IP Library Granted Patent US 11,026,732
Granted Patent B2
US 11,026,732 · App. 16/512,807 · Granted Jun 8, 2021

Ligament fixation system, implants, and devices with a compression cap, and methods of use

Inventors: Randy Allard (Golden, CO); Albert Dacosta (Lone Tree, CO); Sean Gill (Denver, CO); Peter Andrew Mladinich (Lakewood, CO); Richard David Hunt (Arvada, CO); Frank S. Bono (Castle Rock, CO); Benjamin Majors (Englewood, CO)
Assignee: Paragon 28, Inc.
A61B17/8685A61B17/863A61B17/8645A61F2/0805A61F2/0811A61B2017/681A61F2002/0829A61F2002/0882A61F2210/0004A61F2220/0033A61F2220/0075A61F2250/0012
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Quick Facts
Patent No.
US 11,026,732
App. No.
16/512,807
Granted
Jun 8, 2021
Kind
B2
Abstract

Implants, devices, systems, and methods for achieving ligament fixation are disclosed. An implant comprises a cap member comprising an internally threaded opening extending from a first end thereof, an anchor portion comprising a first end that defines a tip of the implant and external threads, and a coupling portion extending between the cap member and the anchor portion. The coupling portion of the implant includes an externally threaded portion threadably coupled within the internally threaded opening of the cap member. The cap member of the implant is longitudinally moveable along the coupling portion. Insertion instruments for inserting an implant for ligament fixation are also disclosed. Methods of using an implant for achieving ligament fixation are also disclosed.

Claims (55)

1. An implant, comprising:

a cap member comprising an internally threaded opening extending from a first end thereof;

an anchor portion comprising external threads and a first end that defines a tip of the implant; and

a coupling portion extending between the cap member and the anchor portion, the coupling portion including an externally threaded portion threadably coupled within the internally threaded opening of the cap member,

wherein the cap member is longitudinally moveable along the coupling portion;

wherein the coupling portion comprises a breakaway portion with a circumferential groove;

wherein the coupling portion comprises outer planar surfaces circumferentially arranged about the coupling portion.

2. The implant of claim 1 , wherein the cap member comprises:

a shaft portion that defines the first end of the cap member and includes the internally threaded opening; and

an enlarged head portion extending from the shaft portion that defines a second end of the cap member, the second end of the cap member defining a free end of the implant that opposes the tip of the implant.

3. The implant of claim 2 , wherein the cap member further comprises a noncircular drive opening extending from the second end thereof.

4. The implant of claim 1 , wherein the anchor portion comprises:

a shaft portion with a first end portion, a second end portion and external threads; a proximal coupling portion extending from the first end portion of the shaft portion of the anchor member to the coupling portion; and

a distal portion extending from the second end portion of the shaft portion of the anchor member and defining the first end of the anchor portion.

5. The implant of claim 4 , wherein the distal portion comprises a plurality of circumferentially arranged longitudinally extending flutes positioned proximate to the first end of the anchor portion.

6. The implant of claim 4 , wherein the coupling portion comprises:

a coupling member coupled to the anchor portion; and

an end member coupled to the coupling member,

wherein the coupling member and the end member are separate and distinct components.

7. The implant of claim 6 , wherein the coupling member is made of a bioresorbable material.

8. The implant of claim 6 , wherein the end member comprises the externally threaded portion threaded portion threadably coupled within the internally threaded opening of the cap member, wherein the cap member is longitudinally moveable along the end member of the coupling portion.

9. The implant of claim 6 , wherein the anchor portion comprises a second engagement end that opposes the first end thereof and engages a first engagement end of the coupling member, wherein each of the second engagement end of the anchor portion and the first engagement end of the coupling member include at least one projection and at least one recess, and wherein the at least one projection of the second engagement end of the anchor portion is positioned within the at least one recess of the first engagement end of the coupling member, and the at least one projection of the first engagement end of the coupling member is positioned within the at least one recess of the second engagement end of the anchor portion.

10. The implant of claim 9 , wherein the coupling member comprises a second engagement end the opposes the first engagement end thereof and engages a first engagement end of the end member, wherein each of the second engagement end of the coupling member and the first engagement end of the end member include at least one projection and at least one recess, and wherein the at least one projection of the second engagement end of the coupling member is positioned within the at least one recess of the first engagement end of the coupling member is positioned within the at least one recess of the second engagement end of the coupling member.

11. The implant of claim 6 , wherein the end member comprises a torque application feature comprising outer planar surfaces circumferentially arranged about the end member.

12. The implant of claim 6 , wherein the anchor portion, the coupling member and the end member each include a cannulated opening that are aligned to form a through hole, and wherein the implant further comprises a tension member positioned within the through hole and including a first portion coupled to the end member and a second portion coupled to the anchor member.

13. The implant of claim 12 , wherein the tension member comprises an elastic suture.

14. The implant of claim 12 , wherein the anchor member further comprises at least one transverse opening extending from an exterior surface portion of the anchor member to the cannulated opening thereof, and at least one pin positioned within the at least one transverse opening and extending into the cannulated opening and in abutment with the second portion of the tension member to couple the second portion of the tension member and the anchor portion together.

15. The implant of claim 14 , wherein the anchor further comprises at least one slot extending at least partially through the anchor member from an interior surface of the anchor member that forms the cannulated opening thereof, the at least one slot being aligned with the at least one transverse opening such that the at least one pin positioned within the at least one transverse opening deforms the second portion of the tension member into the at least one slot to couple the second portion of the tension member and the anchor portion together.

16. A system, comprising:

an implant, comprising:

a cap member comprising an internally threaded opening extending from a first end thereof;

an anchor portion comprising external threads and a first end that defines a tip of the implant; and

a coupling portion extending between the cap member and the anchor portion, the coupling portion including an externally threaded portion threadably coupled within the internally threaded opening of the cap member,

wherein the cap member is longitudinally moveable along the coupling portion;

wherein the coupling portion comprises a breakaway portion with a circumferential groove;

wherein the coupling portion comprises outer planar surfaces circumferentially arranged about the coupling portion;

an insertion instrument for coupling to the implant and rotating the implant about an axis of the implant; and

a plate with at least one aperture extending therethrough, wherein the entirety of the anchor portion, the entirety of the coupling portion and only a portion of the cap member are configured to pass through the at least one aperture of the implant.

17. An implant, comprising:

a cap member comprising an internally threaded opening extending from a first end thereof,

an anchor portion comprising external threads and a first end that defines a tip of the implant; and

a coupling portion extending between the cap member and the anchor portion, the coupling portion including an externally threaded portion threadably coupled within the internally threaded opening of the cap member, wherein the cap member is longitudinally moveable along the coupling portion;

a shaft portion with a first end portion, a second end portion and external threads; a proximal coupling portion extending from the first end portion of the shaft portion of the anchor member to the coupling portion; a distal portion extending from the second end portion of the shaft portion of the anchor member and defining the first end of the anchor portion;

wherein the coupling portion comprises: a coupling member coupled to the anchor portion; and an end member coupled to the coupling member, wherein the coupling member and the end member are separate and distinct components;

wherein the anchor portion comprises a second engagement end that opposes the first end thereof and engages a first engagement end of the coupling member, wherein each of the second engagement end of the anchor portion and the first engagement end of the coupling member include at least one projection and at least one recess, and wherein the at least one projection of the second engagement end of the anchor portion is positioned within the at least one recess of the first engagement end of the coupling member, and the at least one projection of the first engagement end of the coupling member is positioned within the at least one recess of the second engagement end of the anchor portion.

18. A system, comprising:

an implant, comprising:

a cap member comprising an internally threaded opening extending from a first end thereof;

an anchor portion comprising external threads and a first end that defines a tip of the implant; and

a coupling portion extending between the cap member and the anchor portion, the coupling portion including an externally threaded portion threadably coupled within the internally threaded opening of the cap member, wherein the cap member is longitudinally moveable along the coupling portion;

a shaft portion with a first end portion, a second end portion and external threads; a proximal coupling portion extending from the first end portion of the shaft portion of the anchor member to the coupling portion; a distal portion extending from the second end portion of the shaft portion of the anchor member and defining the first end of the anchor portion;

wherein the coupling portion comprises: a coupling member coupled to the anchor portion; and an end member coupled to the coupling member, wherein the coupling member and the end member are separate and distinct components;

wherein the anchor portion comprises a second engagement end that opposes the first end thereof and engages a first engagement end of the coupling member, wherein each of the second engagement end of the anchor portion and the first engagement end of the coupling member include at least one projection and at least one recess, and wherein the at least one projection of the second engagement end of the anchor portion is positioned within the at least one recess of the first engagement end of the coupling member, and the at least one projection of the first engagement end of the coupling member is positioned within the at least one recess of the second engagement end of the anchor portion;

an insertion instrument for coupling to the implant and rotating the implant about an axis of the implant; and

a plate with at least one aperture extending therethrough, wherein the entirety of the anchor portion, the entirety of the coupling portion and only a portion of the cap member are configured to pass through the at least one aperture of the implant.

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. 56320/0335 Recorded Nov 10, 2023
From: MIDCAP FINANCIAL TRUST, AS AGENT
To: PARAGON 28, INC.
Reel/Frame 065548/0284 →
RELEASE OF INTELLECTUAL PROPERTY SECURITY INTEREST AT REEL/FRAME NO. 56320/0316 Recorded Nov 10, 2023
From: MIDCAP FINANCIAL TRUST, AS AGENT
To: PARAGON 28, INC.
Reel/Frame 065548/0338 →
SECURITY INTEREST Recorded Nov 2, 2023
From: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
To: ARES CAPITAL CORPORATION
Reel/Frame 065448/0214 →
SECURITY INTEREST (TERM) Recorded May 20, 2021
From: PARAGON 28, INC.
To: MIDCAP FINANCIAL TRUST, AS ADMINISTRATIVE AGENT
Reel/Frame 056320/0335 →
RELEASE OF SECURITY INTEREST Recorded May 20, 2021
From: ZIONS BANCORPORATION, N.A. DBA VECTRA BANK COLORADO, AS SUCCESSOR-BY-MERGER TO ZB, N.A. DBA VECTRA BANK COLORADO
To: PARAGON 28, INC.
Reel/Frame 056320/0224 →
SECURITY INTEREST (REVOLVING) Recorded May 20, 2021
From: PARAGON 28, INC.
To: MIDCAP FINANCIAL TRUST, AS ADMINISTRATIVE AGENT
Reel/Frame 056320/0316 →
SECURITY INTEREST Recorded Nov 19, 2020
From: PARAGON 28, INC.
To: ZIONS BANCORPORATION, N.A. DBA VECTRA BANK COLORADO
Reel/Frame 054484/0600 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 16, 2019
From: ALLARD, RANDY; DACOSTA, ALBERT; GILL, SEAN; MLADINICH, PETER ANDREW; HUNT, RICHARD DAVID; BONO, FRANK S.; MAJORS, BENJAMIN
To: PARAGON 28, INC.
Reel/Frame 049765/0729 →
Continuity (3)
Continuation PCTUS2018057554 · Oct 25, 2018
Provisional Application 62576946 · Oct 25, 2017
Related Publication 20190336190A1 · Nov 7, 2019