Granted Patent B2

US 12,350,403 · App. 15/774,860 · Granted Jul 8, 2025

Inventors: Ebru Oral (Newton, MA); Jeremy V. Suhardi (Boston, MA); Orhun K. Muratoglu (Cambridge, MA); Henrik Malchau (Cambridge, MA); Harry E. Rubash (Marco Island, FL); Andrew A. Freiberg (Weston, MA)

Assignee: The General Hospital Corporation

A61L27/54A61F2/34A61F2/389A61F2/4081A61L27/04A61L27/16A61L27/26A61F2002/30677A61F2002/30971A61L2300/406A61L2300/428A61L2300/608A61L2300/61A61L2420/02A61L2420/04A61L2420/06A61L2420/08A61L2430/24

Abstract

Claims (29)

1. A method of making an antibiotic-eluting implantable medical device comprising:

a. providing a first UHMWPE (ultra-high molecular weight polyethylene) and a second UHMWPE;

b. blending the first UHMWPE with about 6 wt % to about 8 wt % gentamicin;

c. layering the first UHMWPE blended with gentamicin with the second UHMWPE without gentamicin to form a layered UHMWPEs;

d. direct compression molding the layered UHMWPEs, thereby obtaining the antibiotic-eluting implantable medical device, wherein the medical device is not permanent and removed after use, and wherein the implanted medical device elutes the antibiotic for at least 36 weeks.

2. A method of making an antibiotic-eluting implantable medical device comprising:

a. providing a first UHMWPE (ultra-high molecular weight polyethylene) and a second UHMWPE;

b. blending the first UHMWPE with about 6 wt% to about 8 wt% gentamicin to form a first blended UHMWPE;

c. layering the first blended UHMWPE with the second UHMWPE without gentamicin to form a layered UHMWPEs;

d. direct compression molding the layered UHMWPEs, thereby obtaining the antibiotic-eluting implantable medical device, wherein the medical device is not permanent and removed after use, and wherein the implanted medical device elutes the antibiotic for at least 36 weeks.

3. A method of making an antibiotic-eluting implantable medical device comprising:

a. providing a first UHMWPE (ultra-high molecular weight polyethylene);

b. blending the UHMWPE with about 6 wt % to about 8 wt % gentamicin to form the first blended UHMWPE;

c. providing a second UHMWPE;

d. blending the second UHMWPE with di-cumyl peroxide to form the second blended UHMWPE;

e. layering the first and the second blended UHMWPEs to form a layered UHMWPEs;

f. consolidating the layered UHMWPEs, thereby obtaining the antibiotic-eluting implantable medical device, wherein the medical device is not permanent and removed after use, and wherein the implanted medical device elutes the antibiotic for at least 36 weeks.

4. The method according to claim 1 , wherein the first and the second UHMWPEs are pre-mixed with antioxidant.

5. The method according to claim 1 , wherein the antibiotic-eluting implantable medical device is a tibial insert.

6. The method according to claim 5 , wherein the tibial insert is packaged and sterilized.

7. A method of making a tibial insert comprising:

a. providing a first UHMWPE (ultra-high molecular weight polyethylene) and a second UHMWPE;

b. blending the first UHMWPE with about 6 wt % to about 8 wt % gentamicin;

c. layering the first UHMWPE blended with gentamicin with the second UHMWPE without gentamicin to form a layered UHMWPEs;

d. direct compression molding the layered UHMWPEs, thereby obtaining the tibial insert, wherein the tibial insert is not permanent and removed after use, and wherein the implanted tibial insert elutes the antibiotic for at least 36 weeks.

8. A method of making an antibiotic-eluting implantable medical device comprising:

a. providing a UHMWPE (ultra-high molecular weight polyethylene);

b. blending UHMWPE with about 6 wt % to about 8 wt % gentamicin; and

c. direct compression molding the gentamicin-blended UHMWPE, thereby obtaining the antibiotic-eluting implantable device, wherein the medical device is not permanent and removed after use, and wherein the implanted medical device elutes the antibiotic for at least 36 weeks.

Assignments (1)

Continuity (2)

References Cited (167)