Patent Application
20240009067
The present technology relates to devices for the diagnosis, 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 Lymphedema therapy or monitoring. 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.
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.
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.
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.
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.
The present disclosure is directed towards providing medical devices, or the components thereof, for use in the management, monitoring, detection, diagnosis, amelioration, treatment, and/or prevention of circulatory-related conditions having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.
According to some implementations of the present disclosure, a smart, connected platform and/or system for compression therapy for treating circulatory disorders such as lymphedema, is provided. The system includes a compression garment with multiple pneumatic chambers, a valve interface, a pneumatic/electrical conduit, a compression device, a control device running a patient app, and a remote clinician portal. According to some implementations of the present disclosure, the chambers in the compression garment can be dynamically pressurised to compress a limb of interest (e.g., leg, arm, torso, foot, ankle, etc. or any combination thereof) in controlled therapeutic patterns over a therapy session. According to some implementations of the present disclosure, the chambers are high-resolution partitions and/or micro-chambers of a conventional chamber. According to some implementations of the present disclosure, the micro-chambers are interconnected by one or more channels, gaps, and/or openings that define one or more predetermined sequence(s) of air pressurization. When a chamber is pressurised, the micro-chambers of that chamber pressurise in the predetermined sequence(s) so as to create a micro-massage effect on the user wearing the compression garment of the system. The micro-massage can aid in stretching the skin of the user in a way that simulates natural movement of the limb and thereby assists drainage. According to some implementations of the present disclosure, sensors may be used (e.g., imbedded in the compression garment) to determine patient characteristics, such as limb girth, during a testing period and set up therapy mode and parameters before therapy (personalization or customization). According to some implementations of the present disclosure, sensors can be used in a control loop during therapy to dynamically adjust therapy parameters. According to some implementations of the present disclosure, therapy can be controlled and/or monitored using a patient application executing on a control device of the system. According to some implementations of the present disclosure, therapy data from multiple patients can be communicated to a clinician portal for population management.
According to some implementations of the present disclosure, a compression garment for circulatory-related disorder therapy includes a skin contacting layer, a second layer coupled to the skin contacting layer, and one or more connectors disposed on the second layer. The skin contacting layer and the second layer form one or more macro-chambers. Each macro-chamber is partitioned into a plurality of micro-chambers. Each of the plurality of micro-chambers is in direct fluid communication with at least one other of the plurality of micro-chambers. Each of the one or more connectors is configured to supply pressurized air directly into at least a corresponding one of the one or more macro-chambers such that the pressurized air is delivered to at least one of the plurality of micro-chambers within the macro chamber. The coupling of the skin contacting layer and the second layer is along a layer attachment profile that defines the one or more macro-chambers and the plurality of micro-chambers. At least one of the plurality of micro-chambers is linked to another of the plurality of micro-chambers by way of a plurality of openings.
According to some implementations of the present disclosure, a method of fabricating a compression garment for circulatory-related disorder therapy includes forming a fabric first layer having a first geometric shape generally defining at least a portion of the overall shape of the compression garment. A skin contacting layer is formed having a second geometric shape generally conformable to the first geometric shape. The skin contacting layer is welded to the fabric first layer according to a connection profile. The connection profile defines a plurality of macro-chambers between the skin contacting layer and the fabric first layer and a plurality of interconnected micro-chambers within one or more of the plurality of macro-chambers. A plurality of connectors is disposed in the fabric first layer. Each of the plurality of connectors allows pressurized air to be supplied directly into one or more micro-chambers of a respective one of the plurality of macro-chambers.
According to some implementations of the present disclosure, a valve arrangement includes a plurality of valves for a compression garment having a plurality of independent air chambers connectable to a pressure generator for implementing circulatory-related disorder therapy. The plurality of valves is configured to be pneumatically and electrically connected to the compression pressure generator. Each valve is connectable to one of the plurality of independent air chambers and is in a fluid connection with a primary connecting line to allow pressurization of each of the plurality of independent air chambers. Each of the plurality of valves are located on the compression garment.
According to some implementations of the present disclosure, a pneumatic spine for a compression garment includes the above valve arrangement implementation. The compression garment includes a plurality of independent air chambers connectable to a pressure generator for implementing circulatory-related disorder therapy. The plurality of valves of the valve arrangement are located in proximity to each other. A cover assembly with an interior space includes the plurality of valves.
According to some implementations of the present disclosure, a compression garment includes the above valve arrangement implementations.
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.
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.
Other features of the technology will be apparent from consideration of the information contained in the following detailed description.
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:
Before the present technology is described in further detail, it is to be understood that the technology is not limited to the particular examples described herein, which may vary. It is also 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.
Referring to
Referring to
As discussed in more detail herein, the application 2011 of the control device 1010 can be configured to provide limb, pressure, and usage feedback information to a user. The application 2011 can serve as a virtual coach such as by employing an artificial intelligence chat program. The application 2011 can 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. The application 2011 can serve as an electronic store for ordering resupply components of the system (e.g., conduits, 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.
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. 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.
For example, a clinician may provide 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.
The CPG device 1002 communicates with an interface 1008 via link 1006. The CPG device 1002 may generate electrical valve control signals on electric lines of a bus to the interface 1008 and receive electrical valve operation signals from the valves of the interface 1008 on the electric lines of the bus 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 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.
The CPG device 1002 is illustrated in
As discussed in more detail herein, the CPG device 1002 may have 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 up to a maximum of about 50 mmHg into one or more chambers of the compression garment 1004. Similarly, the CPG device 1002 may 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 (
In alternative implementations, the pneumatic chambers may be passively evacuated (depressurized or deflated) without the application of negative pressure to the pneumatic chambers. 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. An exhaust valve 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 distributed over the compression garment 1004 itself. In the latter implementations, the CPG device 1002 may generate exhaust valve control signals on electric lines of a bus forming part of the link 1006 to actuate the one or more active exhaust valves.
Referring to
Referring to
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 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.
Referring to
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).
6.1.1.1 Air filter(s)
Referring back to
The CPG device 1002 may include an inlet muffler 4122 that is located in the pneumatic path upstream of a blower 4142.
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.
Referring to
With continued reference to
Alternatively or additionally, one or more transducers 4270 are located downstream of the pressure device 4140, and upstream of the interface 1008. The one or more transducers 4270 are constructed and arranged to measure properties of the air at that point in the pneumatic path.
Alternatively or additionally, one or more transducers 4270 are located downstream of the interface 1008, and proximate to and/or within the compression garment 1004.
6.1.1.5 Air Conduit and/or Valve Interface
As shown in
Referring to
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).
Input devices 4220 (shown in
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
The central controller 4230 (shown in
The central controller 4230 can be an application-specific integrated circuit. Alternatively, the central controller 4230 can be formed with discrete electronic components.
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.
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.
In a further alternative form of the present technology, the central controller 4230 may include a member selected from the family ARMS-based 32-bit RISC CPUs. For example, an STR9 series microcontroller from ST MICROELECTRONICS may be used.
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.
The central controller 4230 is configured to receive input signal(s) from one or more transducers 4270, and 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.
Thus, the central controller 4230 is configured to provide output signal(s) to one or more of an output device 4290 (e.g., one or more valves of a set of valve(s)), a therapy 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.
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.
In one form of the present technology, the therapy device 4245 (shown in
In one form of the present technology, therapy device controller 4240 (shown in FIG. is a 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 therapy 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.
In one form of the present technology, therapy 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.
The CPG device 1002 in accordance with the present technology optionally includes one or more protection circuits 4250 such as shown in
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.
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.
In accordance with one form of the present technology the CPG device 1002 includes memory 4260 (shown in
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.
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.
Transducers 4270 (schematically shown in
A flow rate transducer 4274 (shown in
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).
A pressure transducer 4272 (shown in
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.
In one form of the present technology a motor speed signal from a motor speed transducer 4276 (shown in
The temperature transducer(s) 4275 (shown in
With continued reference to
A data communication interface 4280 (shown in
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.
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.
In one form, local external communication network 4284 utilises one or more communication standards, such as Bluetooth, or a consumer infrared protocol.
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.
The local external device 4288 can be a personal computer, mobile phone, tablet or remote control.
An output device 4290 (shown in
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 interface 1008) or in the compression garment 1004.
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
The display 4294 (shown in
In a preferred form of the present technology, the therapy device 4245 (
6.2 Conduit and/or Valve Interface
Referring to
The interface 1008 is shown as including sixteen active valves 6297; however, such an interface may have fewer or more of such active valves 6297 depending on the desired configuration of a compression garment and the type and number of chambers in the compression garment to be pressurized by the CPG device 1002.
The connection from the sixteen valves via the sixteen pneumatic connecting lines 6302 is further illustrated in relation to the interface shown in
Use of the conduit and/or valve interface 1008 with the system 1000 may be further considered in reference to
Referring to
Referring to
Referring to
6.3 Passive Valve(s)
Although some versions of the valves interfacing with the CPG device 1002 may be active valves as controlled by the interface 1008, as discussed in more detail herein, some compression garments of the present disclosure can be implemented with passive valves. One or more passive valves may serve to complement the pneumatic operations of the chambers with the active valves and/or as an alternative to active valve implementation. Thus, in some cases, the interface 1008 may direct a pneumatic line to a chamber of the compression garment via a passive valve. Such a passive valve may serve as an inlet to or an outlet from a chamber of the compression garment. Such a passive valve may open depending on a pressure condition applied to one side of the passive valve. In an example, such a passive valve may be implemented, for example, by a flexible flap having a chosen rigidity that is responsive to a desired pressure threshold condition. Such a valve may be a duckbill valve. Thus, when a desired pressure differential is achieved across the mechanism of the passive valve, the passive valve opens to permit air movement across the passive valve. Such a passive valve may be implemented as an aperture (or two or three or more apertures) with a flow restriction(s) to delay flow through the aperture(s) to permit different inflation timings between neighbouring chambers that are separated by the flow restricted aperture(s).
For example, as illustrated in
As shown in
Referring to
In a further example illustrated in
Another example of such a passive valve is illustrated in
6.4 Compression Garment
As described herein, a compression garment 1004 includes a set of 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.
In some implementations, the garment is formed with layers, such as an inner layer (e.g., inner sleeve) and an outer later (e.g., outer sleeve). 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) includes 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.
The chambers and pneumatic pathways may be formed between the 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.
The garment may be generally formed as a sleeve that can be applied around the bodily area of 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.
As previously discussed and as illustrated in
The pneumatic chambers 1-16 may be formed with a material having baffles (e.g., chamber material folds) to more readily permit a vertical expansion of the chamber, where the baffles are the same or similar to that shown in
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 6302/7302 (
Distributed valving confers a number of advantages on a compression garment. With distributed valving, the interface 1008 is a conduit interface with a single pneumatic connection to the link 1006 and a single pneumatic connection to the garment 1004, along with electrical connections to each of the distributed active valves. This enables the garment to be lighter and less bulky. Referring to
In addition, the narrow-gauge conduit between each valve and its connected pneumatic chamber is shorter with distributed valving than in compression garments with a valve interface 1008. Since narrow-gauge conduits have higher pneumatic impedance per unit length, there is less pneumatic impedance between the CPG device and each pneumatic chamber with distributed valving. This enables a smaller CPG device to be used to achieve the same pressure in each pneumatic chamber. Furthermore, a shorter conduit between valve and chamber has less compliance than a longer conduit. This enables a faster pressurisation/depressurization response in the chamber to valve actuation. In turn this means oscillatory (vibratory) compression waveforms (described below) may be delivered relatively more efficiently.
In such cases, a controlled compression zone may be considered a set of one or more pneumatic chambers that may be operated by one or more active valve sets by a controller of the CPG device. Such a zone of chambers may also employ passive valves.
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 by the CPG device 1002.
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). Additional examples of compression garments of the present disclosure are shown in
Referring to
Referring to
Referring to
Referring to
Referring to
Some versions of the compression garments of the present disclosure are designed for leg and/or foot therapies/compression. Examples of such leg and/or foot/boot compression garments are illustrated in
Referring to
Referring to
In some versions of the compression garment, one or more anatomically shaped pneumatic chambers may provide muscular based zones (anatomically shaped surfaces of the pneumatic chambers) for focused compression therapy. Examples of such compression garments are illustrated in
Referring to
Referring to
In some versions, 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.
In some versions, 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. Referring to
Referring to
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 the length of, or portions 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 pneumatic chambers of the compression garment that reside next to or above where the applicator is located. 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. An example of such an applicator 23424 is illustrated in
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 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.
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.
6.5 Micro-Pumped System
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 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 needs no pneumatic conduit between the CPG device 1002 and the garment 1004.
6.6 Non-Pneumatic Systems
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. Some examples of non-pneumatic systems are given below.
Referring to
Another non-pneumatic implementation of a compression therapy system comprises a garment enclosed with a viscous fluid and a speaker. Sound waves generated through the speaker can displace the fluid such that a smooth compression waveform is created (similar to a wave pool).
6.7 CPG Device Algorithms (Diagnostic and Therapy Control)
The central controller 4230 (
Using the data from any of the sensors previously described, and optionally other user input from the control device, the central controller may be configured, such as with one or more detection or sensing module(s), to determine characteristics related to Lymphedema condition. 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) and compression garment related strain (limb girth) in one or more monitoring sessions. Such measures may be determined and recorded over 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.
6.7.1.1 Diagnostics Waveform (Pneumatic Impedance and/or Resistance)
In one example, the central controller may control operation of the blower of the CPG device in a diagnostic process for detection of swelling. The controller may also control operation(s) of one or more active valves when present such as to localize the diagnostic process to a particular zone of the compression garment. In such a process, the controller may generate a compression waveform (pneumatic) by operating the motor of the blower to pneumatically inflate one or more pneumatic chambers of the garment. Such a waveform may be a pressure waveform or a flow rate waveform that varies over a testing period, such as the waveform 23050 illustrated in
During, or immediately after, generation of such a waveform within a predetermined testing period, the controller may measure pneumatic pressure and/or flow rate over time with the sensors of the system. The system may use at least one set frequency, but optionally could use a range of frequencies. A typical frequency range may be 0.1 Hz to 20 Hz. The sensors sense the pneumatic characteristics of the air supplied to and/or received from the compression garment such as the compression garment's response to the generated waveform. Thus, these pneumatic characteristics concern the pressure garment and the condition of the user's limb within the garment. Discrete values for measured pressure and measured flow rate at a given instant in time may be evaluated, such as to determine a pneumatic impedance or pneumatic resistance from the pressure and flow rate values. For example, resistance may be determined by dividing instantaneous pressure by instantaneous flow rate. Impedance may be similarly determined along with considering phase difference between the pressure and flow rate. The impedance and/or resistance over the predetermined time period of the pneumatic test may then provide a signal that may be useful for assessing a swelling condition of the user's limb within the compression garment. Moreover, if the testing process has been localized to a particular zone of the garment, such as by activating, for example, valves to pressurize a lower portion of a compression garment, then the resulting signal concerns a particular portion of the user's limb. For example, if a compression garment has three zones (e.g., lower, middle and upper) that may be isolated by the controller setting the actives valves of the compression garment accordingly, the controller may conduct three testing processes to assess swelling in each zone (by determining the resistance or impedance signal). The determined signal(s) may be evaluated from multiple sessions to detect changes in swelling condition of the user. For example, the CPG device 1002 may be configured to perform such a diagnostic assessment of the particular zone(s) of a compression garment on a daily basis or each time the compression garment is used or several times during compression garment use. With such a signal(s), a display can provide information to a user (via a display such as of the CPG device 1002, control device or portal system) showing an amount of swelling as represented by, or as a function of, the impedance or resistance information as well as the localized areas of the swelling. For example, minor, average, or significant levels of swelling may be associated with various ranges of values of impedance or resistance. By assessing whether a determined value is in a particular range or has a particular value (such as by comparison with one or more thresholds), the associated level of swelling may be identified.
In some versions, an average from the signal (e.g., average resistance) may be recorded. The controller may be configured to evaluate such a value (or other value of resistance or impedance) over time to detect changes. For example, an increase in the signal (or value therefrom) over multiple sessions (such as determined by a comparison of a current value with a previous value or other such threshold), may be taken as an indication of an increase in swelling and a problem with the patient's condition. Such a comparison may trigger, in the controller, a warning to the user or clinician. In some versions, such a comparison may serve as a basis for the controller to increase or change a compression therapy parameter (e.g., higher pressure, a different therapy protocol, or a longer therapy). In this way the controller may implement a compression therapy that is adaptive to changing patient conditions. By way of further example, a decrease in the signal (or value therefrom) over multiple sessions (such as determined by a comparison of a current value with a previous value or other such threshold), may be taken as an indication of a decrease in swelling and an improvement with the patient's condition. Such a comparison may trigger, in the controller, an update or warning to the user or clinician. In some versions, such a comparison may serve as a basis for the controller to decrease or change a compression therapy parameter (e.g., decrease pressure, a different therapy protocol, or a shorter therapy).
In some such versions, the diagnostic process may be performed before providing a compression therapy session, during and/or after providing the compression therapy session. A change in the determined impedance or resistance from before and after, or within, the session, such as a decrease or increase, may be taken, respectively, as an indication that no further compression therapy is necessary or that additional compression therapy is necessary. Thus, the controller may apply the diagnostic periodically during a therapy session to assess when the therapy can be discontinued. The controller may continue therapy if an evaluation of the determined resistance or impedance suggests that further therapy is needed. Alternatively, the controller may discontinue therapy if the evaluation of the determined resistance or impedance suggests that no further therapy is needed.
In some versions, an initial assessment of the determined resistance or impedance may be evaluated to determine the time (duration) or number of repetitions of therapy to be provided. For example, the determined resistance or impedance may be part of a function of the controller to assess therapy time (duration) or repetitions for a particular zone associated with the determined resistance or impedance, which may then serve as a control parameter for the controller to control the therapy for such a determined duration or number of cycles. For example, the function may indicate a shorter therapy time for a certain resistance or impedance associated with a lesser swelling. The function of the controller may indicate a longer therapy time for a certain resistance or impedance associated with a greater swelling. Similarly, in some versions, depending on the level of resistance or impedance, the controller may select a different therapy protocol from the different available therapy protocols provided by the CPG device or repeat a therapy protocol cycle.
In some versions, the pneumatic related impedance or resistance measurement may serve in a function of the controller to derive a girth or volume estimate of the patient's limb. For example, with a known dimension (e.g., volume) of a compression garment (e.g., a cylindrical sleeve) or a zone thereof, the pneumatic related impedance or resistance measurement may provide a proportional indication of how the patient's swelling limb is occupying the volume of the compression garment, or portions of the compression garment on a zone by zone basis. For example, a level of resistance or impedance may serve to functionally scale the known volume of the compression garment. For example, a higher level of resistance or impedance may be taken as a higher level of occupation of the known volume and a lower level of resistance or impedance may be taken as a lower level of occupation of the known volume. Such a relationship may be derived empirically and be adjusted on a garment-by-garment basis. Thus, with the measured resistance or impedance, such as on a zone by zone basis in the compression garment, the controller may provide a girth or volume estimate (e.g., on a zone by zone basis) as an output measure for different portions of a limb, such as on a display of the CPG device 1002, control device or portal system, that can inform the user or clinician, of the nature of the patient's Lymphedema condition, and progression of the Lymphedema condition when determined over a number of sessions or even a given session. Optionally, such a functional determination of volume or girth may also or alternatively be implemented by the controller with a measurement(s) from a tension sensor or a strain gauge or other similar strain sensor when the compression garment includes such sensor(s).
Although the aforementioned processes by the controller are based on a determination and/or assessment of pneumatic impedance or resistance from pneumatic sensing, the controller may alternatively, or in addition thereto, evaluate the patient's condition, and may additionally respond with therapeutic changes and/or information messages, by assessment of skin or body composition such as by measurements from a set of electrodes 23500 of a compression garment 23004-D as shown in
Thus, the controller may have a control module for such a process to make such measurements to provide an indication of swelling. For example, electrical bioimpedance of a particular part of a body may be estimated by measuring the voltage signal developed across a body part by applying a current signal (e.g., a low amplitude low frequency alternating current which may be sinusoidal or pulsed) to the body part via a set of electrodes (e.g., two or more of the compression garment). The bioimpedance may be measured by dividing the measured voltage signal (V) by the applied current signal (I). Bioimpedance (Z) can be a complex quantity and it may have a particular phase angle depending on the tissue properties. Thus, evaluation of the bioimpedance (e.g., magnitude and/or phase angle) may involve the controller comparing measured bioimpedance to one or more thresholds for detection of condition of the skin/body composition in relation to the potential for swelling. Such measurements may be made periodically and provide, through their evaluation by the controller (e.g., threshold comparison(s)), a diagnostic parameter for the controller to generate information characterizing the nature of swelling (e.g., high, medium or low) or Lymphedema (e.g., displayed information and warnings) and/or to control therapy changes. Thus, such an evaluation (e.g., an indication of increased fluid content or swelling) may serve as a basis for the controller to increase or change a compression therapy parameter (e.g., higher pressure, a different therapy protocol, or a longer therapy). Similarly, such an evaluation (e.g., an indication of decreased fluid content or swelling) may serve as a basis for the controller to decrease or change a compression therapy parameter (e.g., lower pressure, a different therapy protocol, or a shorter therapy). Such a process may be similar to the process previously described in relation to the assessment of pneumatic impedance/resistance.
For example, the controller may be configured to evaluate such a bioimpedance value (or values) over time to detect changes. For example, an increase in the values over multiple sessions (such as determined by a comparison of a current value with a previous value or other such threshold), may be taken as an indication of an increase in swelling and a problem with the patient's condition. Such a comparison may trigger, in the controller, a warning to the user or clinician. In some versions, such a comparison may serve as a basis for the controller to change or increase a compression therapy parameter (e.g., higher pressure, a different therapy protocol, or a longer therapy). Similarly, a decrease in the values over multiple sessions (such as determined by a comparison of a current value with a previous value or other such threshold), may be taken as an indication of a decrease in swelling and an improvement with the patient's condition. Such a comparison may trigger, in the controller, an update or warning to the user or clinician. In some versions, such a comparison may serve as a basis for the controller to change or decrease a compression therapy parameter (e.g., lower pressure, a different therapy protocol, or a shorter therapy).
In some such versions, the diagnostic process may be performed before providing a compression therapy session during and/or after providing the compression therapy session. A change in the determined bioimpedance from before, during and/or after the session, such as a reduction or increase, may be taken respectively as an indication that no further compression therapy is necessary or that additional compression therapy is necessary. Thus, the controller may apply the diagnostic periodically during a therapy session to assess when the therapy can be discontinued. The controller may continue therapy (e.g., repeat a cycle of therapy) if an evaluation of the determined bioimpedance suggests that further therapy is needed. Alternatively, the controller may discontinue therapy if the evaluation of the determined impedance suggests that no further therapy is needed.
In some versions, an initial assessment of the determined bioimpedance may be evaluated to determine the time (duration) of therapy or number of cycles to be provided. For example, the determined bioimpedance may be part of a function of the controller to assess therapy time for a particular zone associated with the determined bioimpedance, which may then serve as a control parameter for the controller to control the therapy for such a determined duration or a number of cycles that may achieve the therapy time. For example, the function may indicate a shorter therapy time or fewer cycles for a certain bioimpedance associated with a less swelling. The function of the controller may indicate a longer therapy time or more cycles for a certain bioimpedance associated with a greater swelling. Similarly, in some versions, depending on the level of bioimpedance, the controller may select a different therapy protocol from the different available therapy protocols provided by the CPG device 1002 or repeat a therapy protocol cycle.
The CPG device 1002 and/or any of the compression garments of the present disclosure may include one or more temperature sensors. One or more measurements from any of such temperature sensors may inform the controller about the Lymphedema condition of a user. Thus, the controller may be configured to evaluate temperature measure(s), such as in comparison to one or more thresholds, in providing information to the user or clinician, via a monitor of the CPG device 1002, the control device, and/or the portal system. Similarly, the controller may evaluate temperature measure(s), such as in comparison to one or more thresholds, for adjusting one or more therapy control parameters based on the determined temperature. For example, the controller may be configured to evaluate temperature associated with the condition of the user's skin from any of the sensor measures or zones of the compression garment. The controller, based on the evaluation, may be configured to suspend a therapy, reduce a therapy time, increase a therapy time, increase or reduce a therapy pressure, change a compression protocol or type of therapy, such as in the particular zone of the temperature measure or for all zones of the compression garment. For example, an increase or decrease in temperature (such as determined by comparison between one or more measurements from the temperature sensor and one or more thresholds) may be taken as an indication of a bacterial infection or elimination of a bacterial infection. Such a detection may trigger the controller to send a warning to the user or clinician. Such a detection may also trigger the controller to suspend or reduce a compression therapy, such as in the particular zone of detection, or initiate a compression therapy (e.g., of a lesser or higher than usual pressure in the zone of detection) or initiate a compression therapy so as to control the compression therapy in zones of the compression garment(s) that are not associated with the detected temperature increase or decrease. Other adjustments to the control of the compression therapy based on detected temperature may also be implemented by the controller.
As previously mentioned, the CPG device 1002 and/or any of the compression garments of the present disclosure may include one or more tension sensors (e.g. dielectric elastomer sensors) and/or strain sensors. One or more measurements from any of such sensors may inform the controller about the limb circumference (e.g., girth). Thus, the controller may be configured to evaluate limb circumference measure(s), such as in comparison to one or more thresholds, in providing information to the user or clinician, via a monitor of the CPG device 1002, the control device, and/or the portal system. Similarly, the controller may evaluate limb circumference measure(s), such as in comparison to one or more thresholds, for adjusting one or more therapy control parameters based on the determined circumference. For example, the controller may be configured to evaluate limb circumference from any of the sensor measures or zones of the compression garment. The controller, based on the evaluation, may be configured to suspend a therapy, reduce a therapy time, increase a therapy time, increase or reduce a therapy pressure, change a compression protocol or type of therapy, such as in the particular zone of the limb circumference measure or for all zones of the compression garment.
One or more of the compression garments of the present disclosure may be configured with ultrasound transducers that are connected to the CPG device 1002 via electrical lines of the link 1006. One or more measurements from any such transducers may inform the controller about the Lymphedema condition of a user. Ultrasound sensing is capable of providing deep tissue information such as deeper lymphatic structures and how well fluid is draining.
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 the sensor. 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.
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. Such a Lymphedema therapy may be considered in relation to
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 (e.g., Z1) 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). 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.)
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 (Z2) 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 23004-A in a predetermined order (e.g., first Z1, then Z2, then Z3, then Z4 etc.) Preferably, such an ordering of control by the controller of the different zones of the compression garment 23004-A 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).
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 control parameter for the therapy such as by a manual input to the CPG device 1002. 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.
Optionally, such a massage therapy protocol may be provided by the controller as described with a compression garment that does not include any applicator.
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 for a desired therapy time. Such a Lymphedema therapy may be considered in relation to
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 pneumatic chambers. In relation to the example compression garment illustrated in
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 Z2, by controlling an opening of one or more active valves associated with the second zone Z2. 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 Z2 to close. This may permit the second pressure to be maintained in the pneumatic chamber(s) of the second zone Z2.
This process may be repeated to set the pressure in each succeeding zone (e.g., zone Z3 to zone Z7) to a higher 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 23004-B to open to release the compression pressure in each of the zones Z1-Z7. 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.
Thus, 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 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 gradient therapy and the evaluation may trigger a repeat of the cycle or termination of the therapy session. Similarly, the controller may determine whether to adjust the applied compression pressure gradients (e.g., the high and low and intermediate steps, such as to be higher, lower or at 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 several or all of the zones of the garment depending on the measurement results of each zone.
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.
For example, referring to
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 (e.g., section 4 to section 1), while control of each successive chamber within each section advances (e.g., chamber-by-chamber) in a distal (e.g., downward) direction (e.g., chamber 3 to chamber 1). Table 1 provides an example control protocol of how this may occur.
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 the pressure response as well as the timing. 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.
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.
In some implementations of the present disclosure, the therapy device controller 4240 (shown in
Optionally, in one form of the present technology, the central controller 4230 (FIG. 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:
Upon detection of the fault condition, the corresponding algorithm signals the presence of the fault by one or more of the following:
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.
6.8 Control Device Application
The system 1000 may include a control device 1010 (
Example operations with such an application of the control device may be considered in reference to
Referring to
Referring to
Referring to
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Referring to
Another example of such a user interface control is illustrated in
Optionally, the control device 1010 may organize information in various additional user interface presentations such as illustrated in
The application of the control device 1010 may also provide a communication function. Thus, the control device 1010 may present, such as illustrated in
6.9 Portal Management System
A portal system 2028 (
Referring to
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Similarly, as illustrated in
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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.
6.10 High-Resolution Compression Therapy Systems
The disclosed compression therapy systems, such as those illustrated in
The resolution of such massage therapies may be further increased by partitioning each chamber (e.g., chambers 1.1, 1.2, 1.3 shown in
In some implementations of the present disclosure, the predetermined sequence of pressurization of micro-chambers provides a directional massage that, for example, starts at one end and moves towards another opposing end. For example, the massage starts at a distal end of a user's arm and moves towards a proximal end of the user's arm (or vice versa). For another example, the massage starts at a distal end of a user's leg (near the foot) and moves along a calf muscle and/or shin of the user towards a proximal end of the user's leg near the knee of the user (or vice versa).
Referring to
According to some implementations, a garment has between about 8 toroidal chambers (e.g., rows) and about 32 toroidal chambers (e.g., rows). In some such implementations, each of the toroidal chambers has about 10 micro-chambers. In some implementations, a garment according to the present disclosure includes between about 50 micro-chambers and about 100 micro-chambers. In some implementations, a garment includes about 80 micro-chambers. Various other garments with various other amounts of toroidal chambers/rows and various other amounts of micro-chambers are contemplated to provide compression therapy (e.g. massage emulation).
According to some implementations of the present disclosure, a chamber or macro-chamber is a chamber that is controlled with an active valve. In some such implementations, the macro-chamber is partitioned into smaller sub-chambers or micro-chambers, where each of the micro-chambers is connected with at least one other micro-chamber via passive valves and/or micro-conduits.
In some implementations, a macro-chamber of the present disclosure has a length/height between about 20 millimeters and about 120 millimeters, a width between about 10 millimeters and about 80 millimeters, and a depth/thickness between about 1 millimeter and about millimeters.
In some implementations, a micro-chamber of the present disclosure has a length/height between about between about 0.25 inches (6 mm) and about two inches (50 mm), a width between about 0.25 (6 mm) inches and about two inches (50 mm), and a depth/thickness between about 0.1 inches (0.25 mm) and about 0.5 inches (12.5 mm). In some implementations, a micro-chamber has a length of about 12.5 millimeters, a width of about 12.5 millimeters, and a depth/thickness of about 5 millimeters.
In
According to some implementations, each toroidal chamber/row of a garment is separately pressurized via a separate and distinct active valve. Alternatively, one or more of the toroidal chambers/rows of a garment are fluidly connected to one or more other toroidal chambers/rows of the garment via one or more conduits. In some such implementations, the conduits connecting one toroidal chamber (e.g., macro-chamber) to another have a diameter of about 5 millimeters.
A compression therapy utilising a partitioned chamber such as the toroidal chamber 57000 is thus able to create a micro-massage on the wearer's skin. One aim of a micro-massage is to emulate the stretching effect of natural bodily movement. Lymphedema patients often lack normal mobility and thus their skin is deprived of this natural stretching effect. In addition, the micro-massage can increase pre-load of the lymphatic capillaries and greatly improve lymphatic and venous micro-circulation.
Referring to
Referring to
Another method for producing a third dimension of a micro-massage can involve having different knitting patterns in the textile to dictate the properties of the direction in which the material inflates and thereby have a three-dimensional effect. The third dimension may also be implemented via differing rates of inflation of the micro-chambers of a chamber, which in turn may be implemented via micro-conduits of different resistances to flow (e.g. different minimum diameters of the micro-conduits).
Referring back to
The configuration of the micro-conduits, and therefore the character of the resulting micro-massage, may be personalized for a particular patient. As described above, an ICG scan of the affected areas of a user/patient could provide information on how to personalize the micro-massage for a particular user/patient, such that the direction of the micro-massage matches the natural flow of the lymphatic system (as determined from the scan). Alternatively, as mentioned above, information enabling personalization may be obtained from the patient's clinical history, e.g. the pattern of swelling.
Micro-chambers may also be partitioned from non-toroidal chambers which do not necessarily wrap around a limb. Such chambers could be localised chambers taking any shape, used to target specific areas of the body. One example is an anatomically shaped chamber such as the bicep zone 19410 in
In some implementations, micro-chambers may be coated and/or have a surface finish applied to at least a portion thereof, so as to produce a textured surface to enhance skin stretching, improve comfort, and regulate skin environment. Silicone dot protrusions (e.g., generally circular dot protrusions) may present one particularly suitable option given silicone's natural high-friction surface properties. Alternatively, the micro-chamber surface may be brushed to create the same, or similar, effect.
6.10.1 Cyclic Pressurisation A more intricate control system for the micro-chambers may involve
Cyclic pressurisation is similar to the oscillatory pressurisation waveforms described above in relation to
6.11 Additional Compression Therapy System Implementations
Referring now to
In some implementations, it is also contemplated that a compression garment includes one or more longitudinal chambers that generally extend along the length of a human limb, such as a leg or arm, and effectively parallel the long axis of the limb. For a longitudinal chamber configuration, the chambers may be arranged as adjacent columns. One or more independently pressurized chambers of the garment can be primary chambers partitioned into multiple longitudinal sub-chambers that are also aligned in columns within the primary chamber. In some implementations, chambers of a compression garment may further be anatomically shaped to follow the orientation of core muscle groups of the user around the targeted limb or body part.
Examples of toroidal chambers are provided throughout the present disclosure, including in
In some implementations for transverse chambers (e.g., circumscribing a limb of the user), a toroidal chamber is contemplated to be generally circular when the compression garment with the toroidal chamber is worn by the user. In some implementations, if a radial cross-section of a toroidal chamber that circumscribes a limb of the user were taken at any point relative to the limb, the geometric shape of each cross-section of the chamber would be expected to be generally the same, with similar cross-sectional dimensions. Some variation in shape could be expected to accommodate for the practicalities of a compression garment, including tapering of the chamber, fabrication considerations, and at cross-sections taken at air flow control points between chambers or sub-chambers.
As discussed above for exemplary
In some implementations, one or more chambers may be, or may include, non-toroidal chambers which do not necessarily wrap around a user's body part. Such chambers could be localised chambers taking any shape, used to target specific areas of the body, such as a foot section or to follow certain muscles or physiology.
Turning now to
The general positions of the macro-chambers within the compression garment, as they extend from the multiple tabs 6130a-6130g around the leg, are indicated at macro-chamber sections 6140a-6140g of compression garment 6100. The broken lines identify a portion of the macro-chamber underlying the outer layer 6105 of the compression garment. The macro-chambers and tabs 6130a-6130g are stacked along the longitudinal axis of the limb. In some implementations, one or more macro-chamber sections, such as macro-chamber section 6140a, can be partitioned into a plurality of interconnected micro-chambers (not shown) disposed within the macro-chamber. Each micro-chamber may have one or more links to adjacent micro-chambers within a respective macro-chamber. The links may be in the form of passage(s) and/or opening(s) in the connection profile, (e.g., the disclosed welding patterns in for example
In some implementations, the foot section 6120 can include a separate macro-chamber 6150 that wraps around the foot section 6120. The foot section 6120 can include a sole piece 6125 that allows a user to walk during circulatory-related disorder therapy, such as lymphedema therapy.
In some implementations, it is also contemplated that the compression garment 6100 may include an interface patch 6160 for electronics and/or pneumatic components or systems to be connected to the compression garment.
Turning now to
Referring to
In some implementations, each of the layers is fabricated to include material(s) that are flexible, durable, and preferably smooth to provide comfort to the user during therapy. One exemplary fabric material with such properties for the compression garment includes thermoplastic polyurethane materials (“TPU”), such as TPU films. Materials used to form boundaries of the chambers of a compression garment also include air-tight properties. In some implementations, other textures for materials of the various layers are contemplated depending on the objective of the therapy. For example, in some implementations, a rough surface may be desirable to aid in the breakdown of gel-like or fibrotic tissue in lymphedema patients. In some implementations, the fabrics used for the layers of a compression garment comprise a TPU film laminated to a textile layer.
The three layers 6230, 6240, and 6250 of the exemplary leg compression garment 6210 are coupled together through welding techniques for thermoplastics, such as ultrasonic or radiofrequency welding, that provide the ability to create air tight interfaces between any two layers of the compression garment 6210 and that are flexible and durable. Other coupling methods are contemplated for fabricating compression garments of the present technology that similarly provide air-tight, flexible, and durable properties, and in some implementations. For example, rather than welding, or in addition to welding, layers could alternatively be joined by gluing or otherwise chemically bonding the layers of a compression garment.
A chamber weld profile 6235 provides a specific coupling pattern implemented by a process, such as welding, to attach the skin contact layer 6230 and the second layer 6240 to define a plurality of independent macro-chambers between the skin contact layer 6230 and the second layer 6240. In some implementations, the chamber weld profile is not a layer, but rather a pattern along which the two layers (e.g., skin contacting layer and the second layer) are welded together, and effectively form a seam. The macro-chambers are themselves partitioned or sub-divided into a plurality of interconnected micro-chambers. The weld profile 6235 in the exemplary aspect of compression garment 6210 forms six air-tight transverse macro-chambers (though more or fewer chambers are contemplated including as few as one, between two and five, and more than six), that are fluidly independent of each other as a result of the transverse welds in between each adjacent macro-chamber and welds around the perimeter of the skin contact layer 6230 and the second layer 6240 which couple the layers together. These perimeter welds (e.g. 6236) have no gaps, which prevents or minimizes air from leaving the respective macro-chamber. The perimeter welds also define a maximum total area for a macro-chamber to be inflated. In some implementations, adjacent macro-chambers share a common continuous solid weld 6237 to separate the chambers.
As mentioned above, it is contemplated by the present disclosure that when referring to a “profile”, such as weld profiles 6235, 6245, 6275, use of the term “profile” refers to a pattern, outline or trace along which two layers are attached or connected to each other where the pattern, outline or trace is not necessarily a distinct or separate layer of appreciable thickness. When referring to a “weld profile”, the pattern, outline, or trace is created using welding techniques. Other implementations for creating a profile for attaching two layers can include thermo-stamping, gluing, fusing, or similar techniques. A weld profile, a thermo-stamping profile, a gluing profile, a fusing profile, or a profile created using related techniques can more generally be referred to as a layer attachment profile.
In the exemplary weld profile 6235, each of the plurality of transverse macro-chambers are subdivided into a plurality of transverse micro-chambers through additional welding of the skin contact layer 6230 and the second layer 6240 (or an outer layer). The micro-welds (e.g., welds that form the micro-chambers), may include discontinuous transverse and/or longitudinal welds 6238 to create the plurality of micro-chambers with openings or gaps between the welds that allow for air flow between the micro-chambers. In some implementations, apart from being in fluid communication with one or more adjacent micro-chambers, depending on the welding pattern a micro chamber may also be in fluid communication with one or more non-adjacent micro-chambers or may even be in fluid communication with all micro-chambers within a respective macro-chamber (e.g. see
The micro-welds of a weld profile can effectively operate like seams and define the size and location of each micro-chamber. The size of a micro-chamber varies based on the circulatory-related disorder therapy needed by a user. A desirable aspect of the present disclosure is that the weld profile can be adjusted so that the micro-weld layout and arrangement can be configured as a controllable pattern or array within each of the macro-chambers to accommodate an individual patient's needs. For example, prior to finalizing the fabrication of a compression garment, a weld profile can be digitally or mechanically arranged by systematically patterning the placement of each micro-weld within each macro-chamber of a compression garment. In some implementations, micro-weld width (e.g., the width of the effective seam created by the micro-weld) can range from about 1 mm to about 5 mm. The micro-weld length can also vary, and in some implementations, can range from about 10 mm in length to about 900 mm. The approximately dimensions of a micro-chamber can vary, and in some implementations, can range from about 10 mm by about 100 mm to about 30 mm by 900 mm.
In some implementations, the size of a micro-chamber, or further subdivision of a micro-chamber into micro-cell(s), can be determined based on the location of the welds on the compression garment, and thus, the desired treatment area of the body. For example, around the foot, the micro-chambers may be smaller and may include further subdivision into micro-cells. Around the thigh, the micro-chambers can be larger. Flexibility is desirable because adjusting a weld profile allows fluid gradients to be better mimicked and pressure gradients in the compression garment to be changed. In some implementations, the micro-welds for forming the micro-chambers are independent welds within the macro-chamber. In some implementations, the micro-welds are connected to other micro-welds or to welds defining the perimeter of a macro-chamber.
To allow pressurized air to enter a macro-chamber, the second layer 6240 has a plurality of connectors 6242 mounted or bonded to the second layer such that each macro-chamber is in fluid connection with a respective connector. The supply of pressurized air to a connector in turn causes the pressurized air to further be delivered to one or more micro-chambers and/or micro-cells within their corresponding macro-chambers. In some implementations, the pressurized air is delivered simultaneously to a plurality of micro-cells within a plurality of micro-chambers of a corresponding macro-chamber of the compression garment. The pressure for the supplied air entering a macro-chamber can range from about 15 mm Hg to about 120 mm Hg; and in some implementations between about 15 mm Hg to 100 mm Hg; and in other implementations between about 25 mm Hg to about 65 mm Hg; and in yet other implementations between about 35 mm Hg to about 55 mm Hg.
In some implementations, an outer layer 6250 is coupled to the second layer 6240 by welding or other comparable coupling techniques. Second weld profile 6245 depicts an exemplary weld pattern that includes perimeter welds without any gaps, along with transverse welds extending from the tabs that are generally parallel with the welds defining the macro-chambers in weld profile 6235. The coupling of the outer layer 6250 to the second layer 6240 may also provide a protective system for a pneumatic spine (see
In some implementations, a garment interface patch 6260 is further disposed on the outer layer 6250. Furthermore, outside retention panels 6270 may be secured to each of a plurality of tabs formed in each of the primary layers for the compression garment.
Each of the macro-chambers of an assembled leg compression garment 6210 in the flattened view depicted in
Referring now to
In some implementations, the foot compression garment includes a sole piece 6225 mounted to the perimeter of the foot skin contacting layer 6270. The foot compression garment 6220 desirably provides a user a shoe-like foot section. The sole piece 6225 allows the user to be mobile while wearing the compression garment(s). The sole piece may be fabricated from foam and can be bonded to the base of the foot compression garment 6220 or attached separately like a shoe.
The overall dimensions of an assembled foot compression garment 6220 in the flattened view depicted in
In some implementations, one or more of the skin contact layers 6230, 6270, the second layer 6240, and the outer layers 6250, 6280 can include one or more sublayers. For example, at least one of the skin contacting layer and second layer can include a textile layer laminated to a thermoplastic polyurethane film sublayer. The coupling of any adjacent layers (e.g., skin contacting layer and the second layer, skin contacting layer and outer layer, second layer and outer layer) can include joining all the layers that comprise the adjacent layers.
Turning now to
The leg compression garment skin contact layer 6330 includes exemplary welds, such as perimeter weld 6336 at the outermost boundary of the skin contact layer 6330 and shared transverse macro-chamber welds 6337 defining the boundary between any two adjacent independent macro-chambers 6340a-6340f. The perimeter welds 6336 and shared transverse macro-chamber welds 6337 are solid or continuous with no openings to prevent or minimize the passage of air outside of a welded macro-chamber or between macro-chambers. These continuous welds define the outer edge of each macro-chamber. The perimeter welds may further create the tab for the compression garment (not shown) that includes the depicted skin contacting layer 6330.
Varying layouts or arrangements of typical micro-welds 6338 are contemplated in each of the depicted macro-chambers 6340a-6340f. The micro-welds 6338 define separate interconnected transverse micro-chambers 6350 within the macro-chambers 6340a-6340f. The micro-welds 6338 can be modified in length to customize the dimensions of the micro-chambers, the pressure, and the treatment density for a particular circulatory-related disorder. Openings or gaps 6339 created by discontinuous micro-welds 6338 can be positioned to control the expansion and direction of air through the macro-chambers 6340a-6340f and their corresponding micro-chambers 6350. In some implementations, providing a more rigid outer layer and a flexible inner (e.g., skin contact) layer, on the other hand causes the skin contact layer to mostly be deformed by the pressurization of the respective micro-chamber or macro-chamber, which can improve the overall efficiency of the compression therapy.
In comparing the patterns of skin contacting layers 6230, 6270 (and the overall compression garments 6210, 6220) with the pattern of the skin contacting layer 6330, alternative implementations of the foot section are depicted for a compression garment. For example, skin contacting layer 6230 includes a tongue section 6280 that conforms with the pattern of the garment 6210. The tongue section 6280 attaches with garment 6220 at opening 6215 to provide a two-piece combined leg and foot compression garment. In contrast, the exemplary compression garment based on the pattern of skin contacting layer 6330 is one-piece where a foot section 6320 extends from the macro-chamber 6340f and includes an opening 6325 that allows the foot section 6320 to be wrapped about the user's foot.
Turning now to
One or more of the plurality of micro-chambers are subdivided by a series of discontinuous longitudinal micro-cell welds, such as micro-cell welds 6389a-6389d, extending between transverse welds 6387a, 6387b, 6388a-6388d that define the micro-chamber and macro-chamber boundaries. The series of discontinuous longitudinal welds (e.g., 6389a-6389d) define micro-cells, such as micro-cell 6389, within the micro-chamber (e.g., micro-chamber 6375a). The micro-cells (e.g. 6389) formed along the length of a micro-chamber may further control the air flow and pressures, as well as the timing of the pressurisation, along the length of the micro-chamber (e.g., 6375a).
Turning now to
Section 6400a includes two macro-chamber welds 6430a, 6436a that define boundaries and are continuous with no openings. Similarly, section 6400b includes two macro-chamber welds 6430b, 6436b that are boundaries of another representative independent macro-chamber. Each section 6400a, 6400b further includes representative discontinuous transverse micro-welds 6438a, 6438b with representative openings 6460a, 6460b, that in combination, define a plurality of micro-chambers within the macro-chambers bounded by welds 6430a, 6436a and 6430b, 6436b. The openings in the discontinuous transverse micro-welds direct air flow within the macro-chamber.
Each of the representative sections of the second layer 6440a, 6440b can include a pneumatic connector 6442a, 6442b that is mounted or bonded to the second layer 6440a, 6440b such that the connector 6442a, 6442b penetrates the second layer with an air-tight seal about the connector at the penetration point. The connectors 6442a, 6442b allow pressurized air to enter the respective macro-chambers and disperse among the micro-chambers (or micro-cells, if present) as demonstrated by broken-line arrows showing exemplary air flow 6450a, 6450b within the sections 6400a, 6400b.
Openings along the discontinuous micro-welds are positioned to define compression zones for therapy during the operation of a compression garment, including the inflation and deflation of a particular micro-chamber or micro-cell within a macro-chamber. The micro-welds can be modified in length to customize the pressure and treatment density for a particular circulatory-related disorder. Furthermore, openings created by the discontinuous micro-welds can be positioned to control the movement and the timing of the movement of air through the chamber. For example, a specific change in the impedance of the openings between adjacent micro-chambers, or microcells within a micro-chamber, may create a desired pressure gradient and/or desired pressurizing sequence of the micro-chambers and the micro-cells. The different impedance (or resistance to flow) may be created by using connecting openings or channels of different dimensions (and/or of different shape, material, surface roughness, etc.) between chambers. A compression garment may have, for example, a similar chamber structure as depicted in
The progressively (or otherwise) decreasing opening arrangement may be extended to a series of adjacent micro-cells within a single micro-chamber (e.g., see
Turning now to
A typical air flow pattern 6550, within inflated section 6500, includes pressurized air flowing along larger chamber volumes and then into smaller chambers. Full expansion of a macro-chamber is achieved from the origin of the air entering the chamber, such as at a connector disposed in the second layer (see
Turning now to
Turning now to
Each of the micro-chambers are formed by transverse micro-welds 6738a, 6738b coupling the second layer (e.g., in some implementations the second layer is disposed below the outer layer 6750a, 6750b) to the skin contact layer 6730a, 6730b. Shared transverse macro-chamber welds 6737a, 6737b on the ends of the macro-chamber form a boundary of the macro-chamber with another adjacent macro-chamber. In the deflated state of
In some implementations, gaps or openings between discontinuous transverse micro-welds create bridges 6739 between each micro-chamber 6775a. The bridges can increase the effective treatment surface area of the compression garment where the expanded micro-chambers depress the skin layer 6790a sufficiently to allow the bridges to apply pressure to the skin. These air flow gaps or openings between the discontinuous transverse micro-welds also minimize creasing or distortion of chambers when a compression garment is wrapped around a user's limb. This allows for a tailored fit when the user is wearing the garment.
An advantageous aspect of the present disclosure includes the low-profile nature (e.g., see
Turning now to
Each of the micro-chambers are formed by transverse micro-welds 6838a, 6838b coupling the second layer (e.g., in some implementations the second layer is disposed below the outer layer 6850a, 6850b) to the skin contact layer 6830a, 6830b. Shared transverse macro-chamber welds 6837a, 6837b on the ends of the macro-chamber form a boundary of the macro-chamber with another adjacent macro-chamber. In the deflated state of
In some implementations, the plurality of toroidal (e.g., during use) micro-chambers are welded, during fabrication, to include excess material to provide an expansion volume such that the skin contacting layer expands away from the second layer and toward a patient's skin during pressurization of the compression garment. For example, the skin contacting layer may be at least partially formed into cells before welding the skin contacting layer to the second or outer layer.
An advantageous aspect of the macro-chamber structure in
Turning now to
Alternatively, a distributed valve system can be used where the valves are spread throughout the garment. The valves are still located on the garment and are separated from the CPG where the separation can provide a more pleasing, compact and easy to maintain design, as the pneumatic link between the CPG and the garment still includes a single pressurised line. The links between this main line and each of the valves can be concealed in the structure of the compression garment. In contrast, an alternative scenario can include the valves being in an arrangement separate from the compression garment. In this alternate scenario, each valve would be independently connected to a respective valve on the compressions garment. However, this results in a number of pressurized tubes extending from the valve arrangement (i.e. the valves may be enclosed with the CPG) to the garment, requiring special effort to secure them, to ensure their safe use and to conceal them for a better aesthetic appeal.
In some implementations, the pneumatic spine is about 20 cm to about 30 cm long and about 8 cm to about 10 cm wide. In some implementations, the pneumatic spine can be anywhere between about 5 cm to about 70 cm long and anywhere between about 5 cm to about 30 cm wide. It is contemplated that the spacing of valves in the pneumatic spine is approximately about 2 cm to 3 cm apart. In some implementations, the valve spacing can be anywhere from about 0 cm (i.e., adjacent) to about 10 cm apart.
Compression system 6900 includes an exemplary leg compression garment 6910 with an outer layer 6950. The exemplary system 6900 is a two-piece system with a foot compression garment 6920 that can be attached to the leg compression garment 6910. Other configurations of compression systems are contemplated including a one-piece system (e.g., extending from upper leg to foot or toes) or a multi-piece system (e.g., one for the thigh, one for the lower leg, one for the foot, one for the toes, or combinations thereof). A pneumatic spine 6960 is disposed underneath the outer layer 6950 near the top of the leg compression garment 6910, and provides pressurized air to both compression garments 6910, 6920. Valves controlling the pressurisation and evacuation of the chambers in the compression garments are located in a watertight pneumatic spine 6960.
Turning now to
The valve connectors 7020 are mounted to the bottom layer 7010. A primary air connecting line 7030, via an interior portion 7031, is in fluid connection with one or more secondary air connecting lines 7040 that are each coupled to a corresponding one of the of valve connectors 7020. In some implementations, the pneumatic spine 6960 further includes the exhaust valve connector 7025 that may include a two-way valve for removing air from any one of the macro-chambers in a compression garment. The exhaust valve connector 7025 is connected to the exhaust secondary line 7045 that branches off the interior portion 7031 of the primary air connecting line 7030. The exhaust valve connector allows for chamber air to be exhausted to ambient pressure during depressurization of a chamber.
Separate tertiary macro-chamber air lines 7048 may be optionally included to extend from each of the valve connectors 7020 and penetrate the cover assembly 7050 or the bottom layer 7010 through a sealed opening (not shown) in the cover assembly 7050 or the bottom layer 7010. The valve connectors 7020 are pneumatically connectable to connectors 6242 on the second layer 6240 (
An opening (not shown) in the cover assembly 7050 or the bottom layer 7010 allows a second portion 7032 of the primary connecting line 7030 and the electrical cable 7023 to extend out of the interior space. The opening is sealed about the second portion 7032 of the primary connecting line 7030 and the electrical cable 7023.
In some implementations, the housing (comprising the bottom layer 7010 and the cover assembly 7050), along with the sealed opening(s), provides a water tight and/or air-tight seal around the valve arrangement, to minimize fluid entering the interior space. The bottom layer 7010 and the cover assembly 7050 may be fabricated to include thermoplastic polypropylene materials.
In some implementations, a controller for the pneumatic spine 6960 may be used to cycle the pressurization of the chambers in a compression garment between at least two different pressure levels to provide a massage to a body part of the user. In some implementations, the plurality of valve connectors 7020 are configured to selectively direct pressurized air received from the primary connecting line 7030 to respective chambers in a compression garment via the valve connectors 7020. The controller can be configured to selectively control operation of the valve connectors 7020 to correspond to chambers in different zones of the compression garment. Other valve connector operations by the controller are also contemplated to assist with the pressurization and depressurization of the chambers of a compression garment.
In some implementations, a controller for a compression garment can be divided into multiple zone for purposes of controlling air flow. Each zone can have one or more macro-chambers. For example, the controller operation can identify multiple macro-chambers (e.g., chambers 1, 2, and 3) as being a part of the same pressurization zone (e.g., zone 1) where the CPG can control zones rather than individual macro-chambers by turning on and off the valves necessary to pressurize and/or exhaust the macro-chambers (e.g., chambers 1, 2, and 3) within a controller-identified pressurization zone (e.g., zone 1).
Turning now to
In some implementations, the pneumatic spine 6960 is accessible through the outer layer 6950 via a waterproof resealable mechanism 7180 (e.g., such as a waterproof zipper disposed on the outer layer 6950). In some implementations, for aesthetic reasons, an edge of the outer layer 6950 can include a hidden waterproof zipper than provides access for placing and repairing the pneumatic spine 6960. It is further contemplated that a garment interface patch 7170 may be bonded to the outer layer 6950 to receive the primary connecting line 7030 of the pneumatic spine 6960 and to further allow the pneumatic spine 6960 to interface with components external to the compression garment, such as air and electrical components.
Turning now to
Referring to
The micro-chambers 7250a-7250e are similarly created by the exemplary micro-chamber boundaries 7238 within the interior of the macro-chamber 7240. As pressurized air enters the macro-chamber 7240 at the pneumatic coupling 7242, it propagates along pathways 7260 and through opening 7370d into micro-chamber 7250d and then through progressively smaller openings (e.g., 7370c, 7370b, 7370a) until the pressurized air reaches micro-chamber 7250a at the proximal end 7220 of the macro-chamber 7240.
Referring now to
Macro-chamber 7340a is subdivided into a plurality of micro-chambers 7350a, 7351a, 7352a, 7353a, 7354a with different sized sets of openings 7370a, 7371a, 7372a, 7373a along the respective micro-chamber borders 7338 between the micro-chambers 7350a, 7351a, 7352a, 7353a, 7354a. Similarly, macro-chamber 7340b is subdivided into a plurality of micro-chambers 7350b, 7351b, 7352b, 7353b, 7354b with different sized sets of openings 7370b, 7371b, 7372b, 7373b along the respective micro-chamber borders 7338 between the micro-chambers 7350b, 7351b, 7352b, 7353b, 7354b. Likewise, macro-chamber 7340c is subdivided into a plurality of micro-chambers 7350c, 7351c, 7352c, 7353c, 7354c with different sized sets of openings 7370c, 7371c, 7372c, 7373c along the respective micro-chamber borders 7338 between the micro-chambers 7350c, 7351c, 7352c, 7353c 7354c.
The sets of openings 7374, 7375 connecting each consecutive pair of adjacent macro-chambers can decrease progressively from the distal end 7310 to the proximal end 7320 of the compression garment. Similarly, the sets of openings 7370a-c, 7371a-c, 7372a-c, 7373a-c connecting each consecutive pair of adjacent micro-chambers can also decrease progressively from the distal end 7310 to the proximal end 7320 of the compression garment. The group of three macro-chambers 7340a-7340c are constrained laterally by the perimeter boundary 7336 that may be created via a welding process or other techniques describes elsewhere in the present disclosure. The micro-chambers 7350a-c, 7351a-c, 7352a-c, 7353a-c, 7354a-c are similarly created by the exemplary micro-boundaries 7338 within the interior of their respective macro-chambers 7340a-7340c.
As pressurized air enters the first macro-chamber 7340c at the pneumatic coupling 7342, it propagates along pathways 7360 and through the first set of openings 7373c into micro-chamber 7353c and then through progressively smaller openings (e.g., 7372c, 7371c, 7370c) until the pressurized air reaches macro-chamber 7340b. The pressurized air similarly progresses through macro-chamber 7340b to macro-chamber 7340a until it reaches micro-chamber 7350a at the proximal end 7320 of the macro-chamber 7340a.
The implementation described for
Referring now to
The use of the single macro-chamber 7440 of a compression garment configured similar to
The segmented vs. smooth approaches each have their advantages and can be tailored based on a user's condition. For example, if a user has severe lower leg venous disease related edema, a more gradual or smooth pressure transfer profile will be more desirable. In contrast, if a user has a fibrotic limb, a more segments pressure transfer profile would be desirable.
It is contemplated that opening sizes between macro-chambers, micro-chambers within macro-chambers, or micro-cells within micro-chambers will be different and include larger sizes, smaller sizes, or have some step function with various sequential sizes. The combination of opening sizes between chambers or cells will determine how quickly and how smoothly a compression garment will inflate from bottom to top or from side to side. For instance, if we have decreasing opening sizes from a bottom chamber to a top chamber of a compression garment, it is likely that the garment will quickly inflate its bottom part, but how quickly the top parts will inflate will depend on the specific function used for the sizes of the openings between adjacent interconnected micro-chambers and/or macro-chambers.
In some implementations, it is contemplated that some sizes of openings between chambers of cells may limit or even completely prevent inflation of a chamber or cell of a compression garment for a given low-flow of the CPG. Thus, it is contemplated that an interplay between the provided flow and the size of the opening can provide some level of timing- and/or spatial—control over the inflation of a compression garment.
According to certain aspects of the present disclosure, an Alternative Implementation A is a compression garment for circulatory-related disorder therapy. The compression garment includes a skin contacting layer, a second layer coupled to the skin contacting layer, and one or more connectors disposed on the second layer. The skin contacting layer and the second layer form one or more macro-chambers. Each macro-chamber is partitioned into a plurality of micro-chambers. Each of the plurality of micro-chambers is in direct fluid communication with at least one other of the plurality of micro-chambers. Each of the one or more connectors is configured to supply pressurized air directly into at least a corresponding one of the one or more macro-chambers such that the pressurized air is delivered to at least one of the plurality of micro-chambers within the macro chamber. The coupling of the skin contacting layer and the second layer is along a layer attachment profile that defines the one or more macro-chambers and the plurality of micro-chambers. At least one of the plurality of micro-chambers is linked to another of the plurality of micro-chambers by way of a plurality of openings.
An Alternative Implementation B includes the compression garment aspects of Alternative Implementation A and further includes the skin contacting layer and the second layer form one or more independent macro-chambers.
An Alternative Implementation C includes the compression garment aspects of any one of Alternative Implementations A or B and further includes that each macro-chamber is generally toroidal and is partitioned into a plurality of generally toroidal micro-chambers. The one or more macro-chambers and/or the plurality of micro-chambers are elongated and arranged such that in an operational configuration of the compression garment around a limb of a user. One or more of the macro-chambers and/or one or more of the plurality of micro-chambers form, individually or in combination, a generally toroidal shape.
An Alternative Implementation D includes the compression garment aspects of any one of Alternative Implementations A to C and further includes that at least one of the micro-chambers comprises a plurality of micro-cells and that the pressurized air is delivered substantially simultaneously to the plurality of micro-cells.
An Alternative Implementation E includes the compression garment aspects of any one of Alternative Implementations C or D and further includes that at least some of the plurality of openings between elongated adjacent micro-chambers are positioned along a border between the adjacent micro-chambers.
An Alternative Implementation F includes the compression garment aspects of any one of Alternative Implementations A to C and further includes that the plurality of micro-chambers within each macro-chamber are interlinked such that pressurized air provided to at least one of the micro-chambers can flow to others of the plurality of micro-chambers within a respective macro-chamber.
An Alternative Implementation G includes the compression garment aspects of any one of Alternative Implementations A to F and further includes that the layer attachment profile is formed by welding or fusing.
An Alternative Implementation H includes the compression garment aspects of any one of Alternative Implementations A to G and further includes that the layer attachment profile is formed by welding. A plurality of the one or more macro-chambers are disposed adjacent to each other and separated by welds. Each of the plurality of micro-chambers form at least a portion of a row of a corresponding macro-chamber.
An Alternative Implementation I includes the compression garment aspects of any one of Alternative Implementations B to H and further includes that at least one of the one or more macro-chambers is an independent macro-chamber having at least three rows of fluidly connected micro-chambers.
An Alternative Implementation J includes the compression garment aspects of any one of Alternative Implementations A to I and further includes that each of the one or more macro-chambers has a length, a width, and an uninflated thickness. The length is between about 100 millimeters and about 900 millimeters, the width is between about 70 millimeters and about 150 millimeters, and the uninflated thickness is between about 1 millimeter and about 20 millimeters.
An Alternative Implementation K includes the compression garment aspects of any one of Alternative Implementations A to J and further includes that the compression garment is configured for therapy treatment for a human limb. The layer attachment profile includes perimeter welds about the perimeters of the skin contacting layer and the second layer. A plurality of welds is aligned with the circumference of the limb during operational use of the compression garment. The welds define boundaries of the one or more macro-chambers and further define the boundaries between the plurality of micro-chambers.
An Alternative Implementation L includes the compression garment aspects of Alternative Implementation K and further includes that at least some of the welds defining the micro-chambers are discontinuous.
An Alternative Implementation M includes the compression garment aspects of Alternative Implementation L and further includes that one or more of the plurality of micro-chambers are subdivided by a series of discontinuous welds defining micro-cells within the micro-chamber. The micro-cells control air flow within respective ones of the one or more of the plurality of micro-chambers.
An Alternative Implementation N includes the compression garment aspects of any one of Alternative Implementations A to M and further includes that the plurality of micro-chambers are welded to include an expansion volume such that the skin contacting layer expands away from the second layer and toward a patient's skin during inflation of the compression garment.
An Alternative Implementation O includes the compression garment aspects of any one of Alternative Implementations A to M and further includes that an outer layer disposed on the second layer. The outer layer is a generally flat surface.
An Alternative Implementation P includes the compression garment aspects of Alternative Implementation O and further includes that the outer layer is less flexible than the skin contact layer causing expansion of the compression garment to be generally directed towards the skin contact layer.
An Alternative Implementation Q includes the compression garment aspects of any one of Alternative Implementations O or P and further includes that the thickness of the compression garment is of a low-profile with an uninflated outer layer to a skin contacting layer thickness of less than about 12 mm and an inflated outer layer to skin contacting layer thickness of about less than about 25 mm.
An Alternative Implementation R includes the compression garment aspects of any one of Alternative Implementations A to Q and further includes a pneumatic spine including one or more valves located proximally to each other. Each of the one or more valves are pneumatically connected to a corresponding one of the one or more connectors.
An Alternative Implementation S includes the compression garment aspects of Alternative Implementations R and further includes that the pneumatic spine is disposed underneath the outer layer and extends from approximately a knee location to a thigh location of the compression garment as worn by a user.
An Alternative Implementation T includes the compression garment aspects of any one of Alternative Implementations R or S and further includes that the pneumatic spine includes a primary connecting line connected to one or more secondary connecting lines that are each coupled to a corresponding one of the one or more valves to allow independent pressurization of each of the one or more macro-chambers.
An Alternative Implementation U includes the compression garment aspects of any one of Alternative Implementations R to T and further includes that the pneumatic spine comprises an exhaust valve configured to selectively fluidly connect the one or more macro-chambers to ambient pressure to allow independent depressurisation of each of the one or more macro-chambers.
An Alternative Implementation V includes the compression garment aspects of any one of Alternative Implementations A to U and further includes a controller configured to cycle the pressurization of the one or more macro-chambers between at least two different pressure levels to provide a massage to a user wearing the compression garment on a body part of the user.
An Alternative Implementation W includes the compression garment aspects of any one of Alternative Implementations R to V and further includes that the one or more valves are configured to selectively direct pressurized air received from the primary connecting line to respective ones of the one or more macro-chambers.
An Alternative Implementation X includes the compression garment aspects of any one of Alternative Implementations A to W and further includes that the controller is configured to selectively control operation of a plurality of the one or more valves to correspond to a plurality of the one or more macro-chambers in different zones of the compression garment.
An Alternative Implementation Y includes the compression garment aspects of any one of Alternative Implementations A to X and further includes that the compression garment is an integral one-piece garment configured to extend from the foot to the thigh.
An Alternative Implementation Z includes the compression garment aspects of any one of Alternative Implementations A to Y and further includes that the compression garment is configured for both a human leg and foot. The compression garment is a multiple-piece system for different sections of the leg and foot.
An Alternative Implementation AA includes the compression garment aspects of Alternative Implementation Z and further includes that one section of the compression garment includes a sole piece.
An Alternative Implementation AB includes the compression garment aspects of any one of Alternative Implementations A to AA and further includes that the compression garment includes a leg garment and a foot garment welded to the leg garment.
An Alternative Implementation AC includes the compression garment aspects of any one of Alternative Implementations A to Y and AA and further includes that the compression garment includes a leg garment and a foot garment. The foot garment includes a separate macro-chamber with a plurality of micro-chambers.
An Alternative Implementation AD includes the compression garment aspects of any one of Alternative Implementations R to AC and further includes that the pneumatic spine is disposed within a waterproof arrangement and is accessible from underneath the outer layer via a waterproof closure mechanism.
An Alternative Implementation AE includes the compression garment aspects of any one of Alternative Implementations A to AD and further includes that at least one of the skin contacting layer and the second layer includes one or more sublayers and the coupling of the skin contacting layer and the second layer includes joining all sublayers of the skin contacting layer and the second layer.
An Alternative Implementation AF includes the compression garment aspects of any one of Alternative Implementations A to AE and further includes that at least one of the skin contacting layer and second layer includes a textile layer laminated to a thermoplastic polyurethane film sublayer.
An Alternative Implementation AG includes the compression garment aspects of any one of Alternative Implementations A to AF and further includes that at least some of the one or more macro-chambers or the plurality of micro-chambers are connected via passive valves to control the sequencing of air pressurization of the macro-chambers and micro-chambers.
An Alternative Implementation AH includes the compression garment aspects of Alternative Implementation AG and further includes that the passive valves cause a difference in impedance of one or more openings at the border of adjacent pairs of macro-chambers, micro-chambers or micro-cells.
An Alternative Implementation AI includes the compression garment aspects of any one of Alternative Implementations A to AH and further includes that the passive valves include openings of different dimensions at different locations between adjacent chambers.
An Alternative Implementation AJ includes the compression garment aspects of any one of Alternative Implementations AG to AI and further includes that the one or more macro-chambers comprise a plurality of interconnected macro-chambers. Each of the plurality of macro-chambers includes a plurality of interconnected micro-chambers. A single connector provides pressurized air to one of the plurality of macro-chambers such that the pressurized air further flows, sequentially or in parallel, to others of the plurality of macro-chambers and to the plurality of interconnected micro-chambers.
An Alternative Implementation AK includes the compression garment aspects of any one of Alternative Implementations A to AJ and further includes that at least some openings between adjacent micro-chambers, between adjacent macro-chambers, or between adjacent microcells, are smaller in a direction from the distal to the proximal end of the limb to provide, during use, a fast compression at the garment portions at the distal end of a limb and slower compression of the garment portions at the proximal end of the limb.
An Alternative Implementation AL includes the compression garment aspects of any one of Alternative Implementations A to AK and further includes that the openings between adjacent micro-chambers, between adjacent macro-chambers, or between adjacent micro-cells, are progressively smaller in a direction from the distal to the proximal end of the limb.
An Alternative Implementation AM includes the compression garment aspects of any one of Alternative Implementations A to AL and further includes that the one or more macro-chambers and/or the plurality of micro-chambers within at least one of the one or more macro-chambers, are pressurized in a predetermined sequence.
An Alternative Implementation AN includes the compression garment aspects of any one of Alternative Implementations A to AM and further includes that the skin contacting layer is more flexible than the second layer.
An Alternative Implementation AO includes the compression garment aspects of any one of Alternative Implementations A to AN and further includes that the plurality of micro-chambers have a pre-inflation expansion volume. In response to inflation of the plurality of micro-chambers, the plurality of micro-chambers expand away from the second layer and into finger-like shapes arranged to contact the skin of the user.
According to certain aspects of the present disclosure, an Alternative Implementation BA is a method of fabricating a compression garment for circulatory-related disorder therapy. The method includes forming a fabric first layer having a first geometric shape generally defining at least a portion of the overall shape of the compression garment. A skin contacting layer is formed having a second geometric shape generally conformable to the first geometric shape. The skin contacting layer is welded to the fabric first layer according to a connection profile. The connection profile defines a plurality of macro-chambers between the skin contacting layer and the fabric first layer and a plurality of interconnected micro-chambers within one or more of the plurality of macro-chambers. A plurality of connectors is disposed in the fabric first layer. Each of the plurality of connectors allows pressurized air to be supplied directly into one or more micro-chambers of a respective one of the plurality of macro-chambers.
An Alternative Implementation BB includes the method of fabricating a compression garment aspects of Alternative Implementation BA and further includes that the skin contacting layer and the second layer are welded to form one or more independent generally toroidal macro-chambers. Each macro-chamber is partitioned into a plurality of independent generally toroidal micro-chambers. The one or more macro-chambers and/or the plurality of micro-chambers are elongated and arranged such that in an operational configuration of the compression garment around a limb of a user, at least one of the one or more macro-chambers and/or at least one of the plurality of micro-chambers form, individually or in combination, a generally toroidal shape.
An Alternative Implementation BC includes the method of fabricating the compression garment aspects of Alternative Implementations BA or BB and further includes that the connectors allow the pressurized air to be supplied simultaneous to a plurality of micro-cells within at least one of the plurality of micro-chambers.
An Alternative Implementation BD includes the method of fabricating the compression garment aspects of Alternative Implementations BA to BC and further includes that least some of the plurality of micro-chambers are adjacent to each other and interlinked such that air can be transferred from one micro-chamber to an adjacent micro-chamber via a plurality of openings.
An Alternative Implementation BE includes the method of fabricating the compression garment aspects of Alternative Implementations BA to BD and further includes that the plurality of micro-chambers within each macro-chamber are interlinked to allow pressurized air provided to at least one of the micro-chambers to flow to others of the plurality of micro-chambers within a macro-chamber.
An Alternative Implementation BF includes the method of fabricating the compression garment aspects of Alternative Implementations BA to BE and further includes that the welding of the skin contacting layer to the fabric first layer comprises welding a series of discontinuous welds perpendicular to two adjacent boundaries of one or more of the plurality of micro-chambers, the series of discontinuous welds subdividing the micro-chambers into a plurality of micro-cells.
An Alternative Implementation BG includes the method of fabricating the compression garment aspects of Alternative Implementations BA to BF and further includes that the forming of the skin contacting layer and the welding of the skin contacting layer to the fabric first layer comprises creating the plurality of micro-chambers to have a pre-inflation expansion volume. In response to inflation of the plurality of micro-chambers, the plurality of micro-chambers expand away from the fabric first layer and into finger-like shapes arranged to contact the skin of the user.
According to certain aspects of the present disclosure, an Alternative Implementation CA is a valve arrangement for a compression garment. The compression garment including a plurality of independent air chambers connectable to a pressure generator for implementing circulatory-related disorder therapy. The valve arrangement comprises a plurality of valves configured to be pneumatically and electrically connected to the compression pressure generator. Each valve is connectable to one of the plurality of independent air chambers and is in a fluid connection with a primary connecting line to allow pressurization of each of the plurality of independent air chambers. Each of the plurality of valves are located on the compression garment.
According to certain aspects of the present disclosure, an Alternative Implementation DA is a pneumatic spine for a compression garment. The compression garment includes a plurality of independent air chambers connectable to a pressure generator for implementing circulatory-related disorder therapy. The pneumatic spine comprises the valve arrangement of Alternative Implementation CA where the plurality of valves are located in proximity to each other. A cover assembly with an interior space includes the plurality of valves.
An Alternative Implementation DB includes the pneumatic spine aspects of Alternative Implementation DA and further includes a bottom layer for supporting the plurality of valves.
An Alternative Implementation DC includes the pneumatic spine aspects of Alternative Implementation DB and further includes that the cover assembly is sealingly mounted to the bottom layer to define a housing.
An Alternative Implementation DD includes the pneumatic spine aspects of Alternative Implementation DC and further includes a primary connecting line and one or more secondary connecting lines. Each secondary line pneumatically links a corresponding one of the plurality of valves to the primary line to allow independent pressurization of each of the independent air chambers.
An Alternative Implementation DE includes the pneumatic spine aspects of Alternative Implementation DD and further includes an opening in the housing to allow a portion of the primary connecting line to penetrate the housing and extend out of the interior space. The opening is sealed about the primary connecting line.
An Alternative Implementation DF includes the pneumatic spine aspects of Alternative Implementation DE and further includes that the housing and the sealed opening provide a water tight seal to prevent water from entering the interior space.
An Alternative Implementation DG includes the pneumatic spine aspects of any one of Alternative Implementations DA to DF and further includes a link to an exhaust valve, or an exhaust valve configured to selectively fluidly connect each of the plurality of independent air chambers to ambient pressure to allow independent depressurisation of each of the plurality of independent air chambers.
An Alternative Implementation DH includes the pneumatic spine aspects of any one of Alternative Implementations DB to DG and further includes that the bottom layer and cover assembly have an elongated configuration.
An Alternative Implementation DI includes the pneumatic spine aspects of any one of Alternative Implementations DA to DH and further includes that the plurality of valves is configured to be operated by a controller for selectively directing pressurized air from the primary connecting line to respective air chambers of the compression garment.
An Alternative Implementation DJ includes the pneumatic spine aspects of any one of Alternative Implementations DA to DI and further includes that the plurality of valves is configured to be operated by the controller to cycle pressurization of the plurality of air chambers between at least two different pressure levels to provide a massage to a user wearing the compression garment on a body part.
An Alternative Implementation DK includes the pneumatic spine aspects of any one of Alternative Implementations DA to DJ and further includes that the pneumatic spine is about cm to about 30 cm long and about 8 cm to 10 cm wide.
An Alternative Implementation DL includes the pneumatic spine aspects of any one of Alternative Implementations DA to DK and further includes that the plurality of valves are spaced about 2 cm to about 3 cm apart.
According to certain aspects of the present disclosure, an Alternative Implementation EA is the valve arrangement of Alternative Implementation CA and further includes that the plurality of valves is arranged in at least two groups of valves disposed on the compression garment. At least some of the plurality of valves are disposed at a first area on the compression garment and at least one of the plurality of valves is disposed at a second area that is different from the first area.
An Alternative Implementation FA includes a compression garment including the valve arrangement of any one of Alternative Implementations DA to EA.
According to certain aspects of the present disclosure, an Alternative Implementation GA is a compression garment for circulatory-related disorder therapy. The compression garment includes a skin contacting layer. A second layer is coupled to the skin contacting layer such that the skin contacting layer and the second layer form one or more independent generally toroidal macro-chambers. Each macro-chamber is partitioned into a plurality of generally toroidal micro-chambers. Each of the plurality of micro-chambers is in direct fluid communication with at least one other of the plurality of micro-chambers. One or more connectors are disposed on the second layer. Each of the one or more connectors is configured to supply pressurized air directly into a corresponding one of the one or more macro-chambers such that the pressurized air is delivered to the plurality of micro-chambers. The coupling of the skin contacting layer and the second layer includes a weld profile that defines the one or more macro-chambers and the plurality of micro-chambers.
An Alternative Implementation GB includes the compression garment aspects of Alternative Implementation GA and further includes that a plurality of the one or more macro-chambers are disposed adjacent to each other and separated by respective welds. Each of the plurality of one or more macro-chambers form a row of the compression garment.
An Alternative Implementation GC includes the compression garment aspects of any one of Alternative Implementations GA or GB and further includes that the compression garment comprises one of the one or more independent macro-chambers having at least three rows of fluidly connected micro-chambers.
An Alternative Implementation GD includes the compression garment aspects of any one of Alternative Implementations GA to GC and further includes that each of the one or more macro-chambers has a length, a width, and an uninflated thickness. The length is between about 100 millimeters and about 900 millimeters, the width is between about 70 millimeters and about 150 millimeters, and the uninflated thickness is between about 1 millimeter and about 20 millimeters.
An Alternative Implementation GE includes the compression garment aspects of any one of Alternative Implementations GA to GD and further includes that the compression garment is configured for therapy treatment for a human limb. The weld profile includes perimeter welds about the perimeters of the skin contacting layer and the second layer. A plurality of transverse welds is aligned with the circumference of the limb during operational use of the compression garment. The transverse welds define boundaries of the one or more macro-chambers and further define the boundaries between the plurality of micro-chambers.
An Alternative Implementation GF includes the compression garment aspects of any one of Alternative Implementations GA to GE and further includes that at least some of the transverse welds defining the micro-chambers are discontinuous.
An Alternative Implementation GF includes the compression garment aspects of any one of Alternative Implementations GA to GE and further includes that one or more of the plurality of micro-chambers are subdivided by a series of discontinuous longitudinal welds between transverse welds defining a micro-chamber boundary. The series of discontinuous longitudinal welds define micro-cells within the micro-chamber. The micro-cells control air flow within the one or more of the plurality of micro-chambers.
An Alternative Implementation GG includes the compression garment aspects of any one of Alternative Implementations GA to GF and further includes that the plurality of micro-chambers is welded to include an expansion volume such that the skin contacting layer expands away from the second layer and toward a patient's skin during inflation of the compression garment.
An Alternative Implementation GH includes the compression garment aspects of any one of Alternative Implementations GA to GG and further includes an outer layer disposed on the second layer. The outer layer is a generally flat surface.
An Alternative Implementation GI includes the compression garment aspects of any one of Alternative Implementations GA to GH and further includes that the thickness of the compression garment is of a low-profile with an uninflated outer layer to a skin contacting layer thickness of less than about 12 mm and an inflated outer layer to skin contacting layer thickness of about less than about 25 mm.
An Alternative Implementation GJ includes the compression garment aspects of any one of Alternative Implementations GA to GI and further includes a pneumatic spine comprising one or more valves. Each of the one or more valves is pneumatically connected to a corresponding one of the one or more connectors.
An Alternative Implementation GK includes the compression garment aspects of Alternative Implementation GJ and further includes that the pneumatic spine is disposed underneath the outer layer and extends from approximately a knee location to a thigh location of the compression garment as worn by a user.
An Alternative Implementation GL includes the compression garment aspects of any one of Alternative Implementations GJ or GK and further includes that the pneumatic spine comprises a primary connecting line connected to one or more secondary connecting lines that are each coupled to a corresponding one of the one or more valves to allow independent pressurization of each of the one or more macro-chambers.
An Alternative Implementation GM includes the compression garment aspects of any one of Alternative Implementations GJ to GL and further includes that the pneumatic spine further comprises an exhaust valve configured to selectively fluidly connect the one or more macro-chambers to ambient pressure to allow independent depressurisation of each of the one or more macro-chamber.
An Alternative Implementation GN includes the compression garment aspects of any one of Alternative Implementations GA to GM and further includes a controller configured to cycle the pressurization of the one or more macro-chambers between at least two different pressure levels to provide a massage to a user wearing the compression garment on a body part of the user.
An Alternative Implementation GO includes the compression garment aspects of any one of Alternative Implementations GA to GN and further includes that the one or more valves are configured to selectively direct pressurized air received from the primary connecting line to respective ones of the one or more macro-chambers.
An Alternative Implementation GP includes the compression garment aspects of any one of Alternative Implementations GN or GO and further includes that the controller is further configured to selectively control operation of a plurality of the one or more valves to correspond to a plurality of the one or more macro-chambers in different zones of the compression garment.
An Alternative Implementation GQ includes the compression garment aspects of any one of Alternative Implementations GA to GP and further includes that the compression garment is an integral one-piece garment configured to extend from the foot to the thigh.
An Alternative Implementation GR includes the compression garment aspects of any one of Alternative Implementations GA to GQ and further includes that the compression garment is configured for both a human leg and foot. The compression garment is a multiple-piece system for different sections of the leg and foot.
An Alternative Implementation GS includes the compression garment aspects of any one of Alternative Implementations GA to GR and further includes that one section of the compression garment includes a sole piece.
An Alternative Implementation GT includes the compression garment aspects of any one of Alternative Implementations GA to GS and further includes that the compression garment comprises a leg garment and a foot garment welded to the leg garment.
An Alternative Implementation GU includes the compression garment aspects of any one of Alternative Implementations GA to GT and further includes that compression garment comprises a leg garment and a foot garment. The foot garment includes a separate macro-chamber with a plurality of micro-chambers.
An Alternative Implementation GV includes the compression garment aspects of any one of Alternative Implementations GJ to GU and further includes that the pneumatic spine is disposed within a waterproof capsule.
An Alternative Implementation GW includes the compression garment aspects of any one of Alternative Implementations GJ to GV and further includes that the pneumatic spine is accessible from underneath the outer layer via a waterproof closure mechanism.
An Alternative Implementation GX includes the compression garment aspects of any one of Alternative Implementations GA to GW and further includes that at least one of the skin contacting layer and the second layer includes one or more sublayers.
An Alternative Implementation GY includes the compression garment aspects of any one of Alternative Implementations GA to GX and further includes that the coupling of the skin contacting layer and the second layer includes joining all layers of the skin contacting layer and the second layer.
An Alternative Implementation GZ includes the compression garment aspects of any one of Alternative Implementations GA to GY and further includes that at least one of the skin contacting layer and second layer includes a textile layer laminated to a thermoplastic polyurethane film sublayer.
According to certain aspects of the present disclosure, an Alternative Implementation HA is a method of fabricating a compression garment for circulatory-related disorder therapy. The method includes forming a fabric first layer having a first geometric shape generally defining the overall shape of the compression garment. A skin contacting layer is formed having a second geometric shape conformable to the first geometric shape. The skin contacting layer is welded to the fabric first layer according to a weld profile. The weld profile defines a plurality of independent generally toroidal macro-chambers between the skin contacting layer and the fabric first layer and a plurality of interconnected generally toroidal micro-chambers within one or more of the plurality of macro-chambers. A plurality of connectors is disposed in the fabric first layer. The plurality of connectors allows pressurized air to be supplied directly into the plurality of macro-chambers including the plurality of interconnected micro-chambers.
An Alternative Implementation HB includes the method of fabricating a compression garment aspects of Alternative Implementation HA and further includes that the welding of the skin contacting layer to the fabric first layer comprises welding a series of discontinuous welds perpendicular to two adjacent boundaries of one or more of the plurality of micro-chambers. The series of discontinuous welds subdivides the micro-chambers into a plurality of micro-cells.
An Alternative Implementation HC includes the method of fabricating a compression garment aspects of any one of Alternative Implementations HA or HB and further includes that the forming of the skin contacting layer and the welding of the skin contacting layer to the fabric first layer comprises creating the plurality of micro-chambers to have a pre-inflation expansion volume with a generally toroidal cross-sectional shape. The plurality of micro-chambers are configured to expand away from the fabric first layer during pressurization of the expansion volume.
According to certain aspects of the present disclosure, an Alternative Implementation IA is a pneumatic spine for a compression garment having a plurality of independent air chambers for implementing circulatory-related disorder therapy. The pneumatic spine includes a bottom layer. A plurality of valves is mounted to the bottom layer. Each valve is connectable to one of the plurality of independent air chambers. A primary connecting line is in fluid connection with one or more secondary connecting lines that are each coupled to one of the plurality of valves to allow independent pressurization of each of the independent air chambers. A cover assembly is sealingly mounted to the bottom layer to define a housing with an interior space that includes the plurality of valves, the one or more secondary lines, and a first portion of the primary connecting line. An opening in the housing allows a second portion of the primary connecting line to penetrate the housing and extend out of the interior space. The opening is sealed about the second portion of the primary connecting line. The housing and sealed opening provide a water tight seal to prevent water from entering the interior space.
An Alternative Implementation TB includes the pneumatic spine aspects of Alternative Implementation IA and further includes an exhaust valve configured to selectively fluidly connect the plurality of independent air chambers to ambient pressure to allow independent depressurisation of each of the plurality of independent air chambers.
An Alternative Implementation IC includes the pneumatic spine aspects of any one of Alternative Implementations IA or IB and further includes that the bottom layer and cover assembly have an elongated configuration.
An Alternative Implementation ID includes the pneumatic spine aspects of any one of Alternative Implementations IA to IC and further includes that the plurality of valves is configured to be operated by a controller for selectively directing pressurized air from the primary connecting line to respective air chambers of the compression garment.
An Alternative Implementation IE includes the pneumatic spine aspects of any one of Alternative Implementations IA to ID and further includes that the plurality of valves is further configured to be operated by the controller to cycle pressurization of the plurality of air chambers between at least two different pressure levels to provide a massage to a user wearing the compression garment on a body part.
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
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.
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.
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.
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.
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.
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
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.
Pressure: force per unit area. Pressure may be measured in a range of units, including cmH2O, g-f/cm2, and hectopascals. One (1) cmH2O is equal to 1 g-f/cm2 and is approximately hectopascal. In this specification, unless otherwise stated, pressure is given in units of cmH2O.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
This application is a continuation-in-part of U.S. application Ser. No. 16/849,932, filed on Apr. 15, 2020, the disclosure of which is hereby incorporated by reference herein in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2021/027569 | 4/15/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16849932 | Apr 2020 | US |
| Child | 17919151 | US |
