Intravascular sensor and insertion set combination

• US 20090240121A1
• Filed: 03/21/2008
• Published: 09/24/2009
• Est. Priority Date: 03/21/2008
• Status: Abandoned Application

• Current Assignee: Sanvita Medical Corporation
• Original Assignee: Nova Biomedical Corporation (Nova Chemicals)
• Inventors: Bickoff, Charles
• Application Number:
  US12/052,985
• Publication Number:
  US 20090240121A1
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0014 Connecting a tube to a hub

Abstract

An intravascular sensor assembly insertable into an intravenous catheter, the sensor assembly includes a sheath having a sheath proximal end and a sheath distal end wherein an outer diameter of the sheath is sized to be substantially equal to the outer diameter of an insertion needle of the intravenous catheter, a hub sealingly connected to the sheath proximal end, the hub adapted for removably coupling to the intravenous catheter, a sensor disposed within the sheath, the sensor having a sensor shank with a shank distal end and a shank proximal end, a plurality of sensor elements including a working electrode with a reagent matrix disposed thereon, the reagent matrix comprising an enzyme capable of catalyzing a reaction involving a substrate for the enzyme and a reference electrode, the plurality of sensor elements disposed adjacent the shank distal end, a plurality of connector pads disposed at the shank proximal end where the plurality of connector pads are contained within the hub and the plurality of sensor elements are exposed adjacent the sheath distal end, and a plurality of elongated conductive elements where each of the plurality of conductive elements electrically couples one of the plurality of sensor elements to one of the plurality of connector pads, and a cable electrically coupled to the plurality of connector pads.

Claims

1. An intravascular sensor assembly insertable into an intravenous catheter, the sensor assembly comprising:

a sheath having a sheath proximal end and a sheath distal end wherein an outer diameter of the sheath is sized to be substantially equal to the outer diameter of an insertion needle of the intravenous catheter;

a hub sealingly connected to the sheath proximal end, the hub adapted for removably coupling to the intravenous catheter;

a sensor disposed within the sheath, the sensor having a sensor shank with a shank distal end and a shank proximal end, a plurality of sensor elements including a working electrode with a reagent matrix disposed thereon, the reagent matrix comprising an enzyme capable of catalyzing a reaction involving a substrate for the enzyme and a reference electrode, the plurality of sensor elements disposed adjacent the shank distal end, a plurality of connector pads disposed at the shank proximal end wherein the plurality of connector pads are contained within the hub and the plurality of sensor elements are exposed adjacent the sheath distal end, and a plurality of elongated conductive elements wherein each of the plurality of conductive elements electrically couples one of the plurality of sensor elements to one of the plurality of connector pads; and

a cable electrically coupled to the plurality of connector pads.

2. The sensor of claim 1 wherein the plurality of sensor elements and the shank distal end are exposed beyond the sheath distal end.

3. The sensor of claim 1 wherein the plurality of sensor elements is exposed at an opening in the sheath adjacent the sheath distal end.

4. The sensor of claim 1 wherein the plurality of sensor elements is exposed at orthogonal openings on opposite sides of the sheath adjacent the sheath distal end.

5. The sensor of claim 1 wherein the sensor shank has a plurality of contact ears disposed substantially perpendicular to the longitudinal axis of the sensor shank and having the connector pads exposed thereon.

6. The sensor of claim 5 wherein the contact ears are seated against a reference face within the hub at a base of the hub adjacent a sheath-hub interface.

7. The sensor of claim 1 wherein the hub further includes a resilient component disposed within the hub against the cable and a pressure cap fixedly attached to the hub and sized to provide pressure on the resilient component causing the cable and the connector pads to remain in intimate electrical contact.

8. The sensor of claim 1 further includes conditioning electronics coupled to the cable, the conditioning electronics communicatingly coupled to a monitor.

12. The combination of claim 8 wherein the plurality of sensor elements is exposed at orthogonal openings on opposite sides of the sheath adjacent the sheath distal end.

9. In combination, an intravascular sensor assembly and an intravenous catheter assembly, the combination comprising:

an intravenous catheter assembly comprising an intravenous catheter and an intravenous insertion needle removably and slidably disposed within the intravenous catheter; and

an instravascular sensor assembly comprising a sheath, a hub sealingly connected to a proximal end of the sheath, and a sensor sealingly disposed within the sheath wherein the sensor has a plurality of sensor elements including a working electrode with a reagent matrix disposed thereon, the reagent matrix comprising an enzyme capable of catalyzing a reaction involving a substrate for the enzyme and a reference electrode, the plurality of sensor elements disposed adjacent the shank distal end, a plurality of connector pads disposed at the shank proximal end wherein the plurality of connector pads are contained within the hub and the plurality of sensor elements are exposed adjacent the sheath distal end, and a plurality of elongated conductive elements wherein each of the plurality of conductive elements electrically couples one of the plurality of sensor elements to one of the plurality of connector pads, and a cable electrically coupled to the plurality of connector pads;

wherein the intravascular sensor assembly is removably and sealingly insertable into the intravenous catheter after removal of the insertion needle.

10. The combination of claim 9 wherein the plurality of sensor elements and the shank distal end are exposed beyond the sheath distal end.

11. The combination of claim 9 wherein the plurality of sensor elements is exposed at an opening in the sheath adjacent the sheath distal end.

13. The sensor of claim 9 wherein the sensor shank has a plurality of contact ears disposed substantially perpendicular to the longitudinal axis of the sensor shank and having the connector pads exposed thereon.

14. The sensor of claim 13 wherein the contact ears are seated against a reference face within the hub at a base of the hub adjacent a sheath-hub interface.

15. The sensor of claim 9 wherein the hub further includes a resilient component disposed within the hub against the cable and a pressure cap fixedly attached to the hub and sized to provide pressure on the resilient component causing the cable and the connector pads to remain in intimate electrical contact.