Diagnostic sampling device and system for analyzing body fluids

• US 5,800,779 A
• Filed: 11/20/1995
• Issued: 09/01/1998
• Est. Priority Date: 11/20/1995
• Status: Expired due to Fees

• Current Assignee: Consolidated Polymer Technologies Inc (Compagnie De Saint-Gobain S.A.)
• Original Assignee: Theodore D. Johnson
• Inventors: Johnson, Theodore D.
• Primary Examiner(s): Le, Long V.
• Application Number:
  US08/559,858
• Time in Patent Office: 1,016 Days
• Field of Search: 422/55, 422/58, 422/61, 422/100, 422/101, 422/102, 422/104, 436/63, 436/68, 436/164, 436/165, 436/169, 436/174, 436/175, 436/177, 436/178, 436/163, 436/180, 128/760, 128/771
• US Class Current: 422/408
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: G01N 31/22 using chemical indicators G01N31/02 takes precedence
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

A diagnostic sampling device and system for analyzing body fluids includes a transparent housing defining a test chamber therein in communication with a fluid inlet and a gas outlet, a test strip disposed in the test chamber and having an indicating portion reactive to a condition of the body fluids, and a ruler positionable outside the housing adjacent the test chamber for comparison with indicating portions of the test strip. A plug disposed in the gas outlet of the housing permits gas flow while preventing passage of body fluids, and is preferably formed of a porous material having a capacity to seal the gas outlet when contacted by body fluids. An absorbent filter is also disposed in the housing between the fluid inlet and the test chamber. The fluid inlet can be configured to couple with the proximal end of an enteral feeding tube, in which case the gas outlet is preferably configured to couple with a syringe so that the housing can be filled in-line with aspirated body fluids drawn from the enteral feeding tube by creating suction with the syringe. Alternatively, the fluid inlet can be configured to couple with a syringe such that body fluids can be aspirated from the enteral feeding tube directly using the syringe and expelled into the housing off-line via the fluid inlet.

Claims

1. A diagnostic sampling device for analyzing body fluids comprising

a housing defining a test chamber therein in communication with a fluid inlet and a gas outlet;

and

a test strip disposed in said test chamber, said test strip being visible through said test chamber and having a plurality of indicating portions visibly reactive to pH of the body fluids;

said fluid inlet having a configuration to mate in sealing relation with a source of body fluids and said gas outlet having a configuration to permit gas flow while preventing passage of body fluids so that the diagnostic sampling device is essentially sealed during testing to prevent leakage of body fluids from the device.

2. A diagnostic sampling device as recited in claim 1 and further comprising a plug disposed in said gas outlet to permit gas flow while preventing passage of body fluids.

3. A diagnostic sampling device as recited in claim 2 wherein said plug is formed of a porous material having a capacity to seal said gas outlet when wetted by body fluids.

4. A diagnostic sampling device as recited in claim 1 and further comprising an absorbent filter disposed in said housing between said fluid inlet and said test chamber.

5. A diagnostic sampling device as recited in claim 1 wherein said indicating portions change color when contacted by body fluids, the combination of colors indicating the pH of the body fluids.

6. A diagnostic sampling device as recited in claim 1 wherein said gas outlet is configured to mate sealingly with the dispensing tip of a syringe so that, when a suction force is created with the syringe, body fluids will be drawn into said housing from the source of body fluids.

7. A diagnostic sampling device as recited in claim 6 wherein said fluid inlet is configured to mate sealingly with an access port at proximal end of an enternal feeding tube so that body fluids may be drawn directly from the body into said housing for analysis without exposure.

8. A diagnostic sampling device as recited in claim 1 wherein said fluid inlet is configured to mate sealingly with the dispensing tip a syringe.

15. A diagnostic system for analyzing body fluids comprising a sampling device as recited in claim 1 and further comprising means for interpreting the reaction of the indicating portion of the test strip.

9. A diagnostic system for analyzing body fluids comprising

a sampling device including a housing defining a test chamber therein in communication with a fluid inlet and a gas outlet and a test strip disposed in said test chamber, said test strip being visible through said test chamber and having an indicating portion reactive to a characteristic of the body fluids, said fluid inlet having a configuration to mate in sealing relation with a source of body fluids and said gas outlet having a configuration to permit gas flow while preventing passage of body fluids so that the diagnostic sampling device is essentially sealed during testing to prevent leakage of body fluids from the device;

and

a ruler with at least one reference pattern formed thereon for comparison with the indicating portion of the test strip to determine the characteristic of body fluids contacting said test strip, said ruler being positionable outside said sampling device adjacent said test chamber to permit visual comparison of the indicating portion of the test strip and the reference pattern of the ruler without contaminating the body fluids or exposing medical personnel to infectious diseases.

10. A diagnostic system as recited in claim 9 wherein said ruler includes a plurality of reference patterns corresponding to a range of values used in describing a characteristic of the body fluids.

11. A diagnostic system as recited in claim 10 wherein said test strip includes a plurality of indicating portions and said reference patterns are about the same size and shape as said indicating portions.

12. A diagnostic system as recited in claim 9 wherein said housing and said ruler are configured to mate in at least one position placing a reference pattern alongside said indicating portion for comparison.

13. A diagnostic system as recited in claim 12 wherein said housing includes at least one peg and said ruler is notched to mate with said peg in at least one position.

14. A diagnostic system as recited in claim 10 wherein said indicating portion is reactive to pH and said reference patterns correspond to a range of pH values.

16. A diagnostic system as recited in claim 12 wherein at least a portion of said ruler is transparent so that, when said ruler is mated with said housing, said indicating portion of said test strip is visible through said transparent portion of said ruler for comparison with said reference pattern.

17. A diagnostic system as recited in claim 16 wherein said housing includes a base and said test chamber extends upwardly from said base to position said test strip such that, when said ruler is positioned against said base, said indicating portion of said test strip is visible through said transparent portion of said ruler.

18. A diagnostic sampling device for analyzing body fluids comprising

a housing defining a test chamber therein in communication with a fluid inlet configured to mate sealingly with the dispensing tip of a syringe and a gas outlet;

a plug disposed in said gas outlet and having a configuration to permit gases to vent while preventing passage of body fluids;

said gas outlet including means engaging said plug to prevent expulsion of said plug as body fluids are injected into said fluid inlet from the syringe; and

a test strip disposed in said test chamber, said test strip being visible through said test chamber and having an indicating portion visibly reactive to pH of the body fluids.

19. A diagnostic sampling device for analyzing feeding tube aspirates comprising

a housing defining a test chamber therein in communication with a fluid inlet configured to mate sealingly with an access port at the proximal end of an enteral feeding tube and a gas outlet configured to mate sealingly with a dispensing tip of a syringe;

a plug disposed in said gas outlet and having a configuration to permit gases to flow into the syringe from said housing so that a suction force can be created with the syringe to draw body fluids into said housing from the enteral feeding tube while preventing passage of the body fluids into the syringe through the plug; and

a test strip disposed in said test chamber, said test strip being visible through said test chamber and having an indicating portion reactive to pH of the body fluids.