Bone fixation systems, devices, and methods

Patent metadata

Field	Value
Publication number	US-10517659-B2
Application number	US-201916255244-A
Country	US
Kind code	B2
Filing date	Jan 23, 2019
Priority date	Apr 24, 2015
Publication date	Dec 31, 2019
Grant date	Dec 31, 2019

Abstract

Various systems, devices, and methods for improved bone fixation are disclosed. The system includes a bone plate and a plurality of variable angle screws. The bone plate comprises titanium and the variable angle screws comprise a TiMo alloy treated to have a hardness of at least 35 HRC. A method of manufacturing an implant is also disclosed. The method includes machining the TiMo alloy having a first hardness value and a first % elongation to form an implant; heat treating, quenching, and ageing the bone fastener to have a second hardness value that can be greater than the first hardness value and a second % elongation that can be both less than the first % elongation and greater than about 3% elongation.

First claim

What is claimed is:

1. A bone fixation system, comprising:
a bone plate defining a threaded screw hole that extends through the bone plate along a threaded screw hole axis; and
a variable angle screw configured to attach to the bone plate by engaging the threaded screw hole of the bone plate, the variable angle screw comprising a threaded head having M threads that extend along at least a portion of a length of the threaded head, the variable angle screw comprising a shaft that extends from a distal end of the threaded head, the variable angle screw being formed from a TiMo alloy treated to have a hardness of at least 35 HRC, the variable angle screw being configured to lockingly engage the threaded screw hole in the bone plate such that when lockingly engaged, the M threads of the threaded head cut into N internal threads of the threaded screw hole at a selected angle relative to the threaded screw hole axis.

2. The bone fixation system of claim 1 , wherein the selected angle is between 0 degrees and 30 degrees relative to the threaded screw hole axis.

3. The bone fixation system of claim 1 , wherein N does not equal M.

4. The bone fixation system of claim 1 , wherein N equals three and M equals two.

5. The bone fixation system of claim 1 , wherein the N internal threads of the threaded head comprise two threads having thread starts that are spaced 180 degrees apart about a proximal end of the threaded head.

6. The bone fixation system of claim 1 , wherein at least a portion of at least one of a major diameter or a minor diameter of the threaded head is tapered from a proximal end of the threaded head to the distal end of the threaded head.

7. The bone fixation system of claim 6 , wherein the major diameter of the threaded head circumscribes a sphere.

8. The bone fixation system of claim 1 , wherein each of the M threads of the threaded head has a thread angle between 90 degrees and 110 degrees.

9. The bone fixation system of claim 1 , wherein each of the M threads of the threaded head has a thread angle of 100 degrees.

10. The bone fixation system of claim 1 , wherein each of the N threads of the threaded screw hole has a thread angle of 60 degrees.

11. The bone fixation system of claim 1 , wherein at least one of a major diameter or a minor diameter of a distal portion of the threaded screw hole is tapered towards a distal end of the threaded screw hole.

12. The bone fixation system of claim 11 , wherein at least one of the major diameter or the minor diameter of the threaded screw hole circumscribes a frustocone.

13. The bone fixation system of claim 1 , wherein the shaft of the variable angle screw is at least one of self-tapping, self-drilling, or at least partially threaded.

14. The bone fixation system of claim 13 , wherein:
at least one of a major diameter or a minor diameter of at least a distal portion of the shaft is tapered to a first point on the distal end of the shaft, the first point shaped to have a point angle between 60 degrees and 120 degrees; and
the shaft further includes a helical thread extending from a second point proximate the distal end of the shaft toward a proximal end of the shaft, the helical thread having a pitch between 0.5 mm and 1.25 mm.

15. The bone fixation system of claim 14 , wherein the distal portion of the shaft further comprises a drill portion, the drill portion including a blade that includes a cutting lip and a relief surface trailing from the cutting lip, the cutting lip and relief surface defining an acute angle between the cutting lip and relief surface.

16. The bone fixation system of claim 15 , wherein the drill portion includes two blades that define a flute.

17. The bone fixation system of claim 1 , wherein the TiMo alloy is Ti-15Mo.

18. The bone fixation system of claim 1 , wherein the bone plate is formed from titanium.

19. A method for engaging a bone fastener, the method comprising:
drilling a pilot hole through a near cortex of a bone;
penetrating the near cortex with a bone fastener via the pilot hole, the bone fastener being formed from a TiMo alloy treated to have a hardness of at least 35 HRC, the bone fastener including a head, the head including two threads having thread starts that are spaced 180 degrees apart about a proximal end of the head, at least a portion of at least one of a major diameter or a minor diameter of the threaded head tapering from the proximal end to a distal end thereof, the thread angle of each of the two threads being at least 90 degrees, the bone fastener further including a shaft that extends from the distal end of the head, the shaft including a helical thread that extends from a point proximate a distal end of the shaft towards a proximal end of the shaft, at least one of a major diameter or a minor diameter of at least a distal portion of the shaft tapering to a point on the distal end of the shaft, the distal portion of the shaft further including a drill portion, the drill portion including a blade, the blade including a cutting lip and a relief surface trailing from the cutting lip; and
drilling the bone fastener through at least a portion of the far cortex of the bone, such that a portion of the shaft threadedly engaged with the near cortex and the distal portion of the shaft cooperate to drive the shaft into the far cortex.

20. A bone fixation system, comprising:
a bone fastener formed from a TiMo alloy and treated to have a hardness of at least 35 HRC,
the bone fastener including a head,
the head including two threads having thread starts that are spaced 180 degrees apart about a proximal end of the head,
at least a portion of at least one of a major diameter or a minor diameter of the threaded head tapering from the proximal end to a distal end thereof,
the thread angle of each of the two threads being at least 90 degrees,
the bone fastener further including a shaft that extends from the distal end of the head,
the shaft including a helical thread that extends from a point proximate a distal end of the shaft towards a proximal end of the shaft,
at least one of a major diameter or a minor diameter of at least a distal portion of the shaft tapering to a point on the distal end of the shaft,
the distal portion of the shaft further including a drill portion,
the drill portion including a blade,
the blade including a cutting lip and a relief surface trailing from the cutting lip.

Assignees

• Biomet Mfg Llc

Inventors

• Sixto Robert
• Kortenbach Juergen A
• Perepezko Elizabeth

Classifications

• C22F1/002

  by rapid cooling or quenching; cooling agents used therefor · CPC title

• A61B17/8605

  Heads, i.e. proximal ends projecting from bone · CPC title

• C22F1/183

  of titanium or alloys based thereon · CPC title

• A61B17/8057 Primary

  the interlocking form comprising a thread · CPC title

• A61B2017/00526

  Methods of manufacturing · CPC title