DEVICES AND METHODS FOR INTRA-OPERATIVE SPINAL ALIGNMENT

• US 20180206860A1
• Filed: 08/11/2017
• Published: 07/26/2018
• Est. Priority Date: 05/08/2012
• Status: Active Application

• Current Assignee: Orthalign, Inc.
• Original Assignee: Orthalign, Inc.
• Inventors: van der Walt, Nicholas, Nielsen, Jonathan
• Application Number:
  US15/674,802
• Publication Number:
  US 20180206860A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/7077 for moving bone anchors attached to vertebrae, thereby displacing the vertebrae
• CPC Class Codes: A61B 17/7082 for driving, i.e. rotating, screws or screw parts specially adapted for spinal fixation, e.g. for driving polyaxial or tulip-headed screws driving other bone screws A61B17/8875
• CPC Class Codes: A61B 17/8866 for gripping or pushing bones, e.g. approximators joint distractors A61B17/025
• CPC Class Codes: A61B 2034/2048 using an accelerometer or inertia sensor
• CPC Class Codes: A61B 2090/067 for measuring angles
• CPC Class Codes: A61B 2090/363 Use of fiducial points
• CPC Class Codes: A61B 2090/372 Details of monitor hardware
• 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

Abstract

The present invention provides a spinal alignment system comprising at least one vertebral coupler, at least one reference device and a surgical orientation device. The present invention further provides methods using the spinal alignment system to assist in alignment of the spine during a surgical procedure to correct a deformity due to trauma or degeneration. The present invention also provides a pedicle screw navigation system comprising of a pedicle screw navigator, a first reference device, a second reference device and a surgical orientation device. The present invention provides methods using the pedicle screw navigation system to assist in determining the proper orientation of a pedicle screw during spinal surgery.

Claims

1. A pedicle screw placement system comprising:

a pedicle screw navigator having a first portion configured to temporarily mount to the patient and a second portion moveable relative to the first portion, the second portion configured to contact a posterior portion of vertebral anatomy;

a first reference device coupled with the first portion of the navigator;

a second reference device coupled with the second portion of the navigator; and

a user interface;

wherein the pedicle screw navigation system is configured to guide the insertion of a pedicle screw based at least in part on acquisition of anatomical landmarks using the pedicle screw navigator.

2. The pedicle screw navigation system of claim 1, wherein the first portion of the navigator comprises a mounting block to couple with a proximal portion of the vertebra and the second portion comprises a registration member moveably coupled with the mounting block.

3. The pedicle screw navigation system of claim 2, wherein the registration member is configured to pivot about a first axis and to be extended or retracted along a second axis.

4. The pedicle screw navigation system of claim 2, wherein the registration member is configured to contact at least two lateral anatomical landmarks of a vertebra.

5. The pedicle screw navigation system of claim 2, wherein the registration member is configured to contact first and second transverse processes of a vertebra.

6. The pedicle screw navigation system of claim 1, wherein the first portion of the pedicle screw navigator is adapted to apply a compressive force on a first portion of a vertebra.

7. The pedicle screw navigation system of claim 1, wherein the first portion of the pedicle screw navigator comprises a through hole configured to receive a pin to position the first portion along a first axis.

8. The pedicle screw navigation system of claim 7, wherein the first portion of the pedicle screw navigator comprises a jaw member to temporarily hold the first portion on a vertebra.

9. The pedicle screw navigation system of claim 1, wherein the user interface is housed in a hand-held device having circuitry configured to interact with the first and second reference devices.

10. The pedicle screw navigation system of claim 9, wherein the hand-held device comprises an inertial measurement unit.

11. An intraoperative orthopedic alignment system comprising:

at least one vertebral coupler;

at least one reference device; and

a surgical orientation device;

wherein the surgical orientation device is configured to display orientation of the at least one reference device during a procedure as an indication of alignment of one or more vertebrae of the spine.

12. The system of claim 11, wherein the reference device comprises at least one accelerometer adapted to measure acceleration relative to acceleration due to gravity.

13. The system of claim 11, further comprising:

an inertial measurement unit containing multiple accelerometers;

a digital signal processor to interpret the signals from the accelerometers;

a radio to communicate with the surgical orientation device;

a power supply interface adapted to connect to a power supply to supply power to the reference device;

a housing to enclose and protect the electronic components of the reference device; and

a processor configured to perform one or more of the following functions;

(i) gathering measurements from the accelerometers;

(ii) performing calculations to convert the measurements from the accelerometers to angular orientation; and

(iii) transmitting data representing the angular orientation to the surgical orientation device.

14. The system of claim 13, further comprising multiple reference devices, the radio adapted to communicate with the other reference devices.

15. The system of claim 13, wherein the surgical orientation device is adapted to communicate with multiple reference devices.

16. The system of claim 11, wherein the coupler comprises a first mounting feature on a first end and a second mounting feature on a second end, opposite the first end.

17. The system of claim 16, wherein the first mounting feature comprises a threaded length.

18. The system of claim 16, wherein the first mounting feature is configured to frictionally engage a proximal portion of a vertebra.

19. The system of claim 18, wherein the first mounting feature comprises a jaw device configured to apply a gripping force on lateral sides of a bony prominence of a vertebra.

20. The system of claim 16, wherein the reference device comprises a third mounting feature, the second and third mounting features configured to detachably couple to enable the reference device to be mounted on the coupler.