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US 12,751,751 B2Granted
Temporary antimicrobial cement spacer, assembly, kit, and method of manufacture
AssigneeDePuy Synthes Products, Inc.
InventorsGeoffrey Navarro Vale, Charles Florek, David A. Armbruster, Stanley J. Kmiec, Jr., Eric M. Cozzone, Junior Julien, Michael Good
Life of this patent
Estimating the term…
Abstract
The present disclosure is directed to temporary antimicrobial-eluting cement spacer implants, and assemblies, kits, and methods for forming the same. Particularly preferred disclosures are to modular spacers, assemblies, and kits, as well as methods of manufacturing the same, where the modular nature of the spacer permits the selection of specific desired length spacers, as well as specific selection of antimicrobial compounds and dosages, along with the components and processes for forming the same.
Claims16
A mold assembly for forming a temporary cement spacer, comprising:
- a spacer core comprising:
- a rod defining a central axis of the mold assembly and having a proximal rod end and a distal rod end opposite the proximal rod end along the central axis, the rod further defining an outer rod surface extending between the proximal rod end and the distal rod end;
- a locking component defining a distal locking end and a proximal locking end opposite the distal locking end along the central axis, the distal locking end attached to the rod at the proximal rod end, the locking component further defining at least one locking bore extending through the locking component in a radial direction with respect to the central axis, the at least one locking bore configured to receive a locking screw;
- and,
- a mold body extending along the central axis, the mold body defining a proximal mold end and a distal mold end opposite the proximal mold end along the central axis, the proximal mold end including a proximal mold opening and the distal mold end including a distal mold opening, wherein the mold body defines an inner mold surface extending between the proximal mold opening and the distal mold opening, the inner mold surface defines a mold lumen, and the spacer core is disposed within the mold lumen such that the locking component is disposed within the mold lumen at the proximal mold end;
- at least one bore plug disposed in the at least one locking bore;
- and,
- an adapter configured to operably couple to the mold body at the distal mold end, the adapter configured to operably couple the mold body to a bone cement injection device so as to provide a fluid pathway from the bone cement injection device through the distal mold opening to the mold lumen.
5 more elements
A kit for forming a temporary cement spacer, comprising:
- at least one rod defining a proximal rod end and a distal rod end opposite the proximal rod end;
- a locking component configured to operably couple to the rod, the locking component defining a distal locking end and a proximal locking end opposite the distal locking end, the distal locking end configured to attach to the rod at the proximal rod end, the locking component further defining at least one locking bore extending through the locking component and configured to receive a locking screw, wherein the at least one rod and the locking component are configured to form a spacer core when operably coupled;
- at least one bore plug configured to be removably disposed within the at least one locking bore;
- a mold body defining a proximal mold end and a distal mold end opposite the proximal mold end and an outer mold surface extending from the proximal mold end and the distal mold end, the mold body further defining a proximal mold opening at the proximal mold end and a distal mold opening at the distal mold end and an inner mold surface extending between the proximal mold opening and distal mold opening, the inner mold surface defining a mold lumen extending therebetween, wherein the spacer core is configured to be disposed in the mold lumen;
- an adapter configured to operably couple to the mold body at the distal mold end, wherein the adapter is further configured to couple a bone cement injection device to the distal mold opening so as to provide a fluid pathway from the cement injection device to the mold lumen;
- and,
- a cap configured to operably couple to the distal rod end.
4 more elements
A method of preparing an antimicrobial-eluting temporary cement spacer, the method comprising:
- inserting a spacer core into a lumen of a mold body, the spacer core including a rod and a locking component connected to the rod, wherein the locking component includes at least one locking bore;
- coupling a bone cement injection device to the mold body via an adapter to provide a fluid pathway from the bone cement injection device into the lumen of the mold body;
- disposing at least one bore plug into the at least one locking bore;
- injecting bone cement material including one or more antimicrobial agents into the lumen of the mold body through the fluid pathway and along at least a portion of an outer surface of the rod;
- curing the bone cement material on the outer surface of the rod so as to form a cement coating on the spacer core, thereby forming the antimicrobial eluting temporary cement spacer;
- decoupling the bone cement injection device from the mold body;
- removing the at least one bore plug from the at least one locking bore;
- and,
- separating the mold body from the antimicrobial eluting temporary cement spacer.
6 more elements
Dependencies are inferred from the claim text.