IP Library Granted Patent US 12697416
Granted Patent B2
US 12697416 · App. 17/432,537 · Granted Aug 4, 2026

Reinforced biocompatible scaffold

Inventors: Elizabeth Anne Boughton (Burwood, AU); Philip Boughton (Burwood, AU)
Assignee: Global Surgical Innovations Pty Ltd
A61L27/3834A61L27/446A61L27/48A61L27/54A61L27/56A61L27/58A61L27/60A61L2300/232A61L2300/236A61L2300/252A61L2300/406A61L2300/414A61L2300/64A61L2400/12C12N5/0068C12N5/0602C12N2533/12C12N2533/40
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Quick Facts
Patent No.
US 12697416
App. No.
17/432,537
Granted
Aug 4, 2026
Kind
B2
Abstract

A reinforced biocompatible scaffold facilitates integration of biological tissue. The reinforced scaffold comprises a porous biocompatible scaffold and an arrangement of at least one biocompatible filament embedded within and fixed to the biocompatible scaffold, and/or at least one biocompatible conduit embedded within and fixed to the biocompatible scaffold.

Claims (57)

1 . A method of making a porous biocompatible scaffold, comprising:

providing a composition comprising one or more biocompatible polymer materials, wherein the one or more biocompatible polymer materials comprises solid polycaprolactone and wherein polycaprolactone is present within a range of 10 to 50% w/v;

heating the composition comprising the one or more biocompatible polymer materials to provide a heated at least partially fluid composition comprising the one or more biocompatible polymer materials;

mixing the at least partially fluid composition comprising the one or more biocompatible polymer materials and one or more organic solvents to provide a heated fluid composition;

providing a porogen construct;

combining the porogen construct and the heated fluid composition to form a temporary composite;

immersing the temporary composite in water; and

allowing a membrane to at least partially form on at least part of a surface of the temporary composite;

removing the at least partially formed membrane from the at least part of the surface of the temporary composite;

allowing ingress of water substantially throughout the temporary composite;

allowing coagulation of the at least one or more biocompatible polymer materials within the porogen construct to form a coagulated scaffold;

removing the water, porogen construct, and one or more solvents from the temporary composite to provide a scaffold having a hierarchical interconnected porosity, wherein the scaffold has a porosity within the range of 30 to 95% of the volume of the scaffold; and

introducing an arrangement of one or more biocompatible filaments and/or at least one biocompatible conduit into the scaffold to reinforce the porous scaffold,

wherein the at least one biocompatible conduit has a first open end and a second open end, the at least one biocompatible conduit is embedded such that the first open end is at a surface of the scaffold to enable filling of the conduit with a substance, and

wherein the second open end is sealed during a surgery to enable drug elution.

2 . The method of claim 1 , wherein the organic solvent is acetone and mixing the heated polycaprolactone and organic solvent to provide a mixture having a proportion of approximately 17% w/w concentration of polycaprolactone.

3 . The method of claim 1 , further including:

heating the coagulated scaffold at a temperature just under the melting temperature of the scaffold such that the outer surfaces of the scaffold are softened; and

coating the coagulated scaffold with bioactive glass powder.

4 . The method of claim 3 , wherein the bioactive glass powder has a diameter within the range of 10 μm to 15 μm.

5 . The method of claim 1 , wherein the one or more filaments and/or the at least one biocompatible conduit is helical.

6 . The method of claim 5 , further including embedding the one or more biocompatible filaments and/or at least one biocompatible conduit within the biocompatible scaffold, and fusing the one or more biocompatible filaments and/or at least one biocompatible conduit within the scaffold.

7 . The method of claim 6 , wherein embedding the one or more biocompatible filament and/or the at least one biocompatible conduit comprises:

providing a helical wire substantially identical in shape and size to the at least one helical filament or conduit, the helical wire having a first end and a second end;

attaching one end of a helical biocompatible filament to the second end of the helical wire;

rotatably inserting the helical wire into the scaffold to create a helical channel to house the biocompatible filament within the scaffold;

removing the helical wire from the scaffold by continuing to rotate the helical wire through the scaffold until the path is filled with the biocompatible filament and the helical wire is out of the scaffold; and

detaching the helical wire from the biocompatible filament.

8 . The method of claim 6 , wherein fusing the one or more biocompatible filaments to the scaffold to fix each filament within the scaffold includes solvent welding using a solution comprising acetone and polycaprolactone.

9 . The method of claim 5 , wherein fusing each filament or conduit to the scaffold to fix each filament or conduit within the scaffold includes spot welding the filament by applying water or saline at a temperature within the range of 60 degrees Celsius to 70 degrees Celsius to each filament or conduit.

10 . The method of claim 1 , wherein the porosity of the biocompatible scaffold comprises an interconnected porous structure comprising a distribution of macropores, mesopores and nanopores.

11 . A method of making a porous biocompatible scaffold, comprising:

providing a composition comprising one or more biocompatible polymer materials, wherein the one or more biocompatible polymer materials comprises solid polycaprolactone and wherein polycaprolactone is present within a range of 10 to 50% w/v;

heating the composition comprising the one or more biocompatible polymer materials to provide a heated at least partially fluid composition comprising the one or more biocompatible polymer materials;

mixing the heated at least partially fluid composition comprising the one or more biocompatible polymer materials and one or more organic solvents to provide a heated fluid composition;

providing a porogen construct;

combining the porogen construct and the heated fluid composition to form a temporary composite;

immersing the temporary composite in water;

allowing a membrane to at least partially form on at least part of a surface of the temporary composite;

removing the at least partially formed membrane from the at least part of the surface of the temporary composite;

allowing ingress of water substantially throughout the temporary composite;

allowing coagulation of the at least one or more biocompatible polymer materials within the porogen construct;

removing the water, porogen construct, and one or more solvents from the temporary composite to provide a scaffold having a hierarchical interconnected porosity, wherein the scaffold has a porosity within the range of 30 to 95% of the volume of the scaffold;

introducing an arrangement of one or more biocompatible filaments and/or at least one biocompatible conduit into the scaffold to reinforce the porous scaffold, wherein the one or more filaments and/or the at least one biocompatible conduit is helical; and

embedding the one or more biocompatible filaments and/or at least one biocompatible conduit within the biocompatible scaffold, and fusing the one or more biocompatible filaments and/or at least one biocompatible conduit within the scaffold,

wherein embedding the one or more biocompatible filament and/or the at least one biocompatible conduit comprises:

providing a helical wire substantially identical in shape and size to the at least one helical filament or conduit, the helical wire having a first end and a second end;

attaching one end of a helical biocompatible filament to the second end of the helical wire;

rotatably inserting the helical wire into the scaffold to create a helical channel to house the biocompatible filament within the scaffold;

removing the helical wire from the scaffold by continuing to rotate the helical wire through the scaffold until the path is filled with the biocompatible filament and the helical wire is out of the scaffold; and

detaching the helical wire from the biocompatible filament.

12 . The method of claim 11 , wherein the organic solvent is acetone and mixing the heated polycaprolactone and organic solvent to provide a mixture having a proportion of approximately 17% w/w concentration of polycaprolactone.

13 . The method of claim 11 , further including:

heating the coagulated scaffold at a temperature just under the melting temperature of the scaffold such that the outer surfaces of the scaffold are softened; and

coating the coagulated scaffold with bioactive glass powder.

14 . The method of claim 13 , wherein the bioactive glass powder has a diameter within the range of 10 μm to 15 μm.

15 . The method of claim 11 , wherein the porosity of the biocompatible scaffold comprises an interconnected porous structure comprising a distribution of macropores, mesopores and nanopores.