Fluid sample collection and introduction device and method

• US 5,638,828 A
• Filed: 08/18/1995
• Issued: 06/17/1997
• Est. Priority Date: 10/28/1993
• Status: Expired due to Term

• Current Assignee: i STAT Corporation (Abbott Laboratories Incorporated)
• Original Assignee: i STAT Corporation (Abbott Laboratories Incorporated)
• Inventors: Rogers, Joseph W., Lauks, Imants R.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/516,660
• Time in Patent Office: 669 Days
• Field of Search: 128/760, 128/763, 128/765, 128/766, 128/770, 128/771, 604/51, 604/52, 604/132, 604/181, 604/183, 604/185, 422/61, 422/68.1
• US Class Current: 600/573
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2300/0809 rectangular shaped
• CPC Class Codes: B01L 2300/0838 Capillaries
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 9/065 specially adapted for capillary tubes
• CPC Class Codes: G01N 35/1079 with means for piercing stoppers or septums

Abstract

A device and method for collecting a fluid sample and introducing it into a sensing device for real time analysis providing flexibility and simplicity in the way sample fluid sample collection is accomplished and cooperating with a disposable cartridge of the sensing device to permit quick and easy sample introduction and eliminate the risk of sample spillage, an exemplary embodiment of the collection device includes a capillary tube capable of receiving or drawing a fluid sample and introducing the fluid sample into the disposable cartridge, a reservoir chamber capable of receiving a fluid sample and a capillary tube holder capable of supporting one end of the capillary tube in the reservoir chamber to draw the fluid sample by capillary action. Alternative embodiments of the invention are used in combination with the variety of blood collection assemblies employed by the medical industry to collect fluid samples.

Claims

1. A disposable sensing system for analyzing a fluid sample comprising:

a housing;

a sample collection device separate from the housing capable of collecting a fluid sample, the sample collection device having a capillary tube with a first end and a second end, the capillary tube supported in an enclosure, the enclosure capable of being secured to the housing in a first air tight relationship to introduce the fluid sample therein; and

pneumatic sample displacement means for displacing the fluid sample from the sample collection device into the housing.

2. The disposable sensing system as in claim 1, wherein the sample collection device includes:

a reservoir chamber; and

means for supporting the first end of the capillary tube in the reservoir chamber.

3. A disposable sensing system as in claim 2 wherein the means for supporting the capillary tube includes:

a support element; and

a sleeve supported by the support element, the support element projecting outwardly from the sleeve and attached to a wall of the reservoir chamber.

4. A disposable sensing system as in claim 2 further comprising a ledge projecting from a wall of the reservoir chamber.

5. A disposable sensing system as in claim 2 wherein the housing includes:

a component for receiving the collection device, the component having a cavity for receiving the capillary tube, and a port for interfacing with the reservoir chamber.

6. A disposable sensing system as in claim 5 wherein the port includes securing means to secure the collection device to the component.

7. A disposable sensing system as in claim 5 wherein the reservoir chamber and the port are adapted to permit formation of the first air tight relation therebetween.

8. A disposable sensing system as in claim 5 wherein the capillary tube and the cavity are adapted to permit formation of a second air tight relation therebetween.

9. A disposable sensing system as in claim 5 wherein:

the means for supporting the capillary tube includes a sleeve forming a second air tight relation between the capillary tube and the sleeve; and

the sleeve and the cavity are adapted to permit formation of a third air tight relation therebetween.

10. A disposable sensing device as in claim 5 wherein:

the reservoir chamber and the port are adapted to permit formation of the first air tight relation therebetween;

the capillary tube and the cavity are adapted to permit formation of a second air tight relation therebetween;

the first air tight relation, the second air tight relation, the reservoir chamber and the housing are adapted to permit formation of a sealed volume; and

the sample displacement means includes an air bladder adapted to permit pneumatic connection to the sealed volume.

11. A disposable sensing device as in claim 5 wherein:

the means for supporting the capillary tube includes a sleeve forming a second air tight relation between the capillary tube and the sleeve;

the sleeve and the cavity are adapted to permit formation of a third air tight relation therebetween;

the reservoir chamber and the port are adapted to permit formation of the first air tight relation therebetween;

the first air tight relation, the second air tight relation, the third air tight relation, the reservoir chamber and the housing are adapted to permit formation of a sealed volume; and

the sample displacement means includes an air bladder adapted to permit pneumatic connection to the sealed volume.

12. A method for analyzing a fluid sample with a disposable sensing device having a housing, a sample collection device separate from the housing capable of collecting a fluid sample, the sample collection device having a capillary tube with a first end and a second end, the capillary tube supported in an enclosure, the enclosure capable of being secured to the housing in a first air tight relationship to introduce the fluid sample therein, and pneumatic sample displacement means for displacing the fluid sample from the sample collection device into the housing, comprising the steps of:

collecting the fluid sample with the sample collection device;

securing the fluid sample collection device to the housing; and

displacing the fluid sample with the sample displacement means into the housing.

13. The method as in claim 12, wherein the fluid sample collection device includes a reservoir chamber, and a means for supporting the first end of the capillary tube in the reservoir chamber, the step of collecting the fluid sample comprising the steps of:

creating a dermal puncture through which a pool of blood forms; and

placing the second end of the capillary tube in the pool.

14. The method as in claim 12, wherein the fluid sample collection device includes a reservoir chamber, and a means for supporting the first end of the capillary tube in the reservoir chamber, and wherein the fluid sample collection device is used in connection with a test tube-type vessel for collecting fluid samples, the step of collecting the fluid sample comprising the steps of:

collecting the fluid sample in the vessel; and

placing the second end of the capillary tube in the fluid sample collected in the vessel.

15. The method as in claim 12, wherein the fluid sample collection device includes a reservoir chamber, and a means for supporting the first end of the capillary tube in the reservoir chamber, and wherein the fluid sample collection device is used in connection with a syringe, the step of collecting the fluid sample further comprising:

collecting the fluid sample in the syringe; and

depositing the fluid sample from the syringe into the reservoir chamber.

16. The method as in claim 12, wherein the fluid sample collection device includes a reservoir chamber, a capillary tube having a first and a second end, and a means for supporting the first end of the capillary tube in the reservoir chamber, the securing step comprising:

forming a sealed volume between the housing and the reservoir chamber.

17. The method as in claim 16, the displacing step comprising:

forcing air into the sealed volume.

18. A disposable sensing system for analyzing a fluid sample comprising:

a housing having a cavity;

a sample introduction device separate from the housing capable of introducing a fluid sample therein, the sample introduction device having a capillary tube with a first end and a second end, the capillary tube supported in an enclosure, the enclosure capable of being secured to the housing in a first air tight relationship to introduce the fluid sample therein, the first end of the capillary tube introduced into the cavity;

sample displacement means for displacing the fluid sample from the sample introduction device into the housing;

wherein the sample displacement means is pneumatic.

19. A method for analyzing a fluid sample with a disposable sensing device having housing with a cavity, a sample introduction device separate from the housing capable of introducing a fluid sample therein, the sample introduction device having a capillary tube with a first end and a second end, the capillary tube supported in an enclosure, the enclosure capable of being secured to the housing in a first air tight relationship to introduce the fluid sample therein, the first end of the capillary tube introduced into the cavity, and sample displacement means for displacing the fluid sample from the sample introduction device into the housing, wherein the sample displacement means is pneumatic, and wherein the sample introduction device comprises a capillary tube in a support element, and wherein the support element is adapted to form an air tight relation between the sample introduction device and the housing, comprising the steps of:

collecting the fluid sample with the sample introduction device;

securing the fluid sample introduction device in an air tight relation to the housing; and

displacing the fluid sample with the sample displacement means into the housing.