to the controller 5 of the compression system 1 that produces a sound. In an embodiment, the reminder is a multi-tone audible reminder. At step 2332, 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 2334, the computer executable instructions cause the one or more processors 7 to not increment the compliance time before ending the method 2300. In embodiments, therapy using compression garment 10 is not stopped by stopping 2334 the compliance time, and the compliance time remains in its current state until a response is received via a display device and / or input device (eg, from a human user).

[0122] Reference Fig.23C, the computer executable instructions cause the one or more processors 7 to determine whether the population standard deviation 2314 (σ) for the entire low-pass filtered signal (e.g., 1024 samples) is greater than or equal to a wraparound threshold (e.g., 0.35) at step 2336. When the one or more processors 7 determine that the population standard deviation is not greater than or equal to the wraparound threshold, the method 2300 continues back to step 2302. When the one or more processors 7 determine that the population standard deviation is greater than or equal to the wraparound threshold, the method 2300 continues to step 2338 and / or step 2340.

[0123] In an embodiment, the method 2300 continues to step 2338, where the computer executable instructions cause the one or more processors 7 to determine whether the population standard deviation 2314 (σ) for the entire low-pass filtered signal (e.g., 1024 samples) is less than or equal to a maximum limit threshold (e.g., 10.0). When the one or more processors 7 determine that the population standard deviation for the entire low-pass filtered signal is not less than or equal to the maximum limit threshold, the method 2300 ends. When the one or more processors 7 determine that the population standard deviation for the entire low-pass filtered signal is less than or equal to the maximum limit threshold, the method 2300 continues to step 2340.

[0124] At step 2340, the computer executable instructions cause the one or more processors 7 to determine whether each of the predetermined number of segments (e.g., sample groups) into which the low pass filtered signal has been divided is greater than or equal to a winding threshold (e.g., 0.35). In an embodiment, the one or more processors 7 divide the low pass filtered signal into five sample groups and determine 2340 whether the standard deviation of each of the five sample groups is greater than or equal to the winding threshold. Alternatively, the one or more processors 7 divide the low pass filtered signal into five sample groups and determine 2340 whether the standard deviation of at least three of the five sample groups is greater than or equal to the winding 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 winding threshold, the method 2300 continues back to step 2302 to retry the loop. When the one or more processors 7 determine that each of the predetermined number of segments is greater than or equal to the winding threshold, the process continues to steps 2342 and / or 2344.

[0125] At step 2342, the computer executable instructions cause the one or more processors 7 to determine whether each of the 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 each not less than or equal to the maximum limit threshold, the method 2300 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, the method 2300 continues to step 2344.

[0126] At step 2344, the computer executable instructions cause the one or more processors 7 to determine whether the maximum magnitude (e.g., maximum amplitude) in the 0.5-4.0 Hz range of the time-to-frequency transformed (e.g., Fast Fourier Transformed) signal is both greater than a threshold value Y (e.g., 20) and less than or equal to a threshold value Z (e.g., 50.0). When the one or more processors 7 determine that the maximum magnitude in the 0.5-4.0 Hz range is neither greater than the threshold value Y nor less than or equal to the threshold value Z, the method 2300 ends. When the one or more processors 7 determine that the maximum magnitude in the 0.5-4.0 Hz range is both greater than the threshold value Y and less than or equal to the threshold value Z, the one or more processors 7 determine that the compression garment 10 is in a wrapped configuration 2346 around a limb of the wearer of the garment. In an embodiment, when the Boolean result of step 2336 is a logical true value and the result of step 2338 is a logical true value and the result of step 2340 is a logical true value and the result of step 2342 is a logical true value and the result of step 2344 is a logical true value, the computer executable instructions cause the one or more processors 7 to declare that the compression garment 10 is in a wrapped configuration (e.g., the wearer is wearing the compression garment). Alternatively, when the Boolean result of step 2336 is a logical true value and the result of step 2340 is a logical true value and the result of step 2344 is a logical true value, the computer executable instructions cause the one or more processors 7 to declare that the compression garment 10 is in a wrapped configuration.

[0127] Upon determining that the compression garment 10 is in the wrapped configuration 2346 , the method 2300 continues to step 2348 , where the computer-executable instructions cause the one or more processors 7 to increment the compliance time before ending the method 2300 .

[0128] While certain embodiments have been described, other embodiments are possible, in addition or alternatively.

[0129] Although the compression system has been described for use with a thigh-length compression sleeve, 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 a knee-length compression sleeve and / or with a sleeve having different numbers of bladders that are configured to be positioned over different areas of the wearer's body.

[0130] Embodiments may be implemented in digital electronic circuitry or in computer hardware, firmware, software, or a combination thereof. The controller of the compression system may be implemented in a computer program product tangibly embodied or stored in a machine-readable storage device for execution by a programmable processor; and the method actions may be performed by the programmable processor executing a program of instructions to perform the functions of the controller of the compression system by operating on input data and generating output. The controller of the compression system may be implemented in one or more computer programs executable on a programmable system, the programmable system comprising at least one programmable processor coupled to receive data and instructions from and transmit data and instructions to a data storage system, at least one input device, and at least one output device. Each computer program may be implemented in a high-level procedural or object-oriented programming language, or in assembly or machine language where desired; and in any case, the language may be a compiled or interpreted language.

[0131] As an example, suitable processors include both general-purpose and special-purpose microprocessors. Generally, the processor will receive instructions and data from a read-only memory and / or a random access memory. Generally, the computer will include one or more mass storage devices for storing data files; such devices include disks, such as internal hard disks and removable disks; magneto-optical disks; and optical disks. Storage devices suitable for tangibly embodying computer program instructions and data include all forms of non-volatile memory, including semiconductor memory devices such as EPROM, EEPROM, and flash memory devices as examples; disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM disks. Any of the foregoing can be supplemented with an ASIC (Application Specific Integrated Circuit) or an FPGA (Field Programmable Gate Array) or incorporated therein.

[0132] Several embodiments have been described. Nevertheless, it will be appreciated that various modifications may be made without departing from the spirit and scope of the present disclosure. For example, although a controller having a single pressure sensor has been described, additional pressure sensors (e.g., one for each inflatable bladder) may also be used without departing from the scope of the present disclosure. Accordingly, other embodiments are within the scope of the following claims.

Claims

1. A compression garment controller for monitoring compliance of a user with wearing a compression device based on information indicative of pulsations associated with a heart beat of the wearer, the controller comprising: a computer-readable storage medium configured to store one or more monitored parameters; one or more processors coupled to the computer-readable storage medium; as well as Computer executable instructions embodied on the computer readable storage medium, the computer executable instructions comprising instructions for causing the one or more processors to: receiving information indicative of a pressure of a compression garment including one or more inflatable bladders from a pressure sensor during an active compression therapy cycle in which at least one of the one or more inflatable bladders is inflated to apply pressure to the wearer; extracting information indicative of pulsations associated with a heart beat of the wearer from the information indicative of a pressure of the one or more inflatable bladders; determining that a condition of the compression garment has changed based on the extracted information indicative of pulsation associated with a heart beat of the wearer; and In response to determining that a condition of the compression garment has changed, a state of at least one monitored parameter is changed.

2. The compression garment controller of claim 1, wherein the information indicative of pulsation associated with the wearer's heart beating is different from the wearer's actual heart rate.

3. The compression garment controller of claim 1 , wherein the compression therapy treatment cycle includes an inflation period and a pressure hold period, and information indicative of the pressure of the one or more inflatable bladders is received during the pressure hold period.

4. The compression garment controller of claim 1, wherein the extracting comprises band pass filtering the information indicative of the one or more inflatable bladders to extract signal frequencies from 0.5 Hz to 25 Hz.

5. The compression garment controller of claim 4, further comprising: The extracted signal frequency is smoothed according to a rectangular window of five times the moving range of the extracted signal.

6. The compression garment controller of claim 4, further comprising: The frequency range of the extracted signal was verified to be 30 beats per minute (bpm) to 240 bpm.

7. The compression garment controller of claim 4, further comprising: One or more peaks in the extracted signal are detected and the frequency range of the one or more peaks is verified to be 30 beats per minute (bpm) to 240 bpm.

8. The compression garment controller of claim 1, wherein the pressure of the compression garment is 5 to 20 mmHg.

9. A computer-readable storage medium configured to store computer-executable instructions executable by a processor to perform the following steps: receiving information indicative of a pressure of a compression garment including one or more inflatable bladders from a pressure sensor during an active compression therapy cycle in which at least one of the one or more inflatable bladders is inflated to apply pressure to a wearer; extracting, by a controller, information indicative of pulsations associated with a heartbeat of the wearer from the information indicative of a pressure of the one or more inflatable bladders; determining that a condition of the compression garment has changed based on the extracted information indicative of pulsation associated with a heart beat of the wearer; and In response to determining that a condition of the compression garment has changed, a state of at least one monitored parameter stored in the computer-readable storage medium is changed.

10. The computer-readable storage medium of claim 9, wherein the information indicative of pulsation associated with the wearer's heart beating is different from the wearer's actual heart rate.

11. The computer-readable storage medium of claim 9, wherein the compression therapy treatment cycle includes an inflation period and a pressure hold period, and information indicative of the pressure of the one or more inflatable bladders is received during the pressure hold period.

12. The computer-readable storage medium of claim 9, wherein the extracting comprises bandpass filtering the information indicative of the one or more inflatable bladders to extract signal frequencies from 0.5 Hz to 25 Hz.

13. The computer-readable storage medium of claim 12, further comprising: The extracted signal frequency is smoothed according to a rectangular window of five times the moving range of the extracted signal.

14. The computer-readable storage medium of claim 12, further comprising: One or more peaks in the extracted signal are detected, and it is verified that the frequency range of the one or more peaks is 30 beats per minute (bpm) to 240 bpm.

15. The computer readable storage medium of claim 9, wherein the compression garment has a pressure of 5 to 20 mmHg.

16. A system comprising: a compression garment comprising one or more inflatable bladders, the compression garment being configured to engage a limb of a wearer; a pressure sensor communicatively coupled to the one or more inflatable bladders; and A controller comprising a computer-readable storage medium configured to store one or more monitored parameters, one or more processors coupled to the computer-readable storage medium, and computer-executable instructions embodied on the computer-readable storage medium, the computer-executable instructions comprising instructions for causing the one or more processors to: receiving information indicative of a pressure of the one or more inflatable bladders from a pressure sensor during an active compression therapy cycle in which at least one of the one or more inflatable bladders is inflated to apply pressure to the wearer; extracting information indicative of pulsations associated with a heart beat of the wearer from the information indicative of a pressure of the one or more inflatable bladders; determining that a condition of the compression garment has changed based on the extracted information indicative of pulsation associated with a heart beat of the wearer; and In response to determining that a condition of the compression garment has changed, a state of at least one monitored parameter is changed.

17. The system of claim 16, wherein the information indicative of pulsation associated with the wearer's heart beating is different from the wearer's actual heart rate.

18. The system of claim 16, wherein the compression therapy treatment cycle includes an inflation period and a pressure hold period, and information indicative of the pressure of the one or more inflatable bladders is received during the pressure hold period.

19. The compression garment controller of claim 16, wherein the extracting comprises band pass filtering the information indicative of the one or more inflatable bladders to extract signal frequencies from 0.5 Hz to 25 Hz.

20. The compression garment controller of claim 16, wherein the compression garment has a pressure of 5 to 20 mmHg.

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