Adaptive compression therapy systems and methods

• US 10,076,462 B2
• Filed: 04/27/2017
• Issued: 09/18/2018
• Est. Priority Date: 04/27/2016
• Status: Active Grant

• Current Assignee: Radial Medical Inc.
• Original Assignee: Radial Medical Inc.
• Inventors: Johnson, Eric, Fogarty, Thomas J., Lucatero, Sylvester, Laroya, Gilbert, Wall, James K., Salinas, Conrad
• Primary Examiner(s): Douglas, Steven
• Application Number:
  US15/499,850
• Publication Number:
  US 20170312165A1
• Time in Patent Office: 509 Days
• CPC Class Codes: A41D 1/005 with embedded cable or connector
• CPC Class Codes: A43B 3/38 with power sources
• CPC Class Codes: A43B 7/00 Footwear with health or hygienic arrangements
• CPC Class Codes: A43B 7/146 provided with acupressure points or means for foot massage
• CPC Class Codes: A43C 1/06 tightened by draw-strings
• CPC Class Codes: A43C 11/16 Fastenings secured by wire, bolts, or the like
• CPC Class Codes: A43C 11/165 characterised by a spool, reel or pulley for winding up cables, laces or straps by rotation
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/02042 Determining blood loss or bleeding, e.g. during a surgical procedure
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02141 Details of apparatus construction, e.g. pump units or housings therefor, cuff pressurising systems, arrangements of fluid conduits or circuits A61B5/02233, A61B5/0235 take precedence
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes
• CPC Class Codes: A61B 5/4238 stomach
• CPC Class Codes: A61B 5/4255 Intestines, colon or appendix
• CPC Class Codes: A61B 5/4836 : Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4842 : Monitoring progression or stage of a disease
• CPC Class Codes: A61B 5/4848 : Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6812 : Orthopaedic devices
• CPC Class Codes: A61B 5/6824 : Arm or wrist
• CPC Class Codes: A61B 5/6828 : Leg
• CPC Class Codes: A61B 5/6829 : Foot or ankle
• CPC Class Codes: A61F 5/01 : Orthopaedic devices, e.g. splints, casts or braces
• CPC Class Codes: A61F 5/0123 : for the knees A61F5/0106 takes precedence
• CPC Class Codes: A61F 5/013 : for the arms, hands or fingers A61F5/0118 takes precedence
• CPC Class Codes: A61F 5/02 : Orthopaedic corsets arm-rests for use as writing aids B43L15/00
• CPC Class Codes: A61H 1/006 : Apparatus for applying pressure or blows for compressive stressing of a part of the skeletal structure, e.g. for preventing or alleviating osteoporosis
• CPC Class Codes: A61H 2011/005 : with belt or strap expanding and contracting around an encircled body part
• CPC Class Codes: A61H 2201/0103 : inflatable
• CPC Class Codes: A61H 2201/0176 : By stopping operation
• CPC Class Codes: A61H 2201/0192 : Specific means for adjusting dimensions
• CPC Class Codes: A61H 2201/1215 : Rotary drive
• CPC Class Codes: A61H 2201/165 : Wearable interfaces
• CPC Class Codes: A61H 2201/50 : Control means thereof
• CPC Class Codes: A61H 2201/501 : connected to external computer devices or networks
• CPC Class Codes: A61H 2201/5038 : freely programmable by the user
• CPC Class Codes: A61H 2201/5046 : Touch screens
• CPC Class Codes: A61H 2201/5061 : Force sensors
• CPC Class Codes: A61H 2201/5064 : Position sensors
• CPC Class Codes: A61H 2201/5069 : Angle sensors
• CPC Class Codes: A61H 2201/5071 : Pressure sensors
• CPC Class Codes: A61H 2201/5084 : Acceleration sensors
• CPC Class Codes: A61H 2201/5089 : Gas sensors, e.g. for oxygen or CO2
• CPC Class Codes: A61H 2205/06 : Arms
• CPC Class Codes: A61H 2205/067 : Fingers
• CPC Class Codes: A61H 2205/084 : Chest
• CPC Class Codes: A61H 2205/10 : Leg
• CPC Class Codes: A61H 2209/00 : Devices for avoiding blood stagnation, e.g. Deep Vein Thrombosis [DVT] devices
• CPC Class Codes: A61H 2230/045 : used as a control parameter for the apparatus
• CPC Class Codes: A61H 2230/065 : used as a control parameter for the apparatus
• CPC Class Codes: A61H 2230/208 : used as a control parameter for the apparatus
• CPC Class Codes: A61H 2230/255 : used as a control parameter for the apparatus
• CPC Class Codes: A61H 2230/305 : used as a control parameter for the apparatus A61H2230/045 takes precedence
• CPC Class Codes: A61H 2230/505 : used as a control parameter for the apparatus
• CPC Class Codes: A61H 2230/60 : Muscle strain, i.e. measured on the user, e.g. Electromyography [EMG]
• CPC Class Codes: A61H 2230/625 : used as a control parameter for the apparatus
• CPC Class Codes: A61H 2230/655 : used as a control parameter for the apparatus
• CPC Class Codes: A61H 2230/85 : Contour of the body
• CPC Class Codes: A61H 31/004 : Heart stimulation
• CPC Class Codes: A61H 31/005 : with feedback for the user
• CPC Class Codes: A61H 31/006 : Power driven
• CPC Class Codes: A61H 31/008 : Supine patient supports or bases, e.g. improving air-way access to the lungs
• CPC Class Codes: A61H 7/001 : without substantial movement between the skin and the device
• CPC Class Codes: G16H 20/30 : relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising

Abstract

Systems, devices and methods for providing active and/or passive compression therapy to a body part can include a compression device worn over a compression stocking. The compression device can have a pulley based drive train that is driven by a motor to tighten and loosen compression elements, such as compression straps, in a precise, rapid, and balanced manner. Sensors can be used in the compression device and/or compression stockings to provide feedback to modulate the compression treatment parameters.

Claims

1. A system for providing compression treatment to a subject, the system comprising:

a wearable compression device configured to provide compression to a body part of the subject, the wearable compression device comprising a non-deformable compression plate, one or more motors disposed on the non-deformable compression plate, one or more compression mechanisms configured to be wrapped around the body part and tightened or loosened by the one or more motors, one or more sensors disposed on the non-deformable compression plate configured to measure physiological data from the body part of the subject and device performance data of the compression device, a controller for controlling the one or more motors according to a set of parameters, and a wireless communications module in communication with the controller and the one or more sensors; and

a remote device configured to wirelessly communicate with the wireless communications module of the wearable compression device and to receive the measured physiological data and device performance data and to modulate the set of parameters for controlling the one or more motors.

2. The system of claim 1, further comprising a server or cloud computing network in communication with the remote device, the server or cloud computing network comprising a database that includes population health data, and personal health data, wherein the population health data comprises data from a population of subjects that used or are using compression treatment, wherein the personal health data comprises the subject'"'"'s medical data, the subject'"'"'s physiological data, and the device performance data, wherein the remote device, server or cloud computing network is configured to modulate the set of parameters for controlling the one or more motors based on the population health data and the personal health data.

3. The system of claim 1, wherein the remote device is selected from the group consisting of a smart phone, a smart watch, a tablet computer, a laptop computer, server, computing device, and a desktop computer.

4. The system of claim 1, wherein the remote device is programmed to wirelessly operate the wearable compression device.

5. The system of claim 4, wherein the remote device is programmed to wirelessly operate the wearable compressive device, alternating between an active compression mode and a passive compression mode.

6. The system of claim 4, wherein the remote device is programmed to wirelessly operate the wearable compression device according to one or more treatment protocols.

7. The system of claim 6, wherein the treatment protocols are predetermined.

8. The system of claim 6, wherein the treatment protocols are customizable by the subject and/or a healthcare provider.

9. The system of claim 6, wherein the controller and/or the remote device is programmed to modify one or more of the treatment protocols based on the measured physiological data and/or the device performance data.

10. The system of claim 6, wherein the controller and/or the remote device is programmed to select one of the treatment protocols based on the measured physiological data and/or the device performance data.

11. The system of claim 1, wherein the remote device is programmed to display the measured physiological data and/or the device performance data.

12. The system of claim 1, wherein the remote device is programmed to monitor subject compliance and display subject compliance data.

13. The system of claim 1, wherein the one or more sensors are selected from the group consisting of a strain gauge, a pressure sensor, a force sensor, a heart rate sensor, GPS device, a blood pressure sensor, microphone, Hall effect sensor, sweat biochemistry sensor, light sensor, an impedance sensor, a blood clot detection sensor, a blood flow sensor, an ultrasound sensor, a temperature sensor, a gas sensor, a blood chemistry sensor, a physical activity sensor, oxygen sensor, EKG sensor, gyroscope, and an accelerometer.

14. The system of claim 1, wherein the measured physiological data includes plethysmography data.

15. The system of claim 14, wherein the controller and/or the remote device is programmed to determine a disease state and/or treatment efficacy based in part from the plethysmography data.

16. The system of claim 14, wherein the controller and/or the remote device is programmed to modify one or more of the treatment protocols based on the plethysmography data.

17. The system of claim 1, wherein the remote device is programmed to prompt the subject for treatment related data.

18. The system of claim 1, wherein the remote device is programmed to send the subject reminders regarding the compression treatment and/or compliance with the compression treatment.

19. The system of claim 1, wherein the remote device is programmed to send updates regarding the compression treatment and/or the subject to healthcare providers, family members, and/or other authorized individuals.

20. The system of claim 1, wherein the remote device is configured to upload the measured physiological data and/or device performance data to the server or cloud computing network.

21. A system for providing compression treatment to a subject, the system comprising:

a wearable compression device configured to provide compression to a body part of the subject according to a set of treatment parameters, the wearable compression device comprising a plurality of sensors configured to measure a level of compression applied to the body part and to measure subject specific physiological data and wearable compression device performance data, wherein at least one sensor of the plurality of sensors is positioned adjacent to a non-deformable compression plate configured to provide compression to the body part, memory to record the level of compression applied to the body part, a controller for controlling the compression delivered by the wearable compression device, and a wireless communications module in communication with the controller;

a remote device configured to wirelessly communicate with the wireless communications module of the wearable compression device and to receive the measured subject specific physiological data and wearable compression device performance data and to modulate the set of treatment parameters for controlling the wearable compression device; and

a remote computing network in communication with the remote device, the remote computing network comprising a database that includes population health data, and subject specific personal health data, wherein the population health data comprises data from a population of subjects that used or are using compression treatment, wherein the subject specific personal health data comprises the subject'"'"'s medical data, the subject'"'"'s physiological data, and the wearable compression device performance data, wherein the remote computing network is configured to modulate the set of parameters for controlling the wearable compression device based on the population health data and the subject specific personal health data.

22. The system of claim 21, wherein the plurality sensors are configured to measure subject specific physiological data selected from the group consisting of a subject specific body part girth, body part volume, posture, physical activity level, venous filling time, venous reflux, venous index, ulcer status, heart rate, oxygen level, temperature, blood pressure, sweat biochemistry, impedance, temperature, oxygen level, electrical activity, and blood flow dynamics.

23. The system of claim 21, wherein the set of treatment parameters for controlling the compression device includes compression level, compression duration, compression frequency, and compression speed.

24. The system of claim 21, wherein the compression device further includes a pulley based drivetrain that is driven by one or more motors.

25. The system of claim 21, wherein the set of parameters for controlling the compression device are modified based on artificial intelligence or machine learning algorithms.

26. The system of claim 21, wherein the remote device, server, or cloud computing network is programmed to monitor the subject'"'"'s compliance with the compression treatment.

27. The system of claim 21, wherein the remote device, server, or cloud computing network is programmed to send reminders to the subject to initiate compression treatment.

28. The system of claim 21, wherein the remote device, server, or cloud computing network is configured to generate status updates regarding the subject'"'"'s compression treatment that can be viewed by the subject and other authorized individuals.