IP Library Granted Patent US 11,058,437
Granted Patent B2
US 11,058,437 · App. 16/370,402 · Granted Jul 13, 2021

Systems and methods for pedicle screw implantation using flexible drill bit

Inventors: Allison Christine Capote (Boulder, CO); Adam Costanza (Aurora, CO); David Lee Skaggs (Los Angeles, CA); Frank J. Schwab (New York, NY)
Assignee: Zimmer Biomet Spine, Inc.
A61B17/1631A61B17/1615A61F2/4611A61B17/1757A61B17/70
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Quick Facts
Patent No.
US 11,058,437
App. No.
16/370,402
Granted
Jul 13, 2021
Kind
B2
Abstract

A method of implanting a bone anchor in a vertebra comprises engaging a tip of a flexible drill bit with boney structure of the vertebra, rotating the flexible drill bit at a slow speed, pushing the drill bit into exterior cortical bone of the boney structure of the vertebra, guiding the flexible drill bit into cancellous bone of the vertebra, receiving a tactile output generated by the flexible drill bit indicating resistance of interior cortical bone of the boney structure against the flexible drill bit, and reorienting a trajectory of the flexible drill bit toward the cancellous bone of the vertebra in reaction to the tactile output.

Claims (73)

1. A method of implanting a bone anchor in a vertebra, the method comprising:

engaging a tip of a flexible drill bit with boney structure of the vertebra;

rotating the flexible drill bit at a slow speed;

pushing the drill bit into exterior cortical bone of the boney structure of the vertebra;

guiding the flexible drill bit into cancellous bone of the vertebra;

receiving a tactile output generated by the flexible drill bit indicating resistance of interior cortical bone of the boney structure through the flexible drill bit; and

reorienting a trajectory of the flexible drill bit toward the cancellous bone of the vertebra in reaction to the tactile output;

wherein feeling vibration of the flexible drill bit comprises feeling bending of the flexible drill bit.

2. The method of claim 1 , wherein rotating the flexible drill bit at a slow speed comprises rotating the flexible drill bit with a powered driver.

3. The method of claim 2 , wherein rotating the flexible drill bit at a slow speed comprises rotating the flexible drill bit at approximately one to three revolutions per second.

4. The method of claim 2 , further comprising receiving the tactile output at the powered driver by feeling vibration of the flexible drill bit.

5. The method of claim 1 , wherein bending of the flexible drill bit comprises bending the flexible drill bit between a necked-down shaft portion and a bulbous drill tip.

6. The method of claim 1 , wherein engaging the tip of the flexible drill bit with the boney structure of the vertebra further comprises:

forming a centering hole in the exterior cortical bone of the boney structure; and

engaging the tip of the flexible drill bit with the centering hole.

7. The method of claim 1 , further comprising:

withdrawing the flexible drill bit from the boney structure to leave a bone canal; and

confirming formation of the bone canal with a ball tip probe.

8. The method of claim 1 , further comprising:

withdrawing the flexible drill bit from the boney structure to leave a bone canal;

widening the bone canal with an enlarging drill bit to a diameter of a threaded fastener of the bone anchor; and

inserting the threaded fastener into the widened bone canal.

9. The method of claim 1 , further comprising:

withdrawing the flexible drill bit from the boney structure to leave a bone canal;

widening the bone canal with a reamer to a diameter of a threaded fastener of the bone anchor; and

inserting the threaded fastener into the widened bone canal.

10. The method of claim 1 , further comprising:

withdrawing the flexible drill bit from the boney structure to leave a bone canal; and

inserting a bone anchor into the bone canal, wherein the flexible drill bit has a diameter equal to or smaller than a threaded shaft of the bone anchor.

11. The method of claim 1 , further comprising checking a depth of the flexible drill bit in the vertebra by referencing cortical bone against indicia provided on a flexible portion of the flexible drill bit.

12. The method of claim 9 , wherein inserting the bone anchor into the bone canal comprises:

coupling a sleeve to a driver shaft;

coupling the driver shaft to the bone anchor;

grasping the sleeve;

guiding the driver shaft toward the boney structure to insert the bone anchor into the bone canal;

rotating the driver shaft within the sleeve using a powered driver; and

translating the sleeve along the driver shaft to guide the bone anchor to the bone canal and to receive the tactile output of the flexible drill bit.

13. A method of implanting a pedicle screw into a pedicle of a vertebra, the method comprising:

determining a trajectory for a pedicle screw shaft into a cancellous bone canal behind a cortical bone wall to avoid interior cortical bone;

engaging a tip of a drill bit having a tapered shaft with a starting point of the trajectory on the cortical bone wall of the pedicle of the vertebra;

rotating the drill bit using rotational input from a powered driver;

pushing the powered driver to penetrate the tip of the drill bit through the cortical bone wall along the trajectory;

guiding the drill bit into the cancellous bone canal;

sensing engagement of the tip of the drill bit with the interior cortical bone; and

reorienting the drill bit along the trajectory away from the interior cortical bone,

wherein sensing engagement of the tip of the drill bit comprises receiving a tactile feedback at the powered driver;

wherein the tactile feedback comprises a vibration of the drill bit transmitted to the powered driver; and

wherein the drill bit comprises:

a first shaft portion for coupling to a driver;

a tapered portion extending from the first shaft portion at a first end to a reduced diameter at a second end; and

a second shaft portion extending from the second end of the tapered portion, the second shaft portion having a diameter of in the range of 1.0 mm to 2.0 mm;

wherein the vibration of the drill bit is caused by bending of the second shaft portion of the drill bit.

14. The method of claim 13 , further comprising producing a centering hole in the cortical bone wall at the starting point before engaging the tip of the drill bit with the cortical bone wall.

15. The method of claim 13 , wherein bending of the necked-down shaft of the drill bit causes the tip of the drill bit to deflect away from the interior cortical bone.

16. The method of claim 13 , further comprising:

withdrawing the flexible drill bit from the vertebra to leave a bone canal;

confirming formation of the bone canal with a ball tip probe; and

inserting a bone anchor into the bone canal.

17. The method of claim 1 , wherein the bending occurs proximal of the distal bulbous drill tip.

18. A method of implanting a bone anchor in a vertebra, the method comprising:

engaging a tip of a flexible drill bit with boney structure of the vertebra;

rotating the flexible drill bit at a slow speed;

pushing the drill bit into exterior cortical bone of the boney structure of the vertebra;

guiding the flexible drill bit into cancellous bone of the vertebra;

receiving a tactile output generated by the flexible drill bit indicating resistance of interior cortical bone of the boney structure through the flexible drill bit; and

reorienting a trajectory of the flexible drill bit toward the cancellous bone of the vertebra in reaction to the tactile output;

wherein inserting the bone anchor into the bone canal comprises:

coupling a sleeve to a driver shaft;

coupling the driver shaft to the bone anchor;

grasping the sleeve;

guiding the driver shaft toward the boney structure to insert the bone anchor into the bone canal;

rotating the driver shaft within the sleeve using a powered driver; and

translating the sleeve along the driver shaft to guide the bone anchor to the bone canal and to receive the tactile output of the flexible drill bit.

Assignments (7)
CHANGE OF NAME Recorded Dec 24, 2024
From: ZIMMER BIOMET SPINE, LLC
To: HIGHRIDGE MEDICAL, LLC
Reel/Frame 069772/0248 →
CHANGE OF NAME Recorded Dec 24, 2024
From: ZIMMER BIOMET SPINE, INC.
To: ZIMMER BIOMET SPINE, LLC
Reel/Frame 069772/0121 →
RELEASE OF SECURITY INTEREST Recorded Apr 2, 2024
From: JPMORGAN CHASE BANK, N.A.
To: EBI, LLC; ZIMMER BIOMET SPINE, LLC (F/K/A ZIMMER BIOMET SPINE, INC.)
Reel/Frame 066973/0833 →
GRANT OF A SECURITY INTEREST -- PATENTS Recorded Apr 1, 2024
From: ZIMMER BIOMET SPINE, LLC; EBI, LLC
To: CERBERUS BUSINESS FINANCE AGENCY, LLC
Reel/Frame 066970/0806 →
SECURITY INTEREST Recorded Mar 2, 2022
From: BIOMET 3I, LLC; EBI, LLC; ZIMMER BIOMET SPINE, INC.; ZIMMER DENTAL INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 059293/0213 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 2, 2019
From: SCHWAB, FRANK J.
To: ZIMMER BIOMET SPINE, INC.
Reel/Frame 048761/0343 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 29, 2019
From: CAPOTE, ALLISON CHRISTINE; COSTANZA, ADAM; SKAGGS, DAVID LEE
To: ZIMMER BIOMET SPINE, INC.
Reel/Frame 048745/0474 →