IP Library Granted Patent US 11,786,282
Granted Patent B2
US 11,786,282 · App. 17/340,899 · Granted Oct 17, 2023

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 (Parker, CO); Richard David Hunt (Arvada, CO); Frank S. Bono (Castle Rock, CO); Benjamin Majors (Englewood, CO)
Assignee: Paragon 28, Inc.
A61B17/8685A61B17/683A61B17/842A61B17/863A61B17/8645A61F2/0805A61F2/0811A61B2017/681A61F2002/0829A61F2002/0882A61F2210/0004A61F2220/0033A61F2220/0075A61F2250/0012
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 11,786,282
App. No.
17/340,899
Granted
Oct 17, 2023
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 (48)

1. A method for inserting an implant, comprising:

obtaining the implant, wherein the implant comprises:

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 configured to be 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;

engaging the coupling portion with an insertion instrument;

inserting the coupled coupling portion and anchor portion into a patient to position the coupling portion at least partially in a first bone and the anchor portion in a second bone; and

threadably engaging the externally threaded portion of the coupling portion within the internally threaded opening of the cap member and longitudinally translating the cap member along the coupling portion toward the anchor portion to such an extent that the cap member engages the first bone and the implant compresses the first and second bones together,

wherein longitudinally translating the cap member along the coupling portion comprises rotating the cap member about the coupling portion.

2. The method 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 method of claim 2 , wherein the cap member further comprises a non-circular drive opening extending from the second end thereof.

4. The method 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 portion to the coupling portion; and

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

5. The method 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 method 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 method of claim 6 , wherein the coupling member is comprised of a bioresorbable material.

8. The method of claim 6 , wherein the end member comprises the externally threaded portion configured to be 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 method of claim 6 , wherein the end member comprises a torque application feature comprising said outer planar surfaces, and said planar surfaces are circumferentially arranged about the end member.

10. A method for inserting an implant, comprising:

positioning a bone fixation device adjacent a first bone;

placing a stabilization wire through the first bone and a second bone adjacent the first bone;

positioning a drill bit over the stabilization wire, wherein the drill bit comprises a cannulated opening configured to receive at least a portion of the stabilization wire;

creating an opening in the first bone and the second bone using the drill bit, wherein the opening comprises a longitudinal axis;

removing at least one of the drill bit and the stabilization wire;

inserting an implant at least partially into the opening using an insertion instrument, wherein at least a portion of the implant contacts the first and second bones;

positioning a groove of a breakaway portion of a coupling portion of the implant between bones, wherein the coupling portion comprises planar surfaces; and

securing a cap to an end of the implant, wherein actuation of the cap increases or decreases a distance between the first and second bones.

11. A method for inserting an implant, comprising:

obtaining the implant, wherein the implant comprises:

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 configured to be threadably coupled within the internally threaded opening of the cap member,

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

engaging the coupling portion with an insertion instrument;

inserting the coupled coupling portion and anchor portion into a patient to position the coupling portion at least partially in a first bone and the anchor portion in a second bone; and

threadably engaging the externally threaded portion of the coupling portion within the internally threaded opening of the cap member and longitudinally translating the cap member along the coupling portion toward the anchor portion to such an extent that the cap member engages the first bone and the implant compresses the first and second bones together,

wherein longitudinally translating the cap member along the coupling portion comprises rotating the cap member about the coupling portion;

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

12. The method of claim 11 , wherein the implant further comprises a tension member.

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 Sep 8, 2021
From: ALLARD, RANDY; DACOSTA, ALBERT; GILL, SEAN; MLADINICH, PETER ANDREW; HUNT, RICHARD DAVID; BONO, FRANK S.; MAJORS, BENJAMIN
To: PARAGON 28, INC.
Reel/Frame 057410/0379 →
Continuity (4)
Continuation 16512807 · Jul 16, 2019
Continuation PCTUS2018057554 · Oct 25, 2018
Provisional Application 62576946 · Oct 25, 2017
Related Publication 20210290281A1 · Sep 23, 2021