Integral fluid and waste container for blood analyzer

• US 5,882,602 A
• Filed: 03/11/1997
• Issued: 03/16/1999
• Est. Priority Date: 05/20/1996
• Status: Expired due to Fees

• Current Assignee: SenDx Medical, Inc. (Danaher Corporation)
• Original Assignee: SenDx Medical, Inc. (Danaher Corporation)
• Inventors: Savage, Douglas R., Weinzierl, Michael C.
• Primary Examiner(s): Le, Long V.
• Application Number:
  US08/815,425
• Time in Patent Office: 735 Days
• Field of Search: 422/102, 422/63, 422/100, 422/103, 422/104, 436/43, 436/174, 436/180, 222/94, 222/95, 222/132, 222/325, 220/403, 220/404, 137/614.03, 137/604.05, 137/6, 251/149.6, 251/902, 251/149.7
• US Class Current: 422/537
• CPC Class Codes: B01L 3/0293 for liquids
• CPC Class Codes: B01L 3/505 flexible containers not provided for above
• CPC Class Codes: G01N 2001/2893 Preparing calibration standards
• CPC Class Codes: G01N 35/00594 Quality control, including calibration or testing of components of the analyser
• CPC Class Codes: G01N 35/00693 Calibration
• CPC Class Codes: G01N 35/1002 Reagent dispensers
• CPC Class Codes: Y10T 137/87949 Linear motion of flow path sections operates both
• CPC Class Codes: Y10T 137/87965 Valve- or closure-operated by coupling motion
• CPC Class Codes: Y10T 436/11 Automated chemical analysis
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

A calibration fluid cartridge for a medical device, such as a blood analyzer. The cartridge includes at least one calibrant bag that is filled with a flexible calibration fluid and a flexible waste bag for holding fluid waste from the blood analyzer. The calibrant bags contract as calibration fluid exits the bags, leaving a void in the cartridge that is filled by the waste bag, which expands with waste fluids as the calibrant bags contract. Thus, the cartridge can be made compact and light-weight, making it particularly suited for use in a portable blood analyzer. The calibrant bags have fluid ports with self-sealing valves and a flange to secure them within the cartridge, as well as a compliant member for facilitating a secure, fluid-tight seal between fluid fitting on the blood analyzer and the calibrant and waste bags. The calibrant bags can be directly coupled to the blood analyzer to reduce diffusion of gases from the calibrant bags.

Claims

1. A fluid communication port for a calibration bag coupled to a blood analysis device, the blood analysis device having a calibration bag locating element for coupling a calibration bag that contains a blood analysis calibration fluid to the blood analysis device, the blood analysis device also having a flow fitting, the communication port comprising:

a. a port body having a fluid communication path extending throughout the length of the port body, the port body having a fitting end for accepting the flow fitting of the blood analysis device and a bag end engaging the calibration bag that contains the blood analysis calibration fluid;

b. a self-sealing valve, located substantially within the fluid communication path, that (1) substantially prevents flow of blood analysis calibration fluid from the calibration bag and of fluid into the calibration bag unless the flow fitting is engaging the self-sealing valve and (2) substantially prevents escape of gas from the blood analysis calibration fluid in the calibration bag; and

c. a flange, coupled to the port body, for securing the fluid communication port to the calibration bag locating element of the blood analysis device.

2. The fluid communication port of claim 1 wherein the flange removably secures the fluid communication port to thee calibration bag locating element.

3. The fluid commination port of claim 1 wherein the flange is a substantially rectangular flange that substantially surrounds a portion of the outside surface of the port body.

4. The fluid communication port of claim 3 wherein the flange and the port body are integral.

5. The fluid communication port of claim 1 wherein the bag end of the port body has a substantially elliptical shape.

6. The fluid communication port of claim 5 wherein the calibration bag is formed substantially from a flexible aluminum material, and the substantially elliptical shape of the bag end of the port body facilitates bonding of the flexible aluminum material to the port body.

7. The fluid communication port of claim 6 wherein the substantially elliptical bag end and the flexible aluminum calibration bag are heat sealed together.

8. The fluid communication port of claim 1 wherein the port body is made from a polyolefin material.

9. The fluid communication port of claim 1 wherein the bag end and the calibration bag are secured together by an adhesive.

10. The fluid communication port of claim 1 wherein the self-sealing valve has a valve stem and a, valve stop;

wherein the fluid communication path has a sealing surface; and

wherein the valve stop presses the valve stem against the sealing surface to substantially prevent fluid flow through the fluid communication path unless the flow fitting is inserted into the fluid communication path and deflects the valve stem from the sealing surface.

11. A fluid communication port for a fluid bag coupled to a fluid analysis device for analyzing bodily fluids, the fluid analysis device having a flow fitting and the fluid bag containing a calibration fluid for analysis of a bodily fluid, comprising:

a. a port body having a fluid communication path extending throughout the length of the port body, the port body having a fitting end for accepting the flow fitting of the fluid analysis device and a bag end engaging the fluid bag that contains the calibration fluid for analysis of a bodily fluid;

b. a self-sealing valve, located substantially within the fluid communication path, that (1) substantially prevents flow of the calibration fluid from the fluid bag and of fluid into the fluid bag unless the flow fitting is engaging the self-sealing valve and (2) substantially prevents escape of gas from the calibration fluid in the fluid bag; and

c. an alignment flange that aligns the fluid communication port to the fluid analysis device.

12. The fluid communication port of claim 11 wherein the flange is a substantially rectangular flange that substantially surrounds a portion of the outside surface of the port body.

13. The fluid communication port of claim 11 wherein the bag end of the port body has a substantially elliptical shape.

14. The fluid communication port of claim 13 wherein the calibration bag is formed substantially from a flexible aluminum material, and the substantially elliptical shape of the bag end of the port body facilitates bonding of the flexible aluminum material to the port body.

15. The fluid communication port of claim 11 wherein the self-sealing valve has a valve stem and a valve stop;

wherein the fluid communication path has a sealing surface; and

wherein the valve stop presses the valve stem against the sealing surface to substantially prevent fluid flow through the fluid communication path unless the flow fitting is inserted into the fluid communication path and deflects the valve stem from the sealing surface.

16. A calibration fluid container for a blood analysis device, the blood analysis device having a fluid container locating element and a flow fitting, the calibration fluid container comprising:

a. a bag holding a blood analysis calibration fluid; and

b. a fluid communication port, secured to the bag, including;

(1) a port body having a fluid communication path extending throughout the length of the port body, the port body having a fitting end for accepting the flow fitting of the blood analysis device and a bag end engaging the bag,

(2) a self-sealing valve, located substantially within the fluid communication path, that (1) substantially prevents flow of the blood analysis calibration fluid out of the bag and of fluid into the bag unless the flow fitting is engaging the self-sealing valve and (2) substantially prevents escape of gas from the blood analysis calibration fluid in the bag, and

(3) a flange, coupled to the port body, for securing the fluid communication port to the fluid container locating element on the blood analysis device.

17. The fluid container of claim 16 wherein the flange and the port body are integral.

18. The fluid container of claim 16 wherein the bag end of the port body has a substantially elliptical shape.

19. The fluid container of claim 18 wherein the bag is formed substantially from a flexible aluminum material, and the substantially elliptical shape of the bag end of the port body facilitates bonding of the flexible-aluminum material to the port body.

20. The fluid container of claim 19 wherein the substantially elliptical bag end and the flexible aluminum bag are heat sealed together.

21. The fluid container of claim 16 wherein the self-sealing valve has a valve stem and a valve stop;

wherein the fluid communication path has a sealing surface; and

wherein the valve stop presses the valve stem against the sealing surface to substantially prevent fluid flow through the fluid communication path unless the flow fitting is inserted into the fluid communication path and deflects the valve stem from the sealing surface.