IP Library Granted Patent US 11,464,522
Granted Patent B2
US 11,464,522 · App. 17/345,402 · Granted Oct 11, 2022

Distractors having attachable paddles, impaction devices, and methods for use in total ankle replacement

Inventors: Mark Ray Dalton (Austin, TX); Jeffrey Christensen (Everett, WA); Aaron Kannard (Los Angeles, CA); Daniel J. Lee (Denver, CO); Joseph Dogué (Aurora, CO)
Assignee: PARAGON 28, INC.
A61B17/15A61B17/025A61B17/1604A61B17/1682A61B17/1775A61B90/39A61F2/4684A61B2090/3966A61F2/4202
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Quick Facts
Patent No.
US 11,464,522
App. No.
17/345,402
Granted
Oct 11, 2022
Kind
B2
Abstract

A distractor system for use in a joint between two bone surfaces of an anatomical structure includes, for example, distractor and at least one detachable tool comprising a body having a proximal portion and a distal portion, said proximal portion being releasably attachable to at least one of a first end of the distractor and/or a second end of the distractor. The distal portion of the detachable tool being operably positionable in the joint between the two bone surfaces of the anatomical structure. The detachable tools may include a detachable paddle.

Claims (58)

1. A distractor system for use in a joint between two bone surfaces of an anatomical structure, said distractor system comprising:

a first pivotable member having a first user engageable arm and an opposite first end;

a second pivotable member having a second user engageable arm and an opposite second end, said first pivotable member pivotably connected to said second pivotable member between said user engageable arms and said ends;

a first connecting member having a first end and a second end, said first end pivotally connected to said first end of said first pivotable member;

a second connecting member having a first end and a second end, said first end pivotally connected to said second end of said second pivotable member;

a biasing member for biasing said first arm away from said second arm so that said second end of said first connecting member is biased towards said second end of said second connecting member; and

at least one detachable tool comprising a first detachable tool comprising:

a proximal portion comprising a recess configured to facilitate releasable coupling with at least one of said second end of said first connecting member and/or said second end of said second connecting member; and

a distal portion operably positionable in the joint between the two bone surfaces of the anatomical structure,

wherein the distal portion comprises a planar surface and at least one cutting and/or punch pin disposed on the planar surface, each of said at least one cutting and/or punch pin defining a longitudinal axis disposed substantially orthogonally to the planar surface, and

wherein said at least one cutting and/or punch pin comprises longitudinal serrations that extend a distance greater than a radius of the at least one cutting and/or punch pin.

2. The distractor system of claim 1 , wherein said at least one cutting and/or punch pin comprises a plurality of cutting and/or punch pins disposed perpendicular to a longitudinal axis of said distal portion.

3. The distractor system of claim 2 , wherein the distal portion is elongated along a second longitudinal axis, wherein a distal end of the distal portion defines a free end a free end of the at least one detachable tool of the at least one detachable tool along the second longitudinal axis, and wherein the plurality of cutting and/or punch pins are positioned at the distal end of the distal portion.

4. The distractor system of claim 2 , wherein the at least one detachable tool further comprises a tibial trial component comprising a base portion with a distal side and a bone engagement side opposing the distal side, the bone engagement side at least partially corresponding to a tibial implant component of a total ankle replacement prosthesis, wherein the base portion of the tibial trial component comprises a plurality of through holes extending between the distal side and the bone engagement side thereof, and wherein the physical arrangements of the plurality of through holes and the plurality of cutting and/or punch pins correspond to each other.

5. The distractor system of claim 1 , wherein said proximal portion comprises a first longitudinal axis and said distal portion comprises a second longitudinal axis offset from said first longitudinal axis.

6. The distractor system of claim 1 , wherein said distal portion comprises radiographic marker.

7. The distractor system of claim 1 , wherein said at least one detachable tool further comprises a plurality of detachable paddles, a detachable resection guide, and a detachable implant trialing and cutting guide.

8. The distractor system of claim 1 , wherein said second end of said first connecting member comprises a first post, and said second end of said second connecting member comprises a second post.

9. The distractor system of claim 8 , wherein said first post comprises a first axis, said second post comprises a second axis, and said first axis being maintained parallel to said second axis.

10. The distractor system of claim 1 , wherein said second end of said first connecting member comprises a first post having a laterally-extending projection, and said second end of said second connecting member comprises a second post having a laterally-extending projection.

11. The distractor system of claim 1 , further comprising a ratchet pivotally attached to said second arm and selectively releasably attachable to said first arm, and a scissors mechanism for connecting said first connecting member to said second connecting member and operably movably to maintain said first connecting member to be parallel to said second connecting member.

12. The distractor system of claim 1 , wherein said at least one detachable tool is sized for being received between two bone surfaces of an ankle joint.

13. The distractor system of claim 1 , wherein said at least one detachable tool is sized for being received between a tibia and a talus of an ankle joint.

14. The distractor system of claim 1 , wherein the distal portion is elongated along a second longitudinal axis, wherein the at least one cutting and/or punch pin comprises a pair of cutting and/or punch pins that are spaced along a lateral direction that is oriented orthogonally to the second longitudinal axis, and wherein the planar surface extends laterally between the pair of cutting and/or punch pins.

15. The distractor system of claim 1 , wherein the at least one detachable tool further comprises a tibial trial component comprising a base portion with a distal side and a bone engagement side opposing the distal side that is configured to engage a distal tibia, the bone engagement side at least partially corresponding to a tibial implant component of a total ankle replacement prosthesis, and wherein the distal side of the tibial trial component comprises a recess configured to mate with the distal portion of the first detachable tool to couple the first detachable tool and the tibial trial component together.

16. The distractor system of claim 15 , wherein the at least one cutting and/or punch pin of the first detachable tool comprises a plurality of cutting and/or punch pins, wherein the base portion of the tibial trial component comprises a plurality of through holes extending between the distal side and the bone engagement side thereof, and wherein the physical arrangements of the plurality of cutting and/or punch pins and the plurality of through holes correspond to each other such that the plurality of cutting and/or punch pins extend through the plurality of through holes when the first detachable tool and the tibial trial component are coupled together.

17. A surgical method comprising:

providing the distractor of claim 1 ;

attaching the proximal portion of the first detachable tool with the second end of the first connecting member of the distractor or with the second end of the second connecting member of the distractor;

inserting the first detachable tool in the joint between the two bone surfaces of the anatomical structure; and

applying a force to the distractor to force the at least one cutting and/or punch pin of the first detachable tool into one of the two bone surfaces.

18. A distractor system for use in a joint between two bone surfaces of an anatomical structure, said distractor system comprising:

a first pivotable member having a first user engageable arm and an opposite first end;

a second pivotable member having a second user engageable arm and an opposite second end, said first pivotable member pivotably connected to said second pivotable member between said user engageable arms and said ends;

a first connecting member having a first end and a second end, said first end pivotally connected to said first end of said first pivotable member;

a second connecting member having a first end and a second end, said first end pivotally connected to said second end of said second pivotable member;

a biasing member for biasing said first arm away from said second arm so that said second end of said first connecting member is biased towards said second end of said second connecting member; and

at least one detachable tool comprising a first detachable tool comprising a proximal portion and a distal portion, said proximal portion comprising a recess configured to facilitate releasable attachment to at least one of said second end of said first connection member and/or said second end of said second connecting member, said distal portion being operably positionable in the joint between the two bone surfaces of the anatomical structure,

wherein the distal portion comprises a planar surface and at least one cutting and/or punch pin extending proximately from the planar surface on a proximate side of the distal portion, each of said at least one cutting and/or punch pin defining a first longitudinal axis disposed substantially orthogonally to the planar surface,

wherein said distal portion comprises a second longitudinal axis that is orthogonal to the first longitudinal axis, and

wherein a distal side of the distal portion that opposes the proximate side thereof comprises a radiographic marker that extends perpendicular to said second longitudinal axis.

19. The distractor system of claim 18 , wherein said distal portion of said at least one detachable tool comprises a detachable paddle.

20. The distractor system of claim 19 , wherein a surface of said distal portion of said detachable paddle comprises a raised center portion and a recessed peripheral portion.

21. The distractor system of claim 18 , wherein said distal portion of said at least one detachable tool comprises a detachable resection guide.

22. The distractor system of claim 18 , wherein said distal portion of said at least one detachable tool comprises a detachable implant trialing and cutting guide.

23. The distractor system of claim 18 , wherein said proximal portion comprises a first longitudinal axis, and said distal portion comprises a second longitudinal axis offset from said first longitudinal axis.

24. The distractor system of claim 18 , wherein said at least one detachable tool further comprises a plurality of detachable paddles, a detachable resection guide, and a detachable implant trialing and cutting guide.

25. The distractor system of claim 18 , wherein said second end of said first connecting member comprises a first post, and said second end of said second connecting member comprises a second post.

26. The distractor system of claim 25 , wherein said first post comprises a first axis, said second post comprises a second axis, and wherein said first axis is parallel to said second axis.

27. The distractor system of claim 25 , wherein said first post comprises a laterally-extending projection, and said second post comprises a laterally-extending projection.

28. The distractor system of claim 18 , further comprising a ratchet pivotally attached to said second arm and selectively releasably attachable to said first arm, and a scissors mechanism for connecting said first connecting member to said second connecting member and operably movably to maintain said first connecting member to be parallel to said second connecting member.

29. The distractor system of claim 18 , wherein said at least one detachable tool is sized for being received between two bone surfaces of an ankle joint.

30. The distractor system of claim 18 , wherein said at least one detachable tool is sized for being received between a tibia and a talus of an ankle joint.

31. A surgical method comprising:

providing the distractor system of claim 18 ;

attaching the first detachable tool to one of said second end of said first connection member or said second end of said second connecting member; and

inserting the at least one detachable tool in the joint between the bone surfaces of the anatomical structure.

32. The method of claim 31 , further comprising applying a compressive force to the arms of the distractor to separate the two bone surfaces.

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 Aug 11, 2021
From: DALTON, MARK RAY; CHRISTENSEN, JEFFREY; KANNARD, AARON; LEE, DANIEL J.; DOGUÉ, JOSEPH
To: PARAGON 28, INC.
Reel/Frame 057148/0625 →
Continuity (5)
Continuation PCTUS2019066398 · Dec 13, 2019
Provisional Application 62898854 · Sep 11, 2019
Provisional Application 62779436 · Dec 13, 2018
Provisional Application 62779092 · Dec 13, 2018
Related Publication 20210361293A1 · Nov 25, 2021
Cited By (1)
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