IP Library Granted Patent US 12,575,819
Granted Patent B2
US 12,575,819 · App. 18/061,693 · Granted Mar 17, 2026

Soft tissue implant systems, instruments, and related methods

Inventors: Kyle Hartson (Denver, CO); Paul Devasconcellos (Parker, CO)
Assignee: Paragon 28, Inc.
A61B17/0401A61B2017/0409A61B2017/0464
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Quick Facts
Patent No.
US 12,575,819
App. No.
18/061,693
Granted
Mar 17, 2026
Kind
B2
Abstract

The present disclosure relates to instruments, implant systems, and methods for joining bone and/or tissue portions. The instrument includes a handle portion; an inserter portion comprising an insertion portion and a tip portion; a guide portion comprising a medial end component and a distal end component, the guide portion extending from a distal end portion of the handle portion to a bone engagement end of the inserter portion; a passageway extending through the inserter portion from the distal end of the handle portion to the bone engagement end of the inserter portion; and a hole that extends from an exterior surface of the handle portion and the guide portion to the passageway, wherein the insertion portion and the tip portion of the inserter portion are positioned past the distal end component of the guide portion when the handle portion, the inserter portion, and the guide portion are mated.

Claims (46)

1 . A bone and/or tissue joining system, comprising:

an instrument system for implanting a bone and/or tissue joining implant system, comprising:

a handle portion;

an inserter portion comprising an insertion portion extending from a distal handle end portion of the handle portion to a tip portion that defines a free end of the inserter portion; and

a guide portion comprising a proximal end portion, a distal end portion and a passageway extending through the guide portion between the medial and distal end portions,

wherein the guide portion and the inserter portion are mated such that the inserter portion extends through the passageway of the guide portion and the guide portion is freely slidably received on the inserter portion,

wherein the guide portion and inserter portion are configured such that in a pre-implant arrangement thereof, the tip portion of the inserter portion is positioned past the distal end portion of the guide portion,

wherein the tip portion comprises a pair of grooves extending proximally from a forked free end,

wherein the distal end portion of the guide portion comprises a distal engagement portion that is narrower than a proximal portion of the distal end portion of the guide portion, wherein the distal engagement portion of the distal end portion of the guide portion extends about and engages an exterior surface of the inserter portion, and the proximal portion of the distal end portion is spaced from the exterior surface of the inserter portion.

2 . The system according to claim 1 , wherein the forked free end comprises a pair of tines and a base portion extending therebetween.

3 . The system according to claim 2 , wherein the pair of grooves extend proximally from portions of the base portion between the pair of tines.

4 . The system according to claim 1 , wherein the pair of grooves are positioned on substantially opposing sides of the insertion portion.

5 . The system according to claim 1 , wherein at least one tine of the pair of tines forms a bone engaging tooth with a pointed tip.

6 . The system according to claim 1 , wherein the guide portion further comprises a guide handle extending laterally from the insertion portion.

7 . The system according to claim 1 , wherein the guide portion and inserter portion are configured such that in the pre-implant arrangement thereof, the proximal end portion of the guide portion is positioned distally of the distal handle end portion of the handle portion.

8 . The system according to claim 1 , wherein the guide portion and the inserter portion are mated such that the guide portion is freely slidable off the inserter portion by translating distally over the tip portion.

9 . The system according to claim 1 , further comprising the bone and/or tissue joining implant system, the bone and/or tissue joining implant system comprising a first soft bone anchor mounted on the forked free end.

10 . The system according to claim 9 , wherein the first soft bone anchor extends over the forked free end and along the pair of grooves.

11 . The system according to claim 9 , wherein the bone and/or tissue joining implant system further comprises at least one suture member extending through the first soft bone anchor in a configuration that deforms the first soft bone anchor.

12 . The system according to claim 11 , wherein the handle portion comprises a first groove that extends along a length of handle portion and is in communication with a second groove that extends about a portion of the handle portion.

13 . The system according to claim 12 , wherein the first soft bone anchor extends over the forked free end and along the pair of grooves.

14 . The system according to claim 13 , wherein the forked free end comprises a pair of tines and a base portion extending therebetween, and wherein a medial portion of the first soft bone anchor extends over the base portion and end portions of the first soft bone anchor extend along the pair of grooves.

15 . The system according to claim 11 , wherein the bone and/or tissue joining implant system further comprises a second soft bone anchor, and wherein the at least one suture member extends through the second soft bone anchor in a configuration that deforms the second soft bone anchor via tensioning of the at least one suture member.

16 . A method of forming a bone and/or tissue joining implant system, the method comprising:

obtaining an instrument system for implanting a bone and/or tissue joining implant system, the instrument system comprising:

a handle portion;

an inserter portion comprising an insertion portion extending from a distal handle end portion of the handle portion to a tip portion that defines a free end of the inserter portion; and

a guide portion comprising a proximal end portion, a distal end portion and a passageway extending through the guide portion between the medial and distal end portions,

wherein the guide portion and the inserter portion are mated such that the inserter portion extends through the passageway of the guide portion and the guide portion is freely slidably received on the inserter portion,

wherein the guide portion and inserter portion are configured such that in a pre-implant arrangement thereof, the tip portion of the inserter portion is positioned past the distal end portion of the guide portion,

wherein the tip portion comprises a pair of grooves extending proximally from a forked free end, and

wherein the distal end portion of the guide portion comprises a distal engagement portion that is narrower than a proximal portion of the distal end portion of the guide portion, wherein the distal engagement portion of the distal end portion of the guide portion extends about and engages an exterior surface of the inserter portion, and the proximal portion of the distal end portion is spaced from the exterior surface of the inserter portion; and

mounting a first soft bone anchor of the bone and/or tissue joining implant system on the forked free end, the bone and/or tissue joining implant system further comprising at least one suture member extending through the first soft bone anchor in a configuration that deforms the first soft bone anchor via tensioning of the at least one suture member.

17 . A bone and/or tissue joining system, comprising:

an instrument system for implanting a bone and/or tissue joining implant system, comprising:

a handle portion;

an inserter portion comprising an insertion portion extending from a distal handle end portion of the handle portion to a tip portion that defines a free end of the inserter portion; and

a guide portion comprising a proximal end portion, a distal end portion and a passageway extending through the guide portion between the medial and distal end portions,

wherein the guide portion and the inserter portion are mated such that the inserter portion extends through the passageway of the guide portion and the guide portion is freely slidably received on the inserter portion,

wherein the guide portion and inserter portion are configured such that in a pre-implant arrangement thereof, the tip portion of the inserter portion is positioned past the distal end portion of the guide portion,

wherein the tip portion comprises a pair of grooves extending proximally from a forked free end,

wherein the inserter portion comprises a second passageway through the insertion portion from the distal handle end portion of the handle portion to the tip portion, and

wherein the guide portion extends from a distal end portion of the handle portion to the tip portion of the inserter portion.

18 . The system according to claim 17 , wherein the distal end portion of the guide portion comprises a distal engagement portion that is narrower than a proximal portion thereof.

19 . The system according to claim 18 , wherein the distal engagement portion extends about and engages an exterior surface of the inserter portion, and the proximal portion of the distal end portion of the guide portion is spaced from the exterior surface of the inserter portion.

20 . The system according to claim 17 , wherein the handle portion comprises a hole that extends from an exterior surface of the handle portion to the second passageway.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 18, 2026
From: HARTSON, KYLE; DEVASCONCELLOS, PAUL
To: PARAGON 28, INC.
Reel/Frame 073823/0631 →
RELEASE OF SECURITY INTEREST Recorded Apr 22, 2025
From: ARES CAPITAL CORPORATION
To: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
Reel/Frame 070908/0038 →
SECURITY INTEREST Recorded Nov 2, 2023
From: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
To: ARES CAPITAL CORPORATION
Reel/Frame 065448/0214 →
Continuity (3)
Continuation PCTUS2021034769 · May 28, 2021
Provisional Application 63034066 · Jun 3, 2020
Related Publication 20230115148A1 · Apr 13, 2023
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