PRESSURE BASED REFILL STATUS MONITOR FOR IMPLANTABLE PUMPS

• US 20090082757A1
• Filed: 08/27/2008
• Published: 03/26/2009
• Est. Priority Date: 09/26/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rogers, Charles Randall, Kalpin, Scott L., Mitchell, William J.
• Granted Patent: US 8,535,280 B2
• Time in Patent Office: Days
• US Class Current: 604/891.100
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3382 Upper level detectors
• CPC Class Codes: A61M 2205/3386 Low level detectors
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16854 by monitoring line pressure

Abstract

The present invention includes systems and methods for detecting fluid flow into or out of a port chamber or a reservoir of an implantable medical device utilizing a pressure sensor. The system detects characteristic pressure profiles associated with fluid flowing into the medical device, out of the medical device, and also whether one or both of the port chamber or reservoir are substantially empty or substantially full. In addition, the present invention may generate a sensory cue to a clinician to indicate the fluid status.

Claims

1. A method for detecting fluid flow into and out of an implantable infusion device, the device including a port assembly defining the port chamber, the method comprising:

sensing a pressure change in the port chamber; and

,

determining whether the sensed pressure change is indicative of fluid flow into or out of the port chamber.

2. The method of claim 1, further comprising:

generating a sensory cue if the sensed pressure change is indicative of fluid flow into the port chamber.

3. The method of claim 1, further comprising:

generating a sensory cue if the sensed pressure change is indicative of fluid flow from the port chamber.

5. The method of claim 3, wherein generating the sensory cue comprises generating the sensory cue from a second device, the second device being in wireless communication with the infusion device.

6. The method of claim 5, wherein generating the sensory cue from the second device comprises generating the cue from a programmer device.

4. The method of clam 3, wherein generating the sensory cue comprises generating an audible cue.

7. An implantable infusion device comprising:

a housing;

a port assembly defining a port chamber, the port assembly being disposed in the housing such that the chamber is accessible by a needle inserted through the exterior of the housing;

a pressure sensor in fluid communication with the port chamber; and

,

electronics disposed in the housing and operably coupled to the pressure sensor, the electronics including a computer readable medium containing instructions that when implemented cause the device to detect, via the pressure sensor, a pressure fluctuation in the port chamber associated with a status of fluid flow into or out of the port chamber.

8. The device of claim 7, wherein the pressure sensor is operably disposed in the port chamber.

9. The device of claim 7, further comprising a reservoir in fluid communication with the port chamber.

10. The device of claim 7, wherein the pressure fluctuation detected is indicative of a substantially full or substantially empty reservoir.

11. The device of claim 7, wherein the pressure sensor is operably disposed in the reservoir.

12. The device of claim 7, wherein the pressure sensor is operably disposed between the port chamber and the reservoir.

13. The device of claim 7, wherein the port assembly is a refill port assembly.

14. The device of claim 11, wherein the port assembly is a catheter access port assembly.

15. The device of claim 11, wherein the pressure fluctuation detected is indicative of a substantially full or substantially empty reservoir.

16. A method comprising:

inserting a needle into a patient to access a port chamber defined by a port assembly of an infusion device implanted in the patient, the port chamber being accessible from an exterior of the infusion device and being fluidly connected to a reservoir contained in the infusion device;

sensing a pressure change in a port chamber or the reservoir;

determining whether the sensed pressure change is indicative of a fluid flow status; and

generating a sensory cue if the sensed pressure change is indicative of a fluid flow status.

17. The method of claim 16 wherein determining whether the sensed pressure change is indicative of a fluid flow status further comprises determining whether the sensed pressure change is indicative of fluid being withdrawn from one or both of the reservoir or the port chamber.

18. The method of claim 16 wherein determining whether the sensed pressure change is indicative of a fluid flow status further comprises determining whether the sensed pressure change is indicative of fluid being inserted into one or both of the reservoir or the port chamber.

19. The method of claim 16 wherein determining whether the sensed pressure change is indicative of a fluid flow status further comprises determining whether the sensed pressure change is indicative of one or both of the reservoir or the port chamber being substantially empty.

20. The method of claim 16 wherein determining whether the sensed pressure change is indicative of a fluid flow status further comprises determining whether the sensed pressure change is indicative of one or both of the reservoir or the port chamber being substantially full.

21. The method of claim 16, further comprising alerting the device that a needle is to be inserted into the port chamber.

22. The method of claim 16, further comprising (i) delivering fluid through the needle, and (ii) determining whether the sensed pressure change is indicative of fluid being injected into the chamber.

23. The method of claim 22, further comprising generating a sensory cue if the sensed pressure change is not indicative of fluid being injected into the chamber.