The present disclosure relates generally to systems for the treatment and/or amelioration of circulatory-related disorders, such as a disorder of the lymphatic system. In particular, the present disclosure relates to medical devices, and their components, such as for Lymphedema therapy, including compression garments, control apparatus, and system for implementing circulatory-related disorder therapy.
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 desirable. The present disclosure is directed to solving these and other problems.
According to some implementations of the present disclosure, a compression garment for implementing circulatory-related disorder therapy includes one or more independently pressurizable macro-chambers. Each macro-chamber is configured to receive pressurized air. One or more air supply tubes are configured to supply pressurized air to a respective one of the one or more independently pressurized macro-chambers. One or more tube guides are configured to maintain a corresponding one of the one or more air supply tubes on a predetermined pathway in or on the garment. One or more valves are pneumatically connected to an air supply tube and to at least one of the one or more independently pressurized macro-chambers. The one or more valves are configured to supply pressurized air to one or more independently pressurizable macro-chambers. The one or more tube guides define predetermined pathways to or from one or more valves, or to or from one or more independently pressurized macro-chambers.
According to some implementations of the present disclosure, a compression garment for implementing circulatory-related disorder therapy includes an inner layer, an outer layer, and an intermediate layer positioned between the inner layer and the outer layer. One or more independently pressurizable macro-chambers are integrally formed between any two layers on the inner layer facing side of the intermediate layer. Each macro-chamber is configured to receive pressurized air. One or more air supply channels are integrally formed within the garment between any two layers on the outer layer facing side of the intermediate layer. The one or more air supply channels are configured to supply pressurized air to a respective one of the one or more independently pressurized macro-chambers. One or more valves are each pneumatically connected to an air supply channel and to one or more independently pressurizable macro-chambers. The one or more valves are configured to supply pressurized air to the one or more independently pressurizable macro-chambers.
According to some implementations of the present disclosure, a compression garment for circulatory-related disorder therapy includes a foot section configured to wrap at least partially around a user's foot. The compression garment comprises a plurality of independently pressurizable chambers including at least one foot-section chamber configured to receive pressurized air. A foot chamber support assembly is configured to support the at least one foot-section chamber at a user's foot. At least a portion of the foot chamber support assembly is flexible to allow bending around a periphery of the user's foot during use, and thereby aid the foot chamber support assembly to conform to the user's foot.
According to some implementations of the present disclosure, a compression garment for circulatory-related disorder therapy includes a plurality of chambers, a plurality of chamber valves, and a main air supply valve. The plurality of chamber valves are each configured to supply pressurized air to a corresponding chamber such that the pressurized air can be delivered to each of the plurality of chambers. The main air supply valve is pneumatically connected to a central air supply line and configured to control the supply of pressurised air to at least two of the plurality of chamber valves. The main air supply valve is located on or in the garment.
According to some implementations of the present disclosure, a circulatory-related disorder therapy system comprises any one of the compression garments configured to be pressurized by a compression pressure generator. A controller, including one or more processors, is configured to control operation of the compression pressure generator in a therapy process to generate pneumatic pressure in the plurality of chambers of the compression garment during a therapy period.
The above summary is not intended to represent each implementation or every aspect of the present disclosure. Rather, the foregoing summary merely provides an example of some of the novel aspects and features set forth herein. The above features and advantages, and other features and advantages of the present disclosure, will be readily apparent from the following detailed description of representative embodiments and modes for carrying out the present invention, when taken in connection with the accompanying drawings and the appended claims. Additional aspects of the disclosure will be apparent to those of ordinary skill in the art in view of the detailed description of various embodiments, which is made with reference to the drawings, a brief description of which is provided below.
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:
While the present disclosure is susceptible to various modifications and alternative forms, specific implementations and embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that it is not intended to limit the present disclosure to the particular forms disclosed, but on the contrary, the present disclosure is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims
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.
Elements and limitations that are disclosed, for example, in the Abstract, Summary, and Detailed Description sections, but not explicitly set forth in the claims, should not be incorporated into the claims, singly, or collectively, by implication, inference, or otherwise. For purposes of the present detailed description, unless specifically disclaimed, the singular includes the plural and vice versa. The word “including” means “including without limitation.” Moreover, words of approximation, such as “about,” “almost,” “substantially,” “approximately,” “generally,” and the like, can be used herein to mean “at,” “near,” or “nearly at,” or “within 3-5% of,” or “within acceptable manufacturing tolerances,” or any logical combination thereof, for example.
Compression garment devices and systems for circulatory therapy are described in U.S. patent application Ser. No. 16/849,932, published as U.S. Patent Application Publication No. 2020/0237607, U.S. application Ser. No. 16/428,512, filed May 31, 2019, published as U.S. Patent Application Publication No. 2020/0113773, and International Application No. PCT/US2019/055474, filed Oct. 9, 2019, published as WO 2020/077008, the disclosures of each of which are hereby incorporated by reference herein in their entireties.
Referring to
In some implementations, the link 1006 includes a separate pneumatic tube and electrical coupling that run in a common tube 1006a for control and operation of the compression garment 1004. In the illustrated embodiment, the combined pneumatic tube and electrical coupling 1006a connect to a valve control component 1006b that includes a printed circuit board assembly (PCBA) configured to issue commands for turning valves in the compression garment on and off. The valve control component 1006b is connected to a combined flexible PCBA and main air supply line 1006c to allow the electrical signals with the commands from the valve control component 1006b to be transmitted to a respective valve in the compression garment 1004. The flexible PCBA in the combined flexible PCBA and main air supply line 1006c includes separate control lines for each valve used to pressurize and depressurize the compression garment 1004. In some implementations, the valve control component 1006b may be integrated into the CPG device 1002.
In one example, the described arrangement allows a use of a CPG device 1002, such as the ResMed AirMini™, Aria Free™, or a similar device, by simply installing a respective software application and without the need to introduce any structural changes to the device. In this case any changes to the operational parameters of the garment are instructed by the CPG device 1002, which communicates with the intermediate (external) valve control component 1006b, which has a microcontroller that controls a series of switches to turn valves on and off. The valve control component is connected to the valves by means of a flexible PCBA 6080. In some implementations, a multi-core cable can be used as an alternative to the flexible PCBA 6080. In practice, the flexible PCBA 6080 can include various electronic components, such as one or more diodes for each valve, to minimise current spikes.
The flexible PCBA in the combined flexible PCBA and main air supply line 1006c includes separate control lines for each valve used to pressurize and depressurize the compression garment 1004. In some implementations, the CPG device 1002 may be modified and the valve control component 1006b may be integrated with CPG device 1002. Alternatively, the valve control component 1006b may be integrated with the garment itself.
Referring to
The system 1000 can include a control application 2011, within the control device 1010, that can be used to control the control device related communications 2003, as well as be configured to provide various information (i.e. limb, pressure, and usage feedback information) to a user. The control application 2011 can serve as a virtual coach such as by employing an artificial intelligence chat program. The control application 2011 can serve as a social networking tool to other patients receiving similar care with a CPG device. The control application 2011 can provide information to the user in relation to troubleshooting operations with the system 1000. The control application 2011 can serve as a symptom tracker such as with input from the user and from the CPG device. The control 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 control application 2011 can serve as an electronic store for ordering resupply components of the system (e.g., conduits, valve interfaces 1008, and compression garments). The control application 2011 can provide informative/educational messages about disease condition (e.g., lymphedema). The control 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 control 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 via link 1006 with a valve interface 1008 that, in some implementations, is on or in the compression garment 1004. The CPG device 1002 may generate electrical valve control signals on electric lines of a bus to the valve interface 1008 and receive electrical valve operation signals from the valves of the valve 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 valve interface 1008 via one or more pneumatic conduits 2007 of the link 1006. The valve interface 1008 may then selectively direct the pressure and/or flow to/from the pressurizable chambers 1009 of the garment 1004 via any of the pneumatic lines 2008 and the valve interface 1008. The valves of the interface 1008 and/or the pneumatic lines 2008 may be integrated with the compression garment 1004, as depicted in
In some implementations, the CPG 1002 may have a compact and/or portable design to simplify use with a compression garment (e.g., compression garment 1004). The CPG device 1002 can include a start/stop button, a communications link button to aid in establishing a communications link (e.g., wireless communications) with the control device 1010, and an electrical interface for electrically coupling with an interface 1008 or valves of the garment 1004. The CPG device 1002 also includes a pneumatic interface (inlet/outlet) for pneumatic coupling with the compression garment 1004, such as via a set of valves.
In some implementations, 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 some 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.
In some implementations, the CPG may further include one or more input devices (e.g., buttons), a central controller, a therapy device controller, a therapy device (e.g., blower with impeller and motor), one or more optional protection circuits, memory, transducers, data communication interface and one or more output devices (e.g., lights, valve control). Electrical components in the CPG 1002 may be mounted on a single PCBA. In an alternative form, the CPG device 1002 may include more than one PCBA. The central controller 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).
As depicted in
The CPG device 1002 can include a flow or pressure device for producing a flow of air at positive pressure using a controllable blower. For example, the blower may include a brushless DC electric motor with one or more impellers housed in a volute. The blower is capable of delivering a supply of air and/or drawing (e.g., evacuating) a supply of air. The flow or pressure device is under the control of a therapy device controller. The CPG device 1002 may also include one or more transducers (e.g., pressure, flow rate, temperature) that are located upstream of the pressure device. The one or more transducers are constructed and arranged to measure properties of the air at that point in the pneumatic path. Alternatively, or additionally, one or more transducers are located downstream of the pressure device, and upstream of the interface 1008. The one or more transducers are constructed and arranged to measure properties of the air at that point in the pneumatic path. Alternatively, or additionally, one or more transducers are located downstream of the interface 1008, and proximate to and/or within the compression garment 1004.
Input devices may include one or more of buttons, switches or dials to allow a person to interact with the CPG device 1002. The buttons, switches or dials may be physical devices, or software devices accessible via an optional touch screen of the CPG device 1002. The buttons, switches or dials may, in one form, be physically connected to the external housing, or may, in another form, be in wireless communication with a receiver that is in electrical connection to the central controller.
A central controller of the CPG device 1002 is a dedicated electronic circuit configured to receive input signal(s) from an input device, and to provide output signal(s) to an output device (e.g., one or more valves of a set of valve(s)) and/or the therapy device controller and/or a data communication interface of the CPG device 1002. The central controller can be an application-specific integrated circuit. Alternatively, the central controller can be formed with discrete electronic components.
The central controller of the CPG device can be configured to receive input signal(s) from one or more transducers, and one or more input devices. The central controller 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.
In some implementations of the present disclosure, a system 1000 is configured to deliver compression therapy to a user wearing the compression garment 1004 under the control of the central controller. The system may include a controllable flow or pressure device, such as the CPG device 1002. Such a device may be implemented with a blower, such as a servo-controlled blower. Such a blower may be implemented with a motor having an impeller in a volute.
In some implementations, the CPG device 1002 includes memory, preferably non-volatile memory. The memory may include battery powered static RAM memory, volatile RAM memory, EEPROM memory, NAND flash memory, or any combination thereof. The memory can be located on a PCBA. Additionally, or alternatively, the CPG device 1002 can include a removable form of memory, for example, a memory card made in accordance with the Secure Digital (SD) standard. The memory 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 may be internal to the CPG device 1002, or external to the CPG device 1002. External transducers may be located on or form part of, for example, the CPG device 1002, the conduit and/or valve interface 1008, and/or the compression garment 1004.
In some implementations, an output device may take the form of a valve driver for a set of active valves such as the pneumatic valves of the interface 1008, which may be integrated with the CPG device 1002, the compression garment 1004 and/or a discrete device board serving as the interface 1008. Each of such active valves may be a pneumatic valve configured to receive a control signal to directionally gate and/or proportionally permit transfer of air selectively through the valve.
For example, an output device may include one or more valve driver(s) for one or more active valves. Such output devices may receive signals from the central controller for driving operation of the valves. Such valve driver(s) or valves 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 and/or valves. 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 and valve drivers 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.
A compression garment 1004 in some implementations includes one or more pneumatic chambers that may be inflated and/or deflated by operation of the CPG device 1002 via one or more pneumatic lines leading to the pneumatic chambers of the compression garment 1004. Such activation may be implemented with one or more active valves and/or passive valves. The garment may typically be lightweight, flexible and washable and may employ a compression fabric.
In some implementations, the compression garment 1004 is formed with layers, such as an inner layer (e.g., inner sleeve) and an outer layer (e.g., outer sleeve) that may be coupled together to assist with forming an air chamber. The garment may be manufactured with a breathable fabric, serving as an inner skin contact interface. Such a material may serve as a barrier to direct user contact with a less permeable material that forms a set of pneumatic chambers of the garment. In some implementations, one or more layers of the garment (e.g., the skin contacting layer) 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.
The compression garment 1004 can include a set of pneumatic chambers positioned about the compression garment 1004 that are sized and located to promote a desired compression therapy. The depicted compression garment 1004 is a lower leg type compression garment with a partial upper foot portion and a leg portion that each provides different sets of chambers or cells for separately compressing discrete portions of the foot and/or leg that are covered by the compression garment 1004. These chambers may be activated in zones, such as a set of chambers in a knee-thigh zone KTZ, a set of chambers in a calf-knee zone CKZ, and a set of chambers in a foot-calf zone FCZ.
The pneumatic chambers may be formed with a material having baffles (e.g., chamber material folds) to more readily permit a vertical expansion of the chamber. The pneumatic chamber may be box shaped with one or more edge folds, such as at each of an inlet end and an outlet end. Such folds may also be at sides of the chamber (not illustrated). Such folds can permit a more uniform rising of the user side surface of the box to provide a more evenly applied compression surface area such as when compared to a more rounded, balloon-shaped type of chamber. Each chamber can provide an isolated compressive force at the surface of the chamber in contact with a user from inflation of the pneumatic chamber, such as in relation to activation of an active valve and/or passive valve, in the location of the inflation. Multiple chambers can be activated to distribute the compressive force. They may also be sequentially activated to move the location of the compressive force.
The compression garment(s) of the present disclosure may also include, or be configured to retain, pneumatic pathways (such as in moulded portions) or conduits inserted therein to fluidically couple pneumatic connecting lines, such as from the interface 1008 and/or the CPG device 1002 for pneumatic purposes, to the pneumatic chambers of the compression garment. Such pathways may also couple discrete pneumatic chambers together, such as when the chambers are separated by a passive valve. In some versions, one active valve may direct gas flow via such a conduit or pathway in relation to one pneumatic chamber or in relation to a group of pneumatic chambers. Thus, a pathway of the compression garment may couple a group of pneumatic chambers or a single pneumatic chamber. Thus, in some cases different active valves may be coupled to different pneumatic chambers or different groups of pneumatic chambers via the pathways of the compression garment. In some versions, the compression garment may include integrated active valves distributed throughout the compression garment. In some versions, the compression garment may include couplers for attachment of pneumatic conduits and/or electrical lines such as to the integrated active valves.
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.
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).
Some implementations 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
In some implementations, a compression garment 1004 can includes a barbed-type pneumatic coupling for establishing a pneumatic connection between the compression garment 1004 and the CPG device 1002 via the link 1006. Such a pneumatic coupling may be co-moulded with the exo-skeleton structure, sewn/stitched into the fabric or ultrasonically welded to the fabric.
In some versions of the compression garment 1004, one or more anatomically shaped pneumatic chambers may provide muscular based zones (anatomically shaped surfaces of the pneumatic chambers) for focused compression therapy. Such muscular based zones, such as for location at the major muscle groups of the arms or legs, can provide targeted manipulation of each muscle area to support lymphatic function and blood flow. In some versions, knitted fabric can separate the set of pneumatic chambers (one or more) in each muscle zone from other muscle zones.
In some implementations, the compression garments of the present disclosure comprise anatomically shaped chambers based on the key points which a physical therapist focuses on when performing Manual Lymphatic Drainage (MLD). As an example, for Lower Limb lymphedema, these points may be inner to outer thigh, behind the knee, the sides of the calf, around the ankle and extremities. This enables the system 1000 to emulate MLD accurately. Such points may each be implemented as one or more zones and may be configured with active and/or passive valves to produce the desired directional manipulation of the points as previously discussed.
In some implementations, the compression garments of the present disclosure may be implemented with a modular configuration to permit use of multiple garments with a common CPG device 1002.
In some implementations, a modular compression garment can include an upper leg compression garment, a lower leg compression garment, and/or a boot or foot compression garment (see
The system 1000 may include a control device 1010 (
A portal system 2028 (
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.
Compression garment systems, such as pneumatic compression garment systems, provide therapeutic relief for circulatory-related disorders, including lymphedema. For example, in some implementations, a pneumatic compression garment provides a pneumatic compression, including a gentle repetitive massage delivered by inflating (e.g., pressurizing) and deflating (e.g., depressurizing) cells (e.g., one or more air chambers), in a wearable garment wrapped or otherwise fitted about a user's limbs (e.g., arm, leg, foot). For the circulatory-related disorder therapy to be effective, the wearable garment needs to be applied and remain secured onto the limb while the air chamber(s) are in an inflated state and a deflated state.
Desirable aspects of the present disclosure include delivering circulatory-related disorder therapy to a subject, such as a user or patient, using a compression garment. Delivering effective circulatory-related disorder therapy to some regions of the body, such as the foot and ankle regions, can be complicated due to the anatomical structure of the body part being receiving therapy, in particular with lymphedema patients who have varying levels of swelling in the region. Swelling for lymphedema patients often changes significantly over the course of having the condition. It can be desirable to provide compression all around a foot, for example, rather than just to certain targeted sections of the foot, while providing support of the compression garment components and the foot itself to allow walking, while still maintaining reasonable ease of use of the compression garment by the patient. The present disclosure contemplates a compression garment that allows the patient to walk while wearing a foot compression garment.
Other desirable aspects of the present disclosure include providing tube guides in a compression garment that reduce or minimize entanglement or dislodging that can occur in a compression garment. The tube guides maintain air supply tubes on a predetermined pathway in or on the garment. The air supply tubes supply pressurized air to respective one(s) of one or more independently pressurized macro-chambers of the compression garment.
Another desirable aspects of the present disclosure, air supply channels are contemplated in a multi-layer compression garment with three or more layers where the air supply channels are integrally formed within the garment between any two layers. The air supply channels supply pressurized air to respective one(s) of one or more independently pressurized macro-chambers of the compression garment.
Yet a further desirable aspect of the present disclosure includes an interface on a compression garment including a main air supply valve that is pneumatically connected to a central air supply line. The main air supply valve is located on or in the compression garment and controls the supply of pressurized air to at least two chamber valves that supply pressurized air to a corresponding air chamber of the compression garment.
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In some implementations, the main air supply valves 4010a, 4010b allow a non-zero flow of pressurized air that is less than the maximum supply of pressurized air into the respective chamber air supply line 4030a, 4030b, such as by the main air supply valve 4010a, 4010b being partially opened, rather than a fully open (e.g., fully on) or fully closed (fully off) position. In some implementations, the main air supply valves 4010a, 4010b control a plurality of different flows of pressurized air into the respective chamber air supply lines 4030a, 4030b.
A circulatory-related disorder therapy system, such as compression therapy systems 1000, 3000a, 3000b, 3000c, can include a compression garment 1004, 3004 as described for FIGS. 1 to 4, along with a CPG device for generating pneumatic pressure for pressurizing a plurality of chambers, a controller, and a controller device. The controller can include one or more processors and be configured to control operation of the CPG device in a therapy process to generate pneumatic pressure in the plurality of chambers of the compression garment during a therapy period. The control device includes one or more processors and a computer readable medium having processor control instructions, that when executed by at least one of the one or more processors of the control device, cause the control device to receive, from the controller, a parameter relating to the therapy process. In some implementations, the control device is a mobile phone or a tablet computer. In some implementations, the processor control instructions further cause the control device to (i) present a graphical user interface on a display of the control device; (ii) receive, through the graphical user interface, a command from a user, the command being configured, when received, to cause the controller to change the operation of the compression pressure generator in the therapy process; and (iii) transmit, to the controller, the received command. In some implementations, the controller can further be configured to selectively control operation of the main air supply valve and the plurality of chamber valves.
The main air supply valve 4010a, 4010b is further desirable because it provides for the centralized shutting off of air flow from a flow generator (such as a CPG device 1002, 3002a, 3002b, 3002c described in
Turning now to
Referring now to
In some implementations, the valve spine arrangements 3008, 4000a, 4000b, 5008, 6008 can be attached in a pocket, e.g., between a skin contacting layer and outer layer, of a compression garment 1004, 3004. It is contemplated that the foam chassis 6070 can provide some rigidity for mechanical integrity of the valve spine arrangement where such rigidity is not sufficient from the other components of the valve spine arrangement. Alternatively, in some implementations, a valve spine arrangement can be attached to the outer layer of a compression garment. A rigid chassis support 6060 and/or top layer 6090, encapsulating the valve spine arrangement, can provide mechanical integrity if the main elements of the valve spine arrangement themselves do not provide sufficient rigidity to protect valves 6040a-g, 6050, air supply lines 6030, and flexible PCBA 6080.
Referring now to
The valve spine interface arrangement 7008, including the main air supply valve 7010, is located on or in the compression garment. The valve spine interface arrangement 7008 includes an exhaust valve 7050 that is pneumatically connected to the chamber air supply line 7030. The exhaust valve 7050, like the chamber valves 7040a-g and the inlet main air supply valve 7010, is controlled by a controller that is part of a compression therapy system (e.g., compression therapy systems 1000, 3002a, 3002b). The exhaust valve 7050, when opened, allows a unidirectional flow of pressurized air out of valve spine interface arrangement 7008 and to atmosphere, via the chamber air supply line 7030. With the chamber air supply line 7030 pneumatically connected to the exhaust valve 7050, and to each of the chambers valves 7040a-g, the pressure in the chambers of a compression garment can be adjusted by controlling the opening (exposed to atmosphere) and closing (sealed from atmosphere) of any of the exhaust valve 7050 and the inlet main air supply valve 7010.
Deflating pneumatic arrangements, such as valve arrangement 7008, without a main air supply valve 7010 can be problematic if an inflow of pressurised air is allowed in the system during the deflation process. Thus, including the main air supply valve 7010 can be advantageous by providing smooth, passive, and efficient deflation of the chambers of a multi-chamber compression garment. For example, the use of the main air supply valve 7010 can minimize issues that can be experienced during deflation when there is an uneven distribution of inflated volume across a chamber creating longer air flow paths from the chamber back to the chamber valve. In addition, the use of the main air supply valve 7010 allows a definitive control and/or termination of any continued air flow from the CPG device into the valve spine interface arrangement 7008 while deflating the chambers of the compression garment.
During the illustrative timing cycle of four and forty-three second timeframe, the exhaust valve V-E is closed thereby sealing the chamber air supply line from atmosphere. Then, starting around time forty-three and forty-four seconds through to sixty-eight seconds, the main air supply valve V-I is closed (or turned off) to stop the flow of pressurized air into the chamber air supply line and exhaust valve V-E is opened to atmosphere. In addition, starting around time forty-five and through to sixty-eight seconds, chamber valves V7 to V1 are also sequentially opened in the reversed order of the chamber filling cycle and the air in the corresponding chambers for V7 to V1 is released to atmosphere through the exhaust valve V-E. Once the garment is deflated, the exhaust valve V-E can be turned off or closed to allow later reinflation of the chambers connected to the chamber valves. For example, at time six-eight seconds when exhaust valve V-E is turned off, valve V-I is opened again and the valve timing cycle repeats.
In some implementations, the described centralized valve spine arrangements 5008, 6008, 7008 are used on a compression garment including a plurality of independently pressurizable macro-chambers for implementing circulatory-related disorder pressure therapy. The chamber valves 4040a-g, 4045a-d, 5040a-g, 6040a-g, 7040a-g are pneumatically connected to at least one of the plurality of independently pressurizable macro-chambers within the compression garment. The macro-chambers of the garment can be subdivided an a plurality of micro-chambers. The micro-chambers can be so interconnected that airflow/pressure provided to one or more of them, can reach all micro-chambers within a single macro-chamber, and even be passed on to an adjacent macro-chamber. The chamber air supply line 4030a, 4030b, 6030, 7030 is pneumatically connected with each one of the plurality of chamber valves 4040a-g, 4045a-d, 6040a-g, 7040a-g to provide independent pressurization of the chambers.
In some implementations, the top layer 6090 of
In some implementations of the valve spine arrangements 5008, 6008, 7008, the shape of the top layer and the bottom layer are substantially the same. In some implementations, the top layer is fabricated from a semi-rigid material. In some implementations, the bottom chassis support layer is fabricated from a semi-rigid material.
In some implementations of the valve spine arrangements 5008, 6008, 7008, a portion of an elongated PCBA, such as PCBA 6080, is disposed between a plurality of valve spacer pads, that may be fabricated with a semi-rigid material.
In some implementations of the valve spine arrangements 5008, 6008, 7008, the valve spacer pads and the plurality of valves are positioned at an acute angle to a longitudinal axis of the chamber air supply line 6030, 7030 and a longitudinal axis of the elongate PCBA layer 6080.
In some implementations of the valve spine arrangements 5008, 6008, 7008, the valve spacer pads and the plurality of valves are positioned at an acute angle to a transverse axis perpendicular the chamber air supply line 6030, 7030 and a transverse axis perpendicular to the long axis of the elongated PCBA.
In some implementations of the valve spine arrangements 5008, 6008, 7008, the plurality of valves 5040a-g, 5050, 6040a-g, 6050, 7040a-g, 7050 are configured to be operated by a controller associated with a PCBA layer, such as PCBA layer 6080, with the controller selectively directing pressurized air from the chamber air supply line 6030, 7030 to respective air chambers of the compression garment.
In some implementations of the valve spine arrangements 5008, 6008, 7008, the plurality of valves 5040a-g, 5050, 6040a-g, 6050, 7040a-g, 7050 is further configured to be operated by the controller to cycle pressurization of the plurality of chambers of the compression garment between at least two different pressure levels to provide a massage to a user wearing the compression garment on a body part. The two pressure levels may vary with time. The transition between the pressure levels may be continuous or incrementally stepped.
In some implementations of the valve spine arrangements 5008, 6008, 7008, a valve spine arrangement is disposed underneath an outer layer of the compression garment and extends from approximately an above-the-knee location to a thigh location of the compression garment during operation by a user. In some implementations, the valve spine arrangement is attached to outer layer of the compression garment and extends from approximately above a knee location to a thigh location of the compression garment during operation by a user. In some implementations, the valve spine arrangement is attached to outer layer of the compression garment.
In some implementations, the valve spine arrangements 5008, 6008, 7008 are compact where the valve spine arrangement does not extend across a joint to limit or minimize complications within the valve spine arrangement, such as the dislocation of entanglement of air supply channels, tube guides, or air supply tubes within the valve spine arrangement.
Turning now to
In some implementations, the three-layer compression garment 9004 includes two layers (e.g., intermediate layer 9200, top layer 9300) dedicated to forming the air supply channels 9010, 9020, 9030, 9040. A separate bottom layer 9100 (e.g., layer closest to skin) and the intermediate layer 9200 are dedicate to forming a plurality of macro-chambers 9150, 9152, 9154, 9156 for the compression garment 9004. It is contemplated in some aspect that macro chambers may be subdivided into a plurality of interconnected inflatable micro-chambers. In such an arrangement where the air supply channels are formed within the same area/space as the macro-chambers, albeit at a different level (e.g. above the macro-chamber), means that a three-layer configuration for the compression garment 9004 provides additional space within the same overall perimeter foot-print of the compression garment 9004 that would not be otherwise there in a two-layer system. For example, a two-layer compression garment with similar air supply channels, along with macro-chambers both formed between two layers, has less space available for the macro-chambers because the available garment space has to be divided between into space for channels and space for chambers. In addition, less space is available for providing compression therapy.
In some implementations, the air supply channels 9010, 9020, 9030, 9040 formed between the intermediate layer 9200 and top layer 9300 can include structural support formations for the air supply channels, such as ribs extending in the top layer 9300, or within the air supply channel itself, along the longitudinal axis of the air supply channels to provide some rigidity to an air supply channel. The add rigidity aids in minimizing closure of an air supply channel during use of the compression garment during compression therapy. An example of a longitudinal structural rib (e.g. in the form of a weld line 9044) is provided in
To form the separate macro-chambers 9150, 9152, 9154, 9156 of compression garment 9004, the intermediate layer 9200 can be welded or otherwise secured to create a boundary line between the macro-chambers. For example, a boundary weld line 9151 along intermediate layer 9200 and bottom layer 9100 between macro-chambers 9150, 9152 forms a separation boundary to aid in forming the macro-chamber 9150. Similar boundary weld lines 9153, 9155 between macro-chambers 9152, 9154, 9156 can be applied to aid formation of the macro-chambers 9152, 9154, 9156.
To form the air channels 9010, 9020, 9030, 9040, the top layer 9300 and intermediate layer 9200 are also welded or otherwise secured (e.g., adhesive bonding) along air channel boundary lines 9016, 9026, 9036, 9046. The air supply channels 9010, 9020, 9030, 9040 extend from the valve spine interface arrangement 9008 to corresponding pneumatic connectors 9012, 9022, 9032, 0942 that are further pneumatically connected to the macro-chambers 9150, 9152, 9154, 9156. In some implementations, the air channels 9010, 9020, 9030, 9040 extend from valve connectors 9014, 9024, 9034, 9034 positioned at the valve spine arrangement 9008 to the pneumatic connectors 9012, 9022, 9032, 9042 that are connected to the respective macro-chambers 9150, 9152, 9154, 9156. As depicted in
In some implementations, the air supply channels 9010, 9020, 9030, 9040 are pneumatically connected to the valve spine arrangement 9008 with a dedicated valve connector for each air supply channel. In some implementations, more than one air supply channel 9010, 9020, 9030, 9040 is pneumatically connected to a single connector in the valve spine arrangement 9008. In some implementations, the air supply channels 9010, 9020, 9030, 9040 extend into the valve spine arrangement 9008 and are directly connected to the chamber valves. In some implementations, one or more of the air supply channels 9010, 9020, 9030, 9040 may have a short tube welded, or otherwise bonded, at the valve spine arrangement side of the air supply channel that provides a rigid or semi-rigid extension that connects to a valve chamber in the valve spine arrangement 9008.
In some implementations, the air supply channels are generally airtight with micro-penetrations in the intermediate layer 9200 that allow a controlled leak of air that is further allowed to diffuse through the bottom layer 9100 adjacent to the skin of the user to provide a cooling or drying effect on the user's limb.
In some garment manufacturing processes, such as RF welding, because of the shared intermediate layer, the formation of the air supply channels and their boundary lines may interfere with that of the macro-chambers. One desirable implementation can include forming the air supply channels and the macro-chambers in different, non-overlapping, areas of the garment. Another desirable implementation can include a four-layer system. Referring to
In some implementations, the four-layer compression garment 10004 includes two layers (e.g., upper intermediate layer 10300, top layer 10300) dedicated to forming the air supply channels 10010, 10020, 10030, 10040. A separate bottom layer 10100 (e.g., layer closest to skin) and a lower intermediate layer 10200 are dedicate to forming a plurality of macro-chambers 10150, 10152, 10154, 10156 for the compression garment 10004.
In some implementations, the air supply channels 10010, 10020, 10030, 10040 formed between the upper intermediate layer 10300 and top layer 10400 can include structural supports (e.g., over-weld lines, ribs, or spacers) extending in the top layer 10400, or within the air supply channel itself, along the longitudinal axis of the air supply channels to provide some rigidity to an air supply channel. The added rigidity aids in minimizing closure of an air supply channel during use of the compression garment during compression therapy. An example of a longitudinal structural rib (e.g., in the form of a weld line 10034) is provided in
To form the separate macro-chambers 10150, 10152, 10154, 10156 of compression garment 10004, the lower intermediate layer 10200 can be welded or otherwise secured (e.g., heat bonded) to create a boundary line between the macro-chambers. For example, with reference to
To form the air channels 10010, 10020, 10030, 10040, the top layer 10400 and upper intermediate layer 10300 are also welded or otherwise secured (e.g., heat bonded) along air channel boundary lines 10016, 10026, 10036, 10046 that extend parallel to the longitudinal axis of each air supply channel. In some implementations, the air channels 10010, 10020, 10030, 10040 extend from valve connectors 10014, 10024, 10034, 10034 positioned at the valve spine arrangement 10008 to the pneumatic connectors 10012, 10022, 10032, 10042 of the respective macro-chambers 10150, 10152, 10154, 10156. As depicted in
In some implementations, the air supply channels 10010, 10020, 10030, 10040 are pneumatically connected to the valve spine arrangement 10008 with a dedicated valve connector for each air supply channel. In some implementations, more than one air supply channel 10010, 10020, 10030, 10040 is pneumatically connected to a single connector in the valve spine arrangement 10008. In some implementations, the air supply channels 10010, 10020, 10030, 10040 extend into the valve spine arrangement 10008 and are directly connected to the chamber valves. In some implementations, one or more of the air supply channels 10010, 10020, 10030, 10040 may have a short tube welded at the valve spine arrangement side of the air supply channel that provides a rigid or semi-rigid extension that connects to a valve chamber in the valve spine arrangement 10008.
In some implementations, the air supply channels are generally airtight with micro-penetrations in the upper intermediate layer 10200 that allow a controlled leak of air that is further allowed to diffuse through the lower intermediate layer 10200 and the bottom layer 10100 adjacent to the skin of the user to provide a cooling or drying effect on the user's limb. Alternatively, the micro-air penetrations may be placed directly on the bottom layer 10100 adjacent to the skin of the user, to provide a cooling or drying effect (e.g., as the chambers inflate, the micro-penetrations will allow some controlled level of airflow onto the skin surface).
In some implementations, the top layer 10400 and the upper intermediate layer 10300 that form the air supply channels 10010, 10020, 10030, 10040 may be separated or float above the lower intermediate layer 10200 that forms the macro-chambers 10150, 10152, 10154, 10156, as depicted in
Referring to
In the example depicted in
In some implementations, compression garments, such as compression garments 90004 and 10004, are used to implement circulatory-related disorder therapy. The compression garments may include an inner layer (e.g., bottom layers 9100, 10100), an outer layer (e.g., top layers 9300, 10400, and one or more intermediate layers (e.g., intermediate layer 9200, lower intermediate layer 10200, upper intermediate layer 10300). The intermediate layer(s) are positioned between the inner layer and the outer layer. One or more independently pressurizable macro-chambers (e.g., macro-chambers 9150, 9152, 9154, 9154, 10150, 10152, 10154, 10156) are integrally formed between any two layers on the inner layer facing side of the intermediate layer. Each macro-chamber is configured to receive pressurized air. One or more air supply channels (e.g., air supply channels 9010, 9020, 9030, 9040, 10010, 10020, 10030, 10040) are integrally formed within the garment between any two layers on the outer layer facing side of the intermediate layer. The one or more air supply channels are configured to supply pressurized air to a respective one of the one or more independently pressurized macro-chambers. One or more valves are each pneumatically connected to an air supply channel and to one or more independently pressurizable macro-chambers. The one or more valves are configured to supply pressurized air to the one or more independently pressurizable macro-chambers.
In some implementations of the compression garments, such as compression garments 9004, 10004, one of the any two layers includes the intermediate layer.
In some implementations of the compression garments, such as compression garments 9004, 10004, one of the any two layers on the inner layer facing side includes the inner layer.
In some implementations of the compression garments, such as compression garments 9004, 10004, one of the any two layers on the outer layer facing side includes the outer layer.
In some implementations of the compression garments, such as compression garment 9004, the compression garment is a three-layer garment including the inner layer, the outer layer, and the intermediate layer. The one or more independent pressurizable macro-chambers are formed between the inner layer and the intermediate layer, and the one or more air supply channels are integrally formed between the outer layer and the intermediate layer.
In some implementations of the compression garments, such as compression garments 9004, 10004, the independently pressurizable macro-chambers and the air supply channels are formed in the same area of the garment.
In some implementations of the compression garments, such as compression garments 9004, 10004, the one or more of the independently pressurizable macro-chambers overlap at least a portion of the one or more of the air supply channels.
In some implementations of the compression garments, such as compression garments 9004, 10004, the one or more air supply channels are formed along seams separating at least two of the one or more independently pressurizable macro-chambers.
In some implementations of the compression garments, such as compression garments 9004, 10004, the any two layers forming an air supply channel include airtight materials.
In some implementations of the compression garments, such as compression garments 9004, 10004, one or more connectors are disposed on the outer layer, and each of the one or more connectors are connected to one or more air supply channels.
A circulatory-related disorder therapy system, such as compression therapy systems 1000, 3000a, 3000b, 3000c, can include a compression garment, such as compression garment 9004, 10004 as described for
Turning now to
Air supply tubes for a compression therapy system include a number of relatively long tubes (e.g., a central air supply tube, or air supply tubes connecting each chamber valve with a respective chamber). In some implementations, tube guides can be beneficial for guiding the tubes along their path during initial insertion, and in some implementations, to also restrict their movement and keep them reliably located in their intended position. Such an arrangement is desirable as it streamlines tube management within the compression garment and minimizes the possibility for any unguided and/or miss-positioned tubing to kink and/or get disconnected from the respective valves, such as at the valve spine interface, or from compression garment inlet connectors.
Referring to both
As depicted in
In some implementations, the tube guides include end openings on either or both ends of the tube guides. Examples of such end openings include end openings 11016, 11017, 11026, 11027, 11036, 11037, 11046, 11047, 11056, 11057, 11066, 11067, 11076, 11077, 12017, 12026, 12036, 12037, 12046, 12047, 12056 (
In some implementations, a compression garment, such as compression garment 1004, 3000a, 3000b, 3000c, 9004, 10004, 13004, can include a pocket for housing an air control assembly that is pneumatically coupled with one or more valves, such as chamber valves, exhaust valves, and main air supply valves.
In some implementations, a compression garment, such as compression garment 1004, 3000a, 3000b, 3000c, 9004, 10004, 13004, can include at least one of (a) one or more independently pressurized macro-chambers, (b) one or more of the tube guides, or (c) a pocket formed between the outer layer and a second layer of the compression garment.
In some implementations, a compression garment, such as compression garment 1004, 3000a, 3000b, 3000c, 9004, 10004, 13004, the pocket can include at least a portion of one or more of the tube guides. In some implementations, the air control assembly may be a pneumatic spine, similar to the valve spine arrangements 3008, 4000a, 4000b, 5008, 6008, 7008 depicted in
In some implementations in a compression garment, such as compression garment 1004, 3000a, 3000b, 3000c, 9004, 10004, 13004, the one or more valves can be arranged in two rows in close proximity to each other, such as depicted in
The one or more of the tube guides 11010, 11020, 11030, 11040, 11050, 11060, 11070 depicted in
In some implementations, airtight air supply channels, air supply tubes, tube guides, or combinations thereof, can be integrated into a base structure of a compression garment, or included as an additional layer within the compression garment while still integral to the compression garment operation. The materials used for forming the channels, tubes, and/or guides can include textiles with thermoplastic film backing that may be bonded or welded or include silicone thermoplastic films that may or may not include a fabric, depending on the implementation. In some implementations, it can be advantageous to have a combination of air supply tubes and tube guides in certain sections of the compression garment and air supply channels in other parts (e.g. having tubes and tube guides in areas where there is repetitive bending, such as at the knee or other joint, and airtight air supply channels in areas, such as along the calf or thigh where there is minimal bending).
A circulatory-related disorder therapy system, such as compression therapy systems 1000, 3000a, 3000b, 3000c, can include a compression garment, such as compression garment 11004, 12004 as described for
Referring now to
Varying layouts or arrangements of typical micro-welds 13338 are contemplated in the macro-chambers 13150a-g. The micro-welds 13338 define separate interconnected transverse micro-chambers 13350 within the macro-chambers 13150a-g. The micro-welds 13338 can be modified in length to customize the pressure and treatment density for a particular circulatory-related disorder. Openings or gaps 13339 created by discontinuous micro-welds 13338 can be positioned to control the expansion and direction of air through the macro-chambers 13150a-g and their corresponding micro-chambers 13350.
In some implementations, the exemplary compression garment 13004, based on the pattern of skin contacting layer 13330, is one-piece where a foot section 13320 extends from the macro-chamber 13340f and includes an opening 13325 define by macro-chamber 13150g that extends outwardly for implementing therapy to the top of the foot and allows the foot section 13320 to be wrapped about the user's foot.
Referring now to
While the macro-chambers 13150 of
In some implementations, it is contemplated that the introduction of macro- and/or micro-chambers of specific structure in a compression garment, such as an ankle chamber or a foot chamber, can allow the respective specific macro/micro-chamber to better target, and thereby improve, treatment of a specific limb area. The contemplated compression garment can have the ability to fit and/or pressurize/massage a limb with a different spatial resolution and pressurization pattern provided by the numerous micro-chambers in a specific area of the compression garment, as described for example for
Another advantageous outcome of the selection of a specific type of macro/micro-chambers, is the mitigation of non-uniform inflation and/or deflation of the compression garment. As depicted, for example, in
In some implementations, one or more macro-chambers, such as macro-chamber 14150 of
In some implementations, instead of the generally parallel seam lines shown in
According to some implementations, a compression garment for circulatory-related disorder therapy includes a skin contacting layer and at least one second layer, at least one of the at least one second layers being coupled to the skin contacting layer such that the skin contacting layer and the coupled second layer form at least one macro-chamber. One or more of the at least one macro-chambers can be partitioned into a plurality of micro-chambers. One or more of the plurality of micro-chambers can be in direct fluid communication with at least one other of the plurality of micro-chambers. Each macro-chamber is configured to receive pressurized air. The coupling of the skin contacting layer and the second layer includes a weld profile. The second macro-chamber includes perimeter micro-chambers and interior micro-chambers. The weld profile defines a plurality of interior micro-chambers in direct fluid communication with adjacent generally square shaped micro-chambers. In some implementations, the weld profile may define a plurality of interior micro-chamber that are non-square (e.g., rectangular, rhomboidal, parallelogram, curved etc.).
Referring now to
A flexible sole 15100 is attached to an exterior surface 15020 of the foot chamber support assembly 15000 as depicted in the flattened bottom view of
The foot chamber support assembly 15000 includes wrapping portions 15030, 15040 for securing the assembly 15000 about the sides and top of the user's foot during use. In addition, a toe loop 15060 and a heel loop 15070 further secure the foot chamber support assembly 15000 at the front and back of the user's foot. The fastener pads 15050a-n are positioned at multiple positions on the interior surface 15010 of the wrapping portions 15030, 15040, the toe loop 15060, and the toe loop 15070 that overlap with other surface of the foot chamber support assembly 15000 to secure the assembly 15000 to the user's foot. The wrapping portions 15030, 15040, toe loop 15060, and toe loop 15070 are fabricated from flexible conformal material that allow for an adjustable snug fit of the foot chamber support assembly 15000 about a user's foot.
The flexible outer sole 15100 provides support within the foot chamber support assembly 15000 for both the one or more pressurization foot chambers, as well as for the user's foot itself to allow the user to walk during compression therapy while wearing a leg compression garment. The flexible sole 15100 is bendable in one or both a horizontal plane defined by a base surface 15110 of flexible sole and a vertical plane perpendicular to the horizontal plane. This flexibility allows the sole to, when a user wears the foot assembly on the user's foot, to at least partially bend up and around the peripheral edges of the foot, facilitating a good fit of the assembly. The inclusion of such a flexible sole in the assembly allows the use to walk while wearing the assembly, without the sole compromising the quality of the assembly fit.
In some implementations, the foot chamber support assembly 15000, and in particular the flexible sole 15100, is contemplated for use with a leg compression garment to allow a user to tighten the compression garment around the foot. In some aspects, the flexible sole 15100 can be fabricated from a flexible foam, rubber, or other flexible synthetic or non-synthetic materials. It is contemplated that the flexible sole can also include a flexible outer sole that allows for an easier fit for the user. A heat bonded, or a similar technique (e.g., welding), approach can be used to join the flexible sole with a fabric wrap of the foot chamber support assembly 15000, such as the fabric that may be used to fabricate support assembly base 15090. In some implementations, the foot chamber support assembly is a uni-body fabric wrap with a welded inner foam to provide cushioning for users and to allow for a heat bonding or a similar technique (e.g. welding) approach to joining the flexible outer sole.
Referring to
In some implementations, the foot-chamber support assemblies 15000, 16000 can be attached or connected, pneumatically and/or electrically, to a compression garment 16004 applicable to the user's leg, and compliment the overall therapy by providing one or more macro-chambers for compression therapy of the user's foot. For example, macro-chambers can be included in the wrapping portions 15030, 15040, 16030, 16040, the toe loop 15060, 16060, and/or the heel loop 15070, 16070.
In some implementations, the foot chamber support assemblies 15000, 16000 are independent devices that are an accessory component to the compression garment 16004 that aid a user with walking, moving, standing, and other mobility-related functions, while minimizing interference (e.g., the foot chamber support assembly with flexible sole provide support to a user rather than compression chamber alone) with the circulatory-disorder therapy device. The accessory component can also be integrated with the lower portion of the compression garment 16004, and continue allowing for user mobility.
In some implementations, the flexible soles 15100, 16100 provides cushioning and wear resistance for the compression garment 16004 when used for limited activity, such as standing, rather than for more active activities where arch support, heel strike cushioning, and/or toe roll may be desirable.
In some implementations, a compression garment for circulatory-related disorder therapy includes a foot section that can be wrapped at least partially around a user's foot. The compression garment includes a plurality of independently pressurizable chambers including at least one foot-section chamber that can receive pressurized air. A foot chamber support assembly, such as foot chamber support assembly 15000, 16000, supports the at least one foot-section chamber at a user's foot. At least a portion of the foot chamber support assembly, including the supporting outer sole 15100, is flexible to allow bending around a periphery of the user's foot during use to aid the foot chamber support assembly with conforming to the user's foot. In some implementations, the foot chamber support assembly and/or the supporting outer sole 15100 are flexible and are configured to extend along the entire underside of the user's foot (including at least the width and/or the length of the foot) so as to aid the user in walking while the at least one foot-section chamber of the compression garment is operably positioned on the user's foot.
In some implementations, a foot chamber support assembly, such as foot chamber support assembly 15000, 16000, is separate from the plurality of independently pressurizable chambers. The foot chamber support assembly may include a wrapping portion and a flexible sole coupled to the wrapping portion. The wrapping portion can at least partially wrap around the user's foot and secure the foot chamber assembly to the user's foot during use with a flexible sole, such as flexible sole 15100, 16100, extending along the entire underside of the user's foot.
In some implementations, a foot chamber support assembly, such as foot chamber support assembly 15000, 16000, at least partially wraps around the user's foot during use to secure the foot chamber support assembly to the user's foot. At least a peripheral portion of the flexible sole can bend around the periphery of the user's foot to allow a good fit of the support assembly to the foot. In some implementations, the bending is in both a horizontal plane defined by the flexible sole and a vertical plane perpendicular to the horizontal plane.
In some implementations, the flexible sole includes a flexible outer sole bonded to an underside surface of the foot chamber support assembly, such as foot chamber support assembly 15000, 16000. The flexible sole is flexible to allow bending around a periphery of the user's foot during use. The sole can extend along the entire length of the foot to facilitate walking.
In some implementations, a foot chamber support assembly, such as foot chamber support assembly 15000, 16000, includes a foam layer attached to an inner surface of a wrapping portion such that, during use, the foam layer is operably positioned immediately below a user's foot.
In some implementations, a foot chamber support assembly, such as foot chamber support assembly 15000, 16000, includes at least two wrapping wings for extending a wrapping portion of the foot chamber support assembly about the sides and top of the user's foot.
In some implementations, a foot chamber support assembly, such as foot chamber support assembly 15000, 16000, includes at least one wrapping extension for securing the foot chamber support assembly about the heel of the user's foot. In some implementations, the foot chamber support assembly includes at least one wrapping extension for securing the foot chamber support assembly about the toes of the user's foot.
A circulatory-related disorder therapy system, such as compression therapy systems 1000, 3000a, 3000b, can include a compression garment, such as compression garment 16004 or foot chamber support assembly 16000, as described for
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.
One or more elements or aspects or steps, or any portion(s) thereof, from one or more of any of claims 1 to 44 below can be combined with one or more elements or aspects or steps, or any portion(s) thereof, from one or more of any of the other claims 1 to 44 or combinations thereof, to form one or more additional implementations and/or claims of the present disclosure.
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.
The present application claims priority to and the benefit of U.S. Provisional Patent Application No. 63/138,176, filed Jan. 15, 2021, entitled “SYSTEMS FOR CIRCULATORY-RELATED DISORDERS,” the disclosure of which is hereby incorporated by reference herein in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2022/012624 | 1/14/2022 | WO |
Number | Date | Country | |
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63138176 | Jan 2021 | US |