SENSING ELEMENT HAVING AN ADHESIVE BACKING

• US 20090024015A1
• Filed: 07/03/2008
• Published: 01/22/2009
• Est. Priority Date: 07/17/2007
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Curry, Kenneth M.
• Application Number:
  US12/167,903
• Publication Number:
  US 20090024015A1
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• 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 5/6833 Adhesive patches
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor

Abstract

The present invention is directed to a sensing element that comprises a flexible substrate having first and second opposite surfaces; at least one sensor disposed on the first surface of the flexible substrate; an adhesive layer substantially covering the second surface of the flexible substrate; and a release liner releasably adhered to the adhesive layer so that upon removal of the release liner the adhesive layer is exposed for securing the sensing element to the catheter. The release liner permits the sensing element to be positioned at a desired location within the catheter after which the release liner can be removed to expose the adhesive layer. The adhesive layer can then be used to attach and secure the sensing element at a desired location on the catheter. As a result, the need for additional adhesives can be reduced or eliminated.

Claims

1. A sensing element for incorporation into a catheter and for monitoring of a physiological parameter in a blood vessel, the sensing element comprising:

a flexible substrate having first and second opposite surfaces;

at least one sensor disposed on the first surface of the flexible substrate;

an adhesive layer covering at least a portion of the second surface of the flexible substrate; and

a release liner releasably adhered to the adhesive layer so that upon removal of the release liner the adhesive layer is exposed for securing the sensing element to the catheter.

2. The sensing element of claim 1, further comprising one or more electrical wires each having an end connected to at least one sensor, and an opposite end for connecting to an electrical connector of the catheter.

3. The sensing element of claim 1, wherein the sensing element comprises a flex circuit.

4. The sensing element of claim 1, wherein the sensor comprises a working electrode and a counter electrode.

5. The sensing element of claim 1, wherein the sensor comprises an electrode having a reactant disposed thereon.

6. The sensing element of claim 5, wherein the reactant comprises glucose oxidase.

7. The sensing element of claim 1, wherein the adhesive layer comprises a pressure sensitive adhesive.

8. The sensing element of claim 1, wherein the adhesive layer covers a substantial portion of the second surface.

9. A catheter assembly for detecting a physiological parameter in a blood vessel, comprising:

an elongated tube having a distal and proximal end, and a longitudinal axis extending therebetween;

a recess formed in an outer wall of the tube between the distal and proximal ends of the tube;

at least one lumen extending longitudinally through the tube and in communication with at least a portion of the recess; and

a sensing element for detecting a physiological parameter in the blood vessel, the sensing element comprising;

a flexible substrate having first and second opposite surfaces;

at least one sensor disposed on the first surface of the flexible substrate;

an adhesive layer covering at least a portion of the second surface of the flexible substrate; and

a release liner releasably adhered to the adhesive layer so that upon removal of the release liner the adhesive layer is exposed for securing the sensing element to the tube adjacent to the recess.

10. The catheter assembly of claim 9, wherein the recess comprises a sensing port formed in the outer wall of the tube and defines an opening through which a bodily fluid can flow through the sensing port and into the lumen.

11. The catheter assembly of claim 9, wherein a plurality of lumens are disposed in the tube.

12. The catheter assembly of claim 9, wherein at least one of the lumens is an infusion lumen having an infusion port for introducing an infusant into the blood vessel.

13. The catheter assembly of claim 12, wherein the infusion port is disposed towards the distal end of the tube with respect to the sensing port.

14. The catheter assembly of claim 9, wherein the sensing element comprises a flex circuit having an amperometric sensor.

15. The catheter assembly of claim 14, wherein the amperometric sensor comprises a working electrode and a reference electrode, and wherein glucose oxidase is disposed on the working electrode for reacting with glucose in the blood vessel.

16. The catheter assembly of claim 15, wherein the amperometric sensor further includes a counter electrode.

17. The catheter assembly of claim 9, wherein the recess includes an opening that is in communication with the lumen through which one or more electrical wires of the sensing element are insertable.

18. A method of preparing a catheter for detecting a physiological parameter in a blood vessel, the method comprising:

providing a catheter assembly having

an elongated tube having a distal and proximal end, and a longitudinal axis extending therebetween,

a recess formed in an outer wall of the tube between the distal and proximal ends of the tube;

positioning a sensing element for detecting the physiological parameter in the blood vessel into the recess, the sensing element comprising;

a flexible substrate having first and second opposite surfaces;

at least one sensor disposed on the first surface of the flexible substrate;

an adhesive layer covering at least a portion of the second surface of the flexible substrate; and

a release liner releasably adhered to the adhesive layer;

removing the release liner to thereby expose the adhesive layer; and

contacting the adhesive layer to a surface of the tube adjacent to the recess to thereby secure the sensing element to the tube.

19. The method of claim 18, wherein the sensing element includes one or more electrical wires each having one end that is connected to at least one sensor and a second end for connecting to an electrical connector of the catheter, the method further comprising the step of feeding the wires into the tube through an opening formed in the recess and towards the proximal end of the catheter.

20. The method of claim 18, wherein the catheter assembly further comprises at least one lumen extending longitudinally through the tube and in communication with the recess, and wherein the recess comprises a sensing port defining an opening through which a bodily fluid can flow through the sensing port and into the lumen.

21. The method of claim 20, further comprising the steps of:

positioning the sensing element within the lumen adjacent to the sensing port; and

contacting the adhesive layer to an inner surface of the lumen adjacent to the sensing port to thereby secure the sensing element to the lumen.

22. The method of claim 18, further comprising the step of forming the sensing element comprising the steps of:

forming a plurality of sensors on the first surface of the flexible substrate;

thereafter, applying a layer of a pressure sensitive adhesive to the second surface of the flexible substrate;

covering the adhesive layer with a release liner; and

separating the flexible substrate into a plurality of individual sensing elements wherein each sensing element includes a working electrode and a counter electrode.

23. The method of claim 18, further comprising the step of applying a reagent to a surface of the sensor.

24. The method of claim 23, wherein the reagent comprises an enzyme.

25. The method of claim 18, wherein the sensing element is positioned in the recess so that it is flush with an outer surface of the tube.

26. The method of claim 18, wherein the adhesive layer of the sensing element covers a substantial portion of the second surface.

27. A method for forming a sensing element for incorporation into a catheter and for monitoring of a physiological parameter in a blood vessel, comprising the steps of:

forming a plurality of sensors on the first surface of the flexible substrate;

thereafter, applying a layer of a pressure sensitive adhesive to the second surface of the flexible substrate;

covering the adhesive layer with a release liner; and

separating the flexible substrate into a plurality of individual sensing elements wherein each sensing element includes a working electrode and a counter electrode.