Methods and apparatus for directly sensing and measuring blood related parameters

• US 5,025,798 A
• Filed: 07/30/1990
• Issued: 06/25/1991
• 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 F
• Application Number:
  US07/547,381
• Time in Patent Office: 330 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-reusable 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, wherein said step of directing is performed utilizing a capillary tube located within said encapsulating means;

(c) sensing and measuring said preselected parameter entirely within said encapsulating means; and

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

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

(a) introducing an unadulterated blood sample into non-reusable disposable encapsulating means for performing both the sensing and measuring of a preselected blood related parameter, wherein said step of introducing further comprises the step of creating a partial vacuum within said encapsulating means to prevent contamination of said blood sample by airborne contaminants;

(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; and

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

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

(a) introducing an unadulterated blood sample into non-reusable disposable encapsulating means for performing both the sensing and measuring of a preselected blood related parameter, wherein said step of introducing further comprises the steps of (a1) inserting said encapsulating means within a blood drawing device;

(a2) drawing a blood sample directly from a patient via said blood drawing device; and

(a3) directly introducing said drawn sample into said encapsulating means as the blood sample is being drawn;

(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; and

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

4. Apparatus for directly sensing and measuring blood related parameters, comprising encapsulating means including means for performing both the sensing and measuring of a preselected blood related parameter entirely within said encapsulating means, wherein said means for performing is calibrated prior to encapsulation thereby eliminating the need for calibration at time of use.

5. Apparatus for directly sensing and measuring blood related parameters, comprising:

(a) encapsulating means including means for performing both the sensing and measuring of a preselected blood related parameter entirely within said encapsulating means;

(b) means for sealing said encapsulating means which permits the introduction of an unadulterated blood sample into said encapsulating means;

(c) means for assuring that a blood sample introduced into said encapsulating means remains unadulterated and is placed in proximity to said means for performing both the sensing and measuring of said preselected blood related parameter to thereby permit direct analysis of said unadulterated blood sample; and

(d) means, coupled to said means for sensing and measuring, for outputting the measured value of said preselected parameter.

6. Apparatus as set forth in claim 5 further comprising means for communicating a signal indicative of the measured value of said parameter between said means for outputting and the outside of said encapsulating means.

7. Apparatus as set forth in claim 5 wherein said means for sealing comprises stopper means including a puncturable portion which may be used to permit the introduction of said blood sample via a needle.

8. Apparatus as set forth in claim 7 wherein said means for assuring comprises a capillary tube, located in an evacuated portion of said encapsulating means, coupled between the puncturable portion of said seal and said means for sensing and measuring, to thereby permit blood injected into said encapsulating means, through the puncturable portion of said seal, to flow via capillary action to said means for sensing and measuring.

9. Apparatus as set forth in claim 6 wherein said means for outputting comprises at least one lead wire coupled between said means for sensing and measuring and said means for communicating.

10. Apparatus as set forth in claim 9 wherein said means for communicating comprises at least one contact pin.

11. 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, comprising:

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

(b) 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;

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

(d) means for sensing the blood sample introduced into said encapsulating means is conveyed, in unadulterated form, to said means for sensing and measuring so that direct analysis of said sample may be performed, wherein said means for assuring further comprises a capillary tube, located in an evacuated portion of said encapsulating means, coupled between the puncturable portion of said seal and said means for sensing and measuring, to thereby permit blood injected into said encapsulating means, through the puncturable portion of said seal, to flow via capillary action to said means for sensing and measuring;

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

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

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