IP Library Granted Patent US 11,478,286
Granted Patent B2
US 11,478,286 · App. 15/614,423 · Granted Oct 25, 2022

Bone fixation devices

Inventors: Gregory J. Kowalczyk (Little Silver, NJ); Selene G. Parekh (Cary, NC); Brian R. McLaughlin (Yarmouth, ME)
Assignee: PARAGON ADVANCED TECHNOLOGIES, INC.
A61B17/8095A61B17/809A61B17/8061A61B2017/00526A61B2017/561A61B2017/565
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Quick Facts
Patent No.
US 11,478,286
App. No.
15/614,423
Granted
Oct 25, 2022
Kind
B2
Abstract

There is a fixation device for promoting fusion and/or osteosynthesis of a first bone segment and a second bone segment, comprising a bone plate portion including an outer surface, an inner surface and at least one fixation aperture extending from the outer surface to the inner surface and a bone wedge portion extending from the plate portion at a first end and a free opposite end, the bone wedge portion comprising a porous architecture configured to promote bone ingrowth, the wedge portion defining first and second engagement surfaces for engaging the first bone segment and a second bone segment, respectively. There is also a method of manufacturing a fixation device for promoting fusion and/or osteosynthesis of a first bone segment and a second bone segment, a method of promoting fusion and/or osteosynthesis of a first bone segment and a second bone segment, and a fixation kit.

Claims (31)

1. A fixation device for promoting fusion and/or osteosynthesis of a first bone segment and a second bone segment, the fixation device comprising:

a bone plate portion including an outer surface, an inner surface and at least one fixation aperture extending from the outer surface to the inner surface; and

a bone wedge portion extending from the plate portion at a first end to a free opposite end, the bone wedge portion comprising:

a framework structure comprising a plurality of interconnected substantially solid frame members that form a wedge shape frame with a plurality of cavities; and

a lattice structure extending within the cavities of the framework structure comprising a plurality of strut elements that define a plurality of pores, the plurality of strut elements and pores forming a porous architecture with a variable porosity configured to promote bone ingrowth,

wherein the wedge portion defines first and second engagement sides for engaging a first bone segment and a second bone segment, respectively, and an inner aperture that extends between the first and second engagement sides that is free of said lattice structure and configured to receive bone growth material therein to promote growth of new bone material,

wherein the porous architecture has a plurality of different layers, at least two different layers of said plurality of different layers have a different porosity, and

wherein said framework structure forms a first outer side surface at the first engagement side of the bone wedge portion, and wherein the lattice structure extends beyond the first outer side surface.

2. The fixation device as in claim 1 , wherein the lattice structure has at least one of a variable pattern or a substantially consistent pattern of the plurality of strut elements and pores.

3. The fixation device as in claim 1 , wherein the porous architecture comprises at least one cell that is shaped in at least one of a honeycomb or diamond shaped pattern.

4. The fixation device as in claim 1 , wherein said framework structure forms a second outer side surface at the second engagement side of the bone wedge portion, and wherein the lattice structure extends beyond the second outer side surface.

5. The fixation device as in claim 4 , wherein the first and second outer side surfaces forms first and second outer planes.

6. The fixation device as in claim 4 , wherein the lattice structure forms at least two different planar surfaces, wherein said at least two different planar surfaces extend substantially transverse to each other.

7. The fixation device as in claim 1 , wherein the lattice structure forms at least one surface that extends beyond the first outer side surface in a rounded manner.

8. The fixation device as in claim 1 , wherein the bone wedge portion is tapered in shape from the first end to the free opposite end.

9. The fixation device as in claim 1 , wherein the plate portion and the wedge portion are of one-piece construction.

10. The fixation device of claim 1 , further comprising at least one fixation aperture that extends into the wedge portion to one of the first and second engagement sides.

11. The fixation device of claim 1 , wherein the inner aperture of the wedge portion is bounded by the framework structure.

12. The fixation device as in claim 1 , wherein said bone wedge portion has a substantially rough outer surface formed by the lattice structure.

13. The fixation device of claim 1 , further including at least one bone fixation member extending through the at least one fixation aperture.

14. The fixation device of claim 1 , wherein the plate portion includes at least one open aperture extending from the outer surface to the wedge portion.

15. A bone wedge comprising:

a frame portion comprising a plurality of interconnected substantially solid frame members that form a plurality of cavities; and

a porous portion extending from within the cavities of the frame portion, the porous portion comprising a lattice structure comprising a plurality of strut elements that define a plurality of pores, the plurality of strut elements and pores forming a porous architecture configured to promote bone ingrowth, the porous portion defining opposing first and second bone engagement surfaces for engaging a first bone segment and a second bone segment, respectively, wherein the porous architecture has a plurality of different layers, wherein at least two different layers of said plurality of different layers have a different porosity, and wherein the first and second bone engagement surfaces taper toward each other as they extend from a first end to a second end of the bone wedge,

wherein the bone wedge defines an inner aperture that extends between the first and second engagement surfaces that is free of said lattice structure and configured to receive bone growth material therein to promote growth of new bone material, and

wherein the frame portion forms a first outer side on the same side of the bone wedge as the first engagement surface of the porous portion that is recessed from the first engagement surface.

16. The bone wedge as in claim 15 , wherein the first outer side of wherein the first outer side of the frame forms at least a first outer plane.

17. The bone wedge as in claim 16 , wherein the lattice structure forms at least two different planar surfaces, wherein said at least two different planar surfaces extend substantially transverse to each other.

18. The bone wedge as in claim 16 , wherein the lattice structure forms at least one surface that extends beyond the first outer plane in a rounded manner.

19. The bone wedge as in claim 15 , further comprising at least one fixation aperture that extends into the porous portion.

20. The fixation device as in claim 15 , wherein the frame portion forms a second outer side surface on the same side of the bone wedge as the second engagement surface of the porous portion that is recessed from second engagement surface.

Assignments (9)
RELEASE OF SECURITY INTEREST Recorded Apr 22, 2025
From: ARES CAPITAL CORPORATION
To: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
Reel/Frame 070908/0038 →
RELEASE OF INTELLECTUAL PROPERTY SECURITY INTEREST AT REEL/FRAME NO. 56970/0320 Recorded Nov 10, 2023
From: MIDCAP FUNDING IV TRUST, AS AGENT
To: PARAGON ADVANCED TECHNOLOGIES, INC.
Reel/Frame 065549/0940 →
RELEASE OF INTELLECTUAL PROPERTY SECURITY INTEREST AT REEL/FRAME NO. 56950/0847 Recorded Nov 10, 2023
From: MIDCAP FINANCIAL TRUST, AS AGENT
To: PARAGON ADVANCED TECHNOLOGIES, INC.
Reel/Frame 065549/0963 →
SECURITY INTEREST Recorded Nov 2, 2023
From: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
To: ARES CAPITAL CORPORATION
Reel/Frame 065448/0214 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 6, 2022
From: MCLAUGHLIN, BRIAN R.
To: ADDITIVE ORTHOPAEDICS, LLC
Reel/Frame 058581/0867 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT (REVOLVING LOAN) Recorded Jul 19, 2021
From: PARAGON ADVANCED TECHNOLOGIES, INC.
To: MIDCAP FUNDING IV TRUST
Reel/Frame 056970/0320 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT (TERM LOAN) Recorded Jul 19, 2021
From: PARAGON ADVANCED TECHNOLOGIES, INC.
To: MIDCAP FINANCIAL TRUST
Reel/Frame 056950/0847 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 4, 2021
From: ADDITIVE ORTHOPAEDICS, LLC
To: PARAGON ADVANCED TECHNOLOGIES, INC.
Reel/Frame 056445/0470 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 22, 2021
From: KOWALCZYK, GREGORY J.; PAREKH, SELENE G.
To: ADDITIVE ORTHOPAEDICS, LLC
Reel/Frame 056009/0456 →
Continuity (4)
Provisional Application 62425363 · Nov 22, 2016
Provisional Application 62404923 · Oct 6, 2016
Provisional Application 62345536 · Jun 3, 2016
Related Publication 20170360488A1 · Dec 21, 2017
Cited By (2)
US 12,653,680 US 12,667,461