DEVICE, SYSTEM, AND METHOD FOR THE TREATMENT, PREVENTION AND DIAGNOSIS OF CHRONIC VENOUS INSUFFICIENCY, DEEP VEIN THROMBOSIS, LYMPHEDEMA AND OTHER CIRCULATORY CONDITIONS

• US 20120065561A1
• Filed: 09/06/2011
• Published: 03/15/2012
• Est. Priority Date: 09/03/2010
• Status: Abandoned Application

• Current Assignee: Epoch Medical Innovations, Inc.
• Original Assignee: Epoch Medical Innovations, Inc.
• Inventors: BALLAS, MICHAEL THOMAS, BALLAS, GARY JOSEPH, BERMAN, EDWARD, UDD, THOMAS E., GOLDEN, CAREY M., LOCKEN, NICHOLAS
• Application Number:
  US13/226,386
• Publication Number:
  US 20120065561A1
• Time in Patent Office: Days
• US Class Current: 601/152
• CPC Class Codes: A61H 2201/0157 portable
• CPC Class Codes: A61H 2201/165 Wearable interfaces
• CPC Class Codes: A61H 2201/5002 Means for controlling a set of similar massage devices acting in sequence at different locations on a patient
• CPC Class Codes: A61H 2201/5012 using the internet
• CPC Class Codes: A61H 2201/5015 using specific interfaces or standards, e.g. USB, serial, parallel
• CPC Class Codes: A61H 2201/5041 control is restricted to certain individuals
• CPC Class Codes: A61H 2201/5071 Pressure sensors
• CPC Class Codes: A61H 2201/5084 Acceleration sensors
• CPC Class Codes: A61H 2201/5087 Flow rate sensors
• CPC Class Codes: A61H 2201/5097 wireless
• CPC Class Codes: A61H 2205/06 Arms
• CPC Class Codes: A61H 2205/065 Hands
• CPC Class Codes: A61H 2205/106 for the lower legs
• CPC Class Codes: A61H 2205/108 for the upper 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 2230/305 used as a control parameter for the apparatus A61H2230/045 takes precedence
• CPC Class Codes: A61H 2230/425 used as a control parameter for the apparatus
• CPC Class Codes: A61H 2230/50 Temperature
• CPC Class Codes: A61H 9/0078 : with intermittent or alternately inflated bladders or cuffs mattresses for preventing bed-sores with alternated pressurized chambers A61G7/05776
• CPC Class Codes: A61H 9/0092 : Cuffs therefor

Abstract

A compression device for applying compression to an extremity of a mammal includes a cuff adapted to be placed around and secured to the extremity. A control and tensioning unit is attached to the cuff and is operable to control a tension of the cuff to thereby control the compression applied to the extremity. The cuff may further include a bladder system, in which case the compression device further includes a hydraulic pump that is operable to transfer fluid within the bladder system to control the compression applied to the extremity.

Claims

1. A compression device, comprising:

a compression band adapted to be placed around an extremity of a patient to apply compression to the extremity, the compression band being formed from an inelastic material and having a circumference when in place around the extremity; and

a control and tensioning unit coupled to the compression band and operable to control a circumferential displacement of the compression band to control the compression that the compression band applies to the extremity.

2. The compression device of claim 1, wherein the control and tensioning unit controls the compression band to apply inelastic compression to the extremity.

3. The compression device of claim 1,

wherein the control and tensioning device is further operable to monitor the pressure the compression band applies to the extremity;

and

wherein the control and tensioning device is further operable to control the circumferential displacement of the compression band responsive to the monitored pressure.

4. The compression device of claim 3, wherein the control and tensioning unit is operable in response to the pressure applied by the compression band reaching a minimum pressure threshold to increase the circumferential displacement of the compression band and thereby decrease the circumference of the compression band.

5. The compression device of claim 3,

wherein the control and tensioning unit is operable in response to the pressure applied by the compression band reaching a maximum pressure threshold to decrease the circumferential displacement of the compression band and thereby increase the circumference of the compression band.

6. The compression device of claim 5, wherein monitoring the pressure includes sensing the instantaneous pressure applied over time.

7. The compression device of claim 5,

wherein monitoring the pressure includes sensing the instantaneous pressure applied over time;

and

wherein the control and tensioning unit is operable in response to a moving average of the sensed instantaneous pressure reaching the minimum or maximum pressure threshold, the moving average being calculated using the values of the sensed instantaneous pressure.

8. The compression device of claim 1, wherein the control and tensioning unit is further operable in a non-ambulatory mode to set the circumference of the compression band at a first constant value for a first time interval and is operable to maintain the circumference of the compression band at a second constant value for a second time interval.

9. The compression device of claim 8,

wherein the first constant value is less the second constant value;

and

wherein the control and tensioning unit is operable to alternately set the circumference of the compression band at the first and second values during a cycle time of operation.

10. The compression device of claim 9, wherein the control and tensioning unit is operable to adjust the ratio of the first time interval to the cycle time to apply a desired average pressure to the extremity.

11. The compression device of claim 1, where in the compression band comprises an open-weave material.

12. The compression device of claim 1, wherein the compression band comprises a corset-type compression band.

13. The compression device of claim 1, wherein the compression band comprises:

a slip compression band; and

a fluid-filled outer sleeve adapted to surround the slip compression band and interface directly with the extremity.

14. The compression device of claim 13 wherein the fluid-filled outer sleeve comprises a plurality of fluid-filled cells.

15. The compression device of claim 1,

wherein the control and tensioning unit further comprises inertial sensors operable to sense an ambulatory or non-ambulatory state of the patient;

and

wherein the control and tensioning unit is further operable to adjust the pressure applied by the compression band responsive to the sensed ambulatory or non-ambulatory state.

16. The compression device of claim 1, wherein the control and tensioning unit is operable to control the circumferential displacement of the compression band to apply constant pressure to the extremity.

17. The compression device of claim 1, wherein the control and tensioning unit is further operable to limit further circumferential displacement responsive to a minimum circumference associated with extremity being reached.

18. The compression device of claim 1, wherein the control and tensioning unit controls the compression band to operate in an elastic manner, the compression band being controlled to have a target spring constant.

19. A compression system, comprising:

a compression device, including,

a compression band adapted to be placed around an extremity of a patient to apply inelastic compression to the extremity, the compression band having a circumference when in place around the extremity;

a control and tensioning unit coupled to the compression band and operable to control a circumferential displacement of the compression band to control the inelastic compression the compression band applies to the extremity; and

a computer system operable to communicate with the control and tensioning unit to control the operation of the compression device.

20. The compression system of claim 19, wherein the compression system further comprises a plurality of compression devices.

21. The compression system of claim 20 further comprising a remote control unit operable to communicate with the compression devices and the computer system and to control the operation of the communication devices.

22. The compression system of claim 20 wherein each of the compression devices is further operable to communicate with the other compression devices to synchronize the operation of the plurality of compression devices.

23. A method of treating circulatory conditions, comprising:

applying compression to an extremity of a patient through an inelastic compression band having a circumference; and

controlling the circumference of the inelastic compression band to apply a desired compression profile to the extremity.

24. The method of claim 23 wherein the operation of controlling comprises setting the circumference of the inelastic compression band to a fixed value.

25. The method of claim 23 wherein the operation of controlling comprises varying the circumference of the inelastic compression band to apply a fixed pressure to the extremity.

26. The method of claim 23 wherein the operation of controlling comprises:

sensing a characteristic of the patient; and

controlling the circumference of the inelastic compression band as a function of the sensed characteristic.

27. The method of claim 26 wherein the sensed characteristic comprises one or more of the patient'"'"'s ambulatory or non-ambulatory state, temperature of the extremity, and force the compression band applies to the extremity.

28. The method of claim 23 wherein the operation of controlling comprises controlling the circumference of the inelastic compression band to apply a desired compression profile to the extremity to detect the existence of a circulatory condition.

29. A portable device for applying compression to an extremity of a mammal comprising:

a cuff comprising;

a closed bladder system;

incompressible fluid in said closed bladder system; and

a hydraulic pump.

30. The portable device of claim 29, wherein said cuff further comprises a sensor system.

31. The portable device of claim 30, wherein said cuff further comprises:

a band disposable around said extremity, said band comprising an inner side and outer side; and

wherein said closed bladder system comprises one or more membranes disposed on the inner side of said band and a reservoir disposed on the outer side of said band.

32. The portable device of claim 30, wherein said closed bladder system comprises a plurality of interconnected chambers.

33. The portable device of claim 29, wherein said hydraulic pump comprises an electro-active polymer.

34. The portable device of claim 29, wherein said hydraulic pump is configured to operate substantially without noise.

35. The portable device of claim 31, wherein said device further comprises a valve system with one or more fluid control valves disposed between said reservoir and said membranes, and wherein said sensor system comprises one or more sensors that detect pressure, flow rate, and/or temperature.

36. The portable device of claim 31, wherein said sensor system comprises one or more sensors that detect pressure, flow rate, temperature and/or inertial sensors.

37. The portable device of claim 31, wherein membranes expanded by incompressible fluid from the reservoir impart a controlled pressure on said extremity.

38. The portable device of claim 35, wherein said device further comprises a battery operated control unit removably attached to said cuff.

39. The portable device of claim 38, wherein said control unit comprises a wireless data transmitter and receiver.

40. The portable device of claim 36, wherein said device further comprises a battery operated control unit removably attached to said cuff, said control unit measuring hydraulic pump input voltage and recording time, and wherein said sensors are configured to measure pressure and incompressible fluid temperature, said control unit configured to estimate a fluid flow volume using said measurements.

41. The portable device of claim 36, wherein said device further comprises a battery operated control unit removably attached to said cuff, and wherein said sensors are configured to measure pressure with said bladder system, said control unit controlling pressure within said bladder system by actively measuring said pressure and actively controlling said pump.

42. The portable device of claim 36 further comprising a method of treating a patient having deep vein thrombosis, said method comprising:

(a) attaching a device according to claim 36 to an extremity of said patient;

(b) actuating the hydraulic pump;

(c) filling the bladder system with incompressible fluid from the reservoir;

(d) measuring the pressure exerted by the bladder against the extremity with a pressure sensor;

(e) modulating the hydraulic pump to maintain a target pressure; and

(f) ending pump actuation and allowing fluid from the bladder to return to the reservoir, and

wherein compression cycle steps (b) through (f) are repeated.

43. The method of claim 42, wherein said device further comprises a single battery operated control unit comprising a wireless data transmitter and a receiver.

44. The method of claim 43, wherein a second device is attached to another patient extremity, and wherein the compression cycling in said the devices is coordinated through said wireless data transmitters and receivers.

45. The method of claim 42, wherein said device further comprises a second cuff comprising a closed bladder system, an incompressible fluid in said closed bladder system and a hydraulic pump, and wherein said compression cycling in each cuff is controlled by a single battery operated control unit removably attached to one of said cuffs.

46. The method of claim 45, wherein the first cuff is proximate and the second cuff is distal to the heart of said patient, further comprising:

actuating the pump in the distal cuff until the bladder system exerts a known first pressure against the extremity;

actuating the pump in the proximate cuff until the bladder system exerts a known, lower second pressure against the extremity;

releasing fluid from the bladder system of the distal cuff;

repeatedly measuring the pressure exerted by the bladder system of the proximate cuff against the extremity until the lower second pressure is reached;

measuring the time required to reach the lower second pressure;

storing said measurements in said control unit as extremity stiffness characteristics; and

comparing said extremity stiffness characteristics against known baseline extremity stiffness characteristics,

wherein a change in the extremity stiffness characteristics is an indicator of the presence of deep vein thrombosis in the extremity.

47. The portable device of claim 40 further comprising a method for characterizing the stiffness of an extremity comprising:

(a) attaching a device according to claim 40 to an extremity of said patient;

(b) actuating the hydraulic pump;

(c) filling the bladder system with incompressible fluid from the reservoir;

(d) measuring the time required to reach a first, higher target pressure;

(e) repeatedly measuring the pressure exerted by the bladder system against the extremity and the incremental volumetric displacement of the incompressible fluid until said first target pressure is reached;

(f) modulating the hydraulic pump to maintain said first target pressure;

(g) ending pump actuation and allowing fluid from the bladder to return to the reservoir;

(h) measuring the time required to reach a second, lower target pressure;

(i) repeatedly measuring the pressure exerted by the bladder system against the extremity and the incremental volumetric displacement of the incompressible fluid until said second target pressure is reached;

(j) storing said pressure in comparison to said and incremental volumetric displacement measurements in said control unit as extremity stiffness characteristics; and

(k) repeating (b) through (j) to establish a sufficient number of times to quantify statistical mean and short term variations in baseline extremity stiffness characteristic measurements.

48. The portable device of claim 47 further comprising a method for detecting changes in fluid flow within an extremity of a mammal, comprising:

(a) attaching a device according to claim 47 to an extremity of said patient;

(b) establishing baseline extremity stiffness characteristics according to the method of claim 47;

(c) actuating the hydraulic pump;

(d) repeating the method of claim 47, wherein steps (b) through (k) are performed at a first, higher fluid fill rate, and wherein steps (b) through (k) are repeated at a second lower fluid fill rate to establish the fill rate dependency in the baseline extremity stiffness characteristics at said lower rate; and

(e) comparing the extremity stiffness characteristics with baseline extremity stiffness characteristics;

wherein a statistically significant change in the extremity stiffness characteristics at either of said higher or lower fluid fill rates is an indicator of the presence of deep vein thrombosis in the extremity.

49. The method of claim 48 wherein a statistically significant increase in temperature is an indicator of the presence of deep vein thrombosis in the extremity.

51. The method of claim 45, wherein the actuating in said cuffs is sequential, intermittent, or concurrent.

52. The method of claim 45, wherein the compression cycling in said devices is asynchronous or synchronous.

50. A portable device for applying compression to an extremity of a mammal comprising:

more than one cuff, each cuff comprising;

a closed bladder system;

incompressible fluid in said closed bladder system; and

a hydraulic pump,

wherein said cuffs are controlled by a single battery operated control unit removably attached to one of said cuffs.