IP Library Granted Patent US 11,992,412
Granted Patent B2
US 11,992,412 · App. 17/198,075 · Granted May 28, 2024

Radial head fracture treatment system

Inventors: Alan G. Taylor (Memphis, TN); Rebecca Hawkins Wahl (Escondido, CA)
Assignee: In2Bones USA, LLC
A61F2/3804A61B17/92A61F2/4605A61F2/4684A61B2017/922A61F2002/30607A61F2002/3827
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Quick Facts
Patent No.
US 11,992,412
App. No.
17/198,075
Granted
May 28, 2024
Kind
B2
Abstract

A system and methods are provided for treating radial head fractures. The system includes an implant, a sterile instrument kit for radial head arthroplasty, and a head sizer and assembly tray for sizing and assembling implants. The implant includes a head that is coupled with a stem. The head is adapted to be placed into sliding contact with a capitellum of the radiocapitellar joint. The stem is configured to be inserted into a hole reamed into a medullary canal of the radial head. The sterile instrument kit comprises a multiplicity of instruments including any one or more of trial heads and trial stems, a starter awl, a reamer, a planar, an inserter cap, and an impactor. The instruments are configured for implanting the implant into the radiocapitellar joint such that the implant restores biomechanical properties of the joint.

Claims (41)

1. A system for treating radial head fractures, the system comprising:

one or more implants configured for radial head arthroplasty;

one or more sterile instrument kits comprising a multiplicity of instruments including any one or more of trial heads and trial stems, a starter awl, a reamer, a planar, an inserter cap, and an impactor, the multiplicity of instruments being configured for implanting the one or more implants into a patient's body such that the implant restores biomechanical properties of the native radial head;

a head sizer and assembly tray configured to correspond to sizes of the one or more implants;

wherein the inserter cap is configured to be coupled with the planar for pushing any one of the one or more implants into a radial head medullary hole during a radial head arthroplasty;

wherein the inserter cap comprises a central hole and a smooth distal surface, the central hole adapted to receive a distal stem extending from the planar wherein the inserter cap is removably fixated onto the planar; and

wherein the distal surface is configured to be pressed against the any one of the one or more implants.

2. The system of claim 1 , wherein the one or more implants each includes a head that is coupled with a stem.

3. The system of claim 2 , wherein the head is a cylindrical member comprising:

a rounded periphery comprising a smooth surface configured to contact bone and tissues surrounding a radiocapitellar joint without causing damage or trauma to the bone and tissues;

a contact surface adapted to be placed into sliding contact with a capitellum comprising the radiocapitellar joint; and

a tapered bore configured to fixedly receive a tapered shank comprising the stem.

4. The system of claim 2 , wherein the stem is an elongate member configured to be inserted into a hole reamed into a medullary canal of a radial head and comprises:

a tapered shank configured to be fixated within a tapered bore of the head; and

a tapered tip configured to facilitate inserting the stem into the hole.

5. The system of claim 1 , wherein the starter awl comprises a proximal handle coupled with a shaft that terminates at a distal tip and is configured for creating an opening in a radial head medullary canal during a radial head arthroplasty.

6. The system of claim 5 , wherein the proximal handle comprises a biocompatible plastic that is injection molded onto the shaft during manufacturing the starter awl.

7. The system of claim 1 , wherein the reamer comprises a proximal handle coupled with a shaft that terminates at a distal cutting teeth area and is configured to be used to form a hole in a radial head medullary canal during a radial head arthroplasty.

8. The system of claim 7 , wherein the proximal handle comprises a biocompatible plastic that is injection molded onto the shaft during manufacturing the reamer.

9. The system of claim 1 , wherein the planar comprises a proximal handle coupled with a shaft that includes planar cutting teeth and a distal stem, the planar being configured to facilitate forming a smooth contact surface on a radial neck during a radial head arthroplasty.

10. The system of claim 9 , wherein the proximal handle is configured to be grasped in a hand during inserting the distal stem into a radial head medullary hole and during twisting the planar to cut the smooth contact surface into the radial neck.

11. The system of claim 9 , wherein the proximal handle comprises a biocompatible plastic that is injection molded onto the shaft during manufacturing the planar.

12. The system of claim 1 , wherein the head sizer and assembly tray is configured to facilitate determining a suitable diameter of a head comprising the one or more implants to be implanted during a radial head arthroplasty.

13. The system of claim 12 , wherein the tray comprises a flat member including multiple sizer portions, each of the multiple sizer portions including a circular depression having a diameter corresponding to a specific diameter of the head.

14. The system of claim 13 , wherein the diameter is displayed by way of a size indicator within the circular depression.

15. The system of claim 13 , wherein the head sizer and assembly tray is configured to facilitate assembling the one or more implants to be implanted.

16. The system of claim 1 , wherein the impactor is a generally cylindrical member having a concentric hole and a flat surface disposed at each of opposite ends of the impactor.

17. The system of claim 16 , wherein the concentric hole is configured to receive a portion of a stem comprising the one or more implants; and wherein the flat surface is configured to be struck with a mallet to push the stem into a head comprising the one or more implants.

18. The system of claim 17 , wherein the concentric hole at one end of the impactor has a first depth suitable for receiving a standard size stem and the concentric hole at the opposite end of the impactor has a second depth suitable for receiving a longer size stem.

19. A method for a radial head fracture treatment system, the method comprising:

configuring one or more implants for radial head arthroplasty;

configuring a head sizer and assembly tray to correspond to sizes of the one or more implants; and

assembling a sterile instrument kit comprising a multiplicity of instruments including any one or more of trial heads and trial stems, a starter awl, a reamer, a planar, an inserter cap, and an impactor, the multiplicity of instruments being configured for implanting the one or more implants into a patient's body such that the implant restores biomechanical properties of the native radial head;

coupling the inserter cap with the planar for pushing any one of the one or more implants into a radial head medullary hole during a radial head arthroplasty;

providing the inserter cap with a central hole and a smooth distal surface, the central hole adapted to receive a distal stem extending from the planar wherein the inserter cap is removably fixated onto the planar; and

configuring the distal surface to be pressed against the any one of the one or more implants.

20. The method of claim 19 , wherein assembling the sterile instrument kit includes manufacturing any one or more of the starter awl, the reamer, and the planar by injection molding a proximal handle comprising a biocompatible plastic onto a shaft to form an instrument for performing the radial head arthroplasty.

21. The method of claim 20 , wherein assembling further comprises:

storing the one or more implants in a first sterile container;

storing any one or more of the multiplicity of instruments in a second sterile container; and

storing the head sizer and assembly tray in a third sterile container.

Assignments (6)
SECURITY INTEREST Recorded Jul 21, 2025
From: CONMED CORPORATION; BIOREZ, INC.; BUFFALO FILTER LLC; IN2BONES USA, LLC; LINVATEC CORPORATION; SURGIQUEST, INC.; VIKING SYSTEMS, INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 072097/0762 →
CORRECTIVE ASSIGNMENT TO CORRECT THE CORRECT THE ASSIGNOR INFORMATION FROM IN2BONES GLOBAL, INC. TO IN2BONES USA, LLC PREVIOUSLY RECORDED AT REEL: 69665 FRAME: 701. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Jan 7, 2025
From: IN2BONES USA, LLC
To: MEDARTIS AG
Reel/Frame 069837/0219 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 23, 2024
From: IN2BONES GLOBAL, INC.
To: MEDARTIS AG
Reel/Frame 069665/0701 →
NOTICE OF PARTIAL TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENT RIGHTS Recorded Aug 20, 2024
From: JPMORGAN CHASE BANK, N.A.
To: IN2BONES USA, LLC
Reel/Frame 068725/0198 →
SECURITY INTEREST Recorded Aug 10, 2022
From: IN2BONES USA, LLC
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 061144/0169 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 19, 2022
From: TAYLOR, ALAN G.; WAHL, REBECCA HAWKINS
To: IN2BONES USA, LLC
Reel/Frame 059641/0755 →