Vascular access device pathogenic status indication

• US 8,163,237 B2
• Filed: 05/07/2007
• Issued: 04/24/2012
• Est. Priority Date: 05/08/2006
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Crawford, Mark A., Harding, Weston F.
• Primary Examiner(s): Nagpaul, Jyoti
• Application Number:
  US11/745,362
• Publication Number:
  US 20070287989A1
• Time in Patent Office: 1,814 Days
• Field of Search: 422 99-100, 422500-501, 422/50, 436/180, 604/93, 116/206
• US Class Current: 422/50
• CPC Class Codes: A61M 2005/1402 Priming
• CPC Class Codes: A61M 2005/3132 having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase
• CPC Class Codes: A61M 2039/0258 for vascular access, e.g. blood stream access
• CPC Class Codes: A61M 2039/0285 with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port
• CPC Class Codes: A61M 2205/273 preventing reuse, e.g. of disposables
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: A61M 39/16 having provision for disinfection or sterilisation A61M39/143 takes precedence; methods or apparatus for disinfection or sterilisation A61L2/00
• CPC Class Codes: A61M 39/18 Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/16836 by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247
• CPC Class Codes: A61M 5/284 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: G09F 3/0291 Labels or tickets undergoing a change under particular conditions, e.g. heat, radiation, passage of time
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

A vascular access device for communicating with the vascular system of a patient may include a status indicator. The status indicator may detect and signal that a pathogen is in communication with the vascular access device.

Claims

1. A medical device, comprising:

a vascular access device for communicating with the vascular system of a patient, wherein the vascular access device comprises;

a body with a lumen;

a septum disposed within the lumen having a slit through which a device may introduce a substance into the lumen and

the body having a status indicator disposed within the lumen, wherein the status indicator detects the presence of a pathogen in communication with the vascular access device and signals the presence of the detected pathogen.

2. The medical device of claim 1, further comprising:

a second vascular access device with a proximal end and a distal end, wherein the distal end of the second vascular access device is introduced into the vascular system, and wherein the vascular access device is a connector affixed directly or indirectly to the proximal end of the second vascular access device.

3. The medical device of claim 1, wherein the status indicator provides an indication of the extent of pathogenic presence or absence.

4. The medical device of claim 3, wherein the status indicator senses a pathogenic culture within a range of 100 to 100,000 colony-forming units.

5. The medical device of claim 4, wherein the status indicator produces at least one of colorimetric, fluorescent, luminescent, chemiluminescent, and electrochemical signals.

6. The medical device of claim 4, wherein the status indicator requires radiopharmaceutical visualization or fluorescent visualization.

7. The medical device of claim 3, wherein the status indicator senses a pathogenic culture of less than about 100 colony-forming units.

8. The medical device of claim 1, wherein the status indicator includes a protein that detects pathogen secretion.

9. The medical device of claim 1, wherein the status indicator includes at least one of a bioreporter, an antigen, an antibody, a plasmid, and a polyamine.

10. The medical device of claim 1, wherein the status indicator includes a DNA array detection chip.

11. The medical device of claim 1, wherein the status indicator includes electric biosensor technology.

12. The medical device of claim 1, wherein the status indicator includes at least one of a perfume, a carbohydrate, and an analyte.

13. The medical device of claim 1, wherein the status indicator includes an impedance sensor.

14. A method of using a medical device, comprising:

attaching a status indicator to a vascular access device, the vascular access device comprising a body with a lumen and a septum disposed within the lumen having a slit through which a device may introduce a substance into the lumen, the status indicator being disposed within the lumen, the said status indicator being active during usage of the device;

detecting with the status indicator the presence of a pathogen; and

signaling with the status indicator the presence of the detected pathogen.

15. The method of claim 14, wherein signaling with the status indicator the presence of the detected pathogen includes signaling in response to a specific chemical or physical agent within the environment of the status indicator.

16. The method of claim 15, further comprising:

transcribing a promoter gene when the pathogen is present in the environment of the status indicator;

transcribing a reporter gene during or after transcribing the promoter gene;

producing reporter proteins during or after transcribing the reporter gene; and

generating a detectable signal as a result of the production of reporter proteins.

17. The method of claim 16, wherein signaling with the status indicator the presence of the detected pathogen includes signaling through at least one of a colorimetric, fluorescent, luminescent, chemiluminescent, and electrochemical signal.

18. A medical device, comprising:

means for accessing the vascular system of a patient, said means including a vascular access device having a body with a lumen, a septum disposed within the lumen, the septum having a slit through which a device may introduce a substance into the lumen;

means for detecting a pathogen in communication with the means for accessing the vascular system of a patient; and

means for signaling a status change of the means for accessing the vascular system after or during detecting a pathogen in communication with the means for accessing the vascular system of a patient, the means for signaling a status change being disposed within the lumen of the vascular access device.

19. The medical device of claim 18, wherein means for detecting a pathogen in communication with the means for accessing the vascular system of a patient and means for signaling a status change of the means for accessing the vascular system after or during detecting a pathogen in communication with the means for accessing the vascular system of a patient include the same structure.

20. The medical device of claim 19, wherein means for detecting a pathogen in communication with the means for accessing the vascular system of a patient and means for signaling a status change of the means for accessing the vascular system after or during detecting a pathogen in communication with the means for accessing the vascular system of a patient include a pathogen staining solution.