Cartridge having an integrated collection element for point of care system

• US 20040176705A1
• Filed: 03/04/2003
• Published: 09/09/2004
• Est. Priority Date: 03/04/2003
• Status: Abandoned Application

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Ellis, Robert G., Crawford, Jamieson W., Francavilla, Frank, Wilkinson, Bradley M., Hwang, Charles G., Newby, C. Mark, Stevens, Timothy A.
• Application Number:
  US10/377,621
• Publication Number:
  US 20040176705A1
• Time in Patent Office: Days
• US Class Current: 600/584
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles 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 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A system is provided which may be used for collecting and testing fluid samples at a patient point of care location. A disposable collection and containment device is provided for collecting a fluid sample directly into a containment chamber containing testing mechanisms using an integrated collection mechanism for immediate evaluation of the collected sample. The integrated collection cartridge contains an array of electrical contacts, electrochemical sensors and circuitry configured to electrically couple with an analytical device, such as a personal digital assistant (PDA) or a stand-alone computer workstation, which controls the testing of the fluid sample within the cartridge and provides a rapid indication of test results at the point of care.

Claims

1. An integrated collection device for collecting fluid samples and performing fluid sample analysis, comprising:

a housing comprising an inlet orifice and a top and bottom containment wall, said top wall mechanically coupled to said bottom wall to define a containment chamber, wherein said containment chamber is accessible through said inlet orifice, said housing further having an integrated collection mechanism and an electrical connector;

said integrated collection mechanism comprising a distal port and a body cavity in fluid communication with said distal port adapted to collect fluid from a patient and communicate a fluid sample of said collected fluid into said containment chamber via said inlet orifice;

said electrical connector of said housing comprising a first set of electrical contacts adapted to engage a second set of electrical contacts located on an analytical device, said first set of electrical contacts electrically coupled to a sensory apparatus disposed about said containment chamber; and

said sensory apparatus comprising at least one sensor adapted to detect fluid properties, said sensory apparatus electrically coupled to said first set of electrical contacts and accessible by said analytical device via said electrical connector.

2. An integrated collection device for collecting fluid samples and performing fluid sample analysis as claimed in claim 1, wherein said distal port of said integrated collection mechanism comprises a collection element engagement mechanism.

3. An integrated collection device for collecting fluid samples and performing fluid sample analysis as claimed in claim 2, wherein said collection element engagement mechanism comprises a conical luer fitting.

4. An integrated collection device for collecting fluid samples and performing fluid sample analysis as claimed in claim 2, wherein said collection element is selected from the group consisting of an intra-venous needle, intra-arterial needle, venous catheter, arterial catheter, capillary tube, microneedle array and lancet.

5. An integrated collection device for collecting fluid samples and performing fluid sample analysis as claimed in claim 2, wherein said collection element engagement mechanism comprises a shielding mechanism adapted to shield said collection element.

6. An integrated collection device for collecting fluid samples and performing fluid sample analysis as claimed in claim 5, wherein said housing further comprises a first user interface control to control said shielding mechanism.

7. An integrated collection device for collecting fluid samples and performing fluid sample analysis as claimed in claim 1, wherein said integrated collection mechanism is adapted to create a vacuum and in response, said distal port is adapted to collect fluid from a patient into said body cavity and communicate said fluid sample of said collected fluid into said containment chamber.

8. An integrated collection device for collecting fluid samples and performing fluid sample analysis as claimed in claim 7, wherein said integrated collection mechanism further comprises a plunger assembly slidably engaged within said body cavity wherein said movement of said plunger assembly within said body cavity creates said vacuum.

9. An integrated collection device for collecting fluid samples and performing fluid sample analysis as claimed in claim 7, wherein said distal port is adapted to communicate said fluid sample of said collected fluid into said containment chamber via a capillary action created by at least one of said inlet orifice and said containment chamber.

10. An integrated collection device for collecting fluid samples and performing fluid sample analysis as claimed in claim 7, wherein said distal port is adapted to communicate said fluid sample of said collected fluid into said containment chamber via said vacuum created by said integrated collection mechanism.

11. An integrated collection device for collecting fluid samples and performing fluid sample analysis as claimed in claim 8, wherein said plunger assembly comprises a second user interface control to control said movement of said plunger assembly.

12. An integrated collection device for collecting fluid samples and performing fluid sample analysis as claimed in claim 1, wherein said integrated collection mechanism is adapted to expose fluid from a patient and in response, said distal port is adapted to collect fluid from a patient into said body cavity and communicate said fluid sample of said collected fluid into said containment chamber.

13. An integrated collection device for collecting fluid samples and performing fluid sample analysis as claimed in claim 12, wherein said distal port is adapted to communicate said fluid sample of said collected fluid into said containment chamber via a capillary action created by at least one of said distal port, body cavity, inlet orifice and said containment chamber.

14. An integrated collection device for collecting fluid samples and performing fluid sample analysis as claimed in claim 1, wherein said second electrical connector comprises a second set of electrical contacts, said second electrical connector adapted to engage said first electrical connector of said collection cartridge and electrically couple said first and second set of electrical contacts.

15. An integrated collection device for collecting fluid samples and performing fluid sample analysis as claimed in claim 1, wherein said analytical device is adapted to perform user directed analytical tests on said fluid sample using said sensory apparatus via said first and second sets of electrical contacts.

16. An integrated collection device for collecting fluid samples and performing fluid sample analysis as claimed in claim 1, wherein said analytical device is selected from the group consisting of a hand-held analyzer, personal digital assistant and computer workstation.

17. A cartridge assembly for collecting fluid samples and performing fluid sample analysis as claimed in claim 1, wherein said fluid sample properties include at least one of a pH, pCO₂, pO₂, pCl, pNO₃, Na⁺, Ca⁺⁺, K⁺, hematocrit and glucose level in said sample.

18. A cartridge assembly for collecting fluid samples and performing fluid sample analysis as claimed in claim 1, wherein said fluid sample properties includes a temperature of said fluid sample.