Method for building a dynamic compression garment

• US 9,161,878 B1
• Filed: 01/28/2015
• Issued: 10/20/2015
• Est. Priority Date: 02/11/2014
• Status: Active Grant

• Current Assignee: Koya Medical, Inc.
• Original Assignee: Compression Kinetics, Inc.
• Inventors: Dennis, Robert Glenn, Pamplin, John C.
• Primary Examiner(s): TRINH, MINH N
• Application Number:
  US14/607,285
• Time in Patent Office: 265 Days
• Field of Search: 295/921, 29503-594, 29/253.5, 294/63, 66/55, 662/32, 661/32.R, 2 6/9, 240/9, 223/9, 602/44, 602/53, 602/76
• US Class Current: 1/1
• CPC Class Codes: A61F 13/08 Elastic stockings; for contracting aneurisms
• CPC Class Codes: A61H 11/00 Belts, strips or combs for massage purposes
• CPC Class Codes: A61H 2011/005 with belt or strap expanding and contracting around an encircled body part
• CPC Class Codes: A61H 2201/02 heated or cooled
• CPC Class Codes: A61H 2201/0207 heated
• CPC Class Codes: A61H 2201/0214 cooled
• CPC Class Codes: A61H 2201/5007 computer controlled
• CPC Class Codes: A61H 2205/02 Head
• CPC Class Codes: A61H 2205/04 neck
• CPC Class Codes: A61H 2205/06 Arms
• CPC Class Codes: A61H 2205/106 for the lower legs
• CPC Class Codes: A61H 2205/12 Feet
• CPC Class Codes: A61H 2209/00 Devices for avoiding blood stagnation, e.g. Deep Vein Thrombosis [DVT] devices
• 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 23/02 with electric or magnetic drive
• CPC Class Codes: A61H 7/001 without substantial movement between the skin and the device
• CPC Class Codes: A61H 7/007 Kneading

Abstract

A method to form a compression garment apparatus for a body part of a human and/or animal. The method includes forming a segmented flex frame and installing a shape memory alloy on struts of the segmented flex frame. The method further includes connecting the shape memory alloy to first and second terminals on the frame creating a mechanical and electrical connection. The method includes installing a controller that applies current to the shape memory alloy at intervals using and executing intermittent, sequenced, or continuous compression therapy using the controller by creating at least one heating phase causing the shape memory alloy to reach a target transition temperature to either lengthen or shorten and at least one cooling phase causing the length of the shape memory alloy at the target transition temperature to lengthen or shorten opposite of the length change caused by the heating phase.

Claims

1. A method to form a compression garment for a body part of an animal comprising:

a. forming a segmented flex frame, wherein the segmented flex frame comprises a first terminal and a second terminal;

b. installing the shape memory alloy on the plurality of struts of the segmented flex frame;

c. connecting a first end of the shape memory alloy to the first terminal and a second end of the shape memory alloy to the second terminal, the first terminal and the second terminal performing a mechanical connection and an electrical connection forming a circuit incorporating the shape memory alloy;

d. connecting the segmented flex frame with the shape memory alloy to a flexible backing;

e. connecting an attaching means connected to the flexible backing, wherein the attaching means is used to hold the flexible backing onto the body part;

f. connecting a controller with a means for timing to the shape memory alloy and to the segmented flex frame, wherein the controller is operatively connected to the first terminal and the second terminal, further wherein the controller is configured to apply a current to the shape memory alloy at defined intervals using the means for timing thereby providing compression therapy to the body part with the shape memory alloy; and

g. connecting a power supply to the controller, wherein the power supply provides the current to the shape memory alloy; and

h. the controller executes either an intermittent, sequenced, or continuous compression therapy to the body part, the compression therapy comprising;

(i) at least one heating phase causing a length of the shape memory alloy to reach a target transition temperature to either lengthen or shorten the shape memory alloy from 0.25 percent to 10 percent; and

(ii) at least one cooling phase causing the length of the shape memory alloy at the target transition temperature to lengthen or shorten opposite of the length change caused by the at least one heating phase.

2. The method of claim 1, further comprising installing a fabric cover disposed over the shaped memory alloy attached to the segmented flex frame.

3. The method of claim 1, further comprising installing a tensioner to the flexible backing to apply a baseline pressure to the body part.

4. The method of claim 1, further comprising using as the attaching means a tube of expandable fabric or a plurality of fastening straps.

5. The method of claim 1, further comprising using the shape memory alloy in the form of at least one of:

a ribbon, a wire, a mesh, a sheet, a film, or combinations thereof.

6. The method of claim 1, further comprising using a plurality of segmented flex frames, wherein each segmented flex frame of the plurality of segmented flex frames comprises:

a. the plurality of struts, wherein each strut of the plurality of strut has a groove for receiving the shape memory alloy;

b. a plurality of spring links, wherein each spring link of the plurality of spring links is configured to transition between an expanded shape and a contracted shape, and wherein at least one spring link of the plurality of spring links is connected between a pairs of struts of the plurality of struts;

c. a plurality of bridges, wherein each bridge of the plurality of bridges is connected between the at least one spring link and either and an additional spring link or at least one strut of the plurality of struts;

wherein the plurality of segmented flex frames are adapted to contract the plurality of spring links at least 1 percent to 10 percent in width to the contracted shape when the shape memory alloy contracts, and the plurality of segmented flex frames are configured to expand the plurality of spring links from the contracted shape to the expanded shape when the shape memory alloy relaxes.

7. The method of claim 1, further comprising disposing the shape memory alloy on alternating components of the segmented flex frame.

8. The method of claim 1, further comprising using the controller comprising a microprocessor powered by the power supply, the microprocessor in communication with a data storage, wherein the data storage comprising computer instructions to instruct the microprocessor to:

a. provide preset levels for current to provide the compression therapy; and

b. provide current based on preset units of time.

9. The method of claim 8, further comprising installing computer instructions in the data storage to instruct the microprocessor to compare sensed real time measured garment dimensions to preset garment dimension values and change current delivery to the shape memory alloy to achieve the preset garment dimension values.

10. The method of claim 1, further comprising installing a sensor onto the segmented flex frame after installing the fabric backing and connecting the sensor to the controller for sensing and generating signals to the controller representing at least one of:

changes in dimension of the compression garment, stiffness of the body part, changes in dimension of the body part, measurable physiological parameters of the animal, or combinations thereof.

11. The method of claim 1, further comprising using a series of timers, wherein each timer is adapted to provide current to the shape memory alloy when the timer is “

on” and

no current to the shape memory alloy when the timer is “

off”

, and wherein each timer is adapted to provide current to at least a portion of the shape memory alloy on at least a portion of a segmented flex frame.

12. The method of claim 11, further comprising operating the series of timers sequentially to control different circuits.

13. The method of claim 1, wherein the animal is a human or a non-human living creature.

14. The method of claim 1, further comprising delivering a current that is a direct current (DC) or an alternating current (AC) operating from 3 volts to 48 volts.

15. The method of claim 1, further comprising configuring the controller to create the least one heating phase that raises the temperature of the shape memory alloy to the target transition temperature from 40 degrees Centigrade to 110 degrees Centigrade to shorten or lengthen the length of the shape memory alloy.

16. The method of claim 15, further comprising using a shape memory alloy that shortens or lengthens within 10 degrees Centigrade of the target transition temperature.

17. The method of claim 1, further comprising configuring the controller to create at least one standby phase that maintains the temperature of the shape memory alloy just below the target transition temperature keeping the length of the shape memory alloy unchanged but preparing the shape memory alloy for the shortening or lengthening of the shape memory alloy.

18. The method of claim 1, further comprising using the shape memory alloy as a sensor to measure at least one physical characteristic of the compression garment including at least one of:

changes in dimension of the compression garment, stiffness of the body part, or combinations thereof.