IP Library Granted Patent US 11,883,038
Granted Patent B2
US 11,883,038 · App. 17/248,454 · Granted Jan 30, 2024

Implants, devices, systems, kits and methods of implanting

Inventors: Albert Dacosta (Lone Tree, CO); Benjamin Majors (Englewood, CO); Jens Cole (Golden, CO); Frank S. Bono (Castle Rock, CO)
Assignee: Paragon 28, Inc.
A61B17/152A61B17/1775A61B17/8095A61F2/4225A61F2/4606A61F2/4603A61F2002/30131A61F2002/30281A61F2002/4238A61F2002/4681A61F2002/4687
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Quick Facts
Patent No.
US 11,883,038
App. No.
17/248,454
Granted
Jan 30, 2024
Kind
B2
Abstract

Implants, devices, instruments, kits and methods for correcting bone deformities in the foot are disclosed. Specifically, implants, devices, instruments, kits and methods used for lower extremity osteotomy procedures are disclosed.

Claims (49)

1. A surgical method, comprising:

performing an osteotomy procedure to form an opening in a bone, wherein the bone is a calcaneus;

selecting an implant for insertion into the opening;

coupling the implant to an insertion instrument;

inserting the implant into the opening;

removing the insertion instrument from the implant; and

completing the osteotomy procedure, wherein the implant comprises:

a body having a first end and a second end, with an opening extending through the body from a proximal surface to a distal surface, wherein the implant further comprises a three-dimensional matrix positioned in the opening and comprises:

at least one linear member extending across the opening and coupled to the body; and

at least one spike coupled to the at least one linear member and extending out from the body;

a first leg extending from a first side of the body, wherein the first leg includes an exterior surface, wherein the exterior surface is curved as the first leg extends between the first end and the second end; and

a second leg extending from a second side of the body, wherein the second leg is wider than the first leg, wherein the second leg includes an exterior surface, wherein the exterior surface is angled as the second leg extends between the first end and the second end.

2. The surgical method of claim 1 , further comprising inserting one or more trial sizers into the opening in the bone to determine an approximate size of the implant for a desired anatomical correction.

3. The surgical method of claim 2 , wherein the one or more trial sizers comprise a geometry that corresponds to the geometry of the implant.

4. The surgical method of claim 1 , wherein the insertion instrument comprises:

a body having a first end and a second end, wherein an impact portion is positioned at the first end;

a nose portion, wherein the nose portion is positioned at the second end and comprises:

a contact surface shaped to match a shape of a first end of the implant;

an alignment pin extending from the contact surface to mate with an alignment opening in the implant; and

a securement opening; and

a securement member extending through the securement opening and projecting past the contact surface to couple to a securement opening in the implant.

5. The surgical method of claim 1 , further comprising coupling a fastener guide system with the implant, wherein the fastener guide system comprises;

an alignment arm with a first end and a second end, the alignment arm comprising:

a base member; and

a first arm coupled to the base member at the second end;

an insertion guide removably coupled to the first end of the alignment arm; and

a fixation member removably coupled to the second end of the alignment arm and extending through the alignment arm to engage the implant.

6. The surgical method of claim 5 , further comprising inserting the insertion guide through the fastener guide system at a desired trajectory.

7. The surgical method of claim 6 , further comprising inserting a k-wire through the insertion guide and advancing the k-wire across the osteotomy site.

8. The surgical method of claim 7 , further comprising removing the insertion guide and the fastener guide system.

9. The surgical method of claim 8 , further comprising inserting a cannulated fastener over the k-wire and advancing the fastener across the osteotomy site through the implant.

10. The surgical method of claim 9 , further comprising removing the k-wire from the osteotomy site.

11. The surgical method of claim 10 , further comprising performing an incision to expose the osteotomy site.

12. The surgical method of claim 11 , further comprising obtaining a resection guide and coupling the resection guide to the implant, wherein the resection guide comprises:

the resection guide comprises:

a central portion with a first side opposite a second side and a first end opposite a second end;

at least one first slot positioned on the first side of the central portion;

at least one second slot positioned on the second side of the central portion;

a first arm extending away from the first end on a first side and angled with respect to the central portion;

a second arm extending away from the first end on a second side and angled with respect to the central portion;

a first leg extending from the second end on the first side and angled with respect to the central portion; and

a second leg extending from the second end on the second side and angled with respect to the central portion;

wherein the at least one first slot and at least one second slot extend along the entire length of the central portion and into at least a portion of the at least one of the first leg and the second leg.

13. The surgical method of claim 12 , further comprising inserting a cutting instrument through the at least one first slot of the resection guide based on a side of the implant and cutting a first portion of the bone surrounding the implant.

14. The surgical method of claim 13 , further comprising inserting the cutting instrument through the at least one second slot of the resection guide that corresponds to the at least one first slot of the resection guide and cutting a second portion of the bone surrounding the implant.

15. The surgical method of claim 14 , further comprising decoupling the resection guide from the implant and removing the implant from the osteotomy site.

16. The surgical method of claim 15 , wherein the implant is a first implant, and wherein the method further comprises obtaining a second implant, wherein the second implant is of a different size than the first implant.

17. The surgical method of claim 12 , wherein the at least one first slot and the at least one second slot of the resection guide form bi-angled openings, and wherein the angle of the at least one first slot matches an angle of the proximal surface of the implant and the angle of the at least one second slot matches an angle of the distal surface of the implant.

18. The surgical method of claim 1 , wherein the body of the implant includes a dorsal to plantar taper and a medial to lateral taper.

Assignments (7)
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. 62354/0016 Recorded Nov 11, 2023
From: MIDCAP FUNDING IV TRUST, AS AGENT
To: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
Reel/Frame 065548/0364 →
RELEASE OF INTELLECTUAL PROPERTY SECURITY INTEREST AT REEL/FRAME NO. 62354/0006 Recorded Nov 10, 2023
From: MIDCAP FINANCIAL TRUST, AS AGENT
To: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
Reel/Frame 065548/0313 →
SECURITY INTEREST Recorded Nov 2, 2023
From: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
To: ARES CAPITAL CORPORATION
Reel/Frame 065448/0214 →
SECURITY AGREEMENT SUPPLEMENT (REVOLVING)) Recorded Jan 11, 2023
From: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
To: MIDCAP FUNDING IV TRUST
Reel/Frame 062354/0016 →
SECURITY AGREEMENT SUPPLEMENT (TERM) Recorded Jan 11, 2023
From: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
To: MIDCAP FINANCIAL TRUST
Reel/Frame 062354/0006 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 20, 2021
From: DACOSTA, ALBERT; MAJORS, BENJAMIN; COLE, JENS; BONO, FRANK S.
To: PARAGON 28, INC.
Reel/Frame 056914/0881 →
Continuity (4)
Division 15920887 · Mar 14, 2018
Continuation PCTUS2018000076 · Feb 16, 2018
Provisional Application 62459772 · Feb 16, 2017
Related Publication 20210145457A1 · May 20, 2021
Cited By (4)
US 1,105,184 US 1,107,226 US 1,117,376 US 1,117,756