GARMENT

1. CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63/189,811, filed May 18, 2021, which is hereby incorporated by reference herein in its entirety.

2. FIELD OF THE PRESENT DISCLOSURE

[0002] The present technology relates to devices for the treatment and/or amelioration of circulatory-related disorders, such as a disorder of the lymphatic system. In particular, the present technology relates to medical devices, and their components, such as for compression therapy (e.g. Lymphedema therapy). Such technology may relate to components, for example, control apparatus, systems, and devices, for compression therapy such as for monitoring and/or treating the condition of a circulatory-related disorder.

3. BACKGROUND

[0003] The lymphatic system is crucial to keeping a body healthy. The system circulates lymph fluid throughout the body. This circulation collects bacteria, viruses, and waste products. The lymphatic system carries this fluid and the collected undesirable substances through the lymph vessels, to the lymph nodes. These wastes are then filtered out by lymphocytes existing in the lymph nodes. The filtered waste is then excreted from the body.

[0004] Lymphedema concerns swelling that may occur in the extremities, in particular, any of the arms, legs, feet, etc. The swelling of one or more limbs can result in significant physical and psychological morbidity. Lymphedema is typically caused by damage to, or removal of, lymph nodes such as in relation to a cancer therapy. The condition may result from a blockage in the lymphatic system, a part of the immune system. The blockage prevents lymph fluid from draining. Lymph fluid build-up leads to the swelling of the related extremity.

[0005] Thus, Lymphedema occurs when lymph vessels are unable to adequately drain lymph fluid, typically from an arm or leg. Lymphedema can be characterized as either primary or secondary. When it occurs independently from other conditions it is considered primary Lymphedema. Primary Lymphedema is thought to result from congenital malformation. When it is caused by another disease or condition, it is considered secondary Lymphedema. Secondary Lymphedema is more common than primary Lymphedema and typically results from damage to lymphatic vessels and/or lymph nodes.

[0006] Lymphedema is a chronic and incurable disease. If untreated, Lymphedema leads to serious and permanent consequences that are costly to treat. Many of the high-cost health consequences from Lymphedema might be prevented by early detection and access to appropriate remedial services. As there is no presently known cure for lymphedema, improvement in treating this and other circulatory-related conditions, such as, for example, deep vein thrombosis, chronic venous insufficiency, and restless leg syndrome, is desired. The present disclosure is directed to solving these and other problems.

4. SUMMARY OF THE PRESENT DISCLOSURE

[0007] The present disclosure is directed towards providing medical devices, or the components thereof, for use in the management, amelioration, treatment, and/or prevention of circulatory -related conditions having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

[0008] According to some implementations of the present disclosure, a pneumatic compression apparatus capable of determining physical shape properties of a limb during compression garment therapy is provided. The pneumatic compression apparatus includes a compression pressure generator, a plurality of sensors, and a controller including at least one processor. The compression pressure generator is configured to generate pneumatic pressure for pressurizing a set of pneumatic chambers of a compression garment for a user. The plurality of sensors is configured to measure a pressure characteristic of pneumatic pressure and/or a flow rate characteristic of pneumatic flow attributable to the pressure generator and/or the compression garment. The controller is configured to execute a diagnostic process including: controlling operation of the compression pressure generator to generate a pneumatic waveform to one or more pneumatic chambers of the set of pneumatic chambers of the compression garment during a testing period; receiving a signal representing the flow rate characteristic from the flow rate sensor in the testing period; receiving a signal representing the pressure characteristic from the pressure sensor in the testing period; and determining a parameter representing a physical shape property of a limb based at least in part on the received flow rate characteristic signal and the received pressure characteristic signal.

[0009] According to some implementations of the present disclosure, a method for determining a physical shape property of a limb during compression garment therapy is provided. The method includes: controlling operation of a compression pressure generator to generate a pneumatic waveform in one or more pneumatic chambers of a set of pneumatic chambers of a compression garment during a testing period; receiving signals from a plurality of sensors during the testing period, the signals being indicative of pressure characteristics of pneumatic pressure and flow rate characteristics of pneumatic flow attributable to the compression garment; determining a parameter representing a physical shape property of a limb of the user of the compression garment based at least in part on the received signals; and initiating a follow-up action based at least in part on the determined parameter.

[0010] According to some implementations of the present disclosure, an apparatus for determining physical shape properties of a limb during compression garment therapy is provided. The apparatus includes a compression pressure generator, one or more measuring instruments positioned at different locations about the compression garment, and a controller including at least one processor. The compression pressure generator is configured to generate pneumatic pressure for pressurizing a set of pneumatic chambers of a compression garment for a user. The one or more measuring instruments are integrated into the compression garment and are configured to measure different lengths of the compression garment at their respective locations. The controller is configured to: control operation of the compression pressure generator; receive signals from the one or more measuring instruments, the received signals representing lengths along the compression garment at respective locations of the one or more measuring instruments; and determine a parameter representing a physical shape properties of a limb of the user of the compression garment based at least in part on the received signal from the one or more measuring instruments.

[0011] According to some implementations of the present disclosure, a method for determining an operational fit of a compression garment positioned about a limb of a user is provided. The method includes: receiving signals, during operational use of the compression garment, from a first force sensor and a second force sensor positioned at different locations along the width of the of a pneumatic chamber of the compression garment, the received signals representing force characteristics at the sensor locations; determining a difference between received signals from the first force sensor and the second force sensor; determining a fit of the compression garment based on the determined difference; in response to the determined fit being outside a predetermined fit parameter range, implement a predetermined response (e.g. notify user to adjust the garment to get a better fit, or inflate the garment further); and in response to the determined fit being within the predetermined fit parameter range, initiating a compression therapy session. [0012] According to some implementations of the present disclosure, a method for determining physical shape properties of a limb during compression garment therapy is provided. The method includes: controlling operation of a compression pressure generator in a diagnostic process to generate a pneumatic waveform in one or more pneumatic chambers of a set of pneumatic chambers of a compression garment during a testing period; receiving signals, during operational use, from a first force sensor and a second force sensor positioned at opposing ends of a pneumatic chamber of the compression garment, the received signals representing force characteristics on the compression garment at the sensor locations; determining a force differential between the received signals for the first force sensor and the second force sensor; comparing the force differential to a threshold force differential to identify changes in the force differential; and determining a limb circumference at the compression garment based on the identified changes in the force differential.

[0013] According to some implementations of the present disclosure, a method for determining an operational fit of a compression garment positioned about a limb of a user is provided. The method includes: receiving signals, during operational use of the compression garment, from a sensor positioned on the compression garment, the received signals representing distances from the sensor to an outer surface of the limb or to a surface associated with the outer surface of the limb; determining differences between the distances associated with received signals from the same sensor(s) and distances associated with predetermined fit parameter ranges; determining a fit of the compression garment based on the determined differences; in response to the determined fit being outside a predetermined fit parameter range, implementing a predetermined response; and in response to the determined fit being within the predetermined fit parameter range, initiating a compression therapy session.

[0014] According to some implementations of the present disclosure, method for determining changes in operational fit of a compression garment positioned about a limb of a user is provided. The compression garment includes one or more fit adjustment devices, each fit adjustment device including a plurality of predetermined engagement positions. The method includes: determining, via a first engagement position of one or more of the compression garment adjustment devices, an initial reference fit for the user of the compression garment; determining, via a second engagement position of at least one of the one or more compression garment adjustment devices, a subsequent fit for the user of the compression garment, a difference between the first and the second engagement position indicating a difference between the initial reference fit and the subsequent fit; and in response to determining that the subsequent fit is different from the initial reference fit, initiating a response. [0015] The subject headings used in the detailed description are included only for the ease of reference of the reader and should not be used to limit the subject matter found throughout the disclosure or the claims. The subject headings should not be used in construing the scope of the claims or the claim limitations.

[0016] Various aspects of the described example embodiments may be combined with aspects of certain other example embodiments to realize yet further embodiments. It is to be understood that one or more features of any one example may be combinable with one or more features of the other examples. In addition, any single feature or combination of features in any example or examples may constitute patentable subject matter.

[0017] Other features of the technology will be apparent from consideration of the information contained in the following detailed description.

5. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The present technology is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings, in which like reference numerals refer to similar elements including:

[0019] FIG. 1A is a perspective view of a compression therapy system for a compression therapy and/or circulatory-related disorder monitoring including a compression pressure generator (CPG device) with a link to a compression garment and/or an optional control device, according to some implementations of the present disclosure.

[0020] FIG. IB is a perspective view of a compression therapy system with a second type of connection to the compression garment, according to some implementations of the present disclosure.

[0021] FIG. 2 is a block diagram of a compression therapy system including the components of the system of FIG. 1A, according to some implementations of the present disclosure.

[0022] FIG. 3 is a view of a compression pressure generator (CPG) device suitable for use in a compression therapy system, according to some implementations of the present disclosure. [0023] FIG. 4 is a flow chart of a pneumatic circuit of the CPG device of FIG. 3.

[0024] FIG. 5 is a schematic diagram of some electrical components associated with the CPG device of FIG. 3.

[0025] FIG. 6 is a flow diagram illustrating a process for determining physical shape properties of a limb of a user of a compression therapy system (e.g., the compression therapy system of FIG. 1 A), according to some implementations of the present disclosure. [0026] FIG. 7 illustrates a compression therapy system with a CPG device capable of measuring pressure, according to some implementations of the present disclosure.

[0027] FIG. 8 illustrates a compression garment with sensors in each compartment, according to some implementations of the present disclosure.

[0028] FIG. 9 is a graph illustrating relationship between pressure and volume of introduced air (flow per given time) for two separate therapy sessions, according to some implementations of the present disclosure.

[0029] FIG. 10 illustrates a compression garment with an integrated tape measure, according to some implementations of the present disclosure.

[0030] FIG. 11 illustrates a compression therapy system with tape measures for each compartment of a compression garment of the compression therapy system, according to some implementations of the present disclosure.

[0031] FIG. 12 illustrates a compression garment including stretch sensors, according to some implementations of the present disclosure.

[0032] FIG. 13 is a flow diagram illustrating a process for determining a fit of a compression garment, according to some implementations of the present disclosure.

[0033] FIG. 14 illustrates a compression garment with a force sensor, according to some implementations of the present disclosure.

[0034] FIG. 15 is a flow diagram illustrating a process for determining a limb circumference using a compression garment with a force sensor (e.g., the compression garment of FIG. 14), according to some implementations of the present disclosure.

[0035] FIG. 16A illustrates a compression garment with at least two force sensors, according to some implementations of the present disclosure.

[0036] FIGS. 16B, 16C, and 16D illustrate the at least two force sensors of FIG. 16A at different positions.

[0037] FIG. 17 is a flow diagram illustrating a process for determining a fit of a compression garment, according to some implementations of the present disclosure.

[0038] FIG. 18A illustrates a cross section of a limb and compression garment with a distance sensor, according to some implementations of the present disclosure.

[0039] FIG. 18B illustrates a cross section of a limb and compression garment with a magnetic shape parameter sensor (or a fit-sensor), according to some implementations of the present disclosure.

[0040] FIG. 19 is a flow diagram illustrating a process for determining subsequent fit of a compression garment, according to some implementations of the present disclosure. [0041] FIG. 20 illustrates a compression therapy system having a compression garment with integrated straps, according to some implementations of the present disclosure.

[0042] FIG. 21 is an example graph that relates volume of compression garment to volume of underlying cylinder that the compression garment is wrapped around.

6. DETAILED DESCRIPTION

[0043] Limb volume and limb volume change are useful measures for determining whether a compression therapy (e.g., for lymphedema) is working or not. Most methods for measuring limb volume change rely on external equipment or clinical intervention or use a healthy limb as a comparison. Because such measurements are performed externally and need expert care, they can be inconvenient for the user and are usually performed infrequently. Embodiments of the present disclosure provide systems and methods for use with pneumatic compression devices (PCDs), e.g. pressurizable garments for treating circulatory disorders, for determining changes in the dimensions and/or volume of the underlying limb to which the garment is applied. Since the PCD is used for daily therapy, having any of the proposed inbuilt diagnostic tools can obtain size/volume measurements more frequently, conveniently and potentially more accurately. Such a dynamic feedback on the limb size, and of the current condition of the patient, may allow more frequent and, in some cases, precise adjustment of the applied pressure therapy and/or allow providing a more responsive and efficient treatment.

[0044] While the present disclosure is susceptible to various modifications and alternative forms, specific implementations and embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that the description and the accompanying drawings are not intended to limit the present disclosure to the particular forms disclosed, but on the contrary, the present disclosure is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

[0045] Various embodiments are described with reference to the accompanying figures, where like reference numerals are used throughout the figures to designate similar or equivalent elements. The figures are not necessarily drawn to scale and are provided mainly to illustrate the instant invention. Several aspects of the invention are described below with reference to example applications for illustration. It should be understood that numerous specific details, relationships, and methods are set forth to provide a full understanding of the invention. One having ordinary skill in the relevant art, however, will readily recognize that the invention can be practiced without one or more of the specific details, or with other methods. In other instances, well-known structures or operations are not shown in detail to avoid obscuring the invention. The various embodiments are not limited by the illustrated ordering of acts or events, as some acts may occur in different orders and/or concurrently with other acts or events. Furthermore, not all illustrated acts or events are required to implement a methodology in accordance with the present invention.

[0046] For purposes of the present detailed description, unless specifically disclaimed, the singular includes the plural and vice versa. The word “including” means “including without limitation.” Moreover, words of approximation, such as “about,” “almost,” “substantially,” “approximately,” “generally,” and the like, can be used herein to mean “at,” “near,” or “nearly at,” or “within 3-5% of,” or “within acceptable manufacturing tolerances,” or any logical combination thereof, for example.

[0047] It is to be understood that the terminology used in this disclosure is for the purpose of describing only the particular examples discussed herein, and is not intended to be limiting. In particular, while the condition being monitored or treated is usually referred to below as Lymphedema, it is to be understood that the described technologies are also applicable to treatment and monitoring of other circulatory-related disorders.

[0048] Referring to FIG. 1A, a compression therapy system 1000 for compression therapy and/or lymphedema monitoring is shown. The system 1000 includes a compression pressure generator (CPG) device 1002 and a compression garment 1004. The compression garment 1004 is arranged for donning on a person’s limb (e.g. a leg) as shown in FIGS. 11 and 20. A link 1006, such as to provide pneumatic and/or electrical coupling for control and/or operation of the compression garment 1004, connects the CPG device 1002 and the compression garment 1004. The link 1006 may connect with a conduit and/or valve control interface 1008, such as one that is integrated with, or separate from, the compression garment 1004. If formed separately from the garment, the valve control interface 1008 will be connected to the valves in the garment via a further link 1006’, which is not shown in FIG. 1 A, where the valve control interface 1008 is integrated with the garment 1004. The valves that pressurise the garment may also form part of the valve control interface 1008, in both the integrated and the stand-alone version of the valve control interface 1008. The compression therapy system 1000 optionally includes a control device 1010, such as a mobile phone, tablet, laptop or other computing or computer device, that may interface with the CPG device 1002 and provide user interface for executing an application for setting the operational parameters (e.g., mode, type of therapy, pressure settings, valves, etc.) of the CPG device 1002 and/or monitoring operations and detected parameters of the CPG device 1002 and/or compression garment 1004. [0049] Referring to FIG. 2, various interactions of components of the system 1000 are shown. The system 1000 includes a portal system 2028, such as one with one or more servers, for managing a population of CPG devices. The CPG device 1002 conducts control device related communications 2003, such as wireless communications, with the control device 1010, running a control application 2011. Such communications may involve an exchange of data, such as measurements and/or usage time data, collected by the CPG device 1002 and sent to the control device 1010. Such communications may involve an exchange of control parameters for setting operations of the CPG device 1002, such as valve subset identifiers (zone) for controlling particular valves of the set of valves of the compression garment 1004, a pressure setting for the CPG device 1002, a therapy mode identifier, therapy times, a number of cycles etc. to the CPG device 1002. The wireless communications 2003 may employ a low energy wireless communications protocol such as Bluetooth LE or other.

[0050] As discussed in more detail herein, the application 2011 of the control device 1010 can be configured to provide limb, pressure, and usage data as feedback information to a user, including in chart formats. The application 2011 can serve as a virtual coach such as by employing an artificial intelligence (AI) chat program. The application 2011 can also serve as a social networking tool to other patients receiving similar care with a CPG device. The application 2011 can provide information to the user in relation to troubleshooting operations with the system 1000. The application 2011 can serve as a symptom tracker such as with input from the user and from the CPG device. The application 2011 can permit customization (personalization) with respect to the parameters controlling the therapy pressure waveform provided with the compression garment and the CPG device. Pressure (also pneumatic) waveform in this specification would mean variation in pressure according to any type of function, including a single step (constant) pressure. The application 2011 can serve as an electronic store for ordering resupply components of the system (e.g., conduits, control interfaces 1008, and compression garments). The application 2011 can provide informative/educational messages about disease condition (e.g., lymphedema). The application 2011 can provide user controls to start, stop and set up compression therapy sessions with the CPG device 1002 as well as run diagnostic processes with the CPG device 1002 and compression garment 1004. The application 2011 can simplify use and setup workflow with the CPG device 1002. Alternatively, or in addition to, at least some of the above described AI, coaching, data processing, tracking, messaging and other capabilities may be attributed to a remote (e.g. cloud) server, such as one included in the portal system 2028. In this case the control device 1010 and its application interface may serve more to (i) communicate and visualise, to the user, data and advice generated remotely, and (ii) pass onto the CPG device 1002 commands generated remotely.

[0051] The control device 1010 can be configured for portal related communications 2005, such as wireless communications (e.g., wireless protocol communications WiFi), with the portal system 2028. As mentioned in the above text, the portal system 2028 can receive, from the control device 1010, testing measurements, therapy parameters, and/or usage time, and may communicate to the control device 1010, parameters for setting operations of the CPG device 1002, such as valve subset identifiers (zone) for controlling particular valves of the set of valves of the compression garment 1004, a pressure setting for the CPG device 1002, a therapy mode protocol, therapy times, a number of cycles, etc. Such a portal system 2028 can be managed by a clinician organization to provide actionable insights to patient condition for a population of CPG devices and their users.

[0052] For example, a clinician may provide to the portal system 2028 prescriptive parameters for use of the CPG device 1002 (e.g., therapy control parameters) that may in turn be communicated to a control device 1010 and/or a CPG device 1002. Such communications, such as in relation to receiving testing measurements from the CPG device 1002 via the control device 1010, can permit therapy customization, such as by setting the prescriptive parameters based on the testing measurements. The portal system 2028 may similarly be implemented for compliance management in relation to received usage information from the CPG device 1002. The portal system 2028 may then serve as an integrated part of electronic medical records for a patient’s lymphedema therapy.

[0053] The CPG device 1002 communicates with the valve control interface 1008 via link 1006. The CPG device 1002 may generate electrical valve control signals on electric lines (e.g. in the form of a bus) to the valve control interface 1008 and receive back sensing data from one or more sensors in the CPG device 1002 and/or electrical valve operation signals from the valve control interface 1008 on the electric lines of the link 1006. The CPG device 1002 may also generate air flow such as a controlled pressure and/or flow of air to/from the interface 1008 via one or more pneumatic conduits 2007 of the link 1006. The valve control interface 1008 may then selectively direct the pressure and/or flow to/from the chambers of the garment 1004 via any of the pneumatic lines 2008 between the interface 1008 and the compression garment 2004. Optionally, the valves of the interface 1008 and/or the pneumatic lines 2008 may be integrated (partially and/or fully) with the compression garment 1004.

[0054] Referring to FIG. IB, a perspective view of a compression therapy system 1001 for compression therapy is depicted. The compression therapy system 1001 is similar to the compression therapy system 1000. The difference between the compression therapy system 1001 and the compression therapy system 1000 is that the link 1006 is shown to include at least three components. The link 1006 provides pneumatic and/or electrical coupling for control and/or operation of the compression garment 1004, and connects the CPG device 1002 and the compression garment 1004. The link 1006 may connect with a conduit and/or the valve control interface 1008, such as one that is either integrated with, or is separate from, the compression garment 1004. In some implementations, the valve control interface 1008 is moved from the garmentl004 into a separate control component 1006b, as shown in FIG. IB.

[0055] In some implementations, the link 1006 includes a separate pneumatic tube and electrical coupling that run in a common tube 1006a for control and operation of the compression garment 1004. In the illustrated embodiment in FIG. IB, the combined pneumatic tube and electrical coupling 1006a connect to a valve control component 1006b that can include a printed circuit board assembly (PCBA) configured to, under instructions from a controller in a CPG device 1002 and/or a control device 1010, process commands for turning valves in the compression garment on and off. The valve control component 1006b can then be connected to a combined flexible PCBA and main air supply line 1006c to allow the electrical signals with the commands from the valve control component 1006b to be transmitted to a respective valve in the compression garment 1004. The flexible PCBA in the combined flexible PCBA and main air supply line 1006c, includes separate control lines for each valve used to pressurize and depressurize the compression garment 1004. In some implementations, instead of being moved into a separate valve control device, the valve control component 1006b may be integrated into the CPG device 1002. Alternatively, the valves may be integrated into the valve control component 1006b to form one singular “valve interface” 1008.

[0056] In one example, the described arrangement allows a use of an off-the-shelf CPG device 1002, such as the ResMed AirMini™, Aria Free™, or a similar device, by simply installing a respective software application and without the need to introduce any structural changes to the device. In this case any changes to the operational parameters of the garment are instructed by the CPG device 1002, which communicates with the intermediate (external) valve control component 1006b, which has a microcontroller that controls a series of switches to turn valves within the compression garment on and off. The valves are typically located in the garment, close to each other in a location/structure that is hereby referred to as a “spine”. The common tube 1006a includes electrical links (e.g., a controller area network (CAN) bus) between the AirMini and the valve control component 1006b (e.g., a PCBA or valve PCBA box). The valve control component 1006b is connected to the valves by means of a flexible PCBA. In some implementations, a multi-core cable can be used as an alternative to the flexible PCBA. In practice, the flexible PCBA can include various electronic components, such as one or more diodes for each valve, to minimise current spikes.

[0057] The flexible PCBA in the combined flexible PCBA and main air supply line 1006c includes separate control lines for each valve used to pressurize and depressurize the compression garment 1004. The valve control component 1006b may be integrated with the garment itself. Alternatively, the valves may be integrated in the valve control component 1006b or with CPG device 1002, and the compression garment 1004 may not include any valves. When valves are not present in the compression garment 1004, the compression garment 1004 may not include a spine.

CPG Device

[0058] An exemplary CPG device 1002 may include ResMed’s AirMini™ Automatic CPAP device. An exemplary CPG device 1002 is illustrated in FIG. 3 and may have a compact and/or portable design to simplify use with a compression garment (e.g., compression garment 1004). The CPG device 1002 includes a start/ stop button 3016 and a communications link button 3018 to aid in establishing a communications link (e.g., wireless communications) with the control device 1010 (FIG. 1A). The CPG device 1002 may also include an electrical interface 3020 for wirelessly and/or electrically coupling with an interface 1008 and/or valves of the garment 1004. The CPG device 1002 also includes a pneumatic interface 3022 (inlet/outlet) for pneumatic coupling with the compression garment 1004, such as via a set of valves.

[0059] As discussed in more detail herein, the CPG device 1002 may have a memory including an executable algorithm and a programmable controller to provide operations for compression therapies described herein and diagnostic operations. Such therapies may be provided by control of a blower of the CPG device 1002 that may produce positive pressure and/or negative pressure operations via one or more pneumatic conduits coupled to the compression garment 1004. For example, the CPG device 1002 may be configured to generate varied positive pressure for compression (e.g. of about 50 mmHg) into one or more chambers of the compression garment 1004. In some cases, the CPG device 1002 may be able to produce negative pressure, such as to evacuate one or more pneumatic chambers of the compression garment 1004. Such a generation of positive and/or negative pressure (e.g., sub-ambient pressure, vacuum, etc.) may be controlled to provide compression therapy, including massage therapy, with the compression garment 1004 in relation to a set of pneumatic chambers within the compression garment 1004 that are pneumatically coupled to the blower of the CPG device 1002, such as via one or more valves and/or hoses that may be implemented with the interface 1008 (FIG. 2).

[0060] In alternative implementations, the pneumatic chambers may be passively evacuated (depressurized or deflated). In such implementations, the pneumatic chambers may be selectively pneumatically coupled to atmosphere via one or more active exhaust valves. When pneumatically coupled to atmosphere via an actuated exhaust valve, a pneumatic chamber deflates to ambient pressure. Such implementations allow the use of CPG devices that do not generate negative pressure. One or more exhaust valves may be located on the CPG device 1002 itself. Alternatively, or additionally, one or more exhaust valves may be located in the interface 1008 or located (in a centralised or distributed manner) on the compression garment 1004 itself. In the latter implementations, the CPG device 1002 may generate exhaust valve control signals on electric lines forming part of the link 1006 to actuate the one or more active exhaust valves. Alternatively, valves which have three ports and 2 positions, may be used such that the same valve can either allow air into the chamber in one position and allow air to exhaust to atmosphere in the other position.

[0061] Referring to FIGS. 4 and 5, a compression pressure generator such as the CPG device 1002 may include mechanical and pneumatic components 4100 (FIG. 4), electrical components 4200 (FIG. 5) and may be programmed to execute one or more compression control algorithms. The CPG device 1002 has an external housing (see FIG. 3) that may be formed in two parts, an upper portion and a lower portion. In alternative forms, the external housing may include one or more panel(s). The CPG device 1002 may typically include a chassis that supports one or more internal components of the CPG device 1002. In one form a pneumatic block 4020 (FIG. 4) is supported by, or formed as part of the chassis. The CPG device 1002 may optionally include a handle.

[0062] Referring to FIG. 4, a pneumatic path of the CPG device 1002 may comprise any of an inlet air filter 4112, an inlet muffler 4122, a controllable flow or flow/pressure generator 4140 capable of supplying air at positive pressure (preferably a blower 4142) and/or evacuating air at negative or atmospheric pressure such as by reversing operation of the blower or by opening the system to ambient, as well as an outlet muffler 4124. One or more pressure sensors and flow rate sensors, such as transducers 4270, may be included in the pneumatic path of the device.

[0063] The pneumatic block 4020 may include a portion of the pneumatic path that is located within the external housing. The pneumatic path may then lead to an optional conduit and/or valve control interface 1008, such as for controlled/selective directing of the pressurized air from the compression pressure generator to different pneumatic chambers of a compression garment 1004.

[0064] Referring to FIG. 5, electrical components 4200 associated with the CPG device 1002 are illustrated. The electrical components 4200 associated the CPG device 1002 may include an integrated or separate electrical power supply 4210, such as a battery power supply and/or AC main power supply converter (e.g., alternating current AC to direct current DC), one or more input devices 4220 (e.g., buttons), a central controller 4230, a flow/pressure device controller 4240, a flow/pressure device 4245 (e.g., blower with impeller and motor), one or more optional protection circuits 4250, memory 4260, transducers 4270, data communication interface 4280 and one or more output devices 4290 (e.g., lights, valve control). Electrical components 4200 may be mounted on a single Printed Circuit Board Assembly (PCB A). In an alternative form, the CPG device 1002 may include more than one PCB A. The electrical components 4200, associated with the CPG device 1002, include some elements and devices external to the CPG device 1002. For example, these elements may include a remote external device 4286 (e.g., a computer), a remote external communication network 4282 (e.g., WiFi network), a local external communication network 4284 (e.g., Bluetooth network), a local external device 4288 (e.g., the control device 1010 and other sensors 4271). In some implementations, the CPG device 1002 includes components indicated by the dotted line in FIG. 5.

[0065] The central controller 4230 of the CPG device 1002 is programmed to execute one or more compression mode control algorithms, and may include a detection module (e.g., sine wave generation control and evaluation).

6.1.1 CPG device mechanical & pneumatic components

6.1.1.1 Air filter(s)

[0066] Referring back to FIG. 4, the CPG device 1002 may include an air filter 4110, or a plurality of air filters 4110 (e.g., filter 4112). Such air filters may keep passages of both the device and the compression garment clean of air debris.

6.1.1.2 Muffler(s)

[0067] The CPG device 1002 may include an inlet muffler 4122 that is located in the pneumatic path upstream of a blower 4142. [0068] The CPG device 1002 may include an outlet muffler 4124 that is located in the pneumatic path between the blower 4142 and the compression garment 1004.

6.1.1.3 Flow/pressure device

[0069] Referring to FIGS. 4 and 5, a flow/pressure generator 4140 for producing a flow of air at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC electric motor 4144 with one or more impellers housed in a volute. The blower 4142 is capable of delivering a supply of air and/or drawing (e.g., evacuating) a supply of air. The flow/pressure generator 4140 is under the control of the flow/pressure device controller 4240 (FIG. 5).

6.1.1.4 Transducer(s)

[0070] With continued reference to FIGS. 4 and 5, the CPG device 1002 may include one or more transducers 4270 constructed and arranged to measure properties of the air at that point in the pneumatic path (e.g., pressure, flow rate, temperature). They may be located upstream and/or downstream of the flow/pressure generator 4140.

[0071] One or more transducers 4270 can also be located proximate to and/or within the compression garment 1004.

6.1.1.5 Air conduit and/or valve interface

[0072] As shown in FIGS. 1A and 4, an optional air conduit and/or valve interface 1008, in accordance with an aspect of the present technology, is/are constructed and arranged to allow a flow of air between the pneumatic block 4020 and the compression garment 1004.

6.1.2 CPG device electrical components

6.1.2.1 CPG device

6.1.2.1.1 Power supply

[0073] Referring to FIG. 5, a power supply 4210 supplies power to the other components of the CPG device 1002, such as, the input device 4220, the central controller 4230, the flow/pressure device 4245, and the output device 4290, valves, etc. Such a power supply may provide a DC voltage, such as 24 volts.

[0074] The power supply 4210 can be internal to the external housing of the CPG device 1002, such as in the case of a battery (e.g., a rechargeable battery). Alternatively, the power supply 4210 can be external of the external housing of the CPG device 1002. The internal or external power supply may optionally include a converter such as to provide a DC voltage converted from an AC supply (e.g., a main supply).

6.1.2.1.2 Input device(s)

[0075] Input devices 4220 (shown in FIG. 5) may include one or more of buttons, switches or dials to allow a person to interact with the CPG device 1002. The buttons, switches or dials may be physical devices, or software devices accessible via an optional touch screen of the CPG device 1002. The buttons, switches or dials may, in one form, be physically connected to the external housing, or may, in another form, be in wireless communication with a receiver that is in electrical connection to the central controller 4230.

[0076] The input device 4220 may be constructed and arranged to allow a person to select a value and/or a menu option. Alternatively, the input device 4220 may simply be configured to turn the CPG device 1002 on and/or off.

6.1.2.1.3 Central controller

[0077] The central controller 4230 (shown in FIG. 5) is a dedicated electronic circuit configured to receive input signal(s) from the input device 4220, and to provide output signal(s) to the output device 4290 and/or the flow/pressure device controller 4240 and/or the data communication interface 4280.

[0078] The central controller 4230 can be an application-specific integrated circuit. Alternatively, the central controller 4230 can be formed with discrete electronic components. [0079] The central controller 4230 can be a processor 4230 or a microprocessor, suitable to control the CPG device 1002 such as an x86 INTEL processor.

[0080] The central controller 4230 suitable to control the CPG device 1002 in accordance with another form of the present technology includes a processor based on ARM Cortex-M processor from ARM Holdings. For example, an STM32 series microcontroller from ST MICROELECTRONICS may be used.

[0081] In a further alternative form of the present technology, the central controller 4230 may include a member selected from the family ARM9-based 32-bit RISC CPUs. For example, an STR9 series microcontroller from ST MICROELECTRONICS may be used.

[0082] In certain alternative forms of the present technology, a 16-bit RISC CPU may be used as the central controller 4230 for the CPG device 1002. For example, a processor from the MSP430 family of microcontrollers, manufactured by TEXAS INSTRUMENTS, may be used. [0083] The central controller 4230 is also configured to receive input signal(s) from one or more transducers 4270, as well as from the one or more input devices 4220. The central controller 4230 may also be configured with one or more digital and/or analog input/output ports as previously described such as for implementing the mode of operations and detection modules in conjunction with the operations of the system. For example, such input and/or output ports may provide control over or detect position of active pneumatic valves controlled by the central controller for directing compression related pressure to pneumatic chambers of the compression garment 1004.

[0084] Thus, the central controller 4230 is configured to provide output signal(s) to one or more of an output device 4290 (e.g., a display, one or more valves of a set of valve(s)), the flow/pressure device controller 4240, and a data communication interface 4280. Thus, the central controller 4230 may also be configured with one or more digital and/or analog output ports as previously described such as for implementing the mode of operations or detection module in conjunction with the operations of the CPG device 1002.

[0085] The central controller 4230, or multiple processors, is configured to implement the one or more methodologies described herein such as the one or more algorithms, as described in more detail herein, expressed as computer programs stored in a computer readable storage medium, such as memory 4260. In some cases, as previously discussed, such processor(s) may be integrated with the CPG device 1002. However, in some devices the processor(s) may be implemented discretely from the pressure generation components of the CPG device 1002, such as for purpose of performing any of the methodologies described herein without directly controlling delivery of a compression therapy. For example, such a processor may perform any of the methodologies described herein for purposes of determining control settings for the compression garment 1004 and/or monitoring of a circulatory-related disorder by analysis of stored data such as from any of the sensors described herein. Such a processor may also perform any of the methodologies relating to the different mode of operations as described in more detail herein.

6.1.2.1.4 Flow/pressure device

[0086] In one form of the present technology, the flow/pressure device 4245 (shown in FIG. 5) is configured to deliver compression therapy to a user wearing the compression garment 1004 under the control of the central controller 4230. The flow/pressure device 4245 may be the controllable flow/pressure generator 4140, such as a positive and/or negative air flow/pressure device. Such a device may be implemented with a blower, such as a servo- controlled blower. Such a blower may be implemented with a motor having an impeller in a volute.

6.1.2.1.5 Flow/pressure device controller

[0087] In one form of the present technology, the flow/pressure device controller 4240 (shown in FIG. 5) is a compression therapy control module that may implement features of the compression related algorithms executed by or in conjunction with the central controller 4230. In some cases, the compression flow/pressure device controller 4240 may be implemented with a motor drive. It may also optionally be implemented with a valve controller. Thus, such algorithms may generate motor control signals to operate a motor of blower to control generation of compression related pressure/flow. Such algorithms may also generate valve control signals to control operation of a set of valves for directing location of such compression related pressure/flow via one or more valves of the set of valves coupled with pneumatic chambers of the compression garment 1004.

[0088] In one form of the present technology, flow/pressure device controller 4240 includes a dedicated motor control integrated circuit. For example, in one form a MC33035 brushless DC motor controller, manufactured by ONSEMI is used.

6.1.2.1.6 Protection circuits

[0089] The CPG device 1002 in accordance with the present technology optionally includes one or more protection circuits 4250 such as shown in FIG. 5.

[0090] One form of protection circuit 4250 in accordance with the present technology is an electrical protection circuit. Another form of protection circuit 4250 in accordance with the present technology is a temperature or pressure safety circuit.

[0091] In some versions of the present technology, a protection circuit 4250 may include a transient absorption diode circuit configured to absorb energy generated or converted from rotational kinetic energy, such as from the blower motor, which may be applied to charging a battery of the CPG device. According to another aspect of the present technology, a protection circuit 4250 may include a fault mitigation integrated circuit.

6.1.2.1.7 Memory

[0092] In accordance with one form of the present technology the CPG device 1002 includes memory 4260 (shown in FIG. 5), preferably non-volatile memory. The memory 4260 may include battery powered static RAM memory, volatile RAM memory, EEPROM memory, NAND flash memory, or any combination thereof. The memory 4260 can be located on a PCBA (not shown).

[0093] Additionally or alternatively, the CPG device 1002 can include a removable form of memory 4260, for example, a memory card made in accordance with the Secure Digital (SD) standard.

[0094] The memory 4260 can act as a computer readable storage medium on which is stored computer program instructions expressing the one or more methodologies described herein, such as the one or more algorithms discussed herein.

6.1.2.1.8 Transducers

[0095] Transducers 4270 (schematically shown in FIGS. 4 and 5) may be internal to the CPG device 1002, or external to the CPG device 1002. External transducers may be located on or form part of, for example, the CPG device 1002, the conduit and/or valve interface 1008, and/or the compression garment 1004.

6.1.2.1.8.1 Flow rate

[0096] A flow rate transducer 4274 (shown in FIG. 5) in accordance with the present technology may be located in the CPG device 1002 and be based on a differential pressure transducer, for example, an SDP600 Series differential pressure transducer from SENSIRION. The differential pressure transducer is in fluid communication with the pneumatic circuit, with one of each of the pressure transducers connected to respective first and second points in a flow restricting element.

[0097] In use, a signal representing a total flow rate Q from the flow rate transducer 4274 is received by the central controller 4230. However, other sensors for producing such a flow rate signal or estimating flow rate may be implemented. For example, a mass flow sensor, such as a hot wire mass flow sensor, may be implemented to generate a flow rate signal in some embodiments. Optionally, flow rate may be estimated from one or more signals of other sensors described herein (e.g., speed and pressure sensor).

6.1.2.1.8.2 Pressure

[0098] A pressure transducer 4272 (shown in FIG. 5) may be located in the CPG device 1002 and be, in accordance with the present technology, in fluid communication with the pneumatic circuit. An example of a suitable pressure transducer is a sensor from the HONEYWELL ASDX series. An alternative suitable pressure transducer is a sensor from the NPA Series from GENERAL ELECTRIC.

[0099] In use, a signal from the pressure transducer 4272 is received by the central controller 4230. In one form, the signal from the pressure transducer 4272 is filtered prior to being received by the central controller 4230.

6.1.2.1.8.3 Motor speed

[0100] In one form of the present technology a motor speed signal from a motor speed transducer 4276 (shown in FIG. 5) is generated. A motor speed signal is preferably provided by flow/pressure device controller 4240. Motor speed may, for example, be generated by a speed sensor, such as a Hall Effect sensor.

6.1.2.1.8.4 Temperature

[0101] The temperature transducer(s) 4275 (shown in FIG. 5) may measure temperature of the gas in the pneumatic circuit. One example of the temperature transducer 4275 is a thermocouple or a resistance temperature detector (RTD).

6.1.2.1.9 Other Sensors

[0102] With continued reference to FIG. 5, in one form of the present technology, additional sensors 4271 may be coupled (e.g., wirelessly or wired) to the CPG device 1002 (e.g., via link 1006 or data communication interface 4280) such as for detection of bio-related conditions within the compression garment 1004. For example, as discussed in more detail herein, one or more sets of electrodes 4273 may be contained within the compression garment and provide measurements to the CPG device 1002 (e.g., central controller 4230). Such electrodes may be implemented to measure bioimpedance of the user in one or more zones of the compression garment 1004. Such electrode-based measurements may be evaluated, such as by the central controller 4230 or control device or other portal system, to determine body composition as an indication of condition of circulatory disorders (e.g. lymphedema). Similarly, as previously mentioned, one or more temperature sensors 4277 may be located in zones of the compression garment 1004 to measure a temperature associated with the zone to provide an indication of a skin temperature of the user in the particular zone. Such measurements may be provided, such as via wireless connection or a bus, to the central controller 4230, such as for creating a log of measurements and/or providing an adjustment to a compression protocol based on the measurements such as for the particular zone. The central controller 4230 or control device may also generate warnings (e.g., communications) to report a temperature, such as one exceeding a threshold, to inform a user or clinician (e.g., via a portal system) of a need for treatment (e.g., antibiotic for an infection). As discussed in more detail herein, in some versions, pressure sensors located throughout the garment, or tension or strain sensor(s) may also be implemented, with the tension or strain sensor(s) being used for measurement of compression strain within the compression garment 1004, such as for detecting limb girth or volume.

6.1.2.1.10 Data communication interface

[0103] A data communication interface 4280 (shown in FIG. 5) can be provided and connected to the central controller 4230. The data communication interface 4280 may be connectable to remote external communication network 4282. The data communication interface 4280 can be connectable to a local external communication network 4284. The remote external communication network 4282 is connectable to the remote external device 4286, such as a population management server communicating with multiple CPG devices. The local external communication network 4284 is connectable to the local external device 4288, such as control device 1010. The data communications interface 4280 may optionally include a wireless communications interface (e.g., a transceiver using a wireless protocol such as Bluetooth, WiFi, Bluetooth LE etc.), such as for communications with the control device 1010, such as when it serves as the local external device 4288. Optionally, such a data communications interface 4280 may communicate, e.g., wirelessly, with one or more sensors of the compression garment 1004 and/or one or more active valves of, or coupled to, the compression garment 1004.

[0104] In one form, data communication interface 4280 is part of the central controller 4230. In another form, data communication interface 4280 is an integrated circuit that is separate from the central controller 4230.

[0105] In one form, the remote external communication network 4282 is a wide area network such as the Internet. The data communication interface 4280 may use wired communication (e.g. via Ethernet, or optical fibre) or a wireless protocol to connect to the Internet.

[0106] In one form, local external communication network 4284 utilises one or more communication standards, such as Bluetooth, or a consumer infrared protocol.

[0107] In one form, the remote external device 4286 is one or more computers, for example a cluster of networked computers. In one form, the remote external device 4286 may be virtual computers, rather than physical computers. In either case, such remote external device 4286 may be accessible to an appropriately authorised person such as a clinician. [0108] In one form, additional sensors (e.g., the sensors 4271) can be communicatively coupled via the data communication interface 4280. The sensors 4271 can reside in, or be coupled to, the compression garment 1004 and generate signals for processing by the central controller 4230.

[0109] The local external device 4288 can be a personal computer, mobile phone, tablet or remote control.

6.1.2.1.11 Output devices including optional display, alarms, active valves

[0110] An output device 4290 (shown in FIG. 5) in accordance with an example of present technology may optionally take the form of one or more of a visual, audio, haptic unit(s) and/or a valve driver for a set of active valves such as the pneumatic valves of the interface 1008, which may be integrated with the CPG device 1002, the compression garment 1004 and/or a discrete device board serving as the interface 1008. Each of such active valves may be a pneumatic valve configured to receive a control signal to directionally gate and/or proportionally permit transfer of air selectively through the valve.

[0111] For example, as discussed in more detail herein, the output device 4290 may include one or more valve driver(s) 4295 for one or more active valves or one or more active valve(s) 4297. Such output devices 4290 may receive signals from the central controller 4230 for driving operation of the valves 4297. Such valve driver(s) 4295 or valves 4297 may be discrete from the CPG device 1002 external housing and coupled to the CPG device 1002 via a bus, such as a Controller Area Network (CAN) bus such as where the central controller 4230 includes a CAN bus controller. A suitable electrical coupler portion of link 1006 may serve to couple the bus with the valve driver 4295 and/or valves 4297. The active valves may be any suitable pneumatic valve for directing air flow, such as a gate valve, a multi-port valve, or a proportional valve, any of which may be operated by an included solenoid. In some implementations, the active valves 4297 and valve drivers 4295 may be within the CPG device 1002 housing or in a discrete housing of an interface (e.g., conduit and/or valve control interface 1008) or in the compression garment 1004.

[0112] An optional visual display 4294 may be a Liquid Crystal Display (LCD) or Light Emitting Diode (LED) display. An optional display driver 4292 (shown in FIG. 5) may receive as an input the characters, symbols, or images intended for display on the display 4294, and converts them to commands that cause the display 4294 to display those characters, symbols, or images. In some forms, visual display 4294 may be a touch screen. [0113] The display 4294 (shown in FIG. 5) may optionally be configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 may be an eight-segment display, in which case the display driver 4292 converts each character or symbol, such as the figure “0”, to eight logical signals indicating whether the eight respective segments are to be activated to display a particular character or symbol.

6.1.2.2 Flow/pressure device

[0114] In a preferred form of the present technology, the flow/pressure device 4245 (FIG. 5) is under the control of the flow/pressure device controller 4240 (e.g., a therapy control module) to generate therapy to the compression garment 1004 worn by a user (e.g., a patient). In some implementations, the flow/pressure device 4245 is the flow/pressure generator 4140 (FIG. 4), such as a positive air pressure device that can generate negative pressure.

6.2 COMPRESSION GARMENT

[0115] As described herein, a compression garment 1004 in some implementations includes one or more pneumatic chambers that may be inflated and/or deflated by operation of the CPG device 1002 via one or more pneumatic lines leading to the pneumatic chambers of the compression garment 1004. Such activation may be implemented with one or more active valves and/or passive valves. The garment may typically be lightweight, flexible and washable and may employ a compression fabric. Structures of compression garment devices for circulatory therapy are described in International Application No. PCT/US2022/012624, filed January 14, 2022, which is hereby incorporated by reference herein in its entirety.

[0116] In some implementations, the garment is formed with two or more layers, such as at least an inner layer (e.g., inner sleeve) and an outer layer (e.g., outer sleeve) that may be coupled together to assist with forming an air chamber. The garment may be manufactured with a breathable fabric, serving as an inner skin contact interface. Such a material may serve as a barrier to direct user contact with a less permeable material that forms a set of pneumatic chambers of the garment. In some implementations, one or more layers of the garment (e.g., the skin contacting layer) may include polyester, elastane, nylon, and thermoplastic polyurethane (TPU). In some such implementations, the TPU is used as a backing to aid in making the garment airtight or near airtight. The proportion of polyester, elastane, and nylon can be adjusted to modify the elasticity of the garment (e.g., the skin contacting layer). In some implementations, a weave technique of one or more layers of the garment can be adjusted to modify the elasticity of the garment.

[0117] The chambers and pneumatic pathways may be formed between two layers. In some forms, the outer layer may be made of a three-dimensional knitted fabric. The outer layer may include one or more moulded portions, such as in a form of a brace, to more rigidly support certain anatomical regions of the limb (e.g., a forearm brace or leg brace) such as along one side of the sleeve. Some areas of the garment may include stretchable or flexible regions to permit movement (e.g., elbow, wrist, ankle or knee regions). Moreover, moulded portions may include pneumatic couplings and/or pneumatic pathways. Such component regions (e.g., of thermoplastic elastomer TPE such as Santoprene) may be sewn into the fabric of the garment, co-moulded, or ultrasonically welded to the fabric.

[0118] The garment may be generally formed as a sleeve that can be applied around the bodily area (usually a limb) for administering the therapy. For example, it may be an arm sleeve, a partial arm sleeve, an above-the-knee leg sleeve, a full leg sleeve, a foot sleeve, a toe-to-thigh sleeve, an ankle-to-knee sleeve, etc.

[0119] The compression garment 1004 can include a set of pneumatic chambers that are sized and located to promote a desired compression therapy. The depicted compression garment 1004 (FIG. 1 A) is a lower leg type compression garment with a partial upper foot portion and a leg portion that each provides different sets of chambers or cells for separately compressing discrete portions of the foot and/or leg that are covered by the compression garment 1004. These chambers may be activated in zones, such as a set of chambers in a knee-thigh zone KTZ, a set of chambers in a calf-knee zone CKZ, and a set of chambers in a foot-calf zone FCZ.

[0120] The pneumatic chambers may be formed with a material having baffles (e.g., chamber material folds) to more readily permit a vertical expansion of the chamber. The pneumatic chamber may be box shaped with one or more edge folds, such as at each of an inlet end and an outlet end. Such folds may also be at sides of the chamber (not illustrated). Such folds can permit a more uniform rising of the user side surface of the box to provide a more evenly applied compression surface area such as when compared to a more rounded, balloon-shaped type of chamber. Each chamber can provide an isolated compressive force at the surface of the chamber in contact with a user from inflation of the pneumatic chamber, such as in relation to activation of an active valve and/or passive valve, in the location of the inflation. Multiple chambers can be activated to distribute the compressive force. They may also be sequentially activated to move the location of the compressive force. [0121] The compression garment(s) of the present disclosure may also include, or be configured to retain, pneumatic pathways (such as in moulded portions) or conduits inserted therein to fluidically couple pneumatic connecting lines, such as from the interface 1008 and/or the CPG device 1002 for pneumatic purposes, to the pneumatic chambers of the compression garment. Such pathways may also couple a plurality of discrete pneumatic chambers together, such as when the chambers are separated by a passive valve. In some versions, one active valve may direct gas flow via such a conduit or pathway in relation to one pneumatic chamber or in relation to a group of pneumatic chambers. Thus, a pathway of the compression garment may couple a group of pneumatic chambers or a single pneumatic chamber. Thus, in some cases different active valves may be coupled to different pneumatic chambers or different groups of pneumatic chambers via pathways of the compression garment. In some versions, the compression garment may include integrated active valves distributed throughout the compression garment. In some versions, the integrated active valves may be located adjacent to each other in a centralised location, which may be part of the garment, or be separate from the garment referred to as “pneumatic spine” of the garment. In some versions, the compression garment may include couplers for attachment of pneumatic conduits and/or electrical lines such as to the integrated active valves.

[0122] Garment-based valving confers a number of advantages on a compression garment. It allows for link 1006 to be a single conduit interface pneumatically interfaced to the garment 1004, along with electrical connections to each of the distributed active valves. This enables the overall system, and specifically the link 1006 between the device 1002 and garment 1008, to be lighter and less bulky.

[0123] The compression garment(s) of the present disclosure may also include sensors, such as pressure, strain, flow rate, temperature, electrodes, or any combination thereof. When measuring skin characteristics, such sensors may be located on a layer of the compression garment to permit skin contact. For example, a temperature sensor, strain sensor and/or a set of electrodes may be in one or more of the zones of the compression garment such as at an inner layer of the garment. Integrated pressure, flow rate, and/or temperature sensors may be located to measure a characteristic of the pneumatic pathway(s) of the garment. In some versions, strain sensors may be implemented in the garment to measure compression strain of the garment in one or more different zones of the garment. Measurements from such sensors may be used for monitoring the effectiveness of the compression therapy and/or for modifying the operation of the CPG device 1002. [0124] Various configurations of the compression garment(s) of the present disclosure can be provided based on the type of compression therapy and target portion of the body of the user (e.g., patient).

[0125] In some implementations, a compression garment 1004 can include a barbed-type pneumatic coupling for establishing a pneumatic connection between the compression garment 1004 and the CPG device 1002 via the link 1006. Such a pneumatic coupling may be co moulded with the exo-skeleton structure, sewn/stitched into the fabric or ultrasonically welded to the fabric.

[0126] In some versions of the compression garment 1004, one or more anatomically shaped pneumatic chambers may provide muscular based zones (anatomically shaped surfaces of the pneumatic chambers) for focused compression therapy. Such muscular based zones, such as for location at the major muscle groups of the arms or legs, can provide targeted manipulation of each muscle area to support lymphatic function and blood flow. In some versions, knitted fabric can separate the set of pneumatic chambers (one or more) in each muscle zone from other muscle zones.

[0127] In some implementations, the compression garments of the present disclosure comprise anatomically shaped chambers based on the key points which a physical therapist focuses on when performing Manual Lymphatic Drainage (MLD). As an example, for Lower Limb lymphedema, these points may be inner to outer thigh, behind the knee, the sides of the calf, around the ankle and extremities. This enables the system 1000 to emulate MLD accurately. Such points may each be implemented as one or more zones and may be configured with active and/or passive valves to produce the desired directional manipulation of the points as previously discussed.

[0128] In some implementations, the compression garments of the present disclosure may be implemented with a modular configuration to permit use of multiple garments with a common CPG device 1002.

[0129] In some implementations, a modular compression garment can include an upper leg compression garment, a lower leg compression garment, and/or a boot or foot compression garment. An upper leg compression garment and lower leg compression garment can have a chaining interface located in a region of the respective garments for direct coupling to a conduit and valve interface of a neighbouring garment. Thus, compression therapy of the several garments may be implemented by bussing signals (pneumatic and electrical) through the respectively coupled garments with a single CPG device 1002 connected to the modular compression garment via an interface. [0130] In some versions, the compression garment, such as at its inner surface, may include, or form, one or more applicator(s). Such applicator(s) may be in contact (directly or indirectly) with the user’s skin. Such applicator(s) may be a flexible rigid structure (e.g., a ridge(s), rib(s) or bump(s)) that may extend along one or more length of, and/or one or more areas of, the compression garment. Such a rigid structure will typically be more rigid than a user’s skin. Such a structure(s) can provide a focused manipulative force when mechanically pressed into the user’s skin by the inflation of one or more particular adjacent pneumatic chambers of the compression garment. Some versions of the applicator have a curving or wavy configuration along the length of the applicator. An applicator may have a contact surface profile that includes hills and valleys relative to the user’s skin. An applicator may have a contact surface profile that snakes or curves along the length of the user’s limb at the contact surface of the user’s skin (such as without hills and/or valleys relative to the skin surface). An applicator, or a series of applicators, may extend over several pneumatic chambers (e.g., two or more, such as three, four, five, six, etc.) of the compression garment. Thus, a sequential activation of the pneumatic chambers can urge the applicator to apply an advancing manipulative force, at the skin-applicator contact area, that advances the manipulative force in a direction of the sequential activation of the pneumatic chambers and along the profile or shape (e.g., curved) of the applicator.

[0131] In some implementations, the compression garments of the present disclosure include air chambers with micro-holes (perforations), which allows air to be diffused out at a controlled rate to provide a cooling and drying effect on the skin. The micro-holes may be evenly distributed throughout the compression garment. Alternatively, the micro-holes may be concentrated in areas where skin is more temperature sensitive, such as at the back of the knee, and/or in areas prone to sweating, such as, for example, skin folds.

[0132] In some implementations, the compression garments of the present disclosure include an open or perforated conduit along the inner layer, such that air flow from the CPG device 1002 and/or exhaust air flow from the pneumatic chambers to atmosphere can be directed through this cooling conduit with the aim of providing a cooling and drying impact on the skin. As with the distribution of micro-holes, the cooling conduit perforations may be evenly distributed throughout the garment. Alternatively, the cooling conduit perforations may be concentrated in areas where skin temperature sensors are denser, such as at the back of the knee, and/or in areas prone to sweating, such as, for example, skin folds. 6.3 MICRO-PUMPED SYSTEM

[0133] An alternative implementation of the system 1000 has micro-pumps embedded into the air chambers enclosed within the garment 1004. When electrically activated by the CPG device 1002 or control device 101, wirelessly or via control lines in the link 1006, the micro-pumps fill the chambers with air and compress the limb. In such an implementation the link 1006, there is strictly no need of CPG device 1002 and/or pneumatic conduit between the CPG device 1002 and the garment 1004. In FIG. IB, an alternate arrangement could have the micro-pump (sometimes referred to as an ultrasonic piezoelectric disc-pump) integrated in as part of the valve interface (1006b). In such an implementation, there would be no need for the CPG device 1002 and/or tube 1006a. The control of the pump and subsequent delivery of therapy would be controlled by the valve interface.

6.4 NON-PNEUMATIC SYSTEMS

[0134] In alternative implementations, a compression therapy system may be driven by non pneumatic methods and/or a hybrid of non-pneumatic and pneumatic methods. The main advantage of such implementations is a high resolution on where the compression is applied, without the need for valves and pneumatic blocks.

6.5 CPG DEVICE ALGORITHMS (DIAGNOSTIC AND THERAPY CONTROL) [0135] The central controller 4230 (FIG. 5) of the CPG device 1002 may be implemented with algorithms in processes or modules to implement the functions of a therapy, diagnostics, and/or monitoring device such as for providing compression as part of a therapy or a diagnostics procedure with one or more of the compression garments. Such methodologies of the controller may implement Lymphedema therapy and/or Lymphedema monitoring. Any one or more of the following example process modules may be included.

6.5.1 Diagnostics Sensing/Monitoring Module(s)

[0136] Using the data from any of the sensors previously described, and optionally other user input to CPG device 1002 and/or control device 1010, the central controller may be configured, such as with one or more detection or sensing module(s), to determine characteristics related to circulatory disorders (i.e. lymphedema). For example, the controller may determine pneumatic impedance, pneumatic resistance, skin/body composition (e.g., fluid versus fat), skin density, skin temperature, bioimpedance, compression garment related volume (limb volume), compression garment related strain (limb girth) and compression garment fit, in one or more monitoring sessions. Such measures may be determined and recorded over hours, days, weeks, months, years, etc. As discussed in more detail herein, such determined characteristics may then serve as input to a therapy module to determine control parameters for setting and controlling a compression therapy session (e.g., type of therapy and settings of therapy). Such measures may also be communicated to a clinician and/or user via the control device and/or portal system for further evaluation.

6.5.2 Therapy Modes Module(s)

[0137] The controller of the CPG device 1002, such as central controller 4230, may be configured to select between different therapy operations modes depending on which compression garment(s) of the present disclosure is/are connected to the CPG device 1002 and/or based on the conditions detected by one or more sensors. Such modes may depend on the number of zones of active valves coupled to the system. Such mode selections may be implemented by the controller in conjunction with clinician or user input (e.g., manual settings of the user interface of the CPG device and/or control device and/or transmitted from a portal system) and measurements from the sensors as previously described. Example control parameters of the controller that may be adjusted include, for example, the type (protocol) of compression therapy, pressure setting parameters, pressure waveform parameters, valve activation parameters such as for activation of zones at different times, and therapy time parameters. Examples of types of compression therapy are described in more detail herein.

6.5.2.1 Applicator Manipulation therapy

[0138] In some versions, the CPG device 1002 may be configured with a control protocol for control of one or more compression garments to provide an applicator manipulation therapy. To provide the applicator manipulation therapy, the controller may selectively activate the blower and/or valves to produce compression (e.g., vibrations) in a desired directional manner so as to induce a desired movement of the applicator on the patient’s skin with sequential pressurization of the pneumatic chambers. One example of applicator manipulation provides a massage therapy that emulates the manual massage performed by physical therapists on lymphedema patients. In such an example, the controller may set the motor of the blower so that the CPG device 1002 produces a positive pressure according to a pressure setting (e.g., a predetermined pressure or a pressure determined based on a previous evaluation of sensor data). The controller may then actively inflate a first zone by activating its valve(s) (open) to direct the pressurized air to the pneumatic chamber(s) of the zone. Such a pressure may optionally be varied by the controller according to a pressure waveform (e.g., sinusoidal or other) to induce a vibratory pressure inflation/deflation wave in the first zone. Such a pressure waveform may optionally be achieved by increasing and decreasing motor current of the blower and/or by opening and closing of the first zone active valve(s). Opening a dedicated zone valve or a central valve to atmosphere is another way to reduce delate one or more chambers of a zone. This inflation/deflation permits the applicator to move to provide a localized force into the patient’s skin responsive to the inflation/deflation. During this time, the controller may refrain from adjusting the active valves of other zones of the compression garment. Such control operations with the first zone may operate for a predetermined time (such as a fraction of the total desired therapy time.)

[0139] After the predetermined time, such a pressure control of the first zone may cease, such as by closing the active valves of the zone to maintain pressure in the zone or allowing the zone to deflate (e.g. partially to a second but lower positive pressure or completely to ambient pressure). The controller may then begin a similar pressurization routine with another zone, such as the next neighbouring zone of the first zone. This may repeat the control as described with reference to the first zone but controlling the valves of the neighbouring zone over a second predetermined time, which may be approximately equal to the first predetermined time. In this manner, the controller may sequentially activate the zones of the compression garment in a predetermined order. Preferably, such an ordering of control by the controller of the different zones of the compression garment provides a sequential progression applying the applicator along the limb of the patient toward the trunk of the patient as a therapy. Thus, the zones may be sequentially activated toward a trunk end (e.g., closer to the patient’s trunk) of the compression garment (e.g., away from an extremity end (further from the patient’s trunk) of the compression garment).

[0140] This process may be repeated by the controller so that the therapy may cycle through each of the zones any number of times. Such a number of repetitions may be set as a pre programmed control parameter for the therapy or by a user input. Optionally, such repetition of a cycle of the applicator manipulation therapy may be based on the controller determining the presence of a certain level of swelling such as with any of the previously described diagnostic processes. For example, any one or more of the resistance, impedance, bioimpedance, girth, volume, skin/body composition, etc. sensing measures may be determined and evaluated by the controller after a cycle of therapy and the evaluation may trigger a repeat of the cycle or a termination of the therapy session. Similarly, the controller may determine whether to adjust the applied compression pressure level(s), such as to be higher, lower, or the same pressure level(s) depending on the evaluation of the sensor measurements. As previously mentioned, such repeated cycles may be controlled to be repeated for one, several or all of the zones of the garment depending on the measurement results of each zone. Instead of alternating the activation of various zones, two or more zones may be so activated that they are simultaneously pressurised for a predetermined length of time. In this case a plurality of zones may be pressurised in a specific sequence, then kept pressurised for a predetermined time, and then depressurised according to the same, or a different, sequence.

[0141] Optionally, such a massage therapy protocol may be provided by the controller as described with a compression garment that does not include any applicator.

6.5.2.2 Gradient Therapy

[0142] In some versions, the CPG device 1002 may be configured with a control protocol for control of one or more compression garments to provide a gradient therapy such as by controlling the valves of multiple zones to provide a pressure compression gradient that may be static or zero, for a desired therapy time. A compression garment may be configured with multiple zones that can be separately activated by the controller of the CPG device 1002 (electrically and/or pneumatically). These zones may optionally include one or more applicator(s) as previously discussed. The compression garment may have fewer or more such zones. In such an exemplary therapy protocol, the controller may be configured to set the pressure of the zones to different levels, such as a different level in each zone. Thus, the controller may be configured to set a first pressure in a first zone, a second pressure in a second zone, a third pressure in a third zone, etc. These set pressures may be different pressure levels (e.g., have a different positive pressure value in some or all of the zones). Optionally, such pressures may be set so as to enforce a pressure compression gradient across a plurality of zones of a compression garment. For example, the third pressure may be greater than the second pressure, and the second pressure may be greater than the first pressure, etc. The zones in question are usually adjacent, but this does not have to be the case. Optionally, such a gradient (increasing or decreasing) may be set in the compression garment 23004-B across adjacent zones extending along the length of the garment, so that its increase or decrease extends along the length of the user’s limb. Such an increase set by the controller over the different zones of the compression garment can provide the gradient so that the pressure decreases along the limb of the patient toward the trunk of the patient or toward a trunk end of the compression garment. Thus, the higher pressures may be in the distal portion of the limb (further from the trunk) and the lower pressures may be in the proximal portion of the limb (closer to the trunk). Alternatively, the controller may set such a gradient with a pressure decrease in the different zones of the compression garment so that the pressure increases along the limb of the patient toward the trunk of the patient or the trunk end of the compression garment.

[0143] In one example to provide the gradient therapy, the controller may be configured with a module or process that sets the zones to the gradient. For example, the controller may selectively activate the blower and/or valves to produce a pressure compression gradient by pressurization of the selected pneumatic chambers. Upon activation of the blower (or CPG device 1002), the controller may initially control the blower motor, such as in a pressure control loop, at a first pressure setting. During this time, the controller may direct a flow of pressurized air to a first zone, by controlling an opening of one or more active valves associated with the first zone. When the measured pressure achieves the desired level associated with the first pressure setting, the controller may then control the one or more active valves associated with the first zone to close. This may permit the first pressure to be maintained in the pneumatic chamber(s) of the first zone.

[0144] Next, the controller may control the blower motor, such as in a pressure control loop, at a second pressure setting that is higher than the first pressure setting. During this time, the controller may direct a flow of pressurized air to a second zone, such as second zone, by controlling an opening of one or more active valves associated with the second zone. When the measured pressure achieves the desired level associated with the second pressure setting, the controller may then control the one or more active valves associated with the second zone to close. This may permit the second pressure to be maintained in the pneumatic chamber(s) of the second zone.

[0145] This process may be repeated to set the pressure in each succeeding zone (e.g., zone three to zone seven) to a higher (or lower) pressure than the preceding zone, until the pressure is set in each zone according to the desired gradient. Optionally, the CPG device 1002 may be disengaged once the zones have been set at the desired pressure levels. The CPG device 1002 may then permit this pressure gradient therapy state to be maintained for a predetermined therapy time or some modified time in relation to the diagnostics process(es) as previously described that may optionally be engaged by the controller and the sensors to adjust the therapy time. Upon expiration of the therapy time as evaluated by an internal processing clock of the controller, the controller may then control the valves of all of the pressurized zones of the compression garment to open to release the compression pressure in each of the zones. Optionally, such a gradient therapy process may be repeated any desired number of times, with a predetermined period of rest (depressurization) between each pressurization cycle that achieves the desired gradient. In some arrangements, the zones may be pressurised not sequentially, but simultaneously - each to its respective pressure so that the predetermined gradient is achieved.

[0146] The gradient therapy cycle may be repeated by the controller so that the therapy may be provided any number of times for a therapy session. Such a number of repetitions may be set as a control parameter for the gradient therapy such as by a manual input to the CPG device 1002. Optionally, such repetition of a cycle of the gradient therapy may be based on the controller determining the presence of a certain level of swelling, which could be detected by one of diagnostic processes to be described later in text. For example, any one or more of the resistance, impedance, bioimpedance, girth, volume, skin/body composition, etc. sensing measures may be determined and evaluated by the controller before or after a cycle of gradient therapy and the evaluation may trigger a repeat of the cycle or termination of the therapy session or modification of one or more pressurization parameters, such as the number and the location of the pressurised zones. Similarly, the controller may determine whether to adjust one or more parameters of the applied compression pressure gradient (e.g., the maximum and/or minimum pressure of the gradient, the gradient steps, the location coverage of each step (pressure level) etc.) depending on the evaluation of the sensor measurements. As previously mentioned, such repeated cycles, may be controlled to be repeated for several or all of the zones of the garment depending on the measurement results of one or more zones.

6.5.2.3 Adaptive Lymphatic Drainage therapy

[0147] In some versions, the CPG device 1002 may be configured with a control protocol for control of one or more compression garments in an Adaptive Lymphatic Drainage therapy mode. The Adaptive Lymphatic Drainage therapy mode includes two phases - a Lymph Unload Phase and a Clearance Phase - and is designed to emulate Manual Lymphatic Drainage therapy as performed by a therapist. The aim of the Lymph Unload Phase is to clear the proximal lymph vessels, such that fluid from the distal areas can be received and ultimately transported through to the circulatory system. To achieve this, the compression garment may comprise a number of sections, such as where each section may have one or more zones. [0148] For example, a compression garment can include four discrete sections (zones), with each section comprising a grouping of air chambers. Activation of a one section (e.g., the first section) and activation of another section (e.g., the second section) is implemented. The Lymph Unload phase begins with the most proximal section, where an oscillatory compression waveform traverses through the chambers in a predetermined or prescribed order. For example, the first chamber will be pressurized first and then the second chamber will follow. As the second chamber is pressurized, the first chamber will be deflated and a third chamber will follow. The same process is repeated in the next section. One aim of an oscillatory waveform is to maximise the level of stimulation provided to the lymph vessels, such that fluid transport can be encouraged.

[0149] Following the Lymph Unload phase, the Clearance phase will begin, with the same waveforms being applied, this time progressing from pressurizing distal sections to pressurizing proximal sections. Thus, in this phase, control of each successive section advances (e.g., section-by-section) in a proximal (e.g., upward) direction, while control of each successive chamber within each section advances (e.g., chamber-by-chamber) in a distal (e.g., downward) direction.

[0150] The time spent pressurizing each section and chamber, and the number of cycles through each phase, may be determined in different ways. One method pressurizes each chamber for 10 seconds and repeats the Lymph Unload phase 5 times, before progressing to the Clearance phase. Alternatively, an adaptive and/or dynamic method receives diagnostic data on the limb condition (e.g., from sensors of the system), such as limb volume, limb girth, etc., allowing the method to adapt various therapy parameters (e.g. the pressure response, the timing etc.). For example, if after the Lymph Unload phase the sensor data suggests that limb volume has gone down sufficiently, the adaptive method could immediately move to the Clearance phase. Alternatively, the adaptive method could cycle through the Lymph Unload phase several more times before progressing to the Clearance phase. In this way, the adaptive method may adapt the level of pressure required and the time spent in each chamber, section, and phase of therapy depending on the patient condition.

6.5.2.4 Walk mode

[0151] Often when patients have completed their massage therapy session and/or want to disconnect from the CPG device 1002, for example, in order to resume their daily routine, they require a degree of static compression in order to ensure that lymphatic fluid doesn’t come back into the extracellular space. To achieve this, a walk mode therapy pre-inflates the compression garment to allow the patient to seamlessly continue with their routine without having to remove their compression garment and change to another, passive garment. The pre-inflate pressure(s) and/or pressure gradient may be predetermined or customizable as per the patient’s needs as previously described. 6.5.3 Control module

[0152] In some implementations of the present disclosure, the flow/pressure device controller 4240 (shown in FIG. 5) receives as an input a target compression pressure Pt, such as per zone, and controls the flow/pressure device 4245 (FIG. 5) to deliver that pressure in relation to a control of one or more active valves. The pressure may be delivered to all of the zones of the compression garment simultaneously or separately according to the timing of the operations of a valve control algorithm (e.g., diagnostic sensing or therapy control protocol) of the controller as described herein.

6.5.4 Detection of fault conditions

[0153] Optionally, in one form of the present technology, the central controller 4230 (FIG. 5) executes one or more methods for the detection of fault conditions. The fault conditions detected by the one or more methods may include at least one of the following:

• Power failure (no power, or insufficient power)

• Transducer fault detection

• Failure to detect the presence of a compression garment component

• Operating parameters outside recommended or plausible sensing ranges (e.g. pressure, flow, temperature)

• Failure of a test alarm to generate a detectable alarm signal.

[0154] Upon detection of the fault condition, the corresponding algorithm signals the presence of the fault by one or more of the following:

• Initiation of an audible, visual and/or kinetic (e.g. vibrating) alarm

• Sending a message to an external device

• Depressurizing the compression garment (e.g., opening the valves and/or evacuating the pneumatic chambers).

• Logging of the incident

[0155] According to another aspect of the present technology, the central controller 4230 omits a software module for detecting fault conditions. Rather, as discussed earlier, the detection of fault conditions may be handled exclusively by the fault mitigation integrated circuit that is separate from the central controller 4230. In some cases, the fault mitigation integrated circuit may serve as a redundant backup to similar fault detection/mitigation module with algorithms processed also within the central controller. 6.6 CONTROL DEVICE APPLICATION

[0156] The system 1000 may include a control device 1010 (FIG. 1 A) (e.g., a mobile phone or tablet computer) for running an application concerning operations with the CPG device 1002; receiving feedback from, and presenting information to, the user; communicating with external servers and interface with one or more compression garments of the present disclosure (e.g., compression garment 1004). Thus, the control device 1010 may include integrated chips, a memory and/or other control instruction, data or information storage medium for such an application. For example, programmed instructions or processor control instructions encompassing the operation methodologies of the control device described herein may be coded on integrated chips in the memory of the device or apparatus to form an application specific integrated chip (ASIC). Such instructions may also or alternatively be loaded as software or firmware using an appropriate data storage medium. Optionally, such processing instructions may be downloaded such as from a server over a network (e.g. the Internet) to the processing device such that when the instructions are executed, the processing device serves as a screening or monitoring device. Thus, the server of the network may also have the information storage medium with such instructions programmed instructions or processor control instructions and may be configured to receive requests for downloading and transmitting such instructions to the control device. In some versions, a portal system described herein may be such a server.

6.7 PORTAL MANAGEMENT SYSTEM

[0157] The portal system 2028 (FIG. 2) may be implemented, such under the control of a clinician or provider, to manage a population of users of compression therapy systems. A clinician or other provider (e.g., health care provider) can serve multiple patients such as by screening patients by medical check-up and prescribing treatment with compression therapy systems 1000 (FIG. 1A). For example, the provider may test a patient using a diagnostic process of a compression therapy system described herein and such testing data along with patient identification information may be uploaded to the portal system server application. Clinical data and therapy information from continued use of the system 1000 by the patients can also be uploaded to the portal system 2028 as previously described. The clinician or provider, having access to the portal system 2028, can then use the portal to help customize care to the individual patient’s needs via the portal system 2028. For example, body metrics (e.g., body composition, girth, etc.) collected using the system 1000 can be transferred to the portal system 2028, which when combined with medical data of the patient, can drive the system 1000 to change settings and therapy parameters to customize the patient’s therapy regimen such as by the automated application of the system 1000 and/or by the guidance of the provider or clinician. Notification of care changes can be made to the patient within the portal system 2028, which in turn can communicate with the control device(s) (e.g. control device 1010) for changing settings of the CPG devices (e.g., CPG device 1002). In some examples, body metric data maintained by the system 1000 may include: body composition, skin density, skin composition, impedance, volume, girth, resistance, swelling, bioimpedance, temperature, etc., or any combination thereof.

[0158] The portal system 2028 may also utilise data analytics methods to personalize care plans. The portal could utilise patient history, therapy data and any diagnostic data to automatically recommend and/or adjust treatment plans. An example of this could be to incorporate data coming from an Indocyanine-Green (ICG) scan, which maps out the flow of fluid through the lymphatic networks. This data could provide information on how to personalize the compression waveform for a particular patient, such that applied direction of compression matches the natural flow of the lymphatic system (as seen in the scan). Following the initial setup in this manner, as the portal system 2028 may receive data from a CPG device over time, as well as clinical data entered from the physician, the portal system 2028 could continue to adapt therapy patterns accordingly. This is one example of how the portal system 2028 can personalize care plans for a patient. Apart from therapy, the portal system 2028 can also recommend changes to exercise patterns, diet, and lifestyle.

6.8 EXEMPLARY ASPECTS OF COMPRESSION GARMENT SYSTEMS [0159] Compression garment systems, such as pneumatic compression garment systems, provide therapeutic relief for circulatory-related disorders, including lymphedema. For example, in some implementations, a pneumatic compression garment provides a pneumatic compression, including a gentle repetitive massage delivered by inflating (e.g., pressurizing) and deflating (e.g., depressurizing) cells (e.g., one or more air chambers), in a wearable garment wrapped or otherwise fitted about a user’s limbs (e.g., arm, leg, foot). For the circulatory- related disorder therapy to be effective, the wearable garment needs to be applied and remain secured onto the limb while the air chamber(s) are in an inflated state and a deflated state. The wearable garment (e.g., the compression garment 1004) should fit around the user’s limb at a given garment fit. The wearable garment, when inflated and deflated, modulates the limb volume (i.e., the volume of the user’s limb) at a given garment fit. A garment fit is a level of tightness (and/or looseness) of the garment when fit around a limb. When the garment is wrapped around the user’s limb, a circumference of the garment is referred to as the garment- adjusted size.

[0160] When referring to a measurement of limb volume, this measurement may be absolute or relative. That is, each technology may take an absolute reading of the current volume of the limb, calculating the limb volume to be some value (e.g., 5000 ml). Alternatively, a relative measurement of limb volume will use some reference point to determine the delta in volume, either qualitatively (e.g., a higher volume or a lower volume) or quantitatively (e.g., 50 ml larger volume or 50 ml smaller volume). This reference point may be previously recorded data from therapy, previously recorded data from an external source (such as a clinical measurement) or even statistical data representing some statistical average of a representative population (say people of similar gender, age etc.). In the most basic form, the data should show that there is a change, potentially not specifying the direction of the change. Furthermore, the measured limb volume may be the overall volume of the limb (when the pneumatic compression devices (PCD) encloses the entire limb) or just the volume of the portion of the limb enclosed by the PCD, in the case when the PCD encloses only a portion of the limb. In both cases, the change in volume provides desirable feedback for the patient’s condition.

6.9 DETERMINING A PARAMETER REPRESENTING A PHYSICAL SHAPE PROPERTY OF A LIMB

[0161] Turning now to FIG. 6, a flow diagram illustrating a process 6000 for determining physical shape properties of a limb of a user of a compression therapy system (e.g., the compression therapy system 1000), according to some implementations of the present disclosure, such as ones illustrated in FIGS. 7 and 8. At 6002, a pneumatic waveform is generated in one or more pneumatic chambers of a set of pneumatic chambers of a compression garment (e.g., the compression garment 1004). As discussed above, pressurized air can be provided to pneumatic chamber(s) of the compression garment 1004. The pressurized air can be provided over time at varied pressures, for example, the CPG device 1002 can produce positive pressure in a sinusoidal fashion to the compression garment 1004.

[0162] At 6004, signals indicative of pressure characteristics of pneumatic pressure and/or flow rate characteristics are received by or provided by one or more sensors. For example, the one or more sensors can be either part of the CPG device 1002, or be embedded in the compression garment 1004 for receiving the signals indicative of the pressure characteristics of the pneumatic pressure and/or the flow rate characteristics. In some implementations, pressure characteristics include pressure achieved within each chamber measured by a pressure sensor. In some implementation, flow rate characteristics include volume of gas (e.g., air) delivered to a chamber measured by one or more flow sensors.

[0163] At 6006, a parameter representing a physical shape property of a limb of the user of the compression garment is determined based at least in part on the received signals of 6004. The pressure and/or flow sensors embedded in the compression garment 1004 and/or the CPG 1002 can be used to determine the parameter representing the physical shape property of the limb. By knowing how much air is being pumped through one or more garment sections of the compression therapy system 1000 to achieve a given pressure and/or what pressure the compression garment 1002 is able to achieve by pumping a given volume of air into one or more chambers (or garment sections), the dimensions and/or volume (or the change in the dimension and/or volume) of the part of the limb around which the compression garment section(s) is wrapped can be determined. In some implementations, pressure differentials can be used to determine a respective change in the size (or volume) of the limb. If the same amount of air is being pumped through the compression garment 1004 at two different points of time, but two different pressures are being achieved, then a relationship between the measured pressure and the limb circumference can be determined. For example, a first pressure can be measured before a therapy session, and a second pressure can be measured after the therapy session. The difference between the first pressure and the second pressure can be indicative of a relative change in size of the limb, and therefore, a relative change in the limb’s volume. In some implementations, the second pressure being smaller than the first pressure indicates a decrease in limb volume.

[0164] In some implementations, absolute dimensions and/or volume of the limb or part of the limb is measured. For example, a characterisation map can be developed for translating, e.g. during a preliminary calibrating measurements, a parameter associated with the compression garment 1004 to a size of the limb. For example, the parameter associated with the compression garment 1004 can be an amount of air required to pump the compression garment 1004 to one or more specific pressures. The characterization map can be determined by and/or coded on the software running on a controller of the CPG device 1002 (e.g., the central controller 4230). The characterization map constructed can be stored in memory. Measurements taken by the sensor 4270 and/or any additional sensors will then be compared to the characterisation map to obtain an “absolute” measure dimensions and/or volume of the limb or part of the limb. [0165] Volume of pressurized air introduced in the compression garment 1004 (or a section or chamber of the compression garment 1004) is related to flow rate and/or pressure parameters. For example, flow rate can be plotted against time at a sampling rate (e.g., around 50 Hz, 100 Hz, etc.). An integration method (e.g., trapezoidal method or any other numerical integration method) can be used to approximate area under the curve for the flow rate to obtain volume of pressurized air. Using the trapezoidal method of integration, volume of pressurized air can be expressed as:

V _air is volume of pressurized air, Q(t) is flow rate as a function of time, t is time, At is time interval between two points (e.g., two flow rate samples), V _i-1 is volume calculated for a previous point, Q _t is the flow rate for the current point, and Qi- is the flow rate at the previous point. V _air can be affected by the size of the limb that the compression garment 1004 is wrapped around, with a larger sized limb having a smaller maximum V _air that can be pumped into the compression garment 1004 when compared to a smaller sized limb.

[0166] In some implementations, volume of pressurized air introduced in the compression garment 1004 can be characterized and related to volume of the limb and/or part of the limb. For example, one or more chambers (or a representative chamber) of the compression garment 1004 can be characterized for different cylinder volumes. That is, each chamber of the compression garment 1004 can be wrapped around different sized objects of different cylinder volumes and inflated to obtain maximum volume of pressurized air in the respective chamber. Maximum volume of pressurized air in the respective chamber is inversely related to the volume of the different sized objects. After obtaining data points, a regression model (e.g., a linear regression) can be applied to the obtained data points to determine a relationship between the volume of pressurized air in the compression garment 1004 and the volume of the object surrounded by the compression garment. In an example, V _object = U ₁ V _air + U ₂ , where V _object is the volume of the object surrounded by the compression garment (e.g., volume of the limb), and t/i and U ₂ are regression parameters. In one example, U ₁ = —2.4637 and U ₂ = 1.2397. [0167] FIG. 21 provides an example graph that relates volume of compression garment to volume of underlying cylinder that the compression garment is wrapped around. Air volume measurements in the compression garment provides different data points (e.g., data point 21002) for different sized cylinders. A regression model 21004 can be obtained that fits the obtained data points.

[0168] Thus, measuring the volume of air introduced into one or more chambers, or in the entire garment, provides an indication of the volume, or the change of volume, of the underlying limb wrapped by the respective chamber (or garment). For instance, if a smaller volume of air is needed to achieve the same pressure as in previous measurement, this may indicate a larger volume of the underlying limb (which may be reflective of a swollen limb and an indication of a worsening condition or an inefficient treatment). The above measurement has to take into account the residual volume of air that is in the garment at the beginning of the measurement process. For example, if the garment is not completely depressurised after a previous use, a substantial volume of residual air may remain in the garment, which could potentially interfere with the new measurement. This can be mitigated by treating the residual air as a constant (an offset) in the above described measurement. For this purpose, one needs to ensure that approximately the same volume of air remains in the garment after each depressurisation. One practical way of achieving that is by depressurising the garment for the same amount of time after each treatment session. Because one can insure a constant residual volume of air in the garment after each depressurisation, an indication of the volume of the underlying limb may also be obtained by measuring not the volume of air introduced in the garment during the most recent pressurisation process, but by measuring the total volume of air in the garment (including the residual, plus the newly introduced volume) after the pressurisation.

[0169] At 6008, a follow-up action is initiated based at least in part on the determined parameter. In some implementations, therapy can be adjusted. For example, the pressure setting/s of the compression therapy system can be increased or can be decreased. In another example, more pressurized air can be pumped into the compression garment. In another example, the duration of therapy can be adjusted (i.e., duration of therapy can be increased or can be decreased). In another example, the specific pressure wave function used during the therapy session and/or the frequency of therapy sessions can be adjusted (i.e., therapy sessions can be scheduled to be more frequent or less frequent). Alternatively, or in addition to modifying the therapy parameters, a notification may be sent to the user, or to a remote server and /or a third party, such as a medical practitioner, notifying them of the change in the measured limb size/volume.

[0170] In some implementations, the signals indicative of pressure characteristics and/or flow rate characteristics of 6004 can be used for diagnostics and monitoring. For example, measurements by the one or more sensors (e.g., the additional sensors 4271, the temperature transducers 4275, the pressure transduce 4272, the flow rate transducer 4274, etc.) can be used for data collection to monitor changes and/or trends over a certain time period. These measurements may be recorded in a device log, an application (i.e. a smart phone application), or sent to a clinician for monitoring. These measurements may be viewed using the control device 1010. The determined parameter of 6006 can be recorded as well for data collection to monitor changes and/or trends over a certain time period. The trend information provided can be simply saved locally and/or on a remote server, and/or sent to the user, a clinician or a caretaker. The trend information can be displayed on a smartphone, laptop, desktop, etc. The trend information can be used to alter a treatment parameter (e.g., alter pressure, flow rate, etc.) or another aspect of the circulatory disorders (i.e. lymphedema) management. The treatment parameter based on trend information can be altered in the same, or a next therapy session. In some implementations, the trend information used for altering the treatment parameter can be based on four therapy sessions, five therapy sessions, ten therapy sessions, etc. Each determined parameter of 6006, as well as an identified trend (say slope) can be also compared to a threshold. If the parameter exceeds a predetermined threshold, an alert may be sent to the user or a third party, indicating the event. Such an alert may be used by e medical practitioner to intervene in therapy, or may trigger the sending of notification - asking the user to seek further medical attention, or congratulating the user for a substantial improvement etc. The alert may also be used as a parameter to modify the delivered therapy by the CPG device 1002 as part of an adaptive therapy algorithm (described previously).

[0171] FIG. 7 illustrates a compression therapy system 7000 including the CPG device 1002 capable of measuring pressure and/or flow, according to some implementations of the present disclosure. The compression therapy system 7000 provides an example system that can be used to perform the process 6000 of FIG. 6. Optionally, the control device 1010 couples to the CPG device 1002 as discussed above in connection with FIGS. 1A and IB. The CPG device 1002 includes pressure sensors and a flow sensor (e.g., a flowmeter). The compression therapy system 7000 includes a first tubing 7002 that connects the CPG device 1002 to a valve box 7004. The compression therapy system 7000 further includes a second tubing 7006 that facilitates gas flow into chambers (e.g., 7008-1, 7008-2, 7008-3, 7008-4, 7008-5, 7008-6, 7008- 7) of a compression garment 7008. The second tubing 7006 connects, via a central valve, to multiple tube airlines 7010 that connect to each chamber of the compression garment 7008. Valve assemblies 7012 are provided at the multiple tube airlines 7010. The valve assemblies 7012 include an inlet valve and an exhaust valve for each chamber of the compression garment 7008.

[0172] Flow can be described in different manners. Flow, in some implementations, is the volume of gas added to each chamber per unit of time. The flowmeter in the CPG device 1002 can deliver a flow reading that is not dependent on any additional venting within the compression therapy system 7000. If additional venting is introduced (e.g., via the valve assemblies 7012), the additional venting can be modelled and calculated to determine actual flow within each chamber by subtracting from the volume of gas injected into the chamber. For example, flow into the chamber 7008-1 involves subtracting modelled gas escape via vents from the volume of gas injected into the chamber 7008-1.

[0173] In some implementations, actual chamber pressure of the chamber 7008-1 is determined by subtracting any potential drop between the chamber 7008-1 and the pressure sensor provided in the CPG device 1002.

[0174] In an embodiment, the compression therapy system 7000 includes one or more pressure sensors and one or more flow sensors. The pressure sensor and the flow sensor can be located in the CPG device 1002 and/or in the compression garment 7008 (e.g., a spine of the compression garment 7008). In some implementations, the pressure sensor and the flow sensor are located in the compression garment 7008, downstream from a main air supply valve 7011. The pressure sensor and the flow sensor can be located along the multiple tube airlines 7010. [0175] In some embodiments, measuring pressure and flow introduces impedance that pressure changes in the chambers (e.g., 7008-1, 7008-2, etc.) can be difficult to detect. Thus, having the pressure sensor and the flow sensor after the main air supply valve 7011 can reduce effects of impedance introduced by the main air supply valve 7011 and/or the multiple valve assemblies 7012. In some implementations, one or more of the chambers (e.g., 7008-1, 7008- 2, etc.) includes dedicated flow and/or pressure sensors for providing a better resolution (i.e., chamber by chamber) when determining change in volume.

[0176] In an embodiment, the compression therapy system 7000 includes one pressure sensor and one flow sensor in the CPG device 1002. In an embodiment, the compression therapy system 7000 includes one pressure sensor and one flow sensor in the compression garment 7008. In an embodiment, the compression therapy system 7000 includes one pressure sensor and one flow sensor in the compression garment 7008 downstream from the main air supply valve 7011. In an embodiment, the compression therapy system 7000 includes multiple pressure sensors and flow sensors in the compression garment 7008.

[0177] FIG. 8 illustrates a compression garment 8000 with sensors in each chamber of the compression garment 8000, according to some implementations of the present disclosure. The compression garment 8000 is shown to have multiple chambers (e.g., 8002-1, 8002-2, 8002-3, 8002-4, 8002-5, 8002-6, 8002-7). Seven chambers are merely used as examples, but in other implementations, there can be more than seven chambers (e.g., eight chambers, nine chambers, etc.) or less than seven chambers (e.g., two chambers, three chambers, four chambers, etc.). At least one of the chambers can include an internal or external sensor (e.g., 8004-1, 8004-2, 8004- 3, 8004-4, 8004-5, 8004-6, 8004-7). In some implementations, the included sensor is a pressure sensor, a strain gauge, or any combination thereof. FIGS. 7 and 8 provide example locations for positioning sensors for measuring pressure and/or flow, according to some implementations of the present disclosure.

6.9.1 Pressure/Flow gradients

[0178] In some implementations, apart from measuring fixed pressure of each chamber (e.g., 7008-1 in FIG. 7, 8002-1 in FIG. 8, etc.), pressure gradient may be measured within each chamber. That is, a rate of change of pressure inflation to reach a maximum delivered pressure can be measured for each chamber. The measured pressure gradient provides further information that can be used to determine limb volume. For example, measuring the change in pressure with respect to a constant flow, or with respect of a predetermined flow gradient (change in flow) can provide insight into garment fit and/or limb hardness. Garment fit can be determined based on initial gradient where chamber pressure is slow to rise with flow. Limb hardness can be determined based on the gradient of pressure over flow indicating the resistance to inflation from the limb tissue. FIG. 9 provides example measurements of using gradients to determine garment fit and limb hardness.

[0179] FIG. 9 is a graph 9000 illustrating relationship between pressure and volume of the air introduced in the garment (the flow for given time) for two separate therapy sessions 9002 and 9004, according to some implementations of the present disclosure. The slope 9008 at the higher pressure end of the graph provides an example of a suitable area for determining a hardness of the limb tissue for the therapy session 9002. The region 9006 at the lower pressure end of the graph provides an example of a suitable region for determination of garment fit. The two therapy sessions 9002 and 9004 can be compared against each other to quantify garment fit and/or limb hardness. When these curves are plotted during each therapy use, comparisons between them will give insight into the characteristics of the limb.

[0180] In some implementations, one or more characterization maps can be constructed for comparison. For example, limb hardness can be characterized for different slopes so that the characterization map stores a relationship between limb hardness and slopes in the region 9008. Similarly, garment fit can be characterized for different volumes in the region 9006 to determine at about what volume of air operating pressure is achieved. The characterization maps can then be used for comparison with measured pressure and volume during therapy sessions to obtain absolute values of limb hardness and/or garment fit. In some implementations, pressure gradient can also be plotted against time, as an example, to determine the characteristics of the limb.

[0181] Flow, pressure, garment fit, and limb hardness can be used alongside limb volume to determine therapy parameters for future therapy sessions. For example, the better the fit (i.e. a tighter garment), the less volume will be needed to reach operating pressure. It is useful to investigate how variables can be adjusted to improve the fit and the therapy. Furthermore, flow, pressure, garment fit, and/or limb hardness can be monitored over therapy sessions to develop trend information as discussed above with respect to FIG. 6. The trend information can be provided on a smartphone and/or can be used to adjust therapy parameters for future therapy sessions. In some implementations, limb volume is used as a measure of improvement with respect to a specific applied therapy. For example, detecting that a limb volume decreases over time via the trend information, can indicate an improvement. It can from there be deducted that the current therapy is working.

[0182] In some implementations, the sensor 8004-1 is a strain gauge that can be arrange to measure the stretch force at a predetermined point, or along a predetermined length of the compression garment 8002. Pressure in the chamber 8002-1 can be obtained along with strain measurements (i.e., stretch measurements) on the chamber 8002-1. Information from the pressure measurements and the strain measurements can be used to calculate limb volume. For example, similar to FIG. 9, a relationship between pressure and strain can be developed for each therapy session.

[0183] In some implementations, garment fit may not be consistent from one therapy session to another. A strain gauge and strain gauge measurements can be used in calibration to improve accuracy of flow rate and/or pressure measurements for comparison between different therapy sessions. The calibration can include first determining garment fit using the strain gauge. The pressure measurement threshold can be adjusted according to the garment fit. Then pressure and/or flow rate characteristics or any other parameter derived from pressure and/or flow rate characteristics can be measured and compared against the pressure measurement threshold. This calibration method can allow for standardizing pressure measurements across different therapy sessions.

6.9.2 Line Gauge

[0184] In some implementations, limb volume can be determined using one or more physical gauges (e.g., a line gauge). FIG. 10 illustrates a compression garment 10000 with an integrated tape measure 10002, according to some implementations of the present disclosure. The compression garment 10000 includes multiple chambers (e.g., 10004), each of which may include the tape measure 10002. In the illustrated example, the chamber 10004 includes the tape measure 10002. The tape measure 10002 can include a window 10006 for viewing measurements. The tape measure 10002 relies on external measurements of the limb at different points. The volume of the limb is then calculated using mathematical formulas that model the limb as a cylinder (4rr ² h), where h is the height of the limb (or a section of the limb being measured) and r is a measured radius. The radius can be determined from measuring the circumference of the limb (or a section of the limb) using the integrated tape measure 10002 and then dividing by 2p. Although cylindrical calculations can be used to estimate limb volume, the present disclosure anticipates other volumetric estimation methods. For example, the frustum sign method can treat the entire limb as one unit or can be subdivided into truncated cone segments. The volume of each truncated cone segment can be summed up to determine the volume of the limb.

[0185] In some implementations, the measurements may be carried out by a clinician, a physical therapist, a nurse, etc., due to the limited mobility of patients or users of compression garments. In some implementations, since the tape measure 10002 is integrated in the compression garment 10000, the patient or the user can read the measurements easily without having to travel to a clinician. This reduces any inconvenience associated with having to visit a clinician’s office. In some implementations, the measurements can be taken automatically by the CPG device 1002 (FIG. 1A) or by a controller in the compression garment 10000. Tape measures can be provided in each chamber of a compression garment as provided in FIG. 11. FIG. 11 illustrates a compression therapy system 11000 with tape measures for each chamber (e.g., 11002-1, 11002-2, 11002-3, 11002-4, 11002-5, 11002-6, 11002-7) of a compression garment of the compression therapy system 11000, according to some implementations of the present disclosure. Each of the tape measures (e.g., 11004-1, 11004-2, 11004-3, 11004-4, 11004-5, 11004-6, 11004-7) can indicate a different circumference for different sections of the limb. Limb volume can be determined for each of the sections as discussed above.

[0186] Measurements obtained via FIGS. 10 and 11 can be continuous, that is, not a fixed setting but a position of the users fit during a specific use. In some implementations, the tape measure is integrated into the garment so that when it is wrapped around a limb, it provides a measurement reading through a window. Similar to the way non-digital weight scales move to the measured value when they are stepped on. The integrated tape measures of FIGS. 10 and/or 11 may be actual tape measures, or callipers, that can automatically record a measurement when the compression garment is donned by the user.

[0187] In some implementations, the integrated tape measures of FIGS. 10 and/or 11 are electronic tape measures, such as a Renpho® Smart Tape Measure. Although shown at each chamber in FIG. 11, the integrated tape measures may only be provided at a selected number of chambers. Furthermore, measurements may be taken at different points in time. For example, measurements may be taken at set time intervals through therapy, midway or at the end of therapy, once a day, once a week etc. Measurements taken can be fed back to a database for monitoring and/or diagnostic purposes. For example, the measurements may be used to determine trend information as discussed above in connection with FIG. 6. In some implementations, measurements may be sent directly to an App and stored on a mobile device, where calculation and/or recording of limb volume can be determined. Providing the integrated tape measures and connectivity to automatically obtain measurements reduces a need for clinical intervention. The patient can make the measurements without a clinician, and the ability to obtain measurements can allow for better monitoring of therapy and better evaluation of the compression garment.

6.9.3 Strain/Stretch Gauge

[0188] A stretch sensor (e.g., a strain gauge) may be used to measure limb girth and/or circumference. These measurements may be used to determine limb volume and/or change in limb volume. FIG. 12 illustrates a compression garment 12000 including stretch sensors (e.g., 12002-1, 12002-2, 12002-3, 12002-4, 12002-5, 12002-6, 12002-7), according to some implementations of the present disclosure. The compression garment 12000 includes multiple chambers (e.g., 12004-1, 12004-2, 12004-3, 12004-4, 12004-5, 12004-6, 12004-7), similar to other compression garments described herein. The stretch sensors are provided on an elastic fabric that forms at least a portion of the length (or width) of the garment and stretches when a limb 12006 is inserted in the elastic fabric. In some implementations, the elastic fabric is integrated in the compression garment 12000. In some implementations, the elastic fabric is an add-on which can be connected to a controller of the compression garment 12000 or can be completely independent from the compression garment 12000. In some implementations, the elastic fabric in a sock/stocking-like configuration is attached to the internal side of the compression garment 12000. When a user or patient dons the compression garment 12000, the limb 12006 is slid through the elastic sock. Then the pressure chambers (e.g., 12004-1, ...) are wrapped around the patient’s leg. The compression garment 12000 can be used to measure an amount that the elastic fabric stretches when the user dons the compression garment 12000 via the stretch sensors (e.g., 12002-1, ...). The measurements of stretch at several points along the length of the limb can be used to determine limb circumference at these points, and as a result - limb volume. In FIG. 12, although the number of stretch sensors are provided in correspondence to the number of pressure chambers, these two numbers can be different. For example, seven stretch sensors can be provided for a four chamber compression garment, three stretch sensors can be provided for a three chamber compression garment, etc.

[0189] In some implementations, girth measurements using stretch sensors can be used to calculate limb volume through mathematical formulas. For example, stretch sensors can be used to determine limb circumference at different locations along the limb, and the frustrum sign method can be used to calculate limb volume. In the frustrum sign method, the limb is modelled as one or more truncated cones with volume of each truncated cone V _t is determined using the formula V _t = j _s the circumference of the top of the truncated cone t, c _t is the circumference of the bottom of the truncated cone t, and h _t is the distance between the top and bottom of the cone t where the two circumferences C _t and c _t were measured. If there is only one cone approximating the limb, then V _t corresponds to the limb volume. If the limb is modelled as a sum of two or more truncated cones, then each determined V _t is summed to determine the total limb volume.

[0190] Such integrated stretch sensors of FIG. 12 can be used to perform repeated measurements and/or an on-demand measurements administered locally by the user, automatically (periodically or otherwise) by a CPG device, or remotely by a clinician/healthcare professional. A remote measurement can be requested in multiple ways. For example, a clinician’s computer can send a request to the CPG device (e.g., via the user’s smartphone). In another example, the clinician’s computer can send a request to the compression garment (e.g., via the user’s smartphone) when the compression garment’s controller is enabled for connecting to either the Internet or the cellular network. Thus, the stretch sensor implemented into the compression garment 12000 can provide automatic measurements without needing the user to make any manual measurements. 6.9.4 Force Sensors

[0191] Turning to FIG. 13, a flow diagram illustrating a process 13000 for determining a fit of a compression garment using force characteristics, according to some implementations of the present disclosure. At 13002, signals representing force characteristics are received from a first force sensor and a second force sensor positioned at different locations along the width of a pneumatic chamber of the compression garment. In some implementations, the first and second force sensors are Honeywell® FSA sensors. In some implementations, the first and second force sensors are Honeywell® FMA sensors.

[0192] At 13004, a difference between the received signals from the first force sensor and the second force sensor is determined. For example, the first force sensor can be positioned at a first position along the width of the pneumatic chamber of the compression garment and the second force sensor is positioned at a second position along the width of the pneumatic chamber of the compression sensor. The first force sensor can be positioned at an extremity (e.g., at a tab or zipper portion of the compression garment), and the second force sensor can be positioned a distance away from the extremity. The second force sensor can be positioned along the same or on a different circumferential line from that on which the first force sensor is located. The force signals received from the first force sensor at the extremity can be much higher than the force signals received from the second force sensor positioned away from the extremity. The farther away the first and second force sensors are positioned (e.g., two force sensors 16004- la and 16004- lb of FIG. 16A), when the garment is in a donned configuration, the higher the force differential that can be generated by the two force sensors.

[0193] At 13006, a garment fit of the compression garment is determined based on the determined difference of 13004. The difference in measured force is proportional to the distance between the two sensors when the compression garment is wrapped around the limb. For example, the two force sensors 16004-la and 16004-lb of FIG. 16A being closer together when wrapped around the limb as indicated in FIGS. 16B and 16D will yield a smaller difference than the case of FIG. 16C. The smaller difference can be indicative of a looser fit when compared to a larger difference.

[0194] At 13008, the determined garment fit is compared against a predetermined fit parameter range. Here comparing the fit is intended to include comparing any parameters associated with the fit, such as the determined difference, to a threshold or predetermined range. If the fit falls outside the predetermined fit parameter range, then at 13010, a predetermined response is implemented. If the fit falls within the predetermined fit parameter range, then at 13012, a compression therapy session is initiated.

[0195] FIG. 14 illustrates a compression garment 14000 with a single force sensor 14006, according to some implementations of the present disclosure. The compression garment 14000 includes one or more chambers (e.g., 14002-1, 14002-2, 14002-3, 14002-4, 14002-5, 14002-6, 14002-7). The compression garment 14000 includes a smart spine assembly 14004 that houses the force sensor 14006. In the illustrated configuration the sensor 14006 is attached to the smart spine assembly 14004. Although one force sensor is shown in FIG. 14, multiple force sensors may be integrated in the at 2 or more locations of the garment outside the area of the smart spine assembly 14004. In one example, the force sensor 14006 is attached along the length of the compression garment 14000 and is aimed at measuring a pressure applied by the user’s limb onto the compression garment 14000 at the respective point, when the compression garment 14000 is donned by the user. When the compression garment 14000 is fitted too tightly, an increased force reading compared to a loosely fitted garment force reading will be registered. In some implementations, these force sensors are placed on an underside of the smart spine assembly 14004 and the fit of the garment can be registered at that point. Measurements from the force sensor 14006 can be used to identify whether the garment is too loose or too tight. As discussed above with respect to 13008 of FIG. 13, a predetermined fit parameter range can be defined for acceptable fit. In some implementations, a threshold value or threshold value range for ideal tightness is used as a reference point or a target garment fit value for the user. The threshold value used as a reference can be used to monitor any deviation from the threshold value during each use of the compression garment 14000 by the user. Incorporating force sensors provides an objective measure of garment fit for both the user and clinician when fitting the compression garment 14000 for the first time, as well as for subsequent therapy sessions. Thus, force sensors can be used for single use measurements or continuous measurements across therapy sessions.

[0196] In some implementations, each of a tight fit and a swollen underlying leg will lead to an increased force reading by the stretch sensor 12002 or the force sensor 14006, thus additional measures may have to be taken in order to establish if the increase in the measured force is caused by swollen underlying limb, or caused by a tightly-fitted compression garment. For example, markings on the garment may be used to indicate that the garment-adjusted size is consistent. If the user aligns their compression garment to the same marks during each use, but the force increases then this may be an indication of swelling of the underlying limb. Alternatively, if the user achieves the same level of force at each fitting of the garment, but at some points the user observes a misalignment in pre-existing marks and a difference in garment-adjusted size, this may also be an indication that the underlying limb is swollen. Similar effects may be used to identify a decrease in the limb volume, e.g. when the pre-existing swelling subsides.

[0197] More than one force sensor can also be used in determining limb circumference. FIG. 15 is a flow diagram illustrating a process 15000 for determining a limb circumference using a compression garment with a pair of force sensors, according to some implementations of the present disclosure, such as the one illustrated in Figs. 16A to 16D. At 15002, a pneumatic waveform is generated in one or more pneumatic chambers of a set of pneumatic chambers of a compression garment. 15002 is similar to or the same as 6002 of FIG. 6.

[0198] At 15004, signals representing force characteristics are received from a first force sensor and a second force sensor. The first force sensor and the second force sensor can be positioned at opposing ends of a pneumatic chamber of the compression garment.

[0199] At 15006, a force differential is determined between the received signals.

[0200] At 15008, the force differential is compared to a threshold force differential to identify changes in the force differential. In some implementations, the force differential is compared to previously measured force differentials.

[0201] At 15010, limb circumference is determined at the compression garment based on the identified changes in the force differential. The process 15000 will be described using the arrangement of FIGS. 16A-16D.

[0202] FIG. 16A illustrates a compression garment 16000 with at least two force sensors 16004- la and 16004- lb, according to some implementations of the present disclosure. The two force sensors 16004-la and 16004-lb are provided on a first chamber 16002-1 of the compression garment 16000. The compression garment includes multiple chambers (e.g., 16002-1, 16002-2, 16002-3, 16002-4, 16002-5, 16002-6, 16002-7). Signals may be received during the operational use of the compression garment 16000 from the first force sensor 16004- la and the second force sensor 16004-lb positioned at different locations along the width of the of the first chamber 16002-1. The received signals represent force characteristics at the respective force sensor locations. The force sensors 16004- la and 16004- lb are positioned generally transverse to the compression garment 16000 direction that extends along the length of the user’s limb. The force sensors 16004- la and 16004- lb are also at generally opposing ends of the first chamber 16002-1. Other configurations are contemplated, for example, more force sensors can be integrated in other chambers of the compression garment 16000. The term width is considered to be the transverse to the garment direction that extends along the length of the user’s limb when in use.

[0203] When the user dons the compression garment 16000, the differential force between the force sensors 16004-la and 16004-lb can be measured. Given the material properties of the compression garment 16000, the compression garment 16000’s flexibility and ability to move around the limb of the user, the force differential will change proportionately based on the size of the limb, as the force sensors will be measuring at two different points. The smaller the limb, the more overlap there will be when wrapping the compression garment 16000, whereas the larger the limb, the less overlap there will be. FIGS. 16B, 16C, and 16D illustrate the at least two force sensors 16004-la and 16004-lb at different positions. In FIG. 16B, when the compression garment 16000 is being donned, the force sensors 16004-la and 16004-lb move toward each other. In FIG. 16C, the compression garment 16000 is shown wrapped around a smaller limb. The force differential between the two force sensors 16004-la and 16004-lb is likely to be large in the configuration of FIG. 16C. In FIG. 16D, the compression garment 16000 is shown wrapped around a larger limb, the force differential between the two force sensors 16004-la and 16004-lb is likely to be comparatively smaller than that of FIG. 16C. [0204] The force calculated at each sensor, and the force differential between the two sensors, can help identify how much overlap there is between the two sensors. For example, FIG. 16D has the sensors overlapping, and FIG. 16C does not have an overlap between the sensors. This differential can then be used to determine the limb circumference. The force differential is proportional to the distance between the two force sensors 16004- la and 16004- lb as discussed above. This force differential can thus be reflective of the size of the limb, indicating that the greater the distance, the smaller the limb. In some implementations, the force measurement at two different points can be extended to track the force measurement at multiple points along the compression garment 16000 by using a force-sensitive mat or by incorporating more than two sensors into the compression garment 16000. For example, the TekScan® I-ScanTM system is a pressure mapping system that has a larger cross-sectional area. This pressure mapping technology can be applied along the circumference of the compression garment 16000 to produce a pressure map when donned.

[0205] In some implementations, distance between a position of a sensor and an outer surface of the limb of the user can be used to quantify garment fit. FIG. 17 is a flow diagram illustrating a process 17000 for determining a fit of a compression garment, according to some implementations of the present disclosure, such as illustrated in FIGS. 18A and 18B. At 17002, signals are received from a sensor positioned on the compression garment. The signals represent distances from the sensor to a surface associated with an outer surface of the limb of the user. In some implementations, the sensor is an ultrasonic sensor embedded in a smart spine assembly. In some implementations, the sensor is a light sensor that uses light from a light emitting diode to determine distance.

[0206] At 17004, differences between the distances associated with the received signals and distances associated with predetermined fit parameter ranges are determined.

[0207] At 17006, garment fit is determined based on the determined differences of 17004. [0208] At 17008, the determined garment fit is compared against predefined limits. Here comparing the fit is intended to include comparing any parameters associated with the fit, such as the determined difference, to one or more thresholds defining the predefined limits. For example, an acceptable fit range can have a lower limit and an upper limit, and the lower and upper limits are used as the one or more thresholds such that being below the lower limit indicates overly loose fit and being above the upper limit indicates an overly tight fit. If the fit falls outside the predefined limits, then at 17010, a predetermined response is implemented. If the difference and/or fit falls within the predefined limits, then at 17012, a compression therapy session is initiated. The process of FIG. 17 will be described using two different types of sensors provided in the cross-sections 18000 and 18001 of FIGS. 18A and 18B, respectively. [0209] FIG. 18A illustrates conceptually a cross section of a limb 18004 and a compression garment 18006 with a distance sensor 18002, according to some implementations of the present disclosure. The distance sensor 18002 can be an ultrasonic sensor used to determine distance between the sensor 18002 and the limb 18004. With this distance determined, garment fit for the compression garment 18006 can be determined. The determined garment fit can be compared to a threshold value, and if the determined garment fit is greater than the threshold value, the user would be prompted to adjust the compression garment 18006 for a better fit. In some implementations, the distance sensor 18002 uses light to determine distance (e.g., via a light emitting diode or a vertical cavity surface emitting laser). The sensor 18002 can be embedded into an underside of the compression garment 18006 that is exposed to the user in order to obtain a more accurate reading.

[0210] FIG. 18B illustrates a cross section of the limb 18004 and a compression garment 18010 with magnets 18012 and 18016, according to some implementations of the present disclosure. Distance between the magnets 18012 and 18016 can be used to infer distance between the compression garment 18010 and the limb 18004. In FIG. 18B, one end of the compression garment 18010 is flush with the limb 18004 (the end that includes the magnet 18012-2), and the other end sits atop (the end that includes the magnet 18012-1). A magnetic sensor 18014 can be used to determine the magnetic field generated between the two magnets 18012-1 and 18012-2. The straight line distance between the two magnets is indicated as M12 in FIG. 18B. The magnetic sensor 18014 in some implementations is a Hall sensor and the second magnet 18012 can actually be part of the Hall sensor. The determined magnetic field can be used to compute or estimate the distance M12, which may be an indication of the size of the leg and/or fit of the compression garment 18010 to the limb 18004. By determining the distance M12 between the magnets 18012 and 18016, a metric for garment fit can be recorded and used to understand how well the user has donned the compression garment 18010. That is, the distance M12 can be used in comparison to predefined limits as discussed above in connection with 17008.

[0211] In some implementations, pre-set engagement positions can be used to identify changes of garment fit between therapy sessions. FIG. 19 is a flow diagram illustrating a process 19000 for determining subsequent garment fit of a compression garment, according to some implementations of the present disclosure. At 19002, an initial reference fit for the compression garment is determined for or by the user. The fit cam be determined experimentally by the user - say by fitting the garment for a convenient therapy and noting a particular parameter associated with a specific dimension, pressure, flow, force etc., associated with the garment, using a visual indicator and/or a measured parameters using one or more of the sensors associated with the garment and/or the pressurisation device. Alternatively, the fit can be provided to the user externally, again in the form of a particular parameter associated with a specific dimension, pressure, flow, force etc., associated with the garment, using a visual indicator and/or a measured parameter.

[0212] At 19004, a subsequent fit is determined for or by the user.

[0213] At 19006, the initial reference fit of 19002 and the subsequent fit of 19006 are compared. Here comparing the fit is intended to include comparing any parameters associated with the fits, including the underlying parameters that define the fits.

[0214] At 19008, a response is initiated in response to determining that the subsequent fit is different from the initial reference fit. FIG. 20 will be used to describe the process 19000 of FIG. 19.

[0215] FIG. 20 illustrates a compression therapy system 20000 having a compression garment 20002 with integrated straps (e.g., 20008-1), according to some implementations of the present disclosure. The integrated straps have a number of predetermined settings (e.g., engagement positions) with different levels of tightness. That is, the user has options of a discrete number of predetermined fastening positions for each of the chambers (e.g., 20002-1, 20002-2, 200002- 3, 200002-4, 20002-5, 20002-6, 20002-7). The integrated strap 20008-1 includes an indicator 20006-1 that communicates the predetermined settings. The integrated strap 20008-1 interfaces with a lock 20004-1 to hold the chamber 20002-1 in place. The different chambers can have different tightening settings.

[0216] When donning the compression garment 20002, the user will engage a specific setting that presumably provides the right “fit” for the user. Any change of the setting, used by the user for example because the original fit is no longer comfortable or even possible, may be indicative of respective changes in the limb circumference and/or volume. Since in this case these changes are a discrete length measurement, a relative change between each fitting of the compression garment 20002 can be recorded. The integrated strap 20008-1 can have a scale/graded fit that can be seen by the user. When donning the compression garment 20002 at each subsequent use, the user can have a setting that allows them to achieve the same subjective fit, as in a previous use. Apart from providing a suitable way of adjusting the tightness of the garment, the compression garment 20002 may also be helpful in identifying changes in the volume of the underlying limb.

[0217] A pre-calibration of the predetermined settings can establish a correspondence between each of the predetermined settings and a specific circumference of the underlying limb. If after a number of therapy sessions, the user has to move up/down a level in their fit, this can be recorded and identified as a potential increase/reduction in the limb circumference and/or volume at the particular location on the limb. In a robust approximation, the limb may be considered as a cylinder and the change of its circumference in a specific point along the height of the cylinder may be used to calculate the change in volume of the cylinder. Alternatively, having a number of such adjustment arrangements located along the length of the limb (as shown in FIG. 20), may allow the circumference of the limb to be determined at several points, thus allowing any changes of limb’s overall dimensions and/or volume to be monitored in a more precise manner.

[0218] In some implementations, instead of the integrated strap and lock, hook and loop material-based tabs (e.g. Velcro®) may be used. Respective marks along the length of each tab may be used as an indication of what length of the tab is engaged each donning instance, providing an indirect measurement of any change in the limb’s circumference. The marks and indicators of fit may be used at different points along the length of a limb or at a single position. When a single point is used, the most likely for a lower-limb is at the ankle or behind the knee as this is where swelling is most prominent. The upper thigh and the toes are also candidates for monitoring. [0219] In other implementations, integrated hook and loop material-based strap and lock tabs (e.g. Velcro® tabs) may be used in combination with a zipper extending along the length of the garment along the length of the limb. This will allow an initial fitting of the garment using the straps. After the initial adjustment, the user should be able to unzip and zip back the garment, without further use of the straps. This will save the user time and will make for a much more convenient use of the garment. However, if a size of the limb changes, an adjustment may need to be introduced using again the tabs. Such an adjustment may be a trigger for recording the changes in the length of the various straps, allowing for calculation of the change of limb parameter and/or volume. This may again trigger various notifications and/or adjustments in the therapy.

7. GLOSSARY

[0220] For the purposes of the present disclosure, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present disclosure, alternative definitions may apply.

7.1 ASPECTS OF CPG DEVICES

[0221] Blower or flow generator: a device that produces a flow of air at a pressure above ambient pressure. Such a device may be reversed (e.g., by reversing a motor direction) to draw (evacuate) a flow of air at a negative pressure below ambient pressure.

[0222] Controller: a device or portion of a device that adjusts an output based on an input. For example, one form of controller has a variable that is under control -the control variable- that constitutes the input to the device. The output of the device is a function of the current value of the control variable, and a set point for the variable. A CPG device (e.g., CPG device 1002) may include a controller that has pressure as an input, a target pressure as the set point, a level of pressure as an output, or any combination thereof. Another form of input may be a flow rate from a flow rate sensor. The set point of the controller may be one or more of fixed, variable or learned. A pressure controller may be configured to control a blower or pump to deliver air at a particular pressure. A valve controller may be configured to open or close one or more valves selectively according to a programmed protocol such as in response to a measure such as time and/or any of the signals provided by one or more sensors. A controller may include or be one or more microcontrollers, one or more microprocessors, one or more processors, or any combination thereof. [0223] Therapy: therapy in the present context may be one or more of compression therapy, such as static compression therapy, sequential compression therapy, including massage therapy, as well as the therapies described in more detail herein, or any combination thereof. [0224] Motor: a device for converting electrical energy into rotary movement of a member. In the present context the rotating member can include an impeller, which rotates in place around a fixed axis so as to impart a pressure increase or decrease to air moving along the axis of rotation.

[0225] Transducers: a device for converting one form of energy or signal into another. A transducer may be a sensor or detector for converting mechanical energy (such as movement) into an electrical signal. Examples of transducers include pressure sensors, flow rate sensors, and temperature sensors.

[0226] Volute: the casing of the centrifugal pump that directs the air being pumped by the impeller, such as slowing down the flow rate of air and increasing the pressure. The cross- section of the volute increases in area towards the discharge port.

7.2 CPG DEVICE PARAMETERS

[0227] Flow rate: the instantaneous volume (or mass) of air delivered or drawn per unit time. In some cases, a reference to flow rate will be a reference to a scalar quantity, namely a quantity having magnitude only. In other cases, a reference to flow rate will be a reference to a vector quantity, namely a quantity having both magnitude and direction (e.g., out of the CPG device or into the CPG device). Flow rate is given the symbol Q.

[0228] Pressure: force per unit area. Pressure may be measured in a range of units, including cmFhO, g-f/cm ² , and hectopascals. One (1) cmFhO is equal to 1 g-f/cm ² and is approximately 0.98 hectopascal. In this specification, unless otherwise stated, pressure is given in units of cmFhO.

8. OTHER REMARKS

[0229] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever. [0230] Unless the context clearly dictates otherwise and where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limit of that range, and any other stated or intervening value in that stated range is encompassed within the technology. The upper and lower limits of these intervening ranges, which may be independently included in the intervening ranges, are also encompassed within the technology, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the technology.

[0231] Furthermore, where a value or values are stated herein as being implemented as part of the technology, it is understood that such values may be approximated, unless otherwise stated, and such values may be utilized to any suitable significant digit to the extent that a practical technical implementation may permit or require it.

[0232] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of the exemplary methods and materials are described herein.

[0233] When a particular material is identified as being preferably used to construct a component, obvious alternative materials with similar properties may be used as a substitute. Furthermore, unless specified to the contrary, any and all components herein described are understood to be capable of being manufactured and, as such, may be manufactured together or separately.

[0234] One or more elements or aspects or steps, or any portion(s) thereof, from one or more of any of claims 1 to 52 below can be combined with one or more elements or aspects or steps, or any portion(s) thereof, from one or more of any of the other claims 1 to 52 or combinations thereof, to form one or more additional implementations and/or claims of the present disclosure.

[0235] It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include their plural equivalents, unless the context clearly dictates otherwise. [0236] All publications mentioned herein are incorporated by reference to disclose and describe the methods and/or materials which are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present technology is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed. [0237] Moreover, in interpreting the disclosure, all terms should be interpreted in the broadest reasonable manner consistent with the context. In particular, the terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.

[0238] The subject headings used in the detailed description are included only for the ease of reference of the reader and should not be used to limit the subject matter found throughout the disclosure or the claims. The subject headings should not be used in construing the scope of the claims or the claim limitations.

[0239] Although the technology herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some instances, the terminology and symbols may imply specific details that are not required to practice the technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order but may be utilised to distinguish between distinct elements. Furthermore, although process steps in the methodologies may be described or illustrated in an order, such an ordering is not required. Those skilled in the art will recognize that such ordering may be modified and/or aspects thereof may be conducted concurrently or even synchronously. [0240] It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the technology.