Orthopedic implants, particularly bone screws, and methods for producing same

• US 10,154,865 B2
• Filed: 03/03/2016
• Issued: 12/18/2018
• Est. Priority Date: 03/24/2015
• Status: Active Grant

• Current Assignee: Biotronik AG (Biotronik SE & Company KG)
• Original Assignee: Biotronik AG (Biotronik SE & Company KG)
• Inventors: Bayer, Ullrich, Lootz, Daniel
• Primary Examiner(s): Yang, Andrew
• Application Number:
  US15/059,553
• Publication Number:
  US 20160278829A1
• Time in Patent Office: 1,020 Days
• CPC Class Codes: A61B 17/846 Nails or pins, i.e. anchors without movable parts, holding by friction only, with or without structured surface A61B17/72, A61B17/86 take precedence
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 17/8625 Shanks, i.e. parts contacting bone tissue
• CPC Class Codes: A61B 17/863 with thread interrupted or changing its form along shank, other than constant taper
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 2017/561 Implants with special means for releasing a drug
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/08 Materials for coatings
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

An orthopedic implant, such as a bone screw with a self-tapping thread, is formed of a biodegradable material such as a magnesium alloy. A bioactive surface coating is provided on the implant, such as at the threading. The coating contains micro-abrasives which assist with screw/implant penetration, and/or contains microcapsules containing lubricant, wherein the microcapsules rupture from pressure and frictional heat as the implant penetrates bone.

Claims

1. An orthopedic implant having a bone-penetrating portion:

a. formed primarily of a biodegradable material,

b. having a surface coating thereon, the surface coating including microcapsules containing at least one of;

(1) a lubricant, and

(2) a bioactive substance configured to promote bone growth,

wherein the microcapsules are configured to rupture as the bone-penetrating portion penetrates bone.

2. The orthopedic implant of claim 1 wherein:

(1) the surface coating further includes micro-abrasives, and

(2) the micro-abrasives include crystalline hydroxyapatite.

3. The orthopedic implant of claim 2 wherein the micro-abrasives are needle-shaped.

4. The orthopedic implant of claim 1 wherein the bioactive substance includes bone morphogenetic proteins.

5. The orthopedic implant of claim 1 wherein the microcapsules include a biopolymer shell.

6. The orthopedic implant of claim 5 wherein the biopolymer shell is at least partially formed of a polylactide.

7. The orthopedic implant of claim 1 wherein the microcapsules and/or the micro-abrasives have a maximum dimension between 0.2 and 20 μ

m.

8. The orthopedic implant of claim 1 wherein the bone-penetrating portion is threaded, whereby the bone-penetrating portion defines a screw.

9. The orthopedic implant of claim 1 wherein the bone-penetrating portion has:

a. a length terminating in a pointed tip, and

b. threading extending from the tip,

whereby the bone-penetrating portion defines a self-tapping screw.

10. The orthopedic implant of claim 1 wherein the bone-penetrating portion is cannulated throughout at least a major portion of its length.

11. The orthopedic implant of claim 10 wherein the bone-penetrating portion has a non-circular internal passage extending throughout at least a major portion of a length of the bone-penetrating portion.

12. The orthopedic implant of claim 11 in combination with a pin configured to complementarily fit within the internal passage, whereby the pin may transmit torque to the bone-penetrating portion.

13. The orthopedic implant of claim 10 wherein the bone-penetrating portion has:

a. a maximum outer diameter between 1.5 and 5 mm, and

b. a maximum inner diameter between 0.5 and 2.5 mm.

14. The orthopedic implant of claim 10 wherein the bone-penetrating portion has:

a. a maximum outer diameter between 2.5 and 3.5 mm, and

b. a maximum inner diameter between 0.8 and 1.3 mm.

15. The orthopedic implant of claim 1 wherein the bone-penetrating portion is defined by a tube:

a. formed primarily of a magnesium alloy, and

b. having a self-tapping thread defined thereon, whereby the bone-penetrating portion defines a bone screw.

16. An orthopedic implant having a bone-penetrating portion:

a. formed primarily of a magnesium alloy,

b. defining a screw having a self-tapping thread defined thereon, wherein at least a portion of surface of the thread bears microcapsules containing at least one of;

(1) a lubricant, and

(2) a bioactive substance configured to promote bone growth,

wherein the microcapsules are configured to rupture as the bone-penetrating portion penetrates bone.

17. A method for producing the orthopedic implant of claim 16, the method including the steps of:

a. providing a member formed primarily of a magnesium alloy;

b. forming a self-tapping thread in an outer wall of the member, whereby the threaded member defines the screw;

c. forming the surface coating on at least a portion of the thread; and

d. providing the microcapsules to the surface coating.

18. The method of claim 17 wherein the step of forming the surface coating includes:

a. immersing at least a portion of the thread in a coating liquid, and

b. subsequent drying at elevated temperature.

19. The method of claim 17 wherein the microcapsules are provided to the surface coating prior to forming the surface coating on at least a portion of the thread.

20. The method of claim 17 further including the step of etching at least a portion of the thread before forming the surface coating thereon.