Catheter with integral biosensor

• US 20070219441A1
• Filed: 02/26/2007
• Published: 09/20/2007
• Est. Priority Date: 02/27/2006
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Fjield, Todd, Curry, Kenneth, Higgins, Michael, Carlin, Patrick, Heitzmann, Harold
• Application Number:
  US11/710,834
• Publication Number:
  US 20070219441A1
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/6852 Catheters
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked

Abstract

A single or multilumen intravenous catheter that may include an integral biosensor having an active portion exposed through a sensing port formed in a distal portion of an outer wall of the catheter. The biosensor may be formed on a flex circuit mounted to a support member or probe that displaces the active portion from an inner wall of the catheter for protection from friction during installation through a lumen. The support member or probe may position the biosensor concentrically within the lumen or against an inner diameter of the outer wall. The biosensor may be sealed about the sensing port to prevent passage of fluid therethrough, or a proximal end of the sensing port may remain open to allow flushing of the biosensor with saline infused through the lumen.

Claims

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

an elongated tube having a longitudinal axis;

a sensing port perforating an outer wall of the tube between proximal and distal ends of the tube;

at least one lumen extending longitudinally through the tube and connecting to the sensing port, the lumen having a longitudinal axis offset from the longitudinal axis of the tube;

a support member spanning the sensing port and positioned concentrically within the lumen; and

a biosensor connected to the support member and exposed through the sensing port.

2. The catheter of claim 1, wherein the support member displaces an active portion of the biosensor from an inner wall of the catheter.

3. The catheter of claim 1, wherein the biosensor is mounted concentrically within the support member.

4. The catheter of claim 1, wherein the sensor is mounted to an inner diameter of the outer wall of the tube.

5. The catheter of claim 1, further comprising sealant to prevent passage of fluid into the lumen through the sensing port.

6. The catheter of claim 1, wherein the lumen is sealed at a distal end of the sensing port to prevent passage of fluid through the sensing port into the distal end of the lumen, and wherein the lumen opens to a proximal end of the sensing port to allow passage of fluid from the lumen through the proximal end of the sensing port.

7. The catheter of claim 1, further comprising one or more intermediate ports formed in the outer wall of the tube distally with respect to the sensing port.

8. The catheter of claim 7, wherein the sensing port is proximal to all other ports formed in the outer wall of the tube.

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

an elongated tube;

a recessed area formed on an outer wall of the tube between proximal and distal ends of the tube;

at least one lumen extending longitudinally through the tube and forming an inner wall of the recessed area;

a mounting port formed through a transverse proximal wall of the recessed area; and

a biosensor extending through the mounting port and bonded to the outer wall of the tube on the recessed area.

10. The catheter of claim 9, wherein the mounting port is sealed to prevent passage of fluid therethrough.

11. The catheter of claim 9, further comprising a second mounting port formed through a transverse distal wall of the recessed area, the biosensor extending through the second mounting port.

12. The catheter of claim 11, wherein the first and second mounting ports are sealed to prevent passage of fluid therethrough.

13. The catheter of claim 9, further comprising one or more intermediate ports formed in the outer wall of the tube distally with respect to the recessed area.

14. The catheter of claim 13, wherein the recessed area is proximal to all other ports formed in the outer wall of the tube.

15. The catheter of claim 9, wherein an outermost surface of the biosensor is displaced a radial distance from the axis of the tube that is less than the radius of the outer wall of the tube.

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

an elongated tube having a longitudinal axis;

a sensing port perforating an outer wall of the tube between proximal and distal ends of the tube;

at least one lumen extending from a proximal end of the tube longitudinally through the tube and terminating at a distal end of the sensing port, the lumen having a longitudinal axis offset from the longitudinal axis of the tube;

a probe extending through the lumen to the sensing port; and

a biosensor connected to the probe and exposed through the sensing port.

17. The catheter of claim 16, wherein the probe displaces an active portion of the biosensor from an inner wall of the catheter.

18. The catheter of claim 16, wherein the biosensor is mounted concentrically with respect to the probe.

19. The catheter of claim 16, further comprising a plug positioned in the lumen at a distal end of the sensing port.

20. The catheter of claim 19, wherein the lumen is keyed to guide the probe through the lumen in proper orientation to exposes an active portion of the biosensor through the sensing port when a distal end of the probe reaches the plug.