Prothrombin test apparatus for home use

• US 6,402,704 B1
• Filed: 04/18/2000
• Issued: 06/11/2002
• Est. Priority Date: 04/18/2000
• Status: Expired due to Fees

• Current Assignee: Sonexxus Incorporated
• Original Assignee: Sonexxus Incorporated
• Inventors: McMorrow, Gerald J.
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US09/552,106
• Time in Patent Office: 784 Days
• Field of Search: 600/573, 600/368, 600/369
• US Class Current: 600/576
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15136 by use of radiation, e.g. laser
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

The apparatus includes a single-use compartment assembly which includes a reservoir for blood and a needle element by which blood is obtained from the user. A vacuum system is actuated which draws blood through the needle element into the blood reservoir. An ultrasound signal is directed through the reservoir. There is no return ultrasound signal until there is sufficient blood in the reservoir. When the blood reaches a given level, it contacts a clotting agent present in the reservoir to begin the clotting process. The ultrasound signals are transmitted and return until clotting has been completed, as determined by a pre-established increase in the two-way propagation time relative to unclotted blood. The prothrombin time is then calculated and compared with an acceptable range.

Claims

1. An apparatus for determining prothrombin time, suitable for home use, comprising:

a compartment assembly which includes a reservoir for blood, the reservoir including a blood clotting agent;

means for obtaining blood from a person being tested;

means for moving said blood into the reservoir;

an ultrasound signal device for generating an ultrasound signal and transmitting it through the blood in the reservoir both at a time when the reservoir contains blood which has not yet begun to clot but in a quantity sufficient to sustain two-way transmission of the ultrasound signal and when the blood has substantially clotted, represented by a known increase in the two-way transmission time; and

processing means for determining the prothrombin time of the blood from the time it takes for the two-way transmission time to increase by a known amount.

2. An apparatus of claim 1, wherein the means for obtaining blood is a needle element which communicates with the reservoir.

3. An apparatus of claim 1, wherein the means for obtaining blood is a laser device which perforates the skin of the person being tested sufficiently to obtain blood therefrom.

4. An apparatus of claim 1, including means for comparing said prothrombin time to an established range and for providing an alarm indication when the prothrombin time is outside said established range.

5. An apparatus of claim 2, wherein said needle element is configured and positioned such that a patient can readily produce a puncture contact between said needle element and said blood vessel by applying pressure on a finger against the needle.

6. An apparatus of claim 1, wherein said blood drawing means is a vacuum chamber which when activated draws blood into the blood reservoir.

7. An apparatus of claim 2, wherein the compartment assembly is configured as a single unit and is arranged for a single use, and wherein the compartment assembly is readily removable and insertable relative to the remainder of the apparatus.

8. An apparatus of claim 6, including a vacuum release member in the vacuum chamber which is activated to terminate the drawing of blood when sufficient blood is in the reservoir to sustain a two-way propagation of the ultrasound signal.

9. An apparatus of claim 1, including an ultrasound transducer which is positioned in the vicinity of one end of the compartment assembly, which in operation produces ultrasound signals which propagate along the length of the reservoir and back.

10. An apparatus of claim 6, wherein the vacuum chamber is manually actuated by the user to initiate operation of the apparatus.

11. An apparatus of claim 1, wherein the frequency of the ultrasound signal is sufficiently high and the blood reservoir is so configured that the difference in time of propagation and return of the ultrasound signal between non-clotted blood and clotted blood is readily ascertainable.

12. An apparatus of claim 11, wherein said time difference is approximately 0.1 microseconds.

13. An apparatus of claim 1, wherein said compartment includes an identification of the clotting agent therein, and wherein the apparatus includes means for reading the identification and transmitting that information to the processing means.

14. An apparatus of claim 13, wherein the identification is a bar code.

15. An apparatus of claim 1, including a vacuum member for engorging the tissue where blood is to be obtained.

16. A single use compartment assembly attached to an apparatus for determining prothrombin time, comprising:

a compartment adapted for removable attachment to said apparatus;

a blood reservoir positioned within the compartment, the reservoir containing a blood clotting agent; and

a needle assembly, communicating with said reservoir for permitting blood obtained from a blood vessel of a person being tested to be moved into said reservoir, wherein the person being tested places a finger on the needle element to produce a puncture contact with a blood vessel and wherein the compartment assembly and the needle assembly are configured as a single unit and are arranged for a single use, and wherein the compartment assembly is readily removable and insertable relative to the apparatus.

17. An apparatus of claim 16, wherein said needle element is configured and positioned such that a patient can readily produce a puncture contact between said needle element and said blood vessel by applying pressure on a finger against the needle element.