System and method for in-vivo hematocrit measurement using impedance and pressure plethysmography

• US 6,766,191 B1
• Filed: 05/16/2000
• Issued: 07/20/2004
• Est. Priority Date: 10/04/1990
• Status: Expired due to Fees

• Current Assignee: Microcor, Inc.
• Original Assignee: Microcor, Inc.
• Inventors: Neese, Jon, Billings, Robert Gail, Clark, Justin S.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US09/571,459
• Time in Patent Office: 1,526 Days
• Field of Search: 600/372, 600/382, 600/384, 600/386, 600/391-393, 600/481, 600/485, 600/490-492, 600/499-500, 600/504, 600/506, 600/385
• US Class Current: 600/547
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/4869 Determining body composition
• CPC Class Codes: H04B 10/077 using a supervisory or additional signal
• CPC Class Codes: H04B 10/07955 Monitoring or measuring power
• CPC Class Codes: H04B 10/2519 using Bragg gratings
• CPC Class Codes: H04B 10/2941 using an equalising unit, e.g. a filter H04B10/296 takes precedence
• CPC Class Codes: H04J 14/0221 Power control, e.g. to keep the total optical power constant

Abstract

The hematocrit of blood (i.e., the percentage of whole blood volume occupied by red blood cells) perfusing a finger is determined by stimulating the finger with two current frequencies, one relatively high (e.g., 10 MHZ) and the other relatively low (e.g., 100 KHz). Voltages induced in the finger in response to the two current frequencies are then captured and separated into baseline and pulsatile components. The hematocrit is determined as a function of the ratio of the high frequency pulsatile component to the low frequency pulsatile component, multiplied by the ratio of the square of the low frequency baseline component to the square of the high frequency baseline component. The volume of blood perfusing the body part at which hematocrit is to be measured may be increased on each pulse by the application of external pressure to the finger, such as by applying a pressure cuff to the finger. Assemblages including two pairs of electrodes are used to effect the determination of hematocrit. The assemblages may also include a component for applying pressure to the body part at which hematocrit is measured.

Claims

1. An assemblage for noninvasively measuring a patient'"'"'s hematocrit, comprising:

a first pair of electrodes configured to at least partially contact a body part of the patient at which hematocrit is to be measured, said first pair of electrodes being connectable to an electrical current source;

a second pair of electrodes configured to at least partially contact the body part at which hematocrit is to be measured, said second pair of electrodes being connectable to an electrical impedance measurement apparatus; and

a pressurization component comprising;

an at least partially hollow, outer rigid member; and

at least one inner pliable member disposed within said outer rigid member, said at least one inner pliable member being partially sealed against said outer rigid member to form a pressurization bladder between said outer rigid member and said at least one inner pliable member, said at least one inner pliable member including a receptacle including a closed end and being configured to receive at least a portion of a body part,

said pressurization component being configured to apply pressure externally to said at least a portion of the body part, at least one electrode of said first and second pairs of electrodes being positionable between a portion of said pressurization component and said at least a portion of the body part.

2. The assemblage of claim 1, wherein said electrical impedance measurement apparatus is configured to measure electrical impedance of at least one frequency between electrodes of said second pair on the body part.

3. The assemblage of claim 1, wherein said pressurization component is associated with a pressure measurement apparatus configured to detect a change in pressure.

4. The assemblage of claim 3, wherein said pressure measurement apparatus is configured to detect a pulsatile change of pressure within said pressurization component.

5. The assemblage of claim 3, wherein said pressure measurement apparatus comprises a pressure cuff.

6. The assemblage of claim 1, wherein, upon introducing pressure into said pressurization bladder, said at least one inner pliable member applies pressure to at least a portion of a body part disposed within said receptacle.

7. The assemblage of claim 1, wherein at least one electrode of said first and second pairs of electrodes includes an elongate member configured to contact the body part.

8. The assemblage of claim 7, wherein at least one of said first and second pairs of electrodes further includes another elongate member configured to connect to said electrical current source.

9. The assemblage of claim 8, wherein said at least one electrode is substantially linear.

10. The assemblage of claim 8, wherein said at least one electrode is nonlinear.

11. The assemblage of claim 1, further comprising at least one connector configured to connect at least one electrode to external electronic componentry.

12. The assemblage of claim 11, wherein said at least one connector is configured to connect at least two electrodes to external electronic componentry.

13. The assemblage of claim 11, wherein said at least one connector is further configured to connect said pressurization component to a pressure supply and control apparatus.

14. The assemblage of claim 11, wherein said at least one connector is further configured to connect said pressurization component to a pressure source.

15. The assemblage of claim 1, wherein at least two electrodes of said first and second pairs of electrodes are positionable between said pressurization component and the body part.

16. The assemblage of claim 15, wherein said pressurization component is configured to apply a pressure externally to at least a portion of the body part.

17. The assemblage of claim 15, wherein at least a portion of said pressurization component is pliable.

18. The assemblage of claim 15, wherein said pressurization component carries at least a portion of at least one electrode of each of said first and second pairs of electrodes.

19. The assemblage of claim 15, wherein said pressurization component carries each electrode of each of said first and second pairs of electrodes.

20. The assemblage of claim 1, further comprising at least one retaining component configured to retain at least one electrode on the body part.

21. The assemblage of claim 20, wherein said at least one retaining component comprises at least one of adhesive material, a retaining sleeve configured to receive an end of said at least one electrode, a receptacle and electrode end configured to be interconnected, and a material that remains substantially deformed.

22. An assemblage for noninvasively measuring a patient'"'"'s hematocrit, comprising:

a first pair of elongate electrodes configured to at least partially contact a body part of the patient at which hematocrit is to be measured in mutually parallel relation to one another, said first pair of elongate electrodes being connectable to an electrical current source;

a second pair of elongate electrodes configured to at least partially contact the body part at which hematocrit is to be measured in mutually parallel relation to one another, said second pair of elongate electrodes being connectable to an electrical impedance measurement apparatus; and

at least one retention component on at least one elongate electrode of each of said first and second pairs of elongate electrodes with one of said first and second pairs of elongate electrodes being positioned between the other of said first and second pairs of elongate electrodes, said at least one retention component being configured to secure at least one elongate electrode to the body part and including a receptacle on said at least one elongate electrode and an end portion of said at least one elongate electrode being configured to interconnect with said receptacle, said end portion including;

retaining regions, each retaining region having a retaining width that is greater than a receptacle width of said receptacle; and

a constricted region located adjacent each retaining region, said constricted region having a constricted width that is at most about equal to said receptacle width.

23. The assemblage of claim 22, wherein said at least one retention component comprises a retaining sleeve on said at least one elongate electrode, said retaining sleeve configured to receive and hold an end of said at least one elongate electrode.

24. The assemblage of claim 22, further comprising a pressurization component.