Granted Patent B2

US 12,239,538 · App. 17/401,843 · Granted Mar 4, 2025

Inventors: Brian de Beaubien (Fenton, MI); Jude Paganelli (Coronado, CA); Daniel Pflaster (Charlotte, VT); Daivon Deans (San Diego, CA); Ryan Watson (Boulder, CO); Brian Bowman (Carlsbad, CA)

Assignee: Osteal Therapeutics, Inc.

A61F2/30724A61F2/36A61F2/389A61F2/4014A61M1/90A61F2002/3006A61F2002/30672A61F2002/30677

Abstract

Claims (23)

1. A spacer system for treating a patient presenting with a periprosthetic joint infection, the spacer system comprising:

a spacer configured for placement between a first implant and a second implant of a permanent joint prosthesis; and

a catheter, wherein the spacer and catheter are configured for detachable coupling;

wherein the spacer comprises:

a first surface having a convex shape configured for engagement with a corresponding concave shape of the first implant;

a second surface having a concave shape configured for engagement with a corresponding convex shape of the second implant,

an exposed surface disposed between the first surface and the second surface;

a plurality of internal channels extending within the spacer, the plurality of internal channels configured in an array about a center axis of the spacer; and

an inlet through the exposed surface that is configured to detachably couple to the catheter to receive a treatment fluid, the inlet coaxial with a first internal channel of the plurality of internal channels,

wherein the exposed surface of the spacer comprises a first plurality of outlets in fluid communication with the inlet, such that, when the spacer is implanted in the patient, treatment fluid delivered into the inlet flows into the first internal channel of the plurality of internal channels toward the center axis before exiting out through the first plurality of outlets into a joint space between the first implant and the second implant.

2. A spacer system of claim 1 , wherein the spacer system is a hip spacer system, the joint is a hip joint, the first implant is an acetabular cup, and the second implant is a femoral stem comprising a femoral head.

3. A spacer system of claim 1 , wherein the second surface of the spacer comprises a plurality of fluted channels.

4. A spacer system of claim 3 , wherein at least one of the fluted channels comprises a plurality of fluid outlets.

5. A spacer system of claim 3 , wherein the plurality of fluted channels are arrayed about the center axis of the spacer.

6. A spacer system of claim 3 , wherein, when the spacer is implanted, the plurality of fluted channels enables fluid flow under the spacer, between the spacer and the second implant.

7. A spacer system of claim 1 , wherein the spacer is undersized relative to the first implant.

8. A spacer system of claim 1 , wherein the spacer comprises a biocompatible polymer selected from the group consisting of low-density polyethylene (LDPE), high-density polyethylene (HDPE), polypropylene (PP), polyvinyl chloride (PVC) polystyrene (PS) nylon, polytetrafluoroethylene, a thermoplastic polyurethane (TPU), acetyl copolymer, silicone, polyether ether ketone (PEEK), a polyurethane, a biocompatible elastomer, and an ultrahigh molecular weight polyethylene (UHMWPE).

9. The spacer system of claim 1 , wherein the first surface comprises a second plurality of outlets in fluid communication with the inlet and the plurality of internal channels, such that, when the spacer is implanted, treatment fluid delivered into the inlet flows out through the first plurality of outlets into the joint space and out through the second plurality of outlets to the first implant.

10. The spacer system of claim 9 , wherein each internal channel of the plurality of internal channels extends within the spacer and terminates at a respective outlet of either the first plurality of outlets through the exposed surface or the second plurality of outlets through the first surface.

11. The spacer system of claim 1 , wherein the first surface is configured for articulating engagement with the first implant.

12. The spacer system of claim 11 , wherein the second surface of the spacer is configured for articulating engagement with the second implant.

13. The spacer system of claim 1 , wherein the spacer is adapted for temporary placement between said first implant and said second implant of said permanent joint prosthesis.

14. A spacer platform comprising the spacer system of claim 1 and, further comprising a pump assembly configured for coupling to the catheter.

Assignments (2)

Continuity (2)

References Cited (230)