IP Library Granted Patent US 9,636,158
Granted Patent B2
US 9,636,158 · App. 13/802,115 · Granted May 2, 2017

Pedicle screw with reverse spiral cut and methods thereof

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Quick Facts
Patent No.
US 9,636,158
App. No.
13/802,115
Granted
May 2, 2017
Kind
B2
Abstract

A pedicle screw with reverse spiral cut that allows for increased loading on a bone and increased osteointegration through automatic and self-managed expansion after the bone screw is inserted into the bone. The bone screw may be a fixation device comprising an elongated body having proximal and distal ends, said elongated body including an outer surface adapted to penetrate and anchor within a bone, and a head affixed to the distal end of the elongated body and adapted to receive a drive component, wherein the outer surface of the elongated body comprises threads extending from the outer surface in a first direction, and further wherein at least a portion of the outer surface of the elongated body comprises a reverse spiral cut into the outer surface in a second direction.

Claims (33)

1. A fixation device comprising:

a cannulated elongated body having proximal and distal ends and a hollow shaft extending therebetween, said elongated body including an outer surface adapted to penetrate and anchor within a bone; and

a head affixed to the distal end of the elongated body and adapted to mate with a drive component;

wherein the outer surface of the elongated body comprises threads extending from the outer surface in a first direction; and

wherein at least a portion of the outer surface of the elongated body comprises a reverse spiral cut in a second direction into the threads and through the outer surface, such that the reverse spiral cut penetrates the internal structure of the bone screw to form at least one cavity within the elongated body, the cavity having an axial length and a penetration depth that exceeds the axial length.

2. The fixation device of claim 1 , wherein the threads extending from the outer surface of the elongated body in the first direction comprises a right-handed thread and wherein the reverse spiral cut into the outer surface of the elongated body in the second direction comprises a left-handed cut.

3. The fixation device of claim 1 , wherein the threads extending from the outer surface of the elongated body in the first direction comprises a left-handed thread and wherein the reverse spiral cut into the outer surface of the elongated body in the second direction comprises a right-handed cut.

4. The fixation device of claim 1 , wherein a major diameter of the elongated body is operable to be reduced under insertion torque.

5. The fixation device of claim 4 , wherein the major diameter of the elongated body is operable to expand after the insertion torque is removed.

6. The fixation device of claim 1 , wherein the reverse spiral cut is operable to allow bone ongrowth onto the outer surface of the elongated body and bone ingrowth into the internal structure of the fixation device.

7. The fixation device of claim 1 , wherein the fixation device is made from a group consisting of: (a) any biocompatible material (which biocompatible material may be treated to permit bone ingrowth or prohibit bone ingrowth); (b) a plastic; (c) a fiber; (d) a polymer; (e) a metal (e.g., a pure metal such as titanium and/or an alloy such as Ti—Al—Nb, TI-6Al-4V, stainless steel); or (f) any combination thereof.

8. The fixation device of claim 1 , wherein the reverse spiral cut does not penetrate a full thickness of the elongated body.

9. A method of inserting a fixation device into a bone, the method comprising:

drilling a pilot hole into the bone;

mating a drive component to a head of a fixation device, the fixation device comprising a cannulated elongated body having proximal and distal ends and a hollow shaft extending therebetween, said elongated body including an outer surface adapted to penetrate and anchor within a bone, wherein the outer surface of the elongated body comprises threads extending from the outer surface in a first direction, and further wherein at least a portion of the outer surface of the elongated body comprises a reverse spiral cut in a second direction into the threads and through the outer surface, such that the reverse spiral cut penetrates the internal structure of the bone screw to form at least one cavity within the elongated body, the cavity having an axial length and a penetration depth that exceeds the axial length;

rotating the drive component in a first rotational direction with rotational torque, thereby driving the fixation device into the bone, wherein a diameter of the elongated body is reduced under the rotational torque; and

removing the drive component from the head of the fixation device after the fixation device has been driven to its desired location in the bone, wherein the diameter of the elongated body expands when the rotational torque is removed.

10. The method of claim 9 , wherein the threads extending from the outer surface of the elongated body in the first direction is a right-handed thread and wherein the reverse spiral cut into the outer surface of the elongated body in the second direction is a left-handed cut.

11. The method of claim 9 , wherein the threads extending from the outer surface of the elongated body in the first direction comprises a left-handed thread and wherein the reverse spiral cut into the outer surface of the elongated body in the second direction comprises a right-handed cut.

12. The method of claim 9 , wherein the reverse spiral cut is operable to allow bone ongrowth onto the outer surface of the elongated body and bone ingrowth into the internal structure of the fixation device.

13. The method of claim 9 , wherein the fixation device is made from a group consisting of: (a) any biocompatible material (which biocompatible material may be treated to permit bone ingrowth or prohibit bone ingrowth); (b) a plastic; (c) a fiber; (d) a polymer; (e) a metal (e.g., a pure metal such as titanium and/or an alloy such as Ti—Al—Nb, TI-6Al-4V, stainless steel); or (f) any combination thereof.

14. The method of claim 9 , wherein the reverse spiral cut does not penetrate a full thickness of the elongated body.

15. The fixation device of claim 1 , wherein the fixation device is operable to be received about a flexible guide wire inserted through the hollow shaft.

16. The method of claim 9 , further comprising receiving the fixation device about a flexible guide wire inserted through the hollow shaft.

17. A fixation device comprising:

a cannulated elongated body having proximal and distal ends and a hollow shaft extending therebetween, said elongated body including an outer surface adapted to penetrate and anchor within a bone; and

a head affixed to the distal end of the elongated body and adapted to mate with a drive component;

wherein the outer surface of the elongated body comprises threads extending from the outer surface in a first direction, the threads having a first major diameter when the fixation device is in a resting state;

wherein at least a portion of the outer surface of the elongated body comprises a reverse spiral cut in a second direction into the threads and through the outer surface, such that the reverse spiral cut penetrates the internal structure of the bone screw to form at least one cavity within the elongated body;

wherein the major diameter is reduced to a second major diameter upon the application of torque, and automatically expands to return to the first major diameter when torque is removed.

18. The fixation device of claim 17 , wherein:

the second major diameter automatically expands to return to the first major diameter when torque is removed without the application of additional tools or instrumentation; and

the reverse spiral cut reduces structural stiffness by at least 25%.

Assignments (11)
RELEASE OF SECURITY INTEREST Recorded Nov 12, 2024
From: BLUE TORCH FINANCE LLC
To: ISOTIS ORTHOBIOLOGICS, INC.; ORTHOFIX US, LLC; SEASPINE, INC.; SEASPINE ORTHOPEDICS CORPORATION; SPINAL KINETICS LLC; THEKEN SPINE, LLC
Reel/Frame 069358/0110 →
SECURITY INTEREST Recorded Nov 8, 2024
From: ORTHOFIX MEDICAL INC.; ORTHOFIX US LLC; SPINAL KINETICS LLC; SEASPINE ORTHOPEDICS CORPORATION; SEASPINE, INC.; ISOTIS ORTHOBIOLOGICS, INC.; THEKEN SPINE, LLC
To: OXFORD FINANCE LLC, AS AGENT
Reel/Frame 069332/0761 →
SECURITY INTEREST Recorded Jan 10, 2024
From: ORTHOFIX US LLC
To: BLUE TORCH FINANCE LLC, AS COLLATERAL AGENT
Reel/Frame 066256/0423 →
RELEASE OF SECURITY INTEREST Recorded Nov 16, 2023
From: JPMORGAN CHASE BANK, N.A.
To: ORTHOFIX US LLC
Reel/Frame 065609/0223 →
RELEASE OF SECURITY INTEREST Recorded Nov 16, 2023
From: JPMORGAN CHASE BANK, N.A.
To: ORTHOFIX SPINAL IMPLANTS INC.
Reel/Frame 065609/0247 →
ENTITY CONVERSION Recorded Aug 19, 2021
From: ORTHOFIX INC.
To: ORTHOFIX US LLC
Reel/Frame 057247/0265 →
SECURITY INTEREST Recorded Apr 22, 2021
From: ORTHOFIX US LLC
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE ASSISTANT
Reel/Frame 056000/0153 →
MERGER Recorded Jan 14, 2021
From: ORTHOFIX SPINAL IMPLANTS INC.
To: ORTHOFIX HOLDINGS, INC.
Reel/Frame 055002/0751 →
MERGER Recorded Jan 14, 2021
From: ORTHOFIX HOLDINGS, INC.
To: ORTHOFIX INC.
Reel/Frame 055002/0841 →
CHANGE OF NAME Recorded Nov 18, 2020
From: BLACKSTONE MEDICAL, INC.
To: ORTHOFIX SPINAL IMPLANTS INC.
Reel/Frame 054458/0045 →
SECURITY INTEREST Recorded Oct 28, 2019
From: ORTHOFIX SPINAL IMPLANTS INC.
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 050839/0856 →