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

• US 9,586,012 B2
• Filed: 07/01/2013
• Issued: 03/07/2017
• 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:
  US13/932,552
• Publication Number:
  US 20130296830A1
• Time in Patent Office: 1,345 Days
• Field of Search: 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: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• 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 support tool for a supply assembly delivers a functional fluid to an implantable medical device. The supply assembly defines a supply axis. The support tool includes a support member defining an opening. The opening has a support axis, and the opening is configured to receive the supply assembly. The support member includes a three dimensionally contoured nesting surface that conforms to a corresponding three dimensionally contoured surface of the supply assembly. The corresponding surface of the supply assembly nests against the nesting surface to support the supply assembly such that the supply axis remains substantially fixed relative to and aligned with the support axis.

Claims

1. A delivery system for delivery of a functional fluid from outside a patient to an implantable medical device inside the patient, the implantable medical device including a port that defines an insertion axis, the delivery system comprising:

a supply assembly configured to contain the functional fluid and that selectively delivers the functional fluid to the implantable medical device, the supply assembly including a three dimensionally contoured outer surface, the supply assembly defining a supply axis;

a support tool that includes a main body and a removable member that is removably attached to the main body, an opening being included between the main body and the removable member, the opening receiving the supply assembly, the main body and the removable member cooperating to define a three dimensionally contoured nesting surface that conforms to and nests with the three dimensionally contoured outer surface of the supply assembly such that the supply axis remains aligned with and fixed relative to the insertion axis, the removable member being removable from the main body to allow the main body to be moved away from the patient while the supply assembly remains in a fixed position relative to the patient;

a tracking device that tracks a position and orientation of the support tool relative to the implantable medical device; and

a prophylactic member that is removably coupled to the support tool to be disposed between the support tool and the patient to reduce contamination of the support tool.

2. The delivery system of claim 1, further comprising:

the implantable medical device having a localizer configured to generate a navigation field, the tracking device being configured to sense the navigation field, the tracking device being operably coupled to the support tool;

a display device; and

a processor system operably coupled to the tracking device and the display device and operable to determine a real-time location of the support tool relative to the port and a trajectory of the support tool relative to an insertion axis of the port;

wherein the processor system is operable to cause the display device to display a graphical rendering of the instrument as a three-dimensional navigable object having a trajectory orientated about the determined real-time trajectory and being positioned at the determined real-time location of the support tool relative to the port.

3. The delivery system of claim 1, wherein the tracking device includes a plurality of coil groups disposed in a geometric configuration to sense independent and diverse signals.

4. The delivery system of claim 3, wherein the tracking device includes four coil groups positioned at vertices of a tetrahedron, wherein each of the four coil groups include three individual coils of conductive material, wherein each of the three individual coils are aligned on an axis orthogonal to the other two individual coils, and wherein each of the four coil groups are spaced apart from one another.

5. The delivery system of claim 1, further comprising:

the implantable medical device;

a coil array positioned in the implanted medical device including at least one coil having a winding group formed on a circuit;

a power source positioned in the implanted medical device to power all components of the implanted medical device including the coil array; and

a processor operable to energize the coil array according to selected instructions to assist in providing a current to the coil array;

wherein the at least one coil is formed thin in the circuit to provide a thin profile of the circuit.

6. The delivery system of claim 5, wherein the coil array includes a plurality of coils each having a respective winding group formed on the circuit, wherein the circuit is a flexible circuit, wherein the power source is a single power source positioned in the implanted medical device to power all components of the implanted medical device including the coil array, and wherein the processor is operable to energize the coil array according to selected instructions assist in providing a constant amplitude alternating current.

7. The delivery system of claim 1, further comprising a localizer disposed in the implantable medical device, the localizer including:

an operational amplifier operable to receive an input voltage 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 output a constant current based on the output reference voltage;

a first coil;

a first capacitor; and

a first switch to form a connection between the second PMOS current mirror cascode and the first coil and the first capacitor;

wherein the first capacitor is operable to tune a frequency of the output from the first coil to a selected frequency.

8. A delivery system for delivery of a functional fluid from outside a patient to an implantable medical device inside the patient, the implantable medical device including a port that defines an insertion axis, the delivery system comprising:

a supply assembly configured to contain the functional fluid and configured to selectively deliver the functional fluid to the implantable medical device, the supply assembly including a first nesting surface, the supply assembly defining a supply axis;

a support tool separate from the implantable medical device and defining an opening configured to receive the supply assembly, the support tool defining a second nesting surface that conforms to and nests with the first nesting surface of the supply assembly such that the supply axis remains substantially aligned with the insertion axis;

a tracking device that tracks a position and orientation of the separate support tool relative to the implantable medical device; and

a prophylactic member that is removably positioned on the separate support tool to reduce contamination of the support tool.

9. The delivery system of claim 8, further comprising the implantable medical device having a localizer configured to generate a navigation field, the tracking device configured to sense the navigation field, the tracking device configured to be coupled to the support tool.

10. The delivery system of claim 9, wherein the tracking device is removably coupled to the support tool in a keyed arrangement.

11. The delivery system of claim 8, wherein the support tool includes an outer edge and defines a support axis extending along the opening in the support tool and a slot defined between the opening and the outer edge;

and

a removable member configured to removably engage the slot, wherein the removable member is configured to be removable from the support tool to allow the support tool to be moved away from the patient while the supply assembly remains in a fixed position relative to the patient.

12. The delivery system of claim 11, wherein the opening is formed between a main body of the support tool and the removable member and the main body and the removable member each defines a portion of the opening.

13. The delivery system of claim 12, wherein the main body and removable member define the second nesting surface.

14. The delivery system of claim 11, wherein the slot and removable member define a tongue and groove interface.

15. The delivery system of claim 8, wherein the prophylactic member is rigid.

16. The delivery system of claim 15, wherein one of the prophylactic member or the support tool includes a projection and the other of the prophylactic member or the support tool includes an aperture, the aperture removably receiving the projection to removably couple the prophylactic member to the support tool.

17. The delivery system of claim 8, further comprising:

a processor system operably coupled to the tracking device and configured to determine a real-time location of the separate support tool relative to the port of the implantable medical device.

18. The delivery system of claim 8, wherein the first nesting surface is a first three-dimensionally contoured nesting surface and the second nesting surface is a second three-dimensionally contoured nesting surface where the first three-dimensionally contoured nesting surface nests and conforms in shape and contour with the second three-dimensionally contoured nesting surface.

19. The delivery system of claim 18, wherein the supply assembly includes an outer surface and a piercing member extending from the outer surface along the supply axis, wherein the outer surface defines the first three-dimensionally contoured nesting surface.

20. The delivery system of claim 19, wherein the second nesting surface is positioned completely around the opening defined in the separate support member.

21. A delivery system for delivery of a functional fluid from outside a patient, the delivery system comprising:

an implantable medical device configured to be implanted inside the patient, the implantable medical device including a port that defines an insertion axis;

a supply assembly configured to contain the functional fluid and configured to selectively deliver the functional fluid to the implantable medical device, the supply assembly including a first nesting surface and defining a supply axis;

a support member having a main body and a removable member that is removably attached to the main body, the main body and the removable member including a second nesting surface that conforms to and nests with the first nesting surface and defining a bore passing through the support member along a support axis, the removable member configured to be removed from the main body to allow the main body to be moved away from the patient without removing the supply assembly from the patient;

a tracking device configured to track the position of the supply axis relative to the port; and

a prophylactic member that is removably positioned on the support member to reduce contamination of the support member.

22. The delivery system of claim 21, wherein the tracking device is removably coupled to the support member.

23. The delivery system of claim 21, wherein the main body defines a slot configured to removably and slidably receive the removable member to define the second nesting surface.