Method and apparatus for monitoring and diagnosing peripheral blood flow

• US 4,569,355 A
• Filed: 05/28/1982
• Issued: 02/11/1986
• Est. Priority Date: 05/28/1982
• Status: Expired due to Fees

• Current Assignee: Hemodynamics Technology, Inc.
• Original Assignee: Hemodynamics Technology, Inc.
• Inventors: Bitterly, Jack G.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Sykes, Angela D.
• Application Number:
  US06/383,004
• Time in Patent Office: 1,355 Days
• Field of Search: 128/691, 128/736, 128/399-400, 128/402-403, 73/204, 165/34, 62/63, 62/527
• US Class Current: 600/504
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/441 Skin evaluation, e.g. for skin disorder diagnosis

Abstract

A heat exchanger changes the temperature of a predetermined area of the skin at a programmed rate preferably by cooling. The rate at which the area of skin changes in response to temperature change of the heat exchanger and the rate the skin temperature returns to normal are then measured and compared to standard rates over a number of cycles. Impaired peripheral blood flow is evident especially on subsequent cycles as vascular disease slows the rate of return to normal temperature of the skin. The heat exchanger has a cooling chamber with one side of the chamber being a cooling surface adjacent to the skin. An injector is connected to a source of fluid having a boiling point at ambient pressure less than the temperature to which the skin is to be cooled and greater than ambient temperature of the apparatus. The injector injects fluid into the chamber and onto the side of the cooling surface opposite the skin to boil the fluid on the surface to cool the surface and the skin.

Claims

1. A method for monitoring blood flow comprising applying an object of a temperature below normal skin temperature to the surface of an area of skin to lower the temperature of the area of skin;

terminating the application of the object at a temperature below normal skin temperature whereby internal blood flow around the area of skin raises the temperature of the area of skin; and

monitoring the temperature within the area of the skin as the temperature changes in response to the application of the object at a temperature below normal skin temperature and as it returns to its original temperature when the application of the object at a temperature below normal skin temperature is terminated.

2. The method of claim 1 further comprising comparing the skin temperature changes to a predetermined normal change in skin temperature for the area of skin.

3. The method of claim 1 further comprising repeating the steps of application of the object and of termination of application of the object to the area of skin and continuing the monitoring of the temperature of the area of skin.

4. The method of claim 1 further comprising devising a numerical index from the results of the monitoring including integrating the rate of change of temperature of the area of skin per unit time during the time in which the object is being applied to the skin, dividing that result by the integral of the rate of change of the temperature of the area of skin for at least one cycle of application and termination of application of the object.

5. The method of claim 1 further comprising the step of applying a heat exchanger to the area of skin, and varying the temperature of the heat exchanger at a fixed rate for a predetermined time.

6. The method of claim 5 further comprising the step of determining the average rate of change of temperature of the area of skin per unit time.

7. The method of claim 5 further comprising determining the maximum temperature change to the area of skin during the time period.

8. The method of claim 5 further comprising the step of mathematically integrating the change in temperature of the area of skin over time for a specific time period.

9. The method of claim 5 further comprising mathematically integrating the temperature of the area of skin over time for a specific temperature range.

10. The method of claim 1 wherein the step of applying an object to the skin is accomplished by placing a heat exchanger on the skin, the heat exchanger being maintained at a constant temperature for a predetermined length of time.

11. The method of claim 1 wherein the object is applied again a predetermined time after the skin begins returning to its original temperature because of termination of application, the method further comprising the step of modifying the predetermined time for initiating again the application of the object to the skin.

12. The method of claim 1 wherein the object applied to the skin is a heat exchanger, the heat exchanger cooling by injecting into the heat exchanger a liquid having a boiling point lower than skin temperature, the heat generated by normal skin temperature boiling the liquid to cool the heat exchanger and the skin.

13. A method for monitoring blood flow comprising:

artificially cooling an area of skin by applying an object to the skin, the object being at a temperature below normal skin temperature;

monitoring the rate of change of the skin temperature as it changes in response to the application of the object; and

comparing the rate of change of the skin temperature to a predetermined normal rate of change in skin temperature for the area of skin.

14. A method for monitoring blood flow comprising:

artificially changing the temperature of an area of skin by applying an object to the skin for a period of time, the object being at a temperature below normal skin temperature; and

monitoring the skin temperature as it returns to the original temperature after the period of time; and

comparing the rate of change for the skin temperature to a predetermined normal rate of change in skin temperature for the area of skin.

15. A heat exchanger apparatus for cooling an object comprising:

a cooling chamber, one side of the chamber being surface means having two faces, a first face being adjacent to the object for contacting the object;

injecting means connected to a source of fluid, the fluid having a boiling point at ambient pressure less than the temperature to which the object is to be cooled, the injecting means injecting fluid into the chamber and onto the face of the surface means opposite first face and the object to boil the fluid on the surface means to cool the surface and the object.

16. The heat exchanger of claim 15 further comprising wick means on the surface means in the chamber for distributing the fluid along the surface means.

17. The heat exchanger of claim 15 further comprising guide means on the surface means for guiding the fluid from the injecting means to spaced apart locations on the surface means.

18. The heat exchanger of claim 17 wherein the guide means comprises a spiral wall upstanding from the surface means.

19. The heat exchanger of claim 17 further comprising secondary wick means adjacent the injecting means and in contact with the surface means and the guide means for moving fluid not on the surface means to the surface means.

20. The heat exchanger of claim 15 wherein the injecting means comprises dividing means for dividing fluid flow from the source of fluid into two flow paths, first pressure reduction means in one flow path for reducing the pressure in the flow path to a lower pressure, first cell means connected to the first pressure reduction means for receiving the lower pressure fluid flow from the pressure reduction means, the first cell means having a first wall movable in response to pressurized fluid from the pressure reduction means, second cell means connected to the dividing means for receiving higher pressure fluid flow from the second flow path, the second cell means having a second wall having an area less than the area of the first wall, the second wall being movable in response to movement of the first wall to change the volume of the second cell means, the second cell means having an opening to the chamber through which fluid can flow, first check valve means in the second cell means across the opening and being normally closed for blocking fluid flow through the opening when the fluid in the second cell means is at its normal, higher pressure, the first check valve means opening when movement of the second wall decreases the volume of the second cell means to inject fluid through the opening into the chamber.

21. The heat exchanger of claim 20 further comprising first stop means on one side of the first wall for limiting travel of the first wall in a direction to decrease the volume of the first cell means to limit the maximum volume of the second cell means, second stop means on the other side of the first wall to limit travel of the first wall in an opposite direction to limit the minimum volume of the second cell means for precise volume change to control the amount of fluid injected into the chamber.

22. The heat exchanger of claim 21 further comprising governing means between the source of fluid and the first cell means for initiating flow of fluid into the first cell means and stopping flow of fluid into the first cell means.

23. The heat exchanger of claim 22 further comprising sensing means adjacent the object for sensing the temperature of the object, and feedback means between the sensing means and the electrical valve means for controlling the electrical valve means in response to changes in temperature sensed by the sensing means.

24. The heat exchanger of claim 21 further comprising resilient means attached to the first wall for urging the first wall toward the first stop means and moving the first wall toward the first stop means when the governing means stops the flow of fluid into the first cell means to lower the fluid pressure therein.

25. The heat exchanger of claim 20 further comprising inlet means into the second cell means through which higher pressure fluid from the source of fluid flows into the second cell means, second check valve means at the inlet means for permitting one way flow of fluid through the inlet means.

26. The heat exchanger of claim 25 further comprising the first check valve means having first spring means for urging the first check valve means closed, the second check valve means having a second spring means for urging the second check value means closed, the spring constant of the first spring means permitting the first check valve means to open under greater pressure than the second spring means permits the second check valve means to open.

27. The heat exchanger of claim 20 further comprising a secondary outlet means from the source of fluid for directing a controller fluid therethrough, second pressure reduction means downstream from the secondary outlet means for reducing the pressure of the controller fluid from the pressure of the source of fluid, electrical valve means in the path of the controller fluid opening and closing in response to a signal from a regulator circuit, amplifier means downstream from the electrical valve means for receiving the controller fluid when the electrical valve means is open and for receiving the lower pressure fluid flows from the first pressure reduction means for controlling the flow of the lower pressure fluid in response to changes in the flow of the controller fluid from the electrical valve means.

28. The heat exchanger of claim 27 wherein the source of fluid has an upper and a lower portion and contains liquid and gas under pressure, the secondary outlet means being positioned in the upper portion of the source of fluid such that the controller fluid is a gas and a primary outlet from the source of fluid upstream of the dividing means and positioned in the lower portion of the source of fluid such that the fluid directed to the dividing means is liquid.

29. The heat exchanger of claim 27 further comprising sensing means adjacent the object for sensing the temperature of the heat exchanger, and feedback means between the sensing means and the electrical valve means for controlling the electrical valve means in response to changes in temperature sensed by the sensing means.

30. The heat exchanger of claim 27 further comprising heat flux sensing means adjacent the object for sensing the heat flux from the object to the heat exchanger, and feedback means between the sensing means and the electrical valve means for controlling the electrical valve means in response to changes in heat flux sensed by the sensing means.

31. The heat exchanger of claim 20 further comprising a ballonet about the heat exchanger, ballonet opening means through a portion of the ballonet for exposing the surface means there through, attaching means on the ballonet for loosely attaching the ballonet to the object, filling means attached to the ballonet for filing the ballonet with low pressure gas to urge the ballonet and the surface means of the heat exchanger against the object at a controlled pressure.

32. The heat exchanger of claim 28 wherein the source of fluid contains liquid and gas under pressure, the secondary outlet means being positioned in the upper portion of the source of fluid such that the controller fluid is a gas, dividing means for directing a portion of the gas into a filling conduit, pressure lowering means in the filling conduit for lowering the pressure to a controlled level in the conduit and connection means for connecting the filling means to the ballonet.

33. A system for monitoring blood flow comprising:

heat exchanger means for changing the temperature of an area of skin in a controlled manner, the heat exchanger means having a cooling surface, a source of fluid having liquid and vapor phases under pressure, the liquid having a boiling point less than skin temperature at atmospheric pressure, controlling means for controlling injection of the liquid into the heat exchanger means whereby the skin temperature heating the heat exchanger means boils the liquid to cool the heat exchanger means thereby cooling the skin,

cuff means attached to the heat exchanger means for attaching the heat exchanger means to the skin;

monitoring means attached to the cuff means and mounted adjacent to the skin for monitoring he skin temperature as it changes in response to changes in the temperature of the heat exchanger means.

34. The system of claim 33 further comprising dividing means attached to the source of fluid to divide the fluid flow into a main flow in a main line and a control flow in a control line, secondary dividing means downstream of the dividing means for dividing the control flow into a high pressure flow in a high pressure line and a lower pressure flow in a lower pressure line, low pressure valve means in the lower pressure line downstream from the secondary dividing means for regulating flow through the lower pressure line in response to a signal from a controlling circuit, amplifier means having an input from the lower pressure line downstream from the low pressure valve means and having a second input from the high pressure line, a main valve having an input from the amplifier means, a second input from the dividing means and an outlet in the heat exchanger means, the main valve opening in response to flow of the high pressure flow from the amplifier means in response to flow of the lower pressure flow from the low pressure valve means to the amplifier means for opening the main valve and permitting flow of fluid from the source of fluid past the main valve into the heat exchanger.

35. A system for measuring the level of peripheral blood flow comprising:

temperature changing means adapted to be attached to the skin for changing the temperature of the skin,

monitoring means adapted to be attached to the skin adjacent the temperature changing means for monitoring change in skin temperature caused by the temperature changing means,

control means operatively associated with the temperature changing means for selectively operating the temperature changing means through at least two cycles, during each cycle, the temperature changing means changing the skin temperature to a predetermined temperature then permitting the skin temperature to approach normal.

36. A system for measuring the level of peripheral blood flow comprising:

temperature changing means adapted to be attached to the skin for changing the temperature of the skin,

control means for selectively operating the temperature changing means through at least two cycles, during each cycle, the temperature changing means changing the skin temperature for a predetermined time then permitting the skin temperature to approach normal.