Method and apparatus for guiding an external needle to an implantable device

• US 9,216,257 B2
• Filed: 03/11/2011
• Issued: 12/22/2015
• Est. Priority Date: 03/25/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Kalpin, Scott L., Bzostek, Andrew, Hartmann, Steven L., Koenig, Matthew W., Jacobsen, Brad, Sarkinen, Scott A., Borowitz, Peter J., Jascob, Bradley A.
• Primary Examiner(s): Brutus, Joel F
• Application Number:
  US13/045,686
• Publication Number:
  US 20110237937A1
• Time in Patent Office: 1,747 Days
• Field of Search: 600/407, 600/437, 600466-467, 600/424
• US Class Current: 1/1
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/3958 emitting a signal
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61M 2039/0081 Means for facilitating introduction of a needle in the septum, e.g. guides, special construction of septum
• CPC Class Codes: A61M 2039/0238 having means for locating the implanted device to insure proper injection, e.g. radio-emitter, protuberances, radio-opaque markers
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates

Abstract

A system to generate a navigation field relative to an implanted device is disclosed. The system can include a small and/or thin localizer array positioned in the implanted device. A power management scheme and circuits can be provided to conserve and resource power in the implanted device.

Claims

1. A system to generate a field relative to an implanted medical device, comprising:

a coil array positioned in the implanted medical device includes a plurality of coils, each coil of the plurality of coils has a winding group formed on a flexible circuit and positioned with the implanted medical device relative to a port formed by the implanted medical device;

a single power source in the implanted medical device to power all components of the implanted medical device which includes energizing the coil array; and

a processor operable to control the energizing of the coil array from the single power source according to selected instructions to assist in providing at least one of a substantially constant amplitude alternating current or voltage to the coil array;

wherein each coil of the plurality of coils in the coil array is formed substantially thin in the flexible circuit to provide a substantially thin profile of the flexible circuit;

wherein each coil includes a first winding portion separated from a second winding portion by an isolation layer;

wherein the first winding portion and the second winding portion are operable as a single coil that has a selected total number of windings equal to the first winding portion and the second winding portion.

2. The system of claim 1, wherein the plurality of coils includes three coils.

3. The system of claim 2, wherein the first winding portion and the second winding portion of each of the three winding groups includes substantially identical number of turns of a conductive material.

4. The system of claim 3, further comprising:

the isolation layer;

wherein the first winding is formed on a first layer of material and the second winding is formed on a second layer of material separate from the first layer;

wherein the isolation layer is between the first layer and the second layer.

5. The system of claim 4, wherein all of the three coils are each separately spaced apart around the port.

6. The system of claim 1, further comprising:

a tuning capacitor that has a capacitance to maximize current through the coil array.

7. The system of claim 6, further comprising:

a receiving coil array in a tracking device;

a support member includes a three dimensionally contoured nesting surface that conforms to a corresponding three dimensionally contoured surface of a supply assembly, the corresponding surface of the supply assembly nesting against the nesting surface to support the supply assembly such that a supply axis remains substantially fixed relative to and aligned with a support axis, wherein the support member houses the tracking device; and

a display operable to display with annular ring icons a location of the support member relative to the implanted medical device.

8. The system of claim 6, further comprising:

a first tuning capacitor and a second tuning capacitor and a switch;

wherein the switch is operable to switch the flexible circuit to connect at least one coil of the plurality of coils in the coil array to tune to a selected frequency the flexible circuit that includes at least one of the first tuning capacitor or the second tuning capacitor and the at least one coil.

9. The system of claim 6, further comprising:

an operational amplifier configured to have an input voltage and output a reference voltage based on the input voltage;

a first PMOS cascode, a second PMOS cascode, and a NMOS current mirror configured to receive the output from the operational amplifier;

a tuning capacitor that has a capacitance variance over a selected lifespan of less than about 3% and in parallel with the plurality of coils of the coil array; and

a switch to switch the output from the second PMOS cascode to the parallel tuning capacitor and at least one of the plurality of coils.

10. The system of claim 1, further comprising:

a pump operable to pump a functional material from a reservoir in the implanted medical device; and

a telemetry system operable to transmit and receive data regarding the implanted medical device;

wherein the pump and the telemetry system are components of the implanted medical device powered by the single power source.

11. The system of claim 1, wherein the instructions include a power management protocol configured to:

operate the implanted medical device to deliver a therapy to a patient which includes drawing a current from the single power source;

send a stop signal to a receiver in the implanted medical device to stop the operation of the implanted medical device from delivering the therapy;

in response to the stop signal, stop the operation of the implanted medical device from delivering the therapy;

after operation of the implanted medical device is stopped from delivering the therapy, start a port finder routine which has sub-routines operable to assist in finding the port.

12. The system of claim 11, wherein the sub-routines include:

start a port finder timer to time the operation of the port finder routine;

power at least one coil of the plurality of coils to emit a field where the field is operable to be sensed by a receiving coil;

determine whether the port finder timer has expired;

when it is determined that the port finder timer has expired, restart the operation of the implanted medical device to deliver the therapy.

13. A method of operating a localizer associated with an implanted medical device having a single power source to generate a navigation field and transmit telemetry from the implanted medical device, the method comprising:

operating the implanted medical device to deliver a therapy to a patient including drawing a current from the single power source;

sending a stop signal to a receiver in the implanted medical device to stop the operation of the implanted medical device from delivering the therapy;

in response to the stop signal, stopping the operation of the implanted medical device from delivering the therapy;

after stopping operation of the implanted medical device from delivering the therapy, starting a port finder routine having sub-routines including

starting a port finder timer to time the operation of the port finder routine;

powering a coil to emit a field;

determining whether the port finder timer has expired;

when it is determined that the port finder timer has expired, restarting the operation of the implanted medical device to deliver the therapy.

14. The method of claim 13, wherein powering a coil includes powering at least a first coil and a second coil, and further comprising:

starting a gap timer after powering the first coil and prior to powering the second coil;

after powering the second coil, starting a blank time;

wherein during the gap timer and during the blank timer neither of the first coil, nor the second coil are powered.

15. The method of claim 14, wherein the length of the gap timer and the length of the blank timer are different.

16. The method of claim 15, determining with a navigation processor the identification of the first coil or the second coil being powered based on the length of the gap timer or the blank timer.

17. The method of claim 16, further comprising:

sensing a first field emitted by the first coil with an antenna;

sensing a second field emitted by the second coil with the antenna; and

determining a location information of the antenna based on the sensed first field and the sensed second field.

18. The method of claim 17, further comprising:

powering a third coil to emit a third field; and

sensing the third field with the antenna;

wherein determining the location of the antenna is based on sensing all of the first field, the second field, and the third field.

19. The method of claim 13, further comprising:

transmitting or receiving telemetry information with the coil if the port finder timer has expired.

20. A system to provide at least one of a constant amplitude alternating current or voltage to a localizer in an implanted medical device that includes a pump, comprising:

a single power source of the implanted medical device to power the pump and the localizer;

an operational amplifier operable to receive an input voltage from the single power source and output a reference voltage to a precision resistor and a first PMOS current mirror cascode;

a NMOS current mirror operable to receive an output voltage from the precision resistor;

a second PMOS current mirror cascode operable to receive an output voltage from the NMOS current mirror and the first PMOS current mirror cascode to at least one of output a substantially constant amplitude alternating current or voltage based on the output reference voltage;

a first coil configured to generate a field to determine at least one of an orientation or a position of the implanted medical device;

a first capacitor in parallel with the first coil configured to tune an output frequency of the generated field; and

a first switch to form a connection between the second PMOS current mirror cascode and the first coil and the first capacitor such that the first coil and first capacitor receive the at least one of the output substantially constant amplitude alternating current or voltage that is output from the first PMOS current mirror cascode.

21. The system of claim 20, further comprising:

a second coil, a second capacitor, and a second switch; and

a third coil, a third capacitor, and a third switch;

wherein the first switch, the second switch, and the third switch are alternatively activated to energize respective first coil and first capacitor, the second coil and the second capacitor, and the third coil and the third capacitor.

22. The system of claim 21, wherein the first capacitor with the first coil, the second capacitor with the second coil, and the third capacitor with the third coil are operable to tune an oscillation through the respective coil and capacitor circuits to a selected frequency.

23. The system of claim 22, wherein the at least one of the constant amplitude alternating current or voltage varies less than about 1%.

24. The system of claim 22, further comprising:

a first PMOS input signal to the first switch to activate the first switch;

a second PMOS input signal to the second switch to activate the second switch; and

a third PMOS input signal to the third switch to activate the third switch;

wherein the first PMOS input signal, the second PMOS input signal, and the third PMOS input signal are generated to alternatively activate the first switch, the second switch, and the third switch.

25. A system to generate a field relative to an implanted medical device, comprising:

a coil array positioned in the implanted medical device includes a plurality of coils wherein each coil has a winding group formed on a flexible circuit;

a power source in the implanted medical device to power all components of the implanted medical device, wherein the power source is configured to energize the coil array and a second component; and

a processor configured to control the energizing of the coil array according to selected instructions to assist in providing a current to the coil array according to a port finder routine that includes a port finder timer and a stop operation of the second component;

wherein each of the plurality of coils in the coil array is formed substantially thin in the flexible circuit to provide a substantially thin profile of the flexible circuit.

26. The system of claim 25,

wherein the coil array is formed on a flexible circuit;

wherein the power source is a single power source in the implanted medical device to power all components of the implanted medical device that includes the coil array; and

wherein the processor is operable to energize the coil array according to selected instructions to assist in providing a substantially constant amplitude alternating current to the coil array.

27. The system of claim 26, wherein each of the single coil or the plurality of coils in the coil array is formed substantially thin in the flexible circuit to provide a substantially thin profile of the flexible circuit.

28. The system of claim 25,

wherein the plurality of coils includes three coils and the winding group include three winding groups;

wherein each of the three winding groups includes a first winding portion formed on a first layer separated from a second winding portion formed on a second layer by an isolation layer;

wherein the first winding portion and the second winding portion are operable as a single coil that has a selected total number of windings;

wherein the first winding portion and the second winding portion are substantially flat and coiled around an axis substantially perpendicular to the first layer and the second layer.

29. The system of claim 28, wherein the first winding portion and the second winding portion of each of the three winding groups includes substantially identical number of turns of a conductive material.

30. The system of claim 28, wherein the first winding is formed on a first layer of material and the second winding is formed on a second layer of material separate from the first layer.

31. The system of claim 28, wherein the implanted medical device has a port;

wherein all of the single coil or the plurality of coils are spaced apart around the port.

32. The system of claim 28,

wherein each of the winding portions are substantially ovoid in shape.

33. The system of claim 28, wherein the second component includes:

a pump operable to pump a functional material from a reservoir in the implanted medical device; and

a telemetry system operable to transmit and receive data regarding the implanted medical device;

wherein the pump and the telemetry system are components of the implanted medical device powered by the single power source.

34. The system of claim 25, further comprising:

a receiving coil array in a tracking device;

a support member includes a three dimensionally contoured nesting surface that conforms to a corresponding three dimensionally contoured surface of a supply assembly, the corresponding surface of the supply assembly nesting against the nesting surface to support the supply assembly such that a supply axis remains substantially fixed relative to and aligned with a support axis, wherein the support member houses the tracking device; and

a display operable to display with annular ring icons a location of the support member relative to the implanted medical device.

35. The system of claim 25, further comprising:

a first tuning capacitor and a second tuning capacitor and a switch;

wherein the switch is operable to switch the circuit to connect at least one coil of the plurality of coils in the coil array to tune to a selected frequency the circuit that includes at least one of the first tuning capacitor or the second tuning capacitor and the at least one coil.

36. The system of claim 25, further comprising:

an operational amplifier that has an input voltage and outputting a reference voltage based on the input voltage;

a first PMOS cascode, a second PMOS cascode, and a NMOS current mirror receiving the output from the operational amplifier;

a tuning capacitor in parallel with the plurality of coils of the coil array;

a switch to switch the output from the second PMOS cascode to the parallel tuning capacitor and at least one of the plurality of coils.

37. A system to receive a field within an implanted medical device, comprising:

a coil array positioned in the implanted medical device includes a plurality of coils wherein each coil has a winding group formed substantially flat on a circuit, wherein each winding group includes a first winding portion on a first layer and a second winding portion on a second layer, wherein both the first winding portion and the second winding portion are coiled around an axis substantially perpendicular to the first layer and the second layer;

a power source in the implanted medical device to power all components of the implanted medical device;

a processor configured to measure a signal received by the coil array from a field generated external from the implanted medical device and generate data regarding the signal that is measured;

an external processor system configured to execute instructions regarding the generated data, wherein the external processor is external to the implanted medical device and a patient in which the implanted medical device is implanted; and

a telemetry processing system configured to receive the generated data regarding the signal that is measured and transmit the generated data to the external processor system;

wherein the external processor system is operable to determine a location of an emitting system that is generating the field generated external from the implanted medical device.

38. A method of operating a localizer associated with an implanted medical device having a power source to generate a navigation field and transmit telemetry from the implanted medical device, the method comprising:

operating the implanted medical device to deliver a therapy to a patient including drawing a current from the single power source;

sending a stop signal to a receiver in the implanted medical device to stop the operation of the implanted medical device from delivering the therapy;

in response to the stop signal, stopping the operation of the implanted medical device from delivering the therapy;

after stopping operation of the implanted medical device from delivering the therapy, starting a port finder routine having sub-routines including

starting a port finder timer to time the operation of the port finder routine;

powering a coil to emit a field;

determining whether the port finder timer has expired;

when it is determined that the port finder timer has expired, restarting the operation of the implanted medical device to deliver the therapy.

39. The method of claim 38, further comprising:

providing only a single power source within the implanted medical device.

40. The method of claim 38, further comprising:

emitting a field with an antenna system external to the implanted medical device;

sensing the field with the coil; and

determining the location of the antenna based on the sensed field;

wherein the coil can include more than one coil and the antenna can include more than one field emitting portion to allow determination of multiple degrees of freedom location information of the antenna relative to the implanted medical device.

41. The method of claim 38, wherein powering a coil includes powering at least a first coil and a second coil, and further comprising:

starting a gap timer after powering the first coil and prior to powering the second coil;

after powering the second coil, starting a blank time;

wherein during the gap timer and during the blank timer neither of the first coil, nor the second coil are powered.

42. The method of claim 41, wherein the length of the gap timer and the length of the blank timer are different.

43. The method of claim 42, determining with a navigation processor the identification of the first coil or the second coil being powered based on the length of the gap timer or the blank timer.

44. The method of claim 43, further comprising:

sensing a first field emitted by the first coil with an antenna;

sensing a second field emitted by the second coil with the antenna; and

determining a location information of the antenna based on the sensed first field and the sensed second field.

45. The method of claim 44, further comprising:

powering a third coil to emit a third field; and

sensing the third field with the antenna;

wherein determining the location of the antenna is based on sensing all of the first field, the second field, and the third field.

46. The method of claim 42, determining with a navigation processor the identification of the first coil or the second coil and ordering the first coil or the second coil being sensed at a selected time based upon the length of a gap time or a blank time.

47. The method of claim 38, further comprising:

transmitting or receiving telemetry information with the coil if the port finder timer has expired.