Methods and apparatus for directly sensing and measuring blood related parameters

• US 5,048,539 A
• Filed: 09/28/1990
• Issued: 09/17/1991
• Est. Priority Date: 10/31/1988
• Status: Expired due to Fees

• Current Assignee: Medical Systems Development LLC
• Original Assignee: Medical Systems Development Corporation
• Inventors: Schindele, Gary M.
• Primary Examiner(s): Hindenburg, Max
• Application Number:
  US07/639,504
• Time in Patent Office: 354 Days
• Field of Search: 128/635, 128/760, 128/763, 128/771, 604/403, 204/403, 436/16, 436/68, 436/74
• US Class Current: 600/584
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150473 Double-ended needles, e.g. used with pre-evacuated sampling tubes 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 5/150732 Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A disposable cartridge, included in a blood sample analysis system, is described wherein the cartridge itself contains means for both sensing and measuring preselected blood related parameters. The blood sample being analyzed is directly placed in contact with sensing means in the cartridge without intervening buffer solutions, exposure to air, etc. The unadulterated sample is analyzed within the cartridge and the measurement output therefrom is communicated to means outside the cartridge where it can be displayed, be analyzed further, be transmitted to a remote location, etc. The cartridge and its contents do not require on site calibration or a warm up period. This feature allows the system to be used by personnel not necessarily trained in calibrating sophisticated electronic equipment and facilitates rapid data output, particularly vital in critical care and emergency treatment situations.

Claims

1. A method for directly sensing and measuring blood related parameters in a non-reuseable disposable container, the method comprising the steps of:

(a) introducing an unadulterated blood sample into non-reuseable disposable encapsulating means for performing both the sensing and measuring of a preselected blood related parameter;

(b) directing said blood sample to means within said encapsulating means for performing both the sensing and measuring of said preselected blood related parameter;

(c) sensing and measuring said preselected parameter entirely within said encapsulating means directly from said unadulterated blood sample; and

(d) outputting, from said encapsulating means, the measured value of said parameter.

2. A method as set forth in claim 1 further comprising the step of heparinizing the interior surfaces of said encapsulating means to thereby prevent the clotting of blood introduced therein.

3. A method as set forth in claim 1 wherein said encapsulating means is a disposable cartridge.

4. A method as set forth in claim 3 further comprising the step of locating said sensing and measuring means within a housing located within said disposable cartridge.

5. A method as set forth in claim 4 further comprising the step of heparinizing the interior surfaces of said cartridge and the housing located therein to prevent the clotting of blood introduced therein.

6. A method as set forth in claim 5 further comprising the step of releasing pressure from said cartridge and housing via pressure relief valve means whenever overfilling of the volume within said cartridge and housing is attempted.

7. A method as set forth in claim 1 wherein said step of outputting is performed utilizing at least one lead wire coupled between the sensing and measuring device located within said housing and means for communicating said measured value to the outside of said encapsulating means.

8. A method as set forth in claim 7 wherein said means for communicating is at least one contact pin.

9. A method as set forth in claim 1 further comprising the step of displaying said measured value.

10. Apparatus for directly sensing and measuring blood related parameters, comprising non-reuseable disposable encapsulating means including means for performing both the sensing and measuring of a preselected blood related parameter entirely within said encapsulating means directly from an unadulterated blood sample.

11. Apparatus as set forth in claim 10 wherein said encapsulating means is a portable cartridge.

12. Apparatus as set forth in claim 10 wherein said encapsulating means further comprises pressure relief means.

13. A system for obtaining an unadulterated blood sample, analyzing said sample to sense and measure a preselected parameter associated therewith, and output a signal indicative of the measured value of said parameter, said system comprising:

(a) non-reuseable disposable encapsulating means including means for performing both the sensing and measuring of said parameter entirely within said encapsulating means;

(b) means for introducing an unadulterated blood sample into said encapsulating means;

(c) means for assuring the blood sample introduced into said encapsulating means is conveyed, in unadulterated form, to said means for sensing and measuring so that said sensing and measuring may be performed directly from an unadulterated blood sample;

(d) output means, coupled to said means for sensing and measuring, for outputting a signal indicative of the measure of said parameter;

(e) means, coupled between said output means and the outside of said encapsulating means, for communicating said output signal to display means; and

(f) display means for displaying the value of said measured parameter as a function of the value of said signal.

14. A system as set forth in claim 13 wherein said disposable encapsulating means is a portable cartridge.

15. A system as set forth in claim 13 wherein said means for introducing is a syringe.

16. A system as set forth in claim 13 wherein said means for introducing is a drawing system to which said encapsulating means may be coupled so that drawn blood is directly communicated from the patient to said encapsulating means.

17. A system as set forth in claim 13 further comprising means for sealing said encapsulating means, which permits the introduction of an unadulterated blood sample into said encapsulating means through a puncturable portion of said means for sealing.

18. A system as set forth in claim 13 wherein said output means comprises at least one lead wire coupled between said means for sensing and measuring and said means for communicating.

19. A system as set forth in claim 18 wherein said means for communicating comprises at least one contact pin.

20. A system as set forth in claim 13 wherein said encapsulating means further comprises pressure relief means.