Accumulator for implantable infusion device

• US 8,545,484 B2
• Filed: 10/18/2011
• Issued: 10/01/2013
• Est. Priority Date: 10/18/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Haase, James M., Mezera, Ronald L., Gray, John M., Whitehead, Nicholas R., Bodner, Jeffrey P., Egan, Brian C.
• Primary Examiner(s): STIGELL, THEODORE J
• Application Number:
  US13/275,736
• Publication Number:
  US 20130096503A1
• Time in Patent Office: 714 Days
• Field of Search: 604/131, 604/135, 604/151, 604/152, 604/153, 60428801-28804, 604/890.1, 604/891.1
• US Class Current: 604/891.1
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3362 with minimised length of fluid lines; Taking into account the elastic expansion of fluid lines to increase accuracy
• CPC Class Codes: A61M 2205/8212 with means or measures taken for minimising energy consumption
• CPC Class Codes: A61M 2206/22 eliminating pulsatile flows, e.g. by the provision of a dampening chamber
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16809 by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142

Abstract

An accumulator is employed in an implantable infusion device to provide compliance in the flow path of the device. The accumulator may act to increase the pumping accuracy and repeatability while simultaneously reducing the energy requirements of the device. In one example, the accumulator is arranged at the outlet of a fluid delivery pump of the infusion device. The accumulator includes a cover and a diaphragm biased away from the cover and configured to deflect toward the cover under pressure generated by the therapeutic agent in a flow path of the infusion device. The cover of the accumulator is configured to withstand the pressure generated by the therapeutic agent in the flow path without deforming.

Claims

1. An implantable infusion device (IID) comprising:

a reservoir configured to store a therapeutic agent;

a fluid delivery pump configured to receive the therapeutic agent from the reservoir and deliver the therapeutic agent through an outlet of the fluid delivery pump into a flow path; and

an accumulator arranged at the outlet of the fluid delivery pump, the accumulator comprising;

a cover; and

a diaphragm biased away from the cover and configured to deflect toward the cover under pressure generated by the therapeutic agent in the flow path of the IID,

wherein the cover is configured to withstand the pressure generated by the therapeutic agent in the flow path without appreciably deforming.

2. The IID of claim 1, wherein at least one of the cover and the diaphragm comprises at least one of stainless steel, titanium, or a biocompatible polymer.

3. The IID of claim 1, wherein the diaphragm comprises a corrugated diaphragm.

4. The IID of claim 1, wherein the diaphragm comprises a first thickness approximately equal to 0.051 millimeters (0.002 inches) and the cover comprises a second thickness approximately equal to 0.305 millimeters (0.012 inches).

5. The IID of claim 1, wherein the diaphragm comprises a disc shape.

6. The IID of claim 5, wherein the disc shaped diaphragm comprises:

a rim defining a periphery of the disc shaped diaphragm;

a hub defining a central portion of the disc shaped diaphragm that is generally parallel to and offset from the rim; and

a web connecting the rim and the hub.

7. The IID of claim 6, wherein the web comprises at least one corrugation.

8. The IID of claim 6, wherein the outlet comprises:

a check valve configured to allow flow from the pumping mechanism into the catheter through an exit port and to substantially prevent flow from the catheter into the pumping mechanism through the exit port,

wherein the hub is offset from the rim to accommodate the check valve such that the exit port of the check valve is nested in the hub of the disc shaped diaphragm.

9. The IID of claim 1, wherein the diaphragm is arranged with respect to the outlet such that the diaphragm is immediately adjacent the outlet with no intervening structures between the diaphragm and the outlet.

10. The IID of claim 9, wherein the diaphragm is arranged with respect to the outlet such that pressure generated by the therapeutic agent flowing from the pumping mechanism through the outlet is substantially immediately translated to the diaphragm.

11. The IID of claim 1, wherein the diaphragm is offset from the cover by a first distance, and wherein the first distance is selected such that the cover stops the diaphragm before the diaphragm is plastically deformed under the pressure generated by the therapeutic agent in the flow path of the IID.

12. The IID of claim 1, wherein at least one of a shape, material, and size of the diaphragm is selected based on an operational parameter of the fluid delivery pump.

13. The IID of claim 1, wherein the fluid delivery pump comprises a piston pumping mechanism.

14. The IID of claim 13, wherein at least one of a shape, material, and size of the diaphragm is selected based on a stroke volume of the piston pumping mechanism.

15. The IID of claim 14, wherein at least one of a shape, material, and size of the diaphragm is selected such that the accumulator is configured to provide compliance to the flow path that is greater than or equal to 1 times but not more than 10 times the stroke volume of the piston pumping mechanism.

16. A fluid delivery pump for an implantable infusion device (IID), the fluid delivery pump comprising:

an inlet configured to be fluidically connected to a source of a therapeutic agent;

an outlet configured to be fluidically connected to a catheter;

a pumping mechanism configured to receive the therapeutic agent from the source through the inlet and deliver the therapeutic agent through a flow path from the outlet into and through the catheter; and

an accumulator arranged at the outlet, the accumulator comprising;

a cover; and

a diaphragm biased away from the cover and configured to deflect toward the cover under pressure generated by the therapeutic agent in the flow path of the IID,

wherein the cover is configured to withstand the pressure generated by the therapeutic agent in the flow path without appreciably deforming.

17. The fluid delivery pump of claim 16, wherein at least one of the cover and the diaphragm comprises at least one of stainless steel, titanium, or a biocompatible polymer.

18. The fluid delivery pump of claim 16, wherein the diaphragm comprises a corrugated diaphragm.

19. The fluid delivery pump of claim 16, wherein the diaphragm comprises a first thickness approximately equal to 0.051 millimeters (0.002 inches) and the cover comprises a second thickness approximately equal to 0.305 millimeters (0.012 inches).

20. The fluid delivery pump of claim 16, wherein the diaphragm comprises a disc shape.

21. The fluid delivery pump of claim 20, wherein the disc shaped diaphragm comprises:

a rim defining a periphery of the disc shaped diaphragm;

a hub defining a central portion of the disc shaped diaphragm that is generally parallel to and offset from the rim; and

a web connecting the rim and the hub.

22. The fluid delivery pump of claim 21, wherein the web comprises at least one corrugation.

23. The fluid delivery pump of claim 21, wherein the outlet comprises:

a check valve configured to allow flow from the pumping mechanism into the catheter through an exit port and to substantially prevent flow from the catheter into the pumping mechanism through the exit port,

wherein the hub is offset from the rim to accommodate the check valve such that the exit port of the check valve is nested in the hub of the disc shaped diaphragm.

24. The fluid delivery pump of claim 16, wherein the diaphragm is arranged with respect to the outlet such that the diaphragm is immediately adjacent the outlet with no intervening structures between the diaphragm and the outlet.

25. The fluid delivery pump of claim 24, wherein the diaphragm is arranged with respect to the outlet such that pressure generated by the therapeutic agent flowing from the pumping mechanism through the outlet is substantially immediately translated to the diaphragm.

26. The fluid delivery pump of claim 16, wherein the diaphragm is offset from the cover by a first distance, and wherein the first distance is selected such that the cover stops the diaphragm before the diaphragm is plastically deformed under the pressure generated by the therapeutic agent in the flow path of the IID.

27. The fluid delivery pump of claim 16, wherein at least one of a shape, material, and size of the diaphragm is selected based on an operational parameter of the fluid delivery pump.

28. The fluid delivery pump of claim 16, wherein the pumping mechanism comprises a piston pumping mechanism.

29. The fluid delivery pump of claim 28, wherein at least one of a shape, material, and size of the diaphragm is selected based on a stroke volume of the piston pumping mechanism.

30. The fluid delivery pump of claim 29, wherein at least one of a shape, material, and size of the diaphragm is selected such that the accumulator is configured to provide compliance to the flow path that is greater than or equal to 1 times but not more than 10 times the stroke volume of the piston pumping mechanism.

31. A system comprising:

an implantable infusion device (IID); and

a catheter connected to the IID,

wherein the IID comprises;

a reservoir configured to store a therapeutic agent;

a fluid delivery pump configured to receive the therapeutic agent from the reservoir and deliver the therapeutic agent through a flow path from an outlet of the fluid delivery pump into and through the catheter; and

an accumulator arranged at the outlet of the fluid delivery pump, the accumulator comprising;

a cover; and

a diaphragm biased away from the cover and configured to deflect toward the cover under pressure generated by the therapeutic agent in the flow path of the IID,

wherein the cover is configured to withstand the pressure generated by the therapeutic agent in the flow path without appreciably deforming.