Drug infusion device with controllable valve

• US 9,737,660 B2
• Filed: 08/25/2011
• Issued: 08/22/2017
• Est. Priority Date: 08/25/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Robinson, Reginald D., Robischon, Mary E., Li, Bernard Q., Ali, Irfan Z., Christenson, Steven R., Miesel, Keith A.
• Primary Examiner(s): Hayman, Imani
• Assistant Examiner(s): Zhang, Jenna
• Application Number:
  US13/217,981
• Publication Number:
  US 20120053514A1
• Time in Patent Office: 2,189 Days
• Field of Search: 604 31, 604 65, 604 67, 60416701, 60416705, 604246-248
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 39/223 Multiway valves
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/1684 by detecting the amount of infusate remaining, e.g. signalling end of infusion

Abstract

A therapeutic fluid delivery device that includes at least one controllable valve is generally described. In one example, an implantable therapeutic fluid delivery system includes a first fluid pathway configured to convey a first therapeutic fluid and a second fluid pathway configured to convey a second therapeutic fluid, the second fluid pathway being separate from the first fluid pathway. The therapeutic fluid delivery system includes a valve connected to the first fluid pathway and the second fluid pathway, and a processor configured to control actuation of the valve to open and close the first fluid pathway and to open and close the second fluid pathway.

Claims

1. An implantable therapeutic fluid delivery system comprising:

a first fluid pathway configured to convey a first therapeutic fluid;

a second fluid pathway configured to convey a second therapeutic fluid, the second fluid pathway being separate from the first fluid pathway;

a valve connected to the first fluid pathway and the second fluid pathway;

a pump, the first fluid pathway being fluidly connected to the pump;

a reservoir, the first fluid pathway being fluidly connected to the reservoir;

an inlet port configured to receive the first therapeutic fluid and the second therapeutic fluid, wherein the valve is interposed between the inlet port and the reservoir along the first fluid flow pathway;

a processor configured to actuate the valve to selectively open and close the first fluid pathway to control access to the reservoir, and to selectively open and close the second fluid pathway;

a housing configured to be implanted in a patient, wherein the first fluid pathway, the second fluid pathway, the valve, and the reservoir are housed within the housing; and

a catheter connection port configured to connect to a catheter;

wherein the first fluid pathway extends from the inlet port to the catheter connection port and is fluidly connected to the catheter connection port, and the reservoir is interposed between the valve and the catheter connection port along the first fluid pathway, and

wherein the second fluid pathway extends from the inlet port to the catheter connection port and is directly fluidly connected to the catheter connection port without passing through any reservoir or any pump, and the valve is interposed between the inlet port and the catheter connection port along the second fluid pathway;

wherein the system is configured to deliver;

the first therapeutic fluid, via the first fluid pathway, from the inlet port, through the valve, through the reservoir, through the pump, and out the catheter connection port; and

the second therapeutic fluid, via the second fluid pathway, from the inlet port, through the valve, and out the catheter connection port.

2. The implantable therapeutic fluid delivery system of claim 1, wherein the valve comprises a rotary valve.

3. The implantable therapeutic fluid delivery system of claim 1, wherein the valve comprises a first valve connected to the first fluid pathway and a second valve connected to the second fluid pathway, wherein the processor is configured to control actuation of the first valve to open and close the first fluid pathway and to control actuation of the second valve to open and close the second fluid pathway.

4. The implantable therapeutic fluid delivery system of claim 1, wherein the inlet port is located on a peripheral surface of the housing.

5. The implantable therapeutic fluid delivery system of claim 4, wherein the valve comprises a first valve connected to the first fluid pathway and a second valve connected to the second fluid pathway, and wherein the processor is configured to control actuation of the first valve to open and close the first fluid pathway and to control actuation of the second valve to open and close the second fluid pathway.

6. The implantable therapeutic fluid delivery system of claim 4, further comprising a sensor configured to detect entry of a needle into an aperture defined by the inlet port.

7. The implantable therapeutic fluid delivery system of claim 6, wherein the sensor comprises at least one of a flow sensor, plunger valve, pressure sensor, acoustic sensor, optical sensor, switch-based sensor, and inductive sensor.

8. The implantable therapeutic fluid delivery system of claim 6, wherein the processor is configured to control actuation of the valve based at least upon a signal provided by the sensor.

9. The implantable therapeutic fluid delivery system of claim 6, further comprising a memory configured to store an indication when the sensor detects entry of the needle.

10. The implantable therapeutic fluid delivery system of claim 4, further comprising a programmer configured to receive user input, wherein the processor is configured to control actuation of the valve based at least upon the user input.

11. The implantable therapeutic fluid delivery system of claim 10, wherein the processor is configured to cause the programmer to display a fluid pathway indication when at least one of the first fluid pathway or second fluid pathway is open.

12. The implantable therapeutic fluid delivery system of claim 11, wherein the programmer comprises the processor.

13. The implantable therapeutic fluid delivery system of claim 10, further comprising a sensor configured to detect entry of a needle into an aperture defined by the inlet port, wherein the processor is configured to control actuation of the valve based at least upon the user input and a signal provided by the sensor.

14. The implantable therapeutic fluid delivery system of claim 13, wherein the processor is configured to control actuation of the valve to close the first and second fluid pathways if the sensor detects entry of the needle into the aperture defined by the inlet port and the user input did not indicate that the needle would be entering the aperture defined by the inlet port.

15. The implantable therapeutic fluid delivery system of claim 14, wherein the processor is configured to at least one of cause the programmer to display an indication that the sensor detected entry of the needle into the aperture, issue an audible, visual, or tactile alarm, or store an indication that the sensor detected entry of the needle into the aperture in a memory.

16. The implantable therapeutic fluid delivery system of claim 4, wherein the reservoir is configured to house the first therapeutic fluid and the pump is housed within the housing.

17. The implantable therapeutic fluid delivery system of claim 16, wherein the valve comprises a first valve connected to the first fluid pathway and a second valve connected to the second fluid pathway, and wherein the processor is configured to control actuation of the first valve to selectively open and close the first fluid pathway and to control actuation of the second valve to selectively open and close the second fluid pathway.

18. The implantable therapeutic fluid delivery system of claim 16, further comprising a third fluid pathway between the reservoir and the pump, and a second valve connected to the third fluid pathway, wherein the second valve is configured to control fluid communication between the reservoir and the pump.

19. The implantable therapeutic fluid delivery system of claim 18, further comprising a third valve interposed between the pump and the catheter connection port, wherein the processor is configured to control actuation of the second valve and the third valve when delivering therapeutic fluid from the reservoir to the catheter connection port.

20. The implantable therapeutic fluid delivery system of claim 1, wherein the reservoir comprises a first reservoir configured to house the first therapeutic fluid, the system further comprising a second reservoir configured to house a third therapeutic fluid, wherein the first fluid pathway extends from the valve to the first reservoir, and the system further comprises a third fluid pathway that extends from the valve to the second reservoir.

21. The implantable therapeutic fluid delivery system of claim 20, wherein the first reservoir and the second reservoir are disposed side-by-side within the housing.

22. The implantable therapeutic fluid delivery system of claim 20, wherein the first reservoir and the second reservoir are stacked within the housing.

23. The implantable therapeutic fluid delivery system of claim 20, wherein the valve comprises a first valve connected to the first fluid pathway, a second valve connected to the second fluid pathway, and a third valve connected to the third fluid pathway, wherein the processor is configured to control actuation of the first valve to open and close the first fluid pathway, to control actuation of the second valve to open and close the second fluid pathway, and to control actuation of the third valve to open and close the third fluid pathway.

24. The implantable therapeutic fluid delivery system of claim 23, wherein the first valve is configured to control fluid communication between the first reservoir and the pump, and the third valve is configured to control fluid communication between the second reservoir and the pump.

25. The implantable therapeutic fluid delivery system of claim 24, further comprising a fourth valve, wherein the fourth valve is interposed between the pump and the catheter connection port, and the processor is configured to control actuation of the fourth valve and at least one of the first valve or third valve when delivering therapeutic fluid from at least one of the first reservoir or the second reservoir to the catheter connection port.

26. The implantable therapeutic fluid delivery system of claim 1, further comprising:

a sensor configured to detect a fluid characteristic,

wherein the valve is interposed between the first fluid pathway and the sensor and the second fluid pathway and the sensor.

27. The implantable therapeutic fluid delivery system of claim 1, further comprising:

one or more additional fluid pathways configured to convey one or more additional therapeutic fluids,

wherein the valve is connected to the one or more additional fluid pathways and wherein the processor is configured to actuate the valve to open and close each of the one or more additional fluid pathways.

28. The implantable therapeutic fluid delivery system of claim 27, wherein the valve comprises a plurality of valves connected to the first fluid pathway, the second fluid pathway, and the one or more additional fluid pathways, and wherein the processor is configured to control actuation of each of the plurality of valves to open and close the first fluid pathway, the second fluid pathway, and each of the one or more additional fluid pathways, respectively.

29. The implantable therapeutic fluid delivery system of claim 1, wherein the processor is housed within the housing.

30. The implantable therapeutic fluid delivery system of claim 1, wherein the valve comprises a single valve connected to both the first fluid pathway and the second fluid pathway, wherein the processor is configured to control actuation of the single valve to open the first fluid pathway while closing the second fluid pathway and wherein the processor is configured to control actuation of the single valve to close the first fluid pathway while opening the second fluid pathway.

31. A method comprising:

actuating, by a processor, a valve within an implantable therapeutic fluid delivery device to selectively open and close a first fluid pathway of the implantable fluid delivery device to control access to a reservoir fluidly connected to the first fluid pathway, and to selectively open and close a second fluid pathway of the implantable fluid delivery device to selectively access a catheter connection port configured to connect to a catheter,

wherein the first fluid pathway is configured to convey a first therapeutic fluid, the second fluid pathway is configured to convey a second therapeutic fluid, the second fluid pathway is separate from the first fluid pathway, and the valve is connected to the first fluid pathway and the second fluid pathway,

wherein the implantable fluid delivery device comprises an inlet port configured to receive the first therapeutic fluid and the second therapeutic fluid, the valve being interposed between the inlet port and the reservoir along the first fluid flow pathway,

wherein the first fluid pathway extends from the inlet port to the catheter connection port and is fluidly connected to the catheter connection port, and the reservoir is interposed between the valve and the catheter connection port along the first fluid pathway,

wherein the first fluid pathway is fluidly connected to a pump, and the pump is interposed between the reservoir and the catheter connection port,

wherein the second fluid pathway extends from the inlet port to the catheter connection port and is directly fluidly connected to the catheter connection port without passing through any reservoir or any pump, and the valve is interposed between the inlet port and the catheter connection port along the second fluid pathway, and

controlling, by the processor, delivery of;

the first therapeutic fluid, via the first fluid pathway, from the inlet port, through the valve, through the reservoir, through the pump, and out the catheter connection port; and

the second therapeutic fluid, via the second fluid pathway, from the inlet port, through the valve, and out the catheter connection port.

32. The method of claim 31, wherein the valve comprises a first valve connected to the first fluid pathway and a second valve connected to the second fluid pathway, and wherein actuating the valve comprises actuating the first valve to selectively open and close the first fluid pathway and actuating the second valve to selectively open and close the second fluid pathway.

33. The method of claim 31, further comprising:

sensing, by a sensor of the implantable therapeutic delivery device, entry of a needle into an aperture defined by the inlet port; and

storing, by the processor and in a memory, an indication when entry of the needle into the aperture defined by the inlet port is sensed.

34. The method of claim 31, further comprising receiving, by the processor, a user input, wherein actuating the valve comprises actuating the valve based at least upon the received user input.

35. The method of claim 31, further comprising displaying, by the processor, a fluid pathway indication when at least one of the first fluid pathway or the second fluid pathway is open.

36. The method of claim 34, further comprising sensing, by a sensor of the implantable therapeutic fluid delivery device, entry of a needle into an aperture defined by the inlet port, wherein actuating the valve comprises actuating the valve based at least upon a sensed entry of the needle into the aperture defined by the inlet port.

37. The method of claim 36, wherein actuating the valve comprises actuating the valve to be closed if entry of the needle into the aperture defined by the inlet port is sensed and the received user input did not indicate that the needle would be entering the aperture defined by the inlet port.

38. The method of claim 37, further comprising at least one of displaying an indication that entry of the needle into the aperture was sensed, issuing an audible, visual, or tactile alarm in response to sensing entry of the needle into the aperture defined by the inlet port and receiving user input that does not indicate that the needle would be entering the aperture defined by the inlet port, or storing an indication that entry of the needle into the aperture was sensed in a memory.

39. The method of claim 31, further comprising actuating, by the processor, a second valve connected to a third fluid pathway between the reservoir and the pump, wherein the second valve is configured to control fluid communication between the reservoir and the pump.

40. The method of claim 39, further comprising actuating, by the processor, the second valve and a third valve of the implantable therapeutic fluid delivery device interposed between the pump and the catheter connection port to deliver therapeutic fluid from the reservoir to the catheter connection port.

41. The method of claim 31, wherein the reservoir comprises a first reservoir, wherein the first fluid pathway extends from the valve to the first reservoir configured to house the first therapeutic fluid, and a third fluid pathway extends from the valve to a second reservoir configured to house a third therapeutic fluid.

42. The method of claim 41, wherein the valve comprises a first valve connected to the first fluid pathway, a second valve connected to the second fluid pathway, and a third valve connected to the third fluid pathway and wherein actuating the valve comprises actuating the first valve to open and close the first fluid pathway, actuating the second valve to open and close the second fluid pathway, and actuating the third valve to open and close the third fluid pathway.

43. The method of claim 42, wherein the first valve is configured to control fluid communication between the first reservoir and the pump of the therapeutic fluid delivery system, and the third valve is configured to control fluid communication between the second reservoir and the pump.

44. The method of claim 43, further comprising actuating a fourth valve interposed between the pump and the catheter connection port and between at least one of the first valve or the third valve to deliver therapeutic fluid from at least one of the first reservoir or the second reservoir to the catheter connection port.

45. A fluid delivery system comprising:

means for conveying a first therapeutic fluid;

means for conveying a second therapeutic fluid, the means for conveying the second therapeutic fluid being separate from the means for conveying the first therapeutic fluid;

a valve connected to the means for conveying the first therapeutic fluid and the means for conveying the second therapeutic fluid;

a pump, the first fluid pathway being fluidly connected to the pump;

means for storing the first therapeutic fluid, wherein the means for conveying the first therapeutic fluid is fluidly connected to the means for storing;

means for receiving the first therapeutic fluid and the second therapeutic fluid, wherein the valve is interposed between the means for receiving and the means for storing along the means for conveying the first therapeutic fluid;

a housing configured to be implanted in a patient, wherein the means for conveying the first therapeutic fluid, the means for conveying the second therapeutic fluid, the valve, and the means for storing are housed within the housing;

means for connecting a catheter to the housing,

wherein the means for conveying the first therapeutic fluid extends from the means for receiving the first therapeutic fluid and the second therapeutic fluid to the means for connecting the catheter to the housing, and wherein the means for conveying the first therapeutic fluid is connected to the means for connecting the catheter to the housing, and the means for storing is interposed between the valve and the means for connecting the catheter to the housing along the means for conveying the first therapeutic fluid, and

wherein the means for conveying the second therapeutic fluid extends from the means for receiving the first therapeutic fluid and the second therapeutic fluid to the means for connecting the catheter to the housing, and wherein the means for conveying the second therapeutic fluid is directly connected to the means for connecting the catheter to the housing without passing through any means for storing the first therapeutic fluid or any pump, and the valve is interposed between the means for receiving and the means for connecting to the catheter along the means for conveying the second therapeutic fluid; and

means for actuating the valve to selectively open and close the means for conveying the first therapeutic fluid to control access to the means for storing, and to selectively open and close the means for conveying the second therapeutic fluid;

wherein the fluid delivery system is configured to deliver;

the first therapeutic fluid, via the means for conveying the first therapeutic fluid, from the means for receiving, through the valve, through the means for storing, through the pump, and out the means for connecting the catheter to the housing; and

the second therapeutic fluid, via the means for conveying the second therapeutic fluid, from the means for receiving, through the valve, and out the means for connecting the catheter.