Adaptive compression therapy systems and methods

• US 10,166,164 B2
• Filed: 04/27/2017
• Issued: 01/01/2019
• 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): Tsai, Michael
• Assistant Examiner(s): Miller, Christopher
• Application Number:
  US15/499,846
• Publication Number:
  US 20170312161A1
• Time in Patent Office: 614 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 device for providing compression therapy to a body part of a patient, the device comprising:

a base plate;

a drive unit configured to be placed over or against the body part, the drive unit comprising;

one or more motors disposed on the base plate;

a controller configured to control operation of the one or more motors;

a power source in electrical communication with the one or more motors and the controller; and

a plurality of movable pulleys and a plurality of fixed pulleys, wherein the plurality of fixed pulleys are disposed on the base plate such that the fixed pulleys do not move relative to each other, and wherein the movable pulleys are configured to move relative to the fixed pulleys and the base plate;

one or more physical stops that limit the movement of the movable pulleys to an area over the base plate and are configured to align the movable pulleys;

one or more drive elements configured to be tensioned by the one or more motors, wherein the one or more drive elements are threaded around the plurality of movable pulleys and the plurality of fixed pulleys; and

one or more compression mechanisms configured to be wrapped at least partially around a portion of the body part, wherein the one or more compression mechanisms are attached to the movable pulleys and are configured to be tensioned by the fixed pulleys and the movable pulleys.

2. The device of claim 1, wherein the one or more drive elements is selected from a cord, belt, and chain.

3. The device of claim 1, wherein the drive unit comprises a base plate that is articulated and comprises a first plate portion and a second plate portion.

4. The device of claim 3, wherein the one or more motors comprises a first motor disposed on the first plate portion and a second motor disposed on the second plate portion, and wherein the plurality of pulleys comprises a first set of fixed pulleys attached to the first plate portion and a second set of fixed pulleys attached to the second plate portion.

5. The device of claim 1, wherein the fixed pulleys are disposed within one or more channels within the base plate.

6. The device of claim 5, wherein the movable pulleys are disposed within said one or more channels in the base plate.

7. The device of claim 6, wherein the movable pulleys and the fixed pulleys are arranged within the one or more channels such that said one or more drive elements extending between the movable pulleys and the fixed pulleys are aligned with a direction of travel of the movable pulleys within the one or more channels.

8. The device of claim 1, further comprising one or more sensors in communication with the controller, wherein the one or more sensors are configured to measure data related to the compression therapy provided to the patient and/or data related to a status of the patient.

9. The device of claim 1, wherein the one or more sensor comprises a sensor configured to measure a magnitude of pressure applied to the body part by the device.

10. The device of claim 1, wherein the one or more sensors comprises a sensor configured to measure a girth or a volume of the body part.

11. The device of claim 1, further comprising a wireless communication module in communication with the controller.

12. The device of claim 1, wherein the one or more compression mechanisms are integrated into a garment or shoe.

13. The device of claim 1, wherein the drive unit is integrated into the garment or shoe.

14. A method for compressing a body part of a patient, the method comprising:

fastening one or more compression elements of a wearable compression device around the body part, the wearable compression device comprising a compression plate, one or more motors disposed on the compression plate and configured to tighten or loosen the one or more compression elements fastened around the body part, a plurality of movable pulleys and a plurality of fixed pulleys, wherein the plurality of fixed pulleys are disposed on the compression plate such that the fixed pulleys do not move relative to each other, and wherein the movable pulleys are configured to move relative to the fixed pulleys and the compression plate, wherein the compression elements are attached to the movable pulleys, one or more physical stops that limit the movement of the movable pulleys to an area over the compression plate and are configured to align the movable pulleys;

one or more sensors configured to measure physiological data and/or device performance data, and a controller for controlling the one or more motors according to a set of parameters;

adjusting a tension of the one or more compression elements until the one or more sensors measures a predetermined or set force before initiating compression therapy;

initiating a first compression cycle comprising compressing the body part by using the one or more motors to tighten the one or more compression elements, and uncompressing the body part by using the one or more motors to loosen the one or more compression elements;

waiting at least a predetermined or set amount of time before initiating a second compression cycle;

measuring physiological data and/or device performance data using the one or more sensors; and

modulating the set of parameters for controlling the one or more motors based on the measured physiological data and/or device performance data.

15. The method of claim 14, wherein the predetermined or set parameter is an interface pressure between the compression device and the body part.

16. The method of claim 14, wherein the measured physiological data comprises a measurement of the girth of the body part or a volume of the body part.

17. The method of claim 14, further comprising delivering passive compression therapy by adjusting the pressure of the one or more compression elements to a predetermined level and maintaining the tension of the one or more compression elements at the predetermined level for an extended period of time that is at least about 1 minute to 24 hours.

18. The method of claim 14, further comprising wirelessly transmitting the measured physiological data and/or device performance data to a remote device.

19. The method of claim 14, further comprising:

establishing communications between the wearable compression device and a second wearable compression device; and

coordinating delivery of compression therapy between the wearable compression device and the second wearable compression device.

20. The method of claim 14, wherein the one or more compression elements comprises at least two compression elements that are tightened sequentially.

21. A device for compressing a body part, the device comprising:

a compression transmission mechanism having a first end portion and a second end portion, the compression transmission mechanism configured to be wrapped around at least a portion of the body part;

a drive element configured to tighten and/or loosen the compression transmission mechanism;

a first mechanical stop configured to provide a starting location for the first end portion of the compression transmission mechanism;

a second mechanical stop configured to provide a starting location for the second end portion of the compression transmission mechanism;

a sensor configured to measure a strain, force, or pressure applied to the body part by the system;

a plurality of fixed pulleys attached to a base plate and a plurality of movable pulleys that are configured to move relative to the fixed pulleys and base plate, wherein the plurality of movable pulleys are attached to the first end portion and the second end portion of the compression transmission mechanism, wherein the drive element is threaded around the movable pulleys and the fixed pulleys, wherein the first mechanical stop and the second mechanical stop limit the movement of the movable pulleys to an area over the base plate and are configured to align the movable pulleys;

a motor configured to tighten and/or loosen the compression transmission mechanism by simultaneously moving both the first end portion and the second end portion of the compression transmission mechanism by applying or reducing tension on the drive element; and

a controller configured to;

provide an indicator when the sensor measures a set or predetermined strain, force, or pressure; and

initiate compression treatment by actuating the motor after the sensor measures the set or predetermined strain, force, or pressure.

22. The device of claim 21, wherein the compression transmission mechanism comprises one or more compression straps.

23. The device of claim 22, wherein the compression transmission mechanism further comprises one or more pads for distributing pressure generated by the one or more compression straps.

24. The device of claim 21, wherein the compression transmission mechanism comprises one or more laces configured to be tightened by a reel-based tensioning mechanism.

25. A system for delivering compression therapy, the system comprising:

a first compression device comprising a compression plate, one or more motors disposed on the compression plate and configured to tighten or loosen one or more compression elements configured to be fastened around a first body part, one or more sensors configured to measure physiological data and/or device performance data, a communications module, and a controller for controlling the one or more motors according to a set of parameters, wherein the first compression device comprises a pulley-based drive train that is driven by the one or more motors and configured to tighten or loosen the one or more compression elements, wherein the pulley-based drive train comprises a plurality of fixed pulleys attached to the compression plate, a plurality of movable pulleys that are configured to move relative to the fixed pulleys and base plate, and one or more physical stops that limit the movement of the movable pulleys to an area over the base plate and are configured to align the movable pulleys;

wherein the plurality of movable pulleys are attached to the compression elements; and

a second compression device comprising a compression plate, one or more motors disposed on the compression plate and configured to tighten or loosen one or more compression elements configured to be fastened around a second body part, one or more sensors configured to measure physiological data and/or device performance data, a communications module, and a controller for controlling the one or more motors according to a set of parameters;

wherein the first compression device and the second compression device are configured to communicate with each other and coordinate delivery of compression therapy.