Implantable medical pump with pressure sensor

• US 10,406,281 B2
• Filed: 08/21/2017
• Issued: 09/10/2019
• Est. Priority Date: 06/03/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Miesel, Keith A., Haase, James M., Paidosh, Chris J., Janzig, Darren A., Denison, Timothy J.
• Primary Examiner(s): Vu, Quynh-Nhu H.
• Application Number:
  US15/681,957
• Publication Number:
  US 20170340814A1
• Time in Patent Office: 750 Days
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: G01L 15/00 Devices or apparatus for measuring two or more fluid pressure values simultaneously
• CPC Class Codes: G01L 19/0023 for flowthrough systems having a flexible pressure transmitting element
• CPC Class Codes: G01L 19/0069 from the sensor to its support
• CPC Class Codes: G01L 19/086 for remote indication
• CPC Class Codes: G01L 19/143 Two part housings
• CPC Class Codes: G01L 19/148 Details about the circuit board integration, e.g. integrated with the diaphragm surface or encapsulation
• CPC Class Codes: G01L 19/149 of immersion sensor, e.g. where the sensor is immersed in the measuring medium or for in vivo measurements, e.g. by using catheter tips
• CPC Class Codes: G01L 9/0072 using variations in capacitance

Abstract

The disclosure is directed to a pressure sensor of an implantable medical device. The pressure sensor may utilize detect fluid pressure based on a changing capacitance between two capacitive elements. The pressure sensor may define at least a portion of a fluid enclosure of the IMD. In one example, the pressure sensor has a self-aligning housing shape that occludes an opening in the pump bulkhead of the IMD. An operative surface of the pressure and the portion of the fluid enclosure may be formed of a corrosion resistant and/or biocompatible material. A first capacitive element of the pressure sensor may be a metal alloy diaphragm that deflects in response to external fluid pressure. A second capacitive element of the pressure sensor may be a metal coating on a rigid insulator sealed from the fluid by the diaphragm and a housing of the sensor.

Claims

1. An implantable medical device (IMD) comprising:

one or more electrical components within the IMD;

a fluid enclosure wall partially defining a fluid enclosure and defining an opening, wherein the fluid enclosure is configured to accommodate a fluid; and

a pressure sensor comprising an operative surface configured to mate to the fluid enclosure wall, the operative surface occluding the opening to partially define the fluid enclosure and separate the fluid from the one or more electrical components, wherein the one or more electrical components are configured to detect, based on a signal from the pressure sensor, a blockage to delivering the fluid from the IMD to a patient.

2. The IMD of claim 1, wherein the one or more electrical components are configured to determine, from the signal from the pressure sensor, a fluid pressure within the fluid enclosure above a threshold pressure that is indicative of the blockage.

3. The IMD of claim 2, wherein the fluid pressure above the threshold pressure is indicative of the blockage located in a catheter connected to the IMD.

4. The IMD of claim 2, further comprising a memory configured to store the threshold pressure.

5. The IMD of claim 1, wherein the operative surface of the pressure sensor is configured to partially define the fluid enclosure at a position along the fluid enclosure between a pump and a catheter output of the IMD.

6. The IMD of claim 1, wherein the operative surface of the pressure sensor is configured to partially define the fluid enclosure at a position adjacent to a catheter output of the IMD.

7. The IMD of claim 1, wherein the fluid enclosure creates a reservoir configured to store the fluid.

8. The IMD of claim 1, further comprising a telemetry circuit configured to transmit data from the IMD.

9. The IMD of claim 8, wherein the one or more electrical components comprise processing circuitry configured to control, in response to detecting the blockage, the telemetry circuit to transmit the data, wherein the data is representative of an alert indicative of the blockage.

10. The IMD of claim 1, wherein the pressure sensor is sized and shaped to self-align in a predetermined rotational orientation to the opening defined by the fluid enclosure wall.

11. The IMD of claim 1, wherein:

the pressure sensor includes a capacitive pressure sensor;

the operative surface comprises a diaphragm mounted to a sensor housing, the diaphragm configured as a first capacitive plate of the capacitive pressure sensor and configured to deflect in response to a pressure of the fluid; and

the pressure sensor comprises a metal film configured as a second capacitive plate of the capacitive pressure sensor.

12. The IMD of claim 1, further comprising the fluid, wherein the fluid comprises a therapeutic agent.

13. A method comprising:

controlling a pump of an implantable medical device (IMD) to deliver a fluid out of the IMD, wherein the IMD comprises;

one or more electrical components within the IMD;

a fluid enclosure wall partially defining a fluid enclosure and defining an opening, wherein the fluid enclosure is configured to accommodate the fluid; and

a pressure sensor comprising an operative surface configured to mate to the fluid enclosure wall, the operative surface occluding the opening to partially define the fluid enclosure and separate the fluid from the one or more electrical components; and

detecting, with the one or more electrical components and based on a signal from the pressure sensor, a blockage to delivering the fluid from the IMD to a patient.

14. The method of claim 13, wherein detecting the blockage comprises determining, from the signal from the pressure sensor, a fluid pressure within the fluid enclosure above a threshold pressure that is indicative of the blockage.

15. The method of claim 14, wherein the fluid pressure above the threshold pressure is indicative of the blockage located in a catheter connected to the IMD.

16. The method of claim 14, wherein determining the fluid pressure comprises determining the fluid pressure using the operative surface of the pressure sensor, wherein the operative surface partially defines the fluid enclosure at a position along the fluid enclosure between a pump and a catheter output of the IMD.

17. The method of claim 14, wherein determining the fluid pressure comprises determining the fluid pressure using the operative surface of the pressure sensor, wherein the operative surface partially defines the fluid enclosure at a position adjacent to a catheter output of the IMD.

18. The method of claim 13, further comprising controlling a telemetry circuit to transmit data representative of an alert indicative of the blockage to an external device in response to detecting the blockage.

19. The method of claim 13, wherein the fluid comprises a therapeutic agent.

20. A system comprising:

a catheter configured to deliver a fluid to a patient; and

an implantable medical device (IMD) configured to connect with the catheter and deliver the fluid to the patient via the catheter, wherein the IMD comprises;

one or more electrical components within the IMD;

a fluid enclosure wall partially defining a fluid enclosure and defining an opening, wherein the fluid enclosure is configured to accommodate the fluid; and

a pressure sensor comprising an operative surface configured to mate to the fluid enclosure wall, the operative surface occluding the opening to partially define the fluid enclosure and separate the fluid from the one or more electrical components, wherein the one or more electrical components are configured to detect, based on a signal from the pressure sensor, a blockage to delivering the fluid from the IMD to the patient.