IP Library Granted Patent US 11,647,998
Granted Patent B2
US 11,647,998 · App. 17/179,883 · Granted May 16, 2023

Tissue dilation system and methods of use

Inventors: Faheem Sandhu (Washington, DC); Amjad Anaizi (Washington, DC); Scott Koysh (Berryville, VA)
Assignee: K2M, INC.
A61B17/0218A61B17/02A61B17/0206A61B17/3468A61B17/7082A61B17/86A61B17/34A61B17/3472A61B17/885
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Quick Facts
Patent No.
US 11,647,998
App. No.
17/179,883
Granted
May 16, 2023
Kind
B2
Abstract

Disclosed herein are systems and methods for dilating tissue for placement of a pedicle screw without the use of guide wires. The tissue dilation system includes, generally, a stylet and trocar which are used for the initial placement of the tissue dilation system. A second dilator is passed over the first. A second dilator is passed over the first dilator, and further includes a serrated edge for engaging with a target surface. The second dilator may be secured to the target surface by the serrated edge alone, or may additional be secured using one or more temporary fixation pins, which operably couple to the second dilator.

Claims (29)

1. A tissue dilation system comprising:

a trocar having an elongated body with a bore extending therethrough, a distal region of the elongated body having an engagement member for anchoring into bone and including a handle portion configured to be removably attached to the trocar;

a stylet insertable into the bore and configured to threadably couple with the handle portion; and

a first dilator having an elongated body and translatable over an outer surface of the trocar.

2. The tissue dilation system of claim 1 , wherein the engagement member of the trocar includes a helical thread for anchoring into bone.

3. The tissue dilation system of claim 1 , wherein the stylet is configured such that a distal region of the stylet extends distally beyond the distal region of the trocar when the stylet is threadably coupled with the handle portion.

4. The tissue dilation system of claim 1 , further including a retractor assembly including a pedicle screw, a retractor, a screw inserter, and a collar; wherein a distal end of the retractor is coupled to the pedicle screw such that the retractor extends proximally from the pedicle screw; wherein a distal end of the screw inserter is engageable with the pedicle screw while being received within the retractor so as to advance the pedicle screw into bone; and wherein the collar is configured to stabilize a proximal region of the retractor with respect to the screw inserter.

5. The tissue dilation system of claim 4 , wherein the collar has a tapered distal end configured to be inserted into the proximal region of the retractor.

6. The tissue dilation system of claim 4 , further including an outer dilator having an elongated body that is translatable over an outer surface of the first dilator, the outer dilator being configured to receive the retractor assembly therein as the retractor assembly advances distally relative to the outer dilator.

7. A method for dilating tissue comprising:

inserting a stylet into a bore that extends through a trocar between proximal and distal regions thereof, such that a distal region of the stylet extends beyond the distal region of the trocar;

engaging a target surface of a bone with the distal region of the trocar so as to anchor the trocar into the bone at the target surface;

removing the stylet from the bore of the trocar; and

translating a first dilator over the trocar towards the bone at the target surface.

8. The method of claim 7 , further including removably attaching a handle to the trocar.

9. The method of claim 8 , further including detachably securing the stylet to the handle.

10. The method of claim 7 , further including removing the trocar from the target surface.

11. The method of claim 7 , further including translating an outer dilator towards the bone at the target surface while the first dilator is received within a bore of the outer dilator.

12. The method of claim 11 , further including removing the first dilator from the bore of the outer dilator after the step of translating the outer dilator towards the bone.

13. The method of claim 11 , further including advancing a pedicle screw into the bore of the outer dilator and anchoring the pedicle screw to the bone at the target surface, the pedicle screw having a distal end of a retractor coupled thereto such that the retractor extends proximally from the pedicle screw, the retractor defined by first and second longitudinal blades spaced apart from one another.

14. The method of claim 13 , wherein the steps of advancing and anchoring the pedicle screw are performed with a screw inserter engaged with the pedicle screw while the screw inserter is received within the retractor and while a collar is connected to a proximal region of the retractor so as to stabilize the first and second blades at the proximal region of the retractor.

15. The method of claim 14 , further including inserting a tapered distal end of the collar into the proximal region of the retractor.

16. The method of claim 14 , wherein the step of advancing the pedicle screw into the bore of the outer dilator includes the collar moving into engagement with a proximal end of the outer dilator during advancement of the pedicle screw and the retractor, so as to cause the collar to disconnect from the proximal region of the retractor.

17. A method for dilating tissue comprising:

inserting a stylet into a bore that extends through a trocar between proximal and distal regions thereof, such that a distal region of the stylet extends beyond the distal region of the trocar;

engaging a target surface of a bone with the distal region of the trocar;

removing the stylet from the bore of the trocar;

translating a first dilator over the trocar towards the bone at the target surface so that the first dilator is received within a bore of an outer dilator; and

translating the outer dilator towards the bone at the target surface while the first dilator is received within a bore of the outer dilator, wherein translating the first dilator and the outer dilator towards the bone occur simultaneously.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 8, 2025
From: STRYKER EUROPEAN HOLDINGS I, LLC; STRYKER EUROPEAN OPERATIONS HOLDINGS LLC; STRYKER CORPORATION; STRYKER EUROPEAN OPERATIONS LIMITED; HOWMEDICA OSTEONICS CORP.
To: VB SPINE US OPCO LLC
Reel/Frame 073031/0754 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 23, 2025
From: STRYKER CORPORATION
To: VB SPINE US OPCO LLC
Reel/Frame 072926/0540 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 12, 2025
From: K2M, INC.
To: STRYKER CORPORATION
Reel/Frame 071271/0170 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 8, 2021
From: SANDHU, FAHEEM; ANAIZI, AMJAD; KOYSH, SCOTT
To: K2M, INC.
Reel/Frame 055876/0174 →