Electronic guidance of spinal instrumentation

• US 8,348,954 B2
• Filed: 09/16/2008
• Issued: 01/08/2013
• Est. Priority Date: 09/16/2008
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Carls, Thomas, Anderson, Kent
• Primary Examiner(s): Robert, Eduardo C
• Assistant Examiner(s): COMSTOCK, DAVID C
• Application Number:
  US12/211,164
• Publication Number:
  US 20100069919A1
• Time in Patent Office: 1,575 Days
• Field of Search: 606246-279, 606/86.A, 606/86.R, 600/407, 600/424, 600/431, 600433-435
• US Class Current: 606/86.A
• CPC Class Codes: A61B 17/7083 Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2048 using an accelerometer or inertia sensor
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2063 Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis

Abstract

Systems and methods for positioning a connecting element adjacent an anatomical structure in minimally-invasive surgical procedures, including an electronic guidance system associated with the connecting element and at least one receiving portion of a tissue anchor that receives the connecting element in the patient. The electronic guidance system includes a processor subsystem to receive signals from the guidance system and provide relative positional data between the connecting element and the at least one receiving portion to aid the surgeon in guiding the connecting element to the receiving portion. In one embodiment, the systems and methods are used in association with positioning a connecting element adjacent the spinal column in minimally-invasive spinal stabilization procedures.

Claims

1. A system for minimally-invasive surgical procedures in a patient, comprising:

at least one tissue anchor including a tissue engaging portion and a receiving portion coupled to said tissue engaging portion;

an inserter instrument including a proximal handle portion and an inserter arm extending from said proximal handle portion;

a connecting element for implantation in the patient, said connecting element releasably engaged to said inserter arm; and

an electronic guidance system including a targeting device at said receiving portion of said at least one tissue anchor and a tracking device at said connecting element, said tracking device being operable to electrically communicate with said targeting device through tissue of the patient to provide an electronic signal that varies in accordance with a relative position between said connecting element and said receiving portion, said electronic guidance system further including a processor subsystem that receives said electronic signal, said processor subsystem being programmed to determine a change in a relative position between said receiving portion and said connecting element based on said electronic signal, said electronic guidance system further including a feedback device operable to communicate said change in said relative position as said connecting element is guided through tissue of the patient;

wherein said connecting element includes a leading end and an opposite trailing end, said trailing end being coupled to said inserter instrument and said connecting element extending away from said trailing end to said leading end, said leading end including said tracking device and said tracking device includes one of an anode and a cathode;

wherein said receiving portion including a target location to receive said connecting element and said targeting device is positioned at said target location, said targeting device including the other said anode and said cathode, wherein an electric current flow path is provided between said anode and said cathode through tissue of the patient when said leading end of said connecting element is in contact with tissue of the patient;

wherein as said leading end of said connecting element approaches said at least one receiving portion electric current flow between said anode and said cathode increases and as leading end of said connecting element moves away from said receiving portion electric current flow between said anode and said cathode decreases;

wherein said processing subsystem receives signals corresponding to said current flow and is programmed to determine said relative position of said leading end and said receiving portion based on said signals and provide data regarding said relative position to said feedback device; and

wherein said target location includes shielding around said at least one tissue anchor to resist dissipation of current flow into adjacent tissue and to direct current flow to said one of said anode and said cathode at said target location.

2. The system of claim 1, wherein:

said at least one tissue anchor comprises a bone anchor; and

said tissue engaging portion comprises a bone engaging portion configured to engage bony tissue.

3. The system of claim 2, wherein:

said connecting element is a rigid spinal rod having a body extending between a leading end and an opposite trailing end, said trailing end being engaged to said inserter arm and with said connecting element extending away from said inserter arm to said leading end; and

said tracking device is provided at said leading end.

4. The system of claim 1, wherein:

said at least one tissue anchor includes two or more tissue anchors; and

two or more anchor elongated extensions, each of said anchor elongated extensions being releasably mounted to a corresponding one of said two or more tissue anchors.

5. The system of claim 4, wherein:

said two or more tissue anchors comprise bone anchors; and

said tissue engaging portion comprises a bone engaging portion configured to engage bony tissue.

6. The system of claim 1, wherein said feedback device communicates by at least one of visual and audible output.

7. The system of claim 1, wherein:

said shielding includes an electrical charge around said targeting device that corresponds to an electrical charge of said one of said anode and said cathode of said tracking device, said electrical charge including a first voltage; and

said tracking device includes an electrical charge with a second voltage that differs from said first voltage.

8. The system of claim 1, wherein:

said connecting element includes a motion sensor connected thereto and said motion sensor is operable to detect data associated with movement of said connecting element through tissue of the patient;

said motion sensor is linked to said processor subsystem to communicate said movement data to said processor subsystem; and

said processor subsystem is programmed to calculate a target insertion path for said connecting element to direct said connecting element toward said receiving portion.

9. A system for minimally-invasive surgical procedures in a patient, comprising:

at least one tissue anchor including a tissue engaging portion and a receiving portion coupled to said tissue engaging portion;

an inserter instrument including a proximal handle portion and an inserter arm extending from said proximal handle portion;

a connecting element for implantation in the patient, said connecting element releasably engaged to said inserter arm; and

an electronic guidance system including a targeting device at said receiving portion of said at least one tissue anchor and a tracking device at said connecting element, wherein;

said targeting device is operable to generate an electrical field with distinct frequency bands around a target location at said receiving portion;

said tracking device includes a sensor operable to influence changes in said frequency bands as said connecting element is moved toward and away from said target location;

said electronic guidance system further including a processor subsystem and at least said targeting device is operable to communicate a signal corresponding to said changes in said frequency bands, said processor subsystem being programmed to determine a change in a relative position between said receiving portion and said connecting element based on said signal, said electronic guidance system further including a feedback device operable to communicate said change in said relative position as said connecting element is guided through tissue of the patient;

said connecting element includes a leading end and an opposite trailing end, said trailing end being coupled to said inserter instrument and said connecting element extending away from said trailing end to said leading end, said leading end including said tracking device and said tracking device includes one of an anode and a cathode;

said receiving portion including a target location to receive said connecting element and said targeting device is positioned at said target location, said targeting device including the other of said anode and said cathode, wherein an electric current flow path is provided between said anode and said cathode through tissue of the patient when said leading end of said connecting element is in contact with tissue of the patient;

wherein as said leading end of said connecting element approaches said at least one receiving portion electric current flow between said anode and said cathode increases and as leading end of said connecting element moves away from said receiving portion electric current flow between said anode and said cathode decreases;

wherein said processor subsystem receives signals corresponding to said current flow and is programmed to determine said relative position of said leading end and said receiving portion based on said signals and provide data regarding said relative position to said feedback device; and

said targeting device includes shielding means around said target location, said shielding means for dissipating current flow in tissue around said target location.

10. The system of claim 9, wherein:

said at least one tissue anchor comprises a bone anchor; and

said tissue engaging portion comprises a bone engaging portion configured to engage bony tissue.

11. The system of claim 9, wherein said sensor is a magnetic sensor.

12. The system of claim 9, wherein said sensor is an impedance sensor.

13. The system of claim 9, wherein said target location at said receiving portion is grounded and said targeting device includes alternating current signals around said target location generating said electrical field.

14. A method of performing a minimally-invasive surgical procedure in a patient, comprising:

engaging at least one anchor to an anatomical structure;

providing a first electrical charge at a receiving portion of the at least one anchor, the receiving portion configured to receive a connecting element;

inserting the connecting element in tissue adjacent the anatomical structure;

providing the connecting element with a second electrical charge that is opposite the first electrical charge;

establishing current flow between the first and second electrical charges through the tissue;

measuring changes in the current flow as the connecting element moves through the tissue, wherein the current flow changes correspond to relative positional data between the connecting element and the receiving portion; and

changing a direction of movement of the connecting element through the tissue when the current flow decreases.

15. The method of claim 14, wherein the at least one anchor comprises a bone anchor and the anatomical structure comprises a spinal column;

wherein the engaging comprises anchoring the at least one bone anchor to a vertebra of the spinal column; and

wherein the method comprises a method of performing a minimally-invasive spinal stabilization procedure.

16. The method of claim 14, further comprising:

moving the connecting element through the tissue to position a leading end of the connecting element into the receiving portion of the at least one anchor.

17. The method of claim 14, further comprising:

shielding current flow into tissue around the receiving portion with shielding electrical charges around the receiving portion that are opposite the first electrical charge, wherein the shielding electrical charges and the second electrical charge are at different voltages.

18. The method of claim 14, wherein measuring changes in the current flow includes determining a relative position between a leading end of the connecting element and the receiving portion of the anchor.

19. A method of claim 14, further comprising:

determining an insertion path trajectory of the connecting element based on movement data during the inserting of the connecting element, wherein the movement data is determined by a motion sensor at the connecting element;

determining a target trajectory to position the connecting element in the receiving portion based on the relative positional data between the connecting element and the receiving portion; and

communicating changes in the insertion path trajectory to align the connecting element along the target trajectory.

20. A method of performing a minimally-invasive surgical procedure in a patient, comprising:

engaging at least one anchor to an anatomical structure, wherein the at least one anchor includes a target location;

inserting a leading end of a connecting element in tissue adjacent the anatomical structure;

determining a relative position between the leading end of the connecting element and the target location;

determining an insertion path trajectory of the connecting element based on movement data during inserting the connecting element, wherein the movement data is determined by a motion sensor associated with the connecting element;

determining a target trajectory to position the connecting element in the receiving portion based on the relative position between the connecting element and the receiving portion; and

communicating changes in the insertion path trajectory to align the connecting element along the target trajectory.

21. The method of claim 20, wherein the at least one anchor comprises a bone anchor and the anatomical structure comprises a spinal column;

wherein the engaging comprises anchoring the at least one bone anchor to a vertebra of the spinal column; and

wherein the method comprises a method of performing a minimally-invasive spinal stabilization procedure.

22. The method of claim 20, further comprising:

advancing the connecting element from the receiving portion of the at least one anchor into a receiving portion of a second anchor; and

securing the connecting element to the at least one anchor and the second anchor.

23. The method of claim 20, wherein determining the relative position between the leading end of the connecting element and the target location includes measuring a change in electrical current flow between the connecting element and the target location.

24. A system for minimally-invasive surgical procedures in a patient, comprising:

anchor means for engaging an anatomical structure in the patient, said anchor means including a receiving portion extending from the anatomical structure when said anchor means is engaged to the anatomical structure, wherein said receiving portion includes targeting means for providing a target location associated with the anchor means;

an inserter instrument including a proximal handle portion and an inserter arm extending from said proximal handle portion;

a connecting element for implantation through tissue of the patient, said connecting element releasably engaged to said inserter arm, wherein said connecting element includes tracking means electrically communicating with said targeting means for continuously generating an electric signal that varies according to a relative position between said targeting means and said tracking means; and

processing means for receiving said electrical signal and generating an output indicating changes in said relative position as said connecting element is advanced through tissue of the patient;

said connecting element includes a leading end and an opposite trailing end, said trailing end being coupled to said inserter instrument and said connecting element extending away from said trailing end to said leading end, said leading end including said tracking means and said tracking means includes one of an anode and a cathode;

said receiving portion including a target location to receive said connecting element and said targeting means is positioned at said target location, said targeting means including the other of said anode and said cathode, wherein an electric current flow path is provided between said anode and said cathode through tissue of the patient when said leading end of said connecting element is in contact with tissue of the patient;

wherein as said leading end of said connecting element approaches said at least one receiving portion electric current flow between said anode and said cathode increases and as leading end of said connecting element moves away from said receiving portion electric current flow between said anode and said cathode decreases;

wherein said processing means receives signals corresponding to said current flow and is programmed to determine said relative position of said leading end and said receiving portion based on said signals and provide data regarding said relative position to said feedback device; and

wherein said targeting means includes shielding means around said target location, said shielding means for dissipating current flow in tissue around said target location.

25. The system of claim 24, further comprising:

feedback means for communicating said changes in said relative position to a user as said connecting element is advanced through tissue of the patient.

26. The system of claim 24, wherein:

said connecting element further includes sensor means for measuring movement of said connecting element through the tissue of the patient; and

said processing means receives signals corresponding to said measured movement and said processing means includes means for determining a target trajectory based on said relative position between said targeting means and said tracking means, wherein said target trajectory positions said connecting element in said receiving portion when said connecting element is advanced through the tissue along the target trajectory.

27. The system of claim 24, wherein said target means includes means for generating an electrical field around said target location and said tracking means includes means for influencing said electrical field based on said relative position between said targeting means and said tracking means.