Implantable infusion devices including apparatus for confirming fluid flow and systems, apparatus and methods associated with same

• US 8,323,268 B2
• Filed: 12/05/2008
• Issued: 12/04/2012
• Est. Priority Date: 12/06/2007
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Alfred E. Mann Foundation For Scientific Research
• Inventors: Ring, Lawrence Scott, Lord, Peter C., Gibson, Scott R., Bowman, Sam W., Shelton, Brian M.
• Primary Examiner(s): SHUMATE, VICTORIA PEARL
• Application Number:
  US12/329,459
• Publication Number:
  US 20090149810A1
• Time in Patent Office: 1,460 Days
• Field of Search: 604/890.1, 604/891.1
• US Class Current: 604/891.1
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2205/0294 Piezoelectric materials
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• 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 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: G01F 1/28 by drag-force, e.g. vane type or impact flowmeter

Abstract

Implantable infusion apparatus, systems and methods that involve the use of a sensor that is associated with the catheter outlet.

Claims

1. A method of monitoring an infusion device that is implanted within a body and includes a reservoir for an infusible substance, a fluid transfer device, a catheter with an outlet, and a sensor device, which includes a pressure responsive element that is located within the catheter adjacent to the catheter outlet, that senses a characteristic that is representative of pressure, the method comprising the step of:

measuring pressure at the sensor device, which includes a pressure responsive element that is located within the catheter adjacent to the catheter outlet, by wirelessly querying the sensor device.

2. A method as claimed in claim 1, wherein the step of wirelessly querying the sensor device comprises wirelessly querying the sensor device associated with the catheter outlet with a device that is external to the body.

3. A method as claimed in claim 1, further comprising the step of:

powering the sensor device with the wireless query.

4. A method as claimed in claim 1, further comprising the step of:

determining whether fluid is flowing though the catheter outlet based on the result of the wireless query.

5. A method as claimed in claim 4, further comprising the step of:

identifying the location of the catheter outlet relative to the patient in response to a determination that fluid is flowing through the catheter outlet.

6. A method as claimed in claim 5, further comprising the step of:

making an adjustment associated with the infusible substance in response to a determination that the catheter outlet is properly located.

7. A method as claimed in claim 1, wherein the catheter is connected to an outlet port, the method further comprising the step of:

observing the pressure at the outlet port.

8. A method as claimed in claim 1, wherein wirelessly querying the sensor device comprises transmitting electromagnetic field pulses to the sensor device associated with the catheter outlet.

9. A method as claimed in claim 1, wherein wirelessly querying the sensor device comprises measuring the capacitance of the sensor device associated with the catheter outlet.

10. A method as claimed in claim 1, wherein the pressure responsive element includes a diaphragm.

11. An apparatus for use with an implanted infusion device, the implanted infusion device including a catheter, with a closed distal end and an outlet proximal of the closed distal end with no other outlets therebetween, and a sensor device, the sensor device being located within the catheter between the closed distal end and the catheter outlet and configured to measure a characteristic which is indicative of fluid flow through the catheter outlet, the apparatus comprising:

a housing;

a user interface carried by the housing; and

means, associated with the housing, for wirelessly querying the sensor device that is located within the catheter between the closed distal end and the catheter outlet and receiving a signal indicative of the characteristic.

12. An apparatus as claimed in claim 11, wherein the user interface comprises a touch screen.

13. An apparatus as claimed in claim 11, further comprising:

means, responsive to the signal indicative of the characteristic, for determining whether the catheter is blocked.

14. An apparatus as claimed in claim 13, further comprising:

means for providing a visible and/or audible indication that the catheter is blocked.

15. A method of monitoring an infusion device that is implanted within a body and includes a reservoir for an infusible substance, a fluid transfer device, a catheter with an outlet, and a pressure sensor, which includes a pressure responsive element that is located entirely within the catheter at or near the catheter outlet, the method comprising the steps of:

directly wirelessly querying the pressure sensor, which includes a pressure responsive element that is located entirely within the catheter at or near to the catheter outlet, with a device that is external to the body; and

powering the pressure sensor with the wireless query.

16. A method as claimed in claim 15, further comprising the step of:

determining whether fluid is flowing though the catheter outlet based on the result of the wireless query.

17. A method as claimed in claim 15, wherein the catheter is connected to an outlet port, the method further comprising the step of:

observing the pressure at the outlet port.

18. A method as claimed in claim 15, wherein the pressure responsive element includes a diaphragm.

19. A method of monitoring an infusion device that is implanted within a body and includes a reservoir for an infusible substance, a fluid transfer device, a catheter with an outlet, and a pressure sensor, which includes a pressure responsive element that is located entirely within the catheter adjacent to the catheter outlet, the method comprising the step of:

directly wirelessly querying the pressure sensor, which includes a pressure responsive element that is located entirely within the catheter adjacent to the catheter outlet, with a device that is external to the body.

20. A method as claimed in claim 19, further comprising the step of:

determining whether fluid is flowing though the catheter outlet based on the result of the wireless query.

21. A method as claimed in claim 19, wherein the catheter is connected to an outlet port, the method further comprising the step of:

observing the pressure at the outlet port.

22. A method as claimed in claim 19, wherein the pressure responsive element includes a diaphragm.

23. An apparatus for use with an implanted infusion device, the implanted infusion device including a catheter, with a closed distal end and an outlet proximal of the closed distal end with no other outlets therebetween, and a sensor device, the sensor device being located between the closed distal end and the catheter outlet and configured to measure a characteristic which is indicative of fluid flow through the catheter outlet, the apparatus comprising:

a housing;

a user interface carried by the housing;

means, associated with the housing, for directly wirelessly querying the sensor device between the closed distal end and the catheter outlet and receiving a signal indicative of the characteristic which is indicative of fluid flow through the catheter outlet; and

means, associated with the housing, for determining whether fluid is flowing though the catheter outlet based on the signal indicative of the characteristic which is indicative of fluid flow through the catheter outlet.

24. An apparatus as claimed in claim 23, wherein the user interface comprises a touch screen.

25. An apparatus as claimed in claim 23, further comprising:

means, responsive to the signal indicative of the characteristic, for determining whether the catheter is blocked.

26. An apparatus as claimed in claim 25, further comprising:

means for providing a visible and/or audible indication that the catheter is blocked.